Biosimilars Market
Biosimilars Market Size, Share & Industry Analysis, By Product Type (Monoclonal Antibodies, Insulin, Granulocyte Colony-Stimulating Factor, Erythropoietin, Others), By Application (Oncology, Chronic Diseases, Autoimmune Diseases, Growth Hormone Deficiency, Others), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), By Region (North America, Europe, Asia-Pacific, Latin America, Middle East & Africa) - Share, Size, Outlook, and Opportunity Analysis, 2024-2031
Report Highlights:
“The global biosimilars market is projected to grow from USD 15.6 billion in 2022 to USD 143.9 billion by 2031 at a compound annual growth rate of 24.7%. Now, Europe dominates the market.”
The market for biosimilars is growing quickly due to factors like growing healthcare expenditures, important biologic medication patent expirations, and an increase in the prevalence of chronic illnesses. The fact that biosimilars are cheaply priced substitutes for pricy biologues leads to their adoption. Expanding biosimilars indications, growing patient and physician knowledge, and supportive government regulations all contribute to the ongoing growth of the business.
Market Dynamics:
Rising adoption of biosimilars in cancer and autoimmune diseases marks a trend in the market.
Market expansion in biosimilars is driven by their rapidly increasing use in cancer and autoimmune disease therapy. Oncology biosimilars for drugs like trastuzumab, bevacizumab, and rituximab are becoming more and more popular because to their cost-effectiveness and equal efficacy to reference biologics. Comparatively, for autoimmune diseases such rheumatoid arthritis and inflammatory bowel disease, biosimilars are becoming more common. This tendency may be justified by positive clinical data, physician acceptance, and reasonable payment policies.
In several therapeutic areas, where biologic treatments might be relatively expensive, the cost savings offered by biosimilars are extremely important. Adoption of cancer and autoimmune disease biosimilars is expected to accelerate further as more of them acquire regulatory approvals and enter the market, therefore considerably contributing to the growth of the market.
Market driver patent expiries of blockbuster biologics pave the route to open biosimilars.
The expiration of many blockbuster biologic drugs patents fuels most of the biosimilars industry. As well-known biologics used in cancer, autoimmune diseases, and other therapeutic fields run out, biosimilar manufacturers have opportunity to develop and sell more cheaply priced substitutes. This driver is particularly crucial as biosimilars might save patients and healthcare systems a lot of money while biologics are often very expensive.
The patent cliff for biologics is expected to continue over the coming years as several very valuable biologics lose exclusivity. This creates a stream of opportunities for biosimilar research and commercial introduction. Moreover, as more biosimilars enter the market, greater competition is likely to drive more price reductions, thereby enabling the availability of these treatments to a larger patient population and so boosting the growth of the industry.
The regulatory complexity and development issues of biosimilars reflect market restraints.
Development challenges and regulatory complexities restrict the biosimilars market even with their potential for growth. Unlike generic small molecule drugs, biosimilars are complicated compounds that have to resemble the reference biologic using exhaustive analytical, preclinical, and clinical testing. As a result, this produces more development costs and longer timelines than traditional generics. distinct regions have distinct biosimilar clearance regulations, which challenges manufacturers trying for global market access.
Moreover, some companies discover access difficulties related to the need for certain production facilities and skills. Conducting clinical trials for biosimilars adds further challenges as it may be difficult to locate participants when the reference product is already sold. These components could limit the number of companies able to efficiently develop and commercialize biosimilars, hence potentially slowing down market growth and reducing of competitiveness.
Segment Overview:
Monoclonal antibodies define biosimilars most of all
Monoclonal antibodies (mAbs) are leading and fastest-growing segment in the biosimilars market. This preponderance is driven by the enormous cost of reference mAb biologics and their widespread use in treating numerous illnesses, notably in cancer and autoimmune disorders. Patent expiration of several blockbuster mAb therapies has provided biosimilar alternatives with great potential.
Monoclonal antibody biosimilars provide substantial cost savings even if their safety profile and efficacy match those of their reference pharmaceuticals. Payers and healthcare providers have so adopted this more generally, hence encouraging segment growth. The pipeline for mAb biosimilars is robust and points to continuous large development potential for this industry in the future years, given several items in development at different stages.
Regional Outlook:
Leading the global biosimilars market is Europe.
Taking the stage globally among biosimilars, Europe is probably going to stay in first position for the projected period. A well-established regulatory framework for biosimilars, supporting government efforts, and high rates of patient and healthcare professional acceptance assist to explain the region's supremacy. The European Medicines Agency (EMA) is among the first regulatory bodies to provide clear guidelines for biosimilar clearance; it has supported the commercial release and development going forward.
Many European countries have approved policies meant to encourage biosimilar adoption including preferred reimbursement and biosimilar prescription quotas. These actions have resulted in significant cost savings for healthcare systems, which increases even greater acceptability. Europe has also a sophisticated healthcare system and strong understanding of biosimilars among patients and professionals. Moreover bolstering the market leadership of the area are the presence of major biosimilar manufacturers here. The region is expected to retain dominating global biosimilars market as biosimilar acceptance continues increasing among European countries.
Competitive Landscape:
The biosimilars sector is defined by fierce competition among current pharmaceutical corporations, biotechnology companies, and recently joining rivals focused on biosimilar research. Key strategies used by market participants in order to expand their biosimilar portfolios include strategic partnerships, acquisitions, and R&D spending. Companies are especially focused on developing biosimilars for high-value biologics nearly nearing patent expiration, especially in cancer and autoimmune diseases. Vertical integration is also becoming more frequent; some businesses are financing manufacturing capacity to ensure supply chain management and cost economy.
Regional growth is also rather important as companies seek to use different regulatory frameworks and commercial opportunities all around. The competitive environment is evolving as new businesses from emerging nations confront established enterprises, hence increasing potential competitiveness and price pressure in the future years.
Major Players:
- Novartis AG (Sandoz)
- Pfizer Inc.
- Amgen Inc.
- Samsung Bioepis Co., Ltd.
- Celltrion Healthcare Co., Ltd.
- Teva Pharmaceutical Industries Ltd.
- Coherus BioSciences, Inc.
- Biocon Limited
- Mylan N.V. (now part of Viatris Inc.)
- Boehringer Ingelheim International GmbH
1. INTRODUCTION
1.1. Market Definition
1.2. Study Scope
1.3. Currency Conversion
1.4. Study Period (2022- 2031)
1.5. Regional Coverage
2. RESEARCH METHODOLOGY
2.1. Primary Research
2.2. Secondary Research
2.3. Company Share Analysis
2.4. Data Triangulation
3. EXECUTIVE SUMMARY
3.1. Global Biosimilars Market (2018 – 2022)
3.2. Global Biosimilars Market (2023 – 2031)
3.2.1. Market Segment By Product Type (2023 – 2031)
3.2.2. Market Segment By Application (2023 – 2031)
3.2.3. Market Segment By Distribution Channel (2023 – 2031)
3.2.4. Market Segment By Region (2023 – 2031)
4. MARKET DYNAMICS
4.1. Market Trends
4.1.1. Increasing adoption of biosimilars in oncology and autoimmune diseases
4.1.2. Growing focus on developing biosimilars for rare diseases
4.1.3. Emergence of next-generation biosimilars
4.2. Market Drivers
4.2.1. Patent expiries of blockbuster biologics creating opportunities for biosimilars
4.2.2. Rising prevalence of chronic diseases driving demand for cost-effective treatments
4.2.3. Supportive government policies and initiatives promoting biosimilar adoption
4.3. Market Restraints
4.3.1. Regulatory complexities and development challenges for biosimilars
4.3.2. Resistance from some healthcare providers and patients
4.4. Porter's Five Forces Analysis
4.4.1. Threat of New Entrants
4.4.2. Bargaining Power of Buyers/Consumers
4.4.3. Bargaining Power of Suppliers
4.4.4. Threat of Substitute Products
4.4.5. Intensity of Competitive Rivalry
4.5. Supply Chain Analysis
4.6. Pricing Analysis
4.7. Regulatory Analysis
4.8. Pipeline Analysis
5. BY PRODUCT TYPE (MARKET VALUE (US$ MILLION) – 2022-2031*)
5.1. Monoclonal Antibodies
5.2. Insulin
5.3. Granulocyte Colony-Stimulating Factor
5.4. Erythropoietin
5.5. Others
6. BY APPLICATION
6.1. Oncology
6.2. Chronic Diseases
6.3. Autoimmune Diseases
6.4. Growth Hormone Deficiency
6.5. Others
7. BY DISTRIBUTION CHANNEL
7.1. Hospital Pharmacies
7.2. Retail Pharmacies
7.3. Online Pharmacies
8. GEOGRAPHY
8.1. North America
8.1.1. United States
8.1.2. Canada
8.1.3. Mexico
8.2. South America
8.2.1. Brazil
8.2.2. Argentina
8.2.3. Rest of South America
8.3. Europe
8.3.1. Germany
8.3.2. United Kingdom
8.3.3. France
8.3.4. Italy
8.3.5. Spain
8.3.6. Russia
8.3.7. Rest of Europe
8.4. Asia-Pacific
8.4.1. China
8.4.2. Japan
8.4.3. India
8.4.4. Australia
8.4.5. South Korea
8.4.6. Rest of Asia-Pacific
8.5. Middle-East
8.5.1. UAE
8.5.2. Saudi Arabia
8.5.3. Turkey
8.5.4. Rest of Middle East
8.6. Africa
8.6.1. South Africa
8.6.2. Egypt
8.6.3. Rest of Africa
9. COMPETITIVE LANDSCAPE
9.1. Key Developments
9.2. Company Market Share Analysis
9.3. Product Benchmarking
10. SWOT ANALYSIS
11. COMPANY PROFILES
11.1. Novartis AG (Sandoz)
11.2. Pfizer Inc.
11.3. Amgen Inc.
11.4. Samsung Bioepis Co., Ltd.
11.5. Celltrion Healthcare Co., Ltd.
11.6. Teva Pharmaceutical Industries Ltd.
11.7. Coherus BioSciences, Inc.
11.8. Biocon Limited
11.9. Mylan N.V. (now part of Viatris Inc.)
11.10. Boehringer Ingelheim International GmbH
11.11. Fresenius Kabi AG
11.12. Eli Lilly and Company (*LIST NOT EXHAUSTIVE)
12. MARKET OPPORTUNITIES
By Product Type:
- Monoclonal Antibodies
- Insulin
- Granulocyte Colony-Stimulating Factor
- Erythropoietin
- Others
By Application:
- Oncology
- Chronic Diseases
- Autoimmune Diseases
- Growth Hormone Deficiency
- Others
By Distribution Channel:
- Hospital Pharmacies
- Retail Pharmacies
- Online Pharmacies
By Region:
- North America
- Europe
- Asia-Pacific
- Latin America
- Middle East & Africa
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