Worldwide Biosimilars Industry to 2025 - by Type of Biosimilar, Therapeutic Application and Region

News provided by

Jun 14, 2021, 12:00 ET

DUBLIN, June 14, 2021 /PRNewswire/ -- The "Global Biosimilars Market 2020-2025" report has been added to ResearchAndMarkets.com's offering.

The global biosimilars market should reach $60.1 billion by 2025 from $15.7 billion in 2020 at a compound annual growth rate (CAGR) of 30.9% for the forecast period of 2020 to 2025.

Biosimilar drugs have gained immense popularity because of their impact on the lives of many patients. These drugs belong to several drug classes including hormones, interferons, growth factors (colony stimulating factors, erythropoietin) and monoclonal antibodies, among others. The use of these drugs has aided in the affordable treatment of many life-threatening diseases ranging from cancer and diabetes to chronic inflammatory diseases such as rheumatoid arthritis, psoriatic arthritis and others. The high cost of branded biologics has made biosimilars a lucrative alternative for affordable treatment. According to this report on biosimilars, the global market for biosimilars is expected to reach close to $20.8 billion by 2022, growing at a CAGR of 30.5%. Other drivers for this market include rising aging populations, patent expirations of many blockbuster drugs, and better healthcare provisions.

This updated report provides an in-depth analysis of the market for biosimilars in a global context, including market forecasts and sales through 2025. This study surveys the market for biosimilars in all the geographic regions including North America, Europe, the developed rest of the world (RoW), and emerging markets. The emerging markets include countries like India, China, Taiwan, Africa and Latin America.

The report provides an analysis of the market for biosimilars in various segments, for instance, by type, by region and by application/disease category. The report will include a detailed overview about the subject wherein the classification of biosimilar drugs along with their approval mechanisms, clinical trials and applications under review are elaborated upon.

The report also provides relevant patent analysis in both the U.S. and the European Union and comprehensive profiles of companies that lead the biosimilar drugs industry. The industry structure, focusing on the important biosimilar drug manufacturers/suppliers and their market shares and product offerings, is analyzed. This report also discusses the current market situation by elaborating upon the market drivers, restraints, challenges and opportunities. Separate chapters discuss the regulatory aspects and clinical trials. The latest news pieces including new products, new indications, mergers and acquisitions in the market are also dealt with in sufficient detail.

Excluded from this report are biobetters, generics of small molecule drugs and the biogenerics pertaining to vaccines and blood products. The different requirements for approval and bioequivalence between generics and biosimilars put them in an entirely different regime.

The Report Includes

69 data tables and 73 additional tables
An updated review and industry insights of the global biosimilars market
Analyses of the global market trends, with data from 2018 to 2020, and projections of compound annual growth rates (CAGRs) through 2025
Highlights of the emerging market regulations, clinical trials, and new products launches; and their impact on the stakeholders in this market
Discussion of the biosimilars industry structure, opportunities and complexities, regulatory updates and penetration of biosimilar product classes in various regions worldwide
Estimation of current market size and potential growth forecast for biosimilars market, and corresponding market share analysis by product type, application/disease category and geographic region
A detailed review of patents issued for biosimilars by different assignee categories
Impact analysis of COVID-19 pandemic on the growth of biosimilars market as compared to overall pharmaceuticals industry with respect to clinical trials/approvals
Company profiles of the major market players, including Amgen Inc., Boehringer Ingelheim, Cipla Ltd., Dr Reddy's Laboratories Ltd., Lupin Ltd., Pfizer Inc. and Zydus Cadila

Key Topics Covered:

Chapter 1 Introduction

Chapter 2 Summary and Highlights

Chapter 3 Market and Technology Background

Terminology of Biosimilars
Definitions of Biosimilars
Development of a Biosimilar
Clone Development and Selection
Manufacture of a Biosimilar
Preclinical Studies and Validation of a Biosimilar
Clinical Trials
Approval by Regulatory Agencies
Pharmacovigilance/Post-Approval Monitoring
Biosimilars Versus Biobetters
Popular Types of Biosimilars
Recombinant Hormones
Recombinant Growth Factors
Monoclonal Antibodies (mAbs)
Fusion Proteins
Interferons
Low Molecular Weight Heparins (LMWHs)

Chapter 4 Market Breakdown by Type of Biosimilar

Global Market for Biosimilars by Type
Market Shares
Recombinant Hormone Biosimilars
Recombinant Growth Factor Biosimilars
Monoclonal Antibody Biosimilars
Fusion Protein Biosimilars
Interferons
LMWHs

Chapter 5 Market Breakdown by Therapeutic Application

Global Market for Therapeutic Applications of Biosimilars
Market Revenue
Cancer and Related Disorders
Diabetes
Anemia
Growth Hormone Deficiency
Autoimmune Diseases
Infectious Diseases
Other Types of Diseases

Chapter 6 Market Breakdown by Region

Introduction
Global Trends
Factors Impacting the Global Market for Biosimilars
Market by Geographical Region
North America
Europe
Developed Countries in the RoW Region
Emerging Markets
Recombinant Hormone Biosimilars
Market Revenue
Market Shares
Somatotropin Biosimilars
Follitropin Alfa Biosimilars
Insulin Biosimilars
Teriparatide Biosimilars
Recombinant Growth Factor Biosimilars
Market Revenue
Market Shares
Erythropoietin Biosimilars
Darbepoetin Alfa Biosimilars
Filgrastim Biosimilars
Pegfilgrastim Biosimilars
Monoclonal Antibody Biosimilars
Market Revenue
Market Shares
Adalimumab Biosimilars
Bevacizumab Biosimilars
Infliximab Biosimilars
Ranibizumab Biosimilars
Rituximab Biosimilars
Trastuzumab Biosimilars
Fusion Protein Biosimilars
Market Overview
Market Revenue
Market Shares
Interferon Biosimilars
Market Overview
Market Revenue
Market Shares
Low Molecular Weight Heparin (Enoxaparin Sodium) Biosimilars
Market Overview
Market Revenue
Market Shares

Chapter 7 Industry Structure

Types of Market Players
Established Biologics Companies
Established Generics Companies
Bio-intellectual Companies
Opportunistic Companies
Prioritizers
Emerging Trends in the Biosimilar Industry
Collaborations and Partnerships
Mergers and Acquisitions
Manufacturing Facilities of Major Market Players
Contract Manufacturing Organizations (CMOs)
Leading Manufacturers/Suppliers of Biosimilar Drugs
Recombinant Hormones
Recombinant Growth Factors
Monoclonal Antibodies
Fusion Proteins
Interferons
LMWHs

Chapter 8 Regulatory Aspects

Biosimilar Regulations in Europe
Impact of Brexit
Biosimilar Regulations in the 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
Biosimilar Regulations in Australia
Naming of Biosimilars
FDA Naming Convention
WHO Naming Convention
EMA Naming Convention
Interchangeability and Substitution

Chapter 9 Patent Analysis

Patent Regulations in Favor of Branded Biologics
Market Exclusivity
Patent Regulations in Favor of Biosimilars
Market Exclusivity
Product Versus Process Patents
Patent Activity in Biosimilars, 2018 Through February 2021
U.S. Patents
International Patents

Chapter 10 Clinical Trials

Biosimilars in Clinical Trials
Clinical Trials Analysis
Clinical Trials by Recruitment Status
Clinical Trials by Type of Study
Clinical Trials by Study Phase
Clinical Trials by Biosimilar Active Substance
Clinical Trials by Therapeutic Area
Biosimilar Candidates in Ongoing Clinical Trials

Chapter 11 Analysis of Market Forces

Market Dynamics
Market Drivers
Market Restraints
Opportunities
Issues

Chapter 12 Company Profiles

3S Bio Inc.
Alvotech
Amgen Inc.
Biocad
Biocon Ltd.
Bioeq Gmbh
Biopartners Gmbh
Biosidus S.A.
Bio-Thera Solutions Ltd.
Bioxpress Therapeutics S.A.
Blau Farmaceutica S/A
Boehringer Ingelheim Pharmaceuticals Inc.
Chong Kun Dang Pharmaceutical Corp.
Celltrion Inc.
Cipla Ltd.
Cinnagen
Coherus Biosciences Inc.
DM Bio Ltd.
Dong-A Socio Holdings
Dr. Reddy's Laboratories Ltd.
Emcure Pharmaceuticals Ltd.
Fresenius Kabi Ag
Formycon Ag
Gedeon Richter Plc
Genescience Pharmaceuticals Co., Ltd.
GC Pharma (Formerly Gress Cross Corp.)
Hangzhou Jiuyuan Gene Engineering Co., Ltd.
Hanwha Chemical Corp.
Harvest Moon Pharmaceuticals U.S.A. Inc.
Innovent Biologics Co., Ltd.
Intas Pharmaceuticals Ltd.
JHL Biotech Inc.
JCR Pharmaceuticals Co., Ltd.
Kissei Pharmaceutical Co., Ltd.
LG Chem (Formerly Lg Life Sciences)
Lupin Ltd.
Mabxience S.A.
Mylan N.V. (Now Viatris Inc.)
Nanogen Biopharmaceutical Co.
Neuclone
Nippon Kayaku Co., Ltd.
Pfenex Inc.
Pfizer Inc.
Pharmapark Llc
Prestige Biopharma Pte Ltd.
Probiomed S.A.
Reliance Life Sciences
Samsung Bioepis Co., Ltd.
Sandoz International Gmbh
Shanghai Henlius Biotech Inc.
Stada Arzneimittel Ag
Tanvex Biopharma Inc.
Teva Pharmaceuticals Industries Ltd.
USV Pvt. Ltd.
Wockhardt Ltd.
Xiamen Amoytop Biotech Co., Ltd.
Zydus Cadila

Chapter 13 Appendix: Acronyms

For more information about this report visit https://www.researchandmarkets.com/r/yr6o6i

Media Contact:

Research and Markets
Laura Wood, Senior Manager
[email protected]

For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1904
Fax (outside U.S.): +353-1-481-1716

SOURCE Research and Markets