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Strategic Analysis of Indian Biosimilar Market
Frost & Sullivan, May 2011, Pages: 81
This research deliverable provides deep insights into the Biosimilar market in India. It also includes an overview of the Indian regulatory and R&D process briefing about the biosimilars, trends in regional/local pharmaceutical and biotechnology development as well as the impact of those developments. The research deliverable also covers the overview of the other major biosimilar players like China. The research service also gives a deeper insight into the profiles of the companies that are into this segment in India. It also covers the historical trends and future impacts on Biosimilar Markets.
This Frost & Sullivan research service titled Strategic Analysis of Indian Biosimilar Market presents a comprehensive analysis of the market through primary research, including the evaluation of market size and components, as well as market opportunities, to enable decisions related to future strategies and investments.
Market Overview
Frost & Sullivan: India Emerges as Dominant Participant in the Biosimilar Market
Impending Patent Expiries Encourage Companies to Ramp up Biosimilar Manufacturing Capabilities
The Indian biosimilar market has witnessed robust growth and the country is poised to attain a position of leadership in this space. With the introduction of insulin and erythropoietin biosimilars, India has proved its capability to be a major contributor to this market. With exceptional biosimilar manufacturers such as Wockhardt, Biocon, Dr. Reddy’s, Intas Biopharmaceuticals, and many emerging participants, India is on a sure fire route to market dominance in the global biosimilar market. “Many biologics are going off-patent by 2014, providing a multi-million dollar opportunity to biosimilar manufacturing companies,” notes the analyst of this research service. “With the increasing number of patent expiries, Indian companies are arming themselves with biosimilar manufacturing capabilities, either in the form of joint ventures or alliances with R&D-intensive firms or outsourcing to upcoming Indian contract research organizations (CROs).”
Cost arbitrage is another prominent advantage for the Indian biosimilar industry. The manufacture and development of a biosimilar molecule requires an investment of about $10 to 20 million, as compared to $50 to 100 million in developed countries. Manufacturing in India reduces the investment by about 40 percent, enabling India to become a hub for outsourcing biosimilar manufacturing. Cost efficiency reduces the appeal for imported biosimilars and unleashes huge export potential. Low-cost volunteers and strong clinical trial capabilities in the country have been the major cost-eroding factors for India. Manufacturing a biosimilar requires survival of patent infringements by the innovator biologic company. These litigations last for years and costs fluctuate, depending on the time of litigation and financial prowess of the infringing company. These companies are usually MNCs with a large R&D focus and strong financial muscle to support variable costs.
The Indian Government is playing an important role in encouraging the biosimilar industry. Biotechnology parks are under construction in Hyderabad, Pune, and Bangalore. These provide special tax incentives to participants to support cost containment. The department of biotechnology is inviting proposals from Indian companies, working on biosimilars, under its biotechnology industry partnership program. According to the proposal, the Indian Government will provide support to biotech companies on a cost-sharing basis for development of novel and high-risk futuristic technologies and to enhance existing R & D capacities, specifically for biosimilars. “The rate of growth-both in India and other countries will be largely dependent on the transparency of approval processes and the government’s support for this high-risk, high-return industry,” says the analyst. Indian companies can follow regulatory pathways, depending on the country in which their products are being sold. To sell in Europe and the United States, the company has to have certified facilities with United States Food and Drug Administration (USFDA) and the European Medicines Agency (EMA). This will enhance the credibility of India in the biosimilar market.
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