Biopharmaceutical CMO And CRO - Market Share Analysis, Industry Trends & Statistics, Growth Forecasts (2024 - 2029)
The Biopharmaceutical CMO And CRO Market size is estimated at USD 78.17 billion in 2024, and is expected to reach USD 115.35 billion by 2029, growing at a CAGR of 6.70% during the forecast period (2024-2029).
The market is driven by factors such as growing investment by market players to expand the biopharmaceutical CMO facility, growing robust pharmaceutical pipeline, and increasing strategic activities by the market players such as collaboration and partnership.
Due to the rising trend of outsourcing in the biopharmaceutical industry, the global CMO/CRO market is experiencing significant growth. For instance, in November 2022, Baxter International Inc. unveiled a substantial USD 100 million expansion for its sterile fill and finish manufacturing facility in Halle (Halle Westfalen), Germany. The Halle facility is operated by BioPharma Solutions (BPS), a branch of Baxter that collaborates with renowned pharmaceutical and biotech companies to create and contract-manufacture drug products for injectable pharmaceuticals (parenteral).
Similarly, in June 2022, the Government of Quebec bestowed a loan of USD 18 million upon Jubilant Pharma Limited to facilitate the expansion of the contract manufacturing facility in Montreal. Moreover, in October 2022, Evonik unveiled the completion of an expansion worth EUR 36 million (USD 38.12 million) for its contract manufacturing facilities in the United States and Europe. At various Evonik production sites, cutting-edge technologies encompassing high-potency APIs, fermentation, mPEGs, and continuous processing were either integrated or improved. Thus, expanding these contract manufacturing services is likely to increase their adoption by pharmaceutical and medical device companies and is anticipated to boost market growth.
Moreover, market players are also adopting several strategies, such as mergers, acquisitions, and collaboration, which are expected to boost the biopharmaceutical CMO & CRO market growth over the forecast period. For instance, in November 2023, Ichor Life Sciences, a CRO and longevity biotechnology company, announced the launch of Ichor Clinical Trial Services. With the founding of Ichor Clinical, the company can now serve biotechnology and pharmaceutical clients from early preclinical studies through late-stage clinical trials and F-A approval.
Additionally, in July 2023, TransCure bioServices, a CRO specializing in humanized mouse models, formed a strategic partnership with Precl na Inc., based in South Korea, specializing in autoimmune and inflammatory diseases. This partnership is a significant milestone for TransCure as it expands its presence into the APAC region, strengthens its service portfolio, and enhances the quality of its research outcomes.
Hence, increasing funding for expanding manufacturing facilities and strategic initiatives taken by the CRO and CMO companies is expected to boost the market over the forecast period. However, limited outsourcing among well-established biopharmaceutical manufacturers and regulatory challenges are expected to restrain the market over the forecast period.
Biopharmaceutical CMO And CRO Market Trends
The Oncology Segment is Expected to Hold a Significant Share During the Forecast Period
CROs (contract research organizations) play a significant role in cancer research and drug development. CROs are often involved in managing various phases of clinical trials for cancer therapies. This includes designing and planning trials, patient recruitment, data management, and monitoring trial progress to ensure adherence to regulatory standards. In addition, CRO helps pharmaceutical companies design preclinical studies, providing data analytics and interpretation and regulatory support.
The increasing prevalence of cancer is anticipated to boost the demand for advanced and effective therapeutics, leading to new investments by companies and other stakeholders, like governments, for the identification, testing, and development of novel cancer therapeutics. For instance, as per the Canadian Cancer Statistics 2023 report, about 239.2 thousand new cancer cases were reported in 2023 in Canada, compared to 233.9 thousand in 2022. Thus, the growing burden of cancer is expected to create the demand for drug research and manufacturing services, which will likely contribute to segment growth.
The increasing research & development activities and collaboration with CRO providers to effectively complete the drug research process for cancer are expected to contribute to segment growth. For instance, in June 2023, ITOCHU Corporation and its subsidiary A2 Healthcare Corporation announced a partnership agreement with NRG Oncology as a CRO to promote multicentre joint clinical research within Japan as an affiliate of the National Cancer Institutes. Based on the agreement, A2 Healthcare will continue to engage in the clinical trial support business for drugs that have yet to be approved in Japan. Additionally, in May 2023, George Clinical, a CRO, initiated preparations in Australia for two oncology Phase 1b trials that will examine a Hummingbird Bioscience precision therapy program targeting HER3, a potent driver of tumor growth and resistance against cancer drugs, in biomarker-selected patient populations, including lung cancer.
Hence, increasing research and development activities for cancer drugs will create demand for CRO services over the forecast period.
North America is Expected to Hold a Significant Market Share During the Forecast Period
North America is expected to gain the largest share in the market during the forecast period owing to the increasing incidence of chronic diseases, increasing demand for generics and biologics, rise in demand for biosimilars, and growing investments in R&D by the biopharmaceutical industry. In addition, increasing expansion of manufacturing facilities and strategic activities by the market players are expected to contribute to the market growth.
The increasing pharmaceutical expenditure in the region is also bolstering the market's growth. For instance, according to Federal Research and Development (R&D) Funding: FY2022, funding for R&D is concentrated in a few federal departments and agencies. In FY 2021, five agencies received 93.0% of total federal R&D funding, with the Department of Health and Human Services receiving 27.6%. The most significant price increases in R&D funding would be made to Health and Human Services, up to USD 7.7 billion (17.8%). These initiatives incentivize research and development activities, promote collaboration among stakeholders, and facilitate the translation of scientific discoveries into clinical applications. Contract manufacturers specializing in biopharmaceutical CMO are well-positioned to benefit from these collaborative efforts, supporting the translation of cutting-edge research into tangible healthcare solutions.
Increasing investment in developing and expanding the contract manufacturing facilities is expected to contribute to the market growth during the forecast period. CMOs have increasingly adopted continuous manufacturing for biologics production following FDA approval. For instance, in June 2022, Agilent Technologies and Abzena expanded their continuous manufacturing capabilities. Furthermore, the collaboration and partnership agreement by CDMO with the pharmaceutical company to streamline vaccine manufacturing and development are expected to contribute to market growth. For instance, in May 2023, Moderna Inc. announced a long-term agreement with Ontario-based Novocol Pharma, a CMO to perform aseptic fill-finish, labeling, and packaging of mRNA respiratory vaccines expected to be produced in Canada.
Thus, the high R&D investment and initiatives by key players in the product portfolio expansion are expected to boost the development of new drugs, increasing the demand for outsourcing services such as CMO and CRO, thereby raising the market growth.
Biopharmaceutical CMO And CRO Industry Overview
The biopharmaceutical CMO and CRO market is moderately competitive and consists of several significant players. In terms of market share, a few major players dominate the market. Some prominent players are vigorously making acquisitions of other companies to consolidate their global market positions. Some of the major market players are Lonza Group AG, ICON PLC, Parexel International Corporation, Samsung Biologics, and Charles River Laboratories International Inc.
Additional Benefits:
The market estimate (ME) sheet in Excel format
3 months of analyst support
The market is driven by factors such as growing investment by market players to expand the biopharmaceutical CMO facility, growing robust pharmaceutical pipeline, and increasing strategic activities by the market players such as collaboration and partnership.
Due to the rising trend of outsourcing in the biopharmaceutical industry, the global CMO/CRO market is experiencing significant growth. For instance, in November 2022, Baxter International Inc. unveiled a substantial USD 100 million expansion for its sterile fill and finish manufacturing facility in Halle (Halle Westfalen), Germany. The Halle facility is operated by BioPharma Solutions (BPS), a branch of Baxter that collaborates with renowned pharmaceutical and biotech companies to create and contract-manufacture drug products for injectable pharmaceuticals (parenteral).
Similarly, in June 2022, the Government of Quebec bestowed a loan of USD 18 million upon Jubilant Pharma Limited to facilitate the expansion of the contract manufacturing facility in Montreal. Moreover, in October 2022, Evonik unveiled the completion of an expansion worth EUR 36 million (USD 38.12 million) for its contract manufacturing facilities in the United States and Europe. At various Evonik production sites, cutting-edge technologies encompassing high-potency APIs, fermentation, mPEGs, and continuous processing were either integrated or improved. Thus, expanding these contract manufacturing services is likely to increase their adoption by pharmaceutical and medical device companies and is anticipated to boost market growth.
Moreover, market players are also adopting several strategies, such as mergers, acquisitions, and collaboration, which are expected to boost the biopharmaceutical CMO & CRO market growth over the forecast period. For instance, in November 2023, Ichor Life Sciences, a CRO and longevity biotechnology company, announced the launch of Ichor Clinical Trial Services. With the founding of Ichor Clinical, the company can now serve biotechnology and pharmaceutical clients from early preclinical studies through late-stage clinical trials and F-A approval.
Additionally, in July 2023, TransCure bioServices, a CRO specializing in humanized mouse models, formed a strategic partnership with Precl na Inc., based in South Korea, specializing in autoimmune and inflammatory diseases. This partnership is a significant milestone for TransCure as it expands its presence into the APAC region, strengthens its service portfolio, and enhances the quality of its research outcomes.
Hence, increasing funding for expanding manufacturing facilities and strategic initiatives taken by the CRO and CMO companies is expected to boost the market over the forecast period. However, limited outsourcing among well-established biopharmaceutical manufacturers and regulatory challenges are expected to restrain the market over the forecast period.
Biopharmaceutical CMO And CRO Market Trends
The Oncology Segment is Expected to Hold a Significant Share During the Forecast Period
CROs (contract research organizations) play a significant role in cancer research and drug development. CROs are often involved in managing various phases of clinical trials for cancer therapies. This includes designing and planning trials, patient recruitment, data management, and monitoring trial progress to ensure adherence to regulatory standards. In addition, CRO helps pharmaceutical companies design preclinical studies, providing data analytics and interpretation and regulatory support.
The increasing prevalence of cancer is anticipated to boost the demand for advanced and effective therapeutics, leading to new investments by companies and other stakeholders, like governments, for the identification, testing, and development of novel cancer therapeutics. For instance, as per the Canadian Cancer Statistics 2023 report, about 239.2 thousand new cancer cases were reported in 2023 in Canada, compared to 233.9 thousand in 2022. Thus, the growing burden of cancer is expected to create the demand for drug research and manufacturing services, which will likely contribute to segment growth.
The increasing research & development activities and collaboration with CRO providers to effectively complete the drug research process for cancer are expected to contribute to segment growth. For instance, in June 2023, ITOCHU Corporation and its subsidiary A2 Healthcare Corporation announced a partnership agreement with NRG Oncology as a CRO to promote multicentre joint clinical research within Japan as an affiliate of the National Cancer Institutes. Based on the agreement, A2 Healthcare will continue to engage in the clinical trial support business for drugs that have yet to be approved in Japan. Additionally, in May 2023, George Clinical, a CRO, initiated preparations in Australia for two oncology Phase 1b trials that will examine a Hummingbird Bioscience precision therapy program targeting HER3, a potent driver of tumor growth and resistance against cancer drugs, in biomarker-selected patient populations, including lung cancer.
Hence, increasing research and development activities for cancer drugs will create demand for CRO services over the forecast period.
North America is Expected to Hold a Significant Market Share During the Forecast Period
North America is expected to gain the largest share in the market during the forecast period owing to the increasing incidence of chronic diseases, increasing demand for generics and biologics, rise in demand for biosimilars, and growing investments in R&D by the biopharmaceutical industry. In addition, increasing expansion of manufacturing facilities and strategic activities by the market players are expected to contribute to the market growth.
The increasing pharmaceutical expenditure in the region is also bolstering the market's growth. For instance, according to Federal Research and Development (R&D) Funding: FY2022, funding for R&D is concentrated in a few federal departments and agencies. In FY 2021, five agencies received 93.0% of total federal R&D funding, with the Department of Health and Human Services receiving 27.6%. The most significant price increases in R&D funding would be made to Health and Human Services, up to USD 7.7 billion (17.8%). These initiatives incentivize research and development activities, promote collaboration among stakeholders, and facilitate the translation of scientific discoveries into clinical applications. Contract manufacturers specializing in biopharmaceutical CMO are well-positioned to benefit from these collaborative efforts, supporting the translation of cutting-edge research into tangible healthcare solutions.
Increasing investment in developing and expanding the contract manufacturing facilities is expected to contribute to the market growth during the forecast period. CMOs have increasingly adopted continuous manufacturing for biologics production following FDA approval. For instance, in June 2022, Agilent Technologies and Abzena expanded their continuous manufacturing capabilities. Furthermore, the collaboration and partnership agreement by CDMO with the pharmaceutical company to streamline vaccine manufacturing and development are expected to contribute to market growth. For instance, in May 2023, Moderna Inc. announced a long-term agreement with Ontario-based Novocol Pharma, a CMO to perform aseptic fill-finish, labeling, and packaging of mRNA respiratory vaccines expected to be produced in Canada.
Thus, the high R&D investment and initiatives by key players in the product portfolio expansion are expected to boost the development of new drugs, increasing the demand for outsourcing services such as CMO and CRO, thereby raising the market growth.
Biopharmaceutical CMO And CRO Industry Overview
The biopharmaceutical CMO and CRO market is moderately competitive and consists of several significant players. In terms of market share, a few major players dominate the market. Some prominent players are vigorously making acquisitions of other companies to consolidate their global market positions. Some of the major market players are Lonza Group AG, ICON PLC, Parexel International Corporation, Samsung Biologics, and Charles River Laboratories International Inc.
Additional Benefits:
The market estimate (ME) sheet in Excel format
3 months of analyst support
1 INTRODUCTION
1.1 Study Assumptions and Market Definitions
1.2 Scope of the Study
2 RESEARCH METHODOLOGY
3 EXECUTIVE SUMMARY
4 MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Rising Investment by CMOs For Capacity Expansion
4.2.2 Robust Biopharmaceuticals Pipeline
4.2.3 Cost And Time Saving Benefits Offered By Contract Services
4.3 Market Restraints
4.3.1 Limited Outsourcing Amongst Well-Stablished Biopharmaceutical Manufacturer
4.3.2 Regulatory Challenges
4.4 Porter's Five Forces Analysis
4.4.1 Bargaining Power of Suppliers
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Threat of New Entrants
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5 MARKET SEGMENTATION (MARKET SIZE BY VALUE – USD)
5.1 By Source
5.1.1 Mammalian
5.1.2 Non-mammalian
5.2 By Services Type
5.2.1 Contract Manufacturing
5.2.1.1 Process Development
5.2.1.2 Fill & Finish Operations
5.2.1.3 Analytical & QC Studies
5.2.1.4 Packaging
5.2.2 Contract Research
5.2.2.1 Oncology
5.2.2.2 Inflammation & Immunology
5.2.2.3 Cardiology
5.2.2.4 Neuroscience
5.2.2.5 Others
5.3 By Product
5.3.1 Biologics
5.3.1.1 Monoclonal antibodies (MAbs)
5.3.1.2 Recombinant Proteins
5.3.1.3 Vaccines
5.3.1.4 Antisense, RNAi, & Molecular Therapy
5.3.1.5 Others
5.3.2 Biosimilars
5.4 Geography
5.4.1 North America
5.4.1.1 United States
5.4.1.2 Canada
5.4.1.3 Mexico
5.4.2 Europe
5.4.2.1 United Kingdom
5.4.2.2 Germany
5.4.2.3 France
5.4.2.4 Spain
5.4.2.5 Italy
5.4.2.6 Rest of Europe
5.4.3 Asia-Pacific
5.4.3.1 India
5.4.3.2 Japan
5.4.3.3 China
5.4.3.4 Australia
5.4.3.5 South Korea
5.4.3.6 Rest of Asia-Pacific
5.4.4 Middle East and Africa
5.4.4.1 GCC
5.4.4.2 South Africa
5.4.4.3 Rest of the Middle East and Africa
5.4.5 South America
5.4.5.1 Brazil
5.4.5.2 Argentina
5.4.5.3 Rest of South America
6 COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Boehringer Ingelheim GmbH
6.1.2 Lonza Group AG
6.1.3 Inno Biologics Sdn Bhd
6.1.4 Fujifilm Diosynth Biotechnologies U.S.A. Inc.
6.1.5 Toyobo Co. Ltd
6.1.6 Samsung Biologics
6.1.7 Thermo Fisher Scientific Inc (Patheon & PPD)
6.1.8 WuXi Biologics
6.1.9 Charles River Laboratories International Inc.
6.1.10 ICON PLC
6.1.11 Parexel International Corporation
6.1.12 Laboratory Corporation of America Holdings
7 MARKET OPPORTUNITIES AND FUTURE TRENDS
1.1 Study Assumptions and Market Definitions
1.2 Scope of the Study
2 RESEARCH METHODOLOGY
3 EXECUTIVE SUMMARY
4 MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Rising Investment by CMOs For Capacity Expansion
4.2.2 Robust Biopharmaceuticals Pipeline
4.2.3 Cost And Time Saving Benefits Offered By Contract Services
4.3 Market Restraints
4.3.1 Limited Outsourcing Amongst Well-Stablished Biopharmaceutical Manufacturer
4.3.2 Regulatory Challenges
4.4 Porter's Five Forces Analysis
4.4.1 Bargaining Power of Suppliers
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Threat of New Entrants
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5 MARKET SEGMENTATION (MARKET SIZE BY VALUE – USD)
5.1 By Source
5.1.1 Mammalian
5.1.2 Non-mammalian
5.2 By Services Type
5.2.1 Contract Manufacturing
5.2.1.1 Process Development
5.2.1.2 Fill & Finish Operations
5.2.1.3 Analytical & QC Studies
5.2.1.4 Packaging
5.2.2 Contract Research
5.2.2.1 Oncology
5.2.2.2 Inflammation & Immunology
5.2.2.3 Cardiology
5.2.2.4 Neuroscience
5.2.2.5 Others
5.3 By Product
5.3.1 Biologics
5.3.1.1 Monoclonal antibodies (MAbs)
5.3.1.2 Recombinant Proteins
5.3.1.3 Vaccines
5.3.1.4 Antisense, RNAi, & Molecular Therapy
5.3.1.5 Others
5.3.2 Biosimilars
5.4 Geography
5.4.1 North America
5.4.1.1 United States
5.4.1.2 Canada
5.4.1.3 Mexico
5.4.2 Europe
5.4.2.1 United Kingdom
5.4.2.2 Germany
5.4.2.3 France
5.4.2.4 Spain
5.4.2.5 Italy
5.4.2.6 Rest of Europe
5.4.3 Asia-Pacific
5.4.3.1 India
5.4.3.2 Japan
5.4.3.3 China
5.4.3.4 Australia
5.4.3.5 South Korea
5.4.3.6 Rest of Asia-Pacific
5.4.4 Middle East and Africa
5.4.4.1 GCC
5.4.4.2 South Africa
5.4.4.3 Rest of the Middle East and Africa
5.4.5 South America
5.4.5.1 Brazil
5.4.5.2 Argentina
5.4.5.3 Rest of South America
6 COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Boehringer Ingelheim GmbH
6.1.2 Lonza Group AG
6.1.3 Inno Biologics Sdn Bhd
6.1.4 Fujifilm Diosynth Biotechnologies U.S.A. Inc.
6.1.5 Toyobo Co. Ltd
6.1.6 Samsung Biologics
6.1.7 Thermo Fisher Scientific Inc (Patheon & PPD)
6.1.8 WuXi Biologics
6.1.9 Charles River Laboratories International Inc.
6.1.10 ICON PLC
6.1.11 Parexel International Corporation
6.1.12 Laboratory Corporation of America Holdings
7 MARKET OPPORTUNITIES AND FUTURE TRENDS
