PHARMA GSBD Full and Final

8/8/2019 PHARMA GSBD Full and Final

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OPPORTUNITY FOR

PHARMACEUTICALOUTSOURCING

IN INDIA

GROUP 3


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GROUP MEMBERS

AVELINE PERIS

HARINI SUGANDH AGARWAL

PRANAV PRAKASH

KETAKI JADHAV

HENAL PACNMATIYA

VISHAKHA VERMA


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CONTENTS

Industry overview

Indian Scenario

Leading Companies in India which export

Growth potential

Reforms/Policies

Advantages

Challenges Recommendations

Comparison with IT/BPO


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PHARMACEUTICAL INDUSTRY

TRENDS- GLOBAL SCENARIO Projected of the global pharmaceutical market in 2010 , 4 - 6%

exceeding $825 billion.

The global pharmaceutical market sales expected grow th at a

4 7% CAGR through 2013.

Global pharmaceutical market value is expected to expand to

$975+ billion by 2013

Growth driven by stronger near-term growth in the US market

and is based on the global macro economy, the changing

combination of innovative and mature products apart from the

rising influence of healthcare access and funding on market

demand.


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OUTSOURCING

Used more strategically as a part of business

strategy.

Drug discovery till manufacturing of the products

Pharmaceutical firms have long outsourced

functions such as manufacturing, packaging,

clinical trials and sales force mobilization.

Biotechnology companies


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WHY PHARMA COMPANIES

OUTSOURCE

Cost benefit advantage

Faster and cheaper

Improve manufacturing efficiencies

Reduce excess production capacity by divesting

facilities

Divert resources to focus on other competencies to establish consistency and efficiency across

international networks


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LEADING SERVICE PROVIDERSFUNCTIONS SERVICE PROVIDERS

Drug Discovery/Medicinal Chemistry Aurigene, Divi's Laboratories,Syngene, Suven Lifesciences, GVKBio

Pre-clinicals Vimta Labs, Lambda TherapeuticResearch, Lotus Labs

Central Lab Services SRL Ranbaxy, Vimta Labs

Clinical Research Quintiles, Syngene, Chembiotek,Aurigene, Synchron, Reliance,Covance, Parexel

Manufacturing & Formulations Jubilant Organosys (speciality chemicals/bulk drugs), ShasunChemicals (Custom Synthesis),Medreich, Elder, Divi'sLaboratories

Bio-informatics and other IT services Strand Genomics, TCS, Satyam,

Infosys, GVK Bio, Ocimum, JubilantBiosys


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INDIAN PHARMACEUTICAL INDUSTRY

Estimated worth $ 4.5 billion- growth at 8-9%

India's bio-tech industry at 17% growth with

revenues of Rs 137 Billion Second largest in world in terms of volume

Ranks 14th in terms of value at over Rs 1 lakh crore

Growth is fuelled by exports, increased 25% in 2008-

09

Highly organized sector

Meets around 70% of domestic needs


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INDIAN PHARMACEUTICAL INDUSTRY

Produces almost every type of medicines

De-licensing of the pharma industry

Low costs of production and R&D

Exports drug, intermediaries, active

pharmaceutical ingredients, finished dosage

formulations, bio-pharmaceuticals and clinicalservices.

Top five destinations for such exports are USA,

Germany , Russia, UK and China.


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INDIAINDIA {{ GRADUALLY BUILDING AGRADUALLY BUILDING A

TRACK RECORDTRACK RECORD


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INDIAN PHARMACEUTICAL EVOLUTION

Phase II

Government Control

Indian Patent Act 1970

Drug prices capped

Local companies begin

to make an impact

Phase III

Development Phase

Process

development

Production

infrastructure

creation

Export initiatives

Phase IV

Growth Phase

Rapid expansion of

domestic market

International market

development

Research orientation

Phase V

Innovation and Research

New IP law

Discovery Research

Convergence

1970 1980 1990 2000 2010

Phase I

Early Years

Market sharedomination byforeign companies

Relative absenceof organizedIndian companies


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MOVING UP THE VALUE CHAIN

Specialty

Products

Innovative

Products

TIME

Generic exports

to under-developed &

developing

countries

Generic

exports to

developedcountries

API

Exports

VALUE


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WHY INDIA NOW?

Export procedures simplified

No import duty

Drug laws amended to permit global studies

Patent act amended; IPR in place

Untapped patient population

GCP compliant IRBs

GCP guidelines ICH compliant Start up time reduced to 8-12 weeks

CAP certified central labs

13


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ADVANTAGE INDIA Competent workforce , Large skill base and Vast talent pool

Unmatched Cost Competitiveness

Cost-effective chemical synthesis

Legal & Financial Framework Information & Technology

Globalisation

Consolidation

Strong Local Industry

Speed

Availability Of Capital


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WHY OUTSOURCING INDIA? Greatest potential for cost saving

Regulatory Compliance

Good Service and On time delivery

Govt. policies favoring R & D

Growth in health insurance sector

Biggest market with vast potential


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OUTSOURCING

OPPORTUNITIES

INDIA

BULK DRUGS &FORMULATIONS

MANUFCATURING CONTRACTMARKETING AND

SALES

INTERNATIONAL

CLINICALTRIALS

TECHNICALSERVICES

HERBALSNEUTRACEUTICALS

BIOINFORMATICSBIOSTATISTICS

SOFTWAREDEVELOPMENT

PRIMARYPACKAGINGMATERIALS

PLANT MACHINERYAND PHARMAEQUIPMENT

CONTRACT

R & D

MEDICINAL

CHEMISTRY

OUTSOURCING OPPORTUNITIES IN INDIA


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MNC PHARMA COMPANIES

BRISTOL

MYERS

SQUIBB

ROCHE MERCK

WYETH

ELI LILLYNOVARTI

S

AVENTIS

PFIZER

ASTRA

ZENECA

GSK


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OUTSOURCING IN

PHARMACEUTICAL INDUSTRY

Drug Discovery And Development (R&D)

Contract Research and Manufacturing Services

(CRAMS)

IT Services

Business Process Outsourcing (BPO)


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PRODUCT GROUPS COVERED

Bulk drugs / drug intermediates

Drug formulations

Herbals / Ayurvedics / Homeopathic / Unani

Medicinal Plants

Bio-tech / Biological products

Diagnostics and Surgicals

NeutraceuticalsCollaborative /contract research

Clinical trials

Pharma consultancy services etc.


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DRUG DISCOVERY

ANDDEVELOPMENT (R&D)

The drug innovation process

The key drivers for Outsourcing/ Offshoring of

R&D

Outsourcing across the R&D Value Chain

City Wise Vendor Analysis

Other Emerging Trends


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THE DRUG INNOVATION PROCESS


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ROAD TO MARKET


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C.R.O.

CROs expand the speed and capacity of product

development pipeline while maintaining Quality

and High Levels of Regulatory Compliance

CROs help companies reduced R&D costs

Drug Companies with a high reliance on CROsstay closer to schedule than those making less use

of CROs.


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EMERGING CRO MARKET IN INDIA


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C.R.O. IN INDIA

Fast speed of patient enrollment

Shorter time for clinical trials upto 75% faster

SPEED OFPATIENT

ENROLLMENT

Heterogeneous mix of people

Vast and diverse disease and patient population

GENE POOLADVANTAGE

Highly trained nurses physicians and technicalpersonnel

India has great IT skillsTALENT POOL


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C.R.O. IN INDIA

Numerous world class medical facilities thatmeet global requirements for Clinical TestingINFRASTRUCTURE

30- 35% cheaper than in the USCOST

Compliance with Global Ethical and RegulatoryStandards, such as ISO, ICH, GSP, GLBQUALITY


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OUTSOURCING ACROSS THE

R&D VALUE CHAIN


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R&D VALUE CHAIN


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R&D VALUE CHAIN


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R&D VALUE CHAIN


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OUTSOURCING HUBS


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GROW

TH

Manufacturingand MarketingCompanies

LittleOutsourcing

before 2000

Late 1990s

ContractManufacturing GSK

Clinical Trials andSite Management GSK

Clinical DateManagement - GSK

Early 2000

Contract Manufacturing Pfizer , Novartis, EliLilly, Wyeth

IT Services- -GSK, Astra

Zeneca, WyethDiscovery GSK, Pfizer,Eli Lily

Clinical Trials And SiteManagement - Aventis,Pfizer, Astra Zeneca, EliLilly

Clinical DataManagement - Wyeth

Late 2000 ( 2005

Onwards)Contract Manufacturing Merck, BMS

IT Services- -GSK, Pfizer

Discovery Novartis,Wyeth

Clinical Trials And Site

Management - Novartis,Merck

Clinical Data Management Pfizer

BPO

F&A - GSK

Content Development -

GSK


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INDIA HIGH ON THE OUTSOURCING

LIST FOR CLINICAL TRIALS ! A number of 122 Clinical trials are conducted in India next to

Taiwan,Mexico,Poland,Brazil.

GlaxoSmithKline, among the worlds top ten global pharma majors, is

currently carrying out the largest number of clinical trials in India. UK-based pharma major is conducting 13 drug trials in India for the

treatment of diseases such as cancer,arthritis,heart disease and constipation.

Johnson & Johnson, Eli Lilly are conducting respectively eight studies in

India.

Suven Life Sciences & Sipra Labs are also actively invloved in the Trials.

Clinical Trials in India, costs 50% to 60% less than the average cost in the

US.

AstraZeneca another global pharma company outsourcing significant

number of its trials to India


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CHALLENGES FACED Growth in the domestic formulations market is

slowing down

Competition from cheap imports

Price wars between regional and local pharma

companies

MNC pharma companies are getting more aggressive

at protecting their patents and defending their marketshare after patent expiry.

Confusion in the grant of EMR, due to lack of

transparency in the process.


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OTHER CHALLENGES

Regulatory obstacles

Lack of proper infrastructure

Expensive research equipments Lack of academic collaboration

Underdeveloped molecular discovery program

Divide between the industry and study curriculum

Severe competition


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INDIA

PERCEPTIONS & REALITIESPerception RealityGCP awareness absent or low

Many sites in India are trained in GCP now

mandated by Government

Data integrity in question

Various audits of the study show no adverse

findingIn India U FDA has audited sites with no major

comments

Different languages cause

confusion and escalate costs

because of need to translate

documents

English used for all healthcare- related activities,

systems, procedures and drug labels. Only

patient-related documents need translation

Telecommunication poor

Connectivity poor

Telecommunication facilities good in urban

areas. Connectivity good EDC studies possible

electronic transmission of ECG, imagings

frequent.


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STEPS TO STRENGTHEN THE INDUSTRY

1. Attain the right product-mix for sustained future

growth

2. Focus on core competencies will play an

important role

3. Can look at merger and acquisition options of

either companies or products.

4. Improve their R&D efforts and improve

distribution to penetrate markets.


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GOVERNMENT INITIATIVES

Pharmaceutical units are eligible for weighted tax reduction

at 150% for the research and development expenditure

obtained

Two new schemes New Millennium Indian TechnologyLeadership Initiative and the Drugs and Pharmaceuticals

Research Program have been launched

Contemplating the creation of SRV or special purpose

vehicles with an insurance cover to be used for funding

new drug research

The Department of Pharmaceuticals is mulling the creation

of drug research facilities


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ASSISTANCE TO EXPORTERS

Issue of RCMC certificates

Delegations to foreign countries

Buyer seller meetings

Foreign buyer details

Embassy assistance

Exhibition participation

Seminars and Conferences

Technology assistance


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GROWTH OPPORTUNITIES

New drugs for neglected diseases

Under-penetrated Chinese markets

Global herbal market

R & D outsourcing

Diversify their process re-engineering skills

Drug discovery and development services


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FUTURE SCENARIOAccording to a study by FICCI-Ernst & Young

India will open a probable US$ 8 billion market for MNCs

selling expensive drugs by 2015:

US$ 20 billion by 2015

The Minister of Commerce estimates investments of US$6.31 billion

Public spending on healthcare -7% of GDP in 2007 to 13% of

GDP by 2015

Dr Reddy's Laboratories has tied up with GlaxoSmithKline

Lupin, to tap opportunities of about US$ 200 million in the USoral contraceptives market

Indian pharmaceutical off-shoring industry is designated to

turn out to be a US$ 2.5 billion opportunity by 2012


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CONCLUSION

India has an opportunity to become the Drug

Discovery R&D Outsourcing destination to the

world

Company can focus efforts on core competencies /

skills and contract critical services

Speed to market can be enhanced through

outsourcing strategic needs symbiotic relationship in marketing and

commercialization and outsource partners supply

new innovative products

PHARMA GSBD Full and Final

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