Dynamics of India's Life Sciences Outsourcing Industry - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Dynamics of India's Life Sciences Outsourcing Industry
The tightening of intellectual property rights in India under GATT/TRIPS was a crucial inflection point for pharmaceutical outsourcing in India.

Pharmaceutical Technology

Figure 1
Most innovator companies started working with Indian companies on pure sourcing or outsourcing deals to source analogs, libraries, informatics work, advanced intermediates, custom synthesis, and simple clinical trials or even rescue trials. These projects provided low risk and less of a bureaucratic hurdle than more intricate risk- and reward-sharing deals, which came during the past two years (see Figure 1).

Increased outsourcing to India

Figure 2
Today, major biotech, pharmaceutical, and fine chemicals companies are leveraging India in the form of outsourcing, offshoring, or licensing and collaborations deals (see Figure 2). Companies such as Wyeth and Bristol-Myers Squibb (BMS)are entering India with build-operate-and transfer deals as evidenced by Wyeth's outsourcing pact for synthetic chemistry research with GVK Bio and BMS's deal with Syngene under which Syngene will build and operate a 400-scientist research and development center for BMS.

Two other deals showcase the increasing comfort level of global companies with India. Under a 2007 deal with Eli Lilly, NPILwill develop and, in certain regions, commercialize a select group of Lilly's preclinical drug candidates in multiple therapeutic areas. The companies will equally share risks and rewards, and NPIL is responsible for designing and executing the global clinical development program, including investigational new drug-enabling nonclinical studies and human clinical trials up to Phase III. NPIL will receive a call-back payment and potential milestone payments of up to $100 million, plus royalties on sales upon successful launch of the first compound.

Advinus Therapeutics and Merck and Co. formed a pact in 2006 for the discovery and development of metabolic drugs. Under the deal, Advinus receives an upfront payment, milestone payments up to $74.5 million for each drug target, and potential royalties on sales from products of the collaboration.

Several factors account for the increased comfort level and interest of global companies:

  • Scientists of Indian origin with drug-discovery and clinical-trial experience at global firms are moving back to India to work at Indian companies or to start their own ventures
  • Ability of Indian companies to prove that they can create value in a time and cost-effective manner
  • Emergence of pure-service providers
  • State-of-the-art infrastructure and a wide range of services
  • Ability of Indian companies to offer a complex and broad spectrum of services and products in a transparent manner
  • Opportunities in India's healthcare market based on the emergence of a 300-million-people-strong middle class
  • Most global companies have or are setting up local offices to manage relationships and projects in India
  • Creative deal-structuring by Indian executives for sharing risks and rewards.


blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes
Source: Pharmaceutical Technology,
Click here