Global High Potency API CDMOs Market Size, Share, Trends, Key Growth Drivers, Challenges & Competitive Landscape Analysis by 2027 : Lonza, Sanofi, Pfizer, Novartis, Roche, Bayer, Merck

High potency active pharmaceutical ingredients (HPAPIs) are a class of pharmaceutical compounds that are characterized by their high pharmacological activity at low doses. These are typically drugs which are effective in small quantities, often measured in micrograms (µg) or even nanograms (ng). HPAPIs are used in the development and production of certain specialized medications, mainly in oncology and some other disease segments where precise dosing and minimal side effects are important. HPAPI CDMOs are equipped with the expertise, facilities, and equipment needed to handle HPAPIs safely and efficiently, including their high potency, toxicity, and containment needs. These companies can handle various aspects of HPAPI manufacturing, including process development, scale-up, and commercial production.

Biologic HPAPIs and the Changing Landscape of Drug Development

The pharmaceutical market has been witnessing a growing demand for targeted therapies, particularly in fields like oncology, where high-potency active pharmaceutical ingredients (HPAPIs) play an important role. This demand has propelled the need for specialized CDMOs which have expertise in HPAPI development and manufacturing. Concurrently, drug molecules are growing in complexity, necessitating specialized knowledge and facilities, a demand that HPAPI CDMOs are well-equipped to counter.

For instance,

In March 2022, Lonza and Oasmia announced they had entered into a manufacturing agreement for the production of Oasmia ovarian cancer drug candidate, Cantrixil. Under the terms of the agreement, Lonza will deliver cGMP batches of drug substance for clinical supply to Oasmia, manufactured at its HPAPI laboratories in Nansha, China.

Additionally, regulatory authorities are imposing strict guidelines for HPAPI manufacturing and handling due to their potency and safety concerns, prompting HPAPI CDMOs to adapt and invest in compliance measures. Given the toxicity of HPAPIs, there is a growing focus on containment technologies and strategies to ensure the safety of personnel and environment. HPAPI CDMOs are also investing in advanced containment solutions. Further, partnerships between CMOs, CDMOs, and pharmaceutical companies have become key in the development and commercialization of HPAPIs. Pharmaceutical companies continue to outsource various stages of drug development and manufacturing to CDMOs to streamline their operations, decrease costs, and access specialized expertise. This trend has extended to HPAPI development and manufacturing, driving the growth of the high potency API CDMOs market.

Get a FREE Sample Report on High Potency API CDMOs Market @ https://meditechinsights.com/global-high-potency-api-cdmos-market/

Upcoming Trends in High Potency API CDMOs Market: Insights from the COVID-19 Experience

The demand for high-potency APIs (HPAPIs) experienced a quick rise amid the COVID-19 pandemic. In the initial phase of the COVID-19 pandemic, disruptions in the global supply chains and manufacturing had led to a slowdown in research-related endeavors. However, in the latter half of the pandemic, the industry regained growth due to the heightened need for vaccines to combat the coronavirus. This rise in demand also translated into increased requirements for API molecules' raw materials and intermediate products. Furthermore, the amplified demand for HPAPI molecules throughout the COVID-19 pandemic resulted in price escalations, ultimately contributing to an enhanced revenue growth.

With the prevalence of HPAPIs on the surge, pharmaceutical companies are continually looking out for ways to maintain competitiveness, frequently through improving their existing offerings. High-potency drugs provide the possibility of achieving comparable efficacy with lower dosage levels, an attractive prospect for drug developers as it reduces patient exposure to medications. Further, a considerable proportion of oncology treatments are comprised of HPAPIs, and there is a growing clientele with such compounds.

Advancements and the introduction of novel service offerings are stimulating competition within the global market, while mergers and acquisitions are contributing to the consolidation of the CDMO market, encompassing the HPAPI segment. This trend is driven by companies aiming to expand their scope of capabilities and geographical presence.

For instance,

In June 2022, WuXi STA, a subsidiary of WuXi AppTec, inaugurated an additional high-potency API (HPAPI) facility at its Changzhou site in Jiangsu, China. This new plant has been established in response to the increasing need for high-potency API process research and development, as well as manufacturing services.

North America Accounts for the Largest Market Share in the Global High Potency API CDMOs Market

North America holds the largest market share in the high potency API CDMOs market due to growing demand for HPAPIs, favorable regulatory environment, advanced healthcare infrastructure, and the presence of many leading players in the region. The Asia-Pacific region is poised to witness a rapid growth during the forecast period. An increasing demand for cancer treatment, rising demand for HPAPIs, and surge in the number of R&D activities are some of the key factors to trigger the high potency API CDMOs market's growth in this region.

Competitive Landscape Analysis: High Potency API CDMOs Market

Some of the established and key players operating in the global high potency API CDMOs market are Lonza, Sanofi, Pfizer, Novartis AG, F. Hoffmann-La Roche Ltd, Bristol-Myers Squibb Company, Bayer Healthcare, Merck & Co., Inc., Wuxi STA.

Organic and Inorganic Growth Strategies Adopted by Key Market Players to Establish Their Foothold in the High Potency API CDMOs Market

All leading players operating in the global high potency API CDMOs market are adopting organic and inorganic growth strategies such as capacity expansion, partnerships, and acquisitions of related firms to garner a larger market share.

For instance,

In July 2023, Evonik and Heraeus Precious Metals announced about their collaboration to broaden their respective service portfolios concerning highly potent active pharmaceutical ingredients (HPAPIs). This joint endeavor will harness the unique HPAPI expertise of both firms, offering customers with fully integrated solution from pre-clinical development to commercial manufacturing.

Get A Detailed Report on High Potency API CDMOs Market with Competitive Insights @ https://meditechinsights.com/global-high-potency-api-cdmos-market/

Ruta Halde
Associate, Medi-Tech Insights
+32 498 86 80 79
info@meditechinsights.com
https://meditechinsights.com/

Medi-Tech Insights is a healthcare-focused business research & insights firm. Our clients include Fortune 500 companies, blue-chip investors & hyper-growth start-ups. We have completed 100+ projects in Digital Health, Healthcare IT, Medical Technology, Medical Devices & Pharma Services.

This release was published on openPR.