Key Market Overview:
Biopharmaceuticals Contract Manufacturing market size was worth over USD 17.9 Billion in 2022 and is estimated to reach over USD 27.6 Billion by 2030, growing at a CAGR of 5.6% during the forecast period (2023-2030).
Biopharmaceutical contract manufacturing refers to the outsourcing of the production of biopharmaceutical products by a biopharmaceutical company to a third-party contract manufacturing organization (CMO). The CMO is a specialized biopharmaceutical contract manufacturing business or a division of a larger pharmaceutical contract manufacturing organization. Such CMOs specializes in the production of biopharmaceuticals on behalf of pharmaceutical and biotech companies. They offer a range of services including cell line development, process development, manufacturing, and packaging. The organizations have the necessary equipment, facilities, and expertise to manufacture biopharmaceuticals in compliance with regulatory requirements.
Furthermore, biopharmaceutical manufacturing is a highly regulated industry, and such CMOs are experienced in navigating regulatory requirements. Thus, biopharmaceutical companies have the opportunity to reduce the risk of regulatory compliance issues by outsourcing to a CMO. Moreover, the increased focus by several pharmaceutical manufacturers on specialized expertise, cost savings, scalability, risk mitigation, speed to market, and global reach results in favorable demand for such biopharmaceutical contract manufacturing to focus on the business\'s core competencies and efficiently introduce product innovations to the market.
Biopharmaceuticals Contract Manufacturing Market Coverage
|Market Size in 2030 (USD Billion)
|Mammalian and Microbial (Non-Mammalian)
|By Product Type
|Biologics (Monoclonal Antibodies (MAbs), Recombinant Proteins, Vaccines), Antisense, RNAi, & Molecular Therapy, Biosimilars
|Process Development, Fill & Finish Operations, Analytical & QC studies, Packaging
|By Therapeutic Area
|Autoimmune Diseases, Metabolic Diseases, Cardiovascular Diseases, Oncology, Neurology, Infectious Diseases, Respiratory Diseases, Others
|Asia-Pacific [China, Southeast Asia, India, Japan, Korea, Western Asia]
Europe [Germany, UK, France, Italy, Russia, Spain, Netherlands, Turkey]
North America [United States, Canada, Mexico]
Middle East & Africa [GCC, North Africa, South Africa]
South America [Brazil, Argentina, Columbia, Chile, Peru]
|Lonza, Samsung BioLogics, Boehringer Ingelheim International GmbH, Catalent Inc., Inno Biologics Sdn Bhd, Rentschler Biotechnologies GmbH, JRS Pharma, Tianjin Pharmaceutical, Clininvent Research Pvt. Ltd. (TCG Lifesciences), AGC Biologics, Dr. Reddy\'s Laboratories, ProBioGen, Jubilant Life Sciences, Fujifilm Diosynth Biotechnologies, Toyobo Co., Ltd., Pfizer CentreOne, Piramal, Recipharm, Thermo Fisher Scientific, Inc., WuXi Biologics, AbbVie Inc.
The rising prevalence of chronic diseases especially among the aged population supports the demand for biopharmaceuticals that boosts the biopharmaceuticals contract manufacturing market to outsource manufacturing complex molecules that require specialized manufacturing facilities and expertise. Further, the constant technological advancements in biopharmaceuticals drive the demand for CMOs to meet the increasing demand for a large variety of biopharmaceuticals. Moreover, favorable government regulations and incentives also boost the growth of the market of biopharmaceutical contract manufacturing in terms of grants and incentives.
The high development and commercialization costs combined with extensive time consumption in the availability of biopharmaceutical products limit the market growth. The strict compliance with regulatory requirements in terms of manufacturing facilities of the biopharmaceutical industry majorly hampers market growth due to barriers to entry for new CMOs. Such barriers results in delays in production or product recalls when facilities do not meet regulatory requirements.
The scope of development in new technologies such as gene therapy, cell therapy, and personalized medicine is expected to create lucrative opportunities for market growth due to the need for CMOs as specialized manufacturing capabilities. Moreover, the expansion of biopharmaceuticals in emerging markets such as China, India, and Brazil is estimated to create favorable opportunities for market growth.
Biopharmaceuticals Contract Market Segmentation:
The source segment is bifurcated into mammalian and microbial (non-mammalian). The mammalian segment contributed the largest shares over 60.3% to the market statistics in 2022. The increased usage of mammalian cells due to the ability to perform post-translational modifications (PTMs) such as glycosylation supports the segmental growth that impacts the overall efficacy and safety of the final product. Moreover, the microbial (non-mammalian) segment is also anticipated to contribute substantial shares to the market growth during the forecast period. The growing demand for microbes such as bacteria, yeast, and fungi in the biopharmaceutical industry for the production of therapeutic proteins, vaccines, and other bioactive molecules is anticipated to support segmental growth in terms of recombinant protein, antibodies, and vaccine production.
By Product Type
The product type segment is divided into biologics, antisense, RNAi, & molecular therapy, and biosimilars. The biologics segment contributed the largest shares over 82.7% to the market growth in 2022. The segment is further sub-segmented into monoclonal antibodies (MAbs), recombinant proteins, and vaccines with monoclonal antibodies (MAbs) as a leading contributor to segmental growth. The MAbs are produced by genetically engineered mammalian cells such as Chinese hamster ovary (CHO) cells which results in high demand for such antibodies in the treatment of cancer, autoimmune disorders, and other applications. Moreover, the high demand for biologics in cell therapy for the production of stem cells and T cells supports segmental growth in terms of using specialized bioreactors for such cell therapy.
The service segment is separated into process development, fill & finish operations, analytical & QC studies, and packaging. The process development segment accounted for the largest share contribution of over 35.2% to the market growth in 2022. The critical role of process development for technology transfer from the drug developer to the contract manufacturing organization supports segmental growth in terms of aid in the adaptation of the manufacturing process to the specific capabilities and equipment of the manufacturing organization. Furthermore, the fill & finish operations segment is anticipated to grow with the fastest CAGR during the forecast period. The growing focus on filling & packaging products in sterile environments is expected to boost the segmental growth to maintain the safety and efficacy of final product containers such as vials, syringes, or cartridges.
By Therapeutic Area
The therapeutic area segment comprises autoimmune diseases, metabolic diseases, cardiovascular diseases, oncology, neurology, infectious diseases, respiratory diseases, and others. Autoimmune diseases are anticipated to contribute significant shares to the market growth during the forecast period. The growing dependence on biopharmaceuticals contract manufacturers to produce fusion proteins using recombinant DNA technology in mammalian cell cultures is estimated to support the segment growth for designing medicine to target specific immune cells or molecules involved in the disease process. Moreover, the metabolic diseases segment is projected to register the fastest CAGR growth during the forecast period. The high demand of CMOs to produce recombinant proteins used as therapeutics for metabolic diseases such as diabetes is anticipated to support segmental growth in terms of favorable usage of various expression systems such as bacterial, yeast, or mammalian cell cultures.
The regional segment comprises North America, Asia Pacific, Europe, Latin America, and the Middle East and Africa. North America accounted for the largest contribution in 2022 with over 36.4% market shares. The established presence of the biopharmaceutical industry supports the growth of market statistics in the North American region. Moreover, favorable guidelines and regulations for the manufacturing of biological drugs results in high demand for such CDMOs for getting access to advanced technologies and equipment, especially for process developments.
Further, Asia Pacific is anticipated to grow at a substantial rate with the fastest CAGR during the forecast period. The availability of low maintenance and operations costs especially in countries such as India, China, and Japan is anticipated to support market growth. Also, increased expenditures on research and development of product innovations in existing biopharmaceuticals by major academic and research institutes in mentioned countries are expected to boost the biopharmaceutical contract manufacturing market statistics in the Asia Pacific region.
Biopharmaceuticals Contract Market Competitive Landscape:
The biopharmaceuticals contract manufacturing industry is highly fragmented due to the presence of several small and medium-sized players. However, the growing trend toward market consolidation results in larger players acquiring such small companies to expand their service offerings and geographic reach. Thus, the prevalence of such a trend among contract manufacturing organizations is expected to result in increased focus by manufacturers on quality and regulatory compliance to expand the service offerings and adopt new technologies to remain competitive. Mentioned are the market players currently functioning in the market environment–
• Samsung BioLogics
• Catalent Inc.
• Boehringer Ingelheim International GmbH
• Inno Biologics Sdn Bhd
• Rentschler Biotechnologies GmbH
• JRS Pharma
• Tianjin Pharmaceutical
• TCG Lifesciences
• AGC Biologics
• Dr. Reddy\'s Laboratories
• Jubilant Life Sciences
• Juniper Pharmaceutical Services
• Fujifilm Diosynth Biotechnologies U.S.A., Inc.
• Toyobo Co., Ltd.
• Pfizer Centreone
• Thermo Fisher Scientific, Inc.
• WuXi Biologics
• AbbVie, Inc.
• In January 2022, Recipharm entered into an agreement with a leading pharmaceutical company ranked among the top 10. The partnership is expected to involve supporting the manufacturing of vaccines from a facility of Recipharm located in Kaysersberg, France.
• In July 2022, Boehringer Ingelheim collaborated with Evotec SE, a life science company listed on the Frankfurt Stock Exchange along with bioMérieux, a global leader in in-vitro diagnostics to establish a joint venture. The initiative aims to develop advanced antimicrobials and effective diagnostics to combat Antimicrobial Resistance (AMR).
• In August 2022, a biopharmaceutical company that is focused on advancing immune-oncology technologies called Xenetic Biosciences entered into a manufacturing agreement with Catalent Pharma Solutions. The collaboration was initiated with the plan to address hard-to-treat cancers and support the cGMP manufacturing for recombinant protein offered by the business named Human DNase I.
• In October 2022, Toregem BioPharma, a biotech startup company affiliated with Kyoto University, and WuXi Biologics (WuXi Bio), a prominent global Contract Research, Development, and Manufacturing Organization (CRDMO), signed a Memorandum of Understanding (MOU) to establish a strategic partnership in the advancement of a product called TRG035. The product is a monoclonal antibody that is designed to target USAG-1 for treating congenital adentia.