新興市場国のバイオシミラー市場：高度な組み換え技術プラットフォームと低コスト生産による、インド・中国のバイオシミラー生産における戦略的優位性

新興市場国のバイオシミラー市場は、2002年の3億米ドルから、2010年には33億米ドルへ、年平均(CAGR)34％もの非常に速い速度で成長しました。また、今後（2010〜2018年）も年平均12％の速度で成長すると予測されています。政府の支援策や先発生物製剤の特許失効、増加し続ける人口へより安い医薬品を届ける必要性、新たな疾患の流行などが、市場の成長促進要因となっています。

当レポートでは、新興市場国（インド・中国など）におけるバイオシミラー市場について分析し、バイオシミラー市場全体の構造や特徴、各国市場（インド・中国など）の詳細動向、現在治験中の製品のパイプライン情報、関連企業への戦略提言、資本取引動向といった情報を取りまとめて、概略以下の構成でお届けします。

第1章　目次

第2章　イントロダクション

第3章　市場概況

• バイオシミラー
• バイオシミラーと生物製剤・ジェネリック医薬品の比較
• バイオシミラーの開発
• バイオシミラーの製造
• 市場促進・抑制要因
• 代表的な生物製剤上位10種類（2010年）
• 主な生物製剤の特許失効
• バイオシミラーと関連製品の価格比較

第4章　市場の特徴

• 新興市場国のバイオシミラーの市場規模予測
• 新興市場国の主な市販バイオシミラー

第5章　インド

• バイオシミラー市場の概要
• 市場・研究開発(R&D)の主な傾向
• 規制環境
• 課題と機会
• 主要企業
  • Dr. Reddy's Laboratories (DRL)
  • Biocon
  • Intas Biopharmaceuticals (IBPL)
  • Reliance Life Sciences
  • Wockhardt
  • Lupin
  • Cipla

第6章　中国

• バイオシミラー市場の概要
• 規制環境
• 課題と機会
• 主要企業
  • 3SBio
  • Shanghai CP Guojian Pharmaceutical Co. Ltd.
  • Biotech Pharma

第7章　その他の新興市場国

• ブラジル
• ロシア
• メキシコ
• トルコ
• アルゼンチン
• 南アフリカ
• ベネズエラ
• ベトナム
• タイ

第8章　パイプライン分析

• イントロダクション
• 登録済みパイプライン
• フェーズIIIパイプライン
• フェーズIIパイプライン
• フェーズIパイプライン
• 前臨床パイプライン
• 創薬パイプライン
• IND申請済みパイプライン

第9章　産業のダイナミクス

• ジェネリック医薬品との競争に打ち勝つために、先発生物製剤企業が採用した戦略
• バイオシミラー市場に参入する企業向けの戦略

第10章　取引分析

• 企業合併・買収(M&A)
• ライセンス契約
• 共同開発

第11章　付録

図表一覧

Abstract

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.

TOC

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

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 ($bn), 2002-2011 24
• Table 3: Biosimilars in Emerging Economies, Revenue Forecasts ($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

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 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