Outsourced Clinical Trial and Formulation Market

Outsourced Clinical Trial and Formulation Market Study by Oral and Injectable Dosage Forms for API Manufacturing, Drug Product Development, and Packaging/Labeling from 2024 to 2034

Analysis of Outsourced Clinical Trial and Formulation Market Covering 30+ Countries Including Analysis of US, Canada, UK, Germany, France, Nordics, GCC countries, Japan, Korea and many more

Outsourced Clinical Trial and Formulation Market Outlook (2024 to 2034)

The global outsourced clinical trial and formulation market size is estimated at US$ 16.07 billion and is projected to expand at a CAGR of 6.6% to reach US$ 30.42 billion by 2034-end.

Businesses in the biotechnology and pharmaceutical sectors outsource clinical trials due to time constraints, cost considerations, and resources. Suppliers and contract research organizations (CROs) predominantly manage clinical studies. Advancements in technology, such as the adoption of AI and data analytics, are necessitating partnerships between CROs and technology companies.

Stringent regulatory requirements are necessitating expertise in compliance, which is driving companies to outsource clinical trials to ensure adherence to regulations. Dosage forms, such as tablets, suspensions, and liquids, incorporate active medicinal components. Consequently, an increasing number of companies are subcontracting API production to nations with cost-effective labor, driving the global demand for clinical trial outsourcing.

Key Drivers for Market Growth

  • Operations in the pharmaceutical sector are intricate due to advancements in therapies, personalized drug approaches, and biologics.
  • Industry players seek outsourcing partners with specialized knowledge and skills to navigate the complexities of clinical trial design, execution, and formulation.
  • Outsourcing facilitates the development of new drugs and increases the likelihood of successful clinical trials supported by highly skilled scientists and advanced technology.
  • Rising cost constraints and decreasing new drug development prompts pharmaceutical firms to optimize resource allocation and streamline operations.
  • Contracting clinical trials and formulation processes enables drug sponsors to achieve cost reduction by leveraging the infrastructure and capabilities of CROs and contract development and manufacturing organizations (CDMOs).
  • By outsourcing non-core activities, companies employ their internal resources for core competencies like drug discovery and commercialization, thus driving competitiveness in the global market.
  • Clinical management systems play a pivotal role in both management and industry expansion.
Report Attributes Details
Outsourced Clinical Trial and Formulation Market Size (2024E) US$ 16.07 Billion
Forecasted Market Value (2034F) US$ 30.42 Billion
Global Market Growth Rate (2024 to 2034) 6.6% CAGR
North America Market Share (2024E) 44.2%
East Asia Market Value (2034F) US$ 4.58 Billion
Sales of Oral Dosage Forms (2034F) US$ 17.6 Billion
Small- and Medium-Size Pharma/Biotech Company Segment Value (2034F) US$ 15.66 Billion
Key Companies Profiled
  • Piramal Pharma Solutions
  • Catalent, Inc.
  • SGS S.A.
  • Lonza Group
  • Siegfried Holding AG
  • Ascendia Pharmaceuticals
  • Charles River Laboratories International, Inc.
  • Quotient Sciences
  • Velesco Pharmaceutical Services, Inc.
  • Hermes Pharma GmbH
  • Eurofins Scientific SE
  • Elements Group (Avomeen)
  • Evotec A.G.
  • VxP Pharma
  • Eurofins Scientific SE
  • Hovione
  • Enteris Biopharma, Inc.
  • Aenova Holding GmbH
  • KP Pharmaceutical Technology Inc.
  • NextPharma Technologies
  • Ardena Holding NV
  • Alcami Corporation, Inc.
  • Thermo Fisher Scientific Inc. (Patheon)
  • Glatt GmbH
  • Pharmaceutics International, Inc.
  • Recipharm AB
  • Pace Analytical Services, LLC
  • Almac Group, Inc.
  • Corerx, Inc.
  • Cambrex Corporation
  • Aphena Pharma Solutions
  • Rottendorf Pharma GmbH

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What’s Behind Steady Outsourced Clinical Trial and Formulation Market Growth?

“Growing Investments in Research for Development of New Drugs”

The increasing demand for formulation development in the healthcare sector is resulting in heavy investments in research and development by companies. Due to the lack of capacity for formation development, some small- and medium-sized companies often use formulation development services. To remain competitive, companies are increasingly focusing on research and development, thereby fueling the expansion of the market.

“Collaborations Between Industry Players to Introduce Effective Medications and Gene Therapies”

Pharmaceutical firms play a pivotal role in driving the expansion of the outsourced clinical trial and formulation market size through their focus on cancer formulation development and other medication advancements. These industry leaders are collaborating to pioneer effective medications and gene therapies, leading to the growth of the biotech sector. Over the forecast period, market expansion is projected to be driven by the adoption of new methodologies, enhanced availability, and expanded pharmaceutical services by major players.

Delivering clinical and pharmacological substance development, as well as medicinal products, to patients stands as a primary objective. Market competitors are engaged in fierce competition to expand their businesses by innovating and introducing unique products that stimulate customer demand.

What are the Factors Affecting Market Growth to Some Extent?

“Insufficient Funding to Complete Formulation Development Phase”

The process of developing new drugs is highly time-consuming, costly, and challenging, with no guarantee of success. Each phase of the drug development process requires significant capital investment. These time-consuming procedures and low success rates drive up high research and development costs. Factors restricting the expansion of the market include shifts in the organizational structure of the pharmaceutical sector and insufficient funding to complete the formulation development phase of drug development.

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Country-wise Insights

The North American region is a leading player in the outsourced clinical trial and formulation market and is estimated to hold 44.2% revenue share in 2024. Demand for outsourced clinical trials and formulation solutions is predicted to rise at 6.7% CAGR from 2024 to 2034.

What Makes the United States a Key Market in This Space?

“High Manufacturing Rate and Strong Clinical Infrastructure”

Attribute United States
Market Value (2024E) US$ 5.98 Billion
Growth Rate (2024 to 2034) 6.2% CAGR
Projected Value (2034F) US$ 10.96 Billion

The United States is generating a significant portion of revenue in North America because of high API manufacturing rates, excellent healthcare accessibility, and solid clinical research infrastructure. Further, government initiatives and incentive programs are also contributing to revenue growth players in the outsourced clinical trial and formulation business. The presence of key market players in the country is also supporting market growth.

Which Outsourced Clinical Trial and Formulation Market Trends are Significant in China?

“Growing Healthcare Sector and Government Initiatives Supporting Drug Development”

Attribute China
Market Value (2024E) US$ 1.43 Billion
Growth Rate (2024 to 2034) 7% CAGR
Projected Value (2034F) US$ 2.8 Billion

In the East Asia region, China is projected to account for 59.3% of the outsourced clinical trial and formulation market share in 2024. The increasing demand for outsourced clinical trials and formulation solutions is the result of the growing healthcare sector in the country. Due to the strong manufacturing base, funding by companies and the government for the production of new drugs is creating new opportunities for players in the market.

  • In January 2023, WuXi STA, an affiliate of WuXi AppTec, officially inaugurated its continuous production line. Located in Wuxi City, the line is integrated into the company's formulation development and production facility.

Category-wise Insights

By product type, the market is segmented into oral dosage forms and injectable dosage forms. Even though the oral dosage form accounts for a significant market share, the injectable dosage form segment is projected to expand at 7.5% CAGR from 2024 to 2034.

Why are Oral Dosage Forms Highly Sought After for Outsourced Formulation Development?

“Self-administrable Nature and Flexible Design of Oral Dosage Forms”

Attribute Oral Dosage Forms
Segment Value (2024E) US$ 9.72 Billion
Growth Rate (2024 to 2034) 6.1% CAGR
Projected Value (2034F) US$ 17.6 Billion

In 2024, oral dosage formulations are estimated to occupy 60.5% revenue share. Oral dosage formulations include tablets, syrups, capsules, powders, and many other products that are generally used for common diseases such as infections, fever, migraines, and diabetes. The fact that oral formulations are self-administrable and do not require a trained physician to administer the drug is one of the primary factors influencing their high popularity. These formulations also have more flexible designs than others, which makes them highly sought after for outsourced formulation development.

Why Do Most Pharmaceutical Companies Outsource API Manufacturing?

“Focus on Leveraging Expertise of CDMO and Reducing Costs”

Attribute API Manufacturing
Segment Value (2024E) US$ 7.45 Billion
Growth Rate (2024 to 2034) 6.3% CAGR
Projected Value (2034F) US$ 13.79 Billion

Dosage forms are typically produced separately from tablets, suspensions, and liquids, and therefore, an increasing number of companies are opting to outsource their API manufacturing to regions with lower labor costs. By doing so, emerging and virtual pharmaceutical firms are capitalizing on the operational expertise of contract development and manufacturing organizations (CDMOs).

These partnerships provide access to GMP facilities, quality assurance, safety measures, environmental management systems, standardized operating procedures, and advanced Chemistry, Manufacturing, and Control (CMC) technologies. This offers streamlined production processes and enhances overall efficiency.

Know thy Competitors

Competitive landscape highlights only certain players
Complete list available upon request

Competitive Landscape

Key players in the outsourced clinical trial and formulation market include Piramal Pharma Solutions, Catalent, Inc., SGS S.A., Lonza Group, Siegfried Holding AG, Ascendia Pharmaceuticals, Charles River Laboratories International, Inc., Quotient Sciences, Velesco Pharmaceutical Services, Inc., Hermes Pharma GmbH, Eurofins Scientific SE, Glatt GmbH, Pharmaceutics International, Inc., and Rottendorf Pharma GmbH.

  • In November 2019, it was reported that Dr Reddy's Laboratories, which is placing a large bet on the Chinese market and intends to introduce over 70 items there, had begun contracting with local partners to manufacture a portion of its medication line.

Segmentation of Outsourced Clinical Trial and Formulation Market Research

  • By Product Type :

    • Oral Dosage
      • Solid Dosage
      • Liquid Dosage
      • Semi-solid Dosage
    • Injectable Dosage
  • By Application :

    • API Manufacturing
    • Fill-Finish Product Manufacturing
    • Drug Product Development
    • Packaging/Labeling
  • By End User :

    • Big Pharmaceutical/Biotech Companies
    • Small- & Medium-Size Pharma/Biotech Companies
    • Emerging/Virtual Pharma Companies
    • Nutraceutical Companies
  • By Region :

    • North America
    • Europe
    • Latin America
    • East Asia
    • South Asia & Oceania
    • Middle East & Africa

- FAQs -

How big is the outsourced clinical trial and formulation market?

The global market for outsourced clinical trials and formulations is estimated at US$ 16.07 billion in 2024.

What are the projections for the global market by 2034?

Worldwide revenue from outsourced clinical trials and formulations is projected to reach US$ 30.42 billion by 2034-end.

How fast is market forecasted to expand?

The global outsourced clinical trial and formulation market is projected to advance at a CAGR of 6.6%.

What are the projections for the market in Mexico?

The Mexico market is estimated to reach US$ 601 million in 2024 and thereafter increase at 6% CAGR.

Who are the leading players in the outsourced clinical trial and formulation industry?

Piramal Pharma Solutions, Catalent, Inc., and SGS S.A. are some of the leading companies in the industry.

At what pace is the market projected to grow in Japan?

The market in Japan is projected to expand at a CAGR of 6.6% through 2034.

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Outsourced Clinical Trial and Formulation Market

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