Biopharmaceuticals in India: Evolving from Generics to Innovator Drugs - The new patent regime is challenging the Indian biopharmaceutical industry to transition its focus from process innovation and

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Biopharmaceuticals in India: Evolving from Generics to Innovator Drugs
The new patent regime is challenging the Indian biopharmaceutical industry to transition its focus from process innovation and generic manufacture to novel product innovation.


BioPharm International
Volume 21, Issue 4


Figure 1. Biopharmaceutical segments percentage sales: 2004–2005
The Tamil Nadu Government is planning to set up biotechnology enterprise zones to use the bio-resources available with the state. The Maharashtra government also has been promoting biotech parks and R&D centers. The Karnataka government has formulated a biotechnology policy for the promotion of the biotechnology industry. It is setting up an Institute of Bioinformatics and Applied Biotechnology (IBAB) in partnership with ICICI this year. IBAB has been conducting courses and training programs in bioinformatics and biotechnology. It has also been promoting the incubation of new startups in the biotech industry, and conducting research and development in the field of bioinformatics and other related areas.

Industry Associations and Institutions

There are several associations, such as the Association of Biotech-led Enterprises (ABLE), the Confederation of Indian Industries (CII), the Federation of Indian Chambers of Commerce and Industry (FICCI), Biospectrum, and the All India Biotech Association (AIBA), that actively represent the interests of the biotechnology industry. These associations have been instrumental in bringing about changes in regulations to strengthen the biopharmaceutical market.

Strength of Local Companies


Table 1. Indian biopharmaceutical companies and their performance
Overall, the Indian biopharmaceutical industry comprises 350 biopharmaceutical companies, of which 50% are involved in product development, 20% are involved in clinical development, 15% provide research services, and 5% focus on platform technologies. Companies such as Biocon, Serum Institute, Bharat Biotech, Shantha Biotech, and Panaceam, (Table 1), are some of the key players in the Indian biopharmaceutical sector.

The Indian biopharmaceutical sector registered record sales of $1.45 billion from 2006–2007, showing 26.87% growth over the previous fiscal year. Biotechnology investment, both in R&D and infrastructure, surpassed $51.04 million in 2006–2007, a 38% increase over the previous fiscal year. According to the 2007 Biospectrum-ABLE Survey, the biopharmaceutical sector is export-driven, and about 70% of India's biopharmaceutical exports are small-molecule active pharmaceutical ingredients. The Indian market is witnessing a considerable growth in recombinant products. In 2003–2004, DBT estimated the domestic market for recombinant therapeutics at about $94.19 million. This sector represents about 3.2% of the total pharmaceutical market in India and 1.6% of the world market of recombinant therapeutics. There were 50 branded biotech drugs developed in India in 2006–2007, and this figure could increase to 100 by 2010.

In particular, India is emerging as major player in the vaccines business. In 2005–2006, vaccine sales accounted for more than 38% of India's total biopharmaceutical sector of $1,094.88 billion.6 In 2005–2006, India's vaccines business was estimated at $400 million (Figure 1). Indian companies like Serum institute, Shantha Biotech, Bharat Biotech, Indian immunological, Biocon, have established capacities for manufacturing recombinant therapeutics and vaccines.


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