India Pharma Outlook 2015: Accelerating growth to the next level: Moving up the value chain beyond Generics

Domestic sales improved in 2014, recovering from the slump in the 2013 caused by the market’s reaction to the new drug pricing policy. In 2015, growth is expected to continue to be healthy, as the momentum continues and improving economic growth allow more spending on healthcare. Sun Pharma acquisition of troubled Ranbaxy helped it to become the leading Indian pharma company in terms of domestic market share. Sun’s in-licensing of biologics from Merck also indicates, Indian companies willingness to advance its pipeline towards upper value chain. Though, US market remains the largest market for India generic exports, it is witnessing a slowdown in product approvals and channel consolidation which has impacted overall pricing and margin for the industry. The increase in audits by US FDA staff on the Indian plants of both multinationals and Indian companies have led to an increased number of issuance of warning letters. Indian Pharma companies are trying to diversify into other markets such as Brazil, Mexico, Venezuela and also in some East European markets to lower this growing dependency on the US.

Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers, Government of India under ‘Make in India’ program has decided to declare the year 2015 as ‘Year of Active Pharmaceutical Ingredients (API).’ Under the ‘Make in India’ initiative, it is expected that the government will introduce many industry-friendly policies and incentives to give a major thrust to the growth of Indian bulk drug industry to make it a formidable force globally. State government of Telangana has already announced many incentives for the bulk manufacturing units.

Indian companies are taking center stage in Complex Generics at US and EU markets. In Bio-similars, Indian companies will have perhaps the largest basket aimed at Emerging Countries in 2015-20 and later for Developed countries. Though few but is the beginning of NCE/mAb development by Indian companies is a sign of Indian Generics moving up in the chain. Biopharma/ biotech companies in India, S. Korea, China may have significant advantages of low-cost manufacturing, colossal markets, and healthy government support over potential peers from other regions. The cost barriers in the biosimilar market lead regulated marketed giants to tie up with Asian companies to gain access to these advantages and hedging their bets through a joint-venture strategy.

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