The biopharmaceutical contract manufacturing market size is expected to grow from US$ 40.99 billion in 2024 to US$ 101.05 billion by 2031; it is projected to register a CAGR of 13.8% during 2025-2031. Rising demand for biologics and increasing demand for cost efficiency and flexibility are noteworthy factors contributing to the expansion of the biopharmaceutical contract manufacturing market size. However, the tightened budget and economic uncertainty hinder the biopharmaceutical contract manufacturing market growth.

Monoclonal antibodies, gene therapies, and cell-based treatments have created the need for more innovative, streamlined manufacturing processes. As a result, contract manufacturing organizations (CMOs) are increasingly adopting advanced technologies such as continuous manufacturing, automation, artificial intelligence (AI), and process analytical technologies (PAT) to enhance production capabilities and meet the growing demand for biopharmaceuticals. Continuous manufacturing is rapidly gaining traction in the biopharmaceutical industry as it allows the uninterrupted production of biologics, providing greater consistency, speed, and efficiency. This process reduces downtime between production runs and minimizes the need for intermediate storage, significantly reducing production costs. According to a Baker McKenzie report, continuous manufacturing can reduce the cost of biologic production by 30%. Novartis and Pfizer are among the major companies implementing continuous manufacturing for large-scale biologic production, demonstrating its effectiveness in improving operational efficiency and reducing costs.

Artificial intelligence (AI) can also be used for process optimization, predictive maintenance, and quality control. AI-based tools can analyze vast amounts of production data in real-time, identifying potential issues before they arise and ensuring optimal conditions throughout the production process. This technology helps CMOs minimize downtime and improve yield rates. Companies such as Cognizant are already using AI to predict potential failures in manufacturing processes and improve decision-making. Furthermore, process analytical technologies (PAT) enable real-time monitoring and control of critical process parameters, ensuring consistent quality across large batches of biologics. By integrating PAT, manufacturers can detect variations early in the production process and adjust in real-time to prevent defects or inconsistencies. This results in higher-quality products and more efficient use of resources, reducing both time and cost. Therefore, the increasing adoption of advanced manufacturing technologies such as continuous manufacturing, automation, AI, and PAT is expected to contribute to the growth of the biopharmaceutical contract manufacturing market in the coming years.

Therapeutic Area-Based Insights

Based on the therapeutic area, the biopharmaceutical contract manufacturing market is segmented into oncology, autoimmune disorders, respiratory disorders, metabolic disorders, neurology, infectious diseases, and others. The oncology segment held the largest biopharmaceutical contract manufacturing market share in 2024. As cancer remains a leading cause of death globally, it drives the need for advanced cancer treatments. According to the World Health Organization (WHO), 20 million new cancer cases and 9.7 million cancer-related deaths were reported globally in 2022. This demand is primarily driven by the development of biologics and the production of biologics involves complex cell culture systems and stringent quality control measures, making outsourcing to contract manufacturers a viable solution for many pharmaceutical companies. Keytruda generated US$ 29.48 billion in sales in 2024, highlighting the immense market potential of oncology biologics. Additionally, the increasing trend toward personalized oncology treatments, particularly with CAR-T therapies such as Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel), has also fueled the need for highly specialized contract manufacturing. These treatments require the production of genetically modified immune cells, which creates the demand for CMOs with expertise in cell and gene therapies, thereby fueling the biopharmaceutical contract manufacturing market growth.

World Health Organization (WHO), Global Autoimmune Institute 2022 report, and International Diabetes Federation are among the primary and secondary sources referred to while preparing the biopharmaceutical contract manufacturing market report.