Contract R&D and Clinical Materials Outsourcing in Emerging Markets - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Contract R&D and Clinical Materials Outsourcing in Emerging Markets
As emerging markets become increasingly important for the pharmaceutical majors, companies are re-evaluating their outsourcing strategies. This article is part of the 2010 Outsourcing Resources special issue.

Pharmaceutical Technology
Volume 34, pp. s30-s36

Clinical development and manufacturing

Clinical development and the related supply chain may offer the next opportunity for R&D offshoring. This part of the pharmaceutical value chain involves drug-development activities such as preformulation, formulation development, drug delivery, and drug stability. The shifting geographic footprint for clinical research is providing consideration as to whether and to what extent these drug-development functions can be developed in an outsourcing model in emerging markets. One factor to consider is the shift of clinical research from traditional developed markets to emerging markets, where recruitment rates are higher and competition for patients is lower. This shift, in turn, creates opportunities for contract manufacturing and packaging to grow in emerging markets. Aligning these activities with the locations of clinical trials offers the potential advantages of eliminating import hurdles, increasing speed, and lowering costs.

Although the outsourcing of formulation services, related service, and dose-manufacturing in emerging markets is not that common, certain contract service providers are developing their capabilities in these markets. One such example is Aptuit (Greenwich, CT), a contract drug-development company, which formed a new entity, Aptuit Laurus (Hyderabad, India), in 2007 through a phased acquisition with Laurus Labs (Hyderabad). Aptuit's strategy was to build Aptuit Laurus's development, manufacturing, and informatics capabilities to mirror the capabilities of services offered by Aptuit in North America and Europe (3).

Looking ahead

To what degree preformulation, formulation, and related services will shift to emerging markets remains to be seen. Unlike chemical production for intermediates and APIs, where outsourcing was primarily driven by cost factors, offshoring the clinical supply chain will depend on the related advantages of transferring clinical-trial material supply closer to the sites of clinical trials, and, to a degree, the role that the R&D activities of pharmaceutical companies in emerging markets will play.


1. P. Van Arnum, Pharm. Technol. Sourcing and Management May 2010, http://www.PharmTech/

2. P. Van Arnum, Pharm. Technol. 34 (6), s44–46 (2010).

3. P. Van Arnum, Pharm. Technol. Sourcing and Management Sept. 2007, http://www.PharmTech/


blog comments powered by Disqus
LCGC E-mail Newsletters

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

Which of the following business challenge poses the greatest threat to your company?
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
Building a sustainable pipeline of products
Attracting a skilled workforce
Obtaining/maintaining adequate financing
Regulatory compliance
View Results
Eric Langer Outsourcing Outlook Eric LangerBiopharma Outsourcing Activities Update
Cynthia Challener, PhD Ingredients Insider Cynthia Challener, PhDAppropriate Process Design Critical for Commercial Manufacture of Highly Potent APIs
Jill Wechsler Regulatory Watch Jill Wechsler FDA and Manufacturers Seek a More Secure Drug Supply Chain
Sean Milmo European Regulatory WatchSean MilmoQuality by Design?Bridging the Gap between Concept and Implementation
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Medicare Payment Data Raises Questions About Drug Costs
FDA Wants You!
A New Strategy to Tackle Antibiotic Resistance
Drug-Diagnostic Development Stymied by Payer Concerns
Source: Pharmaceutical Technology,
Click here