Jim Miller

More to the point, CRO and CMO executives should be asking themselves, "What will the new normal look like?" It is clear that the biopharmaceutical and pharmaceutical industries are experiencing more than just a cyclical downturn in drug-development activity like the one they endured in the early years of this decade. We are looking at a wholesale restructuring of the industry that will leave the landscape looking very different than it has in recent years. The factors driving that restructuring are well known—patent expirations, few new drug approvals, national efforts to control healthcare spending—and contract services industry executives must prepare themselves for a new set of market dynamics.

While I don't have a crystal ball, I'm reasonably certain that the "new normal" for the next three to five years will have most of the characteristics outlined herein.

Emergence of new players. As the positions of the current Big Pharma companies change, other companies can be expected to play larger roles. Major Japanese pharmaceutical companies, for example, have become more aggressive in establishing their presence globally; they are no longer content to outlicense their products for sale in North America and Europe. Many of the generic drug companies in India are creating programs to develop proprietary products for domestic and global markets, and Chinese pharmaceutical companies are only a few years behind them. Many of these new players are still vertically integrated and may not be willing to outsource activities, at least not to the degree of the mature pharmaceutical companies of North America and Europe.

Smaller development pipeline. CROs and CMOs will have to fight over a smaller market opportunity in the foreseeable future. The early development pipeline (i.e., preclinical and Phase I) nearly doubled between 1998 and 2008, but the increased number of drug candidates didn't yield a concomitant jump in new products. Now, major pharmaceutical companies are making radical cuts to their portfolios to improve R&D efficiency, while equity investors are cutting back support for early-stage companies and candidates. We expect to see substantially fewer pipeline candidates in the next three to five years, which will have a major impact on CROs and CMOs offering services such as process development, preclinical testing, and clinical-trial materials manufacturing.

No increase in new product approvals. CMOs, in particular, must come to grips with the fact that waiting for the number of new product approvals to increase is like waiting for Godot: it's not coming. The industry should accept that 20 or so approvals annually for new molecular entities (NMEs) are the norm, and that a return to the high numbers of the 1990s is just not in the cards, at least not on a sustained basis. Further, industry consolidation means that these few approvals will be concentrated in the hands of fewer pharmaceutical companies, many of which have captive manufacturing capacity or preferred manufacturing suppliers. That will mean reduced opportunities for many CMOs.