Technological advancement in healthcare is accelerating. With each breakthrough, we are seeing more effective and efficient ways to address complex medical challenges. In this context, demand for High-Potency Active Pharmaceutical Ingredients (HPAPIs) is rising sharply because they deliver strong therapeutic effects at very low doses—often in the microgram or nanogram range. Using smaller quantities of active chemicals to achieve the desired outcome can also lead to fewer side effects for patients. And that’s exactly what we want: better results with less harm.
The core strength of high-potency APIs lie in their ability to enable targeted therapy for serious health conditions, including cancer, hormonal imbalances (such as certain steroids or hormone-based therapies), autoimmune diseases, and central nervous system (CNS) disorders.
A World Health Organisation (WHO) report estimates that there will be more than 35 million new cancer cases by 2050. This alarming projection highlights the urgent need for more powerful and precise treatments.
High-potency APIs are already reshaping the treatment of chronic diseases—especially cancer—through their critical role in Antibody-Drug Conjugates (ADCs). In ADC therapy, an antibody is engineered to carry a toxic payload, which is typically a high-potency API. The antibody guides the payload directly to cancer cells, and once delivered, the HPAPI destroys the cells by damaging their DNA or preventing them from dividing. This targeted approach improves effectiveness while reducing harm to healthy tissue.
With HPAPI demand growing, many companies are investing heavily in this segment, including expanding or building new production facilities. For example, in January 2025, AGC Pharma Chemicals announced the opening of its HPAPI plant in Barcelona.
High-Potency APIs and Manufacturing Challenges
- Success in HPAPI development comes with significant manufacturing challenges, particularly around safety and capital investment.
- Even minimal exposure to HPAPIs can cause serious health risks to workers in production environments. That is why ensuring workforce safety is critical. Manufacturers must implement comprehensive protective equipment, strict containment systems, and robust protocols for handling, processing, and waste management.
- In addition, HPAPI production requires specialised infrastructure. Facilities often need isolated environments with advanced containment technologies, such as isolators and high-grade cleanrooms, to meet regulatory requirements from agencies like the FDA, EMA, and others.
- From an investment standpoint, HPAPIs are usually produced in small quantities, which increases the cost per unit. These costs are further driven by the need for sophisticated equipment, specialised facilities, and a highly trained workforce.
- To avoid large upfront investments and reduce operational risk, many pharmaceutical companies partner with Contract Development and Manufacturing Organisations (CDMOs) that focus specifically on HPAPI manufacturing. These partnerships allow innovators to scale production efficiently while relying on established expertise and compliant infrastructure.
- HPAPI manufacturers must also comply with international quality and safety standards, including ISO 13408 and ISO 14644-1, among others, to ensure sterility, containment, and product integrity throughout production.
Effect of Patent Expiry
As patents for several high-potency drugs approach expiry in the near future, opportunities are expected to expand for generic drug manufacturers. These companies can enter the market with more affordable HPAPI-based products, improving accessibility for patients. At the same time, patent expiry will create new growth avenues for CDMOs, as both innovators and generics seek reliable partners for high-potency manufacturing.
