Biopharmaceutical CDMO Market: Growth, Size, Share, and Trends

The global biopharmaceutical contract manufacturing market is segmented by services into manufacturing, formulation and fill-finish, packaging & labeling, and other services. Among these, the manufacturing services segment has established itself as the dominant category in 2024. This segment includes contract manufacturing services such as upstream and downstream manufacturing. In the biopharmaceutical contract manufacturing process, upstream manufacturing plays a vital role as the initial step. This phase involves cultivating and manipulating living cells or microorganisms to create the desired therapeutic proteins. It begins with a selection of the right cell line and then nurturing it through cell culture and fermentation. Vector amplification, editing, and expansion are critical steps in cellular therapies and viral vector & plasmid DNA manufacturing, as they directly impact the quantity, quality, and functionality. The success of upstream manufacturing determines the quantity and quality of the biologic product, setting the stage for the rest of the manufacturing process.

In 2024 the biologic drug substance manufacturing segment accounted for the largest share in the market. Biologic drug substance manufacturing involves creating the active ingredient of biologic drugs, which are complex molecules derived from living organisms. This process includes cultivating cells or microorganisms, engineering to produce the desired molecule, and then purifying and ensuring the quality of the final product. Strict regulatory standards must be followed to meet health authority requirements. Many pharmaceutical companies choose to outsource this intricate process to specialized contract manufacturing organizations to focus on research and development while ensuring the safety and effectiveness of biologic drugs.

The biopharmaceutical contract manufacturing market is segmented into clinical operations and commercial operations. The commercial operations segment accounted for the larger market share in the market in 2024. The large share of this segment can be attributed to the launch of biosimilars, growing cell & gene therapy approvals, and capacity expansion by biologic CMOs for commercial manufacturing. The commercial production of biologics is a crucial aspect of the biopharmaceutical industry, responding to the rising need for advanced medical treatments. Biologics, which are complex molecules derived from living organisms, hold promising activities for treating a variety of conditions, from cancer to autoimmune diseases. This has prompted increased research and development, leading to more biologics gaining regulatory approval. Commercial production involves upscaling the manufacturing of biologics from lab setups to larger industrial facilities. This expansion is essential to meet the growing demand for these therapies. The process includes stages such as cell culture or fermentation, purification, formulation, and final packaging and labeling. Cutting-edge facilities, advanced technologies, and strict adherence to regulations ensure the creation of safe and effective biologics.

The biopharmaceutical contract manufacturing market is segmented into mammalian expression systems and non-mammalian expression systems such as microbial, yeast, and insects. The mammalian expression systems segment accounted for the largest market share in biopharmaceutical contract manufacturing market in 2024. Mammalian expression systems facilitate the production of a wide spectrum of biopharmaceuticals, including monoclonal antibodies, cytokines, hormones, and viral vectors for gene and cell therapies. The advantages of mammalian cells include proven post-translational modifications, correct protein folding, and improved bioactivity. These advantages are vital for producing biologics necessitating complex 3D arrangements and precise glycosylation patterns, ensuring both therapeutic effectiveness and safety. The versatility of mammalian expression has contributed significantly to its widespread adoption among end users.

The biopharmaceutical contract manufacturing market is segmented into monoclonal antibodies, therapeutic peptides & proteins, cell & gene therapy, vaccines, ADCs, and other molecules. The monoclonal antibodies segment accounted for the largest market share in 2024. The dominance of the segment is mainly attributed to their ability to precisely target cancer cells, marking a significant advancement in the field of cancer therapy. This segment covers both innovator monoclonal antibodies and biosimilar monoclonal antibodies. The rising prevalence of diseases, increasing government initiatives for the development of monoclonal antibody drugs, and the growing number of mAb product candidates currently in development have increased the demand for contract manufacturing of this molecule type.

The biopharmaceutical contract manufacturing market is segmented into oncology, autoimmune diseases, metabolic diseases, cardiovascular diseases, neurology, infectious diseases, and other therapeutic areas. The oncology segment accounted for the largest market share, followed by the autoimmune diseases segment in 2024. Biologics have significantly impacted the field of cancer treatment, offering innovative therapeutic options with targeted mechanisms of action. Biologics offer targeted and often less toxic alternatives to traditional chemotherapy. It provides more customized treatments and potentially better outcomes for cancer patients. Their development has led to advancements in precision medicine and immunotherapy, transforming the landscape of cancer treatment. Biologic drugs target different aspects of cancer biology, including immune checkpoint inhibitors, monoclonal antibodies, antibody-drug conjugates, and cell-based therapies like CAR-T cell therapy. These drugs are approved for a range of cancer types, including melanoma, lung cancer, breast cancer, leukemia, and lymphoma. These approvals subsequently increase the demand for outsourced manufacturing for oncology therapies.