Q1: Why are highly potent active pharmaceutical ingredients (HPAPIs) playing a transformative role in oncology drug development?
A: The rise of precision oncology has elevated HPAPIs to a pivotal role in cancer treatment. These compounds are uniquely effective at delivering therapeutic benefits at extremely low doses, which minimises toxicity compared to traditional cancer therapies like chemotherapy. Because of this, they can be used in a variety of ways including standalone therapies, antibody-drug conjugates (ADCs), and immuno-oncology agents. This versatility, combined with their effectiveness, has consequently led to HPAPIs being included in about 60% of oncology drugs today, underscoring their significance in modern-day cancer care.
HPAPIs also represent a shift towards more targeted therapies, where treatment efficacy is maximised, and adverse effects are reduced. This capability has been particularly beneficial in addressing cancers that were previously deemed too challenging to treat effectively, which broadens the horizons of oncology drug development.
Q2: What makes HPAPIs uniquely suited to oncology, and how is this shaping their manufacturing processes?
A: HPAPIs are particularly well-suited to oncology because of their ability to target diseased cells while sparing healthy tissue. This precision aligns with the growing demand for therapies that balance efficacy and patient safety. As oncology continues to evolve as a therapeutic area, the need for highly targeted treatments has made HPAPIs increasingly valuable.
From a manufacturing perspective, the production of HPAPIs requires strict containment strategies and specialised facilities. Traditional open processing methods are inadequate for these compounds due to the risks of exposure to the CDMO’s operators, which means closed systems and advanced technologies are required to ensure worker and patient safety. For example, the handling of these substances often involves the use of negative pressure environments, isolators, and automated cleaning systems – essentially having facilities with engineered containment strategies built into their design – to operator exposure and significantly reduce cross contamination risk. Consequently, manufacturing HPAPIs demands both scientific and engineering expertise and tailored operational capabilities to meet these exacting requirements.
Q3: How does the growing demand for HPAPIs impact the pharmaceutical manufacturing landscape?
A: The increasing adoption of HPAPIs is driving significant changes in pharmaceutical manufacturing. For example, some reports suggest that the oral solid dosage (OSD) market, which includes highly potent OSD products, could surpass $72 billion by 2030. Similarly, the ADC market – an emerging and highly targeted therapy which leverages HPAPIs linked to monoclonal antibodies to target cancerous cells – is expected to reach $7 billion by 2035. These trends highlight the need for manufacturing facilities that can accommodate both small scale clinical production and large-scale commercial batches for a range of dosage forms, reflecting the demands for both innovation and scalability.
This surge in demand also underscores the importance of collaboration between pharmaceutical companies and experienced CDMOs. As the industry grows more complex, companies with specialised containment capabilities and scalable solutions are better positioned to support the lifecycle of HPAPI-based products, from early development to commercialisation.
