India
Today, India is among the top five pharmaceutical Emerging Markets in the world. While India ranks tenth globally in terms of market value, it is ranked third in volume. The market is expected to grow at a CAGR of 14–17% between 2013 and 2016. Generic brands dominate and constitute around 70-80% of the retail market.
Local players have enjoyed a dominant position in India, driven by development opportunities and early investments. Price levels are low due to intense competition. Indian OTC and Pharma companies have a reputation for producing high-quality generic medicines that are sold around the world.
Speaking of distribution, India relies on a clearing and forwarding agent (CFA) system. While the number of distributors and retail pharmacies is always increasing, there are still inefficiencies in distribution, particularly in rural areas. The main customers are pharmacies (70%) and hospitals (30%). Set to witness the largest number of mergers and acquisitions in the pharmaceutical and healthcare industry, India is poised to become one of the fastest-growing pharmaceutical markets in the world. A survey conducted across 100 companies has revealed that one quarter of respondents were optimistic about India’s potential for acquisitions in the pharmaceutical sector in the coming years.
The top Indian pharmaceutical manufacturers are J.B. Chemicals, Cipla and Sun Pharma. The Indian regulator of pharmaceuticals is the Central Drug Standards Control Organization (CDSCO). Depending on the type of product, drugs need to first go through a new drug approval in order to be registered. For drugs that have never been marketed in India before, the CDSCO typically requires phase III trials to be performed in India. Afterwards, an import registration certificate can be attained, which the importing party uses to obtain an import licence from the CDSCO.