Genpact’s acquisition of Pharmalink expands its capability to offer an increasingly important range of life sciences regulatory services, especially for the pharmaceutical majors. Pharmalink, a small but global player in this niche space, has established important relationships with several of the largest pharmaceutical companies since its inception around 15 years ago. Over the past 10 years, which have been particularly important for the pharmaceutical industry overall, pharma’s largest players have approached patent cliffs with apprehension, particularly as they have also experienced declines in R&D productivity. By the end of 2014, close to $50bn in pharmaceutical revenues will be lost to patent expiration by the industry’s household names, with a mixed bag of substitutes emerging from their pipelines.

It’s in this environment that Pharmalink developed, attracting competition from remarkably only a handful of firms (~4-5 direct competitors in the U.S. and Europe). The barriers to entry in pharmaceutical regulatory consulting are quite high, and Pharmalink has managed to protect its backside in the space quite well. During this time it was also observed within Genpact that its pharmaceutical clients would be willing to increase both the volume of outsourcing contracts and their overall budgets for outsourcing to regulatory specialists were they able to find exceptionally useful services offered at reasonable prices. Once the decision to target an acquisition with Pharmalink’s capabilities was made, there were only a few viable options unless Genpact was interested in acquiring this capability through the acquisition of a much-larger contract research organization (CRO), which it was not.

Genpact has already established relationships with many of the big pharma players that have found value in the niche expertise offered by Pharmalink. In supplement to Genpact’s core services, Pharmalink will employ its base of regulatory experts to maintain client compliance with annual filings and other measures required to maintain/grow pharmaceutical sales in existing markets and introduce products in new ones. Genpact is therefore in a healthy position to leverage this acquisition into a bundle of complimentary services for life-science clients that goes beyond the somewhat commoditized services of ITO and F&A BPO toward offerings that address some of the central commercial activities and concerns within big pharma. That is, with impending patent expirations, market entry and competition from low-priced generics and other commercial challenges, the Genpact-Pharmalink combination goes a long way toward two ends: (1) helping to contain costs through BPO services, and (2) minimizing profit-erosion (and perhaps even growing sales) through regulatory consulting.

Even with Genpact’s acquisition here, there is still considerable room for the growth of small firms in the regulatory consulting space. Still, for big pharma it should be of considerable comfort and benefit to outsource some of these regulatory activities directly to a familiar BPO major such as Genpact. It was wise for Genpact to execute this acquisition relatively early in the development of the regulatory consulting space, as it can now offer an important supplement to the core BPO and analytics services that it provides its life sciences clients.