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Market Research Report

Biosimilars: Global Markets

Published by BCC Research Product code 242224
Published Content info 340 Pages
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Biosimilars: Global Markets
Published: March 28, 2018 Content info: 340 Pages
Description

Report Highlights

The global biosimilars market reached nearly $5.5 billion in 2017 and is expected to reach $20.8 billion by 2022, with a compound annual growth rate (CAGR) of 30.5% from 2017 through 2022.

Report Includes:

  • 80 data tables and 16 additional tables
  • An overview of the global market for biosimilars
  • Analyses of global market trends, with data from 2016 and 2017, and projections of compound annual growth rates (CAGRs) through 2022
  • A look at biosimilar product classes in various regions worldwide, as well as the worldwide pipeline for biosimilars
  • Detailed analysis of the emerging framework in regulated markets, as well as comparisons of biosimilar guidelines in Europe, the U.S., Japan, Canada, as well the guidelines developed by the World Health Organization
  • Technology trends and patent analyses
  • Comprehensive company profiles of key players in the market, including Allergan Plc., Bioton S.A., Cinnagen, Emcure Pharmaceuticals Ltd., LG Life Sciences, Neuclone and Pfizer Inc.

Report Scope

Biosimilars are replicas of the innovator biopharmaceuticals. They offer the advantage of being less expensive as compared to their expensive counterparts. The structural and manufacturing complexities associated with their development have led to extensive approval guidelines and regulations by the federal agencies. This report examines the biosimilar drugs in detail and provides an updated overview including its applications in various arenas of disease sectors. The importance of analytical technologies in the biosimilar manufacturing led BCC Research to focus specifically on the current and emerging trends in biosimilar manufacturing and analytical testing.

The scope of the study is global. BCC analyzes each market and its application, new products and advancements, market projections and market shares. This study surveys each market in all the geographic regions including North America, Europe and Emerging markets. The Emerging market covers all major countries like India, China, South Korea, Taiwan, Australia, New Zealand, Canada, Latin America, much of Africa, etc.

Also included in the report are relevant patent analysis and comprehensive profiles of companies that lead the biosimilar drugs industry. The company profiles highlight the bosimilar pipelines of relevant companies. Some of the major players of the market include Pfizer Inc., Sandoz International GmbH, Biocon Ltd., Dr Reddy's Laboratories Ltd., Amgen Inc., Teva Pharmaceuticals Inc., Celltrion Inc., Samsung Bioepis, and others.

BCC Research analyzes the current market situation by critically discussing the strengths, weaknesses, threats, and opportunities for the global biosimilars market. The market projections and market shares are examined for each region and type. The latest news articles including new products, acquisitions and collaborations in each market are also dealt with in sufficient detail.

The report has also dealt with biobetters, their approval mechanisms and importance in the industry. (Biobetters are described as new molecular entities that are related to existing biologics by target or action, but they are deliberately altered to improve disposition, safety, efficacy, or manufacturing attributes.)

Excluded from this report are the generics of small-molecule drugs, and the biologics per se. The different requirements for approval and bioequivalence between generics and biosimilars puts them in an entirely different regime. The diagnostic methods for monitoring disease progression are also outside the scope of this report.

Analyst Credentials

The analyst of this report holds a PhD degree in Microbial Technology. She has worked as a researcher in Lawrence Berkeley National Lab, California. She has numerous publications in the field of Protein Biochemistry. She was a Gold Medalist throughout her academic career. She has more than 10 years of research experience in fields of microbiology, molecular biology, electron microscopy, and protein biochemistry.

Table of Contents
Product Code: BIO090C

Table of Contents

CHAPTER 1 - INTRODUCTION

  • STUDY GOALS AND OBJECTIVES
  • REASONS FOR DOING THIS STUDY
  • SCOPE OF REPORT
  • INFORMATION SOURCES
  • METHODOLOGY
  • GEOGRAPHIC BREAKDOWN
  • ANALYST'S CREDENTIALS
  • RELATED BCC RESEARCH REPORTS

CHAPTER 2 - SUMMARY AND HIGHLIGHTS

  • SUMMARY TABLE: GLOBAL MARKET FOR BIOSIMILARS, BY TYPE, THROUGH 2022 ($ MILLIONS)
  • SUMMARY FIGURE: GLOBAL MARKET FOR BIOSIMILARS, BY TYPE, 2015-2022 ($ MILLIONS)

CHAPTER 3 - MARKET AND TECHNOLOGY BACKGROUND

  • LIFECYCLE OF A BIOSIMILAR DRUG
    • FIGURE 1 DEPICTION OF A TYPICAL BIOSIMILAR DRUG DEVELOPMENT TIMELINE
  • DEVELOPMENT OF A BIOSIMILAR
    • Cell Line Development and Selection
      • E. coli Cells
        • TABLE 1: List of Biosimilars Produced in E. Coli
      • Mammalian Cells
        • TABLE 2: List of Biosimilars Produced in Mammalian Cells
    • MANUFACTURING OF A BIOSIMILAR
    • PRECLINICAL STUDIES AND VALIDATION OF A BIOSIMILAR
    • CLINICAL TRIALS
    • APPROVAL BY REGULATORY AGENCIES
      • TABLE 3: KEY DIFFERENCES IN APPROVAL PATHWAYS FOR BIOSIMILARS, EUROPEAN UNION (EU) VS. UNITED SATES (U.S.)
    • PHARMACOVIGILANCE/POST-APPROVAL MONITORING
  • POPULAR BIOSIMILAR CANDIDATES
    • RECOMBINANT HORMONES
      • Teriparatide
      • Insulin
      • Human Growth Hormone (HGH)
      • Follicle-Stimulating Hormone (FSH)
        • TABLE 4: Biosimilar Recombinant Hormones
    • RECOMBINANT GROWTH FACTORS
      • Erythropoietin (EPO)
      • Granulocyte-Colony Stimulating Factor (G-CSF)
        • TABLE 5: Biosimilar Recombinant Growth Factors
    • MONOCLONAL ANTIBODIES (MABS)
      • TABLE 6: BIOSIMILAR MONOCLONAL ANTIBODIES
    • FUSION PROTEINS
      • TABLE 7: BIOSIMILAR FUSION PROTEINS
    • OTHERS
      • Low Molecular Weight Heparins
      • FDA Guidance to LMWH Biosimilars
        • TABLE 8: Biosimilar LMWHs
      • Interferons
        • TABLE 9: Biosimilar Interferons
  • DEFINITIONS
    • EMA TERMINOLOGY RELATED TO BIOSIMILARS
      • Bioequivalence
      • Biological Medicine
      • Biosimilar
      • Comparability Exercise
      • Essentially Similar Products
      • Generic Medicinal Product
      • Pharmacovigilance
      • Reference Medicinal Product
      • Therapeutic
    • FDA TERMINOLOGY RELATED TO BIOSIMILARS
      • Bioequivalent Drug Products
      • Biological Products
      • Biosimilar
      • Brand Name
      • Comparability
      • Comparability Protocol
      • Generic
      • Interchangeable Biological Product
      • International Nonproprietary Name (INN)
      • Nonproprietary
      • Originator Biological Product
      • Reference Standard
      • Related Biological Product
      • Regulatory Convergence
      • Regulatory Harmonization
      • Therapeutic Equivalent
    • WHO TERMINOLOGY RELATED TO BIOSIMILARS
      • Biosimilar
      • Pharmacovigilance
      • Reference Biotherapeutic Product (RBP)
      • Biotherapeutic
      • Well-Established Biotherapeutic Product
    • DIFFERENCES BETWEEN COMMON DRUG CLASSIFICATIONS
    • SMALL MOLECULE DRUGS VS. BIOLOGICS
      • TABLE 10: SMALL MOLECULAR DRUGS VS. BIOLOGICS
    • GENERICS VS. BIOSIMILARS
      • TABLE 11: GENERICS VS. BIOSIMILARS
    • BIOSIMILARS VS. BIOBETTERS
      • TABLE 12: BIOSIMILARS VS. BIOBETTERS
  • STRATEGIES TO DEVELOP BIOBETTERS
    • PEGYLATION
    • GLYCOSYLATION
    • FUSION PROTEINS
      • TABLE 13 LIST OF APPROVED FUSION PROTEIN BIOBETTERS

CHAPTER 4 - MARKET BREAKDOWN BY TECHNOLOGY TYPE

  • TABLE 14: NUMBER OF APPROVED BIOSIMILARS, BY TYPE MARKET BY BIOSIMILAR TYPES
  • MARKET REVENUE
    • TABLE 15: GLOBAL MARKET FOR BIOSIMILARS, BY TECHNOLOGY TYPE, THROUGH 2022 ($ MILLIONS)
    • FIGURE 2 GLOBAL MARKET FOR BIOSIMILARS, BY TECHNOLOGY TYPE, 2015-2022 ($ MILLIONS)
  • MARKET SHARES
    • TABLE 16: GLOBAL MARKET SHARE FOR BIOSIMILARS, BY TECHNOLOGY TYPE, 2016 (%)
    • FIGURE 3: GLOBAL MARKET SHARE FOR BIOSIMILARS, BY TECHNOLOGY TYPE, 2016 (%)
  • RECOMBINANT HORMONE BIOSIMILARS
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 17: GLOBAL MARKET FOR RECOMBINANT HORMONE BIOSIMILARS, BY TECHNOLOGY TYPE, THROUGH 2022 ($ MILLIONS)
      • FIGURE 4: GLOBAL MARKET FOR RECOMBINANT HORMONE BIOSIMILARS, BY TECHNOLOGY TYPE, 2015-2022 ($ MILLIONS)
  • RECOMBINANT GROWTH FACTOR BIOSIMILARS
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 18: GLOBAL MARKET FOR RECOMBINANT GROWTH FACTOR BIOSIMILARS, BY TECHNOLOGY TYPE, THROUGH 2022 ($ MILLIONS)
      • FIGURE 5: GLOBAL MARKET FOR RECOMBINANT GROWTH FACTOR BIOSIMILARS, BY TECHNOLOGY TYPE, 2015-2022 ($ MILLIONS)
  • MONOCLONAL ANTIBODIES BIOSIMILARS
    • TABLE 19: BRANDED MONOCLONAL ANTIBODY DRUGS USED AS REFERENCE DRUGS FOR BIOSIMILARS, 2016
    • MARKET OVERVIEW
      • Adalimumab
      • Bevacizumab
      • Infliximab
      • Rituximab
      • Trastuzumab
      • Ranibizumab
    • MARKET REVENUE
      • TABLE 20: GLOBAL MARKET FOR MONOCLONAL ANTIBODY BIOSIMILARS, BY TECHNOLOGY TYPE, THROUGH 2022 ($ MILLIONS)
      • FIGURE 6: GLOBAL MARKET FOR MONOCLONAL ANTIBODY BIOSIMILARS, BY TECHNOLOGY TYPE, 2015-2022 ($ MILLIONS)
  • FUSION PROTEIN BIOSIMILARS
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 21: GLOBAL MARKET FOR FUSION PROTEIN BIOSIMILARS, BY TECHNOLOGY TYPE, THROUGH 2022 ($ MILLIONS)
      • FIGURE 7: GLOBAL MARKET FOR FUSION PROTEIN BIOSIMILARS, BY TECHNOLOGY TYPE, 2015-2022 ($ MILLIONS)
    • OTHERS
      • Interferons
      • LMWHs
    • MARKET OVERVIEW
      • Interferons
      • LMWHs
    • MARKET REVENUE
      • TABLE 2: LIST OF BIOSIMILARS PRODUCED IN MAMMALIAN CELLS
      • FIGURE 8: GLOBAL MARKET FOR OTHER BIOSIMILARS, BY TECHNOLOGY TYPE,2015-2022 ($ MILLIONS)

CHAPTER 5 - MARKET BREAKDOWN BY APPLICATION

  • MARKET BY BIOSIMILAR APPLICATIONS
    • MARKET REVENUE
      • TABLE 23: GLOBAL MARKET FOR BIOSIMILARS, BY APPLICATION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 9: GLOBAL MARKET FOR BIOSIMILARS, BY APPLICATION, 2015-2022 ($ MILLIONS)
    • MARKET SHARES
      • TABLE 24: GLOBAL MARKET SHARE FOR BIOSIMILARS, BY APPLICATION, 2016 (%)
      • FIGURE 10: GLOBAL MARKET SHARE FOR BIOSIMILARS, BY APPLICATION, 2016 (%)
  • CANCER BIOSIMILARS
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 25: GLOBAL MARKET FOR BIOSIMILARS IN CANCER, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 11: GLOBAL MARKET FOR BIOSIMILARS IN CANCER, BY REGION,2015-2022 ($ MILLIONS)
  • BLOOD DISORDERS
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 26: GLOBAL MARKET FOR BIOSIMILARS IN BLOOD DISORDERS, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 12: GLOBAL MARKET FOR BIOSIMILARS IN BLOOD DISORDERS, BY REGION, 2015-2022 ($ MILLIONS)
  • DIABETES
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 27: GLOBAL MARKET FOR BIOSIMILARS IN DIABETES, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 13: GLOBAL MARKET FOR BIOSIMILARS IN DIABETES, BY REGION, 2015-2022 ($ MILLIONS)
  • GROWTH HORMONE DEFICIENCY
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 28: GLOBAL MARKET FOR BIOSIMILARS IN GROWTH HORMONE DEFICIENCY, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 14: GLOBAL MARKET FOR BIOSIMILARS IN GROWTH HORMONE DEFICIENCY, BY REGION, 2015-2022 ($ MILLIONS)
  • INFECTIOUS DISEASES
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 29: GLOBAL MARKET FOR BIOSIMILARS IN INFECTIOUS DISEASES, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 15: GLOBAL MARKET FOR BIOSIMILARS IN INFECTIOUS DISEASES, BY REGION, 2015-2022 ($ MILLIONS)
  • AUTOIMMUNE DISEASES
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 30: GLOBAL MARKET FOR BIOSIMILARS IN AUTOIMMUNE DISEASES, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 16: GLOBAL MARKET FOR BIOSIMILARS IN AUTOIMMUNE DISEASES, BY REGION, 2015-2022 ($ MILLIONS)
  • OTHER DISEASES
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 31: GLOBAL MARKET FOR BIOSIMILARS IN OTHER DISEASES, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 17: GLOBAL MARKET FOR BIOSIMILARS IN OTHER DISEASES, BY REGION, 2015-2022 ($ MILLIONS)

CHAPTER 6 - MARKET BREAKDOWN BY REGION

  • PATENT CHALLENGES
  • INTERCHANGEABILITY
  • PRICING
  • MARKET BY GEOGRAPHICAL REGION
    • MARKET REVENUE
      • TABLE 32: GLOBAL MARKET FOR BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 18: GLOBAL MARKET FOR BIOSIMILARS, BY REGION, 2015-2022 ($ MILLIONS)
    • MARKET SHARES
      • TABLE 33: GLOBAL MARKET SHARE FOR BIOSIMILARS, BY REGION, 2016 (%)
      • FIGURE 19: GLOBAL MARKET SHARE FOR BIOSIMILARS, BY REGION, 2016 (%)
  • RECOMBINANT HORMONE BIOSIMILARS
    • MARKET REVENUE
      • TABLE 34: GLOBAL MARKET FOR RECOMBINANT HORMONE BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 20: GLOBAL MARKET FOR RECOMBINANT HORMONE BIOSIMILARS, BY REGION, 2015-2022 ($ MILLIONS)
    • MARKET SHARES
      • TABLE 35: GLOBAL MARKET SHARE FOR RECOMBINANT HORMONE BIOSIMILARS, BY REGION, 2016 (%)
      • FIGURE 21: GLOBAL MARKET SHARE FOR RECOMBINANT HORMONE BIOSIMILARS, BY REGION, 2016 (%)
  • SOMATOTROPIN BIOSIMILARS
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 36: GLOBAL MARKET FOR SOMATOTROPIN BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 22: GLOBAL MARKET FOR SOMATOTROPIN BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
  • FOLLITROPIN ALFA BIOSIMILARS
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 37: GLOBAL MARKET FOR FOLLITROPIN ALFA BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 23: GLOBAL MARKET FOR FOLLITROPIN ALFA BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
  • INSULIN GLARGINE BIOSIMILARS
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 38: GLOBAL MARKET FOR INSULIN GLARGINE BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 24: GLOBAL MARKET FOR INSULIN GLARGINE BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
  • TERIPARATIDE BIOSIMILARS
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 39: GLOBAL MARKET FOR TERIPARATIDE BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 25: GLOBAL MARKET FOR TERIPARATIDE BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
  • RECOMBINANT GROWTH FACTORS BIOSIMILARS
    • MARKET REVENUE
      • TABLE 40: GLOBAL MARKET FOR RECOMBINANT GROWTH FACTOR BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 26: GLOBAL MARKET FOR RECOMBINANT GROWTH FACTOR BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
    • MARKET SHARES
      • TABLE 41: GLOBAL MARKET SHARE FOR RECOMBINANT GROWTH FACTOR BIOSIMILARS, BY REGION, 2016 (%)
      • FIGURE 27: GLOBAL MARKET SHARE FOR RECOMBINANT GROWTH FACTOR BIOSIMILARS, BY REGION, 2016 (%)
  • ERYTHROPOIETIN BIOSIMILARS
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 42: GLOBAL MARKET FOR ERYTHROPOETIN BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 28: GLOBAL MARKET FOR ERYTHROPOETIN BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
  • DARBEPOETIN ALFA BIOSIMILARS
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 43: GLOBAL MARKET FOR DARBEPOETIN ALFA BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 29: GLOBAL MARKET FOR DARBEPOETIN ALFA BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
  • FILGRASTIM BIOSIMILARS
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 44: GLOBAL MARKET FOR FILGRASTIM BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 30: GLOBAL MARKET FOR FILGRASTIM BIOSIMILARS, BY REGION, 2015-2022 ($ MILLIONS)
  • PEGFILGRASTIM BIOSIMILARS
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 45: GLOBAL MARKET FOR PEGFILGRASTIM BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 31: GLOBAL MARKET FOR PEGFILGRASTIM BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
  • MONOCLONAL ANTIBODY BIOSIMILARS
    • MARKET REVENUE
      • TABLE 46: GLOBAL MARKET FOR MONOCLONAL ANTIBODY BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 32: GLOBAL MARKET FOR MONOCLONAL ANTIBODY BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
    • MARKET SHARES
      • TABLE 47: GLOBAL MARKET SHARE FOR MONOCLONAL ANTIBODY BIOSIMILARS, BY REGION, 2016 (%)
      • FIGURE 33: GLOBAL MARKET SHARE FOR MONOCLONAL ANTIBODY BIOSIMILARS, BY REGION, 2016 (%)
  • ADALIMUMAB BIOSIMILARS
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 48: GLOBAL MARKET FOR ADALIMUMAB BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 34: GLOBAL MARKET FOR ADALIMUMAB BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
  • BEVACIZUMAB BIOSIMILARS
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 49: GLOBAL MARKET FOR BEVACIZUMAB BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 35: GLOBAL MARKET FOR BEVACIZUMAB BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
  • INFLIXIMAB BIOSIMILARS
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 50: GLOBAL MARKET FOR INFLIXIMAB BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 36: GLOBAL MARKET FOR INFLIXIMAB BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
  • RANIBIZUMAB BIOSIMILARS
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 51: GLOBAL MARKET FOR RANIBIZUMAB BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 37: GLOBAL MARKET FOR RANIBIZUMAB BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
  • RITUXIMAB BIOSIMILARS
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 52: GLOBAL MARKET FOR RITUXIMAB BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 38: GLOBAL MARKET FOR RITUXIMAB BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
  • TRASTUZUMAB BIOSIMILARS
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 53: GLOBAL MARKET FOR TRASTUZUMAB BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 39: GLOBAL MARKET FOR TRASTUZUMAB BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
  • FUSION PROTEIN BIOSIMILARS
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 54: GLOBAL MARKET FOR FUSION PROTEIN BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 40: GLOBAL MARKET FOR FUSION PROTEIN BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
    • MARKET SHARES
      • TABLE 55: GLOBAL MARKET SHARE FOR FUSION PROTEIN BIOSIMILARS, BY REGION, 2016 (%)
      • FIGURE 41: GLOBAL MARKET SHARE FOR FUSION PROTEIN BIOSIMILARS, BY REGION, 2016 (%)
  • OTHER BIOSIMILARS
    • MARKET REVENUE
      • TABLE 56: GLOBAL MARKET FOR OTHER BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 42: GLOBAL MARKET FOR OTHER BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
    • MARKET SHARES
      • TABLE 57: GLOBAL MARKET SHARE FOR OTHER BIOSIMILARS, BY REGION, 2016 (%)
      • FIGURE 43: GLOBAL MARKET SHARE FOR OTHER BIOSIMILARS, BY REGION, 2016 (%)
  • INTERFERON BIOSIMILARS
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 58: GLOBAL MARKET FOR INTERFERON BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 44: GLOBAL MARKET FOR INTERFERON BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
  • ENOXAPARIN SODIUM BIOSIMILARS
    • MARKET OVERVIEW
    • MARKET REVENUE
      • TABLE 59: GLOBAL MARKET FOR ENOXAPARIN SODIUM BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
      • FIGURE 45: GLOBAL MARKET FOR ENOXAPARIN SODIUM BIOSIMILARS, BY REGION, 2015-2022 ($ MILLIONS)

CHAPTER 7 - INDUSTRY STRUCTURE

  • TYPES OF MARKET PLAYERS
    • ESTABLISHED BIOLOGICS COMPANIES
    • ESTABLISHED GENERICS COMPANIES
    • BIO-INTELLECTUAL COMPANIES
    • OPPORTUNISTIC COMPANIES
  • EMERGING TRENDS IN BIOSIMILAR INDUSTRY STRUCTURE
    • COLLABORATIONS AND PARTNERSHIPS
    • MERGERS AND ACQUISITIONS
      • TABLE 60: MERGERS AND ACQUISITIONS IN THE BIOSIMILARS MARKET, 2015-2017
    • CONTRACT MANUFACTURING ORGANIZATIONS (CMOS)
  • LEADING MANUFACTURERS/SUPPLIERS OF BIOSIMILAR DRUGS
    • RECOMBINANT HORMONES
      • TABLE 61: LEADING MANUFACTURERS/SUPPLIERS OF RECOMBINANT HORMONE BIOSIMILARS, 2016
    • MARKET SHARE
      • TABLE 62: GLOBAL MARKET SHARES OF LEADING MANUFACTURERS/SUPPLIERS OF RECOMBINANT HORMONE BIOSIMILARS, 2016 (%)
      • FIGURE 46: GLOBAL MARKET SHARES OF LEADING MANUFACTURERS/SUPPLIERS OF RECOMBINANT HORMONE BIOSIMILARS, 2016 (%)
    • RECOMBINANT GROWTH FACTORS
      • TABLE 63: LEADING MANUFACTURERS/SUPPLIERS OF RECOMBINANT GROWTH FACTOR BIOSIMILARS, 2016
    • MARKET SHARE
      • TABLE 64: GLOBAL MARKET SHARES OF LEADING MANUFACTURERS/SUPPLIERS OF RECOMBINANT GROWTH FACTOR BIOSIMILARS, 2016 (%)
      • FIGURE 47: GLOBAL MARKET SHARES OF LEADING MANUFACTURERS/SUPPLIERS OF RECOMBINANT GROWTH FACTOR BIOSIMILARS, 2016 (%)
    • MONOCLONAL ANTIBODIES
      • TABLE 65: LEADING MANUFACTURERS/SUPPLIERS OF MONOCLONAL ANTIBODY BIOSIMILARS, 2016
    • MARKET SHARE
      • TABLE 66: GLOBAL MARKET SHARES OF LEADING MANUFACTURERS/SUPPLIERS OF MONOCLONAL ANTIBODY BIOSIMILARS, 2016 (%)
      • FIGURE 48: GLOBAL MARKET SHARES OF LEADING MANUFACTURERS/SUPPLIERS OF MONOCLONAL ANTIBODY BIOSIMILARS, 2016 (%)
    • FUSION PROTEINS
      • TABLE 67: LEADING MANUFACTURERS/SUPPLIERS OF FUSION PROTEIN BIOSIMILARS, 2016
    • MARKET SHARE
      • TABLE 68: GLOBAL MARKET SHARES OF LEADING MANUFACTURERS/SUPPLIERS OF FUSION PROTEIN BIOSIMILARS, 2016 (%)
      • FIGURE 49: GLOBAL MARKET SHARES OF LEADING MANUFACTURERS/SUPPLIERS OF FUSION PROTEIN BIOSIMILARS, 2016 (%)
    • OTHERS
      • TABLE 69: LEADING MANUFACTURERS/SUPPLIERS OF OTHER BIOSIMILARS, 2016
    • MARKET SHARE
      • TABLE 70: GLOBAL MARKET SHARES OF LEADING MANUFACTURERS/SUPPLIERS OF OTHER BIOSIMILARS, 2016 (%)
      • FIGURE 50: GLOBAL MARKET SHARES OF LEADING MANUFACTURERS/SUPPLIERS OF OTHER BIOSIMILARS, 2016 (%)

CHAPTER 8 - PATENT REVIEW

  • PATENT REGULATIONS IN FAVOR OF BRANDED BIOLOGICS
    • MARKET EXCLUSIVITY
    • PATENT DANCE
    • LICENSING NOTICE
  • PATENT REGULATIONS IN FAVOR OF BIOSIMILARS-EMERGING TRENDS
    • MARKET EXCLUSIVITY OPTION
      • TABLE 71: INTER PARTES REVIEW (IPR) CHALLENGES BY BIOSIMILAR DEVELOPERS
    • PATENT DANCE DEVELOPMENTS
    • LICENSING NOTICE
    • PRODUCT VS PROCESS PATENTS
  • PATENT ACTIVITY IN BIOSIMILARS, 2015-2017
    • UNITED STATES PATENTS
      • Patents by Year
        • TABLE 72: Patents for Biosimilars, by Year, 2015-November 2017 (Number/%)
        • FIGURE 51: Global Share of Patent Issued for Biosimilars, by Year, 2015-November 2017 (%)
      • Patents by Type
        • TABLE 73: Patents for Biosimilars, by Type, 2015-November 2017 (Number/%)
        • FIGURE 52: Global Share of Patents Issued for Biosimilars, by Type, 2015-November 2017 (%)
      • Patents by Company
        • TABLE 74: Patents for Biosimilars, by Company, 2015-November 2017 (Number/%)
      • Patents by Country
        • TABLE 75: Patents for Biosimilars, by Country, 2015-November 2017 (Number/%)
        • FIGURE 53: Global Share of Patent Issued for Biosimilars, by Country, 2015-November 2017 (%)
      • Patents by Assignee
        • TABLE 76: Patents for Biosimilars, by Assignee, 2015-November 2017 (Number/%)
        • FIGURE 54: Global Share of Patent Issued for Biosimilars, by Assignee, 2015-November 2017 (%)
    • EUROPEAN PATENTS
      • TABLE 77: SIGNIFICANT EUROPEAN PATENT APPLICATIONS FOR BIOSIMILARS, 2015-NOVEMBER 2017

CHAPTER 9 - NEW DEVELOPMENTS

  • MAJOR COMPANIES IN THE BIOSIMILARS MARKET
    • TABLE 78: MAJOR COMPANIES WITH BIOSIMILARS IN PIPELINE
    • TABLE 79: PFIZER'S BIOSIMILARS IN PIPELINE, AS OF AUGUST 2017
  • BIOSIMILARS IN CLINICAL TRIALS
    • TABLE 80: MAJOR BIOSIMILAR CANDIDATES WITH PATENT EXPIRATIONS
  • OVERVIEW
    • TABLE 81: BIOSIMILARS IN VARIOUS PHASES OF CLINICAL TRIALS, BY TYPE
  • BIOSIMILAR RECOMBINANT HORMONES IN CLINICAL TRIALS
    • TABLE 82: BIOSIMILAR RECOMBINANT HORMONES IN CLINICAL TRIALS
  • BIOSIMILAR RECOMBINANT GROWTH FACTORS IN CLINICAL TRIALS
    • TABLE 83: BIOSIMILAR RECOMBINANT GROWTH FACTORS IN CLINICAL TRIALS
  • BIOSIMILAR MONOCLONAL ANTIBODIES IN CLINICAL TRIALS
    • TABLE 84: BIOSIMILAR MONOCLONAL ANTIBODIES IN CLINICAL TRIALS
  • BIOSIMILAR FUSION PROTEINS IN CLINICAL TRIALS
    • TABLE 85: BIOSIMILAR FUSION PROTEINS IN CLINICAL TRIALS
  • OTHER BIOSIMILARS IN CLINICAL TRIALS
    • TABLE 86: OTHER BIOSIMILARS IN CLINICAL TRIALS
  • BIO-BETTERS IN CLINICAL TRIALS
    • TABLE 87: REPRESENTATIVE BIO-BETTERS IN CLINICAL TRIALS

CHAPTER 10 - REGULATORY ASPECTS

  • BIOSIMILAR REGULATIONS IN EUROPE
    • TABLE 88: PRODUCT-SPECIFIC BIOSIMILAR GUIDELINES, EMA
    • TABLE 89: RELATED BIOSIMILAR GUIDELINES, EMA
    • TABLE 90: REFUSED/WITHDRAWN BIOSIMILARS, EMA
  • BIOSIMILAR REGULATIONS IN U.S.
    • PRINCIPLE OF EXCLUSIVITY
    • REQUIREMENT OF 351(K) APPLICATION
    • APPROACHES TO DEMONSTRATE BIOSIMILARITY
  • BIOSIMILAR REGULATIONS IN EMERGING MARKETS
    • BIOSIMILAR GUIDELINES IN INDIA
  • BIOSIMILAR REGULATIONS IN SOUTH KOREA
  • BIOSIMILAR REGULATIONS IN JAPAN
  • SIGNIFICANT REGULATORY ACTIVITIES
    • TABLE 91: LIST OF APPROVED BIOSIMILAR DRUGS, BY COUNTRY, 2015-DECEMBER 2017
  • REGULATORY GUIDELINES FOR BIO-BETTERS
    • TABLE 92: LIST OF APPROVED BIOBETTERS
  • NAMING OF BIOSIMILARS
    • NAMING CONVENTION BY FDA
      • TABLE 93: FDA RECOMMENDATIONS FOR A PROPOSED SUFFIX IN A BIOSIMILAR
  • PRODUCT NAME
    • NAMING CONVENTION BY WHO
    • NAMING CONVENTION BY EMA

CHAPTER 11 - TECHNOLOGIES USED IN BIOSIMILAR MANUFACTURING AND

  • ANALYTICAL TESTING, EMERGING TRENDS
    • EMERGING TRENDS IN BIOSIMILAR MANUFACTURING
      • IMPROVEMENTS IN CELL LINES
      • CLONE SCREENING
      • CONTINUOUS MANUFACTURING
      • PROCESS ANALYTICAL TECHNOLOGIES AND QUALITY BY DESIGN (QBD)
      • OUTSOURCING-CONTRACT MANUFACTURING ORGANIZATIONS (CMOS)
      • EMERGING TRENDS IN ANALYTICAL METHODS
        • TABLE 94: COMMONLY USED ANALYTICAL METHODS TO ESTABLISH BIOSIMILARITY
    • POPULAR ANALYTICAL TECHNOLOGIES FOR BIOSIMILAR
    • CHARACTERIZATION
      • Mass spectrometry (MS)
      • Chromatography (UHPLC)
      • Capillary electrophoresis (CE)
      • Nuclear Magnetic Resonance (NMR)
      • Reporter-gene assays
        • TABLE 95: New Technological Developments for Biosimilar Characterization, 2015-2017

CHAPTER 12 - ANALYSIS OF MARKET OPPORTUNITIES

  • FIGURE 55: SWOT ANALYSIS OF BIOSIMILARS MARKET
  • STRENGTHS OF BIOSIMILARS MARKET
    • GROWING AGING POPULATION
    • RISING INCIDENCE OF DISEASES
    • PATENT EXPIRATIONS
    • GROWING PIPELINE
    • DRIVE TO REDUCE COSTS
    • GOVERNMENT INCENTIVES
      • Incentives in Europe
      • Incentives in Indian Market
    • COLLABORATIONS AND PARTNERSHIPS
    • MERGERS AND ACQUISITIONS
  • WEAKNESSES OF BIOSIMILARS MARKET
    • MANUFACTURING PROCESS OF BIOSIMILARS
    • PROCESS DEFINITION AND TESTING AND VALIDATION
    • LACK OF SKILLED PERSONNEL
    • REGULATORY GUIDELINES
      • Interchangeability
      • Nomenclature of Biosimilars
    • PATENT LITIGATION
  • THREATS OF BIOSIMILARS MARKET
    • UNPREDICTABLE REGULATORY LANDSCAPE
    • PRESCRIPTION BY MEDICAL PRACTITIONERS/PHARMACIES
    • COMPETITION
  • OPPORTUNITIES OF BIOSIMILARS MARKET
    • EMERGING MARKETS
    • TECHNOLOGICAL INNOVATION AND IMPROVED PROCESS KNOWLEDGE
    • PRICING

CHAPTER 13 - COMPANY PROFILES

  • 3S BIO INC.
  • ALLERGAN PLC.
  • AMGEN INC.
  • ANHUI ANKE BIOTECHNOLOGY (GROUP) CO. LTD.
  • APOTEX INC.
  • AVESTHAGEN LTD.
  • BHARAT SERUMS AND VACCINES LTD.
  • BIOCAD
  • BIOCON LTD.
  • BIOSIDUS S.A.
  • BIOTON S. A.
  • BIOXPRESS THERAPEUTICS S.A.
  • BLAU FARMACEUTICA S/A
  • BOEHRINGER INGELHEIM
  • CELLTRION INC.
  • CHINA NATIONAL BIOTEC GROUP (CNBG)
  • CIPLA BIOTEC PVT. LTD.
  • CINNAGEN
  • COHERUS BIOSCIENCES
  • DM BIO LTD.
  • DONG-A SOCIO HOLDINGS
  • DR. REDDY'S LABORATORIES LTD.
  • EMCURE PHARMACEUTICALS LTD.
  • EPIRUS BIOPHARMACEUTICALS INC.
  • FUJIFILM DIOSYNTH BIOTECHNOLOGIES
  • GEDEON RICHTER PLC
  • GENESCIENCE PHARMACEUTICALS CO. LTD.
  • GENEXINE INC.
  • GREEN CROSS CORP.
  • HANALL BIOPHARMA
  • HANGZHOU JIUYUAN GENE ENGINEERING CO. LTD.
  • HANWHA CHEMICAL CORP.
  • HARVEST MOON PHARMACEUTICALS USA INC.
  • INTAS PHARMACEUTICALS LTD.
  • JHL BIOTECH INC.
  • JCR PHARMACEUTICALS CO. LTD.
  • KISSEI PHARMACEUTICAL CO. LTD.
  • LG LIFE SCIENCES
  • LUPIN LTD.
  • MABXIENCE S.A.
  • MEDICE ARZNEIMITTEL PUTTER GMBH AND CO. KG
  • MERCK KGAA
  • MOCHIDA PHARMACEUTICAL CO. LTD.
  • MOMENTA PHARMACEUTICALS
  • MYCENAX BIOTECH INC.
  • MYLAN N.V.
  • NANOGEN BIOPHARMACEUTICAL CO.
  • NEUCLONE
  • NIPPON KAYAKU CO. LTD.
  • PFENEX INC.
  • PFIZER INC.
  • PHARMAPARK LLC
  • PLANTFORM CORP.
  • PRESTIGE BIOPHARMA PTE LTD.
  • PROBIOMED, S.A. DE C.V.
  • RELIANCE LIFE SCIENCES
  • SAMSUNG BIOEPIS CO. LTD.
  • SANDOZ INTERNATIONAL GMBH
  • SCINOPHARM TAIWAN LTD.
  • STADA ARZNEIMITTEL AG
  • TANVEX BIOPHARMA INC.
  • TEVA PHARMACEUTICALS INDUSTRIES LTD
  • USV PVT. LTD.
  • WOCKHARDT LTD.
  • XIAMEN AMOYTOP BIOTECH CO. LTD.
  • ZHONGSHAN HYGENE BIOPHARM CO. LTD.
  • ZYDUS CADILA

CHAPTER 14 - APPENDIX: ABBREVIATIONS

  • TABLE 96: ABBREVIATIONS USED IN BIOSIMILARS: GLOBAL MARKETS

LIST OF TABLES

  • SUMMARY TABLE: GLOBAL MARKET FOR BIOSIMILARS, BY TYPE, THROUGH 2022 ($ MILLIONS)
    • TABLE 1: LIST OF BIOSIMILARS PRODUCED IN E. COLI
    • TABLE 2: LIST OF BIOSIMILARS PRODUCED IN MAMMALIAN CELLS
    • TABLE 3: KEY DIFFERENCES IN APPROVAL PATHWAYS FOR BIOSIMILARS, EUROPEAN UNION (EU) VS. UNITED SATES (U.S.)
    • TABLE 4: BIOSIMILAR RECOMBINANT HORMONES
    • TABLE 5: BIOSIMILAR RECOMBINANT GROWTH FACTORS
    • TABLE 6: BIOSIMILAR MONOCLONAL ANTIBODIES
    • TABLE 7: BIOSIMILAR FUSION PROTEINS
    • TABLE 8: BIOSIMILAR LMWHS
    • TABLE 9: BIOSIMILAR INTERFERONS
    • TABLE 10: SMALL MOLECULAR DRUGS VS. BIOLOGICS
    • TABLE 11: GENERICS VS. BIOSIMILARS
    • TABLE 12: BIOSIMILARS VS. BIOBETTERS
    • TABLE 13: LIST OF APPROVED FUSION PROTEIN BIOBETTERS
    • TABLE 14: NUMBER OF APPROVED BIOSIMILARS, BY TYPE
    • TABLE 15: GLOBAL MARKET FOR BIOSIMILARS, BY TECHNOLOGY TYPE, THROUGH 2022 ($ MILLIONS)
    • TABLE 16: GLOBAL MARKET SHARE FOR BIOSIMILARS, BY TECHNOLOGY TYPE, 2016 (%)
    • TABLE 17: GLOBAL MARKET FOR RECOMBINANT HORMONE BIOSIMILARS, BY TECHNOLOGY TYPE, THROUGH 2022 ($ MILLIONS)
    • TABLE 18: GLOBAL MARKET FOR RECOMBINANT GROWTH FACTOR BIOSIMILARS, BY TECHNOLOGY TYPE, THROUGH 2022 ($ MILLIONS)
    • TABLE 19: BRANDED MONOCLONAL ANTIBODY DRUGS USED AS REFERENCE DRUGS FOR BIOSIMILARS, 2016
    • TABLE 20: GLOBAL MARKET FOR MONOCLONAL ANTIBODY BIOSIMILARS, BY TECHNOLOGY TYPE, THROUGH 2022 ($ MILLIONS)
    • TABLE 21: GLOBAL MARKET FOR FUSION PROTEIN BIOSIMILARS, BY TECHNOLOGY TYPE, THROUGH 2022 ($ MILLIONS)
    • TABLE 2 : IST OF BIOSIMILARS PRODUCED IN MAMMALIAN CELLS
    • TABLE 23: GLOBAL MARKET FOR BIOSIMILARS, BY APPLICATION, THROUGH 2022 ($ MILLIONS)
    • TABLE 24: GLOBAL MARKET SHARE FOR BIOSIMILARS, BY APPLICATION, 2016 (%)
    • TABLE 25: GLOBAL MARKET FOR BIOSIMILARS IN CANCER, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 26: GLOBAL MARKET FOR BIOSIMILARS IN BLOOD DISORDERS, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 27: GLOBAL MARKET FOR BIOSIMILARS IN DIABETES, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 28: GLOBAL MARKET FOR BIOSIMILARS IN GROWTH HORMONE DEFICIENCY, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 29: GLOBAL MARKET FOR BIOSIMILARS IN INFECTIOUS DISEASES, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 30: GLOBAL MARKET FOR BIOSIMILARS IN AUTOIMMUNE DISEASES, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 31: GLOBAL MARKET FOR BIOSIMILARS IN OTHER DISEASES, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 32: GLOBAL MARKET FOR BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 33: GLOBAL MARKET SHARE FOR BIOSIMILARS, BY REGION, 2016 (%)
    • TABLE 34: GLOBAL MARKET FOR RECOMBINANT HORMONE BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 35: GLOBAL MARKET SHARE FOR RECOMBINANT HORMONE BIOSIMILARS, BY REGION, 2016 (%)
    • TABLE 36: GLOBAL MARKET FOR SOMATOTROPIN BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 37: GLOBAL MARKET FOR FOLLITROPIN ALFA BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 38: GLOBAL MARKET FOR INSULIN GLARGINE BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 39: GLOBAL MARKET FOR TERIPARATIDE BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 40: GLOBAL MARKET FOR RECOMBINANT GROWTH FACTOR BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 41: GLOBAL MARKET SHARE FOR RECOMBINANT GROWTH FACTOR BIOSIMILARS, BY REGION, 2016 (%)
    • TABLE 42: GLOBAL MARKET FOR ERYTHROPOETIN BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 43: GLOBAL MARKET FOR DARBEPOETIN ALFA BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 44: GLOBAL MARKET FOR FILGRASTIM BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 45: GLOBAL MARKET FOR PEGFILGRASTIM BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 46: GLOBAL MARKET FOR MONOCLONAL ANTIBODY BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 47: GLOBAL MARKET SHARE FOR MONOCLONAL ANTIBODY BIOSIMILARS, BY REGION, 2016 (%)
    • TABLE 48: GLOBAL MARKET FOR ADALIMUMAB BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 49: GLOBAL MARKET FOR BEVACIZUMAB BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 50: GLOBAL MARKET FOR INFLIXIMAB BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 51: GLOBAL MARKET FOR RANIBIZUMAB BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 52: GLOBAL MARKET FOR RITUXIMAB BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 53: GLOBAL MARKET FOR TRASTUZUMAB BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 54: GLOBAL MARKET FOR FUSION PROTEIN BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 55: GLOBAL MARKET SHARE FOR FUSION PROTEIN BIOSIMILARS, BY REGION, 2016 (%)
    • TABLE 56: GLOBAL MARKET FOR OTHER BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 57: GLOBAL MARKET SHARE FOR OTHER BIOSIMILARS, BY REGION, 2016 (%)
    • TABLE 58: GLOBAL MARKET FOR INTERFERON BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 59: GLOBAL MARKET FOR ENOXAPARIN SODIUM BIOSIMILARS, BY REGION, THROUGH 2022 ($ MILLIONS)
    • TABLE 60: MERGERS AND ACQUISITIONS IN THE BIOSIMILARS MARKET, 2015-2017
    • TABLE 61: LEADING MANUFACTURERS/SUPPLIERS OF RECOMBINANT HORMONE BIOSIMILARS, 2016
    • TABLE 62: GLOBAL MARKET SHARES OF LEADING MANUFACTURERS/SUPPLIERS OF RECOMBINANT HORMONE BIOSIMILARS, 2016 (%)
    • TABLE 63: LEADING MANUFACTURERS/SUPPLIERS OF RECOMBINANT GROWTH FACTOR BIOSIMILARS, 2016
    • TABLE 64: GLOBAL MARKET SHARES OF LEADING MANUFACTURERS/SUPPLIERS OF RECOMBINANT GROWTH FACTOR BIOSIMILARS, 2016 (%)
    • TABLE 65: LEADING MANUFACTURERS/SUPPLIERS OF MONOCLONAL ANTIBODY BIOSIMILARS, 2016
    • TABLE 66: GLOBAL MARKET SHARES OF LEADING MANUFACTURERS/SUPPLIERS OF MONOCLONAL ANTIBODY BIOSIMILARS, 2016 (%)
    • TABLE 67: LEADING MANUFACTURERS/SUPPLIERS OF FUSION PROTEIN BIOSIMILARS, 2016
    • TABLE 68: GLOBAL MARKET SHARES OF LEADING MANUFACTURERS/SUPPLIERS OF FUSION PROTEIN BIOSIMILARS, 2016 (%)
    • TABLE 69: LEADING MANUFACTURERS/SUPPLIERS OF OTHER BIOSIMILARS, 2016
    • TABLE 70: GLOBAL MARKET SHARES OF LEADING MANUFACTURERS/SUPPLIERS OF OTHER BIOSIMILARS, 2016 (%)
    • TABLE 71: INTER PARTES REVIEW (IPR) CHALLENGES BY BIOSIMILAR DEVELOPERS
    • TABLE 72: PATENTS FOR BIOSIMILARS, BY YEAR, 2015-NOVEMBER 2017 (NUMBER/%)
    • TABLE 73: PATENTS FOR BIOSIMILARS, BY TYPE, 2015-NOVEMBER 2017 (NUMBER/%)
    • TABLE 74: PATENTS FOR BIOSIMILARS, BY COMPANY, 2015-NOVEMBER 2017 (NUMBER/%)
    • TABLE 75: PATENTS FOR BIOSIMILARS, BY COUNTRY, 2015-NOVEMBER 2017 (NUMBER/%)
    • TABLE 76: PATENTS FOR BIOSIMILARS, BY ASSIGNEE, 2015-NOVEMBER 2017 (NUMBER/%)
    • TABLE 77: SIGNIFICANT EUROPEAN PATENT APPLICATIONS FOR BIOSIMILARS, 2015-NOVEMBER 2017
    • TABLE 78: MAJOR COMPANIES WITH BIOSIMILARS IN PIPELINE
    • TABLE 79: PFIZER'S BIOSIMILARS IN PIPELINE, AS OF AUGUST 2017
    • TABLE 80: MAJOR BIOSIMILAR CANDIDATES WITH PATENT EXPIRATIONS
    • TABLE 81: BIOSIMILARS IN VARIOUS PHASES OF CLINICAL TRIALS, BY TYPE
    • TABLE 82: BIOSIMILAR RECOMBINANT HORMONES IN CLINICAL TRIALS
    • TABLE 83: BIOSIMILAR RECOMBINANT GROWTH FACTORS IN CLINICAL TRIALS
    • TABLE 84: BIOSIMILAR MONOCLONAL ANTIBODIES IN CLINICAL TRIALS
    • TABLE 85: BIOSIMILAR FUSION PROTEINS IN CLINICAL TRIALS
    • TABLE 86: OTHER BIOSIMILARS IN CLINICAL TRIALS
    • TABLE 87: REPRESENTATIVE BIO-BETTERS IN CLINICAL TRIALS
    • TABLE 88: PRODUCT-SPECIFIC BIOSIMILAR GUIDELINES, EMA
    • TABLE 89: RELATED BIOSIMILAR GUIDELINES, EMA
    • TABLE 90: REFUSED/WITHDRAWN BIOSIMILARS, EMA
    • TABLE 91: LIST OF APPROVED BIOSIMILAR DRUGS, BY COUNTRY, 2015-DECEMBER 2017
    • TABLE 92: LIST OF APPROVED BIOBETTERS
    • TABLE 93: FDA RECOMMENDATIONS FOR A PROPOSED SUFFIX IN A BIOSIMILAR PRODUCT NAME
    • TABLE 94: COMMONLY USED ANALYTICAL METHODS TO ESTABLISH BIOSIMILARITY
    • TABLE 95: NEW TECHNOLOGICAL DEVELOPMENTS FOR BIOSIMILAR CHARACTERIZATION, 2015-2017
    • TABLE 96: ABBREVIATIONS USED IN BIOSIMILARS: GLOBAL MARKETS

LIST OF FIGURES

  • SUMMARY FIGURE: GLOBAL MARKET FOR BIOSIMILARS, BY TYPE, 2015-2022 ($ MILLIONS)
    • FIGURE 1: DEPICTION OF A TYPICAL BIOSIMILAR DRUG DEVELOPMENT TIMELINE
    • FIGURE 2: GLOBAL MARKET FOR BIOSIMILARS, BY TECHNOLOGY TYPE, 2015-2022 ($ MILLIONS)
    • FIGURE 3: GLOBAL MARKET SHARE FOR BIOSIMILARS, BY TECHNOLOGY TYPE, 2016 (%)
    • FIGURE 4: GLOBAL MARKET FOR RECOMBINANT HORMONE BIOSIMILARS, BY TECHNOLOGY TYPE, 2015-2022 ($ MILLIONS)
    • FIGURE 5: GLOBAL MARKET FOR RECOMBINANT GROWTH FACTOR BIOSIMILARS, BY TECHNOLOGY TYPE, 2015-2022 ($ MILLIONS)
    • FIGURE 6: GLOBAL MARKET FOR MONOCLONAL ANTIBODY BIOSIMILARS, BY TECHNOLOGY TYPE, 2015-2022 ($ MILLIONS)
    • FIGURE 7: GLOBAL MARKET FOR FUSION PROTEIN BIOSIMILARS, BY TECHNOLOGY TYPE, 2015-2022 ($ MILLIONS)
    • FIGURE 8: GLOBAL MARKET FOR OTHER BIOSIMILARS, BY TECHNOLOGY TYPE,2015-2022 ($ MILLIONS)
    • FIGURE 9: GLOBAL MARKET FOR BIOSIMILARS, BY APPLICATION, 2015-2022 ($ MILLIONS)
    • FIGURE 10: GLOBAL MARKET SHARE FOR BIOSIMILARS, BY APPLICATION, 2016 (%)
    • FIGURE 11: GLOBAL MARKET FOR BIOSIMILARS IN CANCER, BY REGION,2015-2022 ($ MILLIONS)
    • FIGURE 12: GLOBAL MARKET FOR BIOSIMILARS IN BLOOD DISORDERS, BY REGION, 2015-2022 ($ MILLIONS)
    • FIGURE 13: GLOBAL MARKET FOR BIOSIMILARS IN DIABETES, BY REGION, 2015-2022 ($ MILLIONS)
    • FIGURE 14: GLOBAL MARKET FOR BIOSIMILARS IN GROWTH HORMONE DEFICIENCY, BY REGION, 2015-2022 ($ MILLIONS)
    • FIGURE 15: GLOBAL MARKET FOR BIOSIMILARS IN INFECTIOUS DISEASES, BY REGION, 2015-2022 ($ MILLIONS)
    • FIGURE 16: GLOBAL MARKET FOR BIOSIMILARS IN AUTOIMMUNE DISEASES, BY REGION, 2015-2022 ($ MILLIONS)
    • FIGURE 17: GLOBAL MARKET FOR BIOSIMILARS IN OTHER DISEASES, BY REGION, 2015-2022 ($ MILLIONS)
    • FIGURE 18: GLOBAL MARKET FOR BIOSIMILARS, BY REGION, 2015-2022 ($ MILLIONS)
    • FIGURE 19: GLOBAL MARKET SHARE FOR BIOSIMILARS, BY REGION, 2016 (%)
    • FIGURE 20: GLOBAL MARKET FOR RECOMBINANT HORMONE BIOSIMILARS, BY REGION, 2015-2022 ($ MILLIONS)
    • FIGURE 21: GLOBAL MARKET SHARE FOR RECOMBINANT HORMONE BIOSIMILARS, BY REGION, 2016 (%)
    • FIGURE 22: GLOBAL MARKET FOR SOMATOTROPIN BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
    • FIGURE 23: GLOBAL MARKET FOR FOLLITROPIN ALFA BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
    • FIGURE 24: GLOBAL MARKET FOR INSULIN GLARGINE BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
    • FIGURE 25: GLOBAL MARKET FOR TERIPARATIDE BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
    • FIGURE 26: GLOBAL MARKET FOR RECOMBINANT GROWTH FACTOR BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
    • FIGURE 27: GLOBAL MARKET SHARE FOR RECOMBINANT GROWTH FACTOR BIOSIMILARS, BY REGION, 2016 (%)
    • FIGURE 28: GLOBAL MARKET FOR ERYTHROPOETIN BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
    • FIGURE 29: GLOBAL MARKET FOR DARBEPOETIN ALFA BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
    • FIGURE 30: GLOBAL MARKET FOR FILGRASTIM BIOSIMILARS, BY REGION, 2015-2022 ($ MILLIONS)
    • FIGURE 31: GLOBAL MARKET FOR PEGFILGRASTIM BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
    • FIGURE 32: GLOBAL MARKET FOR MONOCLONAL ANTIBODY BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
    • FIGURE 33: GLOBAL MARKET SHARE FOR MONOCLONAL ANTIBODY BIOSIMILARS, BY REGION, 2016 (%)
    • FIGURE 34: GLOBAL MARKET FOR ADALIMUMAB BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
    • FIGURE 35: GLOBAL MARKET FOR BEVACIZUMAB BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
    • FIGURE 36: GLOBAL MARKET FOR INFLIXIMAB BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
    • FIGURE 37: GLOBAL MARKET FOR RANIBIZUMAB BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
    • FIGURE 38: GLOBAL MARKET FOR RITUXIMAB BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
    • FIGURE 39: GLOBAL MARKET FOR TRASTUZUMAB BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
    • FIGURE 40: GLOBAL MARKET FOR FUSION PROTEIN BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
    • FIGURE 41: GLOBAL MARKET SHARE FOR FUSION PROTEIN BIOSIMILARS, BY REGION, 2016 (%)
    • FIGURE 42: GLOBAL MARKET FOR OTHER BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
    • FIGURE 43: GLOBAL MARKET SHARE FOR OTHER BIOSIMILARS, BY REGION, 2016 (%)
    • FIGURE 44: GLOBAL MARKET FOR INTERFERON BIOSIMILARS, BY REGION,2015-2022 ($ MILLIONS)
    • FIGURE 45: GLOBAL MARKET FOR ENOXAPARIN SODIUM BIOSIMILARS, BY REGION, 2015-2022 ($ MILLIONS)
    • FIGURE 46: GLOBAL MARKET SHARES OF LEADING MANUFACTURERS/SUPPLIERS OF RECOMBINANT HORMONE BIOSIMILARS, 2016 (%)
    • FIGURE 47: GLOBAL MARKET SHARES OF LEADING MANUFACTURERS/SUPPLIERS OF RECOMBINANT GROWTH FACTOR BIOSIMILARS, 2016 (%)
    • FIGURE 48: GLOBAL MARKET SHARES OF LEADING MANUFACTURERS/SUPPLIERS OF MONOCLONAL ANTIBODY BIOSIMILARS, 2016 (%)
    • FIGURE 49: GLOBAL MARKET SHARES OF LEADING MANUFACTURERS/SUPPLIERS OF FUSION PROTEIN BIOSIMILARS, 2016 (%)
    • FIGURE 50: GLOBAL MARKET SHARES OF LEADING MANUFACTURERS/SUPPLIERS OF OTHER BIOSIMILARS, 2016 (%)
    • FIGURE 51: GLOBAL SHARE OF PATENT ISSUED FOR BIOSIMILARS, BY YEAR, 2015-NOVEMBER 2017 (%)
    • FIGURE 52: GLOBAL SHARE OF PATENTS ISSUED FOR BIOSIMILARS, BY TYPE, 2015-NOVEMBER 2017 (%)
    • FIGURE 53: GLOBAL SHARE OF PATENT ISSUED FOR BIOSIMILARS, BY COUNTRY, 2015-NOVEMBER 2017 (%)
    • FIGURE 54: GLOBAL SHARE OF PATENT ISSUED FOR BIOSIMILARS, BY ASSIGNEE, 2015-NOVEMBER 2017 (%)
    • FIGURE 55: SWOT ANALYSIS OF BIOSIMILARS MARKET
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