High Potency API Contract Manufacturing Market Size (2024 - 2029)

High Potency API Contract Manufacturing Market Analysis

The High Potency API Contract Manufacturing Market size is estimated at USD 7.99 billion in 2024, and is expected to reach USD 13.14 billion by 2029, growing at a CAGR of 9% during the forecast period (2024-2029).

The market is growing due to increased drug pipelines, expansion of HPAPI facilities, and outsourcing API. The rise in targeted therapies, especially in oncology and other specialized areas, has increased demand for HPAPIs. These APIs are crucial in manufacturing highly potent drugs that specifically target particular molecular pathways or cellular mechanisms; enhancing treatment efficacy while minimizing side effects will likely contribute to market growth during the forecast period.

For instance, according to the data updated by the Spanish Network of Cancer Registries (REDECAN) in January 2023, an estimated 279,260 new cases of cancer were expected to occur in Spain by the end of 2023, out of which 42,721 new cases of colorectal cancer, 31,282 cases of lung cancer, and 21,694 cases of urinary bladder cancer were expected to occur in Spain in 2023. The surge in chronic diseases like cancer and HPAPIs plays a vital role in these therapeutic areas, driving demand for contract manufacturing services during the forecast period.

Moreover, the growing expansion of high-potency API facilities is expected to positively impact the high-potency API contract manufacturing market. This expansion indicates an increasing demand for specialized facilities that produce high-potency APIs. For instance, in June 2022, MilliporeSigma, the United States and Canada Life Science business of Merck KGaA, doubled its HPAPI production capacity by expanding its facility in Verona, near Madison.

Similarly, in September 2022, Lonza celebrated the expansion of its HPAPI multipurpose manufacturing suite in Visp, boasting enhanced capabilities for antibody-drug conjugate (ADC) payload production. Expanded facilities allow contract manufacturers to offer a more comprehensive range of high-potency APIs, catering to a broader spectrum of pharmaceutical products and therapies. Thus, they are expected to boost the high-potency API contract manufacturing market during the forecast period.

Hence, the CMO companies' favorable regulatory scenario and expansion of HPAPI facilities are expected to boost the market during the forecast period. However, significant investments and complicated safety and handling specifications associated with the production of HPAPIs are expected to restrain the market during the forecast period.

High Potency API Contract Manufacturing Industry Segmentation

The high-potency API (active pharmaceutical ingredient) contract manufacturing market refers to the pharmaceutical segment where specialized companies provide manufacturing services for high-potency APIs on a contractual basis. High-potency APIs often require specialized handling due to their potency or toxicity. The high potency API contract manufacturing market is segmented by product type, application, synthesis, and dosage form. By product type, the market is segmented as innovative and generic. The market is segmented by applications, such as oncology, hormonal disorders, glaucoma, and other applications. By synthesis, the market is segmented as synthetic and biotech. The market is segmented by dosage forms, such as injectables, oral solids, creams, and other dosage forms. The market is segmented by geography, such as North America, Europe, Asia-Pacific, Middle East and Africa, and South America. The report also covers the estimated market sizes and trends for 17 countries across major regions globally. The report offers the value (in USD) for the above segments.