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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
Date:7/2/2012

NEW YORK, July 2, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

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

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.

 

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 2010 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 30

5.4.1 Challenges 30

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 36

5.5.5 Wockhardt 38

5.5.6 Lupin 39

5.5.7 Cipla 40

6 Biosimilars in Emerging Economies – China 42

6.1 Biosimilars Market Overview 42

6.1.1 Marketed Biosimilars in China 43

6.2 Regulatory Landscape in China 43

6.2.1 Regulatory Framework for Biosimilars 43

6.3 Challenges and Opportunities 44

6.3.1 Challenges 44

6.4 Key Companies 44

6.4.1 3SBio 44

6.4.2 Shanghai CP Guojian Pharmaceutical Co. Ltd. 46

6.4.3 Biotech Pharma 47

7 Biosimilars in Emerging Economies – Other Emerging Economies 49

7.1 Brazil 49

7.1.1 Biosimilars Regulatory Framework and Approval Process 49

7.1.2 Biosimilars Coverage and Availability at Reduced Cost 49

7.1.3 Biosimilars Market Opportunity 49

7.1.4 Major Challenge 50

7.2 Russia 50

7.3 Mexico 50

7.4 Turkey 51

7.4.1 Biosimilar Guidelines in Turkey 51

7.4.2 Risk Management Plan 52

7.4.3 New Pharmacovigilance Legislation 52

7.4.4 Actavis and Bioton Collaborate for Insulin 53

7.5 Argentina 53

7.5.1 Major Challenge 53

7.6 South Africa 53

7.6.1 Guidelines for Similar Biological Medicines 54

7.6.2 Genius Biotherapeutics 54

7.6.3 Major Challenges 55

7.7 Venezuela 55

7.8 Vietnam 56

7.8.1 Innogene Kalbiotech 56

7.8.2 Major Challenge 57

7.9 Thailand 58

7.9.1 Major Challenges 59

8 Biosimilars in Emerging Economies – Pipeline Analysis 60

8.1 Introduction 60

8.2 R&D Pipeline – Filed 62

8.3 R&D Pipeline – Phase III 62

8.4 R&D Pipeline – Phase II 64

8.5 R&D Pipeline – Phase I 64

8.6 R&D Pipeline – Pre-clinical 65

8.7 R&D Pipeline – Discovery 67

8.8 R&D Pipeline – IND Filed 68

9 Biosimilars in Emerging Economies – Industry Dynamics 71

9.1 Strategies Adopted By Branded Biologic Companies to Beat Generic Competition 71

9.1.1 Introduction 71

9.1.2 Second Generation Biologics 72

9.1.3 New Formulation 72

9.1.4 Combination Products 72

9.1.5 New Approved Indications 73

9.2 Industry Dynamics: Strategies to Be Adopted by Companies to Enter the Biosimilars Market 73

9.2.1 Product 74

9.2.2 Price 74

9.2.3 Place 75

9.2.4 Promotion 75

9.2.5 People 75

10 Biosimilars in Emerging Economies – Deals Analysis 76

10.1 Mergers and Acquisitions 76

10.1.1 M&A by Year 76

10.1.2 M&A by Value 77

10.1.3 M&A by Type 77

10.1.4 M&A Deals 78

10.2 Licensing Agreements 80

10.3 Co-developments 82

11 Biosimilars in Emerging Economies - Appendix 84

11.1 Market Definitions 84

11.2 Abbreviations 84

11.3 Bibliography 86

11.4 Research Methodology 88

11.4.1 Market Overview 89

11.4.2 Market Characterization 89

11.4.3 India 89

11.4.4 China 89

11.4.5 Other Emerging Economies 89

11.4.6 Pipeline Analysis 90

11.4.7 Industry Dynamics 90

11.4.8 Deals Analysis 90

11.5 Contact Us 90

11.6 Disclaimer 90

 

1.1 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), 2002–2010 24

Table 3: Biosimilars in Emerging Economies, Revenue Forecasts ($bn), 2010–2018 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), 2002–2010 28

Table 8: Biosimilars in Emerging Economies, India, Revenue Forecasts ($bn), 2010–2018 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), 2002–2010 42

Table 19: Biosimilars in Emerging Economies, China, Revenue Forecasts ($bn), 2010–2018 42

Table 20: Biosimilars in Emerging Economies, Marketed Biosimilar Products, China, 2012 43

Table 21: Biosimilars in Emerging Economies, Marketed Biosimilar Products, 3SBio, 2012 44

Table 22: Biosimilars in Emerging Economies, Pipeline Molecules, 3SBio, 2012 45

Table 23: Biosimilars in Emerging Economies, Marketed Biosimilar Products, CPGJ, 2012 46

Table 24: Biosimilars in Emerging Economies, Pipeline Molecules, CPGJ, 2012 46

Table 25: Biosimilars in Emerging Economies, Marketed Biosimilar Products, Biotech Pharma, 2012 47

Table 26: Biosimilars in Emerging Economies, Pipeline Molecules, Filed, 2011 62

Table 27: Biosimilars in Emerging Economies, Pipeline Molecules, Phase III, 2011 62

Table 28: Biosimilars in Emerging Economies, Pipeline Molecules, Phase II, 2011 64

Table 29: Biosimilars in Emerging Economies, Pipeline Molecules, Phase I, 2011 64

Table 30: Biosimilars in Emerging Economies, Pipeline Molecules, Pre-clinical, 2011 65

Table 31: Biosimilars in Emerging Economies, Pipeline Molecules, Discovery, 2011 67

Table 32: Biosimilars in Emerging Economies, Pipeline Molecules, IND Filed, 2011 68

Table 33: Biosimilars in Emerging Economies, Pipeline Molecules, Unknown Phase, 2011 68

Table 34: Biosimilars in Emerging Economies, M&A by Year, 2007–2010 76

Table 35: Biosimilars in Emerging Economies, M&A by Value ($m), 2007–2011 77

Table 36: Biosimilars in Emerging Economies, M&A Deals, 2007–2011 78

Table 37: Biosimilars in Emerging Economies, Licensing Agreements, 2007–2011 80

Table 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 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 13

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, 2010 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 41

Figure 19: Biosimilars in Emerging Economies, China, Revenue Forecasts ($bn), 2002–2018 42

Figure 20: Biosimilars in Emerging Economies, 3SBio, SWOT Analysis, 2012 45

Figure 21: Biosimilars in Emerging Economies, CPGJ, SWOT Analysis, 2012 47

Figure 22: Biosimilars in Emerging Economies, Biotech Pharma, SWOT Analysis, 2012 48

Figure 23: Biosimilars in Emerging Economies, Steps of Risk Management, Turkey, 2012 52

Figure 24: Biosimilars in Emerging Economies, R&D Pipeline by Phase (%), 2011 60

Figure 25: Biosimilars in Emerging Economies, R&D Pipeline by Therapy Class (%), 2011 61

Figure 26: Biosimilars in Emerging Economies, Strategies Adopted By Branded Biologic Companies to Beat Generic Competition, 2011 71

Figure 27: Biosimilars in Emerging Economies, Industry Dynamics, Strategies To Be Adopted by Companies to Enter the Biosimilars Market 73

Figure 28: Biosimilars in Emerging Economies, M&A by Year, 2007–2010 76

Figure 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

 

To order this report:

Generic Drug Industry: 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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Reportlinker
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