Biosimilars: Market Research Report

January 2019 | 243 pages | ID: B4CF055F0A1EN
Global Industry Analysts, Inc

Abstracts

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.

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
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
Apobiologix Wins Health Canada Approval for Lapelga Biosimilar
Mylan Wins Marketing Authorization for Semglee Biosimilar Insulin Glargine in Europe
Amgen Receives CHMP Positive Opinion for ABP 980 Trastuzumab Biosimilar
Celltrion Bags European Approval for Herzuma Trastuzumab Biosimilar
Amgen and Allergan Receive European Marketing Authorization for MVASI Biosimilar Bevacizumab
Intas Pharmaceuticals Launches Pelgraz Pegfilgrastim Biosimilar in Europe
Mabion Receives EMA Review Acceptance for MabionCD20
Pfizer Receives EC Approval for TRAZIMERA
Sandoz Bags Marketing Authorization for Hyrimoz in Europe
Mylan and Fujifilm Receive CHMP Positive Opinion for Hulio Adalimumab Biosimilar
Dr. Reddy’s Introduces Hervycta 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 infliximab-abda in the US
Pfizer Receives FDA Approval for IXIFI Monoclonal Antibody
Mylan Wins FDA Approval for Ogivri
Samsung Bioepis Wins Marketing Authorization for ONTRUZANT in Europe
Fresenius Kabi Submits Marketing Authorization Application for MSB11022 in Europe
Sandoz Bags European Approval for Erelzi 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 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
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

Total Companies Profiled: 71 (including Divisions/Subsidiaries - 77)
The United States (15)
Canada (1)
Japan (3)
Europe (26)
  France (1)
  Germany (8)
  The United Kingdom (5)
  Spain (1)
  Rest of Europe (11)
Asia-Pacific (Excluding Japan) (29)
Middle East (2)
Latin America (1)