High Potency APIs: Major Challenges and Global Opportunities

  • Published On : Jul 28, 2014
A significant portion of many of the new classes of medicinal drugs under research and development currently contain high-potency active pharmaceutical components, also called High Potency APIs or HPAPIs. This is causing an explosive growth of the global High-Potency APIs market.

However, the cytotoxicity of these substances presents many challenges for their handling and requires huge investment for specialized containment devices and methodologies to ensure that employees and their work atmosphere are protected from exposure.  

Market drivers for high potency APIs:

The demand for HPAPIs has seen rapid growth over the last decade, mainly because of advances in research for cancer medicines, and specialty medicines. The field of particular interest in the HPAPI technology is that of HPAPI antibody conjugates, in which monospecific antibodies are used for selective cancer treatment. When HPAPIs unite with the antibodies, they specifically target only the cancerous tissues and spare the non-cancerous tissues from ingesting them with any toxic effects. 

There are many such drugs in the high potency APIs that are commercialized for treating acute cases of cancers, and many more antibody conjugate medicines are in their final stages of research and clinical trials. 

Majority of popular generic drugs in the high potency APIs are nearing patent expiry. When these medicines rule-out of the market, HPAPI manufacturers would gain additional opportunities to cater multiple clients by bulk-manufacturing the generic versions of HPAPIs. 

Challenges before the industry:

Currently, HPAPIs account for nearly 12% shares of the total global pharmaceutical market and this share is expected to rise strongly. Although the growth of the global High Potency API market is quite attractive, it presents a big challenge for manufacturers to upgrade their existing facilities that are commonly capable of handling only the class of nonpotent APIs.  The challenge is, in-fact, associated with the huge capital investment required for specialized containment methodologies and devices for ensuring complete safety of the employees working with them.  

The high potency APIs market is also observing a rapid entry of new manufacturers in the market space, making it more fragmented and posing difficulties for an overall positive growth. The condition of high potency APIs could further worsen owing to the decline in global R&D investments and shortage of FDA approved manufacturing units. 

Regionally active market:

The HPAPI market has good growth opportunities in the Asia-Pacific region, owing to the abundance of skilled manpower and the low cost of labor in this region. These factors have significantly contributed in giving rise to abundant API manufacturing activities and procurement of many globally outsourced research and manufacturing projects in these regions. 

North America, having a highly regulated and developed pharmaceutical industry, is currently the leading manufacturer of HPAPIs. But due to the rising opportunities for the high potency APIs market in the Asia Pacific, this region is expected to become the leading market in the coming few years. 

In summary

The development and production of HPAPIs require considerable planning, extensive workforce training, the most appropriate equipment, implementation of a variety of safety procedures and proper facility design. 

A significant amount of capital investments is necessary and knowledge gained through experience is most valued, which is also rare owing to the novelty of this industry. Robust systems need to be employed in every portion of HPAPI-handling systems, from the initial point of evaluation of the project through the process of equipment cleaning and disposal of wastes. 

As the number of potent ingredients in the manufacturing of pharmaceutical products increase, so will the opportunities for the global manufacturers of HPAPIs, especially for businesses with the capability of entering niche areas such as HPAPI antibody conjugates. 

The leading competitors across the global high potency APIs include international and well known brands such as Novartis, GlaxoSmithkline Pharmaceuticals Ltd., Pfizer, Hospira Inc., Roche, Covidein Plc, Astra Geneca International and BASF Se, among others. 
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