The Biosimilar Monoclonal Antibodies Market Size is valued at 5.02 Billion in 2022 and is predicted to reach 26.14 Billion by the year 2031 at a 20.5 % CAGR during the forecast period for 2023-2031.
Key Industry Insights & Findings from the Report:
- The rising occurence of chronic diseases like cancer, autoimmune disorders, and inflammatory diseases is driving the biosimilar monoclonal antibodies market.
- The termination of patents plays a pivotal role in propelling the growth of the biosimilar monoclonal antibody market.
- North America dominated the market and accounted for a global revenue share in 2023.
- The key challenge for the Biosimilar Monoclonal Antibodies Market is the high cost of development processes and complex manufacturing procedures.
Biosimilars are biological drugs, and they are large, complex biological molecules produced from living organisms that are often difficult to characterize and therefore difficult to copy. Monoclonal antibody biosimilars play a vital role in treating various chronic and autoimmune diseases. They also represent an opportunity to increase access and reduce costs for patients and healthcare systems.
Global Biosimilar Monoclonal Antibodies market growth is attributed to numerous factors such as biosimilar monoclonal antibodies market include the increasing patent expiries of mAbs, innovation of advanced mAbs, the growing number of biosimilars for oncology treatments, rising demand for lower-priced, cost-efficient biosimilar monoclonal antibodies, growing chronic and autoimmune diseases like cancer, rheumatoid arthritis, diabetes, and the rising older population. Moreover, increasing R&D investments for biological drugs are anticipated to fuel market adoption during the forecast period. Growing R&D activities result in innovative drug products, developmental procedures, and healthcare facilities, thereby boosting market growth.
However, the high cost of development processes, complex mAb manufacturing procedures, region-specific government rules regarding the production and use of biosimilars, lack of scientific standards for biosimilars are expected to hamper the market's growth in the coming years.
Competitive Landscape
Some Of The Key Players In The Biosimilar Monoclonal Antibodies Market:
- Pfizer
- Novartis
- Allergan
- Coherus BioSciences
- Biocon
- Amgen
- Boehringer Ingelheim
- Celltrion
- BioXpress Therapeutics
- Intas Pharmaceuticals Limited
- Genor BioPharma Co. Ltd
- BIOCAD
- Reddys Laboratories Ltd
- 3SBio
- Reliance Life Sciences
- Hisun Pharma
- Celgen Biopharma
- Torrent Pharmaceuticals
- Cadila Healthcare
- Mylan Inc.
- BioXpress Therapeutics SA
- Celltrion
- EirGenix, Inc.
- Teva Pharmaceutical Industries Ltd.
- ALTEOGEN Inc.
- Apotex (Apobiologix)
- AryoGen Pharmed
- Prestige BioPharma (PBP)
- PlantForm
- Outlook Therapeutics (Oncobiologics)
- Shanghai CP Guojian Pharmaceutical
- Shanghai Henlius Biotech
- Stada Arzneimittel AG
- Other Prominent Players
Market Segmentation
The Biosimilar Monoclonal Antibodies Market is segmented based on product, indication, and region. By product, the market comprises the infliximab, trastuzumab, rituximab, adalimumab, bevacizumab, cetuximab, ranibizumab, denosumab, eculizumab, and other pipeline products. The infliximab and rituximab segments are projected to hold the highest market share over the forecast period owing to their increasing use in treating various chronic and autoimmune diseases. The market is classified into oncology, inflammatory & autoimmune disorders, chronic diseases, blood disorders, and other indications based on the indication. Among all, The oncology segment is predictable to dominate the market in the coming years due to the surge in biosimilar mAbs approvals for cancer treatments. Regionally, the market is categorized across North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.
North America region dominated this market in 2020 and is expected to continue its trend over the forecast period on account of the favourable reimbursement policies, increasing patent expiration, and the growing rate of biosimilar mAbs approvals.
Recent Developments:
- In May 2024, Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd, has received FDA approval for Yesafili™ (aflibercept-jbvf), its biosimilar of EYLEA® (aflibercept), which is the first of its kind to be filed and is interchangeable. Yesafili™ is used in the treatment of several ophthalmic diseases.
The Biosimilar Monoclonal Antibodies Market Report Scope
Report Attribute |
Specifications |
Market Size Value In 2022 |
USD 5.02 Billion |
Revenue Forecast In 2031 |
USD 26.14 Billion |
Growth Rate CAGR |
CAGR of 20.5 % from 2023 to 2031 |
Quantitative Units |
Representation of revenue in US$ Billion and CAGR from 2023 to 2031 |
Historic Year |
2019 to 2022 |
Forecast Year |
2023-2031 |
Report Coverage |
The forecast of revenue, the position of the company, the competitive market structure, growth prospects, and trends |
Segments Covered |
By Products, By Indication |
Regional Scope |
North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
Country Scope |
U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico ;The UK; France; Italy; Spain; China; Japan; India; South Korea; South East Asia; South Korea; South East Asia |
Competitive Landscape |
Pfizer, Novartis, Allergan, Coherus BioSciences, Biocon, Amgen, Boehringer Ingelheim, Celltrion, BioXpress Therapeutics, Intas Pharmaceuticals Limited, Genor BioPharma Co., Ltd, BIOCAD, Reddys Laboratories Ltd, 3SBio, Reliance Life Sciences, Hisun Pharma, Celgen Biopharma, Torrent Pharmaceuticals, Cadila Healthcare, Mylan Inc., BioXpress Therapeutics SA, Celltrion, EirGenix, Inc., Teva Pharmaceutical Industries Ltd., ALTEOGEN Inc., Apotex (Apobiologix), AryoGen Pharmed, Prestige BioPharma (PBP), PlantForm Outlook Therapeutics (Oncobiologics), Shanghai CP Guojian Pharmaceutical, Shanghai Henlius Biotech, Stada Arzneimittel AG, Other Prominent Players |
Customization Scope |
Free customization report with the procurement of the report, Modifications to the regional and segment scope. Particular Geographic competitive landscape. |
Pricing And Available Payment Methods |
Explore pricing alternatives that are customized to your particular study requirements. |