Biosimilar Monoclonal Antibody Market Expected to Reach $64.7 Billion by 2032—Allied Market Research

According to a new report published by Allied Market Research, titled, “Biosimilar Monoclonal Antibody Market," The biosimilar monoclonal antibody market was valued at $8.7 billion in 2022, and is estimated to reach $64.7 billion by 2032, growing at a CAGR of 22.2% from 2023 to 2032. Biosimilar monoclonal antibodies (mAbs) are biological products designed to be highly similar to existing reference or originator monoclonal antibodies. Monoclonal antibodies are protein molecules designed to pinpoint specific molecules within the body, finding utility in diverse therapeutic contexts, such as combatting cancer, autoimmune disorders, and blood-related issues.

Primary drivers propelling the expansion of the biosimilar monoclonal antibody market encompass the rise in chronic ailment incidence, increase in regulatory approvals, and rising research and development efforts to create biosimilar versions. Additionally, the surge in chronic ailment prevalence, such as cancer, autoimmune disorders, and inflammatory situations, creates a demand for economical treatment alternatives such as biosimilars. Biosimilar mAbs offer effective treatment options for these diseases, addressing unmet medical needs and providing patients with access to therapies that improve their quality of life. As chronic disease prevalence rises, the demand for biosimilar mAbs is anticipated to propel the market growth.

In addition, escalating costs of healthcare have compelled governments, healthcare systems, and payers to seek cost-effective alternatives without compromising on patient care. Biosimilar mAbs, offering similar therapeutic efficacy as reference originator, at lower costs, present a solution to the economic pressures faced by healthcare stakeholders. Further, as many blockbuster biologics' patents have expired or are nearing expiration, it has opened up opportunities for biosimilar manufacturers. As patents reach their expiration, biosimilar creators can attain access to the original manufacturer's clinical trial information. This grants them the capability to produce and introduce biosimilar adaptations of these biologic treatments. As a result, a competitive environment has arisen within the biosimilar monoclonal antibody market, consequently spurring the advancement and release of novel biosimilar offerings.

Furthermore, governments and regulatory agencies globally have implemented supportive measures to encourage the development and approval of biosimilar monoclonal antibodies. Specific regulatory pathways for biosimilars have been established, streamlining the approval process and providing clear guidelines for manufacturers. This supportive regulatory environment stimulates investments in biosimilar development and accelerates the biosimilar monoclonal antibody industry.

In addition, pharmaceutical companies have recognized the potential of the biosimilar monoclonal antibody market and are making substantial investments in R&D. The increasing competition has led to a more diverse and robust pipeline of biosimilar candidates targeting various therapeutic areas. Investments directed towards the advancement of biosimilars have additionally spurred enhancements in production capacities, clinical investigations, and post-market monitoring, contributing to the continued expansion of the biosimilar monoclonal antibody industry.

Moreover, developing economies such as India, China, Brazil, and South Korea are experiencing substantial progress in healthcare availability and infrastructure enhancement. These nations have instituted favorable regulations and endeavors to encourage the integration of biosimilar monoclonal antibodies, aligning with their aims to offer vital and cost-effective healthcare remedies for their inhabitants. Rise in middle-class population with higher healthcare needs in these regions further drives the biosimilar monoclonal antibody market trends

Moreover, efforts to increase awareness and education about biosimilars among healthcare professionals, patients and the general public have been instrumental in driving the market growth. Education programs highlight the safety and efficacy of biosimilars, dispel misconceptions, and emphasize their potential cost-saving benefits, thus fostering greater confidence in the use of these therapies and driving the biosimilar monoclonal antibody market analysis.

Furthermore, governments globally recognize the increasing prevalence of chronic diseases and its impact on public health. Supportive government initiatives, including research funding, regulatory reforms, and policies promote access to affordable patient care and, drive the development and availability of biosimilars. Government support plays a vital role in encouraging pharmaceutical companies to invest in R&D for biosimilars and ensuring patient access to these treatments.

Based on the type, the market is categorized into adalimumab, bevacizumab, infliximab, rituximab, trastuzumab, and others. The infliximab segment accounted for the largest biosimilar monoclonal antibody market share in terms of revenue in 2022. This is attributed to factors such as expiration of patent for infliximab enabling the introduction of biosimilar versions, offering comparable efficacy and cost-effectiveness. In addition, the growing prevalence of autoimmune diseases such as rheumatoid arthritis and Crohn's disease fueled the demand for biosimilar infliximab as an accessible treatment option, thereby driving the segment growth.

On the other hand, adalimumab segment is expected to witness highest CAGR during the forecast period. This is attributed to adalimumab's wide range of therapeutic applications in treating autoimmune diseases such as rheumatoid arthritis, psoriasis, and Crohn's disease, resulting in high demand for cost-effective options, which biosimilar versions offer. In addition, regulatory approvals, increase in physician confidence in prescribing biosimilar adalimumab due to robust clinical data and rigorous comparability studies, and favorable reimbursement policies in certain regions have collectively propelled the adoption of biosimilar adalimumab, thus contributing to its substantial market growth.

On the basis of indication, the market is categorized into oncology, autoimmune diseases, and others. The oncology segment accounted for the largest biosimilar monoclonal antibody market share in 2022 and is expected to register highest CAGR during forecast period, owing to rise in demand for cost-effective potent cancer therapies. Biosimilar monoclonal antibodies offer similar efficacy and safety profiles to original products while being more affordable, driven by patent expirations, supportive regulatory pathways, and growing confidence in their clinical outcomes.

On the basis of end user, the market is segmented into hospitals, cancer treatment centers and others. The hospital segment accounted for the largest biosimilar monoclonal antibody market size in 2022, and is expected to register the highest CAGR during forecast period. This is attributed to increase in adoption of biosimilar mAbs within hospital settings, driven by factors such as cost-effectiveness, expanding patient population and rise in demand for targeted therapies. In addition, hospitals offer better insurance coverage, specialized medical expertise, well equipped infrastructure for complex chronic disease treatments, and wide availability of biosimilar mAbs, thereby fueling the segment growth.

Region-wise, North America accounted for the largest biosimilar monoclonal antibody market size in 2022 and is expected to remain dominant during the forecast period, owing to factors such as increase in number of regulatory approvals, robust healthcare infrastructure enabling efficient distribution and adoption of biosimilars, strong physician acceptance and patient access, favorable reimbursement policies, advanced R&D and manufacturing capabilities, and proactive efforts to raise awareness and education about biosimilar mAbs.

However, Asia-Pacific is anticipated to witness notable growth during the forecast period. This is attributed to increase in demand for cost-effective treatments owing to increase in the number of people suffering from chronic diseases , presence of a large and aging population susceptible to chronic diseases, growing investments in biopharmaceutical research and manufacturing capabilities, and collaborations between local and international pharmaceutical companies, which all collectively foster a favorable environment for the adoption and expansion of biosimilar mAbs in the Asia-Pacific biosimilar monoclonal antibody market forecast.

Key Findings of the Study

• On the basis of type, the adalimumab segment dominated the market in terms of revenue in 2022.
• On the basis of indication, the oncology segment dominated the market in terms of revenue in 2022.
• Based on the end user, the hospitals segment dominated the market in terms of revenue in 2022.
• Region-wise, North America generated the largest revenue in 2022. However, Asia-Pacific is anticipated to grow at the highest CAGR during the forecast period.