Biosimilar Testing and Development Services Market Expected to Reach $7.8 Billion by 2032—Allied Market Research

According to a new report published by Allied Market Research, titled, “Biosimilar Testing and Development Services Market," The biosimilar testing and development services market size was valued at $2.5 billion in 2022, and is estimated to reach $7.8 billion by 2032, growing at a CAGR of 12.1% from 2023 to 2032. The biosimilar testing and development services market trends that drive the growth include, the surge in demand for biosimilars, which results in a growing need for biosimilar testing and development services, and the rise in outsourcing of preclinical, clinical, and laboratory testing services by pharma and biotech companies.

In addition, the rise in the prevalence of chronic diseases such as cancer, arthritis, Crohn’s disease, and others drives the growth during the biosimilar testing and development services market forecast.  According to WHO, in 2020, it was estimated that globally 2.3 million women were diagnosed with breast cancer and about 685,000 deaths occurred due to breast cancer. Trastuzumab (Herceptin), a biological medicine, is a targeted cancer drug. It is used to treat breast cancer and advanced stomach cancer. Examples of biosimilars for trastuzumab include Herzuma and Ontruzant.

Furthermore, rituximab injection is used to treat a type of cancer called non-Hodgkin's lymphoma (NHL). According to the American Cancer Society, the biosimilar of rituximab are Truxima, Ruxience, and Riabni. Furthermore, in 2021, U.S. Food and Drug Administration (U.S. FDA) approved Cyltezo, a biosimilar to Humira (adalimumab) and the first interchangeable biosimilar for inflammatory forms of arthritis, psoriasis and inflammatory bowel disease. Cyltezo is scheduled to become available in 2023. 

The demand for biosimilars has increased the need for biosimilar testing and development services. These services involve comprehensive testing and analytical evaluations to demonstrate the similarity of the biosimilar to the reference biologic in terms of structure, function, purity, and potency. Thus, the surge in demand for biosimilars is expected to drive the growth during biosimilar testing and development services market analysis.

Furthermore, the cost-effectiveness of the biosimilars as compared to the reference biological drug is expected to drive the growth of the biosimilar testing market. As the demand for affordable healthcare continues to rise, biosimilars have gained traction as a viable alternative to expensive originator biologics. Biosimilars require less extensive clinical testing as compared to original biologics. Biosimilars provide more affordable alternatives to expensive biologics.

Biosimilars help governments and healthcare providers control escalating healthcare costs while maintaining the same level of treatment efficacy and safety. This cost-effectiveness benefits healthcare systems as well as improves patient outcomes, as more patients can afford treatments that were previously out of reach. As biosimilars offer a more affordable alternative to costly originator biologics, pharmaceutical companies, and healthcare organizations are increasingly investing in the development and commercialization of biosimilars. Thus, a surge in demand for biosimilars, owing to their cost effectiveness, is expected to increase the demand for biosimilar testing and development services and drive the growth of the biosimilar testing industry.

In addition, demonstrating the similarity of a biosimilar to the reference product requires rigorous testing and analysis to ensure its safety and efficacy. Biosimilar testing and development services play a crucial role in this process. These services involve comprehensive analytical, preclinical, and clinical studies to establish the bio-similarity of the product to the reference biologic. Specialized testing laboratories and contract research organizations (CROs) offer expertise in conducting comparative analytical studies, pharmacokinetic and pharmacodynamic assessments, immunogenicity testing, and others. Thus, the emergence of biosimilars as cost-effective alternatives for more expensive biological drugs is expected to drive the growth of the biosimilar testing and development services market. However, patent expiration of biological drugs is expected to serve as a growth opportunity for the biosimilar testing market size.

Based on type, the market is classified into pharmacokinetics, immunogenicity, and others. Others include ligand binding assay, biomarker, and stability testing. The pharmacokinetics segment was the largest revenue contributor to the biosimilar development services market share in 2022, owing to understanding the pharmacokinetic profile is crucial to demonstrating bioequivalence with the reference biologic. However, the Immunogenicity segment is expected to register the fastest growth during the forecast period owing to immune reactions that can lead to adverse effects or reduced therapeutic efficacy.

Based on end-users, the market is classified into pharmaceutical and biopharmaceutical companies, contract research organizations, and others. The pharmaceutical and biopharmaceutical companies segment was the highest revenue contributor to the biosimilar testing and development services market share in 2022, due to the high demand for biosimilars. However, contract research organizations are expected to register the fastest growth during the forecast period, owing to the high adoption of outsourcing of biosimilar testing and development services as it is a cost-effective method. 

Based on region, North America attained the highest biosimilar testing and development services market share in 2022 and is expected to maintain its lead during the forecast period, owing to a rise in demand for biosimilars to treat chronic diseases and patent expiration. However, Asia-Pacific is expected to exhibit the fastest growth during the forecast period, owing to favorable government initiatives such as funding and a rise in approval of biosimilars.

Key Findings of the Study

• On the basis of type, the pharmacokinetics segment was the highest contributor to the biosimilar development services industry in 2022. However, immunogenicity is expected to register the fastest growth during the forecasted period.
• On the basis of end users, the pharmaceutical and biopharmaceutical companies segment was the highest contributor to the market in 2022. However, contract research organization is expected to register the fastest growth during the forecasted period.
• On the basis of region, North America generated the largest revenue in 2022. However, Asia-Pacific is anticipated to grow at the highest CAGR during the forecast period.