The giants of the pharmaceutical industry may have found their salvation in the wave of consolidation that's changing the face of the industry. But not for the reasons that have been used to justify Pfizer's acquisition of Wyeth, Merck's purchase of Schering-Plough and Genentech's deal with Roche.
The acquirers have hoped those big-ticket transactions will fill gaps in their research-and-development pipelines and buy them time to develop new products. That's important because of the looming "patent cliff," as blockbuster drugs lose their patent protection faster than new ones can emerge. But none of those deals cure the companies' basic innovation problem.
Bain & Co.'s research shows that in the late 1990s, pharma companies spent an average of $1.1 billion to develop and launch a new drug. A decade later, that investment has doubled to $2.2 billion. At the same time, R&D productivity, measured in the number of new molecular entities and biologic license applications per R&D dollar spent, declined by 21% a year. Today the discovery of a blockbuster drug is almost a matter of luck.
So these deals won't plug the growing gaps in R&D. But with them the companies may have stumbled on the solution to a larger problem: building a robust business model for competing in the new global marketplace. As hard as it is to come up with a new drug, many companies find it even harder to persuade regulators that the drug is worth paying for. Or they find that by the time they get to vitally important emerging markets such as India, China and Brazil, competitors who lagged in innovation are already there. What used to be a single hurdle—regulatory approval in the U.S., leading to a measured roll-out in the rest of the world—has multiplied into two or three major obstacles to be surmounted in order to reach a global market all at once. Speed to market really matters, and not just in the U.S.
In that kind of game, scale can be a huge advantage—scale on the order of Pfizer and Wyeth combined, for instance, or Merck plus Schering-Plough. With such mergers, pharmaceutical companies can, in effect, move many promising compounds to market, everywhere, all at the same time. Whether intended or not, these deals provide a platform for building the next strategy for global growth. They do so in three key areas:
First, they speed up the globalization of clinical trials. Increasingly, trials of new drugs are conducted in many countries, to ensure compliance with differing regulatory requirements, because emerging markets offer lower costs for clinical development, and to get access to different pools of patients. Pharma companies face pressure to take their clinical trials abroad and seek regulatory approval in many places at once, and global scale, giving them better ability to do so, can accelerate the commercial returns on those new products.
Second, regulatory approvals in multiple markets are more manageable for a bigger company. Getting a drug approved today is far harder than it used to be. After a regulatory review, the drug must go through extensive analyses of its usefulness known as health technology assessments. Then it must navigate possible resistance form budget-strapped health authorities, and skeptical insurers, doctors and patients who may prefer existing therapies.
In Britain, for example, reimbursements for Velcade, a drug for multiple myeloma, didn't begin until more than a year after it passed regulatory scrutiny. With market access controlled by authorities like the National Institute for Health and Clinical Excellence in Britain and private insurers in the U.S., big pharma companies need global, leading-edge capabilities in health economics. Large scale gives them the power to pursue all markets at once, rather than sequentially, and thereby shortens the time to full global access by several years.
Third, global marketing reach improves with size. Developing and selling medicines primarily in the U.S. and then slowly rolling them out elsewhere is no longer cost-effective, since growth now depends on quickly introducing them in emerging economies as well. That takes global marketing and sales teams that understand the distribution channels in each major market, with the right cost structures set up for each.
Innovation is one area where scale doesn't work. In fact, it's counterproductive. In 2008, bio-pharma companies spent more than $60 billion on R&D worldwide with little to show for it. Innovation can't be manufactured; it must be nurtured in a highly entrepreneurial environment. That argues for acquiring new compounds from a large global pool of smaller, independent, innovation-focused companies. In fact, the big pharma deals have better odds of success if the companies involved move quickly to reduce the scale of their internal research. They should shift 40% to 50% of their current innovation budgets to outside their newly merged companies.
So consolidation may finally prove that scale matters in pharmaceuticals—just not the way most people thought.
Charles Farkas is a partner with the consulting firm Bain & Company. Tim van Biesen is a Bain partner and head of Bain's Americas Healthcare Practice.