Biosimilars Market by Product & Application - Global Forecast to 2020

Various factors have contributed to the rise in demand for biopharmaceutical products such as biologics and biosimilars. Some of these factors include the rising pressure to reduce healthcare expenditure, growing demand for cost-effective alternatives, growing burden of chronic diseases, and growing aging population. Biosimilars are similar versions of their corresponding patented biologic drugs, and are similar with regards to their quality, safety, and efficacy. The global biosimilars market is estimated to be worth $2.29 billion in 2015, and is poised to grow at a CAGR of 22.1% during the forecast period.

This report studies and analyzes the biosimilars market by product and application. On the basis of products, the biosimilars market is segmented into recombinant nonglycosylated proteins, recombinant glycosylated proteins, and recombinant peptides. The recombinant nonglycosylated proteins market is further segmented into insulin, granulocyte colony-stimulating factor (G-CSF), interferons, and human growth hormones; whereas, the recombinant glycosylated proteins market is further segmented into erythropoietin, monoclonal antibodies, and follitropin. The recombinant peptides market is segmented into calcitonin and glucagon. The recombinant glycosylated proteins segment is expected to witness the highest growth rate owing to the increased demand for monoclonal antibodies in the treatment of cancer (oncology), autoimmune disorders, blood disorders, and infectious diseases. On the other hand, the recombinant nonglycosylated proteins segment accounts for the largest share of the market in 2015. The insulin segment is poised to be the fastest-growing segment of the recombinant nonglycosylated proteins market, growing at a CAGR of 28.1% from 2015 to 2020. Growth in this insulin market is attributed to the rising incidences of diabetes; ongoing patent expirations of biologic drugs such as Lantus, Humalog, and Novorapid; and the cost effectiveness of insulin.

On the basis of applications, the biosimilars market is segmented into oncology, blood disorders, growth hormonal deficiency, chronic and autoimmune disorders, and other applications (female infertility, hypoglycemia, myocardial infarction, postmenopausal osteoporosis, and chronic kidney failure).

Geographically, Europe is expected to account for the largest share of the global biosimilars market in 2015 followed by Asia-Pacific. The large share of the European region can be attributed to the rising budgetary pressures to reduce healthcare expenditure, increasing aging population, growing demand for cost-effective alternatives, rising incidences of various diseases, and government initiatives. On the other hand, stringent regulatory environment, high manufacturing complexities and costs, and high-entry barriers are considered to hinder its market growth.


The global biosimilars market is highly competitive, with a large number of big and small market players. As of 2014, the global biosimilars market was dominated by Sandoz International GmbH (Germany), Hospira, Inc. (U.S.), and Teva Pharmaceutical Industries Ltd. (Israel). Furthermore, new product launches and expansions are the major strategies adopted by major players to achieve growth in this market.

Reasons to Buy the Report:
From an insight perspective, this research report focused on various levels of analysis—industry analysis (industry trends and Porter’s five forces model), market share analysis of top players, and company profiles, which together comprise and discuss the basic views on the competitive landscape; emerging and high-growth segments in the biosimilars market; and high-growth regions/countries and their respective regulatory policies, government initiatives, drivers, restraints, and opportunities.

The report will enrich both established firms as well as new entrants/smaller firms to gauge the pulse of the market, which in turn will help the firms in garnering a greater market share. Firms purchasing the report could use any one or combination of the below-mentioned five strategies (market penetration, product development/innovation, market development, market diversification, and competitive assessment) for strengthening their market shares.

The report provides insights on the following pointers:
‧ Market Penetration: Comprehensive information on biosimilar products offered by the top 10 players in the biosimilars market. The report analyzes the biosimilars market by product and application across geographies

‧ Product Development/Innovation: Detailed insights on research and development activities and new product launches in the biosimilars market

‧ Market Development: Comprehensive information about lucrative emerging markets. The report analyzes the markets for various biosimilar products across geographies

‧ Market Diversification: Exhaustive information about new products, untapped geographies, recent developments, and investments in the biosimilars market

‧ Competitive Assessment: In-depth assessment of market shares, strategies, products, distribution networks, and manufacturing capabilities of leading players in the biosimilars market

TABLE OF CONTENTS

1 INTRODUCTION 16
1.1 OBJECTIVES OF THE STUDY 16
1.2 MARKET DEFINITION 16
1.3 MARKET SCOPE 17
1.3.1 MARKET SEGMENTATION 17
1.3.2 YEARS CONSIDERED FOR THE STUDY 18
1.4 CURRENCY 18
1.5 LIMITATIONS 18
1.6 STAKEHOLDERS 19
2 RESEARCH METHODOLOGY 20
2.1 MARKET SIZE ESTIMATION 21
2.2 MARKET BREAKDOWN AND DATA TRIANGULATION 24
2.3 MARKET SHARE ESTIMATION 25
2.3.1 KEY DATA FROM SECONDARY SOURCES 25
2.3.2 KEY DATA FROM PRIMARY SOURCES 26
2.3.2.1 Key industry insights 26
2.4 ASSUMPTIONS FOR THE STUDY 26
3 EXECUTIVE SUMMARY 27
3.1 INTRODUCTION 27
4 PREMIUM INSIGHTS 31
4.1 OVERALL BIOSIMILARS MARKET 31
4.2 BIOSIMILARS MARKET, BY TYPE & REGION 32
4.3 BIOSIMILARS MARKET, BY COUNTRIES 33
4.4 RECOMBINANT NONGLYCOSYLATED PROTEINS MARKET, BY TYPE 34
4.5 LIFECYCLE ANALYSIS, BY REGION 34
5 MARKET OVERVIEW 36
5.1 INTRODUCTION 37
5.2 BIOSIMILARS MARKET SEGMENTATION 37
5.2.1 BY PRODUCT 37
5.2.2 BY APPLICATION 37
5.2.3 BY REGION 38
5.3 MARKET DYNAMICS 38
5.3.1 DRIVERS 39
5.3.1.1 Growing pressure to curtail healthcare expenditure 39
5.3.1.2 Increasing demand for biosimilar drugs due to their cost-effectiveness 39
5.3.1.3 Rising incidences of diseases 39
5.3.1.4 Rise in aging population triggers the incidences of chronic disorders 40
5.3.1.5 Strategic collaborations lead to enhance productivity and clinical trial activities for biosimilars 40
5.3.1.6 Increasing government support and initiatives to develop and promote biosimilars 41
5.3.2 RESTRAINTS 42
5.3.2.1 High manufacturing complexities and costs 42
5.3.2.2 Innovative strategies by biologic drug manufacturers 43
5.3.3 OPPORTUNITIES 44
5.3.3.1 Emerging markets 44
5.3.3.2 Untapped indications 44
5.3.3.3 Biologic products set to be off-patent will offer opportunities for biosimilars 44
5.3.4 CHALLENGES 46
5.3.4.1 Stringent regulatory requirements to adversely affect investments in biosimilars 46
5.3.5 BURNING ISSUES 47
5.3.5.1 Product withdrawals provide significant opportunities for new entrants 47
6 INDUSTRY INSIGHTS 48
6.1 INTRODUCTION 48
6.2 PORTER’S FIVE FORCES ANALYSIS 48
6.2.1 THREAT OF NEW ENTRANTS 49
6.2.2 THREAT OF SUBSTITUTES 49
6.2.3 INTENSITY OF RIVALRY 49
6.2.4 BARGAINING POWER OF SUPPLIERS 49
6.2.5 BARGAINING POWER OF BUYERS 50
6.3 KEY PIPELINE PRODUCTS 50
6.4 REGULATORY OUTLOOK 51
6.4.1 NORTH AMERICA 51
6.4.1.1 U.S. 51
6.4.1.2 Canada 51
6.4.2 EUROPE 52
6.4.3 ASIA-PACIFIC 53
6.4.3.1 China 53
6.4.3.2 India 53
6.4.3.3 Japan 53
6.4.3.4 South Korea 53
6.4.4 REST OF THE WORLD 54
6.4.4.1 Brazil 54
6.4.4.2 Mexico 54
6.4.4.3 Argentina 54
6.4.4.4 Saudi Arabia 54
6.5 BIOSIMILARS SERVICES INDUSTRY INSIGHTS 55
6.5.1 INTRODUCTION 55
6.5.2 CONTRACT MANUFACTURING ORGANIZATIONS 55
6.5.3 CONTRACT RESEARCH ORGANIZATIONS 56
6.5.4 OTHER SERVICES (NONCLINICAL & BIOINFORMATICS) 56
7 BIOSIMILARS MARKET, BY TYPE OF PRODUCT 57
7.1 INTRODUCTION 58
7.2 RECOMBINANT NON-GLYCOSYLATED PROTEINS 59
7.2.1 INSULIN 62
7.2.2 RECOMBINANT HUMAN GROWTH HORMONE (RHGH) 63
7.2.3 GRANULOCYTE COLONY-STIMULATING FACTOR (FILGRASTIM) 64
7.2.4 INTERFERONS 66
7.3 RECOMBINANT GLYCOSYLATED PROTEINS 67
7.3.1 ERYTHROPOIETIN (EPO) 71
7.3.2 MONOCLONAL ANTIBODIES (MABS) 72
7.3.3 FOLLITROPIN 73
7.4 RECOMBINANT PEPTIDES 74
7.4.1 GLUCAGON 77
7.4.2 CALCITONIN 77
8 BIOSIMILARS MARKET, BY APPLICATION 79
8.1 INTRODUCTION 80
8.2 ONCOLOGY 81
8.3 BLOOD DISORDERS 82
8.4 CHRONIC AND AUTOIMMUNE DISEASES 83
8.5 GROWTH HORMONE DEFICIENCY 84
8.6 INFECTIOUS DISEASES 85
8.7 OTHER APPLICATIONS 86
9 BIOSIMILARS MARKET, BY REGION 87
9.1 INTRODUCTION 88
9.2 NORTH AMERICA 91
9.2.1 U.S. 95
9.2.2 CANADA 96
9.3 EUROPE 98
9.3.1 U.K. 101
9.3.2 GERMANY 102
9.3.3 FRANCE 102
9.3.4 SPAIN 103
9.3.5 ITALY 104
9.3.6 REST OF EUROPE 104
9.4 ASIA-PACIFIC 106
9.4.1 CHINA 109
9.4.2 INDIA 110
9.4.3 JAPAN 111
9.4.4 SOUTH KOREA 112
9.4.5 REST OF ASIA-PACIFIC (ROAPAC) 113
9.5 REST OF THE WORLD (ROW) 115
10 COMPETITIVE LANDSCAPE 119
10.1 OVERVIEW 119
10.2 MARKET SHARE ANALYSIS 120
10.3 COMPETITIVE SITUATION AND TRENDS 121
10.3.1 NEW PRODUCT LAUNCHES AND REGULATORY APPROVALS 122
10.3.2 AGREEMENTS AND COLLABORATIONS 122
10.3.3 EXPANSIONS 123
10.3.4 ACQUISITIONS 123
10.3.5 OTHER DEVELOPMENTS 124
11 COMPANY PROFILES 125
(Overview, Financials, Products & Services, Strategy, & Developments)*
11.1 INTRODUCTION 125
11.2 HOSPIRA, INC. 126
11.3 SANDOZ INTERNATIONAL GMBH (A DIVISION OF NOVARTIS INTERNATIONAL AG) 128
11.4 TEVA PHARMACEUTICAL INDUSTRIES LTD. 130
11.5 ROCHE DIAGNOSTICS (A DIVISION OF F. HOFFMANN-LA ROCHE LTD.) 132
11.6 AMGEN 134
11.7 BIOCON LTD. 136
11.8 DR. REDDY'S LABORATORIES 138
11.9 CELLTRION INC. 140
11.10 MYLAN INC. 142
11.11 MERCK KGAA 144

*Details on Financials, Product & Services, Strategy, & Developments might not be captured in case of unlisted companies.

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12 APPENDIX 146
12.1 INSIGHTS FROM INDUSTRY EXPERTS 146
12.2 DISCUSSION GUIDE 147
12.3 INTRODUCING RT: REAL-TIME MARKET INTELLIGENCE 150
12.4 AVAILABLE CUSTOMIZATIONS 151
12.5 RELATED REPORTS 152