The rising demand for high-potency APIs (HPAPI)

High-potency APIs represent a key area of innovation and growth in biopharmaceutical research and development.

The global HPAPI market, estimated at $29.34 billion in 2025, is anticipated to reach $45.7 billion by 2030 with a CAGR of over 9%. In addition, up to 25% of drugs in development today are considered to be highly potent.

• Oncology is a leading contributor to the continued growth of HPAPIs. Cancer treatments represent over 30% of new therapeutics launched in the last ten years, and nearly half of these have been precision therapies.
• Antibody-drug conjugates, or ADCs, are another area of HPAPI innovation, combining monoclonal antibodies with HPAPIs to precisely target and destroy cancer cells. The ADC market continues to expand, with over 100 active clinical trials for ADCs taking place around the world today.
• Other major areas of HPAPI research include hormonal therapies, central nervous system (CNS) drugs, immunosuppressants, and precision medicine.

Because of their complexity and the specialised infrastructure required for HPAPI development and manufacturing, there has been a growing demand for outsourcing in this space.

The global HPAPI contract manufacturing market is expected to grow at a 10.93% CAGR through 2034.

An outsourced partner can help to address the challenging process design considerations, regulatory factors, and containment and infrastructure requirements that are necessary for safe and effective HPAPI manufacturing.

HPAPI development and manufacturing comes with several major challenges, especially related to containment and handling. These challenges include:

• Containment and safety: Containment is the major challenge associated with HPAPI development and manufacturing, as any exposure can put operators at risk. As a result, purpose-built containment measures, like isolators, gloveboxes, and unidirectional airflow, are critical in combination with proper personal protective equipment.
• Regulatory considerations: In addition to GMP guidelines, HPAPI manufacturing must carefully adhere to occupational health and safety (OHS) standards such as OSHA, while also accounting for purity requirements set forth by the ICH, regional regulatory mandates, and more.
• Process design and scalability: Scalability can be particularly challenging for HPAPIs, as it is critical to ensure that the process will remain feasible at a larger scale with appropriate containment measures in place. This must be considered from the early phases of process design to avoid extensive modifications down the line.
• Specialised equipment: Due to the complexity, cost, and sensitivity of typical HPAPIs, purification techniques including high pressure chromatography and lyophilisation are commonly required. The manufacturer therefore requires this specialised equipment and the ability to develop scalable purification procedures.
• Analytical methods: Expertise in sensitive analytical methods like high-performance liquid chromatography (HPLC) and liquid chromatography-mass spectrometry (LC-MS) is crucial for effective analysis.

These challenges are major contributors to the prevalence of outsourcing in HPAPI development and manufacturing. A contract development and manufacturing organisation that already has the specialised infrastructure and experience to support high-potency API projects circumvents these challenges to deliver high-quality end products.

At Sterling, our Wisconsin, US facility specialises in the development and manufacture of high-potency and ultra-high potency APIs. Our capabilities and equipment include:

• Two high-containment cGMP manufacturing suites to support batches up to 10 kg
• Advanced, multi-layered containment approach with engineering controls, isolator technologies, and process downflow booths
• Flexible equipment configuration to support specific project requirements
• Medium and high pressure chromatography systems and lyophilisers at laboratory and pilot scale
• Expertise in toxicological assessments to develop a customised containment strategy

All of this is supported by close scientific partnership, where we work with our customers to design a scalable process that meets their specific requirements while maintaining close alignment at each stage of HPAPI development and manufacture.

If you’re interested in learning more about our HPAPI equipment and capabilities, visit our high-potency API page or get in touch with an expert.

High potency APIs (HPAPIs) are on the rise; driven in part, by an increase in complex therapeutics and growing sophistication in toxicological assessments. In fact, a greater percentage of new drug candidates are classed as highly potent than ever before.

But with these highly potent candidates comes the need for specialised facilities, equipment, processes, and personnel. Adding these capabilities internally is expensive, time consuming, and risky. But choosing the right outsourced partner can be a challenge.

At Sterling, we provide the expertise, proven methodology, and flexibility needed to safely handle your highly potent molecules from development through full commercialisation. With multiple levels of containment, our world-class facilities were purpose-built to ensure the safety of high potency APIs, while providing full asset flexibility to handle solids, liquids, and process considerations such as cryogenics, hydrogenations and milling.

Each programme begins with a full toxicological evaluation, which is used to create a custom containment strategy that is scaled to your requirements. All of this is fully supported by our outstanding culture of compliance and our high potency team, which includes some of the industry’s finest experts in highly potent molecules.

High potency APIs are powerful, but capitalising on their full potential requires the right partner.

Sterling: Service. Passion. Science.

Learn more about our HPAPI offering here or click here to watch our webinar on ‘Positioning your HPAPI programme for success’.

High-potency APIs, or HPAPIs, are active substances that can deliver a significant biological effect at low doses. Generally, HPAPIs have a daily dose below 10 mg and an occupational exposure limit, or OEL, below 10 μg/m3.

As a result of their potency, stringent containment and handling controls are required to safely develop and manufacture HPAPIs while preventing operator exposure.

Because of their precise targeting capabilities, high-potency APIs can minimise damage to surrounding healthy tissue to reduce potential side effects. This makes them powerful in treating a range of complex indications, such as cancer.