The global pharmaceutical CDMO market size was estimated at USD 184.90 billion in 2024 and is projected to surpass USD 368.70 billion by 2034, expanding at a CAGR of 7.2%.
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U.S. Pharmaceutical CDMO Market Highlights:
• By service type, the active pharmaceutical ingredient (API) manufacturing segment has held a major market share of 64.4% in 2024.
• By service type, the finished dosage formulation (FDF) development and manufacturing segment is projected to grow at a solid CAGR of 8.22% during the forecast period.
• By research phase, the phase III segment accounted for the largest market share of 32.5% in 2024.
• By research phase, the phase II segment is expected to grow at a CAGR of 7.81% during the forecast period.
The pharmaceutical CDMO plays a crucial role in the biopharmaceutical industries in the United States and worldwide. The U.S. pharmaceutical CDMO market deals with a strategic union between healthcare contract development and manufacturing organizations and pharmaceutical companies in the United States. Merck, Amgen, Novo Nordisk, Abbott Laboratories, Bristol Myers Squibb, Gilead Sciences, Vertex Pharmaceuticals, Johnson & Johnson, etc. are the prominent players among pharmaceutical and biotechnology industries in the U.S. and globally. They make continuous efforts in research, innovation, and product delivery by addressing the current and future needs of their customers.
These companies play major roles with their well-equipped facilities, well-organized infrastructure, and well-trained team members. They also depend on third-party vendors, contract manufacturing organizations (CMOs), contract research organizations (CROs), or CDMOs to optimize their process workflows by achieving accuracy and precision in their industrial performances.
The CDMOs provide end-to-end or fully integrated clinical services and clinical solutions that are also related to pharmaceutical manufacturing, quality control, good manufacturing practice (GMP), good clinical practice (GCP), drug design and development, current good manufacturing practices (cGMP), etc.
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Major Trends in the U.S. Pharmaceutical CDMO Market
Biopharmaceutical Research and Development Outsourcing: GSK, IQVIA, GE Healthcare,
Novartis, AstraZeneca, Merck, etc. are playing prominent roles in clinical
research, drug discovery and development,
scientific innovations, and new product launching in the market.
The important aspects of clinical research are fulfilled by CDMOs, CROs, or
CMOs which provide promising solutions and services to the clinical research
institutions and organizations. The whole-genome sequencing, computer-aided
drug discovery and drug manufacturing, next-generation sequencing, etc. are possible with
the help of emerging tools and techniques. The biological databases also offer
fruitful insights into scientific research and innovation.
Amalgamation between Biopharmaceutical Companies: There are mergers and acquisitions between different companies like Pfizer, Novartis, Seagen Inc., etc. which are dedicated to research, development, drug discovery, and the launch of healthcare products. These strategic collaborations are also committed to the commercialization of cancer medicines, and medicinal drugs to fight against global health conditions like cardiovascular diseases, diabetes, chronic conditions, heart diseases, etc.
Flexible Manufacturing and Digital Automation: Some of the CDMOs offering end-to-end services and solutions include Thermo Fisher Scientific Inc., Fujifilm Diosynth Biotechnologies, Samsung Biologics, Catalent, etc. The biopharmaceutical companies and research organizations adopt digital technologies like the Internet of Things (IoT), telemedicine, telehealth, remote monitoring, sensory equipment, etc. in their industrial processes to deliver promising products by ensuring accountability and reliability in their performances. The companies perform manufacturing processes related to cell culturing, protein purification, DNA sequencing, antibody production, vaccine design and development, fermentation, etc.
Role of Artificial Intelligence in the U.S. Pharmaceutical CDMO Market
Artificial intelligence helps to establish smart networking between stakeholders, manufacturers, suppliers, and medical professionals working in the healthcare, pharmacy, and biotechnology sectors. The strategic partnerships between pharmaceutical and biotechnology companies allow fruitful scientific innovations through novel research and development processes.
AI-assisted virtual conferences, and business meetings, work promisingly to expand national as well as international contacts. Telemedicine, telehealth, remote patient monitoring, remote monitoring of workflows, etc. are potentially possible due to the insertion of artificial intelligence in healthcare sectors. They help in online tracking of medical health records, and keeping confidentiality of patient’s health information.
U.S. Pharmaceutical CDMO Market Coverage
|
Report Coverage |
Details |
|
U.S. Market Size in 2024 |
USD 40.52 Billion |
|
U.S. Market Size in 2025 |
USD 43.41 Billion |
|
U.S. Market Size by 2034 |
USD 83.25 Billion |
|
U.S. Market Growth Rate from 2024 to 2034 |
CAGR of 7.50% |
|
Base Year |
2023 |
|
Forecast Period |
2024 to 2034 |
|
Segments Covered |
Product, Application, and End User |
Country Insights:
A Strong Expansion of CDMOs Drives the United States:
The United States leads the U.S. pharmaceutical CDMO market significantly due to the massive expansion of various CDMOs all across the United States. The Charles River Laboratories leads as the first CDMO in the North American region. This first CDMO was approved by the European Medicines Agency (EMA) to commercialize its allogeneic cell therapy drug product. This CDMO received the GMP certification after the inspection by EMA.
The Charles River Laboratories received the license to produce an Investigational Medicinal Product (IMP). There were strategic collaborations of Cognate Services, Cobra Biologics, Vigene BioSciences, and Charles River Laboratory in North America to expand their potential to innovate cell-and-gene modified cell therapies.
• In June 2024, Bionova Scientific announced a strategic plan to establish a new business facility in Texas, U.S. to introduce a plasmid DNA business.
• In October 2024, NorthStar Medical Radioisotopes introduced the CDMO facility committed to producing and developing medical radioisotopes.
U.S. Pharmaceutical CDMO Market Segmentation:
Service Type Insights
The active pharmaceutical ingredient (API) manufacturing segment dominated the U.S. pharmaceutical CDMO market in 2024 due to the expansion of API manufacturing facilities in biopharmaceutical industries in the United States. A strong API drug supply chain and success in novel drug discovery and development across the U.S. also drive the growth of the market's active pharmaceutical ingredient (API) manufacturing segment.
The pharmacologic drugs have the potential to elicit a strong immune response and efficient medicinal effects to fight against HIV/AIDS, eye diseases, neurologic disorders, etc. The U.S. accounts for the highest cases of cancer and respiratory illnesses among the U.S. population which drives the rising need for improved diagnostics and therapeutics in the market.
The finished dosage formulation (FDF) development and manufacturing segment is anticipated to be the fastest-growing in the U.S. pharmaceutical CDMO market during the forecast period. There is vast success in the production, manufacturing, and sales of various biopharmaceutical products like tablets, capsules, pills, and other dosage formulations in the U.S. market. The other products include chemical, herbal, and biological products which undergo development and manufacturing by implementing stringent laws and regulations set by the U.S. FDA or the EMA to boost the product portfolio in the market.
Global Pharmaceutical CDMO Market Revenue (USD Billion), By Service Type 2021 to 2023
|
Service Type |
2021 |
2022 |
2023 |
|
Active Pharmaceutical Ingredient (API) Manufacturing |
97.5 |
103.7 |
110.4 |
|
Finished Dosage Formulation (FDF) Development and Manufacturing |
36.8 |
39.4 |
42.3 |
|
Liquid Dose Formulation |
12.9 |
13.9 |
14.9 |
|
Injectable Dose Formulation |
6.7 |
7.4 |
8.2 |
|
Secondary Packaging |
152.6 |
162.5 |
173.2 |
Research Phase Insights
The phase III segment dominated the U.S. pharmaceutical CDMO market in 2024 due to the potential features of phase III clinical trials to ensure the safety and effectiveness of novel therapies, treatments, and medications for people. The rising consciousness in clinical research to conduct phase III clinical trials also drives the growth of this segment in the market. The clinical professionals are empowered to deliver precise medical care to the population.
The phase II segment is expected to be the fastest-growing in the U.S. pharmaceutical CDMO market during the forecast period due to the growing need to ensure the safety and effectiveness of new drugs or therapeutic solutions. The involvement of a group of people in phase II clinical studies helps to predict the success rate of new drugs and to decide their costs in the market.
Global Pharmaceutical CDMO Market Revenue (USD Billion), By Research Phase 2021 to 2023
|
Research Phase |
2021 |
2022 |
2023 |
|
Pre-clinical |
18.4 |
19.6 |
20.9 |
|
Phase I |
22.9 |
24.4 |
26 |
|
Phase II |
34 |
36.3 |
38.8 |
|
Phase III |
48.6 |
51.7 |
55.1 |
|
Phase III |
28.7 |
30.5 |
32.4 |
Discover Additional Market Trends with Our Related Reports:
• Pharmaceutical Manufacturing Market
Size, Share, and Trends 2025 to 2034: The global market size was USD 576.54
billion in 2024, calculated at USD 649.76 billion in 2024 and is projected to
surpass around USD 1,905.76 billion by 2034, expanding at a CAGR of 12.7%.
• Topical Drugs CDMO Market Size, Share, and Trends 2025 to 2034: The global topical drugs CDMO market size surpassed USD 46.62 billion in 2024 and is expected to hit around • USD 124.18 billion by 2033, poised to grow at a CAGR of 11.50%.
• Biologics CDMO Market Size, Share and Trends 2025 to 2034: The global Biologics CDMO market size is expected to be worth USD 21.96 billion in 2024 and is anticipated to reach around USD 92.37 billion by 2034, growing at a solid CAGR of 15.45% over the forecast period 2024 to 2034.
• Pharmaceutical Contract Manufacturing and Research Services Market Size, Share, and Trends 2025 to 2034: The global pharmaceutical contract manufacturing and research services market size was estimated at USD 246.95 billion in 2024 and is expected to hit around USD 464.95 billion by 2033 with a noteworthy CAGR of 7.28%.
• Veterinary CRO And CDMO Market Size, Share, and Trends 2025 to 2034: The global veterinary CRO and CDMO market size accounted for USD 7.13 billion in 2024 and is anticipated to reach around USD 15.98 billion by 2034, expanding at a CAGR of 8.40%.
• Pharmaceutical CRO Market Size, Share and Trends 2025 to 2034: The global pharmaceutical CRO market size is calculated at USD 44.58 billion in 2024 and is anticipated to reach around USD 91.20 billion by 2034, expanding at a CAGR of 7.42%.
Competitive Landscape and Major Breakthroughs in the U.S. Pharmaceutical CDMO Market
The U.S. pharmaceutical CDMO market continues to evolve rapidly, showcasing remarkable advancements in 2023 and 2024 with a dynamic competitive landscape. Major players such as Merck, Novo Nordisk, Abbott Laboratories, Pfizer Inc., Sanofi, GlaxoSmithKline Plc, Amgen Inc., Bristol Myers Squibb Company, Gilead Sciences Inc., Johnson & Johnson, etc. hold a dominating position in the U.S. pharmaceutical CDMO market. These companies are utilizing their vast resources and expertise to provide clinically proven medicines. They are trying to expand their pharmaceutical drug manufacturing capabilities, and offer trustful services through their contract development and manufacturing (CDMO) facilities.
What is Going Around the Globe?
• In May 2024, Enzene Biosciences reported about introducing its novel drug discovery division to expand the capabilities of Enzene’s CDMO services to the biotechnology companies.
• In July 2024, Agilent Technologies Inc. reported about its signed agreement to accept BIOVECTRA for $925 million as the CDMO in North America committed to producing biologics, API, and molecules for targeted therapies.
Segments Covered in the Report:
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
o Tablets
o 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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