Global Biosimilars Market Research Report 2022-2026 & 2031 - Revised FDA Regulations To Facilitate Biosimilar Drug Development

DUBLIN, Sept. 6, 2022 /PRNewswire/ -- The "Biosimilars Global Market Opportunities And Strategies To 2031" report has been added to ResearchAndMarkets.com's offering.

The global biosimilars market reached a value of nearly $11,418.9 million in 2021, having grown at a compound annual growth rate (CAGR) of 34.8% since 2016. The market is expected to grow from $11,418.9 million in 2021 to $25,985.2 million in 2026 at a rate of 17.3%. The market is then expected to grow at a CAGR of 18.0% from 2026 and reach $59,555.8 million in 2031.

This report describes and explains the biosimilars market and covers 2016-2021, termed the historic period, and 2021-2026 termed the forecast period, along with further forecasts for the period 2026-2031. The report evaluates the market across each region and for the major economies within each region.

Growth in the historic period resulted from an increase in cancer prevalence, strong economic growth in emerging markets, an increase in pharmaceutical R&D expenditure, increased healthcare expenditure, growing government initiatives, strong pipeline of drugs, low cost of biosimilars and an increase in patent expiration.

Factors that negatively affected growth in the historic period were regulatory changes, low healthcare access, lack of awareness on biosimilars among primary care physicians and specialists, reimbursement challenges, the coronavirus pandemic and low healthcare reimbursements.

Going forward, increasing prevalence of cancer, increasing demand for prophylaxis with granulocyte colony-stimulating factor (G-CSF), a rise in healthcare expenditure, high potential of emerging economies, technology advances, high penetration of biological drugs, aging population and an increase in healthcare access will drive the growth. Factors that could hinder the growth of the biosimilars market in the future include high costs of drugs, high cost of drug development with threat of failure, pricing pressures from regulators and insufficient and outdated health system.

The biosimilars market is segmented by type into monoclonal antibodies, insulin, erythropoietin, granulocyte-colony stimulating factor, other hormones and others. The monoclonal antibodies market was the largest segment of the biosimilars market segmented by type, accounting for 39.6% of the total in 2021. Going forward, the erythropoietin segment is expected to be the fastest growing segment in the biosimilars market segmented by type, at a CAGR of 28.2% during 2021-2026.

The biosimilars market is also segmented by application into oncology, chronic and autoimmune diseases, growth hormone deficiency, infectious diseases, and other applications. The chronic and autoimmune diseases market was the largest segment of the biosimilars market segmented by application, accounting for 45.6% of the total in 2021. Going forward, infectious diseases segment is expected to be the fastest growing segment in the biosimilars market segmented by end-user, at a CAGR of 24.8% during 2021-2026.

Western Europe was the largest region in the biosimilars market, accounting for 66.0% of the total in 2021. It was followed by North America, and then the other regions. Going forward, the fastest-growing regions in the biosimilars market will be Africa and Eastern Europe where growth will be at CAGRs of 117.0% and 60.1% respectively. These will be followed by South America and Middle East where the markets are expected to grow at CAGRs of 53.854% and 53.851% respectively.

The global biosimilars market is concentrated, with a small number of large players in the market. The top ten competitors in the market made up to 76.98% of the total market in 2021. The market concentration can be attributed to the high barriers to entry in terms of high costs associated with the research and development of pegfilgrastim biosimilars and the stringent regulations set up by the regulatory authorities.

Going forward the market is expected some fragmentation with the rising number of new entrants. Amgen was the largest competitor with 21.23% of the market, followed by Pfizer with 13.37%, Novartis AG with 10.13%, Samsung Bioepis Co., Ltd. with 9.90%, Viatris with 7.37%, Biocon with 3.60%, Celltrion, Inc. with 3.24%, Coherus Biosciences with 4.17%, Elli Lilly and Company with 1.99%, and Dr. Reddy's Laboratories with 1.98%.

The top opportunities in the biosimilars market segmented by type will arise in the monoclonal antibodies segment, which will gain $8,508.0 million of global annual sales by 2026. The top opportunities in the biosimilars market segmented by application will arise in the oncology segment, which will gain $6,889.0 million of global annual sales by 2026. The biosimilars market size will gain the most in the USA at $6,677.4 million.

Market-trend-based strategies for the biosimilars market include focus on robust R&D activities for the development of effective and innovative drugs, focus on focus on M&A growth strategies, focus on establishing strategic partnerships, focus on increasing investments and focus on artificial intelligence.

Player-adopted strategies in the biosimilars market include strengthening product portfolio by new products launches, focusing on expansion strategies in different geographies and increasing research and development for new product development by collaborating with companies having same business.

To take advantage of the opportunities, the publisher recommends the biosimilars companies to launch new products, invest in robotics and artificial intelligence (AI), expand in emerging markets, scale up through merger and acquisition activity, provide competitively priced offerings, continue to participate in events and conferences, take initiatives to educate consumers, target high-growth application areas and increase strategic partnerships.

Key Topics Covered:

1. Biosimilars Market Executive Summary

2. Table of Contents

3. List of Figures

4. List of Tables

5. Report Structure

6. Introduction and Market Characteristics
6.1. General Market Definition
6.2. Summary
6.3. Market Segmentation By Type
6.3.1. Monoclonal Antibodies
6.3.2. Insulin
6.3.3. Erythropoietin
6.3.4. Granulocyte-Colony Stimulating Factor
6.3.5. Other Hormones
6.3.6. Other Types
6.4. Market Segmentation By Application
6.4.1. Oncology
6.4.2. Chronic and Autoimmune Diseases
6.4.3. Growth Hormone Deficiency
6.4.4. Infectious Diseases
6.4.5. Other Applications

7. Major Market Trends
7.1. Robust Research & Development
7.2. Demand For Biosimilars In The Treatment Of Neutropenia
7.3. Growing Mergers And Acquisitions
7.4. Revised FDA Regulations To Facilitate Biosimilar Drug Development
7.5. Large Number Of Strategic Partnerships
7.6. Increasing Investments In Biosimilars Market
7.7. Use of Robots and AI

8. Global Market Size And Growth
8.1. Market Size
8.2. Historic Market Growth, 2016 - 2021, Value ($ Million)
8.2.1. Market Drivers 2016 - 2021
8.2.2. Market Restraints 2016 - 2021
8.3. Forecast Market Growth, 2021 - 2026, 2031F Value ($ Million)
8.3.1. Market Drivers 2021 - 2026
8.3.2. Market Restraints 2021 - 2026

9. Global Biosimilars Market Segmentation
9.1. Global Biosimilars Market, Segmentation By Type, Historic And Forecast, 2016 - 2021, 2026F, 2031F, Value ($ Million)
9.2. Global Biosimilars Market, Segmentation By Application, Historic And Forecast, 2016 - 2021, 2026F, 2031F, Value ($ Million)

10. Biosimilars Market, Regional And Country Analysis
10.1. Global Biosimilars Market, By Region, Historic and Forecast, 2016 - 2021, 2026F, 2031F, Value ($ Million)
10.2. Global Biosimilars Market, By Country, Historic and Forecast, 2016 - 2021, 2026F, 2031F, Value ($ Million)

Companies Mentioned

• AbCellera
• Adello Biologics
• Alvotech
• Amgen
• Amneal Pharmaceuticals
• Astellas
• Biocon Biologics
• Bristol-Myers Squibb
• C-Bridge Capital
• Celgene Corporation
• Celltrion
• ChrysCapital
• Fresenius Kabi
• Fuji Pharma Co., Ltd. 
• Hisun BioRay Bio-pharmaceutical Co., Ltd.
• Impax Laboratories
• Intas Pharmaceuticals
• Japanese JV
• Kashiv Pharma
• Ligand Pharmaceuticals
• PAG
• Pfenex
• Pfizer Healthcare India
• Samsung Bioepis
• Sandoz
• Shire Plc
• Takeda Pharmaceutical
• TetraGenetics
• True North
• Viatris Biosimilars Business
• mAbxience

For more information about this report visit https://www.researchandmarkets.com/r/95f7vz

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