EMERGING TRENDS IN BIOPHARMACEUTICALS

KUNWAR RAJ KUMAR JAMIA HAMDARD, NEW DELHI

INTRODUCTION• India among the top 12 global biotech hotspots• 3rd largest in Asia Pacific (in terms of number of biotech

companies). • Global biotech industry size is currently USD73.12 billion, • Indian biotech industry just crossed the USD2 billion (INR 85.41

billion) mark in 2006-07. • Bio Pharma remained the largest contributor with a value

contribution of INR59.73 billion accounting for a 69.73% contribution.

The report looks at recent trend in biopharma, future market, growth drivers, critical success factors, issues and challenges, core technologies in biopharma and regulatory environment.

MANAGEMENT STRATEGYStrategic positioning of Indian pharmaceutical firms could be distinguished with respect to biotechnology.

• Wait and see• Marketing for Western firms• Producing diagnostics and Speciality chemicals• Contract research• Entry into the biogenerics market and the off- patent market • Contract research• Bioinformatics and IT development• Time to Market

PROBLEMS IN BIO-PHARMACEUTICAL SECTOR• High cost drug discovery economics •Length of time for FDA approval and time to market •Need to double to sustain previous double digit growth rates. •Increased competitive intensity•Traditional “bigger-the-better” and “one size fit for all model” •Impending expiry of blockbuster drug patents •Intellectual Property (IP) Development and Protection • Bioethics

RECOMMENDATION • Rely on specialist bio tech and other research companies to

provide new compounds under licensing and equity share

arrangements • Business process reengineering of clinical trials and other drug

development functions•New alliances with health care companies for distribution.•Scrapping of governmental price control tactics•Allow conducting of Phase1 trials in India• Encourage single agency for approvals on the lines of the

USFDA. •Reform the potency of the patent protection agency • Increase the size of patent specialist staff. •Conditions for contract enforcement and protection of IP must

be

created.

EMERGING TRENDS

FUTURE TRENDS

Increasing government support

IP protection enforcement

Regulatory reforms

Drug price cuts

TECHNOLOGY TRENDS Enterprise Development Trends Strategic alliances Cluster development Increasing R&D investment More international collaboration

STRENGTH WEAKNESS

ConclusionMajor focus of innovative activity is going to be either on “racing to be the first or lowest cost producer” of off-patent products or being a link in the international division of labour supporting the creation of innovations by Western multinationals.

TRIPS is not going to have a significant impact on the two segments given above or on the other preoccupations of Indian pharmaceutical firms

The major effect of TRIPS would seem to be to force Indian firms to put their re-engineered products on the market only when they get off patent

INDIA VENTURING INTO

• Entering in the biogenerics market and off-patent market• Contract research• Creation of new pharmaceutical products• Bioinformatics• Clinical trials• Outsourcing• Biopatnering

Benefits of Emerging Trends in Biopharmaceutical Industry

•Reduce R&D Costs and Improved Margins •Establishing Alliances and Outsourcing Contract Research •Access to New International Markets •Tapping Global Skills •Bioinformatics and IT Services

Skilled work and Low cost work force.Knowledge of biology , chemistryLarge Domestic MarketCost effective clinical trialsQuicker adaptation of new technologyDemocratic Govt.Presence of Large No. of MNCs.

Lack of world class infrastructureLower profit marginsPurchasing power of people is lowMultiple Regulatory AgenciesLack of ethicsWeakness to protect IP

OPPURTUNITYRising middle class societyStreamlining of Regulatory agencies by adopting FDA style GuidelinesProduct Patent recognitionPotential for sourcing skillsHigher opportunity to export Development of quality of skilled and intellectual talent

THREATSHigh cost due to product patent.The Indian patent needs reformsLoopholes in enforcement agenciesBureaucracy and CorruptionInfrastructure taken for granted West could be a big problemThreat of China in Global context.