India’s pharmaceutical industry is the third largest in the world in terms of volume and the tenth largest in value terms. According to the Department of Pharmaceuticals, which is part of India’s Ministry of Chemicals and Fertilizers, the total turnover of India’s pharmaceuticals industry between September 2008-09 was $21.0 billion. The industry is growing at a compound annual growth rate (CAGR) of 14-17% and will reach a turnover of roughly $47 billion by 2018, and $50 billion by 2020, according to IMS. These growth trends have placed India among the top five emerging markets of the world.

Market Dynamics
The domestic drug industry, which is currently valued at $25.9 billion, according to Care Ratings, is also expected to grow in the local market with aggressive rural penetration by drug makers, increased government spending on health, urbanization, and growing health awareness. In addition, India’s biopharmaceutical industry is growing by about 17% with revenues around the $3 billion mark. In 2013, there were over 4,655 pharmaceutical manufacturing plants across the country.

India exports pharmaceutical products to more than 200 countries. These exports are expected to cross the $16 billion mark this year. “The growth would be around 15% and is driven by formulation exports,” said Dr. PV Appaji, of Pharmexcil.

During 2013-14, pharmaceutical exports stood at $14.6 billion. The share of formulations was 71% and growing on annual basis. India also exports drug intermediates, active pharmaceutical ingredients (APIs), finished dosage formulations (FDFs), biopharmaceuticals, CRAM and clinical services across the globe.

The government began to encourage drug manufacturing by Indian companies in the early 1960s, and with the Patents Act in 1970. This patent act removed composition patents five to seven years.

The lack of patent protection made the Indian market undesirable to the multinational companies that had dominated the market. The Indian companies carved a niche in both the domestic arena and world markets with their expertise in reverse engineering, new processes and drug formulation technologies. The critical step however in the market’s growth was manufacturing and supplying affordable drugs at low costs. Though some of the larger Indian players have taken baby steps towards drug innovation, the industry as a whole has been following the above stated business model to date.

Government Initiatives
India’s government unveiled a campaign, Pharma Vision 2020, aimed at making India a global leader in end-to-end drug manufacturing. It has reduced approval time for new facilities to boost investments, and the government has put in place the Drug Price Control Order and the National Pharmaceutical Pricing Authority to address the issue of affordability and availability of medicines. The following are some of the major government initiatives:

• The state government of Andhra Pradesh will provide necessary infrastructure, incentives and upgrades to facilities for the pharma industry. A similar push has been initiated in states of Karnataka and Gujarat;
• The government of India and the pharma industry will jointly float a trust to promote the brand image of Indian pharmaceuticals globally and fight malicious campaigns; and
• India plans to set up industrial parks in the pharmaceutical and information technology (IT) sectors in China to strengthen India-China trade and investment ties.

Road Ahead
Indian generic drug makers are exploring all options to get a foot in the door to Japan’s lucrative, but difficult-to-crack, $111 billion drug industry after its penetration in Europe and the U.S. The penetration of generic drugs in Japan, the world’s largest drug market after the U.S. and Europe, is a little more than 30%.

India’s domestic market will also see a significant growth in sales on the back of increasing affluence, changing lifestyles resulting in higher incidence of lifestyle-related diseases, increasing government expenditure on healthcare through schemes like the Central Government Health Scheme (CGHS), National Program for Healthcare of the Elderly (NPHCE), Rashtriya Arogya Nidhi (RAN) and Janani Suraksha Yojana (JSY) in the next three years, according to Care Analysis.

The rise of pharmaceutical outsourcing and investments by multinational companies, allied with the country’s growing economy, committed health insurance segment and improved healthcare facilities, is expected to drive the market’s growth.

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Dr. Gurpreet Sandhu
Reva Pharmachem

Dr Gurpreet Sandhu (Managing Director) Reva Pharmachem (P) Ltd (India). He can be reached on gsandhu@revapharma.com