Casting their eye on the booming global high potency active pharmaceutical ingredients (HPAPIs) market, the Indian players are fast-equipping themselves to grab the opportunities in these high value, niche segment.
Many of the Indian companies, which have a reputation of quality APIs and manufacturing facilities, are currently planning to enter into the segment working out their expertise to handle ingredients with higher inherent toxicity, pharmacological potency and occupational exposure limits (OELs).
A minimum of 10 to 12 major players including Piramal Healthcare, Matrix Laboratories, Dr Reddy's Laboratories, Dabur Pharma - which has been acquired by the Germany-based Fresenius Kabi in April 2008 - and Hikal Ltd already have their operations in the HPAPI segment, according to industry sources. Along with these companies, various medium scale players with strong API manufacturing capacities are also offering contract manufacturing services for HPAPIs.
The high potency of the ingredients and higher level of inherent toxicity make the HPAPIs more complex to handle. The cytotoxic drugs, prostaglandins, certain hormones and opiates are the major drugs containing potent compounds. In therapeutic segments, the cancer drugs are known for its high potency nature.
"A majority of oncology drugs and some other lifesaving drugs are prepared using high potency APIs. With the expected increase in the global oncology market in the near future, a huge opportunity for manufacturing high potency APIs is opening for the companies in India," said Vinod Chitalia, chief executive officer with Mumbai-based Lifeline Industries Ltd.
According to a recent IMS Health study, the global oncology market is growing at a compounded annual rate of 12 to 15 per cent reaching USD75 to USD80 billion by 2012. While many of the companies are looking forward for new molecules to occupy the market space, the contract manufacturers in India are looking for the opportunities in manufacturing generic HPAPIs. Reports suggest that the oncology drugs worth over $10 billion will lose market exclusivity in the US alone by 2011.
"There is a good opportunity to cash in on the generic high potency APIs segment. There are approximately 10 to 20 high potency drugs lost their patent protection and another 20 drugs are expected to lose their patent in next three years. We are planning to explore the potential in contract manufacturing and production of generic HPAPIs," said Shaharsh Rao, vice president - corporate and planning with the Hyderabad-based Neuland Laboratories. Similarly, the prostaglandins market, which estimated as USD One billion also offer a good opportunity for Indian players in the segment, he added. Neuland Laboratories is currently engaged in manufacturing steroids, prostaglandins and cytotoxic drugs in its latest facility on contract basis.
Apparently, the Indian companies are installing more facilities to grab the potential of HPAPIs. For instance, the Mumbai-based Piramal Healthcare has expanded capacity of its high potency substance production facility at Grangemouth, Scotland to cater the increasing demand for anti-cancer cytotoxic APIs. The company has its HPAPI operations right from the acquisition of UK-based Avecia Pharmaceuticals in 2005.
Similarly, the Ahmedabad-based Dishman Pharmaceuticals with its focus on contract research and manufacturing services (CRAMS) is setting up Asia's largest facility to manufacture high potency drugs including cancer drugs through its Switzerland-based subsidiary - Carbogen Amics AG - in its Bavla Plant. The new facility is expected to be operational by the first quarter of 2009.
However, the huge capital investment required for the installation of HPAPI facility is one of the major challenge for more Indian companies to foray into this sector, said Rao. The companies have to set up separate facilities for manufacturing cytotoxic drugs, prostaglandins and steroids with utmost care to control OELs.