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. 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 -

Allergan Plc
Amgen, Inc.
Biocon Ltd.
Biopartners GmbH
Boehringer Ingelheim International GmbH
Celltrion, Inc.

Table of Contents

1. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS

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

2. INDUSTRY OVERVIEW

• Biosimilars: An Introductory Prelude
• World Healthcare Sector Gears Up for Biosimilar Wave
• Biosimilars Offer Great Promise Despite Challenges
• The US & Europe Drive Momentum in Worldwide Biosimilars Sales
• Emerging Markets also Offer Robust Growth Opportunities
• R&D Funding: Crucial for Future Expansion of Biosimilars Market
  • Table 1: Global Pharmaceutical R&D Spending (in US$ Billion) for the Years 2010 through 2017 (includes corresponding Graph/Chart)
• Prevailing Economic Scenario Favors Funding Pattern
  • Table 2: World Real GDP Growth Rates in % (2016-2019P): Breakdown by Country/Region (includes corresponding Graph/Chart)

3. NOTEWORTHY MARKET TRENDS, GROWTH DRIVERS & ISSUES

• Slew of Product Approvals Scale Up Market Revenues
• Biosimilar Approvals in Europe (as of H1 2018)
• Biosimilar Approvals in the US (as of H1 2018)
• Pipeline Biosimilar Products in the US (as of H1 2018)
• Biosimilar Approvals in South Korea (as of H1 2018)
• Patent Expiry of Major Biopharmaceutical Drugs Leads Way for Biosimilars
• Patent Expiries of Major Biopharmaceutical Drugs in the US and Europe
• Cost Containment Measures Put Focus on Biosimilars
  • Table 3: Per Capita Healthcare Spending (in US$) in Select Countries for the Year 2016 (includes corresponding Graph/Chart)
  • Table 4: Leading Countries with Highest Healthcare Spending as a Percentage of GDP (2016) (includes corresponding Graph/Chart)
• High Cost of Biologics - Favorable for Biosimilars
  • Table 5: 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)
• Efforts to Push Up Biosimilar Adoption Aid Market Expansion
• Increasing Share of Biotech Drugs to Drive Biosimilars Market
  • Table 6: Increasing Share of Biologics in the Global Pharmaceutical Market: 2013-2020 (includes corresponding Graph/Chart)
  • Table 7: Global Biologics Market by Region: Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific, and Rest of World for 2007, 2015 and 2020P (includes corresponding Graph/Chart)
• Progressive Regulatory Framework Accelerates Product Approvals & Subsequently Market Revenues
• Specific Guidelines for Biosimilars in Various Countries with Year of Publication
• Biosimilars Regulatory Agencies in Select Regional Markets
• Improvement in Nomenclature & Interchangeability Enhance Appeal & Image of Biosimilars
• Human Insulin Biosimilars Eye Potential Opportunities
  • Table 8: Global Basal Insulin Market by Brand (2016, 2018E & 2020P): Percentage Market Share Breakdown of Revenues for Basalgar, Lantus, Levemir, Peg Lispro, Toujeo, and Tresiba (includes corresponding Graph/Chart)
• Monoclonal Antibodies - A Key Segment for Biosimilars
• Approved Monoclonal Antibodies (2014-2017)
• Rituximab Biosimilars to Proliferate the Market
• Growing Incidence of Chronic Diseases & Ageing Population Widen Prospects for Biosimilars
  • Table 9: Worldwide Incidence of Cancer (2013, 2020P & 2030P): Number of New Cases Diagnosed (includes corresponding Graph/Chart)
  • Table 10: Worldwide Prevalence of Diabetes: Number of Adults (20-79) with Diabetes (in Millions) by Region for 2017 and 2045 (includes corresponding Graph/Chart)
  • Table 11: Elderly Population (60+ Years) as a Percentage of Total Population (2015 & 2050) (includes corresponding Graph/Chart)
  • Table 12: Global Aging Population in Select Regions/Countries: Population of 60+ Individuals in '000s and as a Percentage of Total Population for 2015 & 2050 (includes corresponding Graph/Chart)
  • Table 13: Life Expectancy at Age 60 and 80 Years - (2010-2015), (2020-2025) & (2045-2050) (includes corresponding Graph/Chart)
• Growing Biosimilars Market - A Clear Advantage for Bioseparation Technologies
• Growth Restraints
• Lack of Uniform Regulations
• High Lead-time
• High Manufacturing Costs
• Difficulties in Delivery & Commercialization
• Automatic Substitution
• Biobetters: A Potential Industry Challenge
• Other Impediments to Market Acceptance

4. PRODUCT OVERVIEW

• Biological Drugs: An Introduction
• Biosimilars: Overview
• Characteristics of Biosimilars
• Development Cycle of Biosimilars
• Industry Participants

5. COMPETITIVE LANDSCAPE

• Leading Players in the World Biosimilars Market
• Indian & Chinese Companies Seek Opportunities
• Increased Penetration of Biosimilars - Implications for Manufacturers
• Comparison of Entry Barriers for Biogenerics in Select Global Markets
• Vendors Emphasize Novel Strategies to Stay Competitive
• Licensing Deals and Development & Commercialization Partnerships Find Favor
  • Select Biosimilar Licensing Deals & Collaborations Announced in the Recent Past
• Contract Manufacturing Gains Traction
• 5.1 Focus on Select Global Players
• Allergan Plc (Ireland)
• Amgen, Inc. (USA)
• Biocon Ltd. (India)
• Biopartners GmbH (Switzerland)
• Boehringer Ingelheim International GmbH (Germany)
• Celltrion, Inc. (South Korea)
• Dr. Reddy's Laboratories Ltd. (India)
• Eli Lilly and Company (USA)
• Fresenius Kabi (Germany)
• Intas Pharmaceuticals Ltd. (India)
• Mylan N.V. (USA)
• Pfizer, Inc. (USA)
• Samsung Bioepis Co., Ltd. (Korea)
• Sandoz International GmbH (Germany)
• STADA Arzneimittel AG (Germany)
• Teva Pharmaceutical Industries Ltd. (Israel)
• 5.2 Product Approvals/Introductions
• Pfizer Bags FDA Approval for NIVESTYM(tm)
• Pfizer Wins FDA Approval for Retacrit Biosimilar Epoetin Alfa
• Amgen Achieves Top-Line Results for infliximab Biosimilar in Phase 3 Study
• Mylan Receives FDA Approval for Fulphila(tm)
• Apobiologix Wins Health Canada Approval for Lapelga(tm) Biosimilar
• Mylan Wins Marketing Authorization for Semglee(tm) Biosimilar Insulin Glargine in Europe
• Amgen Receives CHMP Positive Opinion for ABP 980 Trastuzumab Biosimilar
• Celltrion Bags European Approval for Herzuma(r) Trastuzumab Biosimilar
• Amgen and Allergan Receive European Marketing Authorization for MVASI(r) Biosimilar Bevacizumab
• Intas Pharmaceuticals Launches Pelgraz Pegfilgrastim Biosimilar in Europe
• Mabion Receives EMA Review Acceptance for MabionCD20
• Pfizer Receives EC Approval for TRAZIMERA(tm)
• Sandoz Bags Marketing Authorization for Hyrimoz(r) in Europe
• Mylan and Fujifilm Receive CHMP Positive Opinion for Hulio(tm) Adalimumab Biosimilar
• Dr. Reddy's Introduces Hervycta(r) in India
• Celltrion Receives FDA Approval for BLA Review for CT-P6 mAb Biosimilar
• Celltrion Receives FDA BLA Review Acceptance for CT-P10 mAb Biosimilar
• Merck Rolls Out RENFLEXIS(tm) infliximab-abda in the US
• Pfizer Receives FDA Approval for IXIFI(tm) Monoclonal Antibody
• Mylan Wins FDA Approval for Ogivri(tm)
• Samsung Bioepis Wins Marketing Authorization for ONTRUZANT(r) in Europe
• Fresenius Kabi Submits Marketing Authorization Application for MSB11022 in Europe
• Sandoz Bags European Approval for Erelzi(r) to Treat Mutiple Immunological Diseases
• Fujifilm Kyowa Kirin Receives EMA's MAA Review Acceptance for FKB327 Biosimilar
• Celltrion Bags EMA Approval for Truxima Biosimilar mAb
• Biocon Introduces KRABEVA(r) in India
• Mylan Receives Brazilian Approval for Biosimilar Trastuzumab
• Celltrion Submits Sales Approval Application for Herzuma in Japan
• 5.3 Recent Industry Activity
• Biogen Acquires Additional Stake in Samsung Bioepis
• AbbVie and Mylan Ink Patent License Agreement for HUMIRA(r)
• Amneal Pharmaceuticals and Impax Laboratories Merge
• Amneal Signs Licensing Agreement with mAbxience for Bevacizumab Biosimilar
• Valerius Biopharma Teams Up with Catalent Pharma for Biosimilars Production
• Fresenius Kabi Expands Operations in Runcorn
• STADA to Acquire Additional Stake in BIOCEUTICALS Arzneimittel
• Biocon and Sandoz Ink Global Partnership Deal
• Eli Lilly Partneres with Cipla to Market Basaglar in India
• Cipla to Discontinue to In-House Production of Biosimilar Drugs
• Merck Divests Biosimilars Business to Fresenius
• Nidda Healthcare Holding Acquires STADA Arzneimittel
• Amgen and Simcere to Co-develop and Commercialize New Biosimilars in China
• Aurobindo Pharma Acquires Four Biosimilar Products from TL Biopharmaceutical

6. GLOBAL MARKET PERSPECTIVE

• Table 14: World Recent Past, Current & 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 15: World 5-Year Perspective for Biosimilars by Geographic Region - Percentage Breakdown of Revenues for US, Japan, Europe and Rest of World Markets for Years 2018 & 2022 (includes corresponding Graph/Chart)

7. REGIONAL MARKET PERSPECTIVE

• 7.1 The United States
• A. Market Analysis
  • Spectacular Rise on the Cards
  • Table 16: Percentage (%) Share of the US in the World Biosimilars Market Revenues (2018E & 2022P) (includes corresponding Graph/Chart)
  • Table 17: Global Biosimilars Market - Geographic Regions Ranked by CAGR (Revenues) for 2015-2022: US, Rest of World, Europe, and Japan (includes corresponding Graph/Chart)
  • Latest Developments in the Biosimilars Space
  • Challenges in the US Drug Approval Pathway for Biosimilars
    • Critical Requirements for Marketing Approval
  • Need to Cut Down Prices for Increased Adoption
• B. Market Analytics
  • Table 18: 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)
• 7.2 Japan
• Market Analysis
  • Table 19: 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)
• 7.3 Europe
• A. Market Analysis
  • Europe: The Foremost Propagator of Biosimilars
  • Europe Stays Ahead in the Biosimilars Race
  • Segment-Wise Analysis
  • Payers Eye Biosimilars to Curtail Costs
  • Biosimilar Pricing Competition to Intensify Further
  • Biosimilars Regulatory Framework: Well-Established
    • Biosimilar Regulatory Timeline from Legislation to Approval in the EU
    • Further Clarity Needed Regarding Extrapolation of Biosimilars for Multiple Indications
  • Challenges Ahead
    • Heavy Investment and Regulations
    • Complex Production Process
    • Biocapacity
• B. Market Analytics
  • Table 20: 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 21: European 5-Year Perspective for Biosimilars by Geographic Region - Percentage Breakdown of Revenues for France, Germany, Italy, UK, Spain and Rest of Europe Markets for Years 2018 & 2022 (includes corresponding Graph/Chart)
• 7.3.1 France
• Market Analysis
  • Table 22: 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)
• 7.3.2 Germany
• Market Analysis
  • Table 23: 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)
• 7.3.3 Italy
• Market Analysis
  • Table 24: 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)
• 7.3.4 The United Kingdom
• A. Market Analysis
  • Nascent UK Biosimilars Market
    • NICE's Latest Ruling Bodes Well for Biosimilars
• B. Market Analytics
  • Table 25: 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)
• 7.3.5 Spain
• Market Analysis
  • Table 26: 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)
• 7.3.6 Rest of Europe
• A. Market Analysis
  • Biosimilar-related Developments in Russia
• B. Market Analytics
  • Table 27: 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)
• 7.4 Rest of World
• A. Market Analysis
  • Asia-Pacific: Market Laden with Opportunities
    • High Costs of Biologics Grant Edge to Biosimilars
    • India
    • Biosimilars Evolve into a Niceh Segment within the Thriving Indian Biopharma Industry
    • Collaborations with Western Counterparts in Biosimilar Development
    • Guidelines for Biosimilars in India
    • China
    • New Guidelines to Underpin Sales Growth
    • Asia-Pacific: Regulatory Framework
  • Latin America
  • The Middle East and North Africa
  • Sub-Saharan Africa
  • Canada
    • Biosimilars Set to Register Gains in Canada
    • Future Scenario
    • Regulatory Framework
• B. Market Analytics
  • Table 28: 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)

8. COMPANY PROFILES