Ultra Market Research | United States (U.S.) Pharmaceutical Contract development and manufacturing organizations (CDMO) Market
Key Insights into the U.S. Pharmaceutical CDMO Market - Trends, Growth, and Industry Impact

United States (U.S.) Pharmaceutical Contract development and manufacturing organizations (CDMO) Market

  • Report ID : 620

  • Category : Pharmaceuticals,Biotechnology

  • No Of Pages : 140

  • Published on: August 2024

  • Status: Published

  • Format : Power Point PDF Excel Word

Key Question Answer

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Global Market Outlook

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In-depth analysis of global and regional trends

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Analyze and identify the major players in the market, their market share, key developments, etc.

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To understand the capability of the major players based on products offered, financials, and strategies.

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Identify disrupting products, companies, and trends.

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To identify opportunities in the market.

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Analyze the regional penetration of players, products, and services in the market.

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Comparison of major players financial performance.

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Evaluate strategies adopted by major players.

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Recommendations

United States (U.S.) Pharmaceutical Contract development and manufacturing organizations (CDMO) Market
Growing at a CAGR of XX% from 2024 to 2033, the U.S. pharmaceutical CDMO market was valued at US$ XX billion in 2023 and is projected to reach US$ XX billion by 2033. Through services ranging from research and development to manufacturing, formulation to finishing processes, CDMOs play a crucial role in assisting pharmaceutical firms throughout the whole lifecycle of medicinal product development.
Industry consolidation efforts that have propelled a dynamic landscape of mergers and acquisitions (M&A) have propelled the amazing expansion of the CDMO sector over the last ten years. Global CDMOs with several awards, such as Pfizer CentreOne, use their parent corporations' vast scientific and technological know-how to produce pharmaceuticals and biotech products. The U.S. pharmaceutical CDMO market is growing thanks in large part to this strategic partnership and resource utilization, which also solidifies the company's position as a key link in the pharmaceutical industry's value chain.

Market Overview
Growing need for end-to-end, fully integrated drug research and manufacturing solutions by biotechnology and pharmaceutical businesses is fueling the explosive growth of the U.S. pharmaceutical CDMO sector. A vast range of services are provided by contract development and manufacturing organizations (or CDMOs), such as supply chain management, quality assurance, product packaging, formulation development, regulatory support, clinical trial services, and knowledge transfer solutions. The growth of CDMOs into clinical research services through mergers, acquisitions, or the improvement of internal capabilities is a prominent trend in the sector.
For businesses looking to outsource parts of medication research and manufacturing, this trend offers a lot of potential. It will cut costs, shorten time to market, and guarantee regulatory compliance. As the race to market new pharmaceuticals becomes more intense every year, CDMOs play a crucial role as strategic partners, offering comprehensive services that help pharmaceutical and biotechnology businesses every step of the way from discovery to commercialization. Businesses that have undergone this evolution include Vista Biologicals Corporation in California, which went from being a contract research and development organization to becoming a well-known Contract Development and Manufacturing Organization (CDMO).
 

Report Highlights     
By Product
API category holds the greatest market share in the pharmaceutical contract development and manufacturing organization (CDMO) market in the United States. The primary components of pharmaceutical medicines, known as active pharmaceutical ingredients (APIs), are responsible for a large portion of their therapeutic efficacy. The range of capabilities that CDMOs provide for custom API manufacture includes physicochemical investigations, route scouting, optimization, purification, scale-up, and process development.
. An obvious trend in the sector is the increased outsourcing of early- to late-stage API research and production projects that small- to large-scale biotech and pharmaceutical businesses have been observing. This highlights the critical role that CDMOs play in enabling the productive and efficient manufacture of APIs, satisfying the various demands of the pharmaceutical sector, and leveraging the advantages of outsourcing for increased adaptability and resource efficiency.
In the forecast period, the drug segment is poised for substantial growth within the U.S. pharmaceutical contract development and manufacturing organization (CDMO) market. CDMOs play a crucial role in drug development by undertaking the initial phases of drug formulation and development before proceeding to manufacturing. This strategic outsourcing enables pharmaceutical companies to realize significant cost savings, time efficiencies, and resource optimization, as they no longer need to invest in building and staffing dedicated development and manufacturing facilities. By leveraging the expertise and infrastructure of CDMOs, pharmaceutical firms can streamline the drug development process, accelerate time to market, and focus on core competencies, driving innovation and market competitiveness. As the demand for outsourced drug development and manufacturing services continues to rise, the drug segment is poised to experience remarkable growth, reshaping the landscape of the pharmaceutical industry.


By Dosage Form
With the greatest market size, Solid Dose emerges as the market leader in the pharmaceutical contract development and manufacturing organization (CDMO) sector in the United States. The foundation of the pharmaceutical industry, pharmaceutical solid dosage forms are extensively preferred by a wide range of patient demographics due to their effectiveness and convenience. Interestingly, pharmaceutical companies are devoting significant resources to the study and creation of more potent and palatable solid formulations. Because of the need to meet changing patient needs and pursue improved medication delivery strategies, the solid dose segment of the CDMO market is seeing increased traction.
Over the course of the forecast period, Gaseous Dose is expected to have substantial expansion in the pharmaceutical contract development and manufacturing organization (CDMO) market in the United States. Therapeutically active medications are contained in these dosage forms, which are encased within containers and released upon the application of pressure. Gaseous dosage forms are mostly used for local administration into the mouth and nose or for topical application on the skin. They provide a variety of therapeutic delivery possibilities. They include medicinally active substances meant to be applied topically, injected into bodily cavities, or inhaled through the respiratory system. The growing requirement for gaseous dosage forms highlights their growing significance in pharmaceutical research with an emphasis on improving patient experience and efficacy. This presents CDMOs with profitable potential to broaden their service offerings and meet changing market demands.

By Indication
During the course of the analysis, the U.S. pharmaceutical contract development and manufacturing organization (CDMO) industry is seeing a notable uptick in the pain indication category. Studies on the population, both domestically and internationally, show that those 65 years of age and older have a greater incidence of chronic pain than does the adult population as a whole. The most prevalent chronic pain problems affecting older persons are chronic nonspecific joint pain, chronic back pain, and chronic neck pain, with estimated prevalence rates ranging from 40% to 45% for joint pain, 5% to 45% for back pain, and 20% for neck pain.
Older persons are more likely to experience chronic pain than younger adults, which puts a strain on healthcare systems and is linked to significant suffering, disability, and social isolation. The increasing awareness of the negative effects of chronic pain on quality of life highlights the need for pain management techniques, which is fueling the CDMO market's demand for contract development and manufacturing services customized to pain indication therapies.
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By End-Use
In the pharmaceutical contract development and manufacturing organization (CDMO) market in the United States, the large pharmaceutical sector is the dominating market segment. By utilizing the knowledge of adaptable third-party service providers, CDMOs are essential to pharmaceutical businesses at every stage of the creation of drugs. Widely ranging from formulation and finishing processes to manufacturing and research and development, CDMOs provide end-to-end services customized to meet the demands of major pharmaceutical companies.
By utilizing the specific capabilities of CDMOs, this strategic alliance enables pharmaceutical companies to maximize resources, improve efficiency, and concentrate on their core expertise. The partnership between large pharmaceutical companies and CDMOs is positioned to spur innovation, expedite the development of new products, and influence the direction of the pharmaceutical business as it continues to change.
Over the course of the analysis period, the U.S. pharmaceutical contract development and manufacturing organization (CDMO) market is expected to witness stable expansion in the small and medium-sized pharmaceutical industry. The increasing need for biopharmaceuticals is what is driving this growth trajectory, and it has led to the formation of a specialized business model called the "contract development manufacturing organization (CDMO)"
Small and medium-sized pharmaceutical businesses depend more and more on CDMOs to expedite the creation and execution of production processes. Small and medium-sized pharmaceutical companies can benefit from specialized infrastructure and experience by outsourcing these crucial parts to CDMOs, which in turn enables cost-effective and efficient drug development. The collaboration between small and medium-sized pharmaceutical businesses and CDMOs is expected to stimulate innovation and propel the pharmaceutical industry's growth, given the ongoing surge in demand for biopharmaceuticals.
 

Market Dynamics
Driver 
Advancements in R&D and Quality Standards 
Focus on research and development (R&D) to create next-generation cGMP platforms for cell therapy, viral vectors, and plasmid DNA, together with Thermo Fisher Scientific's advanced therapeutic CDMO network, is a major factor driving the expansion of the pharmaceutical CDMO business in the United States. The superiority of cell therapy and viral vector CDMO services is further enhanced by the incorporation of advanced analytics to handle new regulatory trends and the application of best practices compliant with the most recent international quality and standards criteria.
In addition to guaranteeing the delivery of premium pharmaceutical products, these strategic initiatives place CDMOs at the forefront of innovation and compliance in the ever-changing pharmaceutical industry. As a result of the quest of excellence in advanced therapeutic manufacturing and adherence to strict quality standards, the U.S. pharmaceutical CDMO industry experiencing fast growth.
 

Restraints
Scale-Up Challenges and Volatile Volume Forecasts Constrain 
Unpredictable nature of product volume predictions and the difficulty of scale-up procedures present problems for the pharmaceutical CDMO business in the United States. Historically, CDMOs' accessible and unused manufacturing capacity has helped to minimize development delays and volatility in short-term volume predictions. But these limitations are now impeding commercial expansion. Operational challenges arise from inability to scale up production processes, and manufacturing planning and resource allocation are disrupted by imprecise or quickly changing volume projections. Consequently, the U.S. pharmaceutical CDMO market's potential for growth is limited by the inability to successfully address these issues, underscoring the urgent need for creative solutions to improve scalability and forecast accuracy in the pharmaceutical manufacturing

Opportunities 
Evolution of CDMOs as Technology Innovators 
With alliances with smaller startups and IT titans, CDMOs are well-positioned to expand their role as technological trailblazers and spur innovation in the pharmaceutical sector. To promote cooperation and ease the sharing of knowledge, major corporations are incorporating smaller startups and industry leaders in technology into their operations on a growing basis. It is anticipated that enterprises who prioritize their products will persist in their transition to the CDMO service sector, whilst CDMOs will broaden their range of products.
. Integration of clinical trial services is a new trend that allows CDMOs to enter high-value, low-volume markets like customized medicine. However, this calls for a departure from the conventional volume-first strategy and a move toward a commercial model customized to the particular requirements of personalized care. Consumers increasingly expect CDMOs to offer knowledge across the whole manufacturing process, from manufacture to support during the commercial launch. The U.S. pharmaceutical CDMO market has a lot of opportunity to take advantage of this changing environment to grow its service offerings, leverage innovation, and adapt to the changing demands of the pharmaceutical business.
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Recent Developments

•    In November 2023, SOHM unveiled its new CDMO GMP manufacturing facility in Carlsbad, California.
•    In August 2022, Medipost acquired OmniaBio to launch its CDMO business in North America.
•    In January 2024, Alcami announced the acquisition of West-Coast based Pacific Pharmaceutical Services.
•    In March 2024, Lonza inked an agreement to acquire a large-scale biologics site in Vacaville (US) from Roche.
•    In July 2023, CVC Credit supported Biofarma Group’s acquisition of US Pharma Lab.
•    In May 2023, Baxter finalized a definitive agreement to divest its BioPharma Solutions Business to Advent International and Warburg Pincus for $4.25 billion.
 

Key Players in the U.S. Pharmaceutical CDMO Market
Bushu Pharmaceuticals Ltd.
Nipro Corporation
Thermo Fisher Scientific Inc.
Samsung Biologics
Laboratory Corporation of America Holdings
Siegfried Holding Ag
Catalent, Inc
Lonza Group AG
Recipharm Ab
Piramal Pharma Solutions
Cordenpharma International
Cambrex Corporation
Wuxi Apptec

 

Market Segmentation
By Product
API
By Synthetic
Solid
Liquid
By Type
Traditional Active Pharmaceutical Ingredient (Traditional API)
 Highly Potent Active Pharmaceutical Ingredient (HP-API)
Antibody Drug Conjugate (ADC)
Others
By Drug
Innovative
 Generics
By Manufacturing
Continuous manufacturing
Batch manufacturing
Biotech
By Drug Product
Oral Solid Dose
Semi-solid dose
Liquid Dose
Others

By Dosage Form
Solid
Tablets
Capsules
.Powder
Semi-Solid
Cream
 Paste
Gel
Liquid Dose Formulation
Injectables
Sterile Vials
Single Use/Single Dose
 Multi-Use
Ampules
Prefilled Syringes
Suspension
Emulsion
Gas Dose Formulation
Inhaler
Aerosols

By Indication
Cancer
Cardiovascular Disease
Diabetes
Pain
Respiratory disease
Other Disease

By End-User
Big Pharmaceutical Companies
 Small & Medium-Sized Pharmaceutical Companies
Generic Pharmaceutica

 

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