GBIHC274MR Stem Cell Therapy Market in Asia-Pacific to 2018 … · 10.6 ES Cells International...

Stem Cell Therapy Market in Asia-Pacific to 2018 Commercialization Supported by Favorable Government Policies, Strong Pipeline and Increased Licensing Activity

GBI Research Report Guidance

GBIHC274MR / Published DEC 2012

© GBI Research. This is a licensed product and is not to be photocopied

GBI Research Report Guidance

The second chapter provides an introduction to the stem cell therapy market in Asia-Pacific.

Chapter three provides an introduction and market characterization and forecasts. The chapter includes revenue forecasts, cost of therapy, share of autologous and allogeneic stem cell therapy, and the patient pool. The section also details the key drivers and barriers affecting the stem cell therapy market in Asia-Pacific.

Chapter four provides an introduction, regulatory landscape and market characterization and forecasts for CABG, LSCT and type 2 DM. It includes forecasts for the cost of therapy and patient pool from 2012-2018 for the three indications. The chapter also includes key drivers and barriers affecting the stem cell therapy market in India.

Chapter five provides an introduction, regulatory landscape and market characterization and forecasts for type 1 DM. It includes forecasts for the cost of therapy and patient pool from 2012-2018. The chapter also includes key drivers and barriers affecting the stem cell therapy market in China.

Chapter six provides an introduction, regulatory landscape and market characterization and forecasts for steroid refractory aGvHD. It includes forecasts for the cost of therapy and patient pool from 2012-2018. The chapter also includes key drivers and barriers affecting the stem cell therapy market in Japan.

Chapter seven provides an introduction, regulatory landscape and key drivers and barriers affecting the stem cell therapy market in Singapore.

Chapter eight provides an introduction, regulatory landscape and market characterization and forecasts for Cupistem, Hearticellgram-Acute Myocardial Infarction (HCG-AMI), Cartistem and Cerecellgram (CCG). It includes forecasts for the cost of therapy and patient pool from 2012-2018 for these products. The section also includes key drivers and barriers affecting the stem cell therapy market in South Korea.

Chapter nine provides pipeline analysis by phase, sponsors/collaborators and country. The section contains a list of stem cell molecules analyzed by phase.

Chapter 10 provides company profiles of nine companies.

Chapter 11 provides detailed descriptions of major M&A, licensing and co-developmental deals


© GBI Research. This is a licensed product and is not to be photocopied

Stem Cell Therapy Market in Asia-Pacific to 2018 - Executive Summary

Stem Cell Therapy Market in Asia-Pacific to 2018 - Executive Summary

The Stem Cell Therapy Market in Asia-Pacific is in its Nascent Stage, but is Poised for Significant Growth in the Forecast Period

The stem cell therapy market was valued at $XXm in 2012, and is projected to grow at a Compound Annual Growth Rate (CAGR) of XX% from 2012 to 2018, to attain a value of $XXm in 2018. The following graph shows the forecast revenues for the stem cell therapy market in Asia-Pacific.

Stem Cell Therapy Market in Asia-Pacific to 2018, Revenue Forecasts ($m), 2012-2018

2012 2013 2014 2015 2016 2017 2018

Rev

enue

s ($

m)

CAGR (2012–2018) - XX%

Anticipated launch of CCG in 2015 to increase stem cell therapy market revenues

Anticipated launch of JR-031 for steroid refractory aGvHD to increase the revenues

Source: GBI Research; GBI Research Proprietary Database [Accessed August 10, 2012]

The market is poised for significant growth in the forecast period due to the anticipated launch of JCR Pharmaceuticals’ JR-031 (2014) in Japan and FCB Pharmicell’s Cerecellgram (CCG) (2015) in South Korea.

The stem cell therapy market is poised to offer significant contributions in the forecast period, because of renewed interest by the respective governments of India, China, Japan, South Korea and Singapore to provide cures for a range of diseases. The growth in the stem cell therapy market will not only provide treatment options but will also contribute significantly to the countries’ Gross Domestic Product (GDP). The importance of stem cell therapy can be elucidated from the statement made by the President of South Korea in 2011, who stated that the stem cell field is a “new growth engine” for the nation’s economy.

The stem cell therapy market was valued at $XXm in 2012, and is projected to grow at a Compound Annual Growth Rate (CAGR) of XX% from 2012 to 2018, to attain a value of XXm in 2018


Page 5 © GBI Research. This is a licensed product and is not to be photocopied

Table of Contents

1 Table of Contents

1 Table of Contents................................................................................................................................. 5 1.1 List of Tables............................................................................................................................. 9 1.2 List of Figures...........................................................................................................................12

2 Stem Cell Therapy Market in Asia-Pacific to 2018 - Introduction...........................................................14 3 Stem Cell Therapy Market in Asia-Pacific to 2018 - Overview ...............................................................15

3.1 Introduction ............................................................................................................................15 3.2 Market Characterization and Forecasts - Overview ...................................................................16

3.2.1 Revenue Forecasts ...........................................................................................................16 3.2.2 Cost of Therapy................................................................................................................17 3.2.3 Allogeneic and Autologous Share......................................................................................18 3.2.4 Stem Cell Therapy Patient Pool .........................................................................................19

3.3 Drivers and Barriers .................................................................................................................20 3.3.1 Drivers.............................................................................................................................21 3.3.2 Barriers............................................................................................................................21

4 Stem Cell Therapy Market in Asia-Pacific to 2018 - India ......................................................................22 4.1 Introduction ............................................................................................................................22 4.2 Regulatory Landscape..............................................................................................................22 4.3 Market Characterization and Forecasts - Overview ...................................................................23

4.3.1 Revenue Forecasts ...........................................................................................................23 4.3.2 Cost of Therapy................................................................................................................24 4.3.3 Stem Cell Patient Pool ......................................................................................................24

4.4 CABG Market Characterization and Forecasts ...........................................................................25 4.4.1 Introduction.....................................................................................................................25 4.4.2 Revenue Forecasts ...........................................................................................................25 4.4.3 Cost of Therapy................................................................................................................26 4.4.4 Stem Cell Patient Pool ......................................................................................................27

4.5 Type 2 DM Market Characterization and Forecasts ...................................................................28 4.5.1 Introduction.....................................................................................................................28 4.5.2 Revenue Forecasts ...........................................................................................................29 4.5.3 Cost of Therapy................................................................................................................30 4.5.4 Stem Cell Patient Pool ......................................................................................................31

4.6 LSCT Market Characterization and Forecasts.............................................................................32 4.6.1 Introduction.....................................................................................................................32 4.6.2 Revenue Forecasts ...........................................................................................................32 4.6.3 Cost of Therapy................................................................................................................33 4.6.4 Stem Cell Patient Pool ......................................................................................................34

5 Stem Cell Therapy Market in Asia-Pacific to 2018 - China .....................................................................35 5.1 Introduction ............................................................................................................................35 5.2 Regulatory Landscape..............................................................................................................35 5.3 Market Characterization and Forecasts - Overview ...................................................................36

5.3.1 Type 1 DM Market Characterization and Forecasts ...........................................................36 6 Stem Cell Therapy Market in Asia-Pacific to 2018 - Japan .....................................................................40

6.1 Introduction ............................................................................................................................40 6.2 Regulatory Landscape..............................................................................................................40 6.3 Steroid Refractory aGvHD Market Characterization and Forecasts.............................................42

6.3.1 Overview .........................................................................................................................42 6.3.2 Revenue Forecasts ...........................................................................................................43 6.3.3 Cost of Therapy................................................................................................................44 6.3.4 Stem Cell Patient Pool ......................................................................................................45

7 Stem Cell Therapy Market in Asia-Pacific to 2018 - Singapore...............................................................46



Table of Contents

7.1 Introduction ............................................................................................................................46 7.2 Regulatory Landscape..............................................................................................................46

7.2.1 Ethical, Legal and Social Issues in Human Stem Cell Research, Reproductive and Therapeutic Cloning (June 2002)..........................................................................................................47

7.2.2 Human Tissue Research (November 2002) ........................................................................48 7.2.3 Research Involving Human Subjects (November 2004).......................................................49 7.2.4 Genetic Testing and Genetic Research (November 2005) ...................................................50 7.2.5 Personal Information in Biomedical Research (May 2007) .................................................51 7.2.6 Donation of Human Eggs for Research (November 2008)...................................................51 7.2.7 Human-Animal Combinations in Stem Cell Research (September 2010)..............................51

8 Stem Cell Therapy Market in Asia-Pacific to 2018 - South Korea ...........................................................52 8.1 Introduction ............................................................................................................................52 8.2 Regulatory Landscape..............................................................................................................52 8.3 Market Characterization and Forecasts - Overview ...................................................................54

8.3.1 Revenue Forecasts ...........................................................................................................54 8.3.2 Cost of Therapy................................................................................................................56 8.3.3 Stem Cell Patient Pool ......................................................................................................57

8.4 Cupistem Market Characterization and Forecasts .....................................................................58 8.4.1 Overview .........................................................................................................................58 8.4.2 Revenue Forecasts ...........................................................................................................59 8.4.3 Cost of Therapy................................................................................................................60 8.4.4 Stem Cell Patient Pool ......................................................................................................61

8.5 HCG-AMI Market Characterization and Forecasts .....................................................................62 8.5.1 Overview .........................................................................................................................62 8.5.2 Revenue Forecasts ...........................................................................................................63 8.5.3 Cost of Therapy................................................................................................................64 8.5.4 Stem Cell Patient Pool ......................................................................................................65

8.6 Cartistem Market Characterization and Forecasts.....................................................................66 8.6.1 Overview .........................................................................................................................66 8.6.2 Revenue Forecasts ...........................................................................................................67 8.6.3 Cost of Therapy................................................................................................................68 8.6.4 Stem Cell Patient Pool ......................................................................................................69

8.7 CCG Market Characterization and Forecasts .............................................................................70 8.7.1 Overview .........................................................................................................................70 8.7.2 Revenue Forecasts ...........................................................................................................70 8.7.3 Cost of Therapy................................................................................................................71 8.7.4 Stem Cell Patient Pool ......................................................................................................72

9 Stem Cell Therapy Market in Asia-Pacific to 2018 - Pipeline Analysis.....................................................73 9.1 Pipeline Analysis by Phase........................................................................................................73 9.2 Pipeline Analysis by Sponsors/Collaborators.............................................................................74 9.3 Pipeline Analysis by Country.....................................................................................................75

9.3.1 India Stem Cell R&D Pipeline.............................................................................................76 9.3.2 China Stem Cell R&D Pipeline............................................................................................78 9.3.3 Japan Stem Cell R&D Pipeline ...........................................................................................82 9.3.4 Singapore Stem Cell R&D Pipeline.....................................................................................86 9.3.5 South Korea Stem Cell R&D Pipeline..................................................................................87 9.3.6 Product Profiles of Promising Molecules............................................................................89 9.3.7 Product Profiles of Marketed Products..............................................................................90

10 Stem Cell Therapy Market in Asia-Pacific to 2018 - Competitive Landscape ..........................................92 10.1 Stempeutics Research..............................................................................................................92

10.1.1 Overview .........................................................................................................................92 10.1.2 Product Pipeline ...............................................................................................................93



Table of Contents

10.2 Reliance Life Sciences...............................................................................................................94 10.2.1 Overview .........................................................................................................................94 10.2.2 Product Pipeline ...............................................................................................................94

10.3 International Stem Cell Services ...............................................................................................95 10.3.1 Overview .........................................................................................................................95 10.3.2 Product Pipeline ...............................................................................................................95

10.4 Shenzhen Beike Biotechnology.................................................................................................96 10.4.1 Overview .........................................................................................................................96 10.4.2 Product Pipeline ...............................................................................................................96

10.5 JCR Pharmaceuticals ................................................................................................................97 10.5.1 Overview .........................................................................................................................97 10.5.2 Product Pipeline ...............................................................................................................97

10.6 ES Cells International (Subsidiary of BioTime, Inc) .....................................................................98 10.6.1 Overview .........................................................................................................................98 10.6.2 Product Pipeline ...............................................................................................................98

10.7 Stem Cell Technologies i...........................................................................................................99 10.7.1 Overview .........................................................................................................................99 10.7.2 Product Pipeline ...............................................................................................................99

10.8 Pharmicell .............................................................................................................................100 10.8.1 Overview .......................................................................................................................100 10.8.2 Product Pipeline .............................................................................................................100

10.9 Medipost...............................................................................................................................101 10.9.1 Overview .......................................................................................................................101 10.9.2 Product Pipeline .............................................................................................................101

11 Stem Cell Therapy Market in Asia-Pacific to 2018 - Strategic Consolidations .......................................102 11.1 Overview...............................................................................................................................102 11.2 M&A Deals ............................................................................................................................103

11.2.1 RNL BIO Acquired 10% Stake in Celltex Therapeutics for $10m - October 28, 2011...........103 11.2.2 BioTime Acquired ES Cell International - May 3, 2010......................................................103 11.2.3 BCCL Acquires Stake in Life Cell - May 1, 2007 .................................................................103

11.3 Licensing Deals ......................................................................................................................103 11.3.1 RNL BIO Forms Joint Venture to Develop Stem Cell Therapy - September 29, 2011...........103 11.3.2 Kiadis Pharma Enters into Licensing Agreement with Hospira for ATIR - January 4, 2011 ..103 11.3.3 Cipla Enters into Co-Marketing Agreement with Stempeutics - April 27, 2010..................103 11.3.4 Teijin Enters into Licensing Agreement with SanBio - March 2, 2010 ................................104 11.3.5 Cleveland BioLabs Enters into Licensing Agreement with Zhejiang Hisun Pharma - September

9, 2009 ..........................................................................................................................104 11.3.6 Merck Signs a Licensing Agreement with Japan Tobacco - September 25, 2008 ...............104 11.3.7 ES Cell Enters into Licensing Agreement with ITI Life Sciences - January 31, 2007.............104

11.4 Co-Development Deals...........................................................................................................105 11.4.1 JCR Pharma Enters into Co-Development Agreement with MediPal - September 13, 2011 105 11.4.2 Athersys Enters into Co-Development Agreement with Pfizer - December 21, 2009..........105 11.4.3 Genzyme Enters into Agreement with Osiris Therapeutics - November 4, 2008.....................

.................................................................................................................................105 11.4.4 JCR Pharma Enters into Co-Development Agreement with Mochida Pharma - December 21,

2007 ..............................................................................................................................106 12 Stem Cell Therapy Market in Asia-Pacific to 2018 - Appendix..............................................................107

12.1 Market Definitions.................................................................................................................107 12.2 Abbreviations ........................................................................................................................107 12.3 Bibliography ..........................................................................................................................109 12.4 Research Methodology ..........................................................................................................110

12.4.1 Coverage .......................................................................................................................110



Table of Contents

12.4.2 Secondary Research .......................................................................................................110 12.4.3 Primary Research ...........................................................................................................111

12.5 Therapeutic Landscape ..........................................................................................................111 12.5.2 Market Size by Geography..............................................................................................113

12.6 Geographical Landscape ........................................................................................................114 12.7 Pipeline Analysis ....................................................................................................................114 12.8 Competitive Landscape..........................................................................................................114

12.8.1 Expert Panel Validation ..................................................................................................114 12.9 Contact Us.............................................................................................................................114 12.10 Disclaimer..............................................................................................................................114



Table of Contents

1.1 List of Tables

Table 1: Stem Cell Therapy Market in Asia-Pacific to 2018, Revenue Forecasts ($m), 2012-2018 ..............................................................................................................................16

Table 2: Stem Cell Therapy Market in Asia-Pacific to 2018, Patient Pool for Stem Cell Therapy Forecasts (‘000), 2012-2018....................................................................................................................19

Table 3: Stem Cell Therapy Market in Asia-Pacific to 2018, India, Revenue Forecasts ($m), 2012-2018...23 Table 4: Stem Cell Therapy Market in Asia-Pacific to 2018, India, Patient Pool Forecasts (‘000), 2012-2018

...............................................................................................................................................24 Table 5: Stem Cell Therapy Market in Asia-Pacific to 2018, India, CABG Revenue Forecasts ($’000), 2012-

2018.......................................................................................................................................25 Table 6: Stem Cell Therapy Market in Asia-Pacific to 2018, India, CABG Cost of Therapy Forecasts ($),

2012-2018 ..............................................................................................................................26 Table 7: Stem Cell Therapy Market in Asia-Pacific to 2018, India, CABG Patient Pool Forecasts (Absolute),

2012-2018 ..............................................................................................................................27 Table 8: Stem Cell Therapy Market in Asia-Pacific to 2018, India, Type 2 DM Revenue Forecasts ($m),

2012-2018 ..............................................................................................................................29 Table 9: Stem Cell Therapy Market in Asia-Pacific to 2018, India, Type 2 DM Cost of Therapy Forecasts

($), 2012-2018 ........................................................................................................................30 Table 10: Stem Cell Therapy Market in Asia-Pacific to 2018, India, Type 2 DM Patient Pool Forecasts (‘000),

2012-2018 ..............................................................................................................................31 Table 11: Stem Cell Therapy Market in Asia-Pacific to 2018, India, LSCT Revenue Forecasts ($’000), 2012-

2018.......................................................................................................................................32 Table 12: Stem Cell Therapy Market in Asia-Pacific to 2018, India, LSCT Cost of Therapy Forecasts ($),

2012-2018 ..............................................................................................................................33 Table 13: Stem Cell Therapy Market in Asia-Pacific to 2018, India, LSCT Patient Pool Forecasts (Absolute),

2012-2018 ..............................................................................................................................34 Table 14: Stem Cell Therapy Market in Asia-Pacific to 2018, China, Type 1 DM Revenue Forecasts ($m),

2012-2018 ..............................................................................................................................37 Table 15: Stem Cell Therapy Market in Asia-Pacific to 2018, China, Type 1 DM Cost of Therapy Forecasts

($), 2012-2018 ........................................................................................................................38 Table 16: Stem Cell Therapy Market in Asia-Pacific to 2018, China, Type 1 DM Patient Pool Forecasts

(‘000), 2012-2018....................................................................................................................39 Table 17: Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, aGvHD Revenue Forecasts ($m), 2014-

2018.......................................................................................................................................43 Table 18: Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, aGvHD Cost of Therapy Forecasts ($),

2014-2018 ..............................................................................................................................44 Table 19: Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, aGvHD Patient Pool for Stem Cell

Therapy Forecasts (Absolute), 2014-2018................................................................................45 Table 20: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Revenue Forecasts ($m), 2012-

2018.......................................................................................................................................54 Table 21: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Patient Pool for Stem Cell

Therapy, Forecasts (Absolute), 2012-2018 ...............................................................................57 Table 22: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Cupistem Revenue Forecasts

($m), 2012-2018 .....................................................................................................................59 Table 23: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Cupistem Cost of Therapy

Forecasts ($), 2012-2018.........................................................................................................60 Table 24: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Cupistem Patient Pool Forecasts

(Absolute), 2012-2018.............................................................................................................61 Table 25: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, HCG-AMI Revenue Forecasts

($m), 2012-2018 .....................................................................................................................63 Table 26: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, HCG-AMI Cost of Therapy

Forecasts ($), 2012-2018.........................................................................................................64 Table 27: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, HCG-AMI Patient Forecasts,

2012-2018 ..............................................................................................................................65 Table 28: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Cartistem Revenue Forecasts

($m), 2012-2018 .....................................................................................................................67 Table 29: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Cartistem Cost of Therapy

Forecasts ($), 2012-2018.........................................................................................................68



Table of Contents

Table 30: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Cartistem Patient Pool Forecasts (Absolute), 2012-2018.............................................................................................................69

Table 31: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, CCG Revenue Forecasts ($m), 2015-2018 ..............................................................................................................................70

Table 32: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, CCG Cost of Therapy Forecasts ($), 2015-2018 ........................................................................................................................71

Table 33: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, CCG Patient Pool Forecasts (Absolute), 2015-2018.............................................................................................................72

Table 34: Stem Cell Therapy Market in Asia-Pacific to 2018, R&D Pipeline Analysis by Phase, 2012 ..........73 Table 35: Stem Cell Therapy Market in Asia-Pacific to 2018, R&D Pipeline Analysis by

Sponsors/Collaborators, 2012 .................................................................................................74 Table 36: Stem Cell Therapy Market in Asia-Pacific to 2018, R&D Pipeline Analysis by Country, 2012.......75 Table 37: Stem Cell Therapy Market in Asia-Pacific to 2018, India, R&D Pipeline Analysis by Phase, 2012.76 Table 38: Stem Cell Therapy Market in Asia-Pacific to 2018, India, Phase II/III Pipeline Analysis, 2012......77 Table 39: Stem Cell Therapy Market in Asia-Pacific to 2018, India, Phase II Pipeline Analysis, 2012 ..........77 Table 40: Stem Cell Therapy Market in Asia-Pacific to 2018, India, Phase I/II Pipeline Analysis, 2012........77 Table 41: Stem Cell Therapy Market in Asia-Pacific to 2018, India, Unknown Phase, 2012........................77 Table 42: Stem Cell Therapy Market in Asia-Pacific to 2018, China, R&D Pipeline Analysis by Phase, 201278 Table 43: Stem Cell Therapy Market in Asia-Pacific to 2018, China, Post-Market Pipeline Analysis, 2012..79 Table 44: Stem Cell Therapy Market in Asia-Pacific to 2018, China, Phase II Pipeline Analysis, 2012 .........79 Table 45: Stem Cell Therapy Market in Asia-Pacific to 2018, China, Phase I/II Pipeline Analysis, 2012.......80 Table 46: Stem Cell Therapy Market in Asia-Pacific to 2018, China, Phase I Pipeline Analysis, 2012 ..........80 Table 47: Stem Cell Therapy Market in Asia-Pacific to 2018, China, Clinical Pre-Test Pipeline Analysis, 2012

...............................................................................................................................................81 Table 48: Stem Cell Therapy Market in Asia-Pacific to 2018, China, Unknown Phase, 2012.......................81 Table 49: Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, R&D Pipeline Analysis by Phase, 201282 Table 50: Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, Phase III Stage Molecules Pipeline

Analysis, 2012.........................................................................................................................83 Table 51: Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, Phase II/III Stage Molecules Pipeline

Analysis, 2012.........................................................................................................................83 Table 52: Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, Phase II Stage Molecules Pipeline

Analysis, 2012.........................................................................................................................84 Table 53: Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, Phase I/II Stage Molecules Pipeline

Analysis, 2012.........................................................................................................................85 Table 54: Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, Phase I Stage Molecules Pipeline

Analysis, 2012.........................................................................................................................85 Table 55: Stem Cell Therapy Market in Asia-Pacific to 2018, Singapore, Phase I/II Stage Molecules Pipeline

Analysis, 2012.........................................................................................................................86 Table 56: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, R&D Pipeline Analysis by Phase,

2012.......................................................................................................................................87 Table 57: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Phase III Molecules Pipeline

Analysis, 2012.........................................................................................................................88 Table 58: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Phase II/III Molecules Pipeline

Analysis, 2012.........................................................................................................................88 Table 59: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Phase II Molecules Pipeline

Analysis, 2012.........................................................................................................................88 Table 60: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Phase I/II Molecules Pipeline

Analysis, 2012.........................................................................................................................88 Table 61: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Phase I Molecules Pipeline

Analysis, 2012.........................................................................................................................89 Table 62: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Unknown Phase, 2012.............89 Table 63: Stem Cell Therapy Market in Asia-Pacific to 2018, Stempeutics, R&D Pipeline, 2012.................93 Table 64: Stem Cell Therapy Market in Asia-Pacific to 2018, Reliance Life Sciences, R&D Pipeline, 2012...94 Table 65: Stem Cell Therapy Market in Asia-Pacific to 2018, International Stem Cell Services Limited, R&D

Pipeline, 2012.........................................................................................................................95 Table 66: Stem Cell Therapy Market in Asia-Pacific to 2018, Shenzhen Beike Biotechnology R&D Pipeline,

2012.......................................................................................................................................96 Table 67: Stem Cell Therapy Market in Asia-Pacific to 2018, JCR Pharmaceuticals Co. Ltd, R&D Pipeline,

2012.......................................................................................................................................97



Table of Contents

Table 68: Stem Cell Therapy Market in Asia-Pacific to 2018, Pharmicell, R&D Pipeline, 2012..................100 Table 69: Stem Cell Therapy Market in Asia-Pacific to 2018, Medipost, R&D Pipeline, 2012 ...................101 Table 70: Stem Cell Therapy Market in Asia-Pacific to 2018, Strategic Consolidations Overview, 2007-2012

.............................................................................................................................................102



Table of Contents

1.2 List of Figures

Figure 1: Stem Cell Therapy Market in Asia-Pacific to 2018, Overview, 2012 ...........................................15 Figure 2: Stem Cell Therapy Market in Asia-Pacific to 2018, Revenue Forecasts ($m),

2012-2018 ..............................................................................................................................16 Figure 3: Stem Cell Therapy Market in Asia-Pacific to 2018, Cost of Therapy Overview ($), 2012 .............17 Figure 4: Stem Cell Therapy Market in Asia-Pacific to 2018, Allogeneic vs. Autologous (%), 2012.............18 Figure 5: Stem Cell Therapy Market in Asia-Pacific to 2018, Patient Pool for Stem Cell Therapy Forecasts

(‘000), 2012-2018....................................................................................................................19 Figure 6: Stem Cell Therapy Market in Asia-Pacific to 2018, Drivers and Barriers, 2012 ...........................20 Figure 7: Stem Cell Therapy Market in Asia-Pacific to 2018, India, Revenue Forecasts ($m), 2012-2018...23 Figure 8: Stem Cell Therapy Market in Asia-Pacific to 2018, India, Cost of Therapy Overview ($), 2012....24 Figure 9: Stem Cell Therapy Market in Asia-Pacific to 2018, India, Patient Pool Forecasts (‘000), 2012-2018

...............................................................................................................................................24 Figure 10: Stem Cell Therapy Market in Asia-Pacific to 2018, India, CABG Revenue Forecasts ($’000), 2012-

2018.......................................................................................................................................25 Figure 11: Stem Cell Therapy Market in Asia-Pacific to 2018, India, CABG Cost of Therapy Forecasts ($),

2012-2018 ..............................................................................................................................26 Figure 12: Stem Cell Therapy Market in Asia-Pacific to 2018, India, CABG Patient Pool Forecasts (Absolute),

2012-2018 ..............................................................................................................................27 Figure 13: Stem Cell Therapy Market in Asia-Pacific to 2018, India, Type 2 DM Revenue Forecasts ($m),

2012-2018 ..............................................................................................................................29 Figure 14: Stem Cell Therapy Market in Asia-Pacific to 2018, India, Type 2 DM Cost of Therapy Forecasts

($), 2012-2018 ........................................................................................................................30 Figure 15: Stem Cell Therapy Market in Asia-Pacific to 2018, India, Type 2 DM Patient Pool Forecasts (‘000),

2012-2018 ..............................................................................................................................31 Figure 16: Stem Cell Therapy Market in Asia-Pacific to 2018, India, LSCT Revenue Forecasts ($’000), 2012-

2018.......................................................................................................................................32 Figure 17: Stem Cell Therapy Market in Asia-Pacific to 2018, India, LSCT Cost of Therapy Forecasts ($),

2012-2018 ..............................................................................................................................33 Figure 18: Stem Cell Therapy Market in Asia-Pacific to 2018, India, LSCT Patient Pool Forecasts (Absolute),

2012-2018 ..............................................................................................................................34 Figure 19: Stem Cell Therapy Market in Asia-Pacific to 2018, China, Regulatory Framework Timeline, 1998-

2009.......................................................................................................................................35 Figure 20: Stem Cell Therapy Market in Asia-Pacific to 2018, China, Type 1 DM Revenue Forecasts ($m),

2012-2018 ..............................................................................................................................37 Figure 21: Stem Cell Therapy Market in Asia-Pacific to 2018, China, Type 1 DM Cost of Therapy Forecasts

($), 2012-2018 ........................................................................................................................38 Figure 22: Stem Cell Therapy Market in Asia-Pacific to 2018, China, Type 1 DM Patient Pool Forecasts

(‘000), 2012-2018....................................................................................................................39 Figure 23: Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, MHLW Stem Cell Guidelines, 2010.....40 Figure 24: Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, JR-031 Overview, 2012......................42 Figure 25: Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, aGvHD Revenue Forecasts ($m), 2014-

2018.......................................................................................................................................43 Figure 26: Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, aGvHD Cost of Therapy Forecasts ($),

2014-2018 ..............................................................................................................................44 Figure 27: Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, aGvHD Patient Pool for Stem Cell

Therapy Forecasts (Absolute), 2014-2018................................................................................45 Figure 28: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Stem Cell Therapeutics Approval

Process, 2011..........................................................................................................................52 Figure 29: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Biopharmaceutical

Implementation Strategies, 2011.............................................................................................53 Figure 30: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Revenue Forecasts ($m), 2012-

2018.......................................................................................................................................54 Figure 31: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Autologous and Allogeneic Share

(%), 2012 ................................................................................................................................55 Figure 32: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Marketed Products Share (%),

2012 and 2018........................................................................................................................55



Table of Contents

Figure 33: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Cost of Therapy ($), Overview, 2012.......................................................................................................................................56

Figure 34: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Patient Pool for Stem Cell Therapy, Forecasts (Absolute), 2012-2018 ...............................................................................57

Figure 35: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Cupistem Revenue Forecasts ($m), 2012-2018 .....................................................................................................................59

Figure 36: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Cupistem Cost of Therapy Forecasts ($), 2012-2018.........................................................................................................60

Figure 37: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Cupistem Patient Pool Forecasts (Absolute), 2012-2018.............................................................................................................61

Figure 38: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, HCG-AMI Revenue Forecasts ($m), 2012-2018 .....................................................................................................................63

Figure 39: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, HCG-AMI Cost of Therapy Forecasts ($), 2012-2018.........................................................................................................64

Figure 40: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, HCG-AMI Patient Forecasts (Absolute), 2012-2018.............................................................................................................65

Figure 41: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Cartistem Revenue Forecasts ($m), 2012-2018 .....................................................................................................................67

Figure 42: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Cartistem Cost of Therapy Forecasts ($), 2012-2018.........................................................................................................68

Figure 43: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Cartistem Patient Pool Forecasts (Absolute), 2012-2018.............................................................................................................69

Figure 44: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, CCG Revenue Forecasts ($m), 2015-2018 ..............................................................................................................................70

Figure 45: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, CCG Cost of Therapy Forecasts ($), 2015-2018 ........................................................................................................................71

Figure 46: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, CCG Patient Pool Forecasts (Absolute), 2015-2018.............................................................................................................72

Figure 47: Stem Cell Therapy Market in Asia-Pacific to 2018, R&D Pipeline Analysis by Phase (%), 2012 ....73 Figure 48: Stem Cell Therapy Market in Asia-Pacific to 2018, R&D Pipeline Analysis by

Sponsors/Collaborators (%), 2012............................................................................................74 Figure 49: Stem Cell Therapy Market in Asia-Pacific to 2018, R&D Pipeline Analysis by Country (%), 2012 .75 Figure 50: Stem Cell Therapy Market in Asia-Pacific to 2018, India, R&D Pipeline Analysis by Phase (%),

2012.......................................................................................................................................76 Figure 51: Stem Cell Therapy Market in Asia-Pacific to 2018, China, R&D Pipeline Analysis by Phase (%),

2012.......................................................................................................................................78 Figure 52: Stem Cell Therapy Market in Asia-Pacific to 2018, Japan, R&D Pipeline Analysis by Phase (%),

2012.......................................................................................................................................82 Figure 53: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, R&D Pipeline Analysis by Phase

(%), 2012 ................................................................................................................................87 Figure 54: Stem Cell Therapy Market in Asia-Pacific to 2018, Stempeutics, Overview, 2012.......................92 Figure 55: Stem Cell Therapy Market in Asia-Pacific to 2018, Reliance Life Sciences, Overview, 2012 ........94 Figure 56: Stem Cell Therapy Market in Asia-Pacific to 2018, International Stem Cell Services, Overview,

2012.......................................................................................................................................95 Figure 57: Stem Cell Therapy Market in Asia-Pacific to 2018, Shenzhen Beike Biotechnology Overview, 2012

...............................................................................................................................................96 Figure 58: Stem Cell Therapy Market in Asia-Pacific to 2018, JCR Pharmaceuticals Overview, 2012 ...........97 Figure 59: Stem Cell Therapy Market in Asia-Pacific to 2018, ES Cells International, Overview, 2012 .........98 Figure 60: Stem Cell Therapy Market in Asia-Pacific to 2018, Stem Cell Technologies i, Overview, 2012.....99 Figure 61: Stem Cell Therapy Market in Asia-Pacific to 2018, Pharmicell Overview, 2012 ........................100 Figure 62: Stem Cell Therapy Market in Asia-Pacific to 2018, Medipost, Overview, 2012.........................101 Figure 63: Stem Cell Therapy Market in Asia-Pacific to 2018, Strategic Consolidations Overview (%), 2007-

2012.....................................................................................................................................102 Figure 64: GBI Research Market Forecasting Model ...............................................................................113



Stem Cell Therapy Market in Asia-Pacific to 2018 - Introduction

2 Stem Cell Therapy Market in Asia-Pacific to 2018 - Introduction

The stem cell therapy market in Asia-Pacific is in a nascent stage. The market was valued at $XXm in 2012, and is projected to grow at a CAGR of XX% to reach a value of $XXm in 2018. The high growth rate is attributable to the launch of new stem cell therapies for spinal cord injury (South Korea) and steroid refractory acute graft versus host disease (aGvHD (Japan).

Stem cell research is dominated by autologous stem cell therapies, which use cells from the patient’s body and therefore face fewer regulatory hurdles. They contributed XX% of the revenues in 2012. Allogeneic stem cell therapies contribute XX% of the revenues. Autologous therapies are used for the treatment of various diseases, such as Coronary Artery Bypass Graft (CABG), Limbal Stem Cell Technology (LSCT), and type 1 diabetes mellitus (DM), among others.

The product pipeline for stem cell research comprises XX molecules, with XX% of the molecules being in Phase II or Phase I/II stages. The pipeline is strong and witnesses the presence of both industry and academia. The emergence of institutional research has helped in the progress of stem cell research, particularly as fewer companies are participating in research due to uncertain therapeutic outcomes. This has also led to more licensing agreements during 2007-2012.



Stem Cell Therapy Market in Asia-Pacific to 2018 - Overview

3.2.4 Stem Cell Therapy Patient Pool

The figure below illustrates the patient pool forecasts for stem cell therapy in Asia-Pacific.

Figure 5: Stem Cell Therapy Market in Asia-Pacific to 2018, Patient Pool for Stem Cell Therapy Forecasts (‘000), 2012-2018

2012 2013 2014 2015 2016 2017 2018

Num

ber o

f Pat

ient

s ('0

00)

CAGR (2012–2018) - XX%


Table 2: Stem Cell Therapy Market in Asia-Pacific to 2018, Patient Pool for Stem Cell Therapy Forecasts (‘000), 2012-2018

Year 2012 2013 2014 2015 2016 2017 2018 CAGR (%)

Number of Patients (‘000)


The number of patients is projected to increase from XX million in 2012 to XX million in 2018, at a CAGR of XX%. The moderate nature of the growth is attributable to the high cost of therapy and low patient awareness.



Stem Cell Therapy Market in Asia-Pacific to 2018 - South Korea

8.3.3 Stem Cell Patient Pool

The figure below provides stem cell therapy patient pool forecasts.

Figure 34: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Patient Pool for Stem Cell Therapy, Forecasts (Absolute), 2012-2018

2012 2013 2014 2015 2016 2017 2018

Num

ber o

f Pat

ient

s (A

bsol

ute)

HCG-AMI Stem Cell Patients Cartistem Stem Cell Patients Cupistem Stem Cell Patients CCG Stem Cell Patients

HCG-AMI CAGR (2012–2018) - XX%Cartistem CAGR (2012–2018) - XX%Cupistem CAGR (2012–2018) - XX%CCG CAGR (2015–2018) - XX%

Anticipated launch of CCG is projected to increase the

patients on stem cell therapy

Source: GBI Research

Table 21: Stem Cell Therapy Market in Asia-Pacific to 2018, South Korea, Patient Pool for Stem Cell Therapy, Forecasts (Absolute), 2012-2018

Year 2012 2013 2014 2015 2016 2017 2018 CAGR (%)

HCG-AMI Stem Cell Patients (Absolute)

Cartistem Stem Cell Patients (Absolute)

Cupistem Stem Cell Patients (Absolute)

CCG Stem Cell Patients (Absolute)

Total Stem Cell Patients (Absolute)


The stem cell patient pool for various stem cell therapies in South Korea was XX in 2012. The patients seeking stem cell treatment are projected to increase to XX in 2018, at a CAGR of XX%. The high growth is attributed to the therapies becoming reimbursable in the forecast period, the launch of CCG, and the various advantages offered by these therapies (HCG-AMI, Cartistem, Cupistem and CCG).



Stem Cell Therapy Market in Asia-Pacific to 2018 - Pipeline Analysis

9 Stem Cell Therapy Market in Asia-Pacific to 2018 - Pipeline Analysis

9.1 Pipeline Analysis by Phase

The research is mainly in early stages, with the majority of the molecules being in early stages of development (Phase I/II and Phase II). Phase I/II and Phase II contribute XX% of the pipeline. The figure below provides pipeline analysis by phase.

Figure 47: Stem Cell Therapy Market in Asia-Pacific to 2018, R&D Pipeline Analysis by Phase (%), 2012

Post-Market

Unknown

Phase III

Phase II/III

Clinical Pre-Test

Phase I

Phase I/II

Phase II

Source: GBI Research, Clinical Trial Registry India (CTRI) (2012), CHiCTR (2012), UMIN-CTR (2012), Clinical Research Information Service (CRiS) (2012)

Table 34: Stem Cell Therapy Market in Asia-Pacific to 2018, R&D Pipeline Analysis by Phase, 2012

Phase Number of Molecules

Post-Market

Unknown

Phase III

Phase II/III

Clinical Pre-Test

Phase I

Phase I/II

Phase II

Total

Source: GBI Research, CTRI (2012), CHiCTR (2012), UMIN-CTR (2012), CRiS (2012)

The stem cell pipeline for Asia-Pacific is in its nascent stage. Stem cell therapy is expected to provide benefits to patients suffering from diseases for which only symptomatic treatment or no treatment options are available.

The research is in early stage with Phase I/II and Phase II contributing XX% of the pipeline



Stem Cell Therapy Market in Asia-Pacific to 2018 - Appendix

12 Stem Cell Therapy Market in Asia-Pacific to 2018 - Appendix

12.1 Market Definitions

Stem cell therapy research in Asia-Pacific includes five countries, namely China, India, Japan, Singapore and South Korea

The stem cell therapy market for Asia-Pacific includes four countries, namely China, India, Japan and South Korea.

The revenues are the addition of the stem cell therapy market of China, India, Japan and South Korea.

Stem cell therapy market for Singapore is not estimated as the pipeline molecules are in the early stages of clinical development and are not anticipated to be launched during the forecast period.

12.2 Abbreviations

A*STAR - Agency for Science Technology and Research

ABMS - Autologous Bone Marrow Stem Cells

ABMSCT - Allogeneic Mesenchymal Stem Cells Transplantation

ACC - The American College of Cardiology

aGvHD - Acute Graft Versus Host Disease

AHA - American Heart Association

AIIMS - All India Institute of Medical Sciences

ALL - Acute Lymphoblastic Leukemia

AMI - Acute Myocardial Infarction

AML - Acute myeloid Leukemia

AMSC - Allogeneic Mesenchymal Stem Cells

AS - Ankylosing Spondylitis

BAC - Bioethics Advisory Committee

CABG - Coronary Artery Bypass Graft

CAD - Coronary Artery Disease

CAGR - Compound Annual Growth Rate

CCG - Cerecellgram

CCI - Condrocyte Implantation

CD - Crohn’s Disease

ChiCTR - Chinese Clinical Trial Register

CIK - Cytokine Induced Killer

CLL - Chronic Lymphocytic Leukemia

CML - Chronic Myelogenous Leukemia

COPD - Chronic Obstructive Pulmonary Disease

DBT - Department of Biotechnology

DM - Diabetes Mellitus

DRDO - Defense Research and Development Organization

ESC - Embryonic Stem Cells

GDP - Gross Domestic Product




GMP - Good Manufacturing Practice

GvHD - Graft Versus Host Disease

HCG-AMI - Hearticellgram-Acute Myocardial Infarction

hESCs - Human Embryonic Stem Cells

HSC - Hematopoietic Stem Cells

HSCT - Hematopoietic Stem Cell Transplantation

IBD - Inflammatory Bowel Disease

ICMR - Indian Council of Medical Research

iPSC - Induced Pluripotent Stem Cells

IRB - Institutional Review Board

KFDA - Korea Food and Drug Administration

KOL - Key Opinion Leader

LSCT - Limbal Stem Cell Transplantation

LVPEI - LV Prasad Eye Institute

MDS - Myelodysplastic Syndromes

MHLW - Ministry of Health, Labour and Welfare

MoHW - Ministry of Health and Welfare

MSC - Mesenchymal Stem Cells

NAC-SCRT - National Apex Committee for Stem Cell Research and Therapy

NIDDM - Non-Insulin Dependent Diabetes

NMRC - National Medical Research Council

OA - Osteoarthritis

PCI - Percutaneous Coronary Intervention

PGIMER - Post Graduate Institute of Medical Education and Research

SCNT - Somatic-Cell Nuclear Transfer

TKR - Total Knee Replacement

UC - Ulcerative Colitis




12.3 Bibliography

BIONET (2010). Ethical Governance of Biological and Biomedical Research: Chinese - European Co-operation. Available From http://www2.lse.ac.uk/researchAndExpertise/units/BIONET/pdfs/BIONET%20Final%20Report1.pdf.

Bioethics Advisory Committee (2002a). Ethical, Legal and Social Issues in Human Stem Cell Research, Reproductive and Therapeutic Cloning. Available From http://www.bioethics-singapore.org/uploadfile/60517%20PMHSC%20Research.pdf.

Bioethics Advisory Committee (2002b). Human Tissue Research. Available From http://www.bioethics-singapore.org/uploadfile/60104%20PMHT%20Research.pdf.

Bioethics Advisory Committee (2004). Research Involving Human Subjects: Guidelines for IRBs. Available From http://www.bioethics-singapore.org/uploadfile/55527%20PMHS%20Research.pdf.

Bioethics Advisory Committee (2005). Genetic Testing and Genetic Research. Available From http://www.bioethics-singapore.org/uploadfile/55211%20PMGT%20Research.pdf.

Bioethics Advisory Committee (2007). Personal Information in Biomedical Research. Available From www.bioethics-singapore.org/.../15654%20PMPI%20Report.pdf.

Bioethics Advisory Committee (2008). Donation of Human Eggs for Research. Available From http://www.bioethics-singapore.org/uploadfile/13144%20PMFull%20ED%20Report.pdf.

Bioethics Advisory Committee (2010). Human-Animal Combination in Stem Cell Research. Available From http://www.bioethics-singapore.org/uploadfile/54403%20PMHAC%20Report%20.pdf.

Chinese Clinical Trial Registry (ChiCTR) (2012). Clinical Trials, Stem Cells [database] Available From http://www.chictr.org/en/proj/search.aspx?title=stem%20cell &officialname=&secondaryid=&subjectid=&applier=&studyleader=&ethicalcommitteesanction=&sponsor=&studyailment=&studyailmentcode=&studytype=0&studystage=0&studydesign=0&minstudyexecutetime=&maxstudyexecutetime=&recruitmentstatus=0&gender=0&agreetosign=&secsponsor=&regno=&regstatus=0&country=&province=&city=&institution=&institutionlevel=&measure=&intercode=&sourceofspends=&createyear=0&page=1.

Kim E.S and Kim W.H (2010). Inflammatory Bowel Disease in Korea: Epidemiological, Genomic, Clinical, and Therapeutic Characteristics. Gut and Liver, Vol. 4, No. 1, March 2010, pp. 1-14.

ll-Hoan Oh (2012). Regulatory issues in stem cell therapeutics in Korea: efficacy or efficiency? Korean Journal of Hematology 2012 June; 47(2): 87-89.

ICMR-DBT Guidelines for Stem Cell Research (2012). Guidelines for Stem Cell Research. Available From http://icmr.nic.in/stem_cell_guidelines.pdf.

IDF Diabetes Atlas (2012). The Global Burden. Available From http://www.idf.org/diabetesatlas/5e/the-global-burden. [Accessed August 13, 2012]

LV Prasad Eye Institute (2012). What are Stem Cells? Available From http://patientcare.lvpei.org/eye-hospital/clinical-services/stem-cell.html. [Accessed August 13, 2012]

Rellife (2012). CardioRel. Available From http://rellife.com/pdf/cardiorelinsert.pdf.

MHLW (2010a). Guidelines on clinical research using human stem cells. Available From http://www.mhlw.go.jp/english/policy/health-medical/medical-care/dl/guidelines.pdf.

MHLW (2010b). Guidelines on clinical research using human stem cells. Available From http://www.mhlw.go.jp/english/policy/health-medical/medical-care/dl/guidelines.pdf.

NovoNordisk (2011). The Global Diabetes Care market. Available From http://www.novonordisk.com/images/investors/investor_presentations/2011/CMD2011/03_The_global_diabetes_care_market_CMD2011.pdf.

The American Chamber of Commerce (2011a). Policy Direction for Innovative Biopharmaceuticals in KFDA. Available From http://www.amchamkorea.org/publications/upload/2011/hcseminar/YooMiKim.pdf.




The American Chamber of Commerce (2011b). Policy Direction for Innovative Biopharmaceuticals in KFDA. Available From http://www.amchamkorea.org/publications/hcseminar/19_Yeowon%20Sohn.pdf.

UMIN Clinical Trials Registry [UMIN-CTR] (2012), Clinical Trials, Stem Cells [database] Available From https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi

12.4 Research Methodology

GBI Research’s dedicated research and analysis teams consist of experienced professionals with a pedigree in marketing, market research, consulting backgrounds in the medical devices industry, and advanced statistical expertise.

GBI Research adheres to the codes of practice of the Market Research Society (www.mrs.org.uk) and the Strategic and Competitive Intelligence Professionals (www.scip.org).

All GBI Research databases are continuously updated and revised.

12.4.1 Coverage

The objective of updating GBI Research’s coverage is to ensure that it represents the most up-to-date vision of the industry possible.

Changes to the industry taxonomy are decided on the basis of extensive research of company, association and competitor sources.

Company coverage is based on three key factors: market capitalization, revenues, and media attention/innovation/market potential.

An exhaustive search of 56 member exchanges is conducted, and companies are prioritized on the basis of their market capitalization;

The estimated revenues of all major companies, including private and governmental, are gathered and used to prioritize coverage; and,

Companies which are making the news, or which are of particular interest due to their innovative approach, are prioritized.

GBI Research aims to cover all major news events and deals in the medical industry, with its databases updated on a daily basis.

The coverage is further streamlined and strengthened with additional inputs from GBI Research’s expert panel (see below).

12.4.2 Secondary Research

The research process begins with exhaustive secondary research on internal and external sources being carried out to source qualitative and quantitative information relating to each market.

The secondary research sources that are typically referred to include, but are not limited to:

Company websites, annual reports, financial reports, broker reports, investor presentations and US Securities and Exchanges Commission (SEC) filings.

Industry trade journals, scientific journals and other technical literature.

Internal and external proprietary databases.

Relevant patent and regulatory databases.

National government documents, statistical databases and market reports.

Procedure registries.

News articles, press releases and webcasts specific to the companies operating in the market.




12.4.3 Primary Research

GBI Research conducts hundreds of primary interviews each year with industry participants and commentators, in order to validate its data and analysis. A typical research interview fulfills the following functions:

It provides first-hand information on the market size, market trends, growth trends, competitive landscape, future outlook, etc.

Helps in validating and strengthening the secondary research findings; and

Further develops the analysis team’s expertise and market understanding.

Primary research involves email interactions, telephone interviews, and face-to-face interviews for each market, category, segment and sub-segment across geographies.

The participants who typically take part in such a process include, but are not limited to:

Industry participants: CEOs, VPs, marketing/product managers, market intelligence managers and national sales managers.

Hospital stores, laboratories, pharmacies, distributors and paramedics.

Outside experts: Investment bankers, valuation experts, research analysts specializing in specific medical equipment markets; and

Key Opinion Leaders: Physicians and surgeons specializing in different therapeutic areas corresponding to different kinds of medical equipment.

The report consists of the following four major sections:

Geographic Landscape

Therapeutic Landscape

Pipeline Analysis

Competitive Analysis

12.5 Therapeutic Landscape

The revenues for each indication, by geography, are arrived at by utilizing the GBI Research market forecasting model. The global revenues for each indication are a summarized value of the revenues of all four countries. Only company sponsored molecules which are in late stages of clinical development and are anticipated to launch in the forecast period are considered for market estimation. The data for market estimation was based on extensive primary and secondary research and also from company websites, press releases and GBI Research’s proprietary databases.

The annual cost of therapy for each indication is arrived at by considering the cost of the drugs, dosage of the drugs, and the duration of the therapy.

The marketed drugs section contains an overview of the drugs, their mechanism of action, efficacy and safety issues related to the drugs. The drugs profiled in this section are chosen based on estimated revenues and their mechanism of action.

GBI Research uses the epidemiology-based treatment flow model to forecast the market size for therapeutic indications.

12.5.1.1 Epidemiology-based Forecasting

The forecasting model used at GBI Research makes use of epidemiology data gathered from research publications and primary interviews with physicians to represent the treatment flow patterns for individual diseases and therapies. The market for any disease segment is directly proportional to the volume of units sold and the price per unit.

Sales = Volume of units sold X Price per unit

The volume of units sold is calculated based on the average dosage regimen for that disease, the duration of treatment, and the number of patients who are prescribed drug treatment (the prescription population).




The prescription population is calculated as a percentage of the population diagnosed with a disease (the diagnosis population). The diagnosis population is the population diagnosed with a disease expressed as a percentage of the population that is seeking treatment (the treatment seeking population). The prevalence of a disease (diseased population) is the percentage of the total population who suffer from a disease/condition.

Data on treatment seeking rate, diagnosis rate and prescription rate, if unavailable from research publications, are gathered from interviews with physicians and are used to estimate the patient volumes for the disease under consideration. Therapy uptake and compliance data are fitted in the forecasting model to account for patient switching and compliance behavior.

To account for differences in patient affordability of drugs across various geographies, macroeconomic data such as inflation and GDP, and healthcare indicators such as healthcare spending, insurance coverage and average income per individual, are used.

Annual cost of treatment is calculated using product purchase frequency and the average price of the therapy. Product purchase frequency is calculated from the dosage data available for the therapies, and drug prices are gathered from public sources.

The epidemiology-based forecasting model uses a bottom-up methodology, and makes use of estimations in the absence of data from research publications. Such estimations may result in a final market value that is different from the actual value. To correct this ‘gap’, the forecasting model uses triangulation, with the help of base year sales data (from company annual reports, internal and external databases) and sales estimations.

Analogous Forecasting Methodology

The analogous forecasting methodology is used to account for the introduction of new products, patent expiries of branded products, and the subsequent introduction of generics. Historic data for new product launches and generics penetration are used to arrive at robust forecasts. The increase or decrease of prevalence rates, treatment seeking rate, diagnosis rate and prescription rate are fitted into the forecasting model to estimate the market growth rate.

The proprietary model enables GBI Research to account for the impact of individual drivers and restraints in the growth of the market. The year of impact and the extent of impact are quantified in the forecasting model to provide close-to-accurate data sets.




12.5.2 Market Size by Geography

The treatment usage pattern and annual cost of treatment in each country has been factored in while deriving the individual country market size.

Forecasting Model for Therapeutic Areas

Figure 64: GBI Research Market Forecasting Model

D is ease P opu lati onGener a l Po pu latio n 743,535 ,048

Q ualif ying c ond ition 1 (Age /S ex/O c c upation e tc )Q ualif ying c ond ition 2 (Age /S ex/O c c upation e tc )

Preval ence t issu e va lve disease 0.2% 1,784 ,484 Q ualif ying c ond ition (c om plic ation , s everity)D IS EA SE D P OPULA T IO N 1,784 ,484

T r eatm en t Flow P attern sT reatm ent S eeki ng R at e (Sy m ptom s/ Dis A wareness) 89% 1,588 ,191 Diagn osis Rat e ( Clin ica l and D iagn ostic Test s) 75% 1,191 ,143 Prescr iption R ate ( Ph ysic ian P ercep t io n, Tr eatm ent E ffectiv e n ess)

Tis s ue V a lve 70% 833,800 O ther T rea tm ents fo r Va lve (Sur g /M ed/N one) -

F ulfillm en tA vailab ilit y NAW illingness to Us e (Pa tient Perc ep tions) NAR eady to U se (S urgery e lig ib ility , R eus e e tc ) NA

Affo rd abil it y a t Pr iceH E as % of G DP s pendA verage Inc om e (per ind iv idua l)P at ien t O ut-o f -poc ke t Budget (A nnua l)

Budget a lloc a tion to one-t ime s urgeryBudget a lloc a tion to o ther h ealth needs

A verage Pay or C overageP at ien t L iab ilityTarge t P r ic e ( @ 20% pa t liab )A SP for Cos t of T herapy

T O TA L P AT IEN T V OLU M E SPro du ct P urch ase Fr equ en c y 1

T OT A L U N IT VO LU M ES

Pr ic in g per Un it 18 ,000$ In flat ionP rice D ec reas e due to c om pet it ion

M ar ket Va lu e

G B I R esear ch M ar ket Siz in g M o del


The above figure represents a typical forecasting model constructed by GBI Research. As discussed previously, the model is built on the treatment flow patterns. The model starts with the general population, then diseased population as a percentage of general population, and then follows the treatment seeking population as a percentage of the diseased population, and the diagnosed population as a percentage of the treatment seeking population. Finally, the total volume of units sold is calculated by multiplying the treated population by the average dosage per year per patient.




12.6 Geographical Landscape

GBI Research analyzes seven major geographies, namely, the India, China, Singapore, South Korea and Japan. The total market size for each country is provided, which is the summarized value of the market sizes of all the indications for that particular country.

12.7 Pipeline Analysis

This section provides a list of molecules at different stages in the pipeline for various indications. The list is sourced from internal databases and validated for the accuracy of phase and mechanism of action at clinicaltrials.gov and company websites. The section also includes a list of promising molecules, which is narrowed down based on the results of the clinical trials at various stages and the novelty of the mechanism of action.

12.8 Competitive Landscape

Profiles of leading players are provided, along with an overview of key products marketed by the companies for various indications. An analysis of strengths, weaknesses, opportunities and threats of each company with respect to various indications is also listed.

GBI Research aims to cover all major M&A, licensing deals and co-development deals related to the market. This section is sourced from the companies’ websites and internal databases.

12.8.1 Expert Panel Validation

GBI Research uses a panel of experts to cross-verify its databases and forecasts.

GBI Research’s expert panel comprises marketing managers, product specialists, international sales managers from medical device companies, academics from research universities, and key opinion leaders from hospitals.

Historic data and forecasts are relayed to GBI Research’s expert panel for feedback and adjusted in accordance with their feedback.

12.10 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of the publisher, GBI Research.

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