Biosimilar Monoclonal Antibodies (mAbs) Market

Global Biosimilar Monoclonal Antibodies (mabs) Market Size

The global biosimilar monoclonal antibodies (mAbs) market size was valued at USD 12.18 billion in 2024 and is estimated to reach USD 72.12 billion by 2033, growing at a CAGR of 21.85% during the forecast period (2025–2033). The global biosimilar monoclonal antibodies (mAbs) market is a rapidly developing segment of the biopharmaceutical industry, driven by the surging demand for cost-effective alternatives to branded biologics. Moreover, the market growth is further fueled by patent expirations, regulatory approvals, and increasing adoption in oncology and immunology.

Market Overview

Biosimilar Monoclonal Antibodies (mAbs) are biologic drugs designed to be highly similar to an already approved reference monoclonal antibody, with no clinically meaningful differences in safety, efficacy, or quality. These antibodies are produced using living cells and mimic the function of natural antibodies by targeting specific antigens, making them valuable in treating diseases like cancer, autoimmune disorders, and inflammatory conditions.

Biosimilar monoclonal antibodies (mAbs) offer a cost-effective alternative to original biologics, increasing patient access to advanced therapies. Regulatory agencies like the FDA and EMA ensure rigorous evaluation to confirm their similarity and therapeutic equivalence before approval for clinical use.

Market Drivers

Rising demand for cost-effective biologic therapies

The surging incidence of chronic illnesses, such as cancer and autoimmune disorders, is a significant driver for the global biosimilar monoclonal antibodies (mAbs) market. For instance, according to the World Health Organization, cancer was one of the leading causes of death globally, responsible for approximately 10 million fatalities in 2020. Monoclonal antibodies have become integral in managing these conditions due to their targeted therapeutic actions.

However, the high cost of original biologic therapies poses a financial burden on healthcare systems and patients. Biosimilar monoclonal antibodies (mAbs) offer similar efficacy and safety profiles at reduced prices, facilitating broader access to essential treatments. This cost advantage is particularly beneficial in regions with constrained healthcare budgets, where biosimilars can provide substantial savings without compromising treatment quality.

Market Restraint

Regulatory challenges and market competition

Despite the promising outlook, the global market faces significant challenges related to regulatory complexities and competition. The stringent regulatory requirements for demonstrating biosimilarity, including comprehensive analytical, preclinical, and clinical studies, can be time-consuming and costly. Moreover, originator biologic manufacturers often employ strategies to maintain market dominance, such as developing 2nd-generation products, reformulating existing drugs, and implementing pricing strategies to retain market share.

Furthermore, the need for clear and harmonized regulatory guidelines across different regions adds to the complexity, potentially delaying product approvals and market entry. For example, competition in the biosimilar market is not only among biosimilar manufacturers but also from originator biologic manufacturers who may launch improved versions of their products or compete on price. Consequently, all these factors are estimated to hinder the growth of the global industry.

Market Opportunities

Expanding healthcare access in emerging markets

Emerging regions present a substantial opportunity for the growth of the biosimilar mAbs industry. Many developing countries are experiencing a rise in the incidence of chronic diseases, coupled with increasing healthcare expenditure and improving healthcare infrastructure. However, the high cost of original biologic therapies limits patient access in these regions. Biosimilar monoclonal antibodies (mAbs) offer a viable solution by providing more affordable treatment options, thereby enhancing access to essential medications.

Moreover, supportive government initiatives and policies aimed at promoting the use of biosimilars can further stimulate market growth. For instance, in the Asia-Pacific region, companies like Celltrion and Samsung Bioepis in South Korea and Dr. Reddy's Laboratories and Biocon in India have been instrumental in developing and commercializing biosimilars, contributing to increased access to biologic therapies in these markets.

Market Scope

Segmental Analysis 

The global biosimilar monoclonal antibodies (mAbs) market is segmented by product, application, and distribution channel.

Based on product

The infliximab biosimilar segment holds a dominant share in the global market owing to its widespread use in treating autoimmune diseases such as rheumatoid arthritis, Crohn's disease, and ulcerative colitis. Several biosimilar versions of infliximab, including CT-P13 (Remsima, Inflectra) and SB2 (Renflexis), have gained regulatory approvals across multiple regions. The growing demand for cost-effective biologic treatments, coupled with increasing patient awareness and physician acceptance, is driving the expansion of this segment globally.

Based on application

The oncology segment dominates the global market, driven by the rising global cancer burden and the high cost of originator biologics used in cancer treatment. Biosimilar versions of trastuzumab, bevacizumab, and rituximab have significantly improved access to affordable therapies for breast cancer, lung cancer, and hematological malignancies. Additionally, the adoption of biosimilars in oncology is further supported by regulatory approvals, positive clinical outcomes, and healthcare cost-containment efforts, making them an essential component of modern cancer care.

Based on the distribution channel

Hospital pharmacies represent a key distribution channel for biosimilar monoclonal antibodies (mAbs), as these therapies are primarily administered in clinical settings under professional supervision. The segment benefits from increasing hospital-based treatments for cancer, autoimmune disorders, and other chronic diseases requiring monoclonal antibody therapy. Hospitals also play a crucial role in biosimilar adoption by ensuring quality control, proper administration, and patient education. Government policies promoting biosimilars and favorable reimbursement structures further enhance the growth of the hospital pharmacies segment.

Regional Analysis

Based on region, the global biosimilar monoclonal antibodies (mAbs) market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa.

North America holds a dominant position in the global biosimilar monoclonal antibodies (mAbs) market, driven by a combination of regulatory advancements, healthcare infrastructure, and market dynamics. The region's well-established regulatory framework has been pivotal in facilitating the approval and entry of biosimilar monoclonal antibodies (mAbs). The U.S. FDA has implemented clear guidelines to ensure the safety and efficacy of biosimilars, thereby encouraging their adoption. This regulatory clarity has led to increased market activity, with several biosimilar mAbs receiving approval in recent years.

Additionally, the robust healthcare infrastructure in North America supports the distribution and adoption of biosimilar mAbs. High levels of physician acceptance and patient accessibility contribute to the widespread use of these therapies. Also, the region's advanced capabilities in research and development, as well as manufacturing, have positioned it as a leader in the biosimilar mAbs market.

Furthermore, market dynamics also play a crucial role. For instance, UnitedHealth Group announced plans to remove AbbVie's Humira from some of its preferred drug reimbursement lists starting January 1, 2025, opting for less expensive biosimilar versions instead. This move reflects a broader trend among major U.S. pharmacy benefit managers to favor cost-effective biosimilars, thereby enhancing their market share.

However, despite these favorable conditions, challenges persist in this region. Legal disputes over patent infringements, such as Amgen's lawsuit against Samsung Bioepis regarding biosimilar versions of bone drugs Prolia and Xgeva, highlight the competitive and litigious nature of the market. Thus, North America's market is characterized by a supportive regulatory environment, strong healthcare infrastructure, and dynamic market forces that collectively drive its growth and evolution.

Competitive Landscape

The key global biosimilar monoclonal antibodies (mAbs) market players are

1. Pfizer Inc.
2. Novartis AG
3. Amgen Inc.
4. Celltrion Inc.
5. Samsung Bioepis
6. Dr. Reddy’s Laboratories
7. Biocon Limited
8. Boehringer Ingelheim GmbH
9. Mylan N.V.
10. Teva Pharmaceutical Industries Ltd.
11. and others

Recent Developments by the Key Players

• June 2024- Bengaluru-based biopharmaceutical company Biocon Biologics (BBL) received approval from the European Medicines Agency (EMA) to manufacture biosimilar Bevacizumab at its newly developed multi-product monoclonal antibodies (mAbs) drug substance facility in Bengaluru.