The global high potency API contract manufacturing market size is expected to reach USD 14.87 billion by 2030, registering a CAGR of 10.98% over the forecast period, according to a new report by Grand View Research, Inc. The main drivers of this market are rising demand for oncology drugs, advancements in manufacturing technology, and a rise in capacity to meet the increasing demand. Also, a rise in target therapies to cure chronic diseases is going to accelerate industry growth. The COVID-19 pandemic boosted the demand for high potency APIs (HPAPIs). During the first half of the pandemic, the supply chain was disrupted, which reduced research-based activities.
However, during the second half, the industry started to gain importance due to a rise in demand for vaccines to fight the coronavirus. This rise has also increased the demand for raw materials and product intermediates of API molecules. Moreover, the growing demand for HPAPI molecules during the COVID-19 pandemic has led to the price hike of the same, thus boosting revenue growth in 2020 and 2021. There has been a rise in the outsourcing activities of high potency active pharmaceuticals as it removes the need for investment in expensive infrastructure for containing it.
Also, the installation & maintenance of the facility is complex and requires specialized engineers. The high cost of producing high potency API in-house, combined with the pressure to produce affordable drugs, has significantly contributed to the increasing outsourcing activities by companies. A wide range of outsourcing providers offers HPAPI services, thus making it difficult for companies to choose an appropriate CDMO. The large-scale CDMOs become the most likely choice as they provide large volumes. However, due to the small volumes required for dosage, small-scale providers are also gaining importance.
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The product type segment is classified into innovative and generic. The innovative segment accounted for the largest revenue share in 2024
Based on applications, the oncology segment dominated the industry in 2024 due to a rise in research on new cancer drugs and therapies
The oral solids dosage form segment is anticipated to witness the fastest growth rate during the forecast period
By synthesis, the industry is classified into synthetic and biotech. The biotech segment is estimated to witness a significant growth rate from 2025 to 2030
The Asia Pacific region is estimated to register the fastest CAGR during the forecast period due to the presence of the largest manufacturers of APIs across the globe, such as China
Grand View Research has segmented the global high potency API contract manufacturing market report based on product, application, synthesis, dosage form, and region:
High Potency API Contract Manufacturing Product Outlook (Revenue, USD Million, 2018 - 2030)
Innovative
Generic
High Potency API Contract Manufacturing Application Outlook (Revenue, USD Million, 2018 - 2030)
Oncology
Hormonal Disorders
Glaucoma
Others
High Potency API Contract Manufacturing Synthesis Outlook (Revenue, USD Million, 2018 - 2030)
Synthetic
Biotech
High Potency API Contract Manufacturing Dosage Form Outlook (Revenue, USD Million, 2018 - 2030)
Injectable
Oral Solids
Creams
Others
High Potency API Contract Manufacturing Regional Outlook (Revenue, USD Million, 2018 - 2030)
North America
U.S.
Canada
Mexico
Europe
UK
Germany
France
Italy
Spain
Denmark
Norway
Sweden
Asia Pacific
Japan
China
India
Australia
South Korea
Thailand
Latin America
Brazil
Argentina
MEA
South Africa
Saudi Arabia
UAE
Kuwait
List of Key Players in High Potency API Contract Manufacturing Market
Piramal Pharma Solutions
Lonza
Catalent, Inc.
VxP Pharma, Inc.
Pfizer CentreOne
Gentec Pharmaceutical Group
AbbVie
Aurigene Pharmaceutical Services Ltd.
CordenPharma International
Curia Global, Inc.
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