Biosimilar Monoclonal Antibody Market Size to Surpass USD 69 Billion By 2032

The global biosimilar monoclonal antibody market size was valued at USD 8.6 billion in 2022 and is projected to surpass around USD 69 billion by 2032, expanding at a healthy CAGR of 23.2% from 2023 to 2032.

The global biosimilar monoclonal antibody market size accounted for USD 10.55 billion in 2023 and is expected to reach around USD 36.63 billion by 2029. North America has held the maximum market share of 35% in 2022.

The pharmaceutical sector is witnessing a dramatic transition in the biosimilar monoclonal antibody market. Medical treatments are changing as a result of biotechnological advancements, with biosimilar monoclonal antibodies becoming more affordable than their original equivalents. By imitating the therapeutic properties of current monoclonal antibodies, these created molecules improve accessibility to life-saving therapies. The industry is growing quickly because of the potential to reduce healthcare costs and increase patient access. In order to ensure the efficacy and safety of biosimilars, regulatory frameworks are changing, which gives the market more trust. Thus, the landscape indicates a potential change towards more accessibility to state-of-the-art medical treatments, which represents a noteworthy advancement in the development of the biosimilar monoclonal antibody market.

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Growth factors

• Biosimilar monoclonal antibodies are appealing to patients and healthcare professionals because they provide a more cost-effective substitute for the original biologics. There is an increasing need for affordable treatment choices as healthcare costs rise.
• A large number of the initial monoclonal antibody patents have expired or are about to expire. This gives producers of biosimilars a chance to enter the market and make these biologics at a lower cost.
• Regulatory bodies around the country are opening up to biosimilars and expediting the licensing process. This promotes market expansion by incentivizing firms to allocate resources towards the creation of biosimilar monoclonal antibodies.
• Increased spending on healthcare, particularly in developing nations, fuels the market for biosimilar monoclonal antibodies. There is a greater ability to accept and incorporate biosimilars into therapy regimens as healthcare receives greater funding.
• The development, approval, and commercialization of biosimilar monoclonal antibodies are facilitated by partnerships between regulatory authorities and industry players, as well as collaborations between pharmaceutical corporations and biosimilar manufacturers.

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Key Insights:

• In 2022, the segment with the most market share, infliximab, was 32%.
• Between 2023 and 2032, the adalimumab segment is projected to expand at an astounding CAGR of 24.7%.
• In 2022, the oncology indication segment accounted for about 44% of total revenue.
• Over the anticipated period, the segment related to autoimmune illnesses is expected to grow at the quickest CAGR.
• In 2022, the hospital segment commanded the highest market share of 49%.

Regional Stance

North America accounted for the greatest revenue share of 35% in 2022. There are a number of strong reasons why North America is leading the biosimilar monoclonal antibody industry. The area gains from having a sophisticated healthcare system, an established legal system, and high healthcare spending, all of which support the creation and broad use of biosimilars.

Furthermore, North America's dominance in this market is further supported by a strong pharmaceutical sector, a healthy ecosystem for research and development, and an increasing need for affordable biologic medicines. Among the most important countries in the North American area, the United States, has demonstrated leadership in fostering biosimilar competition, thereby solidifying the region's leading position in the biosimilar monoclonal antibody market.

Asia-Pacific is predicted to grow at the quickest rate throughout the projection period, with a CAGR of 8.3%. For a number of reasons, the biosimilar monoclonal antibody market in Asia-Pacific is expected to rise significantly. Because of the region's high population and rising healthcare costs, there is a need for more economical treatment choices, which makes biosimilars a desirable option. Additionally, the development and approval of biosimilars is facilitated by regulatory systems that are supportive, such as those found in South Korea and India.

The market is further supported by the existence of well-known pharmaceutical businesses and an increasing focus on biotechnology. Furthermore, the increased occurrence of chronic illnesses like cancer in the area generates a considerable need for biosimilar monoclonal antibodies, hence solidifying Asia-Pacific's noteworthy advancements in this field.

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Biosimilar Monoclonal Antibody Market Scope

Market Drivers

Increasing Prevalence of Chronic Diseases:

The growing incidence of chronic illnesses like cancer, autoimmune diseases, and infectious infections is driving the market for biosimilar monoclonal antibodies. Biosimilars are becoming widely used because of the increased demand for biologic medicines that are both cost-efficient and efficacious due to the expanding worldwide burden of these disorders. Biosimilar monoclonal antibodies provide an appealing way to address the growing healthcare needs related to chronic illnesses as individuals look for easily accessible and reasonably priced treatment choices. The significance of biosimilars in fulfilling the treatment needs of an expanding patient base facing various chronic health issues is highlighted by this trend.

Advancements in Analytical Techniques:

As analytical tools continue to evolve, the ability to evaluate and determine the degree of similarity between biosimilar monoclonal antibodies and their reference products has greatly improved. The process of developing biosimilars as a whole is strengthened by these advances in analytical skills. Regulatory agencies and healthcare professionals alike are reassured when biosimilars can be properly analyzed and shown to be identical to their original equivalents. In order to successfully integrate biosimilar monoclonal antibodies into clinical practice and ensure that they meet the strict requirements needed for safety and efficacy in medical treatments, there must be a greater degree of confidence.

Improvements in Manufacturing Processes:

Constant improvements in manufacturing procedures are essential to increasing the manufacture of biosimilars' scalability and efficiency. The advancement of manufacturing technologies has enabled companies to leverage economies of scale, resulting in a decrease in the cost of producing biosimilar monoclonal antibodies. These enhancements help make the production of biosimilars more cost-effective overall while also streamlining the manufacturing process. Consequently, improved production process efficiency creates a more favorable and accessible environment for these biologic therapeutics, thereby increasing their potential influence on patients' access to life-saving therapies.

Market Restraints

Complex Regulatory Processes:

The complex regulatory procedures in the biosimilar monoclonal antibody business provide a major obstacle. Comprehensive clinical trials requiring substantial resources are necessary to show similarity to reference goods according to the strict requirements. This intricacy frequently results in longer development schedules and higher development expenses, which restrains the market's expansion. While necessary to guarantee safety and efficacy, the strict regulatory standards also provide a barrier that may delay the timely and economical introduction of biosimilar monoclonal antibodies into the healthcare system.

Risk of Immunogenicity Concerns:

The use of biosimilar monoclonal antibodies carries a risk of immunogenicity, which is the possibility that a patient's immune system would identify and react to the biosimilar in a way that could compromise its effectiveness and safety. It is difficult to effectively address and mitigate these immunogenicity concerns, which means that monitoring and assessment must be done carefully both throughout the development and post-marketing phases. The possibility of immunological reactions emphasizes how crucial it is to take thorough precautions to guarantee the safety profile and efficacy of the biosimilar in actual clinical situations. Maintaining the trust of patients, healthcare professionals, and regulatory agencies in the use of biosimilar monoclonal antibodies as effective and secure treatment alternatives depends on this constant watchfulness.

Market Access Barriers:

There are a number of variables that can limit the market availability of biosimilar monoclonal antibodies, including physician preferences, formulary decisions, and reimbursement rules. In areas where reimbursement regulations are uncertain or where there is reluctance to changes in clinical practices, market access barriers may pose a threat to the commercial viability of these biologic medicines. Overcoming these obstacles to market access is just as important to the success and broad acceptance of biosimilar monoclonal antibodies as their efficacy and safety. To enable the wider availability and adoption of biosimilar monoclonal antibodies in the healthcare environment, more efforts must be made to address opposition within clinical settings and to clarify payment guidelines.

Market Trends

Therapeutic Diversification:

Biosimilar monoclonal antibodies (mAbs) were first mainly employed to treat autoimmune disorders and cancer. But there has been a noticeable change, with an increasing trend towards diversification into different therapeutic areas. Companies are currently actively researching how biosimilars might be used to treat ailments other than autoimmune disorders and cancer. This pattern entails a broader reach into domains like ophthalmology and inflammatory illnesses, suggesting a deliberate progression in the utilization of biosimilar monoclonal antibodies throughout several medical specialties.

Biosimilar Uptake:

Regional differences might be seen in the uptake of biosimilar monoclonal antibodies (mAbs). Compared to certain other markets, biosimilars have been adopted more widely in Europe, where there is generally a stronger acceptance of them. Biosimilar mAbs are being integrated into medical practices more widely as a result of the region's favorable regulatory climate and well-established frameworks for biosimilar licensing, which have led to better acceptability. Different regulatory environments or various degrees of confidence in the use of biosimilars, on the other hand, may cause a delayed acceptance in other areas.

Biosimilar Naming and Branding:

Regulations and continuous debate have surrounded the name and branding of biosimilars. A more efficient market might result from more accepted biosimilar names and clearer criteria. Standardizing the naming and branding of biosimilars could improve patient and healthcare professional confidence, decrease uncertainty, and facilitate communication as regulatory regimes continue to evolve. The eventual development of a more effective and cohesive biosimilar market may be facilitated by this nomenclature progression.

Related Reports

• Biosimilars Market: The global biosimilars market size surpassed USD 25.12 billion in 2022 and is projected to hit around USD 126.01 billion by 2032, growing at a CAGR of 17.6% during the forecast period from 2023 to 2032.
• Oncology Market: The global oncology market size reached USD 203.42 billion in 2022 and is projected to hit around USD 470.61 billion by 2032, growing at a CAGR of 8.8% during the forecast period from 2023 to 2032.
• Genomics Market: The global genomics market was valued at USD 28 billion in 2022 and is expected to reach over US$ 164.2 billion by 2032, poised to grow at a noteworthy CAGR of 19.4% from 2023 to 2032.

Recent Developments

• AMJEVITA (adalimumab-atto), a biosimilar to Humira (adalimumab), was introduced by Amgen Inc. in the US market in January 2023. The market for this popular medication is anticipated to be greatly impacted by the approval of this biosimilar of Humira, the first of its kind in the United States.
• In October 2022, Biocon and Yoshindo Inc. signed a contract for Biocon to sell its pipeline drugs, ustekinumab and desosumab, in Japan. The Japanese market may see unmet needs for the treatment of inflammatory and autoimmune illnesses addressed by these two biosimilars.
• In September 2022, the FDA approved Celltrion's adalimumab biosimilar, Yuflyma. The third Humira biosimilar to receive approval in the US is called Yuflyma, and it is anticipated to go up against Amgen's AMJEVITA.
• Inflectra, a Pfizer biosimilar to infliximab, was introduced in the US in 2018. With a substantial market share of infliximab, Inflectra is one of the most successful biosimilars to date.
• Humira, Lucentis, and Enbrel biosimilars are among the many effective biosimilars that Novartis offers. Additionally, Novartis is creating biosimilars for other popular biologics like Avastin and Rituxan.

Market Key Players:

• Roche
• Pfizer
• Novartis
• Amgen
• Mylan
• Samsung Bioepis
• Teva Pharmaceutical Industries
• Celltrion
• Fresenius Kabi
• Sandoz
• Biogen
• Boehringer Ingelheim
• Merck
• Amneal Pharmaceuticals
• Biocon

Market Segmentation

By Type

• Adalimumab
• Infliximab
• Bevacizumab
• Trastuzumab
• Rituximab
• Others

By Indication

• Oncology
• Autoimmune diseases
• Others

By End User

• Hospitals
• Cancer treatment centers
• Others

By Geography

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East and Africa

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