The global biosimilar monoclonal antibodies market size was estimated at around USD 8.75 billion in 2022 and it is projected to hit around USD 65.29 billion by 2032, growing at a CAGR of 22.26% from 2023 to 2032.
The growth of the global biosimilar monoclonal antibodies (mAbs) market can be attributed to various factors which include increasing patent expiries of monoclonal antibodies, advancements in mAbs innovation, increasing demand for cost-efficient products, the rising prevalence of chronic and autoimmune diseases like rheumatoid arthritis and cancer, as well as the aging population. Moreover, the rising investments in research and development for biological drugs are expected to drive the adoption during the forecast period. Increased R&D activities lead to the development of innovative drug products, improved developmental procedures, and enhanced healthcare facilities, all such factors contribute to market growth.
The expiration of patents for prominent monoclonal antibodies (mAbs) has increased significant interest among pharmaceutical companies to develop biosimilars. Moreover, the introduction of biosimilars following the patent expiries of key monoclonal antibodies, such as Remicade from Johnson & Johnson, Herceptin from Roche, and Humira from Abbott, is a major driving factor for the market.
Furthermore, strategic collaborations and initiatives among key players in space are boosting industry growth. For instance, in July 2021, Abzena (UK), a global research organization specializing in biologics and bioconjugates, collaborated with BioXpress Therapeutics (Switzerland) to support biosimilar development for third-party customers. This collaboration created an integrated solution between two leading service providers in biosimilar development and GMP manufacturing. Similarly, in February 2020, Mylan (US) launched Ogivri, a biosimilar of trastuzumab. Trastuzumab is a mAb used to treat HER2-positive breast cancer and was previously marketed by Genentech as Herceptin.
However, stringent regulations related to product approvals and the cost structure associated with the manufacturing process may hinder space growth during the forecast period. Additionally, the lack of clarity regarding regulations for the development of biosimilar mAbs in emerging markets could act as a restraint on market growth.
The biosimilar monoclonal antibodies market segmentation is based on product, application, and region. The product segment is based on Infliximab, Rituximab, Abciximab, Trastuzumab, Adalimumab, Bevacizumab, and others. The application segment is based on oncology, chronic and autoimmune diseases, and others. The Asia Pacific region is expected to experience significant growth in the market from 2023 to 2032. Factors contributing to this growth include the increasing burden of chronic diseases, the growing need for cost-effective treatments, and rising government funding for improving healthcare facilities. For instance, in Asia Pacific countries such as China, since the launch of the first biosimilar of Rituximab injection by Henlius in 2019, there have been 142 biosimilar mAbs researched and developed, targeting 16 different treatments. Out of these, 10 products have been launched, including Herceptin (trastuzumab) x 1, Avastin (bevacizumab) x 3, MabThera (rituximab) x 2, and Humira (adalimumab) x 4. China has more than 60 pharmaceutical companies actively involved in the development of products.
Major companies operating in the biosimilar monoclonal antibodies market include:
Pfizer
Novartis AG
AbbVie, Inc.
Coherus BioSciences
Biocon
Biosimilar Monoclonal Antibodies Market Segmentation
By Product
By Application
By Region
Chapter 1. Introduction
1.1. Research Objective
1.2. Scope of the Study
1.3. Definition
Chapter 2. Research Methodology
2.1. Research Approach
2.2. Data Sources
2.3. Assumptions & Limitations
Chapter 3. Executive Summary
3.1. Market Snapshot
Chapter 4. Market Variables and Scope
4.1. Introduction
4.2. Market Classification and Scope
4.3. Industry Value Chain Analysis
4.3.1. Raw Material Procurement Analysis
4.3.2. Sales and Distribution Channel Analysis
4.3.3. Downstream Buyer Analysis
Chapter 5. COVID 19 Impact on Biosimilar Monoclonal Antibodies Market
5.1. COVID-19 Landscape: Biosimilar Monoclonal Antibodies Industry Impact
5.2. COVID 19 - Impact Assessment for the Industry
5.3. COVID 19 Impact: Global Major Government Policy
5.4. Market Trends and Opportunities in the COVID-19 Landscape
Chapter 6. Market Dynamics Analysis and Trends
6.1. Market Dynamics
6.1.1. Market Drivers
6.1.2. Market Restraints
6.1.3. Market Opportunities
6.2. Porter’s Five Forces Analysis
6.2.1. Bargaining power of suppliers
6.2.2. Bargaining power of buyers
6.2.3. Threat of substitute
6.2.4. Threat of new entrants
6.2.5. Degree of competition
Chapter 7. Competitive Landscape
7.1.1. Company Market Share/Positioning Analysis
7.1.2. Key Strategies Adopted by Players
7.1.3. Vendor Landscape
7.1.3.1. List of Suppliers
7.1.3.2. List of Buyers
Chapter 8. Global Biosimilar Monoclonal Antibodies Market, By Product
8.1. Biosimilar Monoclonal Antibodies Market, by Product, 2023-2032
8.1.1. Infliximab
8.1.1.1. Market Revenue and Forecast (2020-2032)
8.1.2. Rituximab
8.1.2.1. Market Revenue and Forecast (2020-2032)
8.1.3. Abciximab
8.1.3.1. Market Revenue and Forecast (2020-2032)
8.1.4. Trastuzumab
8.1.4.1. Market Revenue and Forecast (2020-2032)
8.1.5. Adalimumab
8.1.5.1. Market Revenue and Forecast (2020-2032)
8.1.6. Bevacizumab
8.1.6.1. Market Revenue and Forecast (2020-2032)
8.1.7. Others
8.1.7.1. Market Revenue and Forecast (2020-2032)
Chapter 9. Global Biosimilar Monoclonal Antibodies Market, By Application
9.1. Biosimilar Monoclonal Antibodies Market, by Application, 2023-2032
9.1.1. Oncology
9.1.1.1. Market Revenue and Forecast (2020-2032)
9.1.2. Chronic & Autoimmune Diseases
9.1.2.1. Market Revenue and Forecast (2020-2032)
9.1.3. Others
9.1.3.1. Market Revenue and Forecast (2020-2032)
Chapter 10. Global Biosimilar Monoclonal Antibodies Market, Regional Estimates and Trend Forecast
10.1. North America
10.1.1. Market Revenue and Forecast, by Product (2020-2032)
10.1.2. Market Revenue and Forecast, by Application (2020-2032)
10.1.3. U.S.
10.1.3.1. Market Revenue and Forecast, by Product (2020-2032)
10.1.3.2. Market Revenue and Forecast, by Application (2020-2032)
10.1.4. Rest of North America
10.1.4.1. Market Revenue and Forecast, by Product (2020-2032)
10.1.4.2. Market Revenue and Forecast, by Application (2020-2032)
10.2. Europe
10.2.1. Market Revenue and Forecast, by Product (2020-2032)
10.2.2. Market Revenue and Forecast, by Application (2020-2032)
10.2.3. UK
10.2.3.1. Market Revenue and Forecast, by Product (2020-2032)
10.2.3.2. Market Revenue and Forecast, by Application (2020-2032)
10.2.4. Germany
10.2.4.1. Market Revenue and Forecast, by Product (2020-2032)
10.2.4.2. Market Revenue and Forecast, by Application (2020-2032)
10.2.5. France
10.2.5.1. Market Revenue and Forecast, by Product (2020-2032)
10.2.5.2. Market Revenue and Forecast, by Application (2020-2032)
10.2.6. Rest of Europe
10.2.6.1. Market Revenue and Forecast, by Product (2020-2032)
10.2.6.2. Market Revenue and Forecast, by Application (2020-2032)
10.3. APAC
10.3.1. Market Revenue and Forecast, by Product (2020-2032)
10.3.2. Market Revenue and Forecast, by Application (2020-2032)
10.3.3. India
10.3.3.1. Market Revenue and Forecast, by Product (2020-2032)
10.3.3.2. Market Revenue and Forecast, by Application (2020-2032)
10.3.4. China
10.3.4.1. Market Revenue and Forecast, by Product (2020-2032)
10.3.4.2. Market Revenue and Forecast, by Application (2020-2032)
10.3.5. Japan
10.3.5.1. Market Revenue and Forecast, by Product (2020-2032)
10.3.5.2. Market Revenue and Forecast, by Application (2020-2032)
10.3.6. Rest of APAC
10.3.6.1. Market Revenue and Forecast, by Product (2020-2032)
10.3.6.2. Market Revenue and Forecast, by Application (2020-2032)
10.4. MEA
10.4.1. Market Revenue and Forecast, by Product (2020-2032)
10.4.2. Market Revenue and Forecast, by Application (2020-2032)
10.4.3. GCC
10.4.3.1. Market Revenue and Forecast, by Product (2020-2032)
10.4.3.2. Market Revenue and Forecast, by Application (2020-2032)
10.4.4. North Africa
10.4.4.1. Market Revenue and Forecast, by Product (2020-2032)
10.4.4.2. Market Revenue and Forecast, by Application (2020-2032)
10.4.5. South Africa
10.4.5.1. Market Revenue and Forecast, by Product (2020-2032)
10.4.5.2. Market Revenue and Forecast, by Application (2020-2032)
10.4.6. Rest of MEA
10.4.6.1. Market Revenue and Forecast, by Product (2020-2032)
10.4.6.2. Market Revenue and Forecast, by Application (2020-2032)
10.5. Latin America
10.5.1. Market Revenue and Forecast, by Product (2020-2032)
10.5.2. Market Revenue and Forecast, by Application (2020-2032)
10.5.3. Brazil
10.5.3.1. Market Revenue and Forecast, by Product (2020-2032)
10.5.3.2. Market Revenue and Forecast, by Application (2020-2032)
10.5.4. Rest of LATAM
10.5.4.1. Market Revenue and Forecast, by Product (2020-2032)
10.5.4.2. Market Revenue and Forecast, by Application (2020-2032)
Chapter 11. Company Profiles
11.1. Pfizer
11.1.1. Company Overview
11.1.2. Product Offerings
11.1.3. Financial Performance
11.1.4. Recent Initiatives
11.2. Novartis AG
11.2.1. Company Overview
11.2.2. Product Offerings
11.2.3. Financial Performance
11.2.4. Recent Initiatives
11.3. AbbVie, Inc.
11.3.1. Company Overview
11.3.2. Product Offerings
11.3.3. Financial Performance
11.3.4. Recent Initiatives
11.4. Coherus BioSciences
11.4.1. Company Overview
11.4.2. Product Offerings
11.4.3. Financial Performance
11.4.4. LTE Scientific
11.5. Biocon
11.5.1. Company Overview
11.5.2. Product Offerings
11.5.3. Financial Performance
11.5.4. Recent Initiatives
Chapter 12. Research Methodology
12.1. Primary Research
12.2. Secondary Research
12.3. Assumptions
Chapter 13. Appendix
13.1. About Us
13.2. Glossary of Terms