U.S. Pharmaceutical CDMO Market By Key Takeaways:
· By service type, the active pharmaceutical ingredient (API) manufacturing segment contributed the highest market share of 66% in 2024.
· By service type, the finished dosage formulation (FDF) development and manufacturing segment is projected to grow at a significant CAGR of 8.2% during the forecast period.
· By research phase, phase III segment captured the biggest market share of 35% in 2024.
· By research phase, the phase II segment is expected to grow at a solid CAGR of 7.8% during the forecast period.
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A Contract Development and Manufacturing Organization (CDMO) acts as third-party company providing pharmaceutical and biotechnology companies with facilities and resources for drug development and manufacturing. CDMOs are a key player in the pharmaceutical supply chain while offering a wide range of services such as formulation development, clinical trials, manufacturing of cancer medications, increased efficiency, ensuring quality control and regulatory compliance, reducing production costs and eliminates or mitigates the risks associated with expansions and upgrades for pharmaceutical organizations throughout the U.S.
How is Artificial Intelligence helping pharmaceutical CDMO processes?
The integration of artificial intelligence (AI) and machine learning tools in a pharmaceutical CDMO can significantly assist in streamlining and improving the efficiency of the drug development process by identifying potential drug targets based in disease mechanisms, in molecular docking and simulation, generating de novo drug design processes, optimizing manufacturing parameters which will increase the yield, for analysing clinical trials and enhancing supply chain management thus leading to faster development times, personalized treatment plans and reduced costs while maintaining regulatory compliance and high quality standards.
In Oct 2024, Cellipoint Bioservices, a leading cell therapy CDMO and Mongoose Bio, a private clinical-stage biopharmaceutical company pioneering next generation precision T-cell based therapies targeting solid cancers entered into an agreement for the technology transfer, process development and utilizing cGMP for manufacturing their autologous MGB-001 TCR-T Cell therapy program. Mongoose Bio uses an integrated Generative AI (Gen AI) platform for enhancing antigen discovery and T-cell engineering process thereby aiming to transform cancer treatment.
U.S. Pharmaceutical CDMO Market Growth Factors
· The rapid advancements in clinical trials, development of novel therapies and the rising support from government regulatory agencies for promoting the drug development and manufacturing processes is driving the pharmaceutical companies to outsource their drug research and manufacturing operations through CDMOs for reducing expenses, mitigating risks and adhering to regulatory and quality standards.
· The growing use of biopharmaceuticals in the geriatric population for improving quality of life is promoting the use of CDMOs as source for large-scale manufacturing of these medications to cater the need of the patients.
Market Dynamics
Driver
Increasing demand for therapeutic treatments
The rising prevalence of various chronic illnesses, rare diseases and genetic disorders is creating the demand for targeted therapeutics options for the treatment and improving patient life outcomes. In this scenario, pharmaceutical CDMOs aid in the development and manufacturing of necessary medications as well as in research processes of clinical trials in innovating therapeutic treatments for pharmaceutical companies.
Restraint
Selecting the right CDMO
As many pharmaceutical companies are outsourcing their product development and manufacturing processes towards CDMOs, which allows them to focus on research, clinical trials and product launch. It is extremely necessary for the pharmaceutical companies to choose the right CDMO for their projects. Selecting the correct CDMO helps the companies in avoiding unnecessary errors or bias in their projects while maintaining the timeline and the budget of the project thereby streamlining the development and commercialization process of the products and preventing financial loss of the pharmaceutical businesses.
Opportunity
Rising investments in pharmaceutical R&D processes
The surge in investments and funding’s by public and private sectors for the R&D of safe and effective pharmaceutical treatments for patients. Technological advancements in the manufacturing processes with improved product quality and consistency. The increasing demand of patients for potent medications and growing support government support are the factors creating opportunities for the U.S. pharmaceutical CDMO market.
Report Scope of U.S. Pharmaceutical CDMO Market
|
Report Coverage |
Details |
|
Market Size in 2025 |
USD 43.70 Billion |
|
Market Size by 2034 |
USD 83.86 Billion |
|
Growth Rate From 2024 to 2034 |
CAGR of 7.51% |
|
Base Year |
2024 |
|
Forecast Period |
2024-2034 |
|
Segments Covered |
Product, Application, End User, and Regions |
|
Market Analysis (Terms Used) |
Value (US$ Million/Billion) or (Volume/Units) |
|
Key Companies Profiled |
Thermo Fisher Scientific Inc., Laboratory Corporation of America Holdings, Catalent, Inc, Cambrex Corporation, and Others. |
Segment Insights
U.S. Pharmaceutical CDMO Market By Service Type Insights
The active pharmaceutical ingredient (API) manufacturing segment dominated the U.S. pharmaceutical CDMO market in 2024. CDMOs assist pharmaceutical businesses in the development and manufacturing of APIs owing to the presence of large scale manufacturing plants, access to industrial experts with specialized knowledge and expertise, reduced developmental costs and adherence to strict U.S. FDA standards with quality control thereby helping these pharmaceutical and biotechnology companies for outsourcing their API production and allowing them to focus on clinical trials and market launch of the product. Furthermore, the growing need of effective therapies and medications for patients is boosting the market growth of this segment.
The finished dosage formulation (FDF) development and manufacturing segment is anticipated to grow rapidly in the U.S. pharmaceutical CDMO market during the forecast period. With the growing demand for developing formulations and medications for treating various diseases has likely increased the process of manufacturing finishing and packaging stage products and formulations according to the need of the specific pharmaceutical organization. CDMOs are equipped with state-of-the-art facilities and technologies for managing the production and supplying the pharmaceutical businesses with these FDF while maintaining the timeline, providing successful outcomes and reducing expenses for large-scale manufacturing of these products.
· For instance, in Dec 2024, Cellipoint Bioservices, a leading cell therapy CDMO declared a strategic partnership with Xiogenix, an innovator in biopharmaceutical technology which will allow the CDMO for enhancing the accuracy and efficiency of their cell therapy product filling processes by offering its clients access to the state-of-the-art Ares X20 fill and finish system.
U.S. Pharmaceutical CDMO Market By Research Phase Insights
The phase III segment dominated the U.S. pharmaceutical CDMO market in 2024. Phase III studies involve thousands of volunteers for the evaluation of safety, efficacy and dosage regimen of the drug in diverse demographics. This stage of clinical trials requires facilities for large-scale manufacturing and development of the drugs while adhering to the FDA guidelines, Good Manufacturing Practices (GMP) and quality standards for streamlining the supply to larger populations across various locations.
The availability of state-of-the-art technologies, scalable manufacturing facilities and expertise needed for the development and distribution process of drugs is addressed by the CDMOs for the pharmaceutical businesses outsourcing the production of their innovative drugs and medications.
The phase II segment is anticipated to show the fastest growth over the forecast period. The increasing success rates of preclinical and phase I clinical studies, rising investments in R&D and the growing innovations in pharmaceutical industries are the major factors contributing to market growth of this segment. Additionally, the support from government bodies, expertise provided by CDMOs in development and monitoring of clinical trials are boosting the phase II clinical trials segment in the U.S. region.
U.S. Pharmaceutical CDMO Market By Country-level Insights
Owing to the adherence of strict FDA guidelines in the United States, many pharmaceutical companies are shifting towards CDMOs as a potential option developing and manufacturing medications. Also the adoption of upstream and downstream processes for optimizing large scale manufacturing, reducing production costs, minimizing risks and providing flexible options for manufacturing processes by the CDMOs is promoting the market growth in the U.S. The availability of such feasible and versatile options is drawing attention of pharmaceutical businesses in the U.S.
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Related Report –
Pharmaceutical CDMO Market- The global pharmaceutical CDMO market size was estimated at USD 146.29 billion in 2023 and is projected to hit around USD 295.95 billion by 2033, growing at a CAGR of 7.3% during the forecast period from 2024 to 2033.
U.S. Advanced Therapy Medicinal Products CDMO Market- The U.S. advanced therapy medicinal products CDMO market size was exhibited at USD 2.65 billion in 2023 and is projected to hit around USD 14.24 billion by 2033, growing at a CAGR of 18.31% during the forecast period 2024 to 2033.
Topical Drugs CDMO Market- The topical drugs CDMO market size was exhibited at USD 46.15 billion in 2024 and is projected to hit around USD 137.06 billion by 2034, growing at a CAGR of 11.5% during the forecast period 2024 to 2034.
Advanced Therapy Medicinal Products CDMO Market- The global advanced therapy medicinal products CDMO market size was estimated at USD 6.10 billion in 2023 and is projected to hit around USD 34.53 billion by 2033, growing at a CAGR of 18.93% during the forecast period from 2024 to 2033.
Cell And Gene Therapy CDMO Market- The global Cell And Gene Therapy CDMO market size was estimated at USD 5.90 billion in 2023 and is projected to hit around USD 69.11 billion by 2033, growing at a CAGR of 27.9% during the forecast period from 2024 to 2033.
Some of the prominent players in the U.S. pharmaceutical CDMO market include:
· Thermo Fisher Scientific Inc.
· Laboratory Corporation of America Holdings
U.S. Pharmaceutical CDMO Market Recent Developments
·
In Dec 2024, BioCentriq, a leading cell therapy
CDMO signed a long-term lease agreement with National Business Parks for
developing a cutting-edge manufacturing facility in Princeton, New Jersey which
will also serve as the company’s new headquarters with an immediate $12 million
investment for upgrading the facility with digital advancements.
·
In July 2024, Genezen, a leading gene therapy
organization strategically acquired uniQure’s commercial gene therapy
manufacturing facility in Lexington which is a commercially-licensed viral
vector facility, enabling Genezen for supporting customers from preclinical
development programs through late-phase, commercial manufacturing and also
serve as Genezen's global AAV center of excellence.
· In June 2024, ProBio Inc., a New Jersey based CDMO announced the expansion of its plasmid DNA and viral vector manufacturing facility which will strengthen ProBio’s capability for supporting the manufacturing of transformative cell and gene therapies in North America.
Segments Covered in the Report
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2034. For this study, Nova one advisor, Inc. has segmented the U.S. pharmaceutical CDMO market
By Service Type
· Active Pharmaceutical Ingredient (API) Manufacturing
o Small Molecule
o Large Molecule
o High Potency (HPAPI)
· Finished Dosage Formulation (FDF) Development and Manufacturing
o Solid Dose Formulation
§ Tablets
§ Others (Capsules, Powders, Etc.)
· Liquid Dose Formulation
· Injectable Dose Formulation
· Secondary Packaging
By Research Phase
· Pre-Clinical
· Phase I
· Phase II
· Phase III
· Phase IV
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