1 INTRODUCTION 16
1.1 OBJECTIVES OF THE STUDY 16
1.2 MARKET DEFINITION 16
1.3 MARKET SCOPE 17
1.3.1 MARKET COVERED 17
1.4 YEARS CONSIDERED FOR THE STUDY 18
1.5 CURRENCY 18
1.6 LIMITATIONS 18
1.7 STAKEHOLDERS 18

2 RESEARCH METHODOLOGY 19
2.1 SECONDARY DATA 20
2.1.1 SECONDARY SOURCES 20
2.2 PRIMARY DATA 21
2.2.1 PRIMARY SOURCES 22
2.3 MARKET SIZE ESTIMATION 22
2.3.1 BOTTOM-UP APPROACH 23
2.3.2 TOP-DOWN APPROACH 24
2.4 DATA TRIANGULATION METHODOLOGY 25
2.5 ASSUMPTIONS FOR THE STUDY 26

3 EXECUTIVE SUMMARY 27

4 PREMIUM INSIGHTS 30
4.1 BIOSIMILARS MARKET OVERVIEW 30
4.2 ASIA: BIOSIMILARS MARKET, BY TYPE OF PRODUCT 31
4.3 BIOSIMILARS MARKET, BY REGION 32
4.4 GEOGRAPHICAL SNAPSHOT: BIOSIMILARS MARKET (MAJOR COUNTRIES) 33

5 MARKET OVERVIEW 34
5.1 INTRODUCTION 34
5.2 MARKET DYNAMICS 34
5.2.1 DRIVERS 35
5.2.1.1 Increasing demand for biosimilar drugs due to their cost-effectiveness 35
5.2.1.2 Rising incidence of chronic diseases 35
5.2.1.3 Strategic collaborations resulting in enhanced productivity and clinical trial activities for biosimilars 36
?
5.2.2 RESTRAINTS 37
5.2.2.1 Complexities in manufacturing 37
5.2.2.2 Innovative strategies by biologic drug manufacturers 37
5.2.3 OPPORTUNITIES 38
5.2.3.1 Growth opportunities in emerging markets 38
5.2.3.2 New indications and patent expiry of biologic products 38
5.2.4 CHALLENGES 40
5.2.4.1 Stringent regulatory requirements to adversely affect investments in biosimilars 40

6 REGULATORY OUTLOOK 41
6.1 NORTH AMERICA 41
6.1.1 US 41
6.1.2 CANADA 41
6.2 EUROPE 42
6.3 ASIA PACIFIC 43
6.3.1 CHINA 43
6.3.2 INDIA 43
6.3.3 JAPAN 43
6.3.4 SOUTH KOREA 43
6.4 REST OF THE WORLD 44
6.4.1 BRAZIL 44
6.4.2 MEXICO 44
6.4.3 ARGENTINA 44
6.4.4 SAUDI ARABIA 44

7 BIOSIMILARS MARKET, BY PRODUCT 45
7.1 INTRODUCTION 46
7.2 RECOMBINANT NON-GLYCOSYLATED PROTEINS 47
7.2.1 RECOMBINANT HUMAN GROWTH HORMONE (RHGH) 48
7.2.2 GRANULOCYTE COLONY-STIMULATING FACTOR (FILGRASTIM) 49
7.2.3 INSULIN 51
7.2.4 INTERFERONS 52
7.2.4.1 Interferon-beta 53
7.2.4.2 Interferon-alpha 53
7.3 RECOMBINANT GLYCOSYLATED PROTEINS 54
7.3.1 ERYTHROPOIETIN (EPO) 55
7.3.2 MONOCLONAL ANTIBODIES (MABS) 56
7.3.2.1 Infliximab 57
7.3.2.2 Rituximab 58
7.3.2.3 Adalimumab 59
7.3.2.4 Other monoclonal antibodies 61
?
7.3.3 FOLLITROPIN 62
7.4 RECOMBINANT PEPTIDES 62
7.4.1 GLUCAGON 64
7.4.2 CALCITONIN 64

8 BIOSIMILARS MARKET, BY TYPE OF MANUFACTURING 66
8.1 INTRODUCTION 67
8.2 IN-HOUSE MANUFACTURING 68
8.3 CONTRACT MANUFACTURING 68

9 BIOSIMILARS MARKET, BY DISEASE 70
9.1 INTRODUCTION 71
9.2 ONCOLOGY 72
9.3 CHRONIC DISEASES 73
9.4 AUTOIMMUNE DISEASES 74
9.5 BLOOD DISORDERS 75
9.6 GROWTH HORMONE DEFICIENCY 76
9.7 INFECTIOUS DISEASES 77
9.8 OTHER DISEASES 78

10 BIOSIMILARS MARKET, BY REGION 79
10.1 INTRODUCTION 80
10.2 NORTH AMERICA 81
10.2.1 US 85
10.2.2 CANADA 88
10.3 EUROPE 92
10.3.1 GERMANY 98
10.3.2 FRANCE 100
10.3.3 UK 102
10.3.4 ITALY 104
10.3.5 SPAIN 106
10.3.6 REST OF EUROPE 108
10.4 ASIA 111
10.4.1 INDIA 116
10.4.2 CHINA 121
10.4.3 SOUTH KOREA 124
10.4.4 JAPAN 128
10.4.5 REST OF ASIA 131
10.5 REST OF THE WORLD (ROW) 135
10.5.1 LATIN AMERICA 139
10.5.2 PACIFIC AND OCEANIA 140
10.5.3 MIDDLE EAST AND AFRICA 141

11 COMPETITIVE LANDSCAPE 143
11.1 OVERVIEW 143
11.2 MARKET SHARE ANALYSIS, 2016 144
11.3 COMPETITIVE SCENARIO 145
11.3.1 PRODUCT LAUNCHES AND PRODUCT APPROVALS 145
11.3.2 PARTNERSHIPS, COLLABORATIONS, AND AGREEMENTS 146
11.3.3 ACQUISITIONS 146
11.3.4 EXPANSIONS 147

12 COMPANY PROFILES 148
(Introduction, Products & Services, Strategy, & Analyst Insights, Developments, MnM View)*
12.1 SANDOZ 148
12.2 PFIZER 151
12.3 TEVA PAHRMACEUTICAL 154
12.4 CELLTRION 156
12.5 BIOCON 158
12.6 AMGEN 160
12.7 SAMSUNG BIOLOGICS 162
12.8 MYLAN 164
12.9 DR. REDDY’S LABORATORIES 166
12.10 STADA ARZNEIMITTEL AG 168

*Details on MarketsandMarkets view, Introduction, Product & Services, Strategy, & Analyst Insights, New Developments might not be captured in case of unlisted companies.

13 APPENDIX 170
13.1 INSIGHTS OF INDUSTRY EXPERTS 170
13.2 DISCUSSION GUIDE 171
13.3 KNOWLEDGE STORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL 175
13.4 INTRODUCING RT: REAL-TIME MARKET INTELLIGENCE 177
13.5 AVAILABLE CUSTOMIZATIONS 179
13.6 RELATED REPORTS 180
13.7 AUTHOR DETAILS 181