Global Biopharmaceutical Contract Manufacturing Market - Focused Insights 2024-2029

MARKET INSIGHTS

The global biopharmaceutical contract manufacturing market was valued at USD 15.22 billion in 2023 and is expected to reach USD 38.07 billion by 2029, growing at a CAGR of 16.51% during the forecast period. The market growth is majorly driven by the growing complexity in biologic manufacturing, the surge in R&D activities by bio-pharmaceutical companies, that endeavor to deliver specified treatments to patients, the lack of expertise and resources available in in-house manufacturing plants of biopharma companies, increasing cost of biologics manufacturing, and competition among biopharma companies to launch products early in the market.

To overcome these challenges, the demand for biopharmaceutical contract manufacturing growing rapidly across the world. Contract manufacturing organization (CMO) partners offer potential benefits as well as surety to manufacture high-quality biologics meeting regulatory expectations with more effectivity and efficacy, due to their well-structure infrastructure, available field expertise, experience, and resources.

Biopharmaceutical contract manufacturing is an outsourcing process in which biotech and pharmaceutical companies entrust overall or part of their production/manufacturing process to a third-party/outside partner (Contract Manufacturing Organization) for the manufacturing of biologic drugs. Biopharmaceutical contract manufacturing also refers as biologics contract manufacturing. A biopharmaceutical Contract Manufacturing Organization (CMO) also known as a Contract Development Manufacturing Organization (CDMO) serves the biologics and pharma industry by providing services on a contract basis from the development of a process for the candidate biologics molecules through current good manufacturing processes (cGMP).

RECENT VENDORS ACTIVITIES

1. In 2024, Sanofi one of the leading CMO invested over $1 billion investment in biomanufacturing in France to enhance medicine production capabilities in France. In 2023, GTP Bioways opened two new biopharmaceutical production facilities in France.
2. In 2024, Lonza announced an agreement to Acquired Genentech manufacturing unit in the US from Roche for $1.2 billion capital.
3. In 2024, Thermo Fischer Scientific acquired Olink Holding AB. Olink –a pioneer company in next-generation proteomics solution development.
4. In 2023, Wuxi Biologics one of the leading market players announced that it increasing manufacturing capacity at its facility in Germany. Since 2020, the company has invested in the construction and adaptation of two new facilities in the country.
5. In 2023, Merck opened two new manufacturing plants in Germany that pioneered offering mRNA services. In addition, the company announced the launch of a genetic stability platform that can help to reduce cost by 43% and biosafety testing time by 66%.
6. In 2023, ACG Biologics one of the leading global CDMOs completed expansion of the manufacturing plant at the Milan Cell & Gene Center of Excellence production sites.

KEY TAKEAWAYS

1. Market Growth: The global biopharmaceutical contract manufacturing market was valued at USD 15.22 billion in 2023 and is expected to reach USD 38.07 billion by 2029, growing at a CAGR of 16.51% during the forecast period.
2. By Product: The finished dosage form segment holds the largest market share. The segmental growth is due to the growing demand for safe and innovative medications.
3. By Biologies: The monoclonal antibodies segment holds the largest market share of over 46%, driven by the rising prevalence of - and growingly sophisticated approaches to treating complex and severe health conditions, including cancers.
4. By Expression Systems: The mammalian segment shows the highest growth of 16.78% as they are considered standard for key expression systems and widely accepted in monoclonal antibody production.
5. By Scale of Operations: The commercial segment accounts for the largest market share. The commercial scale of operation is also termed as large-scale manufacturing and they fulfill the requirement of these biologics through commercial manufacturing.
6. By Company Size: The large companies segment holds the largest market share. The segment's growth is driven by CMOs enabling biopharmaceutical companies to focus on higher-value aspects of their value chains while outsourcing manufacturing processes.
7. By Geography: North America dominates the global biopharmaceutical contract manufacturing market. The market dominance is driven by a high concentration of biopharma companies, increased outsourcing, and leading industry players in the region.
8. Growth Factor: The global biopharmaceutical contract manufacturing market is set to grow due to increasing drug approvals by emerging, small & medium-sized biopharma companies and the shift from developed to developing economies.

MARKET TRENDS & DRIVERS

Attention Towards Technology Adoption

Contract Manufacturing Organizations (CMOs) are shifting towards innovative and more advanced manufacturing technologies, such as robotics, automation, and continuous manufacturing. The Manufacturing Dive article (2024) reported that contract manufacturers seek to optimize manufacturing processes to meet demand for combat record-high drug shortages and new and complex drugs. Where Continuous Manufacturing technology become more popular among CMOs. In this technology, input materials are continuously fed into production and transformed, and processed output materials are continuously removed. Automation is a rapidly growing trend among CMOs that delivers more consistency, and precision and minimizes human error. Currently, automation, process control systems, and advanced robotics, that becoming popular to enable continued monitoring and optimization of bioprocesses, to improve product quality and lead to higher yield.

Attention Towards Specialized Capabilities and Services

In the biopharmaceutical industry, research and development, clinical trials, product approvals, and new products in the market have become more and more complex, the biopharma companies seeking more diverse, experienced, and well-established contract manufacturers. However, in recent days, with the growing attention toward more niche and care-demanding therapeutic areas, now biopharma companies looking for more specialized services and capabilities in CMOs. As the biopharmaceutical industry experiences huge competition and challenges from regulatory bodies, biopharma companies looking for CMOs who are experts in specific or single areas. This factor creates opportunities for small and emerging specialized CMOs that can offer tailored solutions and services to meet the unique requirements of biopharma companies.

Increasing Drug Approvals by Emerging, Small & Medium-Sized Biopharma Companies

Small & Medium pharma biotech companies are the most potential clients for CMOs/CDMOs as these entities face several issues in the development and manufacturing of their drugs. New and often small-sized to mid-sized biotech companies are seeking contract manufacturing companies to introduce their products due to a lack of resources and associated capabilities to invest in manufacturing facilities of their own. In the past few years, small-sized biopharma companies have accelerated their R&D and launched around 30% to 40% of new drugs. There are more than 5,500 total small and mid-sized biopharma companies present across the world revealed by Contract Pharma news in 2023, and it is expected that in upcoming years (by 2026-2027) they will contribute more than 55% of new drugs launched.

Rapid Developments in Biopharma Contract Production Services with AI

With the growing competition across the biopharmaceutical contract manufacturing industry, vendors are advancing them with new approaches that drive their efficiency in contract manufacturing. The partnership with the right contract manufacturer is an emerging trend that led to rising advancements among the vendors to stay competitive in the market. The majority of CMOs/CDMOs are developing and expanding their services to keep pace with rapidly evolving the global market. These factors attract more and more biopharma companies towards contract manufacturing and drive market growth. CMOs are advancing their performance with artificial intelligence (AI) and electronic platforms to become more cost-effective and speed up production time.  

INDUSTRY RESTRAINTS

High Cost of Biologics Contract Manufacturing

Biopharmaceuticals are medicines made from living cells that treat common and serious diseases, such as cancer, diabetes, rheumatoid arthritis, and other inflammatory diseases. These are highly targeted and effective, and they are increasingly important in the fight against these diseases. They are relatively complex molecules and are usually composed of proteins for transplantation, carbohydrates, nucleic acids, cells or tissues, or complex complexes of these substances. Their examples include hormones, vaccines, blood products, allergens, mAbs, recombinant therapeutic proteins, C&GT, growth factors, cytokines, and insulin. Unfortunately, most patients cannot afford biologics. Medical costs divide consumers into rich and poor categories. Both categories are stressed due to high biological costs, but the poor stress much more. Expensive biological products are not easily accessible to poor patients. This is more pronounced in low- and middle-income countries.

SEGMENTATION INSIGHTS

INSIGHTS BY PRODUCT

The global biopharmaceutical contract manufacturing market by product is segmented into finished dosage form (FDF) and active pharmaceutical ingredients (API). The finished dosage form (FDF) accounted for the largest market share in 2023. An FDF (Finished Dosage Form) is a drug product that has undergone all stages of production, including manufacturing, testing, and regulatory approval before being made available to the public. The FDF contains both active pharmaceutical ingredients (APIs), which are responsible for the therapeutic effects experienced by the user, and inactive ingredients (excipients), which serve as carriers to facilitate the function of the active ingredients. Producing finished dosage forms requires specialized equipment, advanced technologies, and expertise. As the biopharmaceutical industry continues to expand, many companies are partnering with contract manufacturers to meet global FDF demand and ensure compliance with regulatory standards.

INSIGHTS BY BIOLOGICS

The global biopharmaceutical contract manufacturing market by biologics is categorized into monoclonal antibodies, vaccines, and other biologics. The monoclonal antibodies segment holds the largest market share of over 46% in 2023. Monoclonal antibodies (mAbs) currently dominate the biopharmaceutical product category, primarily driven by the rising prevalence of complex and severe health conditions, such as cancer, and the increasing sophistication of treatment approaches. Furthermore, 53 Biologics, a leading CDMO (Contract Development and Manufacturing Organization), reported a significant rise in research and development activities for monoclonal antibodies following the COVID-19 pandemic. As the demand for highly specific and immune-supportive biopharmaceutical products grows, the need for monoclonal antibody contract manufacturing is rapidly increasing worldwide.

INSIGHTS BY EXPRESSION SYSTEMS

The global biopharmaceutical contract manufacturing market by expression systems is segmented into mammalian and non-mammalian. The mammalian segment shows significant growth, with the fastest-growing CAGR of 16.78% during the forecast period. The development of biopharmaceuticals using transgenic mammalian cell lines remains a cornerstone of the biotechnology and pharmaceutical industries, with the market experiencing exponential growth since the introduction of human tissue plasminogen activator in 1987 and erythropoietin in 1988. Mammalian cells are widely considered for expression systems in biologics manufacturing, particularly for producing monoclonal antibodies. Chinese Hamster Ovary (CHO) cells, for instance, are responsible for over 70% of recombinant pharmaceutical protein production. Their unique ability to perform post-translational modifications, which are critical for drug safety and efficacy, makes mammalian expression systems essential for producing therapeutic proteins, complex proteins, and monoclonal antibodies, further driving their widespread application in the industry.

INSIGHT BY SCALE OF OPERATION

Based on the scale of operation, the commercial segment dominates and holds the largest share of the global biopharmaceutical contract manufacturing market. The commercial-scale operation in biopharma, driven by the outsourcing of biologics production, is significantly contributing to the growth of the commercial segment. By leveraging contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs), biopharma companies can achieve large-scale production efficiently, reducing costs and time-to-market for essential biologics like vaccines, monoclonal antibodies, and cell and gene therapies. This scalability allows companies to meet the rising global demand driven by infectious diseases, chronic illnesses, cancers, and autoimmune disorders. Moreover, outsourcing enables biopharma companies to focus on research and innovation while relying on expert manufacturers to handle production complexities. This model also facilitates faster regulatory compliance and access to advanced manufacturing technologies, enhancing productivity. As a result, the commercial segment benefits from expanded market reach, improved profitability, and the ability to address global health challenges effectively, further fueling its growth.

INSIGHT BY COMPANY SIZE

Based on the company size, the large companies segment accounted for the largest global biopharmaceutical contract manufacturing market share. Following the COVID-19 pandemic, budget constraints have become a common issue for large biopharma companies, primarily due to the substantial financial burden of investments in vaccine and therapeutic development. As a result, many companies are shifting from in-house manufacturing to outsourcing, allowing them to focus on core competencies like innovation while taking advantage of cost-effective contract manufacturing services. This trend is driven by the need to reduce manufacturing costs while ensuring high-quality production. CMOs in developing countries, such as India, South Korea, and Switzerland, are emerging as key players in this shift, offering advanced manufacturing facilities, a familiar regulatory environment, and significant cost savings. This movement toward outsourcing to developing countries is helping large biopharma companies optimize production and remain competitive in the global market.

GEOGRAPHICAL ANALYSIS

North America dominates and holds the largest share of the global biopharmaceutical contract manufacturing market. The market dominance of these regions can be attributed to the high concentration of biopharma companies, the growing trend of outsourcing biopharma contract manufacturing due to cost and regulatory compliance considerations, and the presence of several leading market players. In North America, numerous biopharma companies are actively involved in developing novel biologics. Significant investments in research and development aimed at strengthening pipelines for chronic autoimmune diseases are expected to drive the launch of new therapeutics in the region. The increasing number of approvals for novel therapeutics is creating valuable opportunities for market growth in North America.

COMPETITIVE LANDSCAPE

The global biopharmaceutical contract manufacturing market report consists of exclusive data on 45 vendors. The market is highly competitive. There are several leading, growing, and emerging market players are present across the global market. Some emerging players compete against large and small medium-sized market players. Boehringer Ingelheim, Lonza, Samsung Biologics, AbbVie, Catalent, Emergent BioSolution, FUJIFILM, Merck KGaA, Pfizer, and Wuxi Biologics are leading companies that accounted for major market share in the global biopharmaceutical contract manufacturing market. These vendors are continuously focusing on expanding their biopharmaceutical contract manufacturing services that meet clients' requirements, international regulations, and increase the efficiency of their product, strengthen their market position.