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

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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.

References

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

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/PTSM.com.


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