Biosimilars: Global Markets

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 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.

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

Chapter 3 Market and Technology Background

Lifecycle of a Biosimilar Drug
Development of a Biosimilar
Manufacturing of a Biosimilar
Preclinical Studies and Validation of a Biosimilar
Clinical Trials
Approval by Regulatory Agencies
Pharmacovigilance/Post-Approval Monitoring
Popular Biosimilar Candidates
Recombinant Hormones
Recombinant Growth Factors
Monoclonal Antibodies (mAbs)
Fusion Proteins
Others
Definitions
EMA Terminology Related to Biosimilars
FDA Terminology Related to Biosimilars
WHO Terminology Related to Biosimilars
Differences Between Common Drug Classifications
Small Molecule Drugs vs. Biologics
Generics vs. Biosimilars
Biosimilars vs. Biobetters
Strategies to Develop Biobetters
PEGylation
Glycosylation
Fusion Proteins

Chapter 4 Market Breakdown by Technology Type

Market by Biosimilar Types
Market Revenue
Market Shares
Recombinant Hormone Biosimilars
Market Overview
Market Revenue
Recombinant Growth Factor Biosimilars
Market Overview
Market Revenue
Monoclonal Antibodies Biosimilars
Market Overview
Market Revenue
Fusion Protein Biosimilars
Market Overview
Market Revenue
Others
Market Overview
Market Revenue

Chapter 5 Market Breakdown by Application

Market by Biosimilar Applications
Market Revenue
Market Shares
Cancer Biosimilars
Market Overview
Market Revenue
Blood Disorders
Market Overview
Market Revenue
Diabetes
Market Overview
Market Revenue
Growth Hormone Deficiency
Market Overview
Market Revenue
Infectious Diseases
Market Overview
Market Revenue
Autoimmune Diseases
Market Overview
Market Revenue
Other Diseases
Market Overview
Market Revenue

Chapter 6 Market Breakdown by Region

Patent Challenges
Interchangeability
Pricing
Market by Geographical Region
Market Revenue
Market Shares
Recombinant Hormone Biosimilars
Market Revenue
Market Shares
Somatotropin Biosimilars
Market Overview
Market Revenue
Follitropin alfa Biosimilars
Market Overview
Market Revenue
Insulin Glargine Biosimilars
Market Overview
Market Revenue
Teriparatide Biosimilars
Market Overview
Market Revenue
Recombinant Growth Factors Biosimilars
Market Revenue
Market Shares
Erythropoietin Biosimilars
Market Overview
Market Revenue
Darbepoetin alfa Biosimilars
Market Overview
Market Revenue
Filgrastim Biosimilars
Market Overview
Market Revenue
Pegfilgrastim Biosimilars
Market Overview
Market Revenue
Monoclonal Antibody Biosimilars
Market Revenue
Market Shares
Adalimumab Biosimilars
Market Overview
Market Revenue
Bevacizumab Biosimilars
Market Overview
Market Revenue
Infliximab Biosimilars
Market Overview
Market Revenue
Ranibizumab Biosimilars
Market Overview
Market Revenue
Rituximab Biosimilars
Market Overview
Market Revenue
Trastuzumab Biosimilars
Market Overview
Market Revenue
Fusion Protein Biosimilars
Market Overview
Market Revenue
Market Shares
Other Biosimilars
Market Revenue
Market Shares
Interferon Biosimilars
Market Overview
Market Revenue
Enoxaparin Sodium Biosimilars
Market Overview
Market Revenue

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
Contract Manufacturing Organizations (CMOs)
Leading Manufacturers/Suppliers of Biosimilar Drugs
Recombinant Hormones
Market Share
Recombinant Growth Factors
Market Share
Monoclonal Antibodies
Market Share
Fusion Proteins
Market Share
Others
Market Share

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
Patent Dance Developments
Licensing Notice
Product vs Process Patents
Patent Activity in Biosimilars, 2015-2017
United States Patents
European Patents

Chapter 9 New Developments

Major Companies in the Biosimilars Market
Biosimilars in Clinical Trials
Overview
Biosimilar Recombinant Hormones in Clinical Trials
Biosimilar Recombinant Growth Factors in Clinical Trials
Biosimilar Monoclonal Antibodies in Clinical Trials
Biosimilar Fusion Proteins in Clinical Trials
Other Biosimilars in Clinical Trials
Bio-betters in Clinical Trials

Chapter 10 Regulatory Aspects

Biosimilar Regulations in Europe
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 China
Biosimilar Regulations in South Korea
Biosimilar Regulations in Japan
Significant Regulatory Activities
Regulatory Guidelines for Bio-betters
Naming of Biosimilars
Naming Convention by FDA
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
Single-Use Technologies (SUTs)
Continuous Manufacturing
Process Analytical Technologies and Quality by Design (QbD)
Outsourcing-Contract Manufacturing Organizations (CMOs)
Emerging Trends in Analytical Methods
Popular Analytical Technologies for Biosimilar Characterization

Chapter 12 Analysis of Market Opportunities

Strengths of Biosimilars Market
Growing Aging Population
Rising Incidence of Diseases
Patent Expirations
Growing Pipeline
Drive to Reduce Costs
Government Incentives
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
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"

List of Tables

Summary Table : Global Market for Biosimilars, by Type, Through 2022
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
Table 16 : Global Market Share for Biosimilars, by Technology Type, 2016
Table 17 : Global Market for Recombinant Hormone Biosimilars, by Technology Type, Through 2022
Table 18 : Global Market for Recombinant Growth Factor Biosimilars, by Technology Type, Through 2022
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
Table 21 : Global Market for Fusion Protein Biosimilars, by Technology Type, Through 2022
Table 22 : Global Market for Other Biosimilars, by Technology Type, Through 2022
Table 23 : Global Market for Biosimilars, by Application, Through 2022
Table 24 : Global Market Share for Biosimilars, by Application, 2016
Table 25 : Global Market for Biosimilars in Cancer, by Region, Through 2022
Table 26 : Global Market for Biosimilars In Blood Disorders, by Region, Through 2022
Table 27 : Global Market for Biosimilars In Diabetes, by Region, Through 2022
Table 28 : Global Market for Biosimilars in Growth Hormone Deficiency, by Region, Through 2022
Table 29 : Global Market for Biosimilars in Infectious Diseases, by Region, Through 2022
Table 30 : Global Market for Biosimilars in Autoimmune Diseases, by Region, Through 2022
Table 31 : Global Market for Biosimilars in Other Diseases, by Region, Through 2022
Table 32 : Global Market for Biosimilars, by Region, Through 2022
Table 33 : Global Market Share for Biosimilars, by Region, 2016
Table 34 : Global Market for Recombinant Hormone Biosimilars, by Region, Through 2022
Table 35 : Global Market Share for Recombinant Hormone Biosimilars, by Region, 2016
Table 36 : Global Market for Somatotropin Biosimilars, by Region, Through 2022
Table 37 : Global Market for Follitropin alfa Biosimilars, by Region, Through 2022
Table 38 : Global Market for Insulin glargine Biosimilars, by Region, Through 2022
Table 39 : Global Market for Teriparatide Biosimilars, by Region, Through 2022
Table 40 : Global Market for Recombinant Growth Factor Biosimilars, by Region, Through 2022
Table 41 : Global Market Share for Recombinant Growth Factor Biosimilars, by Region, 2016
Table 42 : Global Market for Erythropoetin Biosimilars, by Region, Through 2022
Table 43 : Global Market for Darbepoetin alfa Biosimilars, by Region, Through 2022
Table 44 : Global Market for Filgrastim Biosimilars, by Region, Through 2022
Table 45 : Global Market for Pegfilgrastim Biosimilars, by Region, Through 2022
Table 46 : Global market for Monoclonal Antibody Biosimilars, by Region, Through 2022
Table 47 : Global Market Share for Monoclonal Antibody Biosimilars, by Region, 2016
Table 48 : Global Market for Adalimumab Biosimilars, by Region, Through 2022
Table 49 : Global Market for Bevacizumab Biosimilars, by Region, Through 2022
Table 50 : Global Market for Infliximab Biosimilars, by Region, Through 2022
Table 51 : Global Market for Ranibizumab Biosimilars, by Region, Through 2022
Table 52 : Global Market for Rituximab Biosimilars, by Region, Through 2022
Table 53 : Global Market for Trastuzumab Biosimilars, by Region, Through 2022
Table 54 : Global Market for Fusion Protein Biosimilars, by Region, Through 2022
Table 55 : Global Market Share for Fusion Protein Biosimilars, by Region, 2016
Table 56 : Global Market for Other Biosimilars, by Region, Through 2022
Table 57 : Global Market Share for Other Biosimilars, by Region, 2016
Table 58 : Global Market for Interferon Biosimilars, by Region, Through 2022
Table 59 : Global Market for Enoxaparin sodium Biosimilars, by Region, Through 2022
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
Table 73 : Patents for Biosimilars, by Type, 2015-November 2017
Table 74 : Patents for Biosimilars, by Company, 2015-November 2017
Table 75 : Patents for Biosimilars, by Country, 2015-November 2017
Table 76 : Patents for Biosimilars, by Assignee, 2015-November 2017
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
Figure 1 : Depiction of a Typical Biosimilar Drug Development Timeline
Figure 2 : Global Market for Biosimilars, by Technology Type, 2015-2022
Figure 3 : Global Market Share for Biosimilars, by Technology Type, 2016
Figure 4 : Global Market for Recombinant Hormone Biosimilars, by Technology Type, 2015-2022
Figure 5 : Global Market for Recombinant Growth Factor Biosimilars, by Technology Type, 2015-2022
Figure 6 : Global Market for Monoclonal Antibody Biosimilars, by Technology Type, 2015-2022
Figure 7 : Global Market for Fusion Protein Biosimilars, by Technology Type, 2015-2022
Figure 8 : Global Market for Other Biosimilars, by Technology Type,2015-2022
Figure 9 : Global Market for Biosimilars, by Application, 2015-2022
Figure 10 : Global Market Share for Biosimilars, by Application, 2016
Figure 11 : Global Market for Biosimilars in Cancer, by Region,2015-2022
Figure 12 : Global Market for Biosimilars in Blood Disorders, by Region, 2015-2022
Figure 13 : Global Market for Biosimilars In Diabetes, by Region, 2015-2022
Figure 14 : Global Market for Biosimilars in Growth Hormone Deficiency, by Region, 2015-2022
Figure 15 : Global Market for Biosimilars in Infectious Diseases, by Region, 2015-2022
Figure 16 : Global Market for Biosimilars in Autoimmune Diseases, by Region, 2015-2022
Figure 17 : Global market for Biosimilars in Other Diseases, by Region, 2015-2022
Figure 18 : Global Market for Biosimilars, by Region, 2015-2022
Figure 19 : Global Market Share for Biosimilars, by Region, 2016
Figure 20 : Global Market for Recombinant Hormone Biosimilars, by Region, 2015-2022
Figure 21 : Global Market Share for Recombinant Hormone Biosimilars, by Region, 2016
Figure 22 : Global Market for Somatotropin Biosimilars, by Region,2015-2022
Figure 23 : Global Market for Follitropin alfa Biosimilars, by Region,2015-2022
Figure 24 : Global market for Insulin glargine Biosimilars, by Region,2015-2022
Figure 25 : Global Market for Teriparatide Biosimilars, by Region,2015-2022
Figure 26 : Global Market for Recombinant Growth Factor Biosimilars, by Region,2015-2022
Figure 27 : Global Market Share for Recombinant Growth Factor Biosimilars, by Region, 2016
Figure 28 : Global Market for Erythropoetin Biosimilars, by Region,2015-2022
Figure 29 : Global Market for Darbepoetin alfa Biosimilars, by Region,2015-2022
Figure 30 : Global Market for Filgrastim Biosimilars, by Region, 2015-2022
Figure 31 : Global Market for Pegfilgrastim Biosimilars, by Region,2015-2022
Figure 32 : Global market for Monoclonal Antibody Biosimilars, by Region,2015-2022
Figure 33 : Global Market Share for Monoclonal Antibody Biosimilars, by Region, 2016
Figure 34 : Global Market for Adalimumab Biosimilars, by Region,2015-2022
Figure 35 : Global Market for Bevacizumab Biosimilars, by Region,2015-2022
Figure 36 : Global Market for Infliximab Biosimilars, by Region,2015-2022
Figure 37 : Global Market for Ranibizumab Biosimilars, by Region,2015-2022
Figure 38 : Global Market for Rituximab Biosimilars, by Region,2015-2022
Figure 39 : Global Market for Trastuzumab Biosimilars, by Region,2015-2022
Figure 40 : Global Market for Fusion Protein Biosimilars, by Region,2015-2022
Figure 41 : Global Market Share for Fusion Protein Biosimilars, by Region, 2016
Figure 42 : Global Market for Other Biosimilars, by Region,2015-2022
Figure 43 : Global Market Share for Other Biosimilars, by Region, 2016
Figure 44 : Global Market for Interferon Biosimilars, by Region,2015-2022
Figure 45 : Global Market for Enoxaparin sodium Biosimilars, by Region, 2015-2022
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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