Outsourced Clinical Trials & Formulation Market is estimated to expand at a CAGR of 6.7% over the forecast period (2022-2032) – Persistence Market Research


Formulation development, being a crucial part of product/drug development, has highly impacted pharmaceutical products’ patentability, sustainability, and success. The global outsourced clinical trials & formulation market recorded sales worth US$ 13.3 Bn in 2021, and is estimated to expand at a CAGR of 6.7% over the forecast period (2022-2032).

In recent years, pharmaceutical companies have been concentrating their efforts on their core competencies. To reduce the amount of time and money spent on trials, most pharmaceutical companies outsource formulation services. Outsourcing helps make use of CROs’ therapeutic and operational knowledge, geographic reach, and well-established procedures and tools, while reserving their own limited resources for value-added tasks. The tendency toward drug discovery in specific therapeutic areas such as cancer is also significant. Small- and medium-sized organizations can outsource clinical trials in these areas if they lack the therapeutic area expertise and/or resources to manufacture the product independently.

Rise in geriatric populations and increased prevalence of chronic diseases are encouraging CDMOs to develop new products to accelerate treatment procedures by pharmaceutical companies. The role of CDMOs is to simplify the supply chain and introduce new products into the market, which, in turn, will increase the growth of CDMOs in the market. An increase in therapeutic applications of biologics and increased pipeline molecules share will boost contract development and manufacturing market growth.

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Since the outsourced clinical trials & formulation market has emerging key players across the globe, it will provide lucrative prospects for new market participants to establish their presence as well as expand their business. Larger and full-service CDMOs can improve efficiency and reduce time-to-market for customers, as well as gain better margins, grow faster, and have greater capital investment and financing capacity through improved access to capital integrated services.

  • For example, on December 1, 2021, Adare Pharma Solutions acquired Frontida BioPharm to expand leading CDMO offerings.

Key Takeaways from Market Study

  • Oral dosage form dominates the product segment in terms of revenue and accounted for more than 61% market share in 2021.
  • With more than 46% market share, API manufacturing is the leading segment by application.
  • Small- and medium-size pharma/biotech companies held more than half of the global market share in 2021.
  • The North America market for outsourced clinical trials & formulations accounted for more than 40% of the global market share in 2021.

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“Patent expiry and increasing demand for generic drugs will boost demand for outsourced clinical trials & formulations over the coming years,” says an analyst of Persistence Market Research.

Market Competition

Key market players involved in outsourced clinical trials & formulations are investing in R&D activities, and expanding their sales footprint by collaborating with emerging companies to gain the attention of healthcare providers in the global market. Along with expansions, market players are also aiming for various new product launches and acquisitions to create goodwill and successfully grow in the market.

  • On November 16, 2020, Aenova completed the product launch of vegan soft capsules, Aenova VegaGels®.
  • On November 22, 2021, Hovione, expanded its facilities at East Windsor, New Jersey, laying the foundation for a state-of-the-art Hovione Campus.

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What Does the Report Cover?

Persistence Market Research offers a unique perspective and actionable insights on the outsourced clinical trials & formulation market in its latest study, presenting a historical demand assessment of 2016 – 2021 and projections for 2022 – 2032.

The research study is based on the product (oral dosage forms {solid dosage forms, liquid dosage forms, semi-solid dosage forms}, injectable dosage forms, and others), application (API manufacturing, fill-finish product manufacturing, drug product development, packaging/labelling, and others), and end user (big pharmaceutical and biotech companies, small and medium pharma/biotech companies, emerging/virtual pharma companies, and nutraceutical companies), across four key regions (North AmericaEuropeAsia Pacific, and the Rest of the World).

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