GBIHC303MR Solid Tumors Market in Asia Pacific to 2019 2 ... · New Drug Approvals and ......

Solid Tumors Market in Asia Pacific to 2019 New Drug Approvals and Anticipated Product Launches to Trigger a Shift in Treatment Paradigm to Targeted Therapies

GBI Research Report Guidance

© GBI Research. This is a licensed product and is not to be photocopied GBIHC303MR / Published SEP 2013

GBI Research Report Guidance

Chapter two provides an overview of the disease, its symptoms, etiology, pathophysiology, diagnosis, classification, epidemiology, prognosis, staging and treatment options.

Chapter three provides detailed profiling for the products that are currently marketed in the solid tumors market in the APAC region.

Chapter four provides a detailed pipeline analysis for diseases including individual product profiles, analysis of the pipeline products on the distribution of molecule types across the solid tumors developmental pipeline, the molecular targets of the pipeline and the developmental program types of the pipeline.

Chapter five provides market forecasts for various APAC countries - India, Australia, China and Japan.

Chapter six provides details of the major deals that have taken place in the solid tumors market in recent years. Coverage includes co-development and licensing agreements, which are segmented on the basis of geography and total value. A concomitant analysis of the licensing deal values for products by molecule types and molecular targets is also provided.


Solid Tumors Market in Asia Pacific to 2019 - Executive Summary

Solid Tumors Market in Asia Pacific to 2019 - Executive Summary

Solid Tumors Market in Asia-Pacific Expected to Record a Modest Growth of XX% to reach $XX billion by 2019

The solid tumors markets – bladder cancer, ovarian cancer, pancreatic cancer and prostate cancer – in the Asia-Pacific (APAC) countries of India, Australia, China and Japan is expected to be worth $XX billion in 2012 and is expected to grow at a Compound Annual Growth Rate (CAGR) of XX% during the forecast period to reach $XX billion in 2019. In 2012, the largest share of the market was held by Japan with $XXm or XX of the total APAC market for solid tumors. The fastest growing market for solid tumors among the four countries named is Australia with an expected CAGR of XX%. A slower growth rate is expected in India (XX%) and China (XX%), due primarily to stricter pricing regulations and recent price cuts. Australia is expected to register robust growth, due primarily to the recent approvals in all the solid tumor types covered in the report with the exception of bladder cancer, and the expected launch of pipeline products in these segments, which are expected to reach the market much more slowly in the other three geographies in the APAC region.

Solid Tumors Market, Asia-Pacific, Market Size ($m), 2012 and 2019

2012 2019

Rev

enue

s ($

m)

Australia China India Japan

CAGR: XX%

Source: GBI Research, Proprietary Database [Accessed July 8, 2013]

Recent Drug Approvals in Solid Tumors to Drive a Modest Growth

The solid tumors market is expected to show modest growth over the forecast period due to recent drug approvals for ovarian, pancreatic and prostate cancers. These new approvals, which occured in the last two years, have the potential to influence disease treatment patterns and therefore may have an effect on market size over the forecast period. There have been no drug approvals for bladder cancer recently, in fact this area has a much lower number of marketed products and a weak pipeline when compared to the other three solid tumors covered in the report. These recent approvals and the anticipated launch of pipeline drugs for ovarian cancer are not guaranteed to drive the growth rate significantly in the forecast period as they do not promise improved efficacy and safety profiles than the current gold-standard treatments. Similarly, recent approvals in pancreatic cancer are for pancreatic Neuro-Endocrine Tumors (pNET), which is a rare form of cancer, leaving the unmet need of the larger disease population intact. The quantity of both recently approved drugs and existing products in prostate cancer is high when compared to the other solid tumor types; this may eventually lead to market saturation. However, the launch of targeted therapies in both ovarian and prostate cancer could trigger a shift in the treatment paradigm in the future.

Recent approvals in ovarian cancer may not significantly drive growth rate due to lack of better efficacy and safety profiles than current gold standard treatments


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Table of Contents

1 Table of Contents

1 Table of Contents ................................................................................................................................. 6 1.1 List of Tables ............................................................................................................................. 9 1.2 List of Figures...........................................................................................................................10

2 Solid Tumors Market in Asia Pacific to 2019 - Introduction ...................................................................11 2.1 Introduction ............................................................................................................................11

3 Solid Tumors Market in Asia Pacific to 2019- Therapeutic Landscape ....................................................12 3.1 Bladder Cancer ........................................................................................................................12

3.1.1 Symptoms ........................................................................................................................12 3.1.2 Etiology ...........................................................................................................................12 3.1.3 Pathophysiology...............................................................................................................12 3.1.4 Diagnosis .........................................................................................................................12 3.1.5 Classification ....................................................................................................................13 3.1.6 Epidemiology ...................................................................................................................14 3.1.7 Prognosis and Disease Staging..........................................................................................15 3.1.8 Treatment Options ...........................................................................................................17

3.2 Ovarian Cancer ........................................................................................................................22 3.2.1 Symptoms ........................................................................................................................22 3.2.2 Etiology ...........................................................................................................................22 3.2.3 Pathophysiology...............................................................................................................23 3.2.4 Diagnosis .........................................................................................................................23 3.2.5 Classification ....................................................................................................................25 3.2.6 Epidemiology ...................................................................................................................25 3.2.7 Prognosis and Disease Staging..........................................................................................26 3.2.8 Treatment Options ...........................................................................................................28

3.3 Pancreatic Cancer ....................................................................................................................31 3.3.1 Symptoms ........................................................................................................................31 3.3.2 Etiology ...........................................................................................................................31 3.3.3 Pathophysiology...............................................................................................................32 3.3.4 Diagnosis .........................................................................................................................32 3.3.5 Classification ....................................................................................................................32 3.3.6 Epidemiology ...................................................................................................................32 3.3.7 Prognosis and Disease Staging..........................................................................................34 3.3.8 Treatment Algorithm........................................................................................................36

3.4 Prostate Cancer .......................................................................................................................37 3.4.1 Symptoms ........................................................................................................................37 3.4.2 Etiology ...........................................................................................................................37 3.4.3 Pathophysiology...............................................................................................................37 3.4.4 Co-Morbidities and Complications ....................................................................................38 3.4.5 Diagnosis .........................................................................................................................38 3.4.6 Classification ....................................................................................................................39 3.4.7 Epidemiology ...................................................................................................................39 3.4.8 Prognosis and Disease Staging..........................................................................................41 3.4.9 Treatment Options ...........................................................................................................43

4 Solid Tumors Market in Asia Pacific to 2019 - Marketed Products .........................................................45 4.1 Bladder Cancer ........................................................................................................................45 4.2 Ovarian Cancer ........................................................................................................................45 4.3 Pancreatic Cancer ....................................................................................................................46 4.4 Prostate Cancer .......................................................................................................................47 4.5 Key Marketed Products ............................................................................................................47

4.5.1 Carboplatin ......................................................................................................................47


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Table of Contents

4.5.2 Cisplatin ...........................................................................................................................48 4.5.3 Gemcitabine ....................................................................................................................48 4.5.4 Paclitaxel .........................................................................................................................49 4.5.5 Doxorubicin......................................................................................................................49 4.5.6 Avastin (bevacizumab) .....................................................................................................50 4.5.7 Tarceva (erlotinib) ............................................................................................................51 4.5.8 Sutent (sunitinib) ..............................................................................................................52 4.5.9 Afinitor (everolimus).........................................................................................................53 4.5.10 Taxotere (docetaxel) ........................................................................................................54 4.5.11 Zytiga (abiraterone acetate) .............................................................................................54 4.5.12 Jevtana (cabazitaxel) ........................................................................................................56

5 Solid Tumors Market in Asia Pacific to 2019 - Pipeline Analysis .............................................................57 5.1 Bladder Cancer Pipeline ...........................................................................................................57

5.1.1 Overall Pipeline ................................................................................................................57 5.1.2 Pipeline Analysis by Molecule Type ...................................................................................58 5.1.3 Pipeline Analysis by Mechanism of Action .........................................................................59

5.2 Ovarian Cancer Pipeline ...........................................................................................................60 5.2.1 Overall Pipeline ................................................................................................................60 5.2.2 Pipeline Analysis by Molecule Type ...................................................................................62 5.2.3 Pipeline Analysis by Mechanism of Action .........................................................................63

5.3 Pancreatic Cancer Pipeline .......................................................................................................64 5.3.1 Overall Pipeline ................................................................................................................64 5.3.2 Pipeline Analysis by Molecule Type ...................................................................................65 5.3.3 Pipeline Analysis by Mechanism of Action .........................................................................66

5.4 Prostate Cancer Pipeline ..........................................................................................................67 5.4.1 Overall Pipeline ................................................................................................................67 5.4.2 Pipeline Analysis by Molecule Type ...................................................................................68 5.4.3 Pipeline Analysis by Mechanism of Action .........................................................................69

5.5 Promising Drug Candidates in the Pipeline ................................................................................70 5.5.1 Abraxane (albumin-bound paclitaxel) ...............................................................................70 5.5.2 AMG 386 (trebananib) .....................................................................................................70 5.5.3 Votrient (pazopanib) ........................................................................................................71 5.5.4 Xtandi (enzalutamide) ......................................................................................................72

6 Solid Tumors Market in Asia Pacific to 2019 - Market Forecast .............................................................73 6.1 Asia-Pacific Market ..................................................................................................................73

6.1.1 Treatment Usage Patterns................................................................................................73 6.1.2 Annual Cost of Treatment .................................................................................................73 6.1.3 Market Size ......................................................................................................................73

6.2 India ........................................................................................................................................75 6.2.1 Treatment Usage Patterns................................................................................................75 6.2.2 Annual Cost of Treatment .................................................................................................75 6.2.3 Market Size ......................................................................................................................75

6.3 Australia ..................................................................................................................................77 6.3.1 Treatment Usage Patterns................................................................................................77 6.3.2 Annual Cost of Treatment .................................................................................................77 6.3.3 Market Size ......................................................................................................................78

6.4 China .......................................................................................................................................80 6.4.1 Treatment Usage Patterns................................................................................................80 6.4.2 Annual Cost of Treatment .................................................................................................80 6.4.3 Market Size ......................................................................................................................80

6.5 Japan .......................................................................................................................................82 6.5.1 Treatment Usage Patterns................................................................................................82


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Table of Contents

6.5.2 Annual Cost of Treatment .................................................................................................82 6.5.3 Market Size ......................................................................................................................82

6.6 Drivers and Barriers for the Solid Tumors Market in APAC .........................................................84 6.6.1 Drivers .............................................................................................................................84 6.6.2 Barriers ............................................................................................................................84

7 Solid Tumors Market in Asia Pacific to 2019 - Deals and Strategic Consolidations..................................86 7.1 Deals Analysis ..........................................................................................................................86 7.2 Major Co-Development Deals...................................................................................................87

7.2.1 ScinoPharm Taiwan and Coland Enter into Agreement to Develop Generic Oncological Drugs ........................................................................................................................................88

7.2.2 Bind Biosciences Enters into Agreement with Amgen to Develop Cancer Drugs ..................88 7.2.3 Merck Enters into Co-Development Agreement with Endocyte for Cancer Drug ..................88 7.2.4 Merck Serono Enters into Co-Development Agreement with Threshold Pharma for TH-302,

Pancreatic Cancer Drug ....................................................................................................89 7.2.5 Seattle Genetics Exercises Option for Co-Development Agreement with Agensys (affiliate of

Astellas) for ASG-15ME ....................................................................................................89 7.3 Major Licensing Deals ..............................................................................................................90

7.3.1 Spectrum Pharma Amends Licensing Agreement with Allergan for Apaziquone ..................91 7.3.2 Chugai Pharma Enters Into Licensing Agreement with Debiopharm Group for FF284 ..........91 7.3.3 Baxter International Enters into Licensing Agreement with Onconova Therapeutics for

Rigosertib ........................................................................................................................91 7.3.4 Dyax Enters Into Licensing Agreement with Kadmon for Oncology Drug .............................91 7.3.5 Medigene Extends Licensing Agreement with Syncore for EndoTAG-1 ................................92

8 Solid Tumors Market in Asia Pacific to 2019 - Appendix........................................................................93 8.1 Pipeline Drugs by Phase ...........................................................................................................93

8.1.1 Phase III ...........................................................................................................................93 8.1.2 Pre-registration/NDA-filed ................................................................................................94

8.2 Market Forecasts to 2018 ........................................................................................................94 8.2.1 APAC ...............................................................................................................................94 8.2.2 Australia ..........................................................................................................................95 8.2.3 China ...............................................................................................................................97 8.2.4 India ................................................................................................................................98 8.2.5 Japan ............................................................................................................................. 100

8.3 Market Definitions ................................................................................................................. 101 8.4 Abbreviations ........................................................................................................................ 101 8.5 Sources.................................................................................................................................. 103 8.6 Research Methodology .......................................................................................................... 106

8.6.1 Coverage ....................................................................................................................... 106 8.6.2 Secondary Research ....................................................................................................... 106 8.6.3 Primary Research ........................................................................................................... 107 8.6.4 Therapeutic Landscape ................................................................................................... 107 8.6.5 Geographical Landscape ................................................................................................ 109 8.6.6 Pipeline Analysis............................................................................................................. 110

8.7 Expert Panel Validation .......................................................................................................... 110 8.8 Contact Us ............................................................................................................................. 110 8.9 Disclaimer.............................................................................................................................. 110


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Table of Contents

1.1 List of Tables

Table 1: Solid Tumors Market, Bladder Cancer, AJCC TNM Staging System, 2010 ...................................16 Table 2: Solid Tumors Market, Bladder Cancer, Treatment by Staging, 2013 ..........................................21 Table 3: Solid Tumors Market, Ovarian Cancer, AJCC’s TNM and FIGO Staging Systems, 2013 ................27 Table 4: Solid Tumors Market, Pancreatic Cancer, AJCC TNM Staging System, 2013 ...............................35 Table 5: Solid Tumors Market, Prostate Cancer, AJCC Staging System, 2013 ..........................................42 Table 6: Solid Tumors Market, Global, Pharmaceutical Pipeline (Phase III), 2013....................................93 Table 7: Solid Tumors Market, Global, Pharmaceutical Pipeline (Pre-registration/NDA-filed), 2013 ........94 Table 8: Solid Tumors Market, Asia-Pacific, Ovarian Cancer, Market Forecast, 2012–2019 .....................94 Table 9: Solid Tumors Market, Asia-Pacific, Bladder Cancer, Market Forecast, 2012–2019 .....................94 Table 10: Solid Tumors Market, Asia-Pacific, Pancreatic Cancer, Market Forecast, 2012–2019 .................95 Table 11: Solid Tumors Market, Asia-Pacific, Prostate Cancer, Market Forecast, 2012–2019 ....................95 Table 12: Solid Tumors Market, Australia, Ovarian Cancer, Market Forecast, 2012–2019 .........................95 Table 13: Solid Tumors Market, Australia, Bladder Cancer, Market Forecast, 2012–2019 .........................96 Table 14: Solid Tumors Market, Australia, Pancreatic Cancer, Market Forecast, 2012–2019 .....................96 Table 15: Solid Tumors Market, Australia, Prostate Cancer, Market Forecast, 2012–2019 ........................96 Table 16: Solid Tumors Market, China, Ovarian Cancer, Market Forecast, 2012–2019 ..............................97 Table 17: Solid Tumors Market, China, Bladder Cancer, Market Forecast, 2012–2019 ..............................97 Table 18: Solid Tumors Market, China, Pancreatic Cancer, Market Forecast, 2012–2019 ..........................98 Table 19: Solid Tumors Market, China, Prostate Cancer, Market Forecast, 2012–2019 .............................98 Table 20: Solid Tumors Market, India, Ovarian Cancer, Market Forecast, 2012–2019 ...............................98 Table 21: Solid Tumors Market, India, Bladder Cancer, Market Forecast, 2012–2019 ...............................99 Table 22: Solid Tumors Market, India, Pancreatic Cancer, Market Forecast, 2012–2019 ...........................99 Table 23: Solid Tumors Market, India, Prostate Cancer, Market Forecast, 2012–2019 ..............................99 Table 24: Solid Tumors Market, Japan, Ovarian Cancer, Market Forecast, 2012–2019............................ 100 Table 25: Solid Tumors Market, Japan, Bladder Cancer, Market Forecast, 2012–2019 ............................ 100 Table 26: Solid Tumors Market, Japan, Pancreatic Cancer, Market Forecast, 2012–2019........................ 100 Table 27: Solid Tumors Market, Japan, Prostate Cancer, Market Forecast, 2012–2019 ........................... 101


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Table of Contents

1.2 List of Figures

Figure 1: Solid Tumors Market, Asia-Pacific, Bladder Cancer, Epidemiology, 2012–2019..........................14 Figure 2: Solid Tumors Market, Bladder Cancer, Treatment Algorithm, Superficial and Stage I, 2013 .......19 Figure 3: Solid Tumors Market, Bladder Cancer, Treatment Algorithm, Stage II and III, 2013 ...................19 Figure 4: Solid Tumors Market, Asia-Pacific, Ovarian Cancer, Epidemiology, 2012–2019 .........................26 Figure 5: Solid Tumors Market, Ovarian Cancer, Treatment Algorithm, Stage I and II, 2013 .....................29 Figure 6: Solid Tumors Market, Ovarian Cancer, Treatment Algorithm, Stage III and IV, 2013 ..................30 Figure 7: Solid Tumors Market, Asia-Pacific, Pancreatic Cancer, Epidemiology, 2012–2019 .....................33 Figure 8: Solid Tumors Market, Pancreatic Cancer, Treatment Algorithm, 2013 ......................................36 Figure 9: Solid Tumors Market, Asia-Pacific, Prostate Cancer, Epidemiology, 2012–2019 ........................40 Figure 10: Solid Tumors Market, Prostate Cancer, Treatment Algorithm, 2013 .........................................44 Figure 11: Solid Tumors Market, Global, Avastin, Annual Sales ($m), 2006–2013e ....................................50 Figure 12: Solid Tumors Market, Global, Tarceva, Annual Sales ($m), 2006–2013e ....................................51 Figure 13: Solid Tumors Market, Global, Sutent, Annual Sales ($m), 2006–2013e......................................52 Figure 14: Solid Tumors Market, Global, Afinitor, Annual Sales ($m), 2009–2013e ....................................53 Figure 15: Solid Tumors Market, Global, Zytiga, Annual Sales ($m), 2011–2013e ......................................55 Figure 16: Solid Tumors Market, Global, Jevtana, Annual Sales ($m), 2010–2013e ....................................56 Figure 17: Solid Tumors Market, Global, Bladder Cancer, Pipeline, 2013 ...................................................57 Figure 18: Solid Tumors Market, Global, Bladder Cancer, Pipeline by Molecule Type, 2013 .......................58 Figure 19: Solid Tumors Market, Global, Bladder Cancer, Pipeline by Mechanism of Action, 2013 .............59 Figure 20: Solid Tumors Market, Global, Ovarian Cancer, Pipeline, 2013 ...................................................61 Figure 21: Solid Tumors Market, Global, Ovarian Cancer, Pipeline by Molecule Type, 2013 .......................62 Figure 22: Solid Tumors Market, Global, Ovarian Cancer, Pipeline by Mechanism of Action, 2013 .............63 Figure 23: Solid Tumors Market, Global, Pancreatic Cancer, Pipeline, 2013 ...............................................64 Figure 24: Solid Tumors Market, Global, Pancreatic Cancer, Pipeline by Molecule Type, 2013 ...................65 Figure 25: Solid Tumors Market, Global, Pancreatic Cancer, Pipeline by Mechanism of Action, 2013 .........66 Figure 26: Solid Tumors Market, Global, Prostate Cancer, Pipeline, 2013 ..................................................67 Figure 27: Solid Tumors Market, Global, Prostate Cancer, Pipeline by Molecule Type, 2013 ......................68 Figure 28: Solid Tumors Market, Global, Prostate Cancer, Pipeline by Mechanism of Action, 2013 ............69 Figure 29: Solid Tumors Market, Asia-Pacific, Market Size ($m), 2012–2019 .............................................74 Figure 30: Solid Tumors Market, India, Market Size ($m), 2012–2019 .......................................................76 Figure 31: Solid Tumors Market, Australia, Market Size ($m), 2012–2019 .................................................79 Figure 32: Solid Tumors Market, China, Market Size ($m), 2012–2019 ......................................................81 Figure 33: Solid Tumors Market, Japan, Market Size ($m), 2012–2019 ......................................................83 Figure 34: Solid Tumors Market, Global, Deals, 2006–2013 ......................................................................86 Figure 35: Solid Tumors Market, Global, Co-development Deals, 2006–2013 ............................................87 Figure 36: Solid Tumors Market, Global, Licensing Deals, 2006-2013 ........................................................90 Figure 37: GBI Research Market Forecasting Model ............................................................................... 109


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Solid Tumors Market in Asia Pacific to 2019 - Introduction

2 Solid Tumors Market in Asia Pacific to 2019 - Introduction

2.1 Introduction

The Solid Tumors Market in Asia Pacific to 2019 report includes market estimations for 2012 and market forecast until 2019 for the four solid tumor types – bladder cancer, ovarian cancer, pancreatic cancer and prostate cancer in the four countries in Asia-Pacific (APAC) region – Australia, China, India and Japan. The Treatment population for these four cancer types combined amounted to an estimated XX in 2012, and is expected to register modest growth to reach XX in 2019. Among the four solid tumor types, prostate cancer has higher prevalence rate and a high-survival rate, and accounts for a major share of the solid tumors market (XX%) due to most number of approvals and a strong pipeline. Comparatively, pancreatic cancer has lowest survival, with a five-year survival rate of just XX-XX%, which did not improve in the last few decades representing a major unmet need. This report explores the areas of recent development and expected growth patterns in the four geographical markets, highlighting the therapeutic segments with high unmet need, and areas that present potential opportunity for drug makers.


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Solid Tumors Market in Asia Pacific to 2019 - Therapeutic Landscape

3.1.6 Epidemiology

The incidence of bladder cancer varies considerably across different regions of the world, with higher incidence in western countries than in Asian countries. Variation is observed more within developed countries and those with less development. Compared to an incidence of XX new cases per XX persons in Australia (Cancer Australia, 2013a), and an estimated XX cases per XX in Japan (National Cancer Research Center, 2013), the incidence of new cases in China is XX new cases per XX, and in India it is just XX new cases per XX of the population (GLOBOCAN, 2008).

Figure 1: Solid Tumors Market, Asia-Pacific, Bladder Cancer, Epidemiology, 2012–2019

China Australia Japan India

C) Five-year prevalence (‘000)

A) Bladder cancer APAC incidence B) Bladder cancer APAC five-year prevalence


Bladder cancer APACincidence per 100,000 (2012) = XX

Bladder cancer APACfive-year prevalence (2012) = XX

2012 2013 2014 2015 2016 2017 2018 2019

Pat

ient

s (‘0

00)


Source: GBI Research, Proprietary Database [Accessed June 18, 2013]

Incidence of bladder cancer is higher in western countries when compared to Asian countries


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Solid Tumors Market in Asia Pacific to 2019 - Market Forecast

6.2 India

6.2.1 Treatment Usage Patterns

Figure 30 shows the treatment usage forecast the four indications in Solid Tumors in India. The five-year Prevalence population of all the four types of cancers covered in the report would be approximately XX. Ovarian cancer has highest incidence among the four solid tumors with an estimated XX new cases added in 2010.

6.2.2 Annual Cost of Treatment

The average Annual cost of treatment for the four indications is estimated to be $XX in 2012 and is expected to grow at a CAGR of XX% to reach $XX by 2019. There are several factors influencing a slower pace of growth in the oncology market in India compared to western markets.

6.2.3 Market Size

Even with a large diseased population, the total market size remained small for these four indications in 2012, estimated to reach $XXm. However, the market is expected to grow at CAGR XX% to reach $XXm by 2019.


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6.3.3 Market Size

The market for solid tumors therapeutics in Australia is expected to reach $XXm by 2019 growing at a CAGR of XX% from 2012. The highest increase in revenues is expected to be seen in ovarian cancer with a high cost of treatment and increasing treatment population.


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Figure 31: Solid Tumors Market, Australia, Market Size ($m), 2012–2019

A) Treatment usage pattern

B) Annual cost of therapy ($)

C) Revenues ($m)

2012 2013 2014 2015 2016 2017 2018 2019

Ann

ual c

ost o

f the

rapy

($)

Bladder cancer Ovarian cancer Pancreatic cancer Prostate cancer

CAGR: XX%Bladder cancer: XX%Ovarian cancer: XX%Pancreatic cancer: XX%Prostate cancer: XX%

2012 2013 2014 2015 2016 2017 2018 2019

Rev

enue

s ($

m)


CAGR: XX%Bladder cancer: XX%Ovarian cancer: XX%Pancreatic cancer: XX%Prostate cancer: XX%

2012 2013 2014 2015 2016 2017 2018 2019

Pat

ient

s ('0

00)

Five-year prevalence population CAGR (2012–2019): XX%

Treatment population CAGR (2012–2019): XX%



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6.4 China

6.4.1 Treatment Usage Patterns

Compared to western markets, incidence of the four solid tumors in China is relatively low. Incidence of bladder cancer is highest; this is estimated to be XX cases per 100,000 persons. Incidence of ovarian, pancreatic and prostate cancers is estimated to be at XX, XX and XX cases per 100,000 persons, respectively.

6.4.2 Annual Cost of Treatment

The Annual cost of treatment is influenced by the coverage of each drug in the NRDL. Among the key oncology drugs discussed in the above sections, carboplatin, cisplatin and 5-FU are on Type-A category list on NRDL, with XX% reimbursement while most of the other drugs are in Type-B category which is eligible for just XX–XX% of coverage. One of these key drugs, Tarceva (erlotinib) is not on 2009 NRDL list.

6.4.3 Market Size

The market size for these four solid tumor indications in China is estimated to grow from $XXm to $XXm by 2019 at a CAGR of XX%. This growth is expected to be driven by increased treatment rates due to availability of more treatment options. Ovarian cancer is expected to show a robust growth of XX% in the forecast period and is estimated to have the largest share of the Chinese solid tumor market in the 2012, with $XXm which is expected to reach $XXm by 2019.


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Solid Tumors Market in Asia Pacific to 2019 - Deals and Strategic Consolidations

7 Solid Tumors Market in Asia Pacific to 2019 - Deals and Strategic Consolidations

7.1 Deals Analysis

The licensing agreements are more frequent both by type and deal value when compared with partnerships. Out of all four disease areas, prostate cancer has the highest frequency and value of deals. Between 2006 and 2010, a large number of deals were completed in prostate cancer, amounting to more than $XX billion. Both the number of and value of deals has decreased since 2010.

Figure 34: Solid Tumors Market, Global, Deals, 2006–2013

B) Deals by deal type, value and indication

2006 2007 2008 2009 2010 2011 2012 2013

Dea

l val

ue ($

m)

Dea

ls (n

umbe

rs)

A) Deals by year and deal value

Asi

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c

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ast a

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B) Deals by region

Licensing agreement Partnerships

Dea

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bn)




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Solid Tumors Market in Asia Pacific to 2019 - Appendix

8 Solid Tumors Market in Asia Pacific to 2019 - Appendix

8.1 Pipeline Drugs by Phase

Please find the drugs in discovery, preclinical, IND/CTA-filed, phase I and phase II stages of development in the attached appendix.

8.1.1 Phase III

Table 6: Solid Tumors Market, Global, Pharmaceutical Pipeline (Phase III), 2013

Drug name Company Targeted area Phase



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8.1.2 Pre-registration/NDA-filed

Table 7: Solid Tumors Market, Global, Pharmaceutical Pipeline (Pre-registration/NDA-filed), 2013

Drug name Company Targeted area Phase


8.2 Market Forecasts to 2018

8.2.1 APAC

8.2.1.1 Ovarian Cancer

Table 8: Solid Tumors Market, Asia-Pacific, Ovarian Cancer, Market Forecast, 2012–2019

Year 2012 2013 2014 2015 2016 2017 2018 2019 CAGR

(%)

Incidence per 100,000

Prevalence population

Treatment population

Annual cost of treatment ($)

Revenue ($m)


8.2.1.2 Bladder Cancer

Table 9: Solid Tumors Market, Asia-Pacific, Bladder Cancer, Market Forecast, 2012–2019

Year 2012 2013 2014 2015 2016 2017 2018 2019 CAGR

(%)





Revenue ($m)



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8.2.1.3 Pancreatic Cancer

Table 10: Solid Tumors Market, Asia-Pacific, Pancreatic Cancer, Market Forecast, 2012–2019

Year 2012 2013 2014 2015 2016 2017 2018 2019 CAGR

(%)





Revenue ($m)


8.2.1.4 Prostate Cancer

Table 11: Solid Tumors Market, Asia-Pacific, Prostate Cancer, Market Forecast, 2012–2019

Year 2012 2013 2014 2015 2016 2017 2018 2019 CAGR (%)

Incidence per100,000




Revenue ($m)


8.2.2 Australia


Table 12: Solid Tumors Market, Australia, Ovarian Cancer, Market Forecast, 2012–2019

Year 2012 2013 2014 2015 2016 2017 2018 2019 CAGR

(%)





Revenue ($m)



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Table 13: Solid Tumors Market, Australia, Bladder Cancer, Market Forecast, 2012–2019

Year 2012 2013 2014 2015 2016 2017 2018 2019 CAGR

(%)





Revenue ($m)



Table 14: Solid Tumors Market, Australia, Pancreatic Cancer, Market Forecast, 2012–2019

Year 2012 2013 2014 2015 2016 2017 2018 2019 CAGR

(%)





Revenue ($m)



Table 15: Solid Tumors Market, Australia, Prostate Cancer, Market Forecast, 2012–2019

Year 2012 2013 2014 2015 2016 2017 2018 2019 CAGR

(%)





Revenue ($m)



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8.2.3 China


Table 16: Solid Tumors Market, China, Ovarian Cancer, Market Forecast, 2012–2019

Year 2012 2013 2014 2015 2016 2017 2018 2019 CAGR

(%)





Revenue ($m)



Table 17: Solid Tumors Market, China, Bladder Cancer, Market Forecast, 2012–2019

Year 2012 2013 2014 2015 2016 2017 2018 2019 CAGR

(%)


Prevalence Population



Revenue ($m)



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Table 18: Solid Tumors Market, China, Pancreatic Cancer, Market Forecast, 2012–2019

Year 2012 2013 2014 2015 2016 2017 2018 2019 CAGR

(%)





Revenue ($m)



Table 19: Solid Tumors Market, China, Prostate Cancer, Market Forecast, 2012–2019

Year 2012 2013 2014 2015 2016 2017 2018 2019 CAGR

(%)





Revenue ($m)


8.2.4 India


Table 20: Solid Tumors Market, India, Ovarian Cancer, Market Forecast, 2012–2019

Year 2012 2013 2014 2015 2016 2017 2018 2019 CAGR

(%)





Revenue ($m)



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Table 21: Solid Tumors Market, India, Bladder Cancer, Market Forecast, 2012–2019

Year 2012 2013 2014 2015 2016 2017 2018 2019 CAGR

(%)





Revenue ($m)



Table 22: Solid Tumors Market, India, Pancreatic Cancer, Market Forecast, 2012–2019

Year 2012 2013 2014 2015 2016 2017 2018 2019 CAGR

(%)





Revenue ($m)



Table 23: Solid Tumors Market, India, Prostate Cancer, Market Forecast, 2012–2019

Year 2012 2013 2014 2015 2016 2017 2018 2019 CAGR

(%)





Revenue ($m)



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8.2.5 Japan


Table 24: Solid Tumors Market, Japan, Ovarian Cancer, Market Forecast, 2012–2019

Year 2012 2013 2014 2015 2016 2017 2018 2019 CAGR

(%)





Revenue ($m)



Table 25: Solid Tumors Market, Japan, Bladder Cancer, Market Forecast, 2012–2019

Year 2012 2013 2014 2015 2016 2017 2018 2019 CAGR

(%)





Revenue ($m)



Table 26: Solid Tumors Market, Japan, Pancreatic Cancer, Market Forecast, 2012–2019

Year 2012 2013 2014 2015 2016 2017 2018 2019 CAGR

(%)





Revenue ($m)



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Table 27: Solid Tumors Market, Japan, Prostate Cancer, Market Forecast, 2012–2019

Year 2012 2013 2014 2015 2016 2017 2018 2019 CAGR

(%)





Revenue ($m)


8.3 Market Definitions

Market coverage: four therapeutic indications in solid tumors: bladder cancer, ovarian cancer, pancreatic cancer and prostate cancer; in four countries in Asia-Pacific: Australia, China, India and Japan.

The prevalence population is the estimated number of people at any given point of time who are affected by solid tumors.

The prescription rate is the percentage of the cancer-suffering population that has been prescribed any drug therapy.

The prescription population refers to the number of people taking any drug for cancer.

8.4 Abbreviations

5-FU: Fluorouracil

ADC: Antibody-Drug Conjugate

ADT: Androgen Deprivation Therapy

AIHW: Australian Institute of Health and Welfare

AJCC: American Joint Committee on Cancer

APAC: Asia-Pacific

AR: Androgen Receptors

BBB: Blood-Brain Barrier

BCG: Bacillus Calmette-Guerin

BPH: Benign Prostatic Hyperplasia

CA-125: Cancer Antigen -125

CAGR: Compound Annual Growth Rate

CI: Confidence Interval

CRPC: Castration-Resistant Prostate Cancer

CSF-1R: Colony Stimulating Factor Receptor Type 1

CT or CAT: Computed Tomography

CYP17- 17 a-hydroxylase/C1720-lyase

DHT: Dihydrotestosterone

EGFR: Epidermal Growth Factor Receptor


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EMA: European Medicines Agency

FAMMM: Familial Atypical Multiple Mole Melanoma

FAP: Familial Adenomatous Polyposis

FDA: Food and Drug Administration

FGFR: Fibroblast Growth Factor Receptors

FIGO: International Federation of Gynecology and Obstetrics

FKBP-12: FK Binding Protein-12

FLT3: Fms-Like Tyrosine kinase-3

FR: Folate Receptor

GIST: Gastrointestinal Stromal Tumor

GnRH: Gonadotropin Releasing Hormone

hCG: human Chorionic Gonadotropin

HNPCC: Hereditary Non-Polyposis Colorectal Cancer

IL: Interleukin

IND: Investigational New Drug

IPR: Intellectual Property Rights

IUAC: International Union Against Cancer

IVP: Intravenous Pyelogram

IVU: Intravenous Urogram

LHRH: Luteinizing-Hormone-Releasing Hormone

MAbs: Monoclonal Antibodies

mCRPC: metastatic Castration-Resistant Prostate Cancer

MDR: Multidrug Resistance

mRCC: metastatic Renal Cell Carcinoma

MRI: Magnetic Resonance Imaging

mTOR: mammalian Target Of Rapamycin

MVAC: Methotrexate, Vinblastine, Doxorubicin and Cisplatin

NCCN: National Comprehensive Cancer Network

NCIC: National Cancer institute of Canada

NDA: New Drug Applications

NSCLC: Non-Small Cell Lung Cancer

ORR: Overall Response Rate

OS: Overall Survival

PBS: Pharmaceuticals Benefits Scheme

PDGFR: Platelet-Derived Growth Factor Receptors

PFS: Progression-Free Survival

P-gp: P-glycoprotein


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PIN Prostatic Intraepithelial Neoplasia

PMDA: Pharmaceuticals and Medical Devices Agency

pNET: pancreatic Neuroendocrine Tumors

PSA: Prostate-Specific Antigen

RAS: Rat Sarcoma

RB1: Retinoblastoma Protein

RCC: Renal Cell Carcinoma

RET: Neurotrophic factor Receptor

RTKs: Receptor Tyrosine Kinases

SEGA: Subependymal Giant cell Astrocytoma

SFDA: State Food and Drug Administration

SREs: Skeletal-Related Events

SWOG: Southwest Oncology Group

TNM: Tumor, Node, Metastatis

TP53: Tumor Protein 53

TTP: Time-To-Progression

TUR: Trans Urethral Resection

TURBT: Transurethral Resection of Bladder Tumor

TVU: Transvaginal Ultrasonography

VEGF: Vascular Endothelial Growth Factor

WHO: World Health Organization

8.5 Sources

Abraxane [Package Insert]. Celgene Corporation, 2013. Available from: http://www.abraxane.com/downloads/Abraxane_PrescribingInformation.pdf

Afinitor [Package Insert] Novartis, 2013 Available from: http://www.pharma.us.novartis.com/product/pi/pdf/afinitor.pdf

AJCC (2002). Ovarian Cancer. American Joint Committee on Cancer. Available from: http://www.cancerstaging.org/products/csmanual6ed-5.pdf

AIHW (2008). Cancer in Australia: An overview. Australian Institute of Health and Welfare. Available from: http://www.aihw.gov.au/publication-detail/?id=6442468196 [Accessed on July 25, 2013]

AIHW (2010a). Cancer in Australia. An overview 2010. Australian Institute of Health and Welfare. Available from: http://www.aihw.gov.au/publication-detail/?id=6442472459 [Accessed on July 25, 2013]

AIHW (2010b). Ovarian cancer in Australia, Cancer Series No: 52. Australian Institute of Health and Welfare and National Breast and Ovarian Cancer Centre. Available from: http://www.aihw.gov.au/WorkArea/DownloadAsset.aspx?id=6442454659 [Accessed on July 22, 2013]

AIHW (2012a). Cancer survival and prevalence in Australia: Period estimates from 1982 to 2010, Supplementary data tables: Bladder cancer. Cancer Series No: 69. Catalog No: CAN 65. Australian Institute of Health and Welfare. Available from: http://www.aihw.gov.au/WorkArea/DownloadAsset.aspx?id=10737422725 [Accessed on July 22, 2013]


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AIHW (2012b). Cancer survival and prevalence in Australia: Period estimates from 1982 to 2010, Supplementary data tables: Ovarian cancer. Cancer series No: 69. Catalog No: CAN 65. Australian Institute of Health and Welfare. Available from: http://www.aihw.gov.au/WorkArea/DownloadAsset.aspx?id=10737422743 [Accessed on July 22, 2013]

AIHW (2012c). Cancer survival and prevalence in Australia: Period estimates from 1982 to 2010, Supplementary data tables: Pancreatic cancer. Cancer Series No: 69. Catalog No: CAN 65. Australian Institute of Health and Welfare. Available from: http://www.aihw.gov.au/WorkArea/DownloadAsset.aspx?id=10737422744 [Accessed on July 22, 2013]

AIHW (2013). Australian Cancer Incidence and Mortality (ACIM) books: Pancreatic Cancer. Australian Institute of Health and Welfare. Available from: http://www.aihw.gov.au/WorkArea/DownloadAsset.aspx?id=60129542452 [Accessed on July 23, 2013]

APGI (2011). Statistics. Australian Pancreatic Cancer Genome Initiative. Available from: http://www.pancreaticcancer.net.au/patientcorner/pancreatic-cancer/what-is-pancreatic-cancer/pancreatic-cancer-statistics [Accessed on July 23, 2013]

Berthold DR et al. (2008). Docetaxel Plus Prednisone or Mitoxantrone Plus Prednisone for Advanced Prostate Cancer: Updated Survival in the TAX 327 Study. Journal of Clinical Oncology; 26(2); 242–245

Bray F, et al. (2013). Estimates of global cancer prevalence for 27 sites in the adult population in 2008. International Journal of Cancer; 132(5): 1133–1145.

Cancer Australia (2013a). Bladder cancer statistics. Cancer Australia. Available from: http://canceraustralia.gov.au/affected-cancer/cancer-types/bladder-cancer/bladder-cancer-statistics [Accessed on July 01, 2013]

Cancer Australia (2013b). Pancreatic cancer statistics. Cancer Australia. Available from: http://canceraustralia.gov.au/affected-cancer/cancer-types/pancreatic-cancer/pancreatic-cancer-statistics [Accessed on July 23, 2013]

Coso S and Williams ED (2009). Prostate Cancer Lymph Node Metastasis. The Open Prostate Cancer Journal; 2: 16–31.

de Bono JS et al. (2010). Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. The Lancet; 376 (9747): 1147–1154.

de Bono JS et al, (2011). Abiraterone and Increased Survival in Metastatic Prostate Cancer. New England Journal of Medicine; 364 (21); 1995–2005

Doxil [Package Insert]. Janssen Products, 2013. Available from: http://www.doxil.com/shared/product/doxil/prescribing-information.pdf

Duncombe J et al. (2009). Bladder Cancer in New South Wales. Cancer Institute NSW. Available from: http://www.cancerinstitute.org.au/media/22605/2009-02_bladder_cancer_in_nsw.pdf

European Medicines Agency (2012). Avastin, EPAR summary for the public. European Medicines Agency, Available from: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000582/WC500029260.pdf

Gemzar [Package Insert]. Eli Lilly, 2013. Available from: http://pi.lilly.com/us/gemzar.pdf

Globocan (2008). Cancer Incidence and Mortality Worldwide [database], IARC CancerBase No. 10 Available from: http://globocan.iarc.fr/

Gupta P et al. (2009). Impact of age and gender on the clinicopathological characteristics of bladder cancer. Indian Journal of Urology; 25: 207–210.

ICMR (2010). Three-Year Reports of Population Based Cancer Registries 2006-2008, National Cancer Registry Program. Indian Council of Medical Research. Available from: http://www.ncrpindia.org/Reports/PBCR_2006_2008.aspx [Accessed on July 1, 2013]


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Jing Li, et al, (2010). Pancreatic Cancer: Pathobiology, Treatment Options, and Drug Delivery. The American Association of Pharmaceutical Scientists (AAPS) Journal. June; 12(2):223:232

Kobayashi H and Wake N (2013). Patient Surveillance After Cancer Treatment. Ovarian Cancer Surveillance Counterpoint: Japan Current Clinical Oncology 2013, Humana Press.

Kricker A (2002). Ovarian cancer in Australian women. National Ovarian Cancer Centre. Available from: http://www.gynaecancercentre.gov.au/sites/default/files/publications/oaw-ovarian-cancer-in-australian-women_504af028c1fef.pdf

Miele H et al (2009). Albumin-bound formulation of paclitaxel (Abraxane® ABI-007) in the treatment of breast cancer. International Journal of Nanomedicine; 4: 99–105

Murthy NS et al. (2009). Changing Trends in the Incidence of Ovarian Cancer in India. Asian Pacific Journal of Cancer Prevention; 1: 1025–1030.

National Cancer Institute (2013a). Stage Information for Bladder Cancer. National Cancer Institute. Available from: http://www.cancer.gov/cancertopics/pdq/treatment/bladder/HealthProfessional/page3 [Accessed on August 12, 2013]

National Cancer Institute (2013b). Stage Information for Ovarian Epithelial Cancer. National Cancer Institute. Available from: http://www.cancer.gov/cancertopics/pdq/treatment/ovarianepithelial/HealthProfessional/page3 [Accessed on August 12, 2013]

National Cancer Institute (2013c). Stage Information for Pancreatic Cancer. National Cancer Institute. Available from: http://www.cancer.gov/cancertopics/pdq/treatment/pancreatic/HealthProfessional/page3 [Accessed on August 12, 2013]

National Cancer Institute (2013d). Stage Information for Prostate Cancer. Available from: http://www.cancer.gov/cancertopics/pdq/treatment/prostate/HealthProfessional/page2 [Accessed on 12 August 2013]

National Comprehensive Cancer Network (2013a). NCCN Clinical Practice Guidelines in Oncology: Bladder Cancer, Version I.2013. Available from: http://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf

National Comprehensive Cancer Network (2013b). NCCN Clinical Practice Guidelines in Oncology: Ovarian Cancer, Version 2.2013. Available from: http://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf [Accessed on 12 August, 2013]

National Comprehensive Cancer Network (2013c). NCCN Clinical Practice Guidelines in Oncology: Pancreatic Adenocarcinoma, Version 1.2013. Available from : http://www.nccn.org/professionals/physician_gls/pdf/pancreatic.pdf [Accessed on 12 August, 2013]

National Cancer Research Center (2013). Cancer Incidence Data by regional cancer registries nationwide estimate in 1975-2008. Cancer Control and Information Services Center, National Cancer Research Center, Japan. Available from: http://ganjoho.jp/data/professional/statistics/odjrh3000000hwsa-att/cancer_incidence(1975-2008).xls [Accessed on July 1, 2013]

PMDA (2013). Profile of Services 2012-2013. Pharmaceutical and Medical Devices Agency, Japan. Available from: http://www.pmda.go.jp/english/about/pdf/profile_of_services.pdf

Pharmaceutical Benefits Advisory Committee (2012). Abiraterone Public Summary Document. Available from: http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/psd/2012-07/abiraterone

Stewart SL (2012). Ovarian Cancer Incidence: Current and Comprehensive Statistics. In: Farghaly S, ed. Ovarian Cancer - Clinical and Therapeutic Perspectives. ISBN: 978-953-307-810-6, InTech.

Surveillance Epidemiology and End Results (2013). SEER Stat Fact Sheets: Pancreas. Available from: http://seer.cancer.gov/statfacts/html/pancreas.html


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Tarceva [Package Insert]. Genentech and OSI Pharmaceuticals, 2013. Available from: http://www.gene.com/download/pdf/tarceva_prescribing.pdf

Taxotere [Package Insert]. Sanofi, 2010. Available from: http://products.sanofi.us/taxotere/taxotere.pdf

Ushijima, K (2010). Treatment for Recurrent Ovarian Cancer—At First Relapse. Journal of Oncology; 2010

Xtandi [Package Insert] Astellas, 2013 Available from: http://www.us.astellas.com/docs/us/12A005-ENZ-WPI.pdf

8.6 Research Methodology

GBI Research’s dedicated research and analysis teams consist of experienced professionals with marketing, market research and consulting backgrounds in the pharmaceutical industry as well as 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.

8.6.1 Coverage

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

Changes to the industry taxonomy are built 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.

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 pharmaceutical industry, updated on a daily basis.

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

8.6.2 Secondary Research

The research process begins with exhaustive secondary research on internal and external sources in order 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 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 web-casts specific to the companies operating in the market


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8.6.3 Primary Research

GBI Research conducts hundreds of primary interviews a 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 and future outlook.

It helps in validating and strengthening the secondary research findings.

It further develops the analysis team’s expertise and market understanding.

Primary research involves email and telephone interviews as well as 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

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

8.6.4 Therapeutic Landscape

Revenues for each indication, geography-wise, are arrived at by utilizing the GBI Research market forecasting model. The global revenue for each indication is the sum value of revenues of all seven regions.

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 generic share of the market for each indication is obtained by calculating the prescription share for generic drugs and the respective cost of treatment.

The treatment usage pattern which includes quantitative data on the diseased population, treatment-seeking population, diagnosed population and treated population for an indication, is arrived at by referring to various sources as mentioned below.

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

8.6.4.1 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 on the average dosage regimen for that disease, duration of treatment and number of patients who are prescribed drug treatment (prescription population). Prescription population is calculated as the percentage of population diagnosed with a disease (diagnosis population). Diagnosis population is the population diagnosed with a disease expressed as a percentage of the population that is seeking treatment (treatment-seeking population). Prevalence of a disease (diseased population) is the percentage of the total population who suffer from a disease/condition.

Data on the 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.


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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 sources for the price of drugs are RxUSA, ZenRx and the British National Formulary.

The epidemiology-based forecasting model uses a bottom-up methodology and it makes use of estimations in the absence of data from research publications. Such estimations may result in a final market value which 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

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

Diseased Population

The diseased population for any indication is the prevalence. The Prevalence population for this report is taken from articles published in various journals.

Prescription Population

Solid Tumors has multiple treatment options depending upon the stage of the disease and -previous effectiveness of other similar treatments. Options for treatment include surgical intervention, radiation therapy, chemotherapy and hormonal or bone drug therapy. The prescription population is defined as the number of patients who are prescribed any drug therapy including chemotherapy. This is calculated as a percentage of the diagnosis population. Prescription population proportion is taken from articles published in various journals.


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8.6.4.2 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 37: GBI Research Market Forecasting Model

D is ea se P opulati onGener al Po pu la tio n 743 ,5 35 ,0 48

Q u alifyin g c on dition 1 (Age /S e x/O c c upatio n etc )Q u alifyin g c on dition 2 (Age /S e x/O c c upatio n etc )

Preva l ence t issue v alve disea se 0.2% 1 ,7 84 ,4 84 Q u alifyin g c on dition (c om plic at ion, s eve rity)D IS EA SE D P OPU LA T IO N 1 ,7 84 ,4 84

T r eatm e nt Flow P attern sT reatm ent S eeki ng R at e (Sy m ptom s / Dis A ware ne ss) 8 9% 1 ,5 88 ,1 91 Diagn osis Rat e ( C lin ical and D ia gn os tic Tes t s) 7 5% 1 ,1 91 ,1 43

Presc r iption R ate ( Ph ys ic ian P erc ep t io n, Tr e atm e nt E ffec tiv e n es s)Tis s ue V alve 7 0% 8 33 ,8 00 O the r T reatm en ts fo r Valve (Su r g/M ed /N o ne) -

F ulfillm en tA vaila bilit y NAW illing ne ss to U s e (Pa tient Perc ep tio ns) NAR ead y to U se (S u rg ery elig ib ility , R eus e etc ) NA

Affo rd abil it y at Pric eH E as % of G D P s p endA verag e Inc om e (per individ ua l)P at ient O ut-o f -p oc ket Bud ge t (A nnu al)

Bu dg et a lloc a tion to on e-t ime s urge ryBu dg et a lloc a tion to othe r h ealth ne eds

A verag e Pay or C overa geP at ient L iabili ty

Targe t Pr ic e ( @ 20 % pat liab )A SP for C o s t o f T hera py

T O TA L P AT IEN T V OLU M E S

Pro du ct P urch ase Fr equ enc y 1 T OT A L U N IT VO LU MES

Pr ic in g pe r Un it 18 ,0 00$ Inf lat ionP rice D ec reas e du e to c om p et it ion

M ar ket Va lu e

G B I R es ear ch M a r ket S iz ing M o del

Source: GBI Research

The above figure represents a typical forecasting model followed in 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 the general population and then follows the treatment seeking population as a percentage of the diseased population and 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.

8.6.5 Geographical Landscape

GBI Research analyzes the major geographies in APAC: Australia, China, India and Japan. The total market size for each country is provided which is the sum value of the market sizes of all the indications for that particular country. The maximum and minimum estimated market sizes are then provided by adjusting all variables expected to impact upon the market during the forecast period in order to provide the best and worst-case scenarios.

Articles from research journals and agency publications, National Institute of Health and ClinicalTrials.gov are the source of data for the estimation of market size and making forecasts.


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8.6.6 Pipeline Analysis

This section provides a list of molecules at various stages in the pipeline for various indications. The list is sourced from internal database 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 mechanism of action. The latest press releases issued by the company and news reports are also the source of information for the status of the molecule in the pipeline. This list of pipeline molecules, in conjunction with a list of ongoing and completed clinical trials, is analyzed in this section, and a full breakdown of pipeline molecules and clinical trials by Phase, molecule type and molecular target is provided.

8.7 Expert Panel Validation

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

GBI Research expert panel comprises marketing managers, product specialists, international sales managers from pharmaceutical 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 are adjusted in accordance with their feedback.

8.9 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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