EMERGING TRENDS IN BIOPHARMACEUTICALS

KUNWAR RAJ KUMAR

JAMIA HAMDARD, NEW DELHI
INTRODUCTION PROBLEMS IN BIO-PHARMACEUTICAL SECTOR
• India among the top 12 global biotech hotspots INDIA VENTURING INTO • High cost drug discovery economics
• 3rd largest in Asia Pacific (in terms of number of biotech •Length of time for FDA approval and time to market
companies). • Entering in the biogenerics market and off-patent market •Need to double to sustain previous double digit growth rates.
• Global biotech industry size is currently USD73.12 billion, • Contract research
• Indian biotech industry just crossed the USD2 billion (INR 85.41 •Increased competitive intensity
• Creation of new pharmaceutical products
billion) mark in 2006-07. •Traditional “bigger-the-better” and “one size fit for all model”
• Bioinformatics
• Bio Pharma remained the largest contributor with a value • Clinical trials •Impending expiry of blockbuster drug patents
contribution of INR59.73 billion accounting for a 69.73% • Outsourcing •Intellectual Property (IP) Development and Protection
contribution. • Biopatnering • Bioethics
The report looks at recent trend in biopharma, future market,
growth drivers, critical success factors, issues and challenges, Benefits of Emerging Trends in Biopharmaceutical RECOMMENDATION
core technologies in biopharma and regulatory environment. Industry • Rely on specialist bio tech and other research companies to
provide new compounds under licensing and equity share
•Reduce R&D Costs and Improved Margins arrangements
EMERGING TRENDS •Establishing Alliances and Outsourcing Contract Research • Business process reengineering of clinical trials and other drug
FUTURE TRENDS •Access to New International Markets
development functions
Increasing government support •Tapping Global Skills
•Bioinformatics and IT Services •New alliances with health care companies for distribution.
IP protection enforcement
•Scrapping of governmental price control tactics
Regulatory reforms
•Allow conducting of Phase1 trials in India
Drug price cuts
• Encourage single agency for approvals on the lines of the
TECHNOLOGY TRENDS MANAGEMENT STRATEGY
Strategic positioning of Indian pharmaceutical firms could USFDA.
Enterprise Development Trends
Strategic alliances be distinguished with respect to biotechnology. •Reform the potency of the patent protection agency
Cluster development • Increase the size of patent specialist staff.
Increasing R&D investment • Wait and see •Conditions for contract enforcement and protection of IP must
More international collaboration • Marketing for Western firms
be
• Producing diagnostics and Speciality chemicals
• Contract research created.
STRENGTH WEAKNESS • Entry into the biogenerics market and the off- patent market
• Contract research
•Skilled work and Low cost work •Lack of world class
force. infrastructure
• Bioinformatics and IT development
• Time to Market Conclusion
•Knowledge of biology , chemistry •Lower profit margins
•Large Domestic Market •Purchasing power of Major focus of innovative activity is going to be either on “racing
•Cost effective clinical trials people is low to be the first or lowest cost producer” of off-patent products or
•Quicker adaptation of new •Multiple Regulatory being a link in the international division of labour supporting the
technology Agencies creation of innovations by Western multinationals.
•Democratic Govt. •Lack of ethics
•Presence of Large No. of MNCs. •Weakness to protect IP
TRIPS is not going to have a significant impact on the two
OPPURTUNITY segments given above or on the other preoccupations of Indian
THREATS
•Rising middle class society
•Streamlining of Regulatory agencies by
•High cost due to product patent. pharmaceutical firms
•The Indian patent needs reforms
adopting FDA style Guidelines •Loopholes in enforcement
•Product Patent recognition The major effect of TRIPS would seem to be to force Indian firms
agencies
•Potential for sourcing skills to put their re-engineered products on the market only when they
•Bureaucracy and Corruption
•Higher opportunity to export get off patent
•Infrastructure taken for granted
• Development of quality of skilled and
•West could be a big problem
intellectual talent •Threat of China in Global
context.