The global formulation development outsourcing market size is estimated to reach USD 60.66 billion by 2030, registering a CAGR of 8.62% from 2025 to 2030, according to a new report by Grand View Research, Inc. The high burden of chronic and infectious diseases, the growing focus on improving the bioavailability of poorly soluble drugs, and the complications associated with drug development are contributing to the demand for formulation development services globally. Furthermore, the COVID-19 outbreak has influenced the need for clinical trials to find an effective treatment against the contagious virus. This has resulted in significant investments in research and development (R&D) to develop therapeutics, which are expected to drive the market.
According to Pharma R&D Annual Review 2022, biopharmaceutical and anticancer drugs are the major drugs in the development stage in the year 2022, this is expected to improve the demand for formulation development of these drugs post-pandemic. Globally, the pharmaceutical companies are making significant contributions to R&D activities. For instance, Merck’s R&D cost was USD 2,516.8 million in 2020 as compared to USD 2,494.8 million in 2019. Similarly, Biogen’s R&D expenses accounted for USD 3,990.9 million in 2020. The company’s R&D expenditure increased by 75% as compared to 2019. The significant increase in R&D expenditure is likely to have a positive impact on the market.
A significant number of drugs fail to reach late-stage clinical trials owing to complications associated with formulation development. Moreover, strict regulations regarding the development of drugs are further contributing to the demand for outsourcing formulation development. Such factors are expected to improve the demand. The COVID-19 incidence has been significantly reduced owing to the growing vaccination drive globally. As a result, the CRO and CDMO are once again concentrating on the development of drugs for oncology and other disorders. For instance, in April 2022, Labcorp collaborated with Xcell Biosciences to support the company in developing cell and gene therapies for treating cancer, Parkinson’s disease, and other rare diseases. Such initiatives by the CDMOs are likely to promote the demand for the formulation development outsourcing of drugs used in the treatment of cancer and other rare diseases.
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Based on services, the preformulation segment is expected to grow at the fastest CAGR during the forecast period.
Based on formulation, the drug product segment is expected to grow at a significant CAGR during the forecast period.
Based on therapeutic area, the oncology segment accounted for the largest market revenue share in 2024.
Asia Pacific held the largest revenue share in 2024, due to the presence of a significant number of CROs providing cost effective formulation development services.
Grand View Research has segmented the global formulation development outsourcing market based on service, formulation, therapeutic area, end-use, and region:
Formulation Development Outsourcing Service Outlook (Revenue, USD Million, 2018 - 2030)
Preformulation
Formulation Development
Formulation Development Outsourcing Formulation Outlook (Revenue, USD Million, 2018 - 2030)
Oral
Injectable
Topical
Others
Formulation Development Outsourcing Therapeutic Area Outlook (Revenue, USD Million, 2018 - 2030)
Infectious Disease
Neurology
Hematology
Respiratory
Cardiovascular
Dermatology
Others
Formulation Development Outsourcing End Use Outlook (Revenue, USD Million, 2018 - 2030)
Pharmaceutical and Biopharmaceutical Companies
Government and Academic Institutes
Others
Formulation Development Outsourcing Regional Outlook (Revenue, USD Million, 2018 - 2030)
North America
U.S.
Canada
Mexico
Europe
UK
Germany
France
Italy
Spain
Netherland
Switzerland
Denmark
Sweden
Norway
Asia Pacific
China
India
Japan
Australia
South Korea
Thailand
Indonesia
Malaysia
Singapore
Taiwan
Latin America
Brazil
Argentina
Colombia
Chile
Middle East & Africa
South Africa
Saudi Arabia
UAE
Israel
Egypt
Kuwait
List of Key Players in the Formulation Development Outsourcing Market
SGS S.A.
Intertek Group plc
Recipharm
Lonza
Charles River Laboratories International, Inc.
Eurofins Scientific SE
Element
Labcorp
Thermo Fisher Scientific, Inc.
Catalent Inc.
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