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Biosimilars Market by Product (Insulin, Filgrastim, Interferons, rHGH), Glycosylated (Monoclonal Antibodies, EPO), Peptides (Glucagon, Calcitonin)) & Application - Global Forecast to 2020.

  • ID: 3315099
  • July 2015
  • Region: Global
  • 153 Pages
  • Markets and Markets

FEATURED COMPANIES

  • Amgen
  • Biocon Ltd
  • Celltrion Inc
  • Dr. Reddy's Laboratories
  • Hospira, Inc
  • Merck Kgaa
  • MORE

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.

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 READ MORE >

Note: Product cover images may vary from those shown

FEATURED COMPANIES

  • Amgen
  • Biocon Ltd
  • Celltrion Inc
  • Dr. Reddy's Laboratories
  • Hospira, Inc
  • Merck Kgaa
  • MORE

1 Introduction
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
2.1 Market Size Estimation
2.2 Market Breakdown And Data Triangulation
2.3 Market Share Estimation
2.3.1 Key Data From Secondary Sources
2.3.2 Key Data From Primary Sources
2.3.2.1 Key Industry Insights
2.4 Assumptions For The Study

3 Executive Summary
3.1 Introduction

4 Premium Insights
4.1 Overall Biosimilars Market
4.2 Biosimilars Market, By Type & Region
4.3 Biosimilars Market, By Countries
4.4 Recombinant Nonglycosylated Proteins Market, By Type
4.5 Lifecycle Analysis, By Region

5 Market Overview
5.1 Introduction
5.2 Biosimilars Market Segmentation
5.2.1 By Product
5.2.2 By Application
5.2.3 By Region
5.3 Market Dynamics
5.3.1 Drivers
5.3.1.1 Growing Pressure To Curtail Healthcare Expenditure
5.3.1.2 Increasing Demand For Biosimilar Drugs 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 Restraints
5.3.2.1 High Manufacturing Complexities And Costs
5.3.2.2 Innovative Strategies By Biologic Drug Manufacturers
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 Challenges
5.3.4.1 Stringent Regulatory Requirements To Adversely Affect Investments In Biosimilars
5.3.5 Burning Issues
5.3.5.1 Product Withdrawals Provide Significant Opportunities For New Entrants

6 Industry Insights
6.1 Introduction
6.2 Porter’S Five Forces Analysis
6.2.1 Threat Of New Entrants
6.2.2 Threat Of Substitutes
6.2.3 Intensity Of Rivalry
6.2.4 Bargaining Power Of Suppliers
6.2.5 Bargaining Power Of Buyers
6.3 Key Pipeline Products
6.4 Regulatory Outlook
6.4.1 North America
6.4.1.1 U.S.
6.4.1.2 Canada
6.4.2 Europe
6.4.3 Asia-Pacific
6.4.3.1 China
6.4.3.2 India
6.4.3.3 Japan
6.4.3.4 South Korea
6.4.4 Rest Of The World
6.4.4.1 Brazil
6.4.4.2 Mexico
6.4.4.3 Argentina
6.4.4.4 Saudi Arabia
6.5 Biosimilars Services Industry Insights
6.5.1 Introduction
6.5.2 Contract Manufacturing Organizations
6.5.3 Contract Research Organizations
6.5.4 Other Services (Nonclinical & Bioinformatics)

7 Biosimilars Market, By Type Of Product
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
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
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 (ROAP)
9.5 Rest Of The World (Row)

10 Competitive Landscape
10.1 Overview
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
(Overview, Financials, Products & Services, Strategy, & Developments)*
11.1 Introduction
11.2 Hospira, Inc.
11.3 Sandoz International GMBH (A Division Of Novartis International Ag)
11.4 Teva Pharmaceutical Industries Ltd.
11.5 Roche Diagnostics (A Division Of F. Hoffmann-La Roche Ltd.)
11.6 Amgen
11.7 Biocon Ltd.
11.8 Dr. Reddy's Laboratories
11.9 Celltrion Inc.
11.10 Mylan Inc.
11.11 Merck Kgaa

*Details On Financials, Product & Services, Strategy, & Developments Might Not Be Captured In Case Of Unlisted Companies.

12 Appendix
12.1 Insights From Industry Experts
12.2 Discussion Guide
12.3 Introducing Rt: Real-Time Market Intelligence
12.4 Available Customizations
12.5 Related Reports

List Of Tables

Table 1 Biosimilars Market: Major Collaborations (2012–2015)
Table 2 Biologics Going Off-Patent To Boost The Market Growth For Biosimilars
Table 3 High Manufacturing Complexities And Costs Restraining The Growth For The Biosimilars Market
Table 4 List Of Key Biologics Under The Threat Of Patent Expiry
Table 5 Growth Prospects In Emerging Markets Fuel The Market Growth
Table 6 Stringent Regulatory Requirements In Major Countries Is A Major Challenge For The Biosimilars Market
Table 7 Biosimilars In Clinical Trials
Table 8 Status Of Regulatory Pathway In North America Region
Table 9 Substitution Status In European Countries
Table 10 Status Of Regulatory Pathway In The Asia-Pacific Region
Table 11 Status Of Regulatory Pathway In The Row
Table 12 Joint Ventures Between Cmos & Pharmaceutical Companies For Biosimilars
Table 13 Biosimilars Market Size, By Product Type, 2013–2020 ($Million)
Table 14 Recombinant Non-Glycosylated Proteins Market Size, By Type,
2013–2020 ($Million)
Table 15 Recombinant Non-Glycosylated Proteins Market Size, By Region,
2013–2020 ($Million)
Table 16 North America: Recombinant Non-Glycosylated Proteins Market Size, By Country, 2013–2020 ($Million)
Table 17 Europe: Recombinant Non-Glycosylated Proteins Market Size,
By Country, 2013–2020 ($Million)
Table 18 Asia-Pacific: Recombinant Non-Glycosylated Proteins Market Size,
By Country, 2013–2020 ($Million)
Table 19 Insulin Market Size, By Region, 2013–2020 ($Million)
Table 20 Recombinant Human Growth Hormone Market Size, By Region,
2013–2020 ($Million)
Table 21 List Of Approved Products From 2012 To 2015.
Table 22 Granulocyte Colony-Stimulating Factor Market Size, By Region,
2013–2020 ($Million)
Table 23 Interferons Market Size, By Region, 2013–2020 ($Million)
Table 24 Recombinant Glycosylated Proteins Market Size, By Type,
2013–2020 ($Million)
Table 25 Recombinant Glycosylated Proteins Market Size, By Region,
2013–2020 ($Million)
Table 26 North America: Recombinant Glycosylated Proteins Market Size,
By Country, 2013–2020 ($Million)
Table 27 Europe: Recombinant Glycosylated Proteins Market Size,
By Country, 2013–2020 ($Million)
Table 28 Asia-Pacific: Recombinant Non-Glycosylated Proteins Market Size,
By Country, 2013–2020 ($Million)
Table 29 Erythropoietin Market Size, By Region, 2013–2020 ($Million)
Table 30 Monoclonal Antibodies Market Size, By Region, 2013–2020 ($Million)
Table 31 Follitropin Market Size, By Region, 2013–2020 ($Million)
Table 32 Recombinant Peptides Market Size, By Type, 2013–2020 ($Million)
Table 33 Recombinant Peptides Market Size, By Region, 2013–2020 ($Million)
Table 34 North America: Recombinant Peptides Market Size, By Country,
2013–2020 ($Million)
Table 35 Europe: Recombinant Peptides Market Size, By Country,
2013–2020 ($Million)
Table 36 Asia-Pacific: Recombinant Peptides Market Size, By Country,
2013–2020 ($Million)
Table 37 Glucagon Market Size, By Region, 2013–2020 ($Million)
Table 38 Calcitonin Market Size, By Region, 2013–2020 ($Million)
Table 39 Biosimilars Market Size, By Application, 2012–2019 ($Million)
Table 40 Biosimilars Market Size For Oncology, By Region, 2012–2019 ($Million)
Table 41 Biosimilars Market Size For Blood Disorders, By Region,
2012–2019 ($Million)
Table 42 Biosimilars Market Size For Chronic And Autoimmune Diseases,
By Region, 2012–2019 ($Million)
Table 43 Biosimilars Market Size For Growth Hormone Deficiency,
By Region, 2012–2019 ($Million)
Table 44 Biosimilars Market Size For Infectious Diseases, By Region,
2012–2019 ($Million)
Table 45 Biosimilars Market Size For Other Applications, By Region,
2012–2019 ($Million)
Table 46 Biosimilars Market Size, By Region, 2013–2020 ($Million)
Table 47 North America: Biosimilars Market Size, By Country,
2013–2020 ($Million)
Table 48 North America: Biosimilars Market Size, By Product,
2013–2020 ($Million)
Table 49 North America: Recombinant Nonglycosylated Proteins Market Size,
By Type, 2013–2020 ($Million)
Table 50 North America: Recombinant Glycosylated Proteins Market Size,
By Type, 2013–2020 ($Million)
Table 51 North America: Recombinant Peptides Market Size, By Type,
2013–2020 ($Million)
Table 52 North America: Biosimilars Market Size, By Application,
2013–2020 ($Million)
Table 53 U.S.: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 54 Canada: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 55 Europe: Biosimilars Market Size, By Product, 2013–2020 ($Million)
Table 56 Europe: Recombinant Nonglycosylated Proteins Market Size,
By Type, 2013–2020 ($Million)
Table 57 Europe: Recombinant Glycosylated Proteins Market Size,
By Type, 2013–2020 ($Million)
Table 58 Europe: Recombinant Peptides Market Size, By Type,
2013–2020 ($Million)
Table 59 Europe: Biosimilars Market Size, By Application, 2013–2020 ($Million)
Table 60 U.K.: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 61 Germany: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 62 France: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 63 Spain: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 64 Italy: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 65 Roe: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 66 Asia-Pacific: Biosimilars Market Size, By Product, 2013–2020 ($Million)
Table 67 Asia-Pacific: Recombinant Nonglycosylated Proteins Market Size,
By Type, 2013–2020 ($Million)
Table 68 Asia-Pacific: Recombinant Glycosylated Proteins Market Size,
By Type, 2013–2020 ($Million)
Table 69 Asia-Pacific: Recombinant Peptides Market Size, By Type,
2013–2020 ($Million)
Table 70 Asia-Pacific: Biosimilars Market Size, By Application,
2013–2020 ($Million)
Table 71 China: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 72 India: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 73 Japan: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 74 South Korea: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 75 Roapac: Biosimilars Market Size, By Type, 2013–2020 ($Million)
Table 76 Row: Biosimilars Market Size, By Product, 2013–2020 ($Million)
Table 77 Row: Recombinant Nonglycosylated Proteins Market Size,
By Type, 2013–2020 ($Million)
Table 78 Row: Recombinant Glycosylated Proteins Market Size, By Type,
2013–2020 ($Million)
Table 79 Row: Recombinant Peptides Market Size, By Type, 2013–2020 ($Million)
Table 80 Row: Biosimilars Market Size, By Application, 2013–2020 ($Million)
Table 81 Recent New Product Launches And Regulatory Approvals, 2012–2015
Table 82 Recent Agreements And Collaborations, 2012–2015
Table 83 Recent Expansions, 2012–2015
Table 84 Recent Acquisitions 2012–2015
Table 85 Recent Other Developments, 2012–2015

List Of Figures

Figure 1 Global Biosimilars Market, By Product Type
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 During The Forecast Period
Figure 9 Europe To Dominate Nonglycosylated Proteins Market During 2015-2020
Figure 10 Biosimilar Market: Geographic Snapshot
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 Germany Dominated The Biosimilars Market In 2014
Figure 14 Insulin Segment To Witness Highest Growth Rate From 2015 To 2020
Figure 15 Asia-Pacific To Witness High Growth In The Biosimilars Market During The Forecast Period
Figure 16 Biosimilars Market: Drivers, Restraints, Opportunities & Challenges
Figure 17 Global Biosimilars Market: Porter’S Five Forces Analysis
Figure 18 Insulin Is Expected To Grow At The Highest Cagr In The Forecast Period
Figure 19 Erythropoietin Is Expected To Dominate The Market In The Forecast Period
Figure 20 Glucagon Will Continue To Dominate The Market In The Forecast Period
Figure 21 Oncology Dominates The Biosimilars Applications Market
Figure 22 Geographic Snapshot (2015): Emerging Markets Hold Significant Growth Opportunities
Figure 23 Asia-Pacific, An Attractive Market For Biosimilars
Figure 24 North America: Market Snapshot
Figure 25 Recombinant Peptides Will Drive The Growth Of The Biosimilar Market In The U.S.
Figure 26 Recombinant Glycosylated Proteins Will Continue To Hold The Largest Share In The European Market
Figure 27 Asia-Pacific: Market Snapshot
Figure 28 Major Players Adopted The Strategy Of Approvals To Enhance Their Market Positions In The Biosimilars Market (2012-2015)
Figure 29 Global Biosimilars Market Share, By Key Player, 2014
Figure 30 Battle For Market Share: New Product Launches And Regulatory Approvals Was The Key Strategy Adopted By Market Players
Figure 31 Product Benchmarking For Top 3 Players
Figure 32 Hospira, Inc.: Company Snapshot
Figure 33 Sandoz International Gmbh: Company Snapshot
Figure 34 Teva Pharmaceutical Industries Ltd.: Company Snapshot
Figure 35 Roche Diagnostics: Company Snapshot
Figure 36 Amgen: Company Snapshot
Figure 37 Biocon Ltd.: Company Snapshot
Figure 38 Dr. Reddy's Laboratories: Company Snapshot
Figure 39 Celltrion Inc.: Company Snapshot
Figure 40 Mylan Inc.: Company Snapshot
Figure 41 Merck Kgaa: Company Snapshot

Note: Product cover images may vary from those shown

FEATURED COMPANIES

  • Amgen
  • Biocon Ltd
  • Celltrion Inc
  • Dr. Reddy's Laboratories
  • Hospira, Inc
  • Merck Kgaa
  • MORE

The biosimilars market is expected to reach $6.22 Billion by 2020 from $2.29 Billion in 2015, growing at a CAGR of 22.1% from 2015 to 2020. Key factors such as growing pressure to curtail healthcare expenditure, growing demand for biosimilar drugs due to their cost-effectiveness, rising incidences of various diseases, increasing number of off-patented drugs, positive outcomes in the ongoing clinical trials, and rising demand for biosimilars in different therapeutic applications such as rheumatoid arthritis and blood disorders are propelling the growth of the global market. However, factors such as high manufacturing complexities and costs, stringent regulatory requirements in countries, and innovative strategies by biologic drug manufacturers to restrict the entry of new players are restraining the growth of this market.

The global biosimilars market is segmented on the basis of products and applications. On the basis of products, the 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 hormone; 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 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). Oncology accounts for the largest share of the global market, owing to the launch of new biosimilars, namely, Remsima (monoclonal antibody) in Europe, and Neutroval and tbo-filgrastim in the U.S. On the other hand, the chronic and autoimmune disorders segment is expected to grow at the highest CAGR of 25.7% from 2015 to 2020. The high growth in this segment can be attributed to the rising incidences of autoimmune disorders such as rheumatoid arthritis, Crohn's disease, ulcerative colitis, psoriatic arthritis, Type 1 diabetes, and psoriasis.

Geography, the biosimilars market is segmented into North America, Europe, Asia-Pacific, and the RoW (Latin America, Middle East, and Africa). In 2015, Europe is expected to dominate the global market; growth in this market can be attributed to the growing pressure to curtail healthcare costs, patent expiry of biologic products, launch of new biosimilar products, rising incidences of chronic disorders (such as cancer, diabetes, and rheumatoid arthritis), and emergence of new market participants in this region. However, the Asia-Pacific market is expected to grow at the highest CAGR from 2015 to 2020, owing to the developing healthcare infrastructure, presence of a large patient population, increasing funding/investment towards the development of biosimilars, and growing focus of both international and domestic players on Asia-Pacific countries.

New product launches and expansions are the key strategies adopted by major players to strengthen their positions in the global biosimilars market. Moreover, strategies such as partnerships, agreements, collaborations, joint ventures, and acquisitions were also adopted by a significant number of market players to strengthen their product portfolios and expand their geographic presence.

The key players in the global biosimilars market include Sandoz International GmbH (Germany), Hospira, Inc. (U.S.), Teva Pharmaceutical Industries Ltd. (Israel), Dr. Reddy’s Laboratories (India), Biocon Limited (India), Mylan, Inc. (U.S.), Amgen (U.S.), Celltrion Inc. (South Korea), Roche Diagnostics (Switzerland), and Merck KGaA (Germany).

Note: Product cover images may vary from those shown

- Amgen
- Biocon Ltd
- Celltrion Inc
- Dr. Reddy's Laboratories
- Hospira, Inc
- Merck Kgaa
- Mylan Inc
- Roche Diagnostics (A Division Of F. Hoffmann-La Roche Ltd.)
- Sandoz International Gmbh (A Division Of Novartis International Ag)
- Teva Pharmaceutical Industries Ltd

Note: Product cover images may vary from those shown
Note: Product cover images may vary from those shown

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