Global Biosimilars Industry 2015

Global Biosimilars Industry 2015

It is said that the first biosimilar drugs hit the Indian market first. Biosimilars are different from the original drugs but the active substance of the biosimilar medicinal product remains similar to the biological reference medicinal product. The biosimilar drug may also contain different inactive ingredients. The pharmaceutical industry, however, remains divided over the issue of immunogenicity of biosimilars. Immunogenicity is the product's ability to provoke an immune response within the body. Since biosimilars are copies of the original drug and not exact replicas, there is a debate over how they will be recognized by the body and whether or not it will produce the specific antibodies. The primary concern remains the lack of knowledge about the ability of biosimilars to cause an immune response in the body.

The global biosimilars industry is expected to reach a value of nearly USD 5 billion by 2016. Since biosimilars are priced nearly 20-30% lower than the branded product, patients are often encouraged to switch over from the branded product in order to save cost. In an era where healthcare costs are spiraling out of control, biosimilars are being seen as a welcoming intervention, making pharmaceutical drugs affordable for the general population. Europe is leading the global biosimilar industry with 13 biosimilar drugs already, followed by Japan where the first biosimilar drug was approved in June 2009.

The United States and France, Germany, Italy, Spain and the United Kingdom remain the major markets for biosimilars around the world and in 2014, these biosimilar markets combined had a market size of USD 150 million. Out of these six developed markets, Germany was the biggest biosimilar market in 2014, followed by the US. The US saw sales of Tev-Tropin and Omnitrope lead the biosimilar market in 2014.

The significant potential of growth in the biosimilars market has attracted the attention of global generic giants such as Teva Pharmaceuticals as well as traditional branded pharmaceutical players like Merck.

Though an emerging industry, there is no doubt that the biosimilar market is poised for exponential growth in the coming years. Taiyou Research takes this opportunity to analyze this growing market in its report Global Biosimilars Industry 2015. The report covers the following:

An analysis of what are biosimilars.

Emergence of biosimilars and the role of the Biologics Price Competition and Innovation (BPCI) Act. Issue of data exclusivity is touched upon.

Biosimilars are defined and their specificity is analyzed. We look at categories of biologics, importance of biosimilars, comparison of biosimilars with generics is carried out and a branded product business model is also included.

An overview of the biopharmaceutical industry includes a market profile and the manufacturing process of biopharmaceuticals.

Analysis of the global biosimilars industry through market profile, market size, market value of branded biologics that face patent expiry, operating margin for biosimilar manufacturers, investor concerns regarding biosimilars and the commercial impact of the European biosimilars industry is looked at.

Key factors that determine success of the biosimilars industry are analyzed such as long term strategy of the market, development of competitive intelligence, proper financial structure, etc.

Impacts on the global biosimilars industry are analyzed, along with market drivers and challenges.

Regulatory framework governing the global biosimilars industry is analyzed in Europe, Japan, and the United States. We also analyze biosimilar approval pathways in the US and Europe.

Factors determining market entry in the global biosimilar industry are looked at including biosimilars manufacturing in emerging markets.

Competition in the industry is analyzed through key industry players, key industry suppliers, generic drug producers, major stakeholders in the industry, developed versus emerging biosimilar markets, biosimilar launches, etc.

Biosimilar markets analyzed in the report include Australia, BRIC countries, European Union nations (France, Germany, Italy, Spain and the UK), Japan and the US.

Analysis of some major biosimilars are carried out - Epoetin, Filgrastim and Somatropin.

Patent expiries of branded drugs and opportunities for biosimilars are analyzed including the strategies being employed by Big Pharma to combat biosimilars.

A country-wise analysis of the biosimilar market is carried out for France, Germany, India, Italy, Japan, Spain, the UK and the United States.

An analysis of the major industry players through a company overview, analysis of the business segments, their presence in the global biosimilars market and a SWOT analysis.

A total of 15 major biosimilar players are analyzed in the report.

Global biosimilars market outlook includes an overall market outlook, forecast for biosimilar sales, forecast for the US biosimilar market, forecast for the European biosimilar market, the Japanese biosimilars market, forecast for biosimilars for monoclonal antibodies against cancer, EPO biosimilar market forecast, hGH biosimilar market forecast, and other biosimilar market forecast is also included.

1. Executive Summary
2. What are Biosimilars?
3. Emergence of Biosimilars
3.1 Role of the Biologics Price Competition and Innovation (BPCI) ACT
3.2 Issue of Data Exclusivity
4. Industry Definition
4.1 Defining Biosimilars
4.2 Specificity of Biosimilars
4.3 Categories of Biologics
4.4 Importance of Biosimilars
4.5 Comparing Biosimilars with Generics
4.6 Branded Product Business Model
5. Overview of the Biopharmaceutical Industry
5.1 Market Profile
5.2 Biopharmaceutical Manufacturing Process
6. Global Biosimilars Market Statistics
6.1 Market Profile
6.2 Market Size
6.3 Market Value of Branded Biologics Facing Patent Expiry
6.4 Operating Margin for Biosimilar Manufacturers
6.5 Investor Concerns regarding Biosimilars
6.6 Commercial Impact of the European Biosimilars Industry
7. Key Success Factors for Biosimilars
7.1 Long Term Strategy
7.2 Developing Competitive Intelligence
7.3 Proper Financial Structure
7.4 Developing Key Biomanufacturing Competencies
7.5 Developing Clinical Capabilities and Regulatory Expertise
7.6 Well Developed Sales and Distribution Channels
8. Factors Impacting the Global Biosimilars Industry
8.1 Growth of the Industry in Developed Countries
8.2 Growth of the Industry in BRIC Countries
8.3 High Cost of Biologics
8.4 Use of Branded Biologics to Increase
8.5 Introduction of Approval Pathways in the US and Japan
8.6 EU’s Draft on Biosimilar Monoclonal Antibody Guidance
8.7 Unfavorable Tendering Procedures
8.8 Problem of Reference Pricing
8.9 Strategy of Biosimilar Companies with Regards to Hospital and Retail Setting
8.10 Issue of Biosimilar Comparability
8.11 Lack of Incentives, Service Agreements and Marketing Costs
8.12 Availability of Second Generation Branded Biologics
8.13 No Automatic Substitution of Branded Biologics
8.14 Cost-containment to Boost Uptake of Biosimilars
8.15 Lack of Proper IP Protection in Emerging Countries
8.16 Ease of Market Entry in BRIC Countries
8.17 Strong Biologic Capabilities in BRIC Countries
8.18 Restricted Market Access for Domestic Players in Emerging Countries
8.19 Problem of Low Purchasing Power in Emerging Markets
9. Biosimilar Market Drivers & Challenges
9.1 Factors Driving Growth of Biosimilars
9.1.1 Need to Lower Healthcare Costs
9.1.2 Lower Development Costs of Biosimilars as compared to New Biologic Drug
9.1.3 Lower Cost of Treatment with Biosimilars
9.1.4 Upcoming Patent Expiries for Blockbuster Biologics
9.1.5 Large Sales of Biologic Drugs
9.1.6 Greater Profitability of Biosimilars as compared to Generic Drugs
9.2 Factors Restraining the Growth of Biosimilars
9.2.1 Lack of Automatic Substitution
9.2.2 High Cost of Development and Manufacturing as compared to Generics
9.2.3 High Entry Barriers to the Biosimilar Industry
9.2.4 Emergence of Second Generation Biologic Drugs
9.2.5 Patent Protection for Biologic Drugs
10. Regulatory Framework
10.1 Regulatory Framework in Europe
10.1.1 EMEA’s Current Position
10.1.2 Bolar Type Provision
10.1.3 Comparability Exercises
10.1.4 Approval Process for Biosimilars
10.2 Regulatory Framework in Japan
10.2.1 Current Position on Biosimilars
10.3 Regulatory Framework in the USA
10.3.1 BPCIA and the Approval Pathway for Biosimilars Role of Biosimilarity and Interchangeability FDA Regulations Biosimilars Approval and Regulation Demonstration on Basis of Data 12 Years of Market and Data Exclusivity Resolution to Patent Dispute Notice of Commercial Marketing to Reference Product Sponsor Substitution of Small Molecular Products
10.4 Differences between FDA & the EMEA
10.5 Issues with Momenta
11. Factors Determining Market Entry in the Global Biosimilar Industry
11.1 Long Drawn-out Biosimilar Clinical Development Timeline
11.2 Approval Pathways for Biosimilars
11.3 High Development Costs of Biosimilars
11.3.1 Costs in Developed Markets
11.4 Biosimilars Manufacturing in Developing Countries – Pros & Cons
11.4.1 Issues with Regulatory Approval
11.4.2 Clinical Trials
11.4.3 Cost of Research & Development
11.4.4 Manufacturing Barriers
11.5 Proving of ‘Biosimilarity’
11.6 Issues with EMA Draft Guidelines for Biosimilar MAb Approval
11.7 Challenges with Patents
11.8 Role of Market Exclusivity for Branded Biologics
11.9 Strategic Partnerships Driving the Industry
11.9.1 Role of M&A Deals Merck & Co. Pfizer
11.10 Lack of Proper Safety Regulations
12. Biosimilar Approval Pathways in the US and Europe
13. Competitive Landscape
13.1 Key Industry Players
13.2 Key Industry Suppliers
13.3 Generic Drug Producers
13.4 Key Investors in the Industry
13.5 Major Stakeholders in the Industry
13.6 Developed versus Emerging Markets
13.7 Biosimilar Launches
13.8 Analysis by Markets
13.8.1 Biosimilars in Australia
13.8.2 Biosimilars in BRIC Countries
13.8.3 Biosimilars in the European Union (France, Germany, Italy, Spain, the UK)
13.8.4 Biosimilars in Japan
13.8.5 Biosimilars in United States
14. Analysis of Major Biosimilars
14.1 Epoetin
14.2 Filgrastim
14.3 Somatropin
15. Upcoming Patent Expiries and Opportunities for Biosimilars
16. Strategies of Big Pharma to Combat Biosimilars
17. Country-wise Biosimilar Market Analysis
17.1 France
17.1.1 Overview of the Healthcare System
17.1.2 Pricing and Reimbursement
17.1.3 Drivers & Challenges for Biosimilars in France
17.2 Germany
17.2.1 Overview of the Healthcare System
17.2.2 Pricing and Reimbursement
17.2.3 Drivers & Challenges for Biosimilars in Germany
17.3 India
17.4 Italy
17.4.1 Overview of the Healthcare System
17.4.2 Pricing and Reimbursement
17.4.3 Drivers & Challenges for Biosimilars in Italy
17.5 Japan
17.6 Spain
17.6.1 Overview of the Healthcare System
17.6.2 Pricing and Reimbursement
17.6.3 Drivers & Challenges for Biosimilars in Spain
17.7 United Kingdom
17.7.1 Overview of the Healthcare System
17.7.2 Pricing and Reimbursement
17.7.3 Drivers & Challenges for Biosimilars in the UK
17.8 United States
18. Major Industry Players
18.1 Dr. Reddy's Laboratories Limited
18.1.1 Company Overview
18.1.2 Business Segments
18.1.3 Presence in Biosimilars Market
18.1.4 SWOT Analysis
18.2 Hospira Inc
18.2.1 Company Overview
18.2.2 Business Segments
18.2.3 Presence in Biosimilars Market
18.2.4 SWOT Analysis (Brief Analysis)
18.3 Sandoz International
18.3.1 Company Overview
18.3.2 Business Segments
18.3.3 Presence in Biosimilars Market
18.3.4 SWOT Analysis
18.4 STADA Arzneimittel AG
18.4.1 Company Overview
18.4.2 Business Segments
18.4.3 Presence in Biosimilars Market
18.4.4 SWOT Analysis
18.5 Teva Pharmaceutical Industries
18.5.1 Company Overview
18.5.2 Business Segments
18.5.3 Presence in Biosimilars Market
18.5.4 SWOT Analysis
18.6 Watson Pharmaceuticals
18.6.1 Company Overview
18.6.2 Business Segments
18.6.3 Presence in Biosimilars Market
18.6.4 SWOT Analysis
18.7 3SBio Inc.
18.8 Biocon Limited
18.9 Biopartners Gmbh
18.10 Celltrion Inc
18.11 Intas Biopharmaceuticals
18.12 Kyowa Hakko Kirin Co., Ltd.
18.13 Reliance Life Sciences
18.14 Shanghai Fosun Pharmaceutical (Group) Co., Ltd
18.15 Wockhardt
19. Global Biosimilars Market Outlook
19.1 Market Outlook
19.2 Forecast for Biosimilar Sales
19.3 Forecast for US Biosimilars Market
19.4 Forecast for European Biosimilars Market
19.5 Forecast for Japanese Biosimilars Market
19.6 Forecast for Biosimilars
19.6.1 Biosimilars for Monoclonal Antibodies against Cancer
19.6.2 Erythropoietin (EPO) Biosimilars Markets
19.6.3 Human Growth Hormone (hGH) Biosimilars Markets
19.6.4 Granulocyte – Colony Stimulating Factor (G-CSF) Biosimilars Markets
19.6.5 Insulin and Insulin Analogs Biosimilars
19.6.6 Interferon alfa Biosimilars
19.6.7 Interferon beta Biosimilars
19.6.8 TNF alfa Inhibitor Biosimilars
20. Appendix
21. Glossary
List of Figures
Figure 1: Chromatographic Differences between a Monoclonal Antibody and its Biosimilar
Figure 2: Complexity of Biologics
Figure 3: Medicare Coverage for Biologic Drugs
Figure 4: Imminent Biosimilar Opportunities
Figure 5: Comparison of Biosimilars with Generics
Figure 6: Development Costs and Timelines for a Biosimilar
Figure 7: Global Biologics Market Forecast, ($bn), 2007–2016
Figure 8: Share of Top 25 Biologics by Therapeutic Class, 2014
Figure 9: Growth for Biologics
Figure 10: Share of Top 25 Biologics by Production System, 2014
Figure 11: Biologics under Development by Therapeutic Class, Global, 2014
Figure 12: Biologics under Development by Disease Category, Global, 2014
Figure 13: Difference between the Distribution Chains for Small Molecule and Biologic Drugs
Figure 14: Challenges and their Solutions in Biopharmaceutical Manufacturing
Figure 15: Biosimilar Market Size: US, France, Germany, Italy, Spain & the UK ($mn), 2014
Figure 16: Value of Branded Biologics Facing Patent Expiry between 2008–2015
Figure 17: Market Share Trends in Value of the European EPO Market
Figure 18: Market Share Trends in Value of the European G-CSF Market
Figure 19: Key Success Factors in the Biosimilar Industry
Figure 20: Factors Impacting the Global Biosimilar Industry
Figure 21: Factors Impacting the Biosimilar Market in BRIC Countries
Figure 22: Biosimilar Drug Uptake in the Hospital and Retail Sectors
Figure 23: Biosimilar Market Drivers & Challenges
Figure 24: Rising Expenditure on Pharmaceuticals
Figure 25: Increase in Elderly Population Indicates Rising Healthcare Expenses
Figure 26: Inflation in Prescription Drug Prices in the US
Figure 27: Costs of Development, Manufacturing and Approval of Biosimilars by Cell Culture Type, ($m)
Figure 28: Objectives of Biosimilar Legislation and Regulatory Frameworks
Figure 29: Drug Approval Process in Europe
Figure 30: Evolution of Regulatory Pathway for Approval of Biosimilars in Europe
Figure 31: Approval Process for Biosimilars in Europe
Figure 32: Data and Market Exclusivity Periods in Europe
Figure 33: Comparability Exercises
Figure 34: Number of Biosimilar Applications in Europe (2004-2009)
Figure 35: Evolution of Regulatory Pathway in Japan
Figure 36: Regulatory Bodies for Biologics in the US
Figure 37: Drug Development and Approval Process in the US
Figure 38: Evolution of Regulatory Pathway in the US
Figure 39: Patent Litigation Provisions in BPCIA – Round 1
Figure 40: Patent Litigation Provisions in BPCIA – Round 2
Figure 41: Development Timeline for Biosimilars in the EU
Figure 42: Issues Facing Biosimilars Manufacturing in Emerging Countries
Figure 43: Approval Pathway for Biosimilars in the EU, US, Japan and Australia
Figure 44: Biosimilars Approval Pathways in the US and Europe, Global, Market Forecasts, ($m), (2009-2016)
Figure 45: Costs of Development, Manufacturing and Approval of Biosimilars by Cell Culture Type
Figure 46: Comparison of Capabilities of Market Entrants
Figure 47: Breakdown of the Biosimilars Market (€250m total)
Figure 48: Approvals of Biosimilars in BRIC Countries, 2013
Figure 49: Region-wise Sales of Major Biologics - Expired & Off-patent (2010-2014)
Figure 50: Sales of Major Biologics - Expired & Off-patent (2010-2014)
Figure 51: Biosimilars Under Development (by type) Worldwide
Figure 52: Biosimilars Under Development (by Region) Worldwide
Figure 53: Factors Impacting Market Entry of Biosimilar Monoclonal Antibody
Figure 54: Sales in Europe / USA of Roche’s Biological Products (first 9 months of 2013; CHFm)
Figure 55: Patent Expiries Per Year (Europe / USA Sales of Biologics, CHFm)
Figure 56: Growth of Insulin Pens
Figure 57: Insulin Market With and Without Biosimilars ($m)
Figure 58: Novo Nordisk’s Diabetes Franchise Sales (DKKm)
Figure 59: Sales in the Lantus Franchise (€m)
Figure 60: Drivers & Challenges for Biosimilars in the French Market
Figure 61: Drivers & Challenges for Biosimilars in the German Market
Figure 62: Drivers & Challenges for Biosimilars in the Italian Market
Figure 63: Drivers & Challenges for Biosimilars in the Japanese Market
Figure 64: Drivers & Challenges for Biosimilars in the Spanish Market
Figure 65: Drivers & Challenges for Biosimilars in the UK Market
Figure 66: Drivers & Challenges for Biosimilars in the US Market
Figure 67: Forecast for the Biosimilars Market ($bn), 2010-2017
Figure 68: Global Biosimilar Sales Forecast (in USD Million), 2012–2017
Figure 69: US Market Forecasts, ($m), 2009–2016
Figure 70: European Market Forecasts, ($m), 2009–2016
Figure 71: Japanese Market Forecasts, ($m), 2009–2016
Figure 72: Expected Market Share in 2016
Figure 73: EPO Biosimilars Market Forecasts, ($m), 2009–2016
Figure 74: hGH Biosimilars Market Forecasts, ($m), 2009–2016
Figure 75: G-CSF Biosimilars Market Forecasts, ($m), 2009–2016
Figure 76: Market Opportunities for Insulin and Insulin Analogs Biosimilars, ($m), 2009–2016
Figure 77: Market Opportunities for Interferon alfa Biosimilar, ($m), 2009–2016
Figure 78: Market Opportunities for Interferon beta Biosimilar, ($m), 2009–2016
Figure 79: Market Opportunities for TNF alfa Inhibitor Biosimilars,($m), 2009–2016
Figure 80: Impact of Data Exclusivity Period on Biosimilars Development
Figure 81: Biosimilars in Regulated Markets
Figure 82: Worldwide Biosimilars Market
Figure 83: Comparison of Biosimilars with Biosimilar Antibodies
Figure 84: Categories of Biosimilars Players
Figure 85: Characteristics of Biosimilar Players
List of Tables
Table 1: Major categories of Biological Products
Table 2: Key Patent Expiries
Table 3: Medicare Formulary Coverage for Top-Selling Biologics
Table 4: Differences between Biosimilars, Generics, and Original Drug
Table 5: Comparison of Small Molecule Drugs and Biologics
Table 6: Biosimilar Market Size: US, France, Germany, Italy, Spain, & the UK, 2014
Table 7: Operating Margins for Branded Biologics, Branded Prescription Drugs, & Generic Companies
Table 8: Major Biosimilar Drugs Launched in Europe
Table 9: Approximated Savings to be Gained with the use of Biosimilar Drugs
Table 10: Cost Comparison for a Biosimilar
Table 11: Patent Expiry for Major Biologic Drugs, 2010–2016
Table 12: Costs of Development, Manufacturing and Approval of Biosimilars by Cell Culture Type, ($m)
Table 13: Patients in Clinical Trials for Marketed Biosimilars
Table 14: Existing Guidelines for Biosimilars in Europe
Table 15: Biosimilar Approvals in Europe
Table 16: Applications Rejected or Withdrawn
Table 17: Biosimilar Approval Pathways
Table 18: Costs Associated with Biosimilars Development and Registration in EU. Japan, US, and BRIC Countries ($m)
Table 19: Differences in Discount compared to Reference Brand Costs in Key Markets (%), 2013
Table 20: Biosimilar Deals of Pharma Companies
Table 21: Success Criteria for Generic Drug Producers
Table 22: Teva Pharmaceutical Sales Forecast
Table 23: Growth Strategies at Sandoz
Table 24: Cost-Sharing Practices by Health Insurers in the US
Table 25: Leading Biosimilar Players in Japan, France, Germany, Italy, Spain and the UK, 2013
Table 26: Leading Biosimilars Companies in India and China, 2013
Table 27: Approvals of Biosimilars in Australia, 2010
Table 28: Status of Biosimilars in 5 EU Markets, 2013
Table 29: Approvals of Biosimilars in Japan
Table 30: Market Uptake of Epoetin versus Others, 2013-2014
Table 31: Market Uptake of Filgrastim versus Neupogen, Neulasta, & Granocyte, 2013-2014
Table 32: Market Uptake of Omnitrope & Tev-Tropin versus Other Somatropins
Table 33: Patent Expiries of Biologics in the US
Table 34: Patent Expiries of Biologics in EU 5
Table 35: Patent Expiries of Biologics in Japan
Table 36: Roche’s Strategy for Ensuring the Long-Term Survival of its Biological Products
Table 37: Roche Treatment Protocols
Table 38: Phase II Results for T-DM1
Table 39: State of Roche’s Products in Phase III or Entering Phase III
Table 40: Patent Expiries on the Main Insulins
Table 41: Biosimilar Product Portfolio of Hospira
Table 42: Biosimilar Product Portfolio of Sandoz/Hexal
Table 43: Biosimilar Product Portfolio of STADA
Table 44: Biosimilar Product Portfolio of Teva
Table 45: Global Biosimilar Sales Forecast in US, EU Markets, Japan, and Others ($m), 2010–2015
Table 46: US Market Forecasts, ($m), 2009–2016
Table 47: European Market Forecasts, ($m), 2009–2016
Table 48: Japanese Market Forecasts, ($m), 2009–2016
Table 49: Market Opportunities for mAb against Cancer Biosimilars, ($m), 2009–2016
Table 50: Market Opportunities for mAb against Cancer Biosimilars, ($m), 2009–2016
Table 51: EPO Biosimilars Market Forecasts, ($m), 2009–2016
Table 52: hGH Biosimilars Market Forecasts, ($m), 2009–2016
Table 53: G-CSF Biosimilars Market Forecasts, ($m), 2009–2016
Table 54: Market Opportunities for TNF alfa Inhibitor Biosimilars,($m), 2009–2016
Table 55: Main Biological Products by Therapeutic Class
Table 56: Clinical and Pharmacovigilance Trials Recommended in European Biosimilar Guidelines
Table 57: Comparison of Small Molecule and Biologic Drugs

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