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).
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,
2. P. Van Arnum, Pharm. Technol.
34 (6), s44–46 (2010).
3. P. Van Arnum, Pharm. Technol. Sourcing and Management Sept. 2007,