The Rise of High Potent APIs: Trends, Technologies, and Manufacturing Best Practices

The latest reports from the Centers for Disease Control and Prevention (CDC) suggest that the number of people suffering from cardiovascular disease, diabetes, and cancer is rising. World Health Organization WHO report indicates that there is an alarming rate of increase in hypertension in the population aged between 30-79. Centers for Disease Control and Prevention (CDC) reports have also shown concerning trends in cancer deaths.

These growing incidences of morbidity and mortality have fueled the demand for high potent APIs.

Definition: High Potent APIs

Small molecules with high potency that are highly effective even in small doses are called HPAPIs. High-potent drugs can evoke high response even with a low concentrated dose amount. Risperidone, fentanyl, and clonazepam can be termed as high-potency drugs.

Trends, Technologies and the Meteoric Rise in Demand of HPAPI

In 2021, the global demand for high-potent APIs stood at approximately $19.7 billion and is assumed to reach approximately $41 billion by 2031. Because HPAPI exhibits higher potency at low doses than traditional APIs, they are in high demand for therapeutic applications in cardiovascular, diabetes, and cancer diseases. Since high-potency active pharmaceutical ingredients (HPAPIs) have shown the greatest efficiency in treating oncologic conditions, there has been a huge surge in demand for potent cancer drugs.

Another reason for the increase in demand for HPAPIs is the patent expiration of various drugs globally. As we all know the expiry of a certain drug patent can have direct effects on its price, making it cost-effective for those pharma companies who are manufacturing that same drug.

Numerous pharmaceutical companies have applied for cost-effective and generic drug compounds that are in the pipeline. Plus there is an increasing number of R&D firms (some big as well as some startups) in physical as well as virtual labs that seem to be driving innovation in the pharmaceutical sector. These companies share among themselves the highest number of patent or regulatory approvals in high-potential APIs or specialty medicines. These high-tech firms are innovative but lack world-class in-house production units.

Opportunities for CMOs and CDMOs:

There is an increased number of partnerships between CMOs (contract manufacturing organizations) or CDMOs (contract development and manufacturing organizations) and pharmaceutical organizations.

The reasons for this partnership are simple:

High potent APIs require state-of-the-art excellence centers and not just a simple traditional production facility. Manufacturing of highly potent APIs needs proper process designs, safe loading/unloading techniques, and cleaning/pre-cleaning techniques. High-potent APIs can be dangerous to handle, it can badly affect the health of production staff. The biggest risk of high-potency active pharmaceutical ingredients (HPAPIs) is cross-contamination.

Segmentation: Type/Therapeutic Application

With product/market type, high-potent APIs are segmented into innovative and generic. With the therapeutic application, the high-potency API industry is segmented into cancer, glaucoma, and hormonal imbalance. When it comes to synthesis, high-potency APIs are segmented into synthetic and biotech.

Processing Challenges and Restraints

High-potent drugs are required to be produced at the gram scale and that is the main challenge. Handling the payload safely, loading and unloading, keeping it contaminant-free, and providing safety to all lab personnel are some of the additional challenges. Therefore, production of high potency active pharmaceutical ingredients requires a proper process design with sophisticated labs that are equipped with high-tech equipment and professionally well-trained staff.

Conclusion:

The rise in demand for small molecules high potency active pharmaceutical ingredients manufacturing keeps rising and it is for CDMOs to adapt well to the rise in demand, and make the necessary investments in processes and equipment for safe handling of ultra-high potency APIs.