世界におけるバイオシミラー市場：制度、製品開発パイプライン...市場調査レポートについてご紹介

1 Table of Contents
1 Table of Contents 7
1.1 List of Tables 12
1.2 List of Figures 14
2 Introduction 15
2.1 Report Scope 15
2.2 Upcoming Related Reports 16
2.3 Recently Published Reports 17
3 Market Overview 18
3.1 Biologics: An Expensive Necessity 18
3.2 Historical Branded Biologic Sales and Forecast 20
3.3 A Trickling Biologics Pipeline 22
3.4 Why Biosimilars? 22
3.4.1 Rising Healthcare Expenditures 23
3.4.2 The Need to Broaden Healthcare Coverage and Drive Macroeconomic Growth 23
3.5 Biosimilars: Not an ‘Easy’ Venture 23
3.5.1 Complex Manufacturing Processes 24
3.5.2 Rigorous Regulatory Requirements 25
3.5.3 No Automatic Substitution 26
3.6 Clinical Trials Landscape 26
4 Biosimilar Deals Trends 31
4.1 Highlighted Deals 32
4.1.1 Baxter International and Coherus Biosciences Announce Biosimilars Collaboration 35
4.1.2 Genor BioPharma and BioCND Form mAb Partnership for International Markets 37
4.1.3 Pfenex Forms JV with Agila Biotech 38
4.1.4 Viropro and Oncobiologics Sign Emerging Markets Biosimilars Deal 39
4.1.5 Samsung Bioepis and Merck Expand Biosimilars Development Agreement 41
4.2 Additional Deals 44
5 Biosimilars Regulation 45
5.1 Biosimilars: Different Names, Common Themes 45
5.2 WHO’s Guidance on SBPs 45
6 Biosimilars in the US 47
6.1 Overview 47
6.2 The US’ Evolving Regulatory Framework for Biosimilars 47
6.2.1 Big Pharma’s Adverse Reaction to Section 505(b)(2) 48
6.2.2 The Patient Protection and Affordable Care Act 50
6.2.3 Recent Guidances on Biosimilars by the FDA 51
6.3 Mixed Feelings among Stakeholders as US States Embrace Biosimilar Substitution 55
6.4 Key Players and Pipelines 56
6.4.1 Hospira 56
6.4.2 Actavis 60
6.4.3 Pfizer 62
6.5 Biosimilars in the US: Market Outlook 64
6.5.1 Efforts to Establish a Regulatory Framework Favors the Development of the Industry 64
6.5.2 Increasing Healthcare Expenditures Will Drive Biosimilars Substitution 65
6.5.3 Large Biotechs and Pharmas Will Aggressively Defend their US Market Share 65
6.5.4 Patent Expirations of Blockbuster Biologics Will Encourage Biosimilar Developers 66
7 Biosimilars in Europe 67
7.1 Overview 67
7.2 EU Approved Biosimilars 67
7.3 Guidelines for Biosimilars Development in the EU 70
7.3.1 Sandoz Triggered the Development of Guidelines for Biosimilars in Europe 70
7.3.2 Applicable Guidance Documents on Biosimilars in Europe 71
7.3.3 Non-Clinical Data and Clinical Studies 72
7.4 Key Players and Pipelines 73
7.4.1 Sandoz 73
7.4.2 Stada Arzneimittel 76
7.4.3 Gedeon Richter 78
7.5 Biosimilars in Europe: Market Outlook 80
7.5.1 Financial Austerity Measures Will Further Drive the Uptake of Biosimilars 80
7.5.2 Companies Will Use the EU Biosimilars Market as a Springboard into the US Market 82
8 Biosimilars in Japan 83
8.1 Overview 83
8.2 Regulatory Framework 83
8.2.1 Organizational Structure 83
8.2.2 Biosimilars Review Process 84
8.2.3 Regulatory Guidelines 85
8.3 Key Players and Pipelines 87
8.3.1 Kyowa Hakko Kirin Co. Ltd. 87
8.3.2 JCR Pharmaceuticals 90
8.4 Biosimilars in Japan: Market Outlook 92
8.4.1 Cost Containment Measures Will Drive Biosimilars Development 92
8.4.2 CMOs Will Leverage Existing Capabilities to Enter Biosimilars Space 92
9 Biosimilars in India 93
9.1 Gradual Transition from a Semi-Regulated to a Regulated Market 93
9.2 Marketed Biosimilars in India 93
9.3 Regulatory Framework for Biosimilars in India 97
9.3.1 Guidelines on Similar Biologics, 2012 101
9.4 Key Players and Pipelines 102
9.4.1 Biocon 102
9.4.2 Dr. Reddy’s Laboratories 106
9.4.3 Ranbaxy Laboratories 108
9.4.4 Reliance Life Sciences 111
9.4.5 Cipla 112
9.5 India Biosimilars Market Outlook 114
9.5.1 Recent Biosimilar Guidelines Will Not Guarantee Approval by Regulators 114
9.5.2 Expertise in Generics Will Encourage Biosimilars Development 115
9.5.3 EU-India Free Trade Agreement Could Open Up Access to the European Market 115
10 Biosimilars in South Korea 117
10.1 Overview 117
10.2 Government Initiatives Aiding the Development of Biosimilars 119
10.3 Joint Ventures and Collaborations Enable Leveraging of Capabilities 120
10.4 Lack of Biologics’ Market Exclusivity Decelerates Time-to-Market 121
10.5 Regulatory Framework for Biosimilars 121
10.5.1 Extrapolation of Indications 123
10.6 Key Players and Pipelines 123
10.6.1 Celltrion 124
10.6.2 Hanwha Chemical 127
10.6.3 Samsung Bioepis 129
10.6.4 LG Life Sciences 129
10.7 Biosimilars in South Korea: Market Outlook 132
10.7.1 Government’s Initiatives Look Poised to Spur the Local Biosimilars Industry 132
10.7.2 Budding Pipeline Signals Boom for the Biosimilars Industry 133
11 Biosimilars in China 134
11.1 Overview 134
11.1.1 Soaring Healthcare Expenditures in China Drive Need for Cheaper Therapeutics 134
11.1.2 Biosimilars and Reimbursement 135
11.1.3 An Intellectual Property Loophole 136
11.2 Regulatory Framework for Biosimilars in China 136
11.3 Key Players and Pipelines 138
11.3.1 3SBio 138
11.3.2 Shandong Kexing Bioproducts 140
11.4 Biosimilars in China: Market Outlook 141
11.4.1 Ongoing Reform Will Boost Biosimilars Industry 141
11.4.2 Increase in Healthcare Access Bodes Well for Biosimilars in China 141
11.4.3 Collaborations between Multinationals and Domestic Companies Will Continue 142
12 Case Study: Teva Pharmaceutical Industries 143
12.1 Business Overview 143
12.2 Biosimilars at Teva 143
12.3 Product Portfolio/Pipeline 144
12.4 Company SWOT Analysis 145
12.4.1 Strengths 145
12.4.2 Weaknesses 147
12.4.3 Opportunities 147
12.4.4 Threats 149
13 Strategic Outlook 151
13.1 Patent Expiries Will Continually Fuel Biosimilars Development 151
13.2 Flurry of Regulatory and Legislative Activities Bodes Well for Biosimilars 151
13.3 Extensive Capabilities Needed Will Serve as a Barrier to Entry in the Near to Mid-term 152
13.4 EU-India FTA Will Significantly Benefit European and Indian Biosimilars Companies 153
13.5 Cost-containment Measures Are Expected to Drive Biosimilars Substitution 154
14 Appendix 156
14.1 Bibliography 156
14.2 Abbreviations 165
14.3 Research Methodology 168
14.3.1 Coverage 168
14.3.2 Secondary Research 169
14.4 About the Author 170
14.4.1 Adam Dion, Industry Analyst 170
14.5 Director of Healthcare Industry Dynamics 170
14.6 Global Head of Healthcare 171
14.7 About the Industry Dynamics Team 171
14.8 About GlobalData 172
14.9 Disclosure Information 172
14.10 Disclaimer 172