Biosimilars in Emerging Economies - Advanced Recombinant Technology Platforms and Low Cost Manufacturing Put India and China at a Strategic Advantage in Biosimilar Production
Summary
GBI Research, the leading business intelligence provider, has released its latest report, “Biosimilars in Emerging Economies - Advanced Recombinant Technology Platforms and Low Cost Manufacturing Put India and China at a Strategic Advantage in Biosimilar Production” that provides key data, information and analysis of the major trends and issues that affect the emerging biosimilars market. The report provides a comprehensive insight into the biosimilars market, with regional market forecasts for biosimilars in India and China, and analysis of the drivers and restraints that affect the market. The report looks at key market companies in the emerging biosimilars industry through profiles and analysis of their strengths, weaknesses, opportunities and threats. The report also provides information on the global biosimilars pipeline. Also discussed in detail are success factors for the emerging biosimilar industry and the regulatory environment in emerging markets with respect to biosimilars. At the end, the report provides an analysis on major deals that have taken place in the industry from 2007 to 2011.
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.
Generic Drug Industry in China
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 Introduction 11
3 Biosimilars in Emerging Economies – Market Overview 12
3.1 Biosimilars 12
3.1.1 Types of Biosimilars 12
3.2 Comparison of Biosimilars with Biologics and Generics 16
3.2.1 Structural Differences between Biologics, Generics and Biosimilars 17
3.3 Development of Biosimilars 18
3.4 Manufacturing of Biosimilars 19
3.4.1 Establishing a New Biosimilar Manufacturing Facility 19
3.5 Drivers and Restraints 20
3.5.1 Drivers 20
3.5.2 Restraints 21
3.6 Top 10 Biologics in 2011 22
3.7 Patent Expiries of Leading Biologics 23
3.8 Price Comparison of Biosimilars and Reference Products 23
4 Biosimilars in Emerging Economies – Market Characterization 24
4.1 Biosimilars Market Size and Forecast for Emerging Economies 24
4.2 Major Marketed Biosimilars in Emerging Economies 25
5 Biosimilars in Emerging Economies – India 28
5.1 Biosimilars Market Overview 28
5.2 Key Market and R&D Trends 29
5.2.1 Biocon’s Deal to Commercialize Biosimilar Versions of Insulin Products with Pfizer Cancelled 29
5.3 Regulatory Landscape in India 29
5.3.1 Regulatory Framework for Biosimilars 29
5.4 Challenges and Opportunities 29
5.4.1 Challenges 29
5.4.2 Opportunities 30
5.5 Key Companies 31
5.5.1 Dr. Reddy’s Laboratories (DRL) 31
5.5.2 Biocon 32
5.5.3 Intas Biopharmaceuticals (IBPL) 34
5.5.4 Reliance Life Sciences 35
5.5.5 Wockhardt 37
5.5.6 Lupin 38
5.5.7 Cipla 39
6 Biosimilars in Emerging Economies – China 41
6.1 Biosimilars Market Overview 41
6.1.1 Marketed Biosimilars in China 42
6.2 Regulatory Landscape in China 42
6.2.1 Regulatory Framework for Biosimilars 42
6.3 Challenges and Opportunities 43
6.3.1 Challenges 43
6.4 Key Companies 43
6.4.1 3SBio 43
6.4.2 Shanghai CP Guojian Pharmaceutical Co. Ltd. 45
6.4.3 Biotech Pharma 46
7 Biosimilars in Emerging Economies – Other Emerging Economies 48
7.1 Brazil 48
7.1.1 Biosimilars Regulatory Framework and Approval Process 48
7.1.2 Biosimilars Coverage and Availability at Reduced Cost 48
7.1.3 Biosimilars Market Opportunity 48
7.1.4 Major Challenge 49
7.2 Russia 49
7.3 Mexico 50
7.4 Turkey 50
7.4.1 Biosimilar Guidelines in Turkey 50
7.4.2 Risk Management Plan 51
7.4.3 New Pharmacovigilance Legislation 51
7.4.4 Actavis and Bioton Collaborate for Insulin 52
7.5 Argentina 52
7.5.1 Major Challenge 52
7.6 South Africa 53
7.6.1 Guidelines for Similar Biological Medicines 53
7.6.2 Genius Biotherapeutics 53
7.6.3 Major Challenges 54
7.7 Venezuela 54
7.8 Vietnam 55
7.8.1 Innogene Kalbiotech 55
7.8.2 Major Challenge 56
7.9 Thailand 56
7.9.1 Major Challenges 57
8 Biosimilars in Emerging Economies – Pipeline Analysis 58
8.1 Introduction 58
8.2 R&D Pipeline – Filed 60
8.3 R&D Pipeline – Phase III 60
8.4 R&D Pipeline – Phase II 62
8.5 R&D Pipeline – Phase I 62
8.6 R&D Pipeline – Pre-clinical 63
8.7 R&D Pipeline – Discovery 65
8.8 R&D Pipeline – IND Filed 66
9 Biosimilars in Emerging Economies – Industry Dynamics 69
9.1 Strategies Adopted By Branded Biologic Companies to Beat Generic Competition 69
9.1.1 Introduction 69
9.1.2 Second Generation Biologics 70
9.1.3 New Formulation 70
9.1.4 Combination Products 70
9.1.5 New Approved Indications 71
9.2 Industry Dynamics: Strategies to Be Adopted by Companies to Enter the Biosimilars Market 71
9.2.1 Product 72
9.2.2 Price 72
9.2.3 Place 72
9.2.4 Promotion 73
9.2.5 People 73
10 Biosimilars in Emerging Economies – Deals Analysis 74
10.1 Mergers and Acquisitions 74
10.1.1 M&A by Year 74
10.1.2 M&A by Value 75
10.1.3 M&A by Type 75
10.1.4 M&A Deals 76
10.2 Licensing Agreements 78
10.3 Co-developments 80
11 Biosimilars in Emerging Economies – Appendix 82
11.1 Market Definitions 82
11.2 Abbreviations 82
11.3 Bibliography 84
11.4 Research Methodology 86
11.4.1 Market Overview 87
11.4.2 Market Characterization 87
11.4.3 India 87
11.4.4 China 87
11.4.5 Other Emerging Economies 87
11.4.6 Pipeline Analysis 88
11.4.7 Industry Dynamics 88
11.4.8 Deals Analysis 88
11.5 Contact Us 88
11.6 Disclaimer 88
List of Tables
Table 1: Biosimilars in Emerging Economies, Key Patent Expiries of Leading Biologics From 2011–2018 23
Table 2: Biosimilars in Emerging Economies, Revenue ($bn), 2002–2011 24
Table 3: Biosimilars in Emerging Economies, Revenue Forecasts ($bn), 2011–2018 24
Table 4: Biosimilars in Emerging Economies, Marketed Biosimilar Products, India, 2012 25
Table 5: Biosimilars in Emerging Economies, Marketed Biosimilar Products, China, 2012 26
Table 6: Biosimilars in Emerging Economies, Marketed Biosimilar Products, Other Emerging Economies, 2012 27
Table 7: Biosimilars in Emerging Economies, India, Revenue ($bn), 2002–2011 28
Table 8: Biosimilars in Emerging Economies, India, Revenue Forecasts ($bn), 2011–2018 28
Table 9: Biosimilars in Emerging Economies, Marketed Biosimilar Products, Dr. Reddy’s, 2012 31
Table 10: Biosimilars in Emerging Economies, Marketed Biosimilar Products, Biocon, 2012 33
Table 11: Biosimilars in Emerging Economies, Pipeline Molecules, Biocon, 2012 33
Table 12: Biosimilars in Emerging Economies, Marketed Biosimilar Products, IBPL, 2012 34
Table 13: Biosimilars in Emerging Economies, Marketed Biosimilar Products, Reliance Life Sciences, 2012 36
Table 14: Biosimilars in Emerging Economies, Pipeline Molecules, Reliance Life Sciences, 2012 37
Table 15: Biosimilars in Emerging Economies, Marketed Biosimilar Products, Wockhardt, 2012 38
Table 16: Biosimilars in Emerging Economies, Pipeline Molecules, Lupin, 2012 39
Table 17: Biosimilars in Emerging Economies, Pipeline Molecules, Cipla, 2012 40
Table 18: Biosimilars in Emerging Economies, China, Revenue ($bn), 2002–2011 41
Table 19: Biosimilars in Emerging Economies, China, Revenue Forecasts ($bn), 2011–2018 41
Table 20: Biosimilars in Emerging Economies, Marketed Biosimilar Products, China, 2012 42
Table 21: Biosimilars in Emerging Economies, Marketed Biosimilar Products, 3SBio, 2012 43
Table 22: Biosimilars in Emerging Economies, Pipeline Molecules, 3SBio, 2012 44
Table 23: Biosimilars in Emerging Economies, Marketed Biosimilar Products, CPGJ, 2012 45
Table 24: Biosimilars in Emerging Economies, Pipeline Molecules, CPGJ, 2012 45
Table 25: Biosimilars in Emerging Economies, Marketed Biosimilar Products, Biotech Pharma, 2012 46
Table 26: Biosimilars in Emerging Economies, Pipeline Molecules, Filed, 2011 60
Table 27: Biosimilars in Emerging Economies, Pipeline Molecules, Phase III, 2011 60
Table 28: Biosimilars in Emerging Economies, Pipeline Molecules, Phase II, 2011 62
Table 29: Biosimilars in Emerging Economies, Pipeline Molecules, Phase I, 2011 62
Table 30: Biosimilars in Emerging Economies, Pipeline Molecules, Pre-clinical, 2011 63
Table 31: Biosimilars in Emerging Economies, Pipeline Molecules, Discovery, 2011 65
Table 32: Biosimilars in Emerging Economies, Pipeline Molecules, IND Filed, 2011 66
Table 33: Biosimilars in Emerging Economies, Pipeline Molecules, Unknown Phase, 2011 66
Table 34: Biosimilars in Emerging Economies, M&A by Year, 2007–2011 74
Table 35: Biosimilars in Emerging Economies, M&A by Value ($m), 2007–2011 75
Table 36: Biosimilars in Emerging Economies, M&A Deals, 2007–2011 76
Table 37: Biosimilars in Emerging Economies, Licensing Agreements, 2007–2011 78
Table 38: Biosimilars in Emerging Economies, Co-developments, 2007–2011 80
List of Figures
Figure 1: Biosimilars in Emerging Economies, EPO Biosimilars Marketed Outside the US and EU, 2011 12
Figure 2: Biosimilars in Emerging Economies, G-CSF Biosimilars Marketed Outside the US and EU, 2011 13
Figure 3: Biosimilars in Emerging Economies, INF Alpha Biosimilars Marketed Outside the US and EU, 2011 14
Figure 4: Biosimilars in Emerging Economies, Biosimilars Comparison With Biologics and Generic, 2012 16
Figure 5: Biosimilars in Emerging Economies, Size and Complexity, Small Molecule Drugs and Proteins, 2012 17
Figure 6: Biosimilars in Emerging Economies, Cost and Timeline for Biosimilar Development, 2011 18
Figure 7: Biosimilars in Emerging Economies, Biosimilars Development, 2011 19
Figure 8: Biosimilars in Emerging Economies, Drivers and Barriers, 2011 20
Figure 9: Biosimilars in Emerging Economies, Top 10 Biologics, 2011 22
Figure 10: Biosimilars in Emerging Economies, Revenue Forecasts ($bn), 2002–2018 24
Figure 11: Biosimilars in Emerging Economies, India, Revenue Forecasts ($bn), 2002–2018 28
Figure 12: Biosimilars in Emerging Economies, DRL, SWOT Analysis, 2012 32
Figure 13: Biosimilars in Emerging Economies, Biocon, SWOT Analysis, 2012 33
Figure 14: Biosimilars in Emerging Economies, IBPL, SWOT Analysis, 2012 35
Figure 15: Biosimilars in Emerging Economies, Reliance Life Sciences, SWOT Analysis, 2012 37
Figure 16: Biosimilars in Emerging Economies, Wockhardt, SWOT Analysis, 2012 38
Figure 17: Biosimilars in Emerging Economies, Lupin, SWOT Analysis, 2012 39
Figure 18: Biosimilars in Emerging Economies, Cipla, SWOT Analysis, 2012 40
Figure 19: Biosimilars in Emerging Economies, China, Revenue Forecasts ($bn), 2002–2018 41
Figure 20: Biosimilars in Emerging Economies, 3SBio, SWOT Analysis, 2012 44
Figure 21: Biosimilars in Emerging Economies, CPGJ, SWOT Analysis, 2012 46
Figure 22: Biosimilars in Emerging Economies, Biotech Pharma, SWOT Analysis, 2012 47
Figure 23: Biosimilars in Emerging Economies, Steps of Risk Management, Turkey, 2012 51
Figure 24: Biosimilars in Emerging Economies, R&D Pipeline by Phase (%), 2011 58
Figure 25: Biosimilars in Emerging Economies, R&D Pipeline by Therapy Class (%), 2011 59
Figure 26: Biosimilars in Emerging Economies, Strategies Adopted By Branded Biologic Companies to Beat Generic Competition, 2011 69
Figure 27: Biosimilars in Emerging Economies, Industry Dynamics, Strategies To Be Adopted by Companies to Enter the Biosimilars Market 71
Figure 28: Biosimilars in Emerging Economies, M&A by Year, 2007–2011 74
Figure 29: Biosimilars in Emerging Economies, M&A by Value ($m), 2007–2011 75
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
