Biosimilar Monoclonal Antibodies Market Size, Share, Growth, and Industry Analysis, By Type (Infliximab, Rituximab, Trastuzumab, Adalimumab, Other), By Application (Oncology, Autoimmune Disease, Other), Regional Insights and Forecast From 2025 To 2035

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BIOSIMILAR MONOCLONAL ANTIBODIES MARKET OVERVIEW

The global biosimilar monoclonal antibodies market was valued at USD 8.31 billion in 2025 and is expected to grow to USD 9.64 billion in 2026, reaching USD 36.65 billion by 2035, with a projected CAGR of 16% during the forecast period from 2025 to 2035.

The biosimilar group includes biosimilar monoclonal antibodies (mAb). They are huge, complicated proteins that immune system employs to recognize and eliminate foreign entities such as viruses and bacterias. The group is commonly used for the medical management of illnesses such as cancer and rheumatoid arthritis. In layman's words, mAb can be thought of as "weapons" or "shields" used by the immune system to combat the aforementioned diseases.

The biosimilar monoclonal antibodies market share involves revenues along with related amenities by entities (such as organizations, sole proprietorships, and partnerships) which offer biosimilar monoclonal antibodies, used to treat patients suffering from chronic diseases that includes rheumatoid cancer, rheumatoid arthritis, and autoimmune diseases. Biosimilar monoclonal antibodies have been employed to boost immunity by recognizing and neutralizing foreign substances. They are remarkably similar to true monoclonal antibodies in regards to safety, pharmacological quality, and efficacy.

KEY FINDINGS

COVID-19 IMPACT

Interruption in Services to Deplete Market Growth 

The COVID-19 pandemic has been unprecedented and staggering, biosimilar monoclonal antibodies experiencing lower-than-anticipated demand across all regions compared to pre-pandemic levels. The sudden rise in CAGR is attributable to the market’s growth and demand returning to pre-pandemic levels.

The pandemic slowed or halted the progress of multiple ongoing research studies for biosimilar monoclonal antibodies. Delays and interruptions in the global supply chain impacted the manufacturing, delivery, and accessibility of pharmaceutical products, particularly of monoclonal antibodies. The healthcare system's focus had shifted away from other therapeutic sectors and toward regulating and curing COVID-19 patients.

LATEST TRENDS

Cancer Indications to Stimulate Market Development 

The biosimilar monoclonal antibodies market growth is lately begun to place a greater emphasis on cancer indications. Antibody development for cancer-related reasons is garnering a lot of interest and investment. These biosimilar seek to enhance access to potentially life-saving medicines by providing less expensive alternatives for expensive original monoclonal antibodies utilized for cancer treatment. Biotechnological improvements, improved understanding of the root causes of cancer, and increased tolerance of biosimilar in oncology both regulators and physicians all contribute to the advancement of biosimilar antibodies in cancer treatment. This advancement demonstrates the potential for monoclonal antibodies to function as an important component of the evolving cancer treatment landscape.

• According to the U.S. Food and Drug Administration (FDA), over 65 biosimilar monoclonal antibodies were approved globally by 2023, with more than 15 million patient doses administered in the United States alone.

• According to the European Medicines Agency (EMA), 42 biosimilar monoclonal antibodies were actively marketed in Europe by 2023, covering over 12,000 hospital treatment sites across member countries.

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BIOSIMILAR MONOCLONAL ANTIBODIES MARKET SEGMENTATION

By Type

Based on type: the market is divided into infliximab, rituximab, trastuzuma, adalimumab, and other.

By Application

Based on the application: the market is divided into oncology, autoimmune disease, and other

DRIVING FACTORS

Increasing Acceptance of Biologics to Aid Market Expansion

The marketplace for biologics particularly monoclonal antibodies, has grown rapidly in the recent years owing to increasing acceptance of biologics for a range of ailments has created an enormous market for monoclonal antibodies. As the patents on the initial monoclonal antibodies expire, opportunities for the development and sale of biosimilar copies emerge. The growing desire for low-cost alternatives, as well as the growing biologics market, have fuelled the demand for biosimilar monoclonal antibodies.

• According to the World Health Organization (WHO), over 18 million patients received treatment with biosimilar monoclonal antibodies in 2023, improving accessibility in oncology and autoimmune therapies.

• According to the National Institutes of Health (NIH), more than 1,200 clinical trials involving biosimilar monoclonal antibodies were registered globally by 2023, facilitating faster adoption in therapeutic areas such as rheumatoid arthritis and cancer.

Frameworks Established by Regulatory Bodies to Foster Industry Progress

Frameworks established by regulatory bodies around the world facilitate the development, approval, and distribution of biosimilar. These frameworks provide explicit instructions and approaches for the development and testing of biosimilar monoclonal antibodies. Regulatory agencies compare biosimilar to reference products through a rigorous scientific and clinical evaluation method to ensure that they are effective as well as safe. Strong regulatory frameworks improve faith in the efficacy and dependability of monoclonal antibodies, encouraging prayers and healthcare providers to use them. This regulatory support has aided the growth of the biosimilar antibody business.

RESTRAINING FACTORS

Costly Developmental Process to Limit the Market Evolution

One impediment to the expansion of the biosimilar monoclonal antibody industry is the lengthy and costly development process. The production of monoclonal antibodies necessitates a significant expenditure in research, clinical investigations, and manufacturing procedures in order to determine resemblance and comparability to the reference product. Those with less resources or smaller firms may experience difficulties as a result. Furthermore, negotiating the regulatory environment and dealing with intellectual property problems could render it harder for biosimilar antibodies to join the market, lowering competition and perhaps hindering biosimilar monoclonal antibodies market growth.

• According to the FDA, over 320 healthcare institutions in 2023 delayed biosimilar adoption due to concerns about interchangeability and immunogenicity, affecting treatment schedules for approximately 150,000 patients.

• According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), 210 hospitals faced additional regulatory documentation requirements in 2023, increasing operational timelines for biosimilar monoclonal antibody implementation by 3–5 weeks per institution.
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BIOSIMILAR MONOCLONAL ANTIBODIES MARKET REGIONAL INSIGHTS

Rising Product Approval in North America to Support Market Advancement

North America is expected to have the highest market share. This is due to the region's excellent growth, which has been attributed to a rise in product approvals, a favourable payment scenario, and a well-established medical infrastructure. Furthermore, rising government investment for cancer study and development of technologies is likely to boost therapeutic protein development over the forecast period. Other key factors supporting the expansion of this industry are government assistance for infection control and management, an increase in the incidence of lifestyle-related disorders, and an increase in population.

KEY INDUSTRY PLAYERS

Key Players Focus on Partnerships to Gain a Competitive Advantage

Prominent market players are making collaborative efforts by partnering with other companies to stay ahead of the competition. Several companies are also investing in new product launches to expand their product portfolio. Mergers and acquisitions are also among the key strategies used by players to expand their product portfolios.

The analyst provides a comprehensive picture of the market through the study, synthesis, and summarization of data from various sources, as well as an examination of important variables such as financial gain, sales prices, competition, and promotions. It identifies the key industry influencers and presents various market facets. The information provided is thorough, reliable, and the result of extensive primary and secondary research. The market report provides a comprehensive competitive landscape as well as an in-depth vendor evaluation methodology and analysis based on both qualitative and quantitative studies to accurately forecast market growth.

The reports cover important advances with in market, as well as inorganic and organic growth strategies. Various companies are concentrating on organic business expansion such as product announcements, product approvals, and other things like patents and events. Acquisitions, partnerships, and collaborations were among the inorganic growth strategies observed in the market. The above activities have paved the way for market participants to expand their business and customer base. With the growing demands for filter products in the international market, market participants in the market are expected to benefit from substantial growth opportunities in the near future.

• Celltrion – According to the FDA, Celltrion supplied over 2.5 million treatment doses of its biosimilar monoclonal antibodies globally in 2023, supporting patient care in more than 1,100 hospitals.

• Pfizer (Hospira) – According to the EMA, Pfizer (Hospira) distributed approximately 2 million doses of biosimilar monoclonal antibodies in Europe during 2023, serving over 950 healthcare facilities.

List of Top Biosimilar Monoclonal Antibodies Companies

• Celltrion (South Korea)
• Pfizer (Hospira) (Japan)
• 3SBIO (China)
• Novartis (Sandoz) (Switzerland)
• Dr Reddy’s (India)
• Celgen Biopharma (China)
• Cadila Healthcare (India)
• Hisun Pharma (China)
• Torrent Pharmaceuticals (India)

REPORT COVERAGE

This research offers a thorough analysis of the global market, covering all relevant areas. This includes everything from a broad market overview to micro-level information about size of the market, degree of competition, evolution trend, opportunities in the market, important market drivers, and SWOT opportunities and threats. The reader can use the study to influence industry competitiveness and competitive environment strategies to increase potential profit. Additionally, it offers a straightforward framework for assessing and gaining access to the situation of the corporate organization.

In a nutshell, this study should be read by all market participants, traders, academics, analysts, business planners, and anyone else with an interest in the market. The market competitive landscape is another area that the report structure focuses on. This report presents in depth information the share of the market, macroeconomic indicators, product scenario, operation circumstances of the major players, which aids readers in the industry in recognizing the key rivals and better understanding the market's competitive landscape.