Dublin, June 15, 2021 (GLOBE NEWSWIRE) -- 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
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