Global Biopharmaceutical Contract Manufacturing Market - Focused Insights 2024-2029

MARKET INSIGHTS

In 2023, the global biopharmaceutical contract manufacturing market was valued at USD 15.22 billion and is projected to reach USD 38.07 billion by 2029, representing a CAGR of 16.51% throughout the forecast period. The growth of this market is primarily driven by the increasing complexity of biologic manufacturing, a rise in research and development activities among biopharmaceutical companies aiming to provide targeted treatments, limited expertise and resources in the in-house manufacturing facilities of these companies, the escalating costs associated with biologics manufacturing, and the competitive pressure for biopharma firms to expedite product launches.

To address these challenges, the demand for biopharmaceutical contract manufacturing is rapidly increasing globally. Contract Manufacturing Organizations (CMOs) can provide significant advantages and assurance in producing high-quality biologics that comply with regulatory standards, thanks to their well-established infrastructure, specialized expertise, extensive experience, and ample resources.

MARKET DEFINITION

Biopharmaceutical contract manufacturing is the process of outsourcing all or part of the production/manufacturing of biologic drugs to a third-party partner known as a Contract Manufacturing Organization. This type of manufacturing is also referred to as biologics contract manufacturing. A biopharmaceutical CMO, sometimes called a ensure Development Manufacturing Organization (CDMO), supports the biologics and pharmaceutical sectors by offering services on a contractual basis, from developing a process for candidate biologic molecules to ensure compliance with current good manufacturing practices (cGMP).

MARKET TRENDS & DRIVERS

Focus on Technology Adoption

Contract Manufacturing Organizations (CMOs) are increasingly embracing innovative and advanced manufacturing technologies such as robotics, automation, and continuous manufacturing. According to a report by Manufacturing Dive (2024), these organizations are striving to optimize their manufacturing processes in response to unprecedented drug shortages and the development of new, complex medications. Continuous Manufacturing technology is gaining traction among CMOs, allowing for the perpetual feeding of input materials into production while simultaneously removing processed output materials. Additionally, automation is a rapidly expanding trend within the industry, offering enhanced consistency and precision while reducing the likelihood of human error. Currently, CMOs are adopting automation, process control systems, and advanced robotics to facilitate ongoing monitoring and optimization of bioprocesses, which ultimately leads to improved product quality and higher yields.

Rapid Advancements in Biopharma Contract Production Services Through AI

As competition intensifies in the biopharmaceutical contract manufacturing sector, companies are adopting innovative strategies to enhance their efficiency. Collaborating with the right contract manufacturer has emerged as a key trend, prompting many CMOs and CDMOs to evolve their services to remain competitive in the rapidly changing market. In response to these dynamics, an increasing number of biopharma firms are turning to contract manufacturing, which is fueling market expansion. CMOs are leveraging artificial intelligence (AI) and electronic platforms to improve their operations, making production more cost-effective and expediting production timelines.

SEGMENTATION INSIGHTS

• Insights by Product: In 2023, finished dosage forms made up the largest global biopharmaceutical contract manufacturing market share. An FDF is a final drug product that has completed all production stages, including manufacturing, testing, and regulatory approval, before it becomes available to consumers. FDFs include both active pharmaceutical ingredients (APIs), which provide therapeutic effects, and inactive ingredients (excipients) that assist the active ingredients. The production of FDFs requires specialized equipment, advanced technologies, and significant expertise. As the biopharmaceutical sector continues to grow, many companies collaborate with contract manufacturers to satisfy global FDF demand and adhere to regulatory standards.
• Insights by Biologics: The monoclonal antibodies segment held over 46% of the global biopharmaceutical contract manufacturing market share in 2023. This segment is primarily propelled by the increasing incidence of complex health issues, like cancer, and the evolving sophistication of treatment strategies. Additionally, 53 Biologics, a prominent Contract Development and Manufacturing Organization (CDMO), reported a marked increase in research and development activities focused on monoclonal antibodies following the COVID-19 pandemic. With the rising demand for highly specific immune-supportive biopharmaceuticals, the need for monoclonal antibody contract manufacturing is rapidly expanding across the globe.
• Insights by Expression Systems: The global biopharmaceutical contract manufacturing market by expression systems is categorized into mammalian and non-mammalian systems. The mammalian segment shows considerable growth, boasting the highest compound annual growth rate (CAGR) of 16.78% during the forecast period. The development of biopharmaceuticals using transgenic mammalian cell lines remains fundamental to the biotechnology and pharmaceutical fields, with the market witnessing substantial growth since the introduction of human tissue plasminogen activator in 1987 and erythropoietin in 1988. Mammalian cells are often preferred for expression systems in biologics manufacturing, particularly in the production of monoclonal antibodies. For example, Chinese Hamster Ovary (CHO) cells are responsible for more than 70% of recombinant pharmaceutical protein production. Their unique capability to perform post-translational modifications, crucial for drug safety and effectiveness, makes mammalian expression systems vital for generating therapeutic and complex proteins, including monoclonal antibodies, thereby further fueling their widespread use in the industry.
• Insight By Scale Of Operation: In terms of operational scale, the commercial segment leads and captures the largest share of the global biopharmaceutical contract manufacturing market. The growth in commercial-scale operations within biopharma, particularly due to the outsourcing of biologics production, significantly fuels this segment's expansion. By partnering with contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs), biopharma companies can efficiently achieve large-scale production, thereby reducing both costs and the time required to bring essential biologics like vaccines, monoclonal antibodies, and cell and gene therapies to market. This scalability is crucial in meeting the increasing global demand driven by infectious diseases, chronic conditions, cancers, and autoimmune disorders. Outsourcing not only allows biopharma companies to concentrate on research and innovation but also lets expert manufacturers tackle production complexities. This strategy enhances regulatory compliance and provides access to cutting-edge manufacturing technologies, improving overall productivity. Consequently, the commercial segment enjoys wider market reach, enhanced profitability, and an improved capability to effectively address global health challenges, further propelling its growth.
• Insight By Company Size: Regarding company size, the large companies segment holds the most substantial share in the global biopharmaceutical contract manufacturing market. In the aftermath of the COVID-19 pandemic, many large biopharma firms face budget constraints due to the significant financial demands tied to vaccine and therapeutic development. This situation has prompted a shift from in-house manufacturing to outsourcing, enabling these companies to concentrate on their core competencies, such as innovation, while benefiting from cost-effective contract manufacturing solutions. This trend stems from the need to minimize manufacturing costs without compromising on quality. Contract manufacturers in developing nations like India, South Korea, and Switzerland are becoming vital players in this transition, offering state-of-the-art facilities, a favorable regulatory environment, and substantial savings. This outsourcing trend aids large biopharma companies in optimizing production efficiency and maintaining competitiveness in the international market.

GEOGRAPHICAL ANALYSIS

North America is the leading region, holding the largest share of the global biopharmaceutical contract manufacturing market. This dominance is due to a high concentration of biopharma companies, an increasing trend of outsourcing for cost and regulatory compliance reasons, and the presence of numerous prominent market players. Many biopharma firms in North America are engaged in the development of innovative biologics. Significant investments in research and development targeting chronic autoimmune diseases are anticipated to spur the introduction of new therapeutics in the region. The growing number of approvals for novel therapeutics presents valuable growth opportunities throughout North America.

COMPETITIVE LANDSCAPE

The global biopharmaceutical contract manufacturing market report features exclusive information about 45 vendors, highlighting the intense competitiveness of the market. A mix of leading, growing, and emerging companies is represented within the global landscape. Key players include Boehringer Ingelheim, Lonza, Samsung Biologics, AbbVie, Catalent, Emergent BioSolutions, FUJIFILM, Merck KGaA, Pfizer, and Wuxi Biologics, all of which command significant market shares. These companies are consistently striving to expand their biopharmaceutical contract manufacturing services to meet client needs, comply with international regulations, and enhance product efficiency, thus strengthening their market positions.

RECENT VENDOR ACTIVITIES

• In 2024, Sanofi invested over $1 billion in biomanufacturing in France to enhance medicine production capabilities.
• In 2023, GTP Bioways opened two new biopharmaceutical production facilities in France.
• In 2023, Merck opened two new manufacturing plants in Germany focused on mRNA services and launched a genetic stability platform aimed at reducing costs by 43% and biosafety testing time by 66%.
• In 2023, ACG Biologics completed the expansion of the manufacturing plant at the Milan Cell & Gene Center of Excellence production sites.