Biosimilars

This report analyzes the worldwide markets for Biosimilars in US$ Million. The report provides separate comprehensive analytics for the US, Japan, Europe, and Rest of World. Annual estimates and forecasts are provided for the period 2015 through 2022. Also, a six-year historic analysis is provided for these markets. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs. The report profiles 71 companies including many key and niche players such as -

Amgen Inc.
Allergan Plc
Biocon Ltd.
Biopartners GmbH
Boehringer Ingelheim GmbH

Table of Contents

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

• Study Reliability and Reporting Limitations
• Disclaimers
• Data Interpretation & Reporting Level
  • Quantitative Techniques & Analytics
• Product Definitions and Scope of Study

II. EXECUTIVE SUMMARY

1. MARKET OVERVIEW

• Introduction to Biosimilars
• Biosimilars Set to Revolutionize Healthcare Sector
• Biosimilars Offer Great Promise despite Challenges
• Specific Guidelines for Biosimilars in Various Countries with Year of Publication
• List of Approved Biosimilars & Pending Biosimilar Applications in the EU
• List of Approved Biosimilars & Pending Biosimilar Applications in the US
• List of Approved Biosimilars in South Korea
• Biosimilars Find More Growth in Emerging Markets
• Comparison of Entry Barriers for Biogenerics in Select Global Markets
• Market Drivers
• Patent Expiry of Leading Biopharmaceuticals Leads Way for Biosimilars
  • Patent Expiries of Major Biopharmaceutical Drugs in the US and Europe
• Cost Containment Measures
  • Table 1: Per-Capita Healthcare Expenditure in Select Regions: 2013 (includes corresponding Graph/Chart)
  • Table 2: Leading Countries with the Highest Healthcare Spending as a Percentage of GDP (2012) (includes corresponding Graph/Chart)
• Growing Aging Population
  • Table 3: Global Population Statistics for the 65+ Age Group (2013) (includes corresponding Graph/Chart)
  • Table 4: Elderly Population (65+ Years) as a % of Total Population (2000 & 2025) (includes corresponding Graph/Chart)
  • Table 5: Percentage of Population Aged 65 and Above in EU-27 Countries, US and Japan (1960-2030) (includes corresponding Graph/Chart)
• Presence of Major Players
• Growth Restraints
• Uncertain Regulations
• High Lead-time
• High Manufacturing Costs
• Delivery and Commercialization
• Automatic Substitution
• Other Impediments to Market Acceptance
• Strategies to Aid Survival of Companies

2. RECENT BIOSIMILAR APPROVALS AND PIPELINE ANALYSIS

• Biosimilar Approvals in 2016, 2015, & 2014
• Select Biosimilar Candidates in Late-Stage Pipeline: 2016
• Biosimilars in Pipeline for Major Biologic Drugs: 2016
• Increasing Collaborations, Licensing Routes and Partnerships
• Indian & Chinese Companies to Emerge Strong in Western Markets
• Improved Regulatory Framework
• European Union Ahead in the Biosimilars Race
• Biosimilars Regulatory Agencies in Select Regional Markets
• US Passes Act to Create Biosimilars Pathway, Finally

3. MARKET DYNAMICS & TRENDS

• Increased Penetration of Biosimilars - Implications for Manufacturers
• Efforts to Push Up Biosimilar Adoption
• Improvements in Nomenclature and Interchangeability
• Contract Manufacturing Favored by Emerging & Major Biosimilar Players
• Companies Eye Human Insulin Biosimilars
  • Table 6: Global Basal Insulin Market by Brand (2016E, 2018E & 2020E): Percentage Market Share Breakdown of Revenues for Basalgar, Lantus, Levemir, Peg Lispro, Toujeo, and Tresiba (includes corresponding Graph/Chart)
• Monoclonal Antibodies - A Key Growth Segment for Biosimilars
• Approved Monoclonal Antibodies for Therapeutic Use: 1986-2014
• Biobetters: Potential Industry Challenge?
• High Cost of Biologics - Favorable for Biosimilars
  • Table 7: Treatment Costs by Drug (2015): Comparative Analysis of Daily Treatment costs with Branded Small-molecule Drug, Generic Small-molecule Drug, and Biologics (Humira, Kadcyla, & Cerezyme) (includes corresponding Graph/Chart)
• R&D Funding Crucial
  • Table 8: Global Biopharmaceutical R&D Expenditure: 2010-2015E (includes corresponding Graph/Chart)
• Growing Biosimilars Market - A Clear Advantage for Bioseparation Technologies

4. GLOBAL BIOLOGICS MARKET

• Global Biopharmaceutical Drug Market - A Primer
  • Table 9: Increasing Share of Biologics in the Global Pharmaceutical Market: 2013-2020 (includes corresponding Graph/Chart)
• US - The Largest Biologics Market Worldwide
  • Table 10: Global Biologics Market by Region: Percentage Share Breakdown for US, Canada, Japan, Europe, Asia-Pacific, and Rest of World for 2007, 2015 and 2020 (includes corresponding Graph/Chart)
• Increasing Share of Biotechnological Drugs to Drive Biosimilars Market
• Intensifying Consolidation Activity
• Recent M&A Activity in the Biologics Industry: 2014 & 2015

5. PRODUCT OVERVIEW

• Introduction
• Characteristics of Biosimilars
• Biological Drugs
• Biological Drugs Manufacturing Process
• Development Cycle of Biosimilars
• Industry Participants

6. PRODUCT APPROVALS/INTRODUCTIONS

• Mylan and Biocon Co-develop trastuzumab Biosimilar
• EC Approves Remicade Biosimilar Flixabi(r) Developed by Samsung Bioepis
• Samsung's BLA for Remicade Biosimilar Accepted by USFDA
• EMA Approves rituximab Biosimilar Developed by Sandoz
• EC Approves New Route of Administration for Sandoz's Biosimilar Binocrit
• USFDA Approves INFLECTRA, Celltrion's Biosimilar to Remicade
• Japanese Ministry Approves Biocon's Biosimilar Insulin Glargine
• EMA Accepts Sandoz's MAA for Neulasta Biosimilar
• FDA Accepts Amgen's BLA for ABP-501
• EC Approves Benepali (Enbrel Biosimilar) Developed by Samsung Bioepis
• Torrent Pharmaceuticals Launches adalimumab Biosimilar
• EMA Accepts Sandoz's MAA for Enbrel Biosimilar
• RENFLEXIS(r) by Samsung Bioepis Approved by Korea's MFDS
• Amgen Submits ABP-501 Marketing Authorization Application to EMA
• FDA Approves Sandoz's BLA for Proposed Enbrel Biosimilar
• Amgen and Allergan Announce Positive Phase 3 Study Results for Biosimilar ABP 215
• Korean Ministry Approves BRENZYS(tm) Co-developed by Merck and Samsung
• Intas Pharmaceuticals Launches Biosimilar to Lucentis
• USFDA Approves First Biosimilar Zarxio(tm) from Sandoz
• Mundipharma Launches Biosimilar MAb Remsima(r) in 6 European Markets
• Intas Pharmaceuticals Launches filgrastim Biosimilar Accofil
• Cadila Launches adalimumab Biosimilar
• EPIRUS Biopharmaceuticals Launches infliximab Biosimilar
• Celltrion Receives Japan's MHLW Approval for Remsima
• Cipla Launches Biosimilar Darbepoetin alfa Under Actorise Brand
• Celltrion Announces Approval of biosimilar mAb Herzuma by MFDS

7. RECENT INDUSTRY ACTIVITY

• Alvotech Acquires Baliopharm GmbH
• Dr. Reddy's Inks Collaboration Agreement with TR-Pharm
• Premier and Oncobiologics Collaborate to Enhance Biosimilars Adoption
• Sandoz Acquires Rights to infliximab Biosimilar from Pfizer
• Sandoz Enters into Exclusive License Agreement with Kyowa Hakko Kirin
• Mylan Enters Into Biosimilars Development Partnership with Momenta Pharmaceuticals
• Merck to Bring Biosimilars to Canada through its Agreement with Samsung
• EPIRUS Biopharmaceuticals to Expand Biosimilar Pipeline through Acquisition of Bioceros
• Pfizer Acquires Hospira
• Astrazeneca Enters into JV with Fujifilm Kyowa Kirin Biologics
• STADA and Richter Sign License/Disribution Agreement for Pegfilgrastim Biosimilar
• Coherus and Baxter Amend Collaboration Agreement for CHS-0214
• Torrent Pharmaceuticals Enters into Licensing Agreement with Reliance Life Sciences
• Mabion Ext,mends Agreement with Altiora for rituximab Biosimilar MabionCD20
• STADA and mAbxience Enter Into In-licensing Agreement for Humira Biosimilar
• Xbrane Bioscience Signs Agreement with Indian Pharmaceutical Major
• Cipla Acquires Mabpharm
• EPIRUS Biopharmaceuticals Merges with Zalicus
• mAbxience Acquires Genhelix
• Ipca and Oncobiologics Enter into Alliance for Development of Biosimilar MAbs
• Lupin and Yoshindo Form Joint Venture YLB for Biosimilar Commercialization
• Bionovis and Merck Sign Agreement
• Catalent Signs Agreement with HISUN
• Aurobindo Pharma Acquires Western European Operations of Actavis
• Samsung and Merck Expand Collaboration to Develop MK-1293 Insulin Glargine Biosimilar

8. FOCUS ON SELECT MARKET PLAYERS

• Amgen Inc. (US)
• Allergan Plc. (Ireland)
• Biocon Ltd. (India)
• Biopartners GmbH (Switzerland)
• Boehringer Ingelheim GmbH (Germany)
• Celltrion Inc. (South Korea)
• Cipla Ltd. (India)
• Cipla BioTec Private Ltd. (India)
• Dr. Reddy's Laboratories Ltd. (India)
• Eli Lilly and Company (US)
• EPIRUS Biopharmaceuticals, Inc. (US)
• Hospira, Inc. (US)
• Intas Biopharmaceuticals Ltd. (India)
• Merck KGaA (Germany)
• Mylan N.V. (US)
• Pfizer Inc. (US)
• Samsung Bioepis Co., Ltd. (Korea)
• Sandoz International GmbH (Germany)
• STADA Arzneimittel AG (Germany)
• Teva Pharmaceutical Industries Ltd. (Israel)

9. GLOBAL MARKET PERSPECTIVE

• Table 11: World Recent Past, Current, and Future Analysis for Biosimilars by Geographic Region - US, Japan, Europe and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
• Table 12: World 7-Year Perspective for Biosimilars by Geographic Region - Percentage Breakdown of Dollar Revenues for US, Japan, Europe and Rest of World Markets for Years 2016 & 2022 (includes corresponding Graph/Chart)

III. MARKET

1. THE UNITED STATES

• A. Market Analysis
  • Market Overview
  • Latest Developments in the Biosimilars Space
  • Slow Take-Off in the US Market
    • List of Approved Biosimilars & Pending Biosimilar Applications in the US
  • Challenges in the US Drug Approval Pathway for Biosimilars
  • Growing Legal Challenges in the Domestic Market
  • Need to Cut Down Prices for Increased Adoption
  • Patent Expiry of Leading Biopharmaceuticals Presents Ray of Hope
    • Patent Expiries of Major Biopharmaceutical Drugs in the US
  • Significant Biosimilar Pipeline Products
  • Product Introductions
  • Strategic Corporate Developments
  • Select Key Players
• B. Market Analytics
  • Table 13: The US Recent Past, Current & Future Analysis for Biosimilars Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

2. JAPAN

• A. Market Analysis
  • Growing Market for Biosimilars
  • Product Introductions
  • Strategic Corporate Developments
• B. Market Analytics
  • Table 14: Japanese Recent Past, Current & Future Analysis for Biosimilars Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

3. EUROPE

• A. Market Analysis
  • List of Approved Biosimilars & Pending Biosimilar Applications in the EU
  • Patent Expiry of Leading Biopharmaceuticals Leads Way for Biosimilars
    • Patent Expiries of Major Biopharmaceutical Drugs in Europe
  • Biosimilar Pricing Competition to Intensify Further
  • Clarity Needed Regarding Extrapolation of Biosimilars for Other Indications
  • Demand for Rituximab Biosimilars
  • Nascent UK Biosimilars Market
    • NICE's Latest Ruling Bodes Well for Biosimilars
  • Spanish Biosimilars Market: A Brief Review
  • Biosimilar-related Developments in Russia
  • Biosimilars Regulatory Framework: Well-Established
    • Biosimilar Regulatory Timeline from Legislation to Approval in the EU
  • Growth Drivers
    • Payers Eye Biosimilars to Curtail Costs
  • Challenges Ahead
    • Heavy Investment and Regulations
    • Complex Production Process
    • Biocapacity
  • Product Introductions
  • Strategic Corporate Developments
  • Select Key Players
• B. Market Analytics
  • Table 15: European Recent Past, Current & Future Analysis for Biosimilars by Geographic Region - France, Germany, Italy, UK, Spain and Rest of Europe Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)
  • Table 16: European 7-Year Perspective for Biosimilars by Geographic Region - Percentage Breakdown of Dollar Revenues for France, Germany, Italy, UK, Spain and Rest of Europe Markets for Years 2016 & 2022 (includes corresponding Graph/Chart)

3a. FRANCE

• Market Analysis
  • Table 17: French Recent Past, Current & Future Analysis for Biosimilars Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

3b. GERMANY

• Market Analysis
  • Table 18: German Recent Past, Current & Future Analysis for Biosimilars Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

3c. ITALY

• Market Analysis
  • Table 19: Italian Recent Past, Current & Future Analysis for Biosimilars Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

3d. UNITED KINGDOM

• Market Analysis
  • Table 20: The UK Recent Past, Current & Future Analysis for Biosimilars Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

3e. SPAIN

• Market Analysis
  • Table 21: Spanish Recent Past, Current & Future Analysis for Biosimilars Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

3f. REST OF EUROPE

• Market Analysis
  • Table 22: Rest of European Recent Past, Current & Future Analysis for Biosimilars Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

4. REST OF WORLD

• A. Market Analysis
  • Asia-Pacific: Market with High Potential
  • Regulatory Framework
    • Asia-Pacific
    • List of Approved Biosimilars in South Korea
    • Latin America
    • Middle East and North Africa
    • Sub-Saharan Africa
  • High Costs and Counteractive Measures
  • Indian Biopharmaceutical Industry Makes Rapid Progress
    • Competition from Western Counterparts in Biosimilar Development
  • China Issues New Guidelines on Biosimilars
  • Overview of Biosimilars in Sub-Saharan Africa
  • Canada
    • Biosimilars Set to Register Gains in Pharmaceutical Sector
    • Future Scenario
    • Regulatory Framework
  • Product Introductions
  • Strategic Corporate Developments
  • Select Key Players
• B. Market Analytics
  • Table 23: Rest of World Recent Past, Current & Future Analysis for Biosimilars Market Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart)

COMPETITIVE LANDSCAPE