High Potency Active Pharmaceutical Ingredients (HPAPIs) is expected to play a major role in the global APIs market in future. With a worldwide value of US$ 9.2 billion in 2011, the HPAPI market is likely to grow at a CAGR of around nine per cent till 2015.
As these compounds are extremely effective in the treatment of cancers, respiratory disorders, and hormonal imbalances, the HPAPIs market is mostly driven by the growth in the oncology therapeutics market worldwide.
The HPAPI compounds are highly effective due to the targeted therapy. Hence, its application for cancers is a major driver. The market of North America is the largest and accounts for major share; followed by Europe. At the same time Asia is growing at a higher CAGR as compared to North America & Europe. The major players for the HPAPI market are SAFC, Novasep, Lonza, Boehringer Ingelheim, and Carbogen Amics.
The main reason for the rising demand of HPAPIs since the last 15 years is due to the advances in clinical pharmacology and oncology research. Large numbers of HPAPIs are currently in clinical trials and will soon reach commercialisation.
Due to potent nature of HPAPIs, it is essential to have a keen eye on evaluation of these compounds for toxicity. Also for manufacturing pharmacists, safety and containment issues must be monitored. Only European Medicines Agency (EMEA) has taken initiative so far to issue one concept paper regarding these type of drugs.
Though HPAPIs is a relatively new segment in the Indian pharmaceutical sector, due to demand of cytotoxic / anticancer drugs in India, the companies are setting up their plants in India. Carbogen Amcis, a Dishman Group company, has set up a 4,300 sq m site at Ahmedabad in 2010 at a cost of $20m which is compliant with current good manufacturing practices (cGMPs). This is the initial step by foreign companies to invest in India’s HPAPI market. Soon more companies are likely to set up their activities in India. Even Indian multinationals like Cipla, Lupin, and Dr Reddy’s Laboratories are setting up their oncology drugs facilities in India.
The global HPAPI market share in 2009 was $7.5 billion in revenue terms which was 10 per cent of global API market. The global HPAPIs market is expected to grow at a CAGR of 8.4 per cent till 2015. The cytotoxic agents (Oncology segment) market s itself growing at CAGR of 12.6 per cent globally. North America predominates in the HPAPIs market in the world with 45 per cent share. The US has dominating share of 93 per cent out of them. Majority of the drugs in this region are from anticancer, hormonal, glaucoma, etc. Major players in the North American market are Teva, SAFC, Carbogen Amcis, Bristol Meyers Squibb, Asymchem, etc.
Europe is the second-largest market with 35 per cent share in the HPAPIs industry. Bristol Meyers Squibb, Lonza, Bayer, Boehringer Ingleheim, Sanofi Aventis, and Carbogen Amcis are some of the companies leading the HPAPI market in Europe. However, in Australia, IDT is leading player for HPAPI. In the Asian scenario, Japan, China and India are the most emerging markets. Companies like Eisai, Arch Pharma Labs, Piramal, Ranbaxy, and Dr Reddy’s Laboratories are taking interest in research, development as well as manufacturing of HPAPIs. In total, it is estimated that more than 25 per cent of drugs in clinical development pipeline are of this category.
The HPAPIs market is growing at least twice as much as the pharmaceutical outsourcing market. HPAPIs are becoming a key focus of the pharmaceutical business, with drug makers from all areas racing to establish a foothold in the market. Several manufacturers are planning to expand operations amid healthy growth in the high-potency HPAPI market. However, increasing raw material costs and the need for tougher standards for pharma ingredients, especially for products imported from Asia, are major issues.
Though HPAPIs are attractive because the plants required to manufacture them are small-scale, the containment buildings required for manufacturing HPAPIs are costly to install and manage. The huge capital investment required for the installation of HPAPI facility is one of the major challenges for more Indian companies to foray into this sector. The potential entrants have to setup separate facilities for manufacturing Cytolosic drugs, prostaglandins and steroids with utmost Care to control OELs.
However, in view of the opportunities existing in the high value, niche API segment, Indian pharmaceutical companies are fast-equipping themselves to grab the same. The major companies, which have a reputation of quality APIs and manufacturing facilities, are planning to enter into the segment working out their expertise to handle ingredients with higher inherent toxicity, pharmacological potency and OELs.
The high potency of the ingredient and higher level of toxicity make the HPAPls more complex to handle. The cytotoxic drugs, prostaglandins, certain hormones and opiates are the major drugs containing potent compounds. In therapeutic segment, the cancer drugs are known for their high potency nature.