Biosimilar Monoclonal Antibodies Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (Infliximab, Rituximab, Abciximab, Trastuzumab, Adalimumab, Bevacizumab, Others), By Application (Oncology, Chronic & Autoimmune Diseases, Others), By Region and Competition, 2020-2030F

Market Overview

Global Biosimilar Monoclonal Antibodies Market was valued at USD 5.47 Billion in 2024 and is expected to reach USD 10.83 Billion in the forecast period with a CAGR of 12.03% through 2030. The biosimilar monoclonal antibodies (mAbs) market has emerged as a dynamic and transformative sector within the biopharmaceutical industry. Biosimilars, often referred to as "generic" versions of biologic drugs, have gained significant attention for their potential to provide cost-effective alternatives to expensive biologics while maintaining comparable safety and efficacy profiles. In recent years, biosimilar mAbs have been making remarkable strides, reshaping the pharmaceutical landscape and opening doors to improved patient access and healthcare affordability. Monoclonal antibodies are a class of biologic drugs designed to target specific proteins, cells, or tissues within the body. They have proven to be highly effective in treating a wide range of diseases, including cancer, autoimmune disorders, and inflammatory conditions. However, the complex nature of mAbs and the intricate manufacturing processes involved have led to high development costs and subsequently elevated treatment expenses. Biosimilar mAbs, in essence, are highly similar versions of approved reference mAbs. They are developed using recombinant DNA technology and manufactured in living cells. While they may not be identical to the reference product due to inherent variability in biologics, they are designed to be as close as possible in terms of safety, efficacy, and quality. One of the primary drivers is the urgent need for cost containment within healthcare systems worldwide. Biosimilar mAbs offer the potential to reduce healthcare expenditure significantly, as they typically enter the market at a lower price point compared to their reference counterparts, hence augmenting the growth of the market in the projected period.

Key Market Drivers

Rising Cancer and Autoimmune Disorders

​In recent years, the healthcare landscape has witnessed a significant surge in the prevalence of cancer and autoimmune disorders, two complex and challenging medical conditions that affect millions of individuals worldwide. As the incidence of these conditions continues to rise, the demand for effective and affordable treatments has led to the emergence and expansion of the biosimilar monoclonal antibodies (mAbs) market. This rapidly evolving market segment is playing a pivotal role in addressing the therapeutic needs of patients while offering potential cost savings for healthcare systems.​ Cancer, a group of diseases characterized by uncontrolled cell growth, remains a leading cause of death globally. In the European Union, new cancer cases rose by 2.3% compared to 2020, reaching 2.74 million in 2022. Similarly, cancer deaths increased by 2.4% over the same period.

Autoimmune disorders, resulting from a misdirected immune response where the body's immune system attacks its own healthy tissues, also contribute to a significant health burden. In the EU, between 27 and 36 million people live with a rare disease, many of which are autoimmune in nature.​

The biosimilar monoclonal antibodies market has witnessed rapid growth due to the increasing demand for more affordable treatment options for cancer and autoimmune disorders. Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have established guidelines and pathways for the approval of biosimilars, ensuring rigorous evaluation of their safety and efficacy. Since the EU approved the first biosimilar in 2006, healthcare professionals have gained increasing experience with their use. Today, biosimilars are an integral part of the effective biological therapies available in the EU, supported by adequate safeguards protecting patient safety.​

As the prevalence of cancer and autoimmune disorders continues to rise, the role of biosimilar monoclonal antibodies in providing cost-effective and accessible treatment options becomes increasingly vital in addressing the therapeutic needs of patients across Europe.

Rising Regulatory Support

​Regulatory agencies worldwide have established comprehensive guidelines to ensure the safety, efficacy, and quality of biosimilar monoclonal antibodies. These guidelines mandate rigorous scientific and clinical evaluations before market approval, aiming to confirm that biosimilars are highly similar to their reference products without clinically meaningful differences. For instance, the European Medicines Agency (EMA) requires developers to demonstrate through extensive comparability studies that their biosimilar matches the reference medicine in terms of quality, safety, and efficacy.​

Similarly, the U.S. Food and Drug Administration (FDA) has approved 44 biosimilars to 14 different reference products as of November 2023, encompassing treatments for conditions such as macular degeneration, rheumatoid arthritis, multiple sclerosis, diabetes, inflammatory bowel disease, and various cancers. These approvals are based on stringent regulatory frameworks that ensure biosimilars meet high standards of quality and performance.​

The expiration of patents for originator monoclonal antibodies has opened the market for biosimilar alternatives, presenting opportunities for manufacturers to offer cost-effective options. The robust regulatory pathways established by agencies like the EMA and FDA have instilled confidence among healthcare professionals and patients regarding the safety and efficacy of biosimilar monoclonal antibodies.​

As the market for biosimilars continues to grow, these regulatory frameworks play a crucial role in facilitating access to affordable and effective biological medicines, thereby enhancing patient care and supporting the sustainability of healthcare systems.

Download Free Sample Report

Key Market Challenges

Manufacturing Complexity

The manufacturing process of biosimilar monoclonal antibodies (mAbs) is inherently complex, largely due to the biological nature of the products involved. Biosimilars are produced using living cells, which introduce variability in terms of expression systems, cell lines, and culture conditions. This variability can result in differences in the final product compared to the reference biologic. Maintaining consistency in product quality and ensuring that the biosimilar closely matches the reference product in terms of physicochemical properties, biological activity, and immunogenicity is a significant challenge. Even minor variations in manufacturing processes can lead to differences in therapeutic outcomes, which can compromise the safety and efficacy profile of the biosimilar. As such, stringent quality control measures and advanced analytical techniques are required to ensure the biosimilar’s comparability to the reference product. This complexity increases the cost and time required for biosimilar development, and achieving regulatory approval demands continuous investment in ensuring manufacturing consistency.

Clinical Trials and Data Requirements

To gain regulatory approval, biosimilar developers must provide comprehensive clinical trial data that demonstrate the safety and efficacy of their product in comparison to the reference monoclonal antibody (mAb). Regulatory agencies such as the EMA and FDA require clinical studies to confirm that the biosimilar performs similarly to the reference product in terms of both therapeutic outcomes and side effect profiles. Designing these trials is a complex task, as it involves selecting appropriate endpoints, patient populations, and ensuring statistical power to demonstrate equivalence. Recruitment for such trials can be resource-intensive, particularly in rare or niche diseases, leading to increased costs and longer development timelines. Furthermore, the trials must be conducted under the same rigorous standards as those for original biologics, ensuring that all potential risks are assessed adequately. As a result, generating sufficient clinical data to meet these requirements can be a challenging and resource-draining aspect of biosimilar development, affecting the speed at which these alternatives can reach the market.

Key Market Trends

Technological Advancements

The pharmaceutical industry has experienced a seismic shift in recent years, driven by remarkable advancements in biotechnology and innovative research methodologies. Among the significant breakthroughs, biosimilar monoclonal antibodies (mAbs) have emerged as a potent force shaping the medical landscape. These cutting-edge therapeutic agents are revolutionizing the treatment of various diseases, ranging from cancer to autoimmune disorders. The rapid growth of the biosimilar mAbs market is intricately intertwined with the continual progress in technology and innovation. Advancements in technology have enabled a deeper understanding of disease mechanisms and patient variability. This has paved the way for the concept of precision medicine, where treatments are tailored to individual patients based on their genetic makeup, disease characteristics, and response to therapy. Biosimilar mAbs hold immense promise in this regard, as they can be developed to target specific disease pathways with greater precision. This approach not only enhances therapeutic outcomes but also minimizes side effects, thereby improving patient quality of life. One of the key drivers behind the biosimilar mAbs market's growth is the continual evolution of bioprocessing and manufacturing technologies. Innovations in cell culture techniques, purification processes, and bioreactor designs have enabled manufacturers to produce biosimilar mAbs with higher purity and yield. This not only ensures the safety of the end product but also reduces production costs, making these therapies more economically viable for patients and healthcare systems. Accurate characterization and comparison of biosimilar mAbs with their reference products are critical to ensuring their safety and efficacy. Technological advancements in analytical techniques, such as mass spectrometry, nuclear magnetic resonance, and high-performance liquid chromatography, have made it possible to comprehensively assess the structural and functional similarities between biosimilars and reference mAbs. This level of detail is essential for regulatory approval and gaining physicians' and patients' trust in the product.

Segmental Insights

Product Insights

Based on the Product, Infliximab emerged as the dominant segment in the Global Biosimilar Monoclonal Antibodies Market in 2024. This is due to its widespread use in the treatment of various chronic and autoimmune conditions, including rheumatoid arthritis, Crohn’s disease, ulcerative colitis, and ankylosing spondylitis. Infliximab, a monoclonal antibody that targets tumor necrosis factor-alpha (TNF-α), plays a critical role in reducing inflammation and immune system overactivity, making it a cornerstone of biologic therapies for these diseases. As patents for the reference infliximab product (Remicade) have expired, the market for its biosimilars has expanded significantly. These biosimilars offer a more affordable alternative to the original biologic, increasing patient access to treatment, particularly in regions with high healthcare costs. The availability of multiple infliximab biosimilars has led to competitive pricing, further driving market growth.

Application Insights

Based on the Application, Chronic & Autoimmune Diseases emerged as the dominant segment in the Global Biosimilar Monoclonal Antibodies Market in 2024. This is due to the growing prevalence of conditions such as rheumatoid arthritis, lupus, inflammatory bowel diseases, and multiple sclerosis, which require long-term treatment with biologic therapies. Monoclonal antibodies (mAbs) are widely used for managing these diseases due to their ability to specifically target immune system dysfunctions and inflammatory pathways, leading to more effective and targeted treatment outcomes. Biosimilars, which are highly similar to their reference biologics, have become increasingly important in managing chronic and autoimmune diseases. The high cost of original biologic therapies has made biosimilars an attractive alternative, providing more affordable treatment options while maintaining efficacy and safety. Regulatory agencies like the EMA and FDA have approved several biosimilars for these indications, facilitating wider access to these treatments.

Download Free Sample Report

Regional Insights

North America emerged as the dominant region in the Global Biosimilar Monoclonal Antibodies Market in 2024. This is driven by the region’s strong healthcare infrastructure, regulatory support, and rising demand for affordable biologic treatments. The United States, in particular, plays a crucial role in this dominance, as it is home to a large population of patients suffering from chronic and autoimmune diseases, such as rheumatoid arthritis, multiple sclerosis, and cancer, who require long-term biologic therapies. The high cost of original biologics has led to a growing preference for biosimilars, which offer similar therapeutic benefits at a significantly lower cost. The U.S. Food and Drug Administration (FDA) has approved several biosimilars in recent years, creating a favorable regulatory environment that facilitates the entry of biosimilars into the market. The FDA’s accelerated approval processes and the introduction of policies to encourage biosimilar adoption have bolstered the uptake of these alternatives.

Asia-Pacific emerged as the fastest growing region in the Global Biosimilar Monoclonal Antibodies Market during the forecast period. The Asia-Pacific region is home to a diverse range of economies, each with its unique healthcare challenges. As the burden of chronic diseases and complex medical conditions increases, the demand for effective and affordable treatment options has grown. Biosimilar monoclonal antibodies offer a viable solution, providing access to advanced therapies that were previously financially out of reach for many patients. With a focus on cost-effectiveness, Asian healthcare systems are increasingly turning to biosimilars to bridge the gap between patient needs and budget constraints.

Recent Developments

• In March 2025, Celltrion, Inc. announced that its infliximab biosimilar will be marketed in Canada under the new brand name Remdantry starting April 1, 2025, following approval from Health Canada. The product retains the same Drug Identification Number (DIN) as Inflectra, with no changes to formulation, indications, or dosage. It continues to be approved for conditions such as rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, fistulising Crohn's disease, and ulcerative colitis.
• In February 2025, Celltrion announced that the European Commission (EC) has granted marketing authorization for two biosimilars: Eydenzelt (CT-P42, aflibercept), a biosimilar to Eylea for treating retinal disorders, and Stoboclo and Osenvelt (CT-P41, denosumab), biosimilars to Prolia and Xgeva. Eydenzelt® treats conditions such as age-related macular degeneration and diabetic macular edema, while Stoboclo and Osenvelt are used for skeletal-related disorders. This approval enhances Celltrion’s biosimilars portfolio in key therapeutic areas, including ophthalmology and skeletal health.
• n September 2024, Fresenius Kabi, a leader in biopharmaceuticals, clinical nutrition, and medical technologies, alongside Formycon AG, a top developer of biosimilars, announced that the U.S. Food and Drug Administration (FDA) has approved Otulfi (ustekinumab-aauz), a biosimilar to Stelara (ustekinumab). Otulfi is approved for treating Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. This approval marks a significant step in Fresenius Kabi’s strategy to expand its Biopharma platform, a key component of its #FutureFresenius initiative.
• In June 2024, Biocon Biologics, a subsidiary of Biocon, secured approval from the European Medicines Agency (EMA) to manufacture its biosimilar Bevacizumab in India. This approval marks a significant milestone for Biocon Biologics as it strengthens its position in the European market for biosimilars. Bevacizumab, a monoclonal antibody used in cancer treatment, is a critical product in oncology therapies. With this EMA approval, Biocon Biologics will now be able to produce the biosimilar in India, which will allow the company to cater to the growing demand for affordable cancer treatments in Europe and beyond.
• In May 2023, Enzene Biosciences introduced Cetuximab, the inaugural biosimilar for cancer treatment. Marketed as Erbitux, Cetuximab is a chimeric monoclonal antibody with therapeutic applications. It serves as a focused treatment for metastatic colorectal cancer (mCRC) and head and neck cancer. The cost for an individual patient's eight-week treatment period is approximately $30,000.
• In July 2023, Aurobindo Pharma has notified the stock exchanges that its fully owned affiliate, CuraTeQ Biologics Private Ltd, has established an exclusive licensing arrangement with BioFactura Inc, a US company, to market BFI-751. This is a potential biosimilar of BioFactura's product Stelara (Ustekinumab).

Key Market Players

• Abbott
• Pfizer
• Novartis AG
• AbbVie, Inc.
• Coherus BioSciences
• Biocon Limited
• Allergan plc.
• Accord Healthcare limited.
• Amgen inc.
• Dr. Reddy’s Laboratory

 Report Scope:

In this report, the Global Biosimilar Monoclonal Antibodies Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Biosimilar Monoclonal Antibodies Market, By Product:

o   Infliximab

o   Rituximab

o   Abciximab

o   Trastuzumab

o   Adalimumab

o   Bevacizumab

o   Others

• Biosimilar Monoclonal Antibodies Market, By Application:

o   Oncology

o   Chronic & Autoimmune Diseases

o   Others

• Biosimilar Monoclonal Antibodies Market, By Region:

o   North America

o   Asia-Pacific

o   Europe

o   Middle East & Africa

o   South America

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Biosimilar Monoclonal Antibodies Market.

Available Customizations:

Global Biosimilar Monoclonal Antibodies Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Middle East & Africa Biosimilar Monoclonal Antibodies Market is an upcoming report to be released soon. If you wish an early delivery of this report or want to confirm the date of release, please contact us at sales@techsciresearch.com