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

 

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.

 

 

 

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

 

 

 

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

 

Contact Clare: clare@reportlinker.com
US:(339) 368 6001
Intl:+1 339 368 6001
 

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