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Analyzing the Global Biosimilars Industry 2016

Analyzing the Global Biosimilars Industry 2016

Biosimilars are the officially approved versions of biopharmaceutical products that are manufactured by a different company following the patent expiry of the original product. Also known as subsequent entry biologics or follow-on biologics, biosimilar drugs are gaining popularity around the world as the development cost of biosimilars is not as high as the original drug.

Also, the regulatory frameworks put in place by many countries are aiding the growth of biosimilars in the world, not to mention the lengthy tendering process of biologics that delays the actual launch of the drug. Meanwhile, biosimilar tendering is becoming more and more commonplace as the uptake of biosimilars is growing.

Aruvian Research analyzes the global biosimilars industry in its research report Analyzing the Global Biosimilars Industry 2016.

In this research report, we analyze what biosimilars are through an industry definition in the EU, US and Japan. We look at the development of biosimilars, the role of the Biologics Price Competition and Innovation Act, and the role of data exclusivity in the Patient Protection & Affordable Care Act for Biosimilars.

The specific nature of biosimilars and the types of biologics available and role of biosimilars are also analyzed, along with the importance of biosimilars and a comparison between biosimilars and generic drugs.

An overview of the biopharmaceutical industry in included in order to understand the growing importance of biosimilars.

Moving to the analysis of the global biosimilars industry, we analyze the market value, market size, upcoming patent expiries for branded biologics and the operating margins of biosimilar manufacturers. Market concerns regarding biosimilars is also included.

Factors driving the market for biosimilars, challenges and impacts on the industry, and industry growth factors, are all analyzed in this in-depth report.

We also take a look at the biosimilar market in developed markets and BRIC countries. Approval pathways and regulatory frameworks in the US, Europe, and Japan are analyzed, along with a comparison of European versus US legislation.

For companies wanting to enter the global biosimilars market, we carry out a market entry analysis through our section K of the report, Entering the Global Biosimilar Industry.

Analysis of competition in the industry is carried out through an analysis of the major industry players, industry suppliers, generic drug manufacturers, investors and stakeholders, major launches, and a country-wise analysis of the biosimilar industry. Biosimilar markets are analyzed in Australia, BRIC nations, EU, Japan, and the United States.

An analysis of Epoetin, Filgrastim, and Somatropin - the major biosimilars - is carried out, along with a look at the emerging opportunities for biosimilars due to the upcoming patent expiries.

The response of Big Pharma against the rise of biosimilars is detailed, followed by an analysis of the major markets and major industry players.

An industry forecast for the global biosimilars industry concludes our comprehensive and cutting-edge analysis of the Global Biosimilars Industry.


A. Executive Summary
B. Introduction to Biosimilars
B.1 What are Biosimilars?
B.2 Industry Definition in the EU, US, & Japan
B.3 Development of Biosimilars
B.4 Biologics Price Competition and Innovation Act
B.5 Data Exclusivity in the Patient Protection & Affordable Care Act for Biosimilars
B.6 Specific Nature of Biosimilars
B.7 Types of Biologics & Role in Biosimilars
B.8 Why Biosimilars are Important?
B.9 Biosimilars versus Generics
C. Introduction to the Biopharmaceutical Industry
D. Analysis of the Global Biosimilars Industry
D.1 Market Value
D.2 Market Size
D.3 Patent Expiries for Branded Biologics: Market Value
D.4 Biosimilar Manufacturers & Operating Margins
D.5 Market Concerns Regarding Biosimilars
E. Industry Drivers & Challenges
E.1 Having a Strong Performance-oriented Strategy
E.2 Competitor Know-How
E.3 Sound Financial Platform
E.4 Having the Economics for Manufacturing Competencies
E.5 Strong R&D Capabilities
E.6 Marketing, Sales and Distribution Channels
E.7 Requirement for Cutting Healthcare Costs
E.8 High Development Costs of Biologics Having an Impact
E.9 Patent Expiries for Major Biologics
E.10 Biosimilars Profitability versus Generics
E.11 High Cost of Biologics
E.12 Increase in Use of Branded Biologics
E.13 US, Japan Approval Pathways
E.14 EMA Draft Guidelines for Biosimilar MAb
E.15 Lengthy Tendering Process
E.16 Reference Pricing
E.17 Lack of Rebates
E.18 Need to Contain Healthcare Costs
E.19 Low Purchasing Power in Emerging Markets
E.20 Role of Automatic Substitution
E.21 High Development Costs
E.22 High Entry Barriers
E.23 Second Generation Biologic Drugs
F. Biosimilar Industry in Developed Markets
G. Biosimilars Industry in BRIC Countries
H. Approval Pathways & Regulatory Framework
H.1 Overview
H.2 Objectives of Biosimilar Legislations
H.3 Biosimilar Regulations in Europe
H.4 Biosimilar Regulations in Japan
H.5 Biosimilar Regulations in the US
H.6 European Regulations versus US Legislation
I. Entering the Global Biosimilar Industry
I.1 Long Clinical Development Timeline
I.2 Dealing with Biosimilar Approval Pathways
I.3 High Cost of Development
I.4 Pricing of Biosimilars in Developed Markets
I.5 Biosimilars Manufacturing in Emerging Markets
I.6 Intellectual Property Issues
I.7 Branded Biologics and Market Exclusivity
I.8 Importance of Corporate Partnerships
I.9 Merger & Acquisition Deals
J. Competition in the Industry
J.1 Players in the Industry
J.2 Industry Suppliers
J.3 Generic Drug Manufacturers
J.4 Large Investors
J.5 Major Stakeholders
J.6 Differences between Developed and Emerging Markets
J.7 Major Launches
J.8 Market Analysis
J.8.1 Australia
J.8.2 BRIC Nations
J.8.3 European Union (France, Germany, Italy, Spain, the UK)
J.8.4 Japan
J.8.5 United States
K. Analyzing Major Biosimilars
K.1 Epoetin
K.2 Filgrastim
K.3 Somatropin
L. Opportunities for Biosimilars with the Patent Expiries
L.1 Overview
L.2 Opportunities for Biosimilar Monoclonal Antibodies
L.3 Opportunities for Second Generation Biosimilars
M. Big Pharma Responds to Biosimilar Threat
M.1 Overview
M.2 Strategy of Roche
M.3 Dealing with the Threat of Insulin Biosimilars
M.4 Cutting-edge Technology of Insulin Injector Pens
M.5 Emergence of Insulin Biosimilars
M.6 Impact of Biosimilars on Sanofi SA and Novo Nordisk
N. Biosimilar Market Analysis
N.1 France
N.2 Germany
N.3 India
N.4 Italy
N.5 Japan
N.6 Spain
N.7 United Kingdom
N.8 United States
O. Analyzing the Major Players
O.1 Biocon Limited
O.1.1 Corporate Analysis
O.1.2 Role in the Biosimilars Industry
O.1.3 SWOT Analysis
O.2 Dr. Reddy's Laboratories Limited
O.2.1 Corporate Analysis
O.2.2 Role in Biosimilars Industry
O.2.3 SWOT Analysis
O.3 Hospira Inc.
O.3.1 Corporate Analysis
O.3.2 Role in the Biosimilars Industry
O.3.3 SWOT Analysis
O.4 Sandoz International
O.4.1 Corporate Analysis
O.4.2 Role in the Biosimilars Industry
O.4.3 SWOT Analysis
O.5 STADA Arzneimittel AG
O.5.1 Corporate Analysis
O.5.2 Role in the Biosimilars Industry
O.5.3 SWOT Analysis
O.6 Teva Pharmaceutical Industries
O.6.1 Corporate Analysis
O.6.2 Role in the Biosimilars Industry
O.6.3 SWOT Analysis
O.7 Watson Pharmaceuticals
O.7.1 Corporate Analysis
O.7.2 Role in the Biosimilars Industry
O.7.3 SWOT Analysis
O.8 3SBio Inc.
O.9 Biopartners Gmbh
O.10 Celltrion Inc.
O.11 Intas Biopharmaceuticals
O.12 Kyowa Hakko Kirin Co., Ltd.
O.13 Reliance Life Sciences
O.14 Shanghai Fosun Pharmaceutical (Group) Co., Ltd
O.15 Wockhardt
P. Future Perspective: Global Biosimilars Industry
P.1 Industry Forecast
P.2 US Biosimilars Market Outlook
P.3 European Biosimilars Market Outlook
P.4 Japan Biosimilars Market Outlook
P.5 Forecast for the Industry: Analysis of Biosimilar Segments
P.6 Monoclonal Antibodies against Cancer
P.7 Erythropoietin (EPO) Biosimilars Markets
P.8 Human Growth Hormone (hGH) Biosimilars Markets
P.9 Granulocyte – Colony Stimulating Factor (G-CSF) Biosimilars Markets
P.10 Insulin and Insulin Analogs Biosimilars
P.11 Interferon alfa Biosimilars
P.12 Interferon beta Biosimilars
P.13 TNF alfa Inhibitor Biosimilars
Q. Glossary
List of Figures
Figure 1: Comparison of Biosimilars with Biosimilar Antibodies
Figure 2: Categories of Biosimilars Players
Figure 3: Characteristics of Biosimilar Players
Figure 4: Chromatographic Differences between a Monoclonal Antibody and its Biosimilar
Figure 5: Complexity of Biologics
Figure 6: Medicare Coverage for Biologic Drugs
Figure 7: Imminent Biosimilar Opportunities, 2015
Figure 8: Comparison of Biosimilars with Generics
Figure 9: Development Costs and Timelines for a Biosimilar
Figure 10: Global Biologics Market Forecast, (in USD Billion), 2010–2019
Figure 11: Share of Top 25 Biologics by Therapeutic Class, 2015
Figure 12: Growth for Biologics
Figure 13: Share of Top 25 Biologics by Production System, 2015
Figure 14: Biologics under Development by Therapeutic Class, Global, 2015
Figure 15: Biologics under Development by Disease Category, Global (%), 2015
Figure 16: Difference between the Distribution Chains for Small Molecule and Biologic Drugs
Figure 17: Challenges and their Solutions in Biopharmaceutical Manufacturing
Figure 18: Biosimilar Market Size: US, France, Germany, Italy, Spain & the UK (in USD Million), 2015
Figure 19: Value of Branded Biologics that have Lost Patent between 2008–2015
Figure 20: Success Factors in the Biosimilar Industry
Figure 21: Biosimilar Market Drivers & Challenges
Figure 22: Rising Expenditure on Pharmaceuticals (Historical)
Figure 23: Increase in Elderly Population Indicates Rising Healthcare Expenses
Figure 24: Inflation in Prescription Drug Prices in the US (Historical)
Figure 25: Costs of Development, Manufacturing and Approval of Biosimilars by Cell Culture Type, (in USD Million)
Figure 26: Factors Impacting the Global Biosimilar Industry
Figure 27: Factors Impacting the Biosimilar Market in BRIC Countries
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 (2009-2014)
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: Comparison of Capabilities of Market Entrants
Figure 44: Breakdown of the Biosimilars Market in 2015 (€250m total)
Figure 45: Approvals of Biosimilars in BRIC Countries, 2015
Figure 46: Region-wise Sales of Major Biologics - Expired & to come Off-patent (2011-2015)
Figure 47: Expected Sales of Major Biologics - Expired & to come Off-patent (2011-2015)
Figure 48: Biosimilars Under Development (by type) Worldwide
Figure 49: Biosimilars under Development (by Region) Worldwide
Figure 50: Factors Impacting Market Entry of Biosimilar Monoclonal Antibody
Figure 51: Sales in Europe / USA of Roche’s Biological Products (first 9 months of 2015; in CHF million)
Figure 52: Patent Expiries per Year (Europe / USA Sales of Biologics, in CHF million)
Figure 53: Insulin Market With and Without Biosimilars ($m)
Figure 54: Novo Nordisk’s Diabetes Franchise Sales (DKKm)
Figure 55: Sales in the Lantus Franchise (€m)
Figure 56: Drivers & Challenges for Biosimilars in the French Market
Figure 57: Drivers & Challenges for Biosimilars in the German Market
Figure 58: Drivers & Challenges for Biosimilars in the Italian Market
Figure 59: Drivers & Challenges for Biosimilars in the Japanese Market
Figure 60: Drivers & Challenges for Biosimilars in the Spanish Market
Figure 61: Drivers & Challenges for Biosimilars in the UK Market
Figure 62: Drivers & Challenges for Biosimilars in the US Market
Figure 63: US Biosimilar Market Forecast, ($m), 2013–2020
Figure 64: European Biosimilar Market Forecast, ($m), 2013–2020
Figure 65: Japanese Biosimilar Market Forecast, ($m), 2013–2020
Figure 66: Market Opportunities for mAb against Cancer Biosimilars, ($m), 2013–2020
Figure 67: Expected Market Share in 2020 (%)
Figure 68: EPO Biosimilars Market Forecasts, ($m), 2013–2020
Figure 69: hGH Biosimilars Market Forecasts, ($m), 2013–2020
Figure 70: G-CSF Biosimilars Market Forecasts, ($m), 2013–2020
Figure 71: Market Opportunities for Insulin and Insulin Analogs Biosimilars, ($m), 2013–2020
Figure 72: Market Opportunities for Interferon alfa Biosimilar, ($m), 2013–2017
Figure 73: Market Opportunities for Interferon beta Biosimilar, ($m), 2013–2017
Figure 74: Market Opportunities for TNF alfa Inhibitor Biosimilars, ($m), 2013–2020
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: Comparison of Small Molecule Drugs and Biologics
Table 5: Biosimilar Market Size: US, France, Germany, Italy, Spain, & the UK, (in USD Billion), 2015
Table 6: Operating Margins for Branded Biologics, Branded Prescription Drugs, & Generic Companies
Table 7: Cost Comparison for a Biosimilar
Table 8: Patent Expiry for Major Biologic Drugs, 2010–2016
Table 9: Approximated Savings to be gained with the use of Biosimilar Drugs
Table 10: Costs of Development, Manufacturing and Approval of Biosimilars by Cell Culture Type, (in USD Million)
Table 11: Patients in Clinical Trials for Marketed Biosimilars
Table 12: Existing Guidelines for Biosimilars in Europe
Table 13: Biosimilar Approvals in Europe
Table 14: Applications Rejected or Withdrawn (Historical)
Table 15: Biosimilar Approval Pathways
Table 16: Costs Associated with Biosimilars Development and Registration in EU. Japan, US, and BRIC Countries (in USD Million, 2015)
Table 17: Differences in Discount compared to Reference Brand Costs in Key Markets (%), 2015
Table 18: Biosimilar Deals of Pharma Companies
Table 19: Success Criteria for Generic Drug Producers
Table 20: Growth Strategies at Sandoz
Table 21: Cost-Sharing Practices by Health Insurers in the US
Table 22: Leading Biosimilar Players in Japan, France, Germany, Italy, Spain and the UK, 2015
Table 23: Leading Biosimilars Companies in India and China, 2015
Table 24: Approvals of Biosimilars in Australia
Table 25: Status of Biosimilars in 5 EU Markets
Table 26: Approvals of Biosimilars in Japan
Table 27: Patent Expiries of Biologics in the US
Table 28: Patent Expiries of Biologics in EU 5
Table 29: Patent Expiries of Biologics in Japan
Table 30: Roche’s Strategy for Ensuring the Long-Term Survival of its Biological Products
Table 31: Roche Treatment Protocols
Table 32: Phase II Results for T-DM1
Table 33: Patent Expiries on the Main Insulins
Table 34: Biosimilar Product Portfolio of Hospira
Table 35: Biosimilar Product Portfolio of Sandoz/Hexal
Table 36: Biosimilar Product Portfolio of STADA
Table 37: Biosimilar Product Portfolio of Teva
Table 38: US Biosimilar Market Forecast, ($m), 2013–2020
Table 39: European Biosimilar Market Forecast, ($m), 2013–2020
Table 40: Japanese Biosimilar Market Forecast, ($m), 2013–2020
Table 41: Market Opportunities for mAb against Cancer Biosimilars, ($m), 2013–2020
Table 42: EPO Biosimilars Market Forecasts, ($m), 2013–2020
Table 43: hGH Biosimilars Market Forecasts, ($m), 2013–2020
Table 44: G-CSF Biosimilars Market Forecasts, ($m), 2013–2020
Table 45: Market Opportunities for TNF alfa Inhibitor Biosimilars, ($m), 2013–2020

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