Biopharmaceutical Contract Manufacturing Market to Grow with a CAGR of 11.01% through 2029

Rising Demand for Biologics and Biosimilars and Cost Efficiency and Capacity Flexibility are expected to drive the Global Biopharmaceutical Contract Manufacturing Market growth in the forecast period, 2025-2029

According to TechSci Research report, “Biopharmaceutical Contract Manufacturing Market – Global Industry Size, Share, Trends, Competition Forecast & Opportunities, 2029”, the Global Biopharmaceutical Contract Manufacturing Market stood at USD 38.25 Billion in 2023 and is anticipated to grow with a CAGR of 11.01% in the forecast period, 2025-2029.

As the regulatory landscape for biologics continues to evolve, biopharmaceutical companies are increasingly relying on Contract Manufacturing Organizations (CMOs) to navigate the complex and often stringent compliance requirements set by global regulatory bodies such as the U.S. FDA and the European Medicines Agency (EMA). These agencies have significantly raised their standards for Good Manufacturing Practices (GMP), particularly in the production of biologics and biosimilars, reflecting heightened concerns over product safety, efficacy, and consistency. CMOs with extensive expertise in adhering to these regulatory frameworks offer a critical advantage to biopharmaceutical companies that need to ensure full compliance, mitigate risks associated with non-compliance, and streamline their manufacturing processes. By outsourcing production to experienced CMOs, companies can shift the responsibility of maintaining stringent regulatory standards to trusted partners, allowing them to focus on core competencies while mitigating the risks of costly regulatory failures.

The increasing complexity of regulatory requirements is one of the primary drivers for outsourcing. It allows biopharmaceutical companies to minimize the internal burden associated with compliance and focus their resources on research and development (R&D), the area that offers the highest potential for growth. As R&D expenditures in the biopharma sector rise, many companies are prioritizing investment in new drug discovery, clinical trials, and formulation development over capital-heavy manufacturing facilities. Outsourcing manufacturing to CMOs not only alleviates the burden of maintaining large-scale production capabilities but also frees up resources for innovation. This shift is particularly relevant in the production of personalized and precision medicines, such as cell and gene therapies, which demand specialized, often small-scale manufacturing processes that require advanced technical expertise and highly flexible, scalable production systems. CMOs equipped to handle these niche and complex needs provide the necessary infrastructure to scale up production while meeting regulatory standards.

The COVID-19 pandemic significantly accelerated the trend of outsourcing manufacturing, particularly in the area of vaccine production. The global urgency for COVID-19 vaccines showcased the importance of flexible, scalable manufacturing solutions. CMOs played a pivotal role in the rapid development and distribution of vaccines, demonstrating their capacity to manage large-scale, high-volume production with tight timelines. The success of this effort underlined the reliability of CMOs in responding to urgent, unpredictable market needs. As the biopharmaceutical industry continues to address public health challenges, there is an increasing recognition of the value that CMOs bring in terms of speed, capacity, and risk management. This trend is expected to persist, with biopharmaceutical companies increasingly turning to CMOs for not only vaccine production during the ongoing pandemic but also for preparing for future outbreaks, booster shots, and other preventive treatments.

The expansion of healthcare infrastructure in emerging markets, such as India, China, and Brazil, is providing new opportunities for CMOs to enhance their global footprint. These regions are rapidly becoming more attractive for biopharmaceutical outsourcing due to a combination of lower production cost, access to a skilled labor force, and government policies that are supportive of the biopharmaceutical sector. Governments in these countries are making strategic investments to boost the biopharma industry, offering tax incentives, infrastructure development, and funding opportunities that enable CMOs to set up manufacturing operations at competitive costs. This not only creates cost efficiencies but also expands the capacity of global CMOs to meet the growing demand for affordable biologics. Additionally, the rising demand for affordable therapies in these emerging markets, driven by increasing healthcare access and a growing middle class, is further fueling the need for contract manufacturing services, which can scale production to meet both local and global demands. The increasing complexity of regulatory requirements, combined with the need for specialized expertise, cost-effective production solutions, and flexible scaling capabilities, continues to drive the biopharmaceutical outsourcing trend. As companies focus on R&D and innovation, while navigating the intricacies of global regulations, CMOs provide an indispensable role in ensuring compliance and enabling efficient, large-scale manufacturing. Additionally, the growing healthcare infrastructure in emerging markets offers CMOs new avenues for expansion, while enabling biopharmaceutical companies to meet global demand for biologics and biosimilars. This dynamic landscape is reshaping the future of biopharmaceutical manufacturing and positioning CMOs as essential partners in driving global healthcare advancements.

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The Global Biopharmaceutical Contract Manufacturing Market is segmented into source, service, drug types, therapeutics area, regional distribution, and company.

Based on its therapeutics area, the oncology segment has emerged as the predominant market leader, Oncology represents one of the largest therapeutic areas for biopharmaceutical development, as cancer remains one of the leading causes of death worldwide. According to the World Health Organization (WHO), cancer cases are expected to rise significantly in the coming years, particularly in emerging markets. This escalating incidence of cancer has led to a surge in the demand for innovative treatments, such as monoclonal antibodies (mAbs), immune checkpoint inhibitors, CAR-T therapies, and bispecific antibodies. As a result, biopharmaceutical companies are increasingly outsourcing the production of these complex biologics to Contract Manufacturing Organizations (CMOs) that specialize in oncology drug manufacturing, especially given the high potency and specialized production needs associated with these treatments. The need for scalable, flexible manufacturing solutions for oncology drugs is a critical driver of the oncology CMO market. Advanced biologics, including gene and cell therapies for cancer treatment, require highly specialized facilities capable of handling small batches, complex formulations, and rigorous regulatory standards. The shift toward personalized medicine, which often targets specific genetic mutations or cancer subtypes, has further increased the complexity of oncology drug manufacturing, emphasizing the demand for CMOs with advanced capabilities​.

Recent years have seen a significant increase in the number of biologic drugs targeting cancer, particularly in the fields of immuno-oncology and biologic drugs for rare cancers. The approval of new monoclonal antibodies and immunotherapies, as well as the advent of cell and gene therapies like CAR-T (Chimeric Antigen Receptor T-Cell) therapy, has substantially expanded the pipeline of oncology drugs. These therapies require specialized manufacturing platforms, often involving highly potent biologics that must be produced in carefully controlled environments with strict adherence to Good Manufacturing Practices (GMP). CMOs are central to this ecosystem, as they have the infrastructure, expertise, and flexibility to manage the complex manufacturing processes associated with oncology biologics. These drugs often involve multi-step processes, including cell culture, protein purification, fill and finish, and lyophilization, all of which require stringent quality control measures. CMOs that can handle these intricate processes at both the clinical and commercial scale are crucial to the timely and efficient delivery of oncology treatments.

The Asia Pacific (APAC) region is poised to witness the fastest market growth in the Global Biopharmaceutical Contract Manufacturing Market. the primary drivers behind the rapid growth of the biopharmaceutical contract manufacturing market in Asia Pacific is the cost advantage offered by countries like China, India, and South Korea. The cost of manufacturing in these regions is significantly lower than in North America and Europe, which offers biopharmaceutical companies a compelling financial incentive to outsource production. The relatively lower labor and operational costs, combined with a large pool of highly skilled workers, make APAC a hub for biopharmaceutical production. This cost-effective environment supports the increasing demand for both generic biologics and biosimilars, which require large-scale production at competitive prices.

The growing demand for biologics, biosimilars, and personalized therapies in emerging markets such as India, China, and Indonesia is a key factor in the rapid market growth in the region. With healthcare infrastructures expanding and access to medical treatments improving, there is a significant rise in demand for biologic therapies to treat chronic conditions, cancer, and rare diseases. Asia Pacific is witnessing a growing middle class with better access to healthcare, which is fueling the demand for affordable and effective biologic drugs. As a result, pharmaceutical companies are increasingly turning to CMOs in the region to meet the rising demand for large-scale biologic production. In addition, many of these countries are home to a large patient population, making them ideal markets for the commercialization of biologic therapies. As a result, APAC is becoming a vital hub for clinical trials and commercial-scale production of biologics, with contract manufacturers playing a key role in ensuring companies can meet the increasing demand for medications across the region.

Major companies operating in Global Biopharmaceutical Contract Manufacturing Market are:

• Boehringer Ingelheim International GmbH
• Lonza Group Ltd
• Rentschler Biopharma SE
• JRS PHARMA GmbH & Co. KG
• AGC Biologics
• ProBioGen AG
• FUJIFILM Diosynth Biotechnologies
• TOYOBO CO., LTD.
• Samsung Biologics
• Thermo Fisher Scientific Inc

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“The Global Biopharmaceutical Contract Manufacturing Market is experiencing robust growth driven by several key factors, including the increasing demand for biologics, the shift toward outsourced manufacturing to optimize costs and capacities, and the rising complexity of biologic drugs such as monoclonal antibodies, biosimilars, and cell & gene therapies. As biopharmaceutical companies focus more on research and development, CMOs are becoming integral partners, providing essential expertise and scalable manufacturing solutions to meet the evolving needs of the industry. Additionally, technological advancements in bioprocessing and the expanding healthcare infrastructure in emerging markets, particularly in Asia Pacific, are further fueling market expansion. Challenges such as regulatory complexity, the need for quality assurance, and the pressure to maintain cost-effectiveness remain. Despite these hurdles, the market’s future growth is solidified by the increasing outsourcing trends and the ability of CMOs to provide flexible and specialized solutions across diverse therapeutic areas. As companies continue to leverage the capabilities of contract manufacturers, the Global Biopharmaceutical Contract Manufacturing Market is expected to thrive, driven by continued innovations and strategic collaborations across the globe.,” said Mr. Karan Chechi, Research Director of TechSci Research, a research-based management consulting firm.

“Biopharmaceutical Contract Manufacturing Market - Global Industry Size, Share, Trends, Opportunity & Forecast, Segmented By Source (Mammalian, Non-mammalian), By Service (Process Development, Fill & Finish Operations, Analytical & QC studies, Packaging & Labelling, Others), By Drug Types (Biologics, Biosimilars), By Therapeutics Area (Oncology, Autoimmune Diseases, Infectious Diseases, Cardiovascular Diseases, Metabolic Diseases, Neurology, Others), By Region, & Competition, 2019-2029F”, has evaluated the future growth potential of Global Biopharmaceutical Contract Manufacturing Market and provides statistics & information on market size, structure and future market growth. The report intends to provide cutting-edge market intelligence and help decision makers take sound investment decisions. Besides, the report also identifies and analyzes the emerging trends along with essential drivers, challenges, and opportunities in Global Biopharmaceutical Contract Manufacturing Market.

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