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  4. > Analysis of the Global Biosimilars Market

Analysis of the Global Biosimilars Market

  • January 2014
  • -
  • Frost & Sullivan
  • -
  • 380 pages

Impending Patent Expiries and Next-generation Biosimilars Pipeline Provide Impetus for Growth

Patent expirations of blockbuster biologics and a promising pipeline of biosimilars present positive opportunities for the global market. The research service provides analysis on regional market penetration and market dynamics. This study also provides a market overview, market engineering measurements, revenue forecasts, competitive analysis, and key trends for the biosimilars market and its segments. Regional analysis includes The United States, European countries such as the United Kingdom, Germany, France, Italy, Spain, Benelux, and Scandinavia as well as Asia-Pacific and Latin America. The study period is 2009–2019, with 2012 as the base year.

Methodology

•The information contained in this research service was derived from a variety of relevant primary and secondary information sources.
•Primary interviews were conducted with industry participants in positions such as chairman and chief executive officer (CEO), director of investor relations, director of business development, chief business officer, media relations, and international key opinion leaders (KOL).
•Secondary data sources include government and public health organisation websites, the World Health Organization (WHO), European Medicines Agency (EMA), the US Food and Drug Administration (FDA) publications (annual reports, US Securities and Exchange Commission (SEC) filings, investor presentations, earnings transcripts, and press releases), government public sources, pharmaceutical industry databases, and published articles in scientific and medical journals.
•For the United States, Europe, and Latin America (LATAM), revenue forecasting is performed using a robust, data-driven, bottom-up approach. Marketed drugs, patent expiries, and potential new entrants in phase 3 of development and beyond are individually forecasted, and aggregate figures are provided. For the Asia-Pacific (APAC) region, forecasting is performed using a top-down model.

Key Findings

•The global biosimilars market will continue to grow from $X million in 2012 to approximately $X million in 2019, at a compound annual growth rate (CAGR) of X%.
•The biosimilars market is a growth market. The period from 2013 to 2015 is considered a time of significance for higher growth, with new products and segments adding up during this time period. Regulatory guidelines have been drafted by the EMA for erythropoietins (EPO), granulocyte colony stimulating factors (G-CSF), human growth hormone (HGH), and monoclonal antibodies (mAbs). The United States, India, and other regions have also drafted guidelines as the pathways are gradually becoming clear.
•The European market seems favourable due to increasing pressure to control the spiralling costs of healthcare. Biosimilar mAbs are thus expected to experience a positive trend in the region.
•The US market is underpenetrated, and a huge opportunity awaits biosimilar manufacturers.
•The Russian government plans to promote the country’s domestic biosimilars industry through subsidies and contracts for companies actively developing biosimilars.
•Several regional governments are actively promoting the growth of biosimilars. For example, the South Korean government is striving to make its country a global market leader, with the goal of attaining a global market share of X% by 2020 and with provisions of both financial and institutional support for those involved.
•Partnerships and alliances are the major focus of firms entering the biosimilars market, and there have been some notable deals between generic participants and biotech firms. Examples include generics giant Teva and a biologicals firm Cephalon, Indian generics manufacturer Lupin Pharmaceuticals and Australian biotech Neuclone, and German STADA Arzneimittel’s mAbs deal with Hungary-based Gedeon Richter.
•Non-pharma participants have made their entry into biosimilars through partnerships. For example, Japanese digital camera maker Fujifilm is developing biosimilars with the biotech firm Kyowa Hakko Kirin, and Korean electronics giant Samsung struck biosimilar deals with contract research organisation (CRO) Quintiles and, more recently, with the US biotech Biogen Idec.

Scope and Segmentation

Geographic Coverage: Global
Study Period: 2009–2019
Base Year: 2012
Forecast Period: 2013–2019
Monetary Unit: US Dollars

This report covers the following geographic markets:
•The United States
•European countries such as the United Kingdom, Germany, France, Italy, and Spain
oThe Benelux region: Belgium, Netherlands, and Luxembourg
oThe Scandinavian region: Denmark, Norway, and Sweden
•APAC: India, China, South Korea, Japan, and Australia
•LATAM: Brazil, Mexico, and Argentina

Key Questions This Study Will Answer

What is the current scenario of the global biosimilars market, and how far will it go?
What are the key factors driving the market, and what are the barriers that need to be resolved?
Which are the key market segments to look out for, and what are the key trends and regulatory aspects?
Who are the key market participants involved, and where do they stand?
What are the factors affecting the biosimilars market in different regions of Europe, and how will these factors affect the market in the future?
What is the future biosimilars market scenario, and what should market participants do to succeed?

Table Of Contents

Analysis of the Global Biosimilars Market
Table of Contents

1. Executive Summary
• Key Findings
• Scope and Segmentation
• Key Questions This Study Will Answer
• Market Engineering Measurements
• CEO's Perspective
• Key Companies to Watch
• Executive Summary—3 Big Predictions
2. Market Overview
• Comparative Analysis: Generics, Biosimilars, and Biologics
• Market Segmentation
• Geographic Perspective
• Timeline of Key Events
• Biosimilar Trends in the Future
3. Competitive Playbook
• New Market Opportunities
• Merger, Acquisition, and Partnership Assessment
4. Drivers, Restraints, and Trends—Total Biosimilars Market
• Market Drivers
• Market Restraints
• Impact Mapping of Drivers and Restraints
5. Forecasts and Trends—Total Biosimilars Market
• Market Engineering Measurements
• Forecast Assumptions and Definitions
• Revenue Forecast
• Revenue Forecast Discussion
• Percent Revenue Forecast by Region
• Revenue Forecast by Region
• Emerging Trends—Biobetters
6. Competitive Environment
• Competitive Landscape Analysis
• Pipeline Analysis
• Market Share Analysis—Global
7. Key Companies to Watch
• Companies to Watch
8. Europe Breakdown
• Market Overview
• Market Engineering Measurements
• Revenue Forecast
• Market Analysis
• Pricing Analysis
• Pricing Trends and Forecast
• PEST Analysis
• Market Share Analysis
• Marketed Product Analysis
• Biologics Patent Expiry Analysis
• Patent Expirations
9. Europe Erythropoietin Segment Breakdown
10. Market Overview
• Market Engineering Measurements
• Revenue Forecast
• Revenue Forecast Discussion
• Regulatory Environment—Europe EPO Biosimilars
11. Europe Granulocyte Colony Stimulating Factors Segment Breakdown
• Market Overview
• Market Engineering Measurements
• Revenue Forecast
• Revenue Forecast Discussion
• Regulatory Environment—Europe G-CSF Biosimilars
12. Europe Human Growth Hormone Segment Breakdown
• Market Overview
• Market Engineering Measurements
• Revenue Forecast
• Revenue Forecast Discussion
• Regulatory Environment—Europe HGH Biosimilars
13. Europe Insulin Segment Breakdown
• Scenario Revenue Forecast
• Scenario Revenue Forecast Discussion
• Regulatory Environment—Europe Insulin Biosimilars
14. Europe Monoclonal Antibodies Segment Breakdown
• Scenario Revenue Forecast
• Scenario Revenue Forecast Discussion
• Regulatory Environment—Europe mAbs Biosimilars
15. Europe Interferons Segment Breakdown
• Scenario Revenue Forecast
• Scenario Revenue Forecast Discussion
• Regulatory Environment—Europe Interferon Biosimilars
16. The United Kingdom Breakdown
• Market Overview
• Market Engineering Measurements
• Revenue Forecast
• Revenue Forecast Discussion
17. Germany Breakdown
• Market Overview
• Market Engineering Measurements
• Revenue Forecast
• Revenue Forecast Discussion
18. France Breakdown
• Market Overview
• Market Engineering Measurements
• Revenue Forecast
• Revenue Forecast Discussion
19. Italy Breakdown
• Market Overview
• Market Engineering Measurements
• Revenue Forecast
• Revenue Forecast Discussion
20. Spain Breakdown
• Market Overview
• Market Engineering Measurements
• Revenue Forecast
• Revenue Forecast Discussion
21. Benelux Breakdown
• Market Overview
• Market Engineering Measurements
• Revenue Forecast
• Revenue Forecast Discussion
22. Scandinavia Breakdown
• Market Overview
• Market Engineering Measurements
• Revenue Forecast
• Revenue Forecast Discussion
23. The United States Breakdown
• Revenue Forecast
• Revenue Forecast Discussion
• Market Analysis
• Regulatory Environment
• Pricing Analysis
• PEST Analysis
• Biologics Patent Expiry Analysis
• Patent Expirations
24. The United States Erythropoietin Segment Breakdown
• Revenue Forecast
• Revenue Forecast Discussion
• Scenario Revenue Forecast
• Scenario Revenue Forecast Discussion
25. The United States Granulocyte Colony Stimulating Factors Segment Breakdown
• Revenue Forecast
• Revenue Forecast Discussion
• Scenario Revenue Forecast
• Scenario Revenue Forecast Discussion
26. The United States Human Growth Hormone Segment Breakdown
• Revenue Forecast
• Revenue Forecast Discussion
• Pricing Trends and Forecast
• Pricing Trends and Forecast Discussion
27. The United States Insulin Segment Breakdown
• Revenue Forecast
• Revenue Forecast Discussion
• Scenario Revenue Forecast
• Scenario Revenue Forecast Discussion
28. The United States Monoclonal Antibodies Segment Breakdown
• Revenue Forecast
• Revenue Forecast Discussion
• Scenario Revenue Forecast
• Scenario Revenue Forecast Discussion
29. The United States Interferons Segment Breakdown
• Revenue Forecast
• Revenue Forecast Discussion
• Pricing Trends and Forecast
• Pricing Trends and Forecast Discussion
30. China Breakdown
• Revenue Forecast
• Revenue Forecast Discussion
• Market Analysis
• PEST Analysis
• Regulatory Environment
• Market Share Analysis
31. China Erythropoietin Segment Breakdown
• Revenue Forecast
• Revenue Forecast Discussion
• Pricing Analysis
• Local Market Participants
32. China Granulocyte Colony Stimulating Factors Segment Breakdown
• Revenue Forecast
• Revenue Forecast Discussion
• Pricing Analysis
• Local Market Participants
33. China Human Growth Hormone Segment Breakdown
• Revenue Forecast
• Revenue Forecast Discussion
• Pricing Analysis
• Local Market Participants
34. China Insulin Segment Breakdown
• Revenue Forecast
• Revenue Forecast Discussion
• Pricing Analysis
• Local Market Participants
35. China Monoclonal Antibodies Segment Breakdown
• Revenue Forecast
• Revenue Forecast Discussion
• Local Market Participants
36. China Interferons Segment Breakdown
• Revenue Forecast
• Revenue Forecast Discussion
• Pricing Analysis
• Local Market Participants
37. India Breakdown
• Revenue Forecast
• Revenue Forecast Discussion
• Market Analysis
• Regulatory Environment
• PEST Analysis
38. South Korea Breakdown
• Revenue Forecast
• Revenue Forecast Discussion
• Market Analysis
• Regulatory Environment
• Reimbursement System and Pricing Analysis
• PEST Analysis
• Marketed Product Analysis
• Pipeline Analysis
39. Japan Breakdown
• Revenue Forecast
• Revenue Forecast Discussion
• Market Analysis
• Regulatory Environment
• Pricing Analysis
• Pricing Trends and Forecast
• PEST Analysis
• Product Analysis
40. Australia Breakdown
• Revenue Forecast
• Revenue Forecast Discussion
• Market Analysis
• Pricing Analysis
• Pricing Trends and Forecast
• PEST Analysis
41. Latin America Breakdown
• Market Overview—Biosimilars
• Revenue Forecast
• Revenue Forecast Discussion
• Market Analysis
• Regulatory Environment
• Pricing Analysis
• Pricing Trends and Forecast
• Pricing Trends and Forecast Discussion
• PEST Analysis
• Competitive Analysis
42. Latin America Erythropoietin Segment Breakdown
• Revenue Forecast
• Revenue Forecast Discussion
43. Latin America Granulocyte Colony Stimulating Factors Segment Breakdown
• Revenue Forecast
• Revenue Forecast Discussion
44. Latin America Human Growth Hormone Segment Breakdown
• Revenue Forecast
• Revenue Forecast Discussion
45. Latin America Insulin Segment Breakdown
• Revenue Forecast
• Revenue Forecast Discussion
46. Latin America Monoclonal Antibodies Segment Breakdown
• Market Overview
47. Latin America Interferons Segment Breakdown
• Revenue Forecast
• Revenue Forecast Discussion
48. Brazil Breakdown
• Revenue Forecast
• Revenue Forecast Discussion
• Market Analysis
49. Mexico Breakdown
• Revenue Forecast
• Revenue Forecast Discussion
• Market Analysis
50. Argentina Breakdown
• Revenue Forecast
• Revenue Forecast Discussion
• Market Analysis
51. The Last Word
• The Last Word—3 Big Predictions
• The Last Word—Discussion
• Legal Disclaimer
52. Appendix
• Market Overview
• Market Definitions
• Market Background
• Drivers Explained
• Restraints Explained
• Market Engineering Methodology
• Learn More—Next Steps
• Decision Support Databases



List of Exhibits


• Total Biosimilars Market: Market Engineering Measurements, Global, 2012
• Comparative Analysis: Generics, Biosimilars, and Biologics, Global, 2012
• Total Biosimilars Market: Market Segmentation, Global, 2012
• Total Biosimilars Market: Percent Revenue by Geographic Region, Global, 2012
• Total Biosimilars Market: Timeline of Key Events, Global, 2012 and 2013
• Total Biosimilars Market: Market Outlook, Global, 2012 and 2022
• Total Biosimilars Market: Game-changing Strategies, Global, 2012
• Total Biosimilars Market: Market Outlook, Global, 2012
• Total Biosimilars Market: Key Market Drivers, Global, 2013-2019
• Total Biosimilars Market: Key Market Restraints, Global, 2013-2019
• Total Biosimilars Market: Impact Mapping of Drivers and Restraints, Global,
2013-2019
• Total Biosimilars Market: Market Engineering Measurements, Global, 2012
• Total Biosimilars Market: Revenue Forecast, Global, 2009-2019
• Total Biosimilars Market: Percent Revenue Forecast by Region, Global, 2009-2017
• Total Biosimilars Market: Revenue Forecast by Region, Global, 2009-2019
• Total Biosimilars Market: Competitive Landscape Analysis, Global, 2012
• Total Biosimilars Market: Pipeline Analysis, Global, 2012
• Total Biosimilars Market: Competitive Landscape, Global, 2012
• Total Biosimilars Market: Percent Sales Breakdown, Global, 2012
• Total Biosimilars Market: Company Market Share Analysis of Top 5 Participants, Global, 2012
• Biosimilars Market: Key Stake Holders, Europe, 2012
• Biosimilars Market: Market Engineering Measurements, Europe, 2012
• Biosimilars Market: Revenue Forecast, Europe, 2009-2019
• Biosimilars Market: Pricing Analysis, Europe, 2012
• Biosimilars Market: Time from Marketing Authorisation to Price Approval, Europe, 2012
• Biosimilars Market: Average Price for EPO, Europe, 2009-2019
• Biosimilars Market: Average Price for G-CSF, Europe, 2009-2019
• Biosimilars Market: Average Price for HGH, Europe, 2009-2019
• Biosimilars Market: PEST Analysis, Europe, 2012
• Biosimilars Market: Percent of Sales, Europe, 2012
• Biosimilars Market: Company Market Share Analysis of Top 5 Participants, Europe, 2012
• Biosimilars Market: Ranking of Key Participants Based on Market Share, Europe, 2012
• Biosimilars Market: Competitive Landscape, Europe, 2012
• Biosimilars Market: Marketed Product Analysis, Europe, 2012
• Biologics Market: Patent Expiry Analysis, Europe, 2012
• Biologics Market: Patent Expirations, Europe, 2000-2030
• EPO Segment: Market Engineering Measurements, Europe, 2012
• EPO Segment: Revenue Forecast, Europe, 2009-2019
• G-CSF Segment: Market Engineering Measurements, Europe, 2012
• G-CSF Segment: Revenue Forecast, Europe, 2009-2019
• HGH Segment: Market Engineering Measurements, Europe, 2012
• HGH Market: Revenue Forecast, Europe, 2009-2019
• Insulin Segment: Scenario Revenue Forecast, Europe 2015-2019
• mAbs Segment: Scenario Revenue Forecast, Europe 2015-2019
• Interferons Segment: Scenario Revenue Forecast, Europe 2015-2019
• Biosimilars Market: Market Engineering Measurements, UK, 2012
• Biosimilars Market: Revenue Forecast, UK, 2009-2019
• Biosimilars Market: Market Engineering Measurements, Germany, 2012
• Biosimilars Market: Revenue Forecast, Germany, 2009-2019
• Biosimilars Market: Market Engineering Measurements, France, 2012
• Biosimilars Market: Revenue Forecast, France, 2009-2019
• Biosimilars Market: Market Engineering Measurements, Italy, 2012
• Biosimilars Market: Revenue Forecast, Italy, 2009-2019
• Biosimilars Market: Market Engineering Measurements, Spain, 2012
• Biosimilars Market: Revenue Forecast, Spain, 2009-2019
• Biosimilars Market: Market Engineering Measurements, Benelux, 2012
• Biosimilars Market: Revenue Forecast, Benelux, 2009-2019
• Biosimilars Market: Market Engineering Measurements, Scandinavia, 2012
• Biosimilars Market: Revenue Forecast, Scandinavia, 2009-2019
• Biosimilars Market: Revenue Forecast, US, 2009-2019
• Biosimilars Market: Revenue Forecast Comparison between Branded Biologics and Biosimilars, US, 2009-2019
• Biosimilars Market: Timeline of Biosimilars Regulatory Activity, US, 2012
• Biosimilars Market: Overview of Application Requirements for Biosimilars, US, 2012
• Biosimilars Market: Biosimilars User Fee Act Fee Structure, US, 2012
• Biosimilars Market: Pricing Analysis, US, 2012
• Biosimilars Market: PEST Analysis, US, 2012
• Biologics Market: Patent Expiry Analysis, US, 2012
• Biologics Market: Patent Expirations, US, 2000-2030
• EPO Segment: Revenue Forecast, US, 2009-2019
• EPO Segment: Scenario Revenue Forecast, US, 2009-2019
• EPO Segment: Optimistic Scenario—Revenue Forecast, US, 2015-2019
• EPO Segment: Frost and Sullivan Scenario—Revenue Forecast, US, 2015-2019
• EPO Segment: Conservative Scenario—Revenue Forecast, US, 2015-2019
• G-CSF Segment: Revenue Forecast, US, 2009-2019
• G-CSF Segment: Scenario Revenue Forecast, US, 2009-2019
• G-CSF Segment: Optimistic Scenario—Revenue Forecast, US, 2015-2019
• G-CSF Segment: Frost and Sullivan Scenario—Revenue Forecast, US, 2015-2019
• G-CSF Segment: Conservative Scenario—Revenue Forecast, US, 2015-2019
• HGH Segment: Revenue Forecast, US, 2009-2019
• HGH Segment: Revenue Forecast Comparison Between Branded Biologics and Biosimilars, US, 2009-2019
• HGH Segment: Annual Cost of Therapy, US, 2009-2019
• HGH Segment: ACT Comparison Between Branded Biologics and Biosimilars, US,
• 2009-2019
• Insulin Segment: Revenue Forecast, US, 2009-2019
• Insulin Segment: Scenario Revenue Forecast, US, 2009-2019
• Insulin Segment: Optimistic Scenario—Revenue Forecast, US, 2015-2019
• Insulin Segment: Frost and Sullivan Scenario—Revenue Forecast, US, 2015-2019
• Insulin Segment: Conservative Scenario—Revenue Forecast, US, 2015-2019
• mAbs Segment: Revenue Forecast, US, 2009-2019
• Biosimilars Market: Marketed mAbs at Risk for Biosimilar Competition, US, 2012
• mAbs Segment: Scenario Revenue Forecast, US, 2015-2019
• mAbs Segment: Optimistic Scenario—Revenue Forecast, US, 2015-2019
• mAbs Segment: Frost and Sullivan Scenario—Revenue Forecast, US, 2015-2019
• mAbs Segment: Conservative Scenario—Revenue Forecast, US, 2015-2019
• Interferons Segment: Revenue Forecast, US, 2009-2019
• Interferons Segment: Annual Cost of Therapy, US, 2009-2019
• Interferons Segment: ACT Comparison Between Branded Biologics and Biosimilars, US, 2009-2019
• Biosimilars Market: Revenue Forecast, China, 2009-2019
• Biosimilars Market: PEST Analysis, China,2012
• Biosimilars Market: Percent of Sales, China, 2012
• EPO Segment: Revenue Forecast, China, 2009-2019
• EPO Segment: Pricing Analysis, China, 2012
• G-CSF Segment: Revenue Forecast, China, 2009-2019
• G-CSF Segment: Pricing Analysis, China, 2012
• HGH Segment: Revenue Forecast, China, 2009-2019
• HGH Segment: Pricing Analysis, China, 2012
• Insulin Segment: Revenue Forecast, China, 2009-2019
• Insulin Segment: Pricing Analysis, China, 2012
• mABs Segment: Revenue Forecast, China, 2009-2019
• Interferons Segment: Revenue Forecast, China, 2009-2019
• Interferons Segment: Pricing Analysis, China, 2012
• Biosimilars Market: Revenue Forecast, India, 2009-2019
• Biosimilars Market: PEST Analysis, India, 2012
• Biosimilars Market: Revenue Forecast, South Korea, 2009-2019
• Biosimilars Market: Regulatory Guidelines, South Korea, 2012
• Biosmilar Market: PEST Analysis, South Korea, 2012
• Biosimilars Market: Pipeline Analysis, South Korea, 2012
• Biosimilars Market: Revenue Forecast, Japan, 2009-2019
• Biosimilars Market: Regulatory Guidelines, Japan, 2012
• Biosimilars Market: Pricing Analysis, Japan, 2012
• Biosimilars Market: Average Price for G-CSF, Japan, 2009-2019
• Biosimilars Market: Average Price for EPO, Japan, 2009-2019
• Biosimilars Market: PEST Analysis, Japan, 2012
• Biosimilars Market: Product Analysis, Japan, 2012
• Biosimilars Market: Revenue Forecast, Australia, 2009-2019
• Biosimilars Market: Pricing Analysis, Australia, 2012
• Biosimilars Market: PEST Analysis, Australia, 2012
• Biosimilars Market: Revenue Breakdown by Segment, Latin America, 2012
• Biosimilars Market: Revenue Forecast, Latin America, 2009-2019
• Biosimilars Market: Pricing Analysis, Latin America, 2012
• Biosimilars Market: Average Price for G-CSF, Latin America, 2009-2019
• Biosimilars Market: Average Price for HGH, Latin America, 2009-2019
• Biosimilars Market: Average Price for Insulin, Latin America, 2009-2019
• Biosimilars Market: Average Price for Interferons, Latin America, 2009-2019
• Biosimilars Market: PEST Analysis, Latin America, 2012
• Biosimilars Market: Top Biosimilar Companies by Rank, Latin America, 2012
• EPO Segment: Revenue Forecast, Latin America, 2009-2019
• G-CSF Segment: Revenue Forecast, Latin America, 2009-2019
• HGH Segment: Revenue Forecast, Latin America, 2009-2019
• Insulin Segment: Revenue Forecast, Latin America, 2009-2019
• Interferons Segment: Revenue Forecast, Latin America, 2009-2019
• Biosimilars Market: Revenue Forecast, Brazil, 2009-2019
• Biosimilars Market: Revenue Forecast, Mexico, 2009-2019
• Biosimilars Market: Revenue Forecast, Argentina, 2009-2019
• Total Biosimilars Market: Pharma Industry and Biosimilar Trends Market, Global, 2012
• Pharmaceutical and Biotech Industry: Revenue Forecast, Global, 2009-2019
• Decision Support Database: Total Pharmaceutical Market, Global, 2008-2018
• Decision Support Database: Pharmaceutical RandD Expenditure, Global, 2008-2018
• Decision Support Database: Number of Biotech Companies, Global, 2008-2018
• Decision Support Database: Government RandD Expenditure in Biotechnology, Global, 2008-2018
• Decision Support Database: Venture Capital Investment in Biotech RandD, Global, 2008-2018

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