According to our new research study on "Biopharmaceutical Contract Manufacturing Market Forecast to 2031 - Global Analysis - by Product Type, Source, Application, and Therapeutic Area," the market is expected to grow from US$ 40.99 billion in 2024 to US$ 101.05 billion by 2031; it is estimated to record a CAGR of 13.8% from 2025-2031. Key factors driving the growth of the biopharmaceutical contract manufacturing market are rising demand for biologics and increasing demand for cost efficiency and flexibility. However, the tightened budget and economic uncertainty hinders the market's growth.

The scope of the biopharmaceutical contract manufacturing market report includes the assessment of the market performance in North America, Europe, Asia Pacific, South & Central America, and the Middle East & Africa. Asia Pacific is anticipated to register the fastest CAGR in the biopharmaceutical contract manufacturing market from 2025 to 2031. Countries such as Australia, India, and South Korea are estimated to witness growth opportunities due to the development of the healthcare sector. In addition, governments of these countries are increasing their efforts to provide clinical trials, supporting the biopharmaceutical contract manufacturing market growth in the Asia Pacific. Also, the rise in the incidence of chronic diseases is likely to offer significant growth opportunities to the market players in the coming years.

China, India, and Japan are three significant contributors to the market growth in this region. China is experiencing several favorable regulatory reforms and strategic industry expansions in terms of biopharmaceutical contract manufacturing. The recent pilot program initiated by the National Medical Products Administration (NMPA) marks a pivotal shift, allowing the segmented production of biological products. This regulatory breakthrough enables biopharma companies to outsource one or more stages of production-such as formulation, fill-finish, or packaging-to contract development and manufacturing organizations (CDMOs), thereby improving production flexibility, reducing operational costs, and enhancing time-to-market efficiency.

Leading CDMOs such as Boehringer Ingelheim BioXcellence are expanding their service offerings within China, introducing tailored service packages for diverse biopharmaceutical production needs. These enhancements support local and multinational biopharma firms to meet complex regulatory and manufacturing requirements and strengthen the sustainable global supply of critical medications. Regulatory advancements and industry investment foster a robust environment for CDMO in China's biopharmaceutical sector, aiding the biopharmaceutical contract manufacturing market growth.

Furthermore, strategic investments and expansions by leading domestic and international companies are supporting the biopharmaceutical contract manufacturing market in Japan. Major industry players increasingly establish and enhance their CDMO capabilities to cater to the growing global demand for advanced therapeutics.

Innovations and the introduction of new technology by key Japanese players are expected to contribute to the biopharmaceutical contract manufacturing market growth. For instance, AGC Inc. has announced an investment of US$ ~0.34 billion to expand its biopharmaceutical CDMO capabilities at the AGC Yokohama Technical Center. This expansion will begin with gene and cell therapy development services in 2025, followed by manufacturing mRNA pharmaceuticals and biopharmaceuticals using mammalian cell cultures in 2026. This substantial investment reflects AGC's commitment to supporting the rapid development of next-generation biologics and advanced therapies.

Terumo Pharmaceutical Solutions (a division of Terumo Corporation) has broadened its contract manufacturing services to include parenteral drugs for global clients. This strategic move positions Terumo as a key player in providing integrated solutions for injectable therapies, meeting the rising demand for sterile drug manufacturing.

Bushu Pharma has expanded its footprint with the launch of the Soka Packaging Center in November 2023, marking its fifth operational base in Japan. Located within the Metropolitan Area Distribution Center run by Suzuken Co., Ltd., this new facility enhances Bushu Pharma's packaging and distribution capacity. Such expansions underscore Japan's growing role as a strategic hub for biopharmaceutical contract manufacturing, driven by advanced infrastructure, skilled workforce, and regulatory support. The presence of globally recognized firms investing in state-of-the-art facilities signals strong confidence in Japan's capability to serve domestic and international biopharma markets.

Moreover, the market in India is gaining momentum, driven by increased domestic investments in high-value biologics infrastructure. A key development reinforcing this trend is Aragen's operational launch of the first phase of its biologics manufacturing facility in Bengaluru in 2024 through its subsidiary, Aragen Biologics Pvt Ltd. As a leading contract research, development, and manufacturing organization (CRDMO) for small molecules and biologics, Aragen's strategic move marks a pivotal step in strengthening India's end-to-end capabilities in the biopharmaceutical value chain. This facility expands India's biologics manufacturing footprint and supports global demand for cost-effective, high-quality development and production services, especially for complex biologics and biosimilars.

The operationalization of cutting-edge infrastructure reflects a broader shift toward self-reliance and global competitiveness in biologics manufacturing. It enhances India's appeal as a reliable CDMO partner for international pharmaceutical and biotechnology companies seeking scalable, flexible, and regulatory-compliant manufacturing solutions.Aragen's expansion is a key driver of growth in India's biopharmaceutical contract manufacturing sector, signaling the country's transition from a generics-dominated hub to a key player in innovative biologics and complex therapeutic manufacturing.

According to a study titled "More and better clinical trials in health care: focusing on people, not just systems and processes," published in March 2023, every year, ~1,000 new clinical trials are commenced in Australia, from phase 1 (first human trials) to phase IV (post-market trials) for medicines and medical devices. The clinical trials market in Australia is growing, with more than 5.2 million people participating in 10,000 clinical trials in Australia over 10 years. Within the US$ 1.5 billion modern manufacturing strategy (MMS), the country is growing its medical product manufacturing industry as one of six national manufacturing priorities. Clinical trials are a vital component of the commercialization process. Clinical trials provide an avenue to test and validate the country's competitiveness in scale-up manufacturing capabilities in research areas such as vaccine production, stem cells, and gene therapy. Therefore, Australia's contract manufacturing sector has grown significantly, primarily due to supportive laws, new technology, and rising clinical trial demand. Due to these advancements, Australia is now a top clinical research site, drawing interest from both domestic and international players. The factors mentioned above are promoting a favorable environment for the biopharmaceutical contract manufacturing market in the region.

Boehringer Ingelheim International GmbH, Thermo Fisher Scientific Inc., Lonza Group AG, Merck KGaA, AbbVie Inc., General Electric Co, Samsung Biologics Co Ltd, WuXi Biologics Inc., Inno Bio Ventures Sdn Bhd, and Ajinomoto Co Inc. are among the leading companies profiled in the biopharmaceutical contract manufacturing market report.

Based on product type, the biopharmaceutical contract manufacturing market is bifurcated into biologics and biosimilar. By source, the market is bifurcated into microbial and mammalian. In terms of application, the biopharmaceutical contract manufacturing market is segmented into commercial and clinical. In terms of therapeutic area, the biopharmaceutical contract manufacturing market is classified into oncology, autoimmune disorders, respiratory disorders, metabolic disorders, neurology, infectious diseases, and others. Geographically, the market is categorized into North America (US, Canada, and Mexico), Europe (France, Germany, UK, Spain, Italy, and Rest of Europe), Asia Pacific (China, Japan, India, South Korea, Australia, and Rest of Asia Pacific), the Middle East & Africa (Saudi Arabia, South Africa, UAE, and Rest of Middle East & Africa), and South & Central America (Brazil, Argentina, and Rest of South & Central America).

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