Biopharmaceutical Contract Manufacturing Market Report: Size, Share and Outlook by 2031

The biopharmaceutical contract manufacturing sector is anticipated to grow significantly, reaching an estimated US$ 27,868.50 million by 2028, up from US$ 15,735.04 million in 2021. This growth represents a compound annual growth rate (CAGR) of 8.5% from 2021 to 2028. A major driver of this expansion is the increasing trend of outsourcing among pharmaceutical companies. Historically, the contract manufacturing industry was considered a specialized service market, providing additional manufacturing capacity or specific services to pharmaceutical firms. The emergence of Contract Manufacturing Organizations (CMOs) has been largely influenced by the rising incidence of drug manufacturing failures.

In the past, pharmaceutical companies typically managed their own manufacturing facilities to produce innovative drugs. However, to mitigate the risks associated with overcapacity, there has been a consistent rise in the demand for outsourced manufacturing solutions. Recently, Revolo Biotherapeutics formed a partnership with the contract development and manufacturing organization Northway Biotech to produce Revolo's binding immuno-regulatory protein 1805. This collaboration encompasses a range of services, including cell line development and protein manufacturing, along with quality assurance and regulatory compliance support.

Similarly, Gland Pharma has been engaged in the production of Remdesivir for multiple companies, including Mylan, since 2021, and has increased its manufacturing capacity in response to heightened demand. In another instance, Samsung Biologics and GI Innovation entered into a contract in 2019 for immunochemotherapy, where Samsung Biologics provided services from cell line development to the production of Phase-I drug substances. The growing number of agreements between biopharmaceutical firms and contract manufacturers indicates a robust expansion of the biopharmaceutical contract manufacturing market.

The global biopharmaceutical contract manufacturing market can be categorized based on product type, service offerings, and source of biologics. In terms of product segmentation, the market is divided into biologics and biosimilars. The biologics segment is projected to capture the largest market share from 2021 to 2028. This segment is expected to experience substantial growth due to the diverse range of products it encompasses, including monoclonal antibodies, recombinant proteins, vaccines, and more. The demand for biologics is on the rise, driven by increased research and development activities aimed at creating new drug products for chronic conditions. Additionally, the COVID-19 pandemic has further propelled the growth of the biologics segment, particularly with the heightened need for vaccines and monoclonal antibodies to address various chronic diseases stemming from metabolic, infectious, neurological, and other origins.

When examining the services offered, the biopharmaceutical contract manufacturing market is divided into several categories: process development, fill and finish operations, analytical and quality control studies, and packaging. The process development segment is expected to dominate the market during the forecast period, as it attracts the highest investments necessary for the production of any biopharmaceutical. The emphasis on scaling up from pilot to commercial production, along with cell line development and other related processes, is likely to create significant growth opportunities within this segment. Furthermore, the process development segment is subdivided into downstream and upstream processing, with downstream processing anticipated to hold a larger market share due to the greater volume of products developed in this area. The analytical and quality control studies segment is also expected to witness the highest growth rate.

In terms of sources, the biopharmaceutical contract manufacturing market is categorized into mammalian and microbial-based biologics/non-mammalian sources. The mammalian segment is projected to maintain a larger market share, as mammalian cell sources are more prevalent in the industry and can produce a wider array of products compared to microbial or non-mammalian sources.

Key organizations such as the World Health Organization (WHO), Association of Clinical Research Organizations (ACRO), European Federation of Pharmaceuticals Industries Associations (EFPIA), and Pharmaceutical Research and Manufacturers of America (PhRMA) are among the primary and secondary sources referenced in the analysis of the biopharmaceutical contract manufacturing market.