Faster growth of the therapeutic segments offering drugs to treat cancer and hormonal disorders are pushing up the demand for sourcing high potency APIs. Even though the majority of facilities producing cytotoxic compounds are located in North America and European countries, companies are turning their focus to developing nations for low-cost processes. Players from Asia-Pacific nations, including India, are expected to benefit as the proportion of firms outsourcing to locations with low-cost production technology increases. The region, noted for its booming HPAPI manufacturing, is a traditionally known hub for cost-competitive generic products.

India, the generic powerhouse, stands alongside Japan and China as a favorable destination for HPAPI services in the Asia-Pacific region. HPAPI manufacturing in these parts is forecast to grow a little higher than the global average.

The Asian region is expected to grow at the highest CAGR of 11.8% while the global HPAPIs market is poised to reach $26.84 billion by 2023 from $17.72 billion in 2018 growing at a CAGR of 8.7%, according to a recent report by Research and Markets. The growing market for contract manufacturers in this region, owing to low labor and manufacturing costs, helps the promotion of HPAPIs, among other things.

Many innovators are on the lookout for facilities that have the capabilities and safety standards to handle HPAPIs for high growth segments such as oncology. CDMOs with integrated capabilities in HPAPIs will have a competitive edge over others as they can add value to companies outsourcing these products in terms of cost and timelines. Undoubtedly, end-to-end service providers that can take care of the entire product lifecycle from discovery to commercialization stand to gain.

Piramal Pharma Solutions, for instance, started offering HPAPI services following its acquisition of Ash Stevens, the Riverview, MI-based contract manufacturer in August 2016. Currently, Piramal provides services ranging from conjugation development to clinical and commercial batch manufacturing and fill/finish to firms located in North America, Europe and Japan.

Ash Stevens’ state-of-the-art manufacturing facility in Michigan has the containment controls for the safe handling and cGMP manufacture of small- and large-scale HPAPIs. Ash Stevens’ track record as a leader in HPAPIs with over five decades of experience in safe handling of potent compounds has proven to be a valuable addition to Piramal. Safety and containment requirements are very high to minimize the risk of handling HPAPIs. Piramal is, reportedly, planning to expand HPAPI capabilities at the Riverview facility.

Piramal is also a noted player in antibody drug conjugates (ADCs) development. ADCs are highly potent biopharmaceutical drugs that link complex biological molecules like mAbs with cytotoxic drugs. ADCs have emerged as a promising class of anti-cancer therapeutics due to their high specificity in delivering cytotoxic/HPAPI drugs to target cells while significantly reducing the side-effects compared to chemotherapies. Steadily increasing demand for ADCs is also fueling the growth of HPAPIs.

Dishman is another player that has expanded HPAPI capabilities through an outbound acquisition. The Ahmedabad-based CMO bought out Carbogen Amcis in 2007. The Swiss firm started a high containment factory at Bavla, in the western Indian state of Gujarat. With containment facilities spread across India, The Netherlands, Switzerland and China, Dishman Group is doing contract manufacturing and development of highly-potent compounds of all categories including cytostatics/cytotoxics.

Several other players including Dr. Reddy’s, Neuland Labs, Arch Labs, and Syngene have capabilities to develop high potency compounds too.

CMO investment in HPAPI facilities in India continues to be low despite the fact that the innovators prefer to outsource these potent agents from specialized manufacturers. The reason seems, primarily, because of the high level of safety standards and the requirement of specialized facilities. Apart from elaborate operating procedures, comprehensive quality management systems, and highly trained staff, it is also essential to have appropriate personnel protective equipment after evaluating occupational exposure to a compound and industrial hygiene programs for running HPAPI facilities.

The absence of a global regulatory framework for handling HPAPIs is another challenge faced by the companies operating in this space.

However, more CMOs are likely to be driven to HPAPIs in the days to come as a considerable number of highly potent drugs including the anti-cancer mAbs will soon fall into the generic domain, losing their patent protection.