Biosimilars in Emerging Economies - Advanced Recombinant Technology Platforms and Low Cost Manufacturing Put India and China at a Strategic Advantage in Biosimilar Production

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Biosimilars in Emerging Economies - Advanced Recombinant Technology Platforms and Low Cost Manufacturing Put India and China at a Strategic Advantage in Biosimilar Production

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Biosimilars in Emerging Economies - Advanced Recombinant Technology Platforms and Low Cost Manufacturing Put India and China at a Strategic Advantage in Biosimilar Production

Summary China India China

This report is built using data and information sourced from proprietary databases, primary and secondary research, and in house analysis by GBI Research's team of industry experts.

The emerging biosimilars market has grown significantly in the recent past and has the ability to grow in the future due to the expiry of patents for major biological drugs, pressure on governments in emerging economies to reduce healthcare costs, and the savings that can be obtained with biosimilars over branded biologics. The emerging biosimilars market was valued at $0.3 billion in 2002 and increased to a value of $3.3 billion in 2010, at a CAGR of 34%. The market is expected to increase to a value of $8 billion in 2018 at a CAGR of 12%. Strategic consolidations, such as M&As, licensing agreements and co-developments, are actively pursued by major pharmaceutical companies, many of which are from India. The launch of a number of biosimilars that are presently in the late stage of development in the R&D pipeline, and government initiatives to develop the biosimilars market in emerging economies, will also drive growth.

Major pharmaceutical companies such as Dr. Reddy's, Biocon and Intas Biopharmaceuticals (IBPL) from India, along with 3SBio from China, have created a strong position for themselves in the emerging biosimilars market, with a number of biosimilar products launched and generating revenue. Companies such as Cipla, Ranbaxy and Lupin have shown interest in the opportunities offered by the emerging biosimilars market and have taken initiatives to enter the market through strategic consolidations and biosimilars R&D. However, the regulatory guidelines for biosimilars require strengthening in most emerging economies in order to meet international standards and increase coverage to include all types of biosimilars.

Scope

- Data and analysis on biosimilars markets in emerging economies - Market forecasts for the emerging biosimilars market to 2018, with regional market forecasts for India and China.- Key drivers and restraints that have had a significant impact on the emerging biosimilars market.- The regulatory environment for biosimilars in India, China and other emerging economies.- Analysis of key companies in the industry, with profiles of major companies in the emerging biosimilars market.- Analysis of the biosimilars R&D pipeline across various stages of development.- Key M&A activities, licensing agreements and co-developments that have taken place in the emerging biosimilar market

Reasons to buy

- Make more informed business decisions from the insightful and in-depth analysis of the emerging biosimilars market and the factors that shape it.- Identify key areas of deal making through an understanding of the deals landscape in the emerging biosimilars market.- Build effective strategies to launch pipeline products by identifying potential target regions.- Identify prominent companies from emerging economies and their capabilities for collaborations.- Exploit in-licensing and out-licensing opportunities by identifying products that might fill your portfolio gaps.1 Table of Contents1 Table of Contents 61.1 List of Tables 91.2 List of Figures 102 Introduction 113 Biosimilars in Emerging Economies – Market Overview 123.1 Biosimilars 123.1.1 Types of Biosimilars 123.2 Comparison of Biosimilars with Biologics and Generics 163.2.1 Structural Differences between Biologics, Generics and Biosimilars 173.3 Development of Biosimilars 183.4 Manufacturing of Biosimilars 193.4.1 Establishing a New Biosimilar Manufacturing Facility 193.5 Drivers and Restraints 203.5.1 Drivers 203.5.2 Restraints 213.6 Top 10 Biologics in 2010 223.7 Patent Expiries of Leading Biologics 233.8 Price Comparison of Biosimilars and Reference Products 234 Biosimilars in Emerging Economies – Market Characterization 244.1 Biosimilars Market Size and Forecast for Emerging Economies 244.2 Major Marketed Biosimilars in Emerging Economies 255 Biosimilars in Emerging Economies – India 285.1 Biosimilars Market Overview 285.2 Key Market and R&D Trends 295.2.1 Biocon's Deal to Commercialize Biosimilar Versions of Insulin Products with Pfizer Cancelled 295.3 Regulatory Landscape in India 295.3.1 Regulatory Framework for Biosimilars 295.4 Challenges and Opportunities 305.4.1 Challenges 305.4.2 Opportunities 305.5 Key Companies 315.5.1 Dr. Reddy's Laboratories (DRL) 315.5.2 Biocon 325.5.3 Intas Biopharmaceuticals (IBPL) 345.5.4 Reliance Life Sciences 365.5.5 Wockhardt 385.5.6 Lupin 395.5.7 Cipla 406 Biosimilars in Emerging Economies – China 426.1 Biosimilars Market Overview 426.1.1 Marketed Biosimilars in China 436.2 Regulatory Landscape in China 436.2.1 Regulatory Framework for Biosimilars 436.3 Challenges and Opportunities 446.3.1 Challenges 446.4 Key Companies 446.4.1 3SBio 446.4.2 Shanghai CP Guojian Pharmaceutical Co. Ltd. 466.4.3 Biotech Pharma 477 Biosimilars in Emerging Economies – Other Emerging Economies 497.1 Brazil 497.1.1 Biosimilars Regulatory Framework and Approval Process 497.1.2 Biosimilars Coverage and Availability at Reduced Cost 497.1.3 Biosimilars Market Opportunity 497.1.4 Major Challenge 507.2 Russia 507.3 Mexico 507.4 Turkey 517.4.1 Biosimilar Guidelines in Turkey 517.4.2 Risk Management Plan 527.4.3 New Pharmacovigilance Legislation 527.4.4 Actavis and Bioton Collaborate for Insulin 537.5 Argentina 537.5.1 Major Challenge 537.6 South Africa 537.6.1 Guidelines for Similar Biological Medicines 547.6.2 Genius Biotherapeutics 547.6.3 Major Challenges 557.7 Venezuela 557.8 Vietnam 567.8.1 Innogene Kalbiotech 567.8.2 Major Challenge 577.9 Thailand 587.9.1 Major Challenges 598 Biosimilars in Emerging Economies – Pipeline Analysis 608.1 Introduction 608.2 R&D Pipeline – Filed 628.3 R&D Pipeline – Phase III 628.4 R&D Pipeline – Phase II 648.5 R&D Pipeline – Phase I 648.6 R&D Pipeline – Pre-clinical 658.7 R&D Pipeline – Discovery 678.8 R&D Pipeline – IND Filed 689 Biosimilars in Emerging Economies – Industry Dynamics 719.1 Strategies Adopted By Branded Biologic Companies to Beat Generic Competition 719.1.1 Introduction 719.1.2 Second Generation Biologics 729.1.3 New Formulation 729.1.4 Combination Products 729.1.5 New Approved Indications 739.2 Industry Dynamics: Strategies to Be Adopted by Companies to Enter the Biosimilars Market 739.2.1 Product 749.2.2 Price 749.2.3 Place 759.2.4 Promotion 759.2.5 People 7510 Biosimilars in Emerging Economies – Deals Analysis 7610.1 Mergers and Acquisitions 7610.1.1 M&A by Year 7610.1.2 M&A by Value 7710.1.3 M&A by Type 7710.1.4 M&A Deals 7810.2 Licensing Agreements 8010.3 Co-developments 8211 Biosimilars in Emerging Economies - Appendix 8411.1 Market Definitions 8411.2 Abbreviations 8411.3 Bibliography 8611.4 Research Methodology 8811.4.1 Market Overview 8911.4.2 Market Characterization 8911.4.3 India 8911.4.4 China 8911.4.5 Other Emerging Economies 8911.4.6 Pipeline Analysis 9011.4.7 Industry Dynamics 9011.4.8 Deals Analysis 9011.5 Contact Us 9011.6 Disclaimer 90

1.1 List of Tables

Table 1: Biosimilars in Emerging Economies, Key Patent Expiries of Leading Biologics From 2011–2018 23Table 2: Biosimilars in Emerging Economies, Revenue ($bn), 2002–2010 24Table 3: Biosimilars in Emerging Economies, Revenue Forecasts ($bn), 2010–2018 24Table 4: Biosimilars in Emerging Economies, Marketed Biosimilar Products, India, 2012 25Table 5: Biosimilars in Emerging Economies, Marketed Biosimilar Products, China, 2012 26Table 6: Biosimilars in Emerging Economies, Marketed Biosimilar Products, Other Emerging Economies, 2012 27Table 7: Biosimilars in Emerging Economies, India, Revenue ($bn), 2002–2010 28Table 8: Biosimilars in Emerging Economies, India, Revenue Forecasts ($bn), 2010–2018 28Table 9: Biosimilars in Emerging Economies, Marketed Biosimilar Products, Dr. Reddy's, 2012 31Table 10: Biosimilars in Emerging Economies, Marketed Biosimilar Products, Biocon, 2012 33Table 11: Biosimilars in Emerging Economies, Pipeline Molecules, Biocon, 2012 33Table 12: Biosimilars in Emerging Economies, Marketed Biosimilar Products, IBPL, 2012 34Table 13: Biosimilars in Emerging Economies, Marketed Biosimilar Products, Reliance Life Sciences, 2012 36Table 14: Biosimilars in Emerging Economies, Pipeline Molecules, Reliance Life Sciences, 2012 37Table 15: Biosimilars in Emerging Economies, Marketed Biosimilar Products, Wockhardt, 2012 38Table 16: Biosimilars in Emerging Economies, Pipeline Molecules, Lupin, 2012 39Table 17: Biosimilars in Emerging Economies, Pipeline Molecules, Cipla, 2012 40Table 18: Biosimilars in Emerging Economies, China, Revenue ($bn), 2002–2010 42Table 19: Biosimilars in Emerging Economies, China, Revenue Forecasts ($bn), 2010–2018 42Table 20: Biosimilars in Emerging Economies, Marketed Biosimilar Products, China, 2012 43Table 21: Biosimilars in Emerging Economies, Marketed Biosimilar Products, 3SBio, 2012 44Table 22: Biosimilars in Emerging Economies, Pipeline Molecules, 3SBio, 2012 45Table 23: Biosimilars in Emerging Economies, Marketed Biosimilar Products, CPGJ, 2012 46Table 24: Biosimilars in Emerging Economies, Pipeline Molecules, CPGJ, 2012 46Table 25: Biosimilars in Emerging Economies, Marketed Biosimilar Products, Biotech Pharma, 2012 47Table 26: Biosimilars in Emerging Economies, Pipeline Molecules, Filed, 2011 62Table 27: Biosimilars in Emerging Economies, Pipeline Molecules, Phase III, 2011 62Table 28: Biosimilars in Emerging Economies, Pipeline Molecules, Phase II, 2011 64Table 29: Biosimilars in Emerging Economies, Pipeline Molecules, Phase I, 2011 64Table 30: Biosimilars in Emerging Economies, Pipeline Molecules, Pre-clinical, 2011 65Table 31: Biosimilars in Emerging Economies, Pipeline Molecules, Discovery, 2011 67Table 32: Biosimilars in Emerging Economies, Pipeline Molecules, IND Filed, 2011 68Table 33: Biosimilars in Emerging Economies, Pipeline Molecules, Unknown Phase, 2011 68Table 34: Biosimilars in Emerging Economies, M&A by Year, 2007–2010 76Table 35: Biosimilars in Emerging Economies, M&A by Value ($m), 2007–2011 77Table 36: Biosimilars in Emerging Economies, M&A Deals, 2007–2011 78Table 37: Biosimilars in Emerging Economies, Licensing Agreements, 2007–2011 80Table 38: Biosimilars in Emerging Economies, Co-developments, 2007–2011 82

1.2 List of Figures

Figure 1: Biosimilars in Emerging Economies, EPO Biosimilars Marketed Outside the US and EU, 2011 12Figure 2: Biosimilars in Emerging Economies, G-CSF Biosimilars Marketed Outside the US and EU, 2011 13Figure 3: Biosimilars in Emerging Economies, INF Alpha Biosimilars Marketed Outside the US and EU, 2011 13Figure 4: Biosimilars in Emerging Economies, Biosimilars Comparison With Biologics and Generic, 2012 16Figure 5: Biosimilars in Emerging Economies, Size and Complexity, Small Molecule Drugs and Proteins, 2012 17Figure 6: Biosimilars in Emerging Economies, Cost and Timeline for Biosimilar Development, 2011 18Figure 7: Biosimilars in Emerging Economies, Biosimilars Development, 2011 19Figure 8: Biosimilars in Emerging Economies, Drivers and Barriers, 2011 20Figure 9: Biosimilars in Emerging Economies, Top 10 Biologics, 2010 22Figure 10: Biosimilars in Emerging Economies, Revenue Forecasts ($bn), 2002–2018 24Figure 11: Biosimilars in Emerging Economies, India, Revenue Forecasts ($bn), 2002–2018 28Figure 12: Biosimilars in Emerging Economies, DRL, SWOT Analysis, 2012 32Figure 13: Biosimilars in Emerging Economies, Biocon, SWOT Analysis, 2012 33Figure 14: Biosimilars in Emerging Economies, IBPL, SWOT Analysis, 2012 35Figure 15: Biosimilars in Emerging Economies, Reliance Life Sciences, SWOT Analysis, 2012 37Figure 16: Biosimilars in Emerging Economies, Wockhardt, SWOT Analysis, 2012 38Figure 17: Biosimilars in Emerging Economies, Lupin, SWOT Analysis, 2012 39Figure 18: Biosimilars in Emerging Economies, Cipla, SWOT Analysis, 2012 41Figure 19: Biosimilars in Emerging Economies, China, Revenue Forecasts ($bn), 2002–2018 42Figure 20: Biosimilars in Emerging Economies, 3SBio, SWOT Analysis, 2012 45Figure 21: Biosimilars in Emerging Economies, CPGJ, SWOT Analysis, 2012 47Figure 22: Biosimilars in Emerging Economies, Biotech Pharma, SWOT Analysis, 2012 48Figure 23: Biosimilars in Emerging Economies, Steps of Risk Management, Turkey, 2012 52Figure 24: Biosimilars in Emerging Economies, R&D Pipeline by Phase (%), 2011 60Figure 25: Biosimilars in Emerging Economies, R&D Pipeline by Therapy Class (%), 2011 61Figure 26: Biosimilars in Emerging Economies, Strategies Adopted By Branded Biologic Companies to Beat Generic Competition, 2011 71Figure 27: Biosimilars in Emerging Economies, Industry Dynamics, Strategies To Be Adopted by Companies to Enter the Biosimilars Market 73Figure 28: Biosimilars in Emerging Economies, M&A by Year, 2007–2010 76Figure 29: Biosimilars in Emerging Economies, M&A by Value ($m), 2007–2011 77

Companies mentioned

Dr. Reddy's Laboratories (DRL)

Biocon

Intas Biopharmaceuticals (IBPL)

Reliance Life Sciences

Wockhardt

Lupin

Cipla

3SBio

Shanghai CP Guojian Pharmaceutical Co. Ltd.

Biotech Pharma

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