Biosimilars Market by Product (Recombinant Non-Glycosylated Proteins (Insulin, Filgrastim, Interferons, rHGH), Glycosylated (Monoclonal Antibodies, EPO), Peptides (Glucagon, Calcitonin)) & Application (Oncology, Blood Disorders) – Global Forecast to 2020

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[조사보고서 개요]

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

[조사보고서 목차]

1 Introduction (Page No. – 15)
1.1 Objectives of the Study
1.2 Market Definition
1.3 Market Scope
1.3.1 Market Segmentation
1.3.2 Years Considered for the Study
1.4 Currency
1.5 Limitations
1.6 Stakeholders

2 Research Methodology (Page No. – 19)
2.1 Market Size Estimation
2.2 Market Breakdown and Data Triangulation
2.3 Market Share Estimation
2.4 Key Data From Secondary Sources
2.5 Key Data From Primary Sources
2.6 Key Industry Insights
2.7 Assumptions for the Study

3 Executive Summary (Page No. – 29)
3.1 Introduction

4 Premium Insights (Page No. – 33)
4.1 Biosimilars Market
4.2 Biosimilars Market, By Type
4.3 Geographical Snapshot of the Biosimilars Market
4.4 Biosimilars Market, By Type
4.5 Recombinant Nonglycosylated Proteins Market, By Type
4.6 Lifecycle Analysis, By Region

5 Market Overview (Page No. – 38)
5.1 Introduction
5.2 Biosimilars Market Segmentation
5.2.1 Biosimilars Market Segmentation, By Product
5.2.2 Biosimilars Market Segmentation, By Application
5.2.3 Biosimilars Market Segmentation, By Region
5.3 Market Dynamics
5.3.1 Market Drivers
5.3.1.1 Growing Pressure to Curtail Healthcare Expenditure
5.3.1.2 Increasing Demand for Biosimilars Drug Due to Their Cost-Effectiveness
5.3.1.3 Rising Incidences of Diseases
5.3.1.4 Rise in Aging Population Triggers the Incidences of Chronic Disorders
5.3.1.5 Strategic Collaborations Lead to Enhance Productivity and Clinical Trial Activities for Biosimilars
5.3.1.6 Increasing Government Support and Initiatives to Develop and Promote Biosimilars
5.3.2 Market Restrains
5.3.2.1 High Manufacturing Complexities and Costs
5.3.2.2 Innovative Strategies By Biologic Drug Manufacturers
5.3.2.3 Stringent Regulatory Requirements to Adversely Affect Investments in Biosimilars
5.3.3 Opportunities
5.3.3.1 Emerging Markets
5.3.3.2 Untapped Indications
5.3.3.3 Biologic Products Set to Be Off-Patent Will Offer Opportunities for Biosimilars
5.3.4 Burning Issues
5.3.4.1 Product Withdrawals Provide Significant Opportunities for New Entrants

6 Industry Insights (Page No. – 52)
6.1 Porter’s Five Forces Analysis
6.1.1 Threat From New Entrants
6.1.2 Threat of Substitutes
6.1.3 Intensity of Rivalry
6.1.4 Bargaining Power of Suppliers
6.1.5 Bargaining Power of Buyers
6.2 Key Pipeline Products
6.3 Regulatory Outlook
6.3.1 U.S.
6.3.2 Canada
6.3.3 Europe
6.3.4 Asia-Pacific
6.3.5 China
6.3.6 India
6.3.7 Japan
6.3.8 South Korea
6.3.9 Rest of the World
6.3.10 Brazil
6.3.11 Mexico
6.3.12 Argentina
6.3.13 Saudi Arabia
6.4 Biosimilars Services Industry Insights
6.4.1 Introduction
6.4.2 Contract Manufacturing Organizations
6.4.3 Contract Research Organizations
6.4.4 Other Services (Nonclinical & Bioinformatics)

7 Biosimilars Market, By Type of Product (Page No. – 63)
7.1 Introduction
7.2 Recombinant Non-Glycosylated Proteins
7.2.1 Insulin
7.2.2 Recombinant Human Growth Hormone (RHGH)
7.2.3 Granulocyte Colony-Stimulating Factor (Filgrastim)
7.2.4 Interferons
7.3 Recombinant Glycosylated Proteins
7.3.1 Erythropoietin (EPO)
7.3.2 Monoclonal Antibodies (MABS)
7.3.3 Follitropin
7.4 Recombinant Peptides
7.4.1 Glucagon
7.4.2 Calcitonin

8 Biosimilars Market, By Application (Page No. – 85)
8.1 Introduction
8.2 Oncology
8.3 Blood Disorders
8.4 Chronic and Autoimmune Diseases
8.5 Growth Hormone Deficiency
8.6 Infectious Diseases
8.7 Other Applications

9 Biosimilars Market, By Region (Page No. – 93)
9.1 Introduction
9.2 North America
9.2.1 U.S.
9.2.2 Canada
9.3 Europe
9.3.1 U.K.
9.3.2 Germany
9.3.3 France
9.3.4 Spain
9.3.5 Italy
9.3.6 Rest of Europe
9.4 Asia-Pacific
9.4.1 China
9.4.2 India
9.4.3 Japan
9.4.4 South Korea
9.4.5 Rest of Asia-Pacific (ROAPAC)
9.5 Rest of the World (RoW)

10 Competitive Landscape (Page No. – 124)
10.1 Overview of Biosimilars
10.2 Market Share Analysis
10.3 Competitive Situation and Trends
10.3.1 New Product Launches and Regulatory Approvals
10.3.2 Agreements and Collaborations
10.3.3 Expansions
10.3.4 Acquisitions
10.3.5 Other Developments

11 Company Profiles (Page No. – 132)
11.1 Introduction
11.2 Hospira, Inc.
11.2.1 Business Overview
11.2.2 Product Offerings
11.2.3 Recent Developments
11.2.4 MnM View
11.3 Roche Diagnostics (A Division of F. Hoffmann-La Roche Ltd.)
11.3.1 Business Overview
11.3.2 Product Offerings
11.3.3 Recent Developments
11.4 Sandoz International GmbH (A Division of Novartis International Ag)
11.4.1 Business Overview
11.4.2 Product Offerings
11.4.3 Recent Developments
11.4.4 MnM View
11.5 Teva Pharmaceutical Industries Ltd.
11.5.1 Business Overview
11.5.2 Product Offerings
11.5.3 Recent Developments
11.5.4 MnM View
11.6 Amgen
11.6.1 Business Overview
11.6.2 Product Offerings
11.6.3 Recent Developments
11.7 Biocon Ltd.
11.7.1 Business Overview
11.7.2 Product Offerings
11.7.3 Recent Developments
11.8 Dr. Reddy’s Laboratories
11.8.1 Business Overview
11.8.2 Product Offerings
11.8.3 Recent Developments
11.9 Celltrion, Inc.
11.9.1 Business Overview
11.9.2 Product Offerings
11.9.3 Recent Developments
11.10 Mylan, Inc.
11.10.1 Business Overview
11.10.2 Product Offerings
11.10.3 Recent Developments
11.11 Merck KGAA
11.11.1 Business Overview
11.11.2 Product Offerings
11.11.3 Recent Developments

12 Appendix (Page No. – 156)
12.1 Discussion Guide
12.2 Introducing RT: Real-Time Market Intelligence
12.3 Available Customizations
12.4 Related Reports of Biosimilars

List of Tables (84 Tables)

Table 1 Biologics Going Off-Patent to Boost the Market Growth for Biosimilars
Table 2 Stringent Regulatory Requirements in Major Countries Restraining the Growth for the Biosimilars Market
Table 3 List of Key Biologics Under the Threat of Patent Expiry
Table 4 Growth Prospects in Emerging Markets Fuel the Market Growth
Table 5 Status of Regulatory Pathway in North America Region
Table 6 Substitution Status in European Countries
Table 7 Status of Regulatory Pathway in the Asia-Pacific Region
Table 8 Status of Regulatory Pathway in the RoW
Table 9 Joint Ventures Between Cmos & Pharmaceutical Companies for Biosimilars
Table 10 Biosimilars Market Size, By Product Type, 2013–2020 ($Million)
Table 11 Recombinant Non-Glycosylated Proteins Market Size, By Type, 2013–2020 ($Million)
Table 12 Recombinant Non-Glycosylated Proteins Market Size, By Region, 2013–2020 ($Million)
Table 13 North America: Recombinant Non-Glycosylated Proteins Market Size, By Country, 2013–2020 ($Million)
Table 14 Europe: Recombinant Non-Glycosylated Proteins Market Size, By Country, 2013–2020 ($Million)
Table 15 Asia-Pacific: Recombinant Non-Glycosylated Proteins Market Size, By Country, 2013–2020 ($Million)
Table 16 Insulin is Expected to Grow at the Highest CAGR in the Forecast Period
Table 17 Insulin Market Size, By Region, 2013–2020 ($Million)
Table 18 Recombinant Human Growth Hormone Market Size, By Region, 2013–2020 ($Million)
Table 19 List of Approved Products From 2012 to 2015.
Table 20 Granulocyte Colony-Stimulating Factor Market Size, By Region, 2013–2020 ($Million)
Table 21 Interferons Market Size, By Region, 2013–2020 ($Million)
Table 22 Recombinant Glycosylated Proteins Market Size, By Type, 2013–2020 ($Million)
Table 23 Recombinant Glycosylated Proteins Market Size, By Region, 2013–2020 ($Million)
Table 24 North America: Recombinant Glycosylated Proteins Market Size, By Country, 2013–2020 ($Million)
Table 25 Europe: Recombinant Glycosylated Proteins Market Size, By Country, 2013–2020 ($Million)
Table 26 Asia-Pacific: Recombinant Non-Glycosylated Proteins Market Size, By Country, 2013–2020 ($Million)
Table 27 Erythropoietin Market Size, By Region, 2013–2020 ($Million)
Table 28 Monoclonal Antibodies Market Size, By Region, 2013–2020 ($Million)
Table 29 Follitropin Market Size, By Region, 2013–2020 ($Million)
Table 30 Recombinant Peptides Market Size, By Type, 2013–2020 ($Million)
Table 31 Recombinant Peptides Market Size, By Region, 2013–2020 ($Million)
Table 32 North America: Recombinant Peptides Market Size, By Country, 2013–2020 ($Million)
Table 33 Europe: Recombinant Peptides Market Size, By Country, 2013–2020 ($Million)
Table 34 Asia-Pacific: Recombinant Peptides Market Size, By Country, 2013–2020 ($Million)
Table 35 Glucagon Market Size, By Region, 2013–2020 ($Million)
Table 36 Calcitonin Market Size, By Region, 2013–2020 ($Million)
Table 37 Biosimilars Market Size, By Application, 2012–2019 ($Million)
Table 38 Biosimilars Market Size for Oncology, By Region, 2012–2019 ($Million)
Table 39 Biosimilars Market Size for Blood Disorders, By Region, 2012–2019 ($Million)
Table 40 Biosimilars Market Size for Chronic and Autoimmune Diseases, By Region, 2012–2019 ($Million)
Table 41 Biosimilars Market Size for Growth Hormone Deficiency, By Region, 2012–2019 ($Million)
Table 42 Biosimilars Market Size for Infectious Diseases, By Region, 2012–2019 ($Million)
Table 43 Biosimilars Market Size for Other Applications, By Region, 2012–2019 ($Million)
Table 44 Biosimilars Market Size, By Region, 2013–2020 ($Million)
Table 45 North America: Biosimilars Market Size, By Country, 2013–2020 ($Million)
Table 46 North America: Biosimilars Market Size, By Product, 2013–2020 ($Million)
Table 47 North America: Recombinant Nonglycosylated Proteins Market Size, By Type, 2013–2020 ($Million)
Table 48 North America: Recombinant Glycosylated Proteins Market Size, By Type, 2013–2020 ($Million)
Table 49 North America: Recombinant Peptides Market Size, By Type, 2013–2020 ($Million)
Table 50 North America: Biosimilars Market Size, By Application, 2013–2020 ($Million)
Table 51 Recombinant Peptides Will Drive the Growth of the Biosimilars Market in the U.S.
Table 52 U.S.: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 53 Canada: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 54 Europe: Biosimilars Market Size, By Product, 2013–2020 ($Million)
Table 55 Europe: Recombinant Nonglycosylated Proteins Market Size, By Type, 2013–2020 ($Million)
Table 56 Europe: Recombinant Glycosylated Proteins Market Size, By Type, 2013–2020 ($Million)
Table 57 Europe: Recombinant Peptides Market Size, By Type, 2013–2020 ($Million)
Table 58 Europe: Biosimilars Market Size, By Application, 2013–2020 ($Million)
Table 59 U.K.: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 60 Germany: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 61 France: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 62 Spain: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 63 Italy: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 64 RoE: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 65 Asia-Pacific: Biosimilars Market Size, By Product, 2013–2020 ($Million)
Table 66 Asia-Pacific: Recombinant Nonglycosylated Proteins Market Size, By Type, 2013–2020 ($Million)
Table 67 Asia-Pacific: Recombinant Glycosylated Proteins Market Size, By Type, 2013–2020 ($Million)
Table 68 Asia-Pacific: Recombinant Peptides Market Size, By Type, 2013–2020 ($Million)
Table 69 Asia-Pacific: Biosimilars Market Size, By Application, 2013–2020 ($Million)
Table 70 China: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 71 India: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 72 Japan: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 73 South Korea: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 74 ROAPAC: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 75 RoW: Biosimilars Market Size, By Product, 2013–2020 ($Million)
Table 76 RoW: Recombinant Nonglycosylated Proteins Market Size, By Type, 2013–2020 ($Million)
Table 77 RoW: Recombinant Glycosylated Proteins Market Size, By Type, 2013–2020 ($Million)
Table 78 RoW: Recombinant Peptides Market Size, By Type, 2013–2020 ($Million)
Table 79 RoW: Biosimilars Market Size, By Application, 2013–2020 ($Million)
Table 80 Recent New Product Launches and Regulatory Approvals, 2012–2015
Table 81 Recent Agreements and Collaborations, 2012–2015
Table 82 Recent Expansions, 2012–2015
Table 83 Recent Acquisitions 2012–2015
Table 84 Recent Other Developments, 2012–2015

List of Figures (39 Figures)

Figure 1 Global Biosimilars Market, By Product
Figure 2 Research Design
Figure 3 Top-Down Approach
Figure 4 Bottom-Up Approach
Figure 5 Breakdown of Primary Interviews: By Company Type, Designation, and Region
Figure 6 Data Triangulation Methodology
Figure 7 Market Snapshot: Recombinant Nonglycosylated Proteins to Dominate the Market
Figure 8 Asia-Pacific to Grow at the Highest Rate
Figure 9 Europe to Dominate Nonglycosylated Proteins Market During 2015-2020
Figure 10 Geographical Analysis of the Biosimilars Market
Figure 11 Biosimilars Market to Grow at A High Rate During the Forecast Period
Figure 12 Recombinant Nonglycosylated Proteins Segment Held the Largest Market Share in 2014
Figure 13 Europe Dominated the Biosimilars Market in 2014
Figure 14 Recombinant Nonglycosylated Proteins Will Continue to Lead the Biosmilar Market in the Forecast Period
Figure 15 Insulin Segment to Witness Highest Growth Rate From 2015 to 2020
Figure 16 Asia-Pacific to Witness High Growth in the Biosimilars Market During the Forecast Period
Figure 17 Biosimilars Market: Drivers, Restraints, & Opportunities
Figure 18 Erythropoietin is Expected to Dominate the Market in the Forecast Period
Figure 19 Glucagon Will Continue to Dominate the Market in the Forecast Period
Figure 20 Oncology Dominates the Biosimilars Applications Market
Figure 21 Geographic Snapshot (2015): Emerging Markets Hold Significant Growth Opportunities for Biosimilars
Figure 22 Asia, an Attractive Market for Biosimilars
Figure 23 Growing Demand for Biopharmaceutical Drugs is Driving Market Growth
Figure 24 Recombinant Glycosylated Proteins Will Continue to Hold the Largest Share in the European Market
Figure 25 Biosimilars Market Growing at the Highest CAGR in Asia-Pacific
Figure 26 Major Players Adopted the Strategy of Approvals to Enhance Their Market Positions in the Biosimilars Market
Figure 27 Global Biosimilars Market Share, By Key Player, 2014
Figure 28 Battle for Market Share: New Product Launches and Regulatory Approvals Was the Key Strategy Adopted By Market Players
Figure 29 Product Benchmarking for Top 3 Players
Figure 30 Hospira, Inc.: Company Snapshot
Figure 31 Roche Diagnostics: Company Snapshot
Figure 32 Sandoz International GmbH: Company Snapshot
Figure 33 Teva Pharmaceutical Industries Ltd.: Company Snapshot
Figure 34 Amgen: Company Snapshot
Figure 35 Biocon Ltd.: Company Snapshot
Figure 36 Dr. Reddy's Laboratories: Company Snapshot
Figure 37 Celltrion, Inc.: Company Snapshot
Figure 38 Mylan, Inc.: Company Snapshot
Figure 39 Merck KGAA: Company Snapshot

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