Meanwhile, the entities created in the mergers are striving to become viable, if not formidable, competitors against Big Pharma. There are advantages to not being a behemoth, such as easier post-merger integration. And, unlike the giants, these companies are not in the throes of dismantling huge sales organizations, having already devised marketing and sales tactics that may serve them well in an era that requires a more varied, segmented approach to the market. They are now stronger regional players—and more attractive comarketing or copromotion partners, especially for companies needing to enter Europe quickly.

5. Delayed Reaction

The Harbinger Three antidiabetes products that launched in the United States in 2006 were approved by FDA more than six months earlier: Sanofi-Aventis' Apidra (approved in April 2004, launched in February 2006), Novo Nordisk's Levemir (approved in June 2005, launched in March 2006), and Pfizer's Exubera (approved in January 2006, launched in July 2006). In Exubera's case, Pfizer needed to build a wide-ranging education program for its novel inhaled delivery, and a complex manufacturing process may have led to scale-up issues.

The Change While there may be strategic reasons for moving slowly between approval and launch—for example, allowing a competing product to bear the cost of conditioning the market—the general goal is to launch first and fast in the United States. Not only is America often a premium-priced market, but it can also account for more than three-quarters of a product's global sales.

Even companies with deep pockets need the revenues from an early US launch to finance launches into other countries. In most cases, a lengthy delay signifies that the product or the company is not ready or that the environment is not right. There is greater uncertainty today about whether FDA will approve a submitted dossier—and less appetite for risking the cost of gearing up manufacturing and sales.

The Implication It is likely that longer gaps between approval and launch will increase as companies focus on specialist products that take the path less traveled. Longer gaps may also result as companies increasingly take a total-systems perspective, linking a drug with a delivery mechanism and a diagnostic test. In today's uncertain environment, flexibility will be key to meeting variable demands in manufacturing and sales.

Surprisingly, the largest companies may have an edge on this point. In Europe, a tactical delay—or even declining to launch—can be the best way to optimize revenue where parallel imports and reference pricing can eat away at value. In the United States, where launch is essential, the drug giants can mobilize the necessary resources with minimum delay. Smaller companies, with less cash flow, will have to plan carefully and have a good feel for the status of the FDA review process. The hardships small companies face raise the possibility of a new kind of partnership with their bigger peers: co-regulatory-affairs deals.

Meanwhile, the argument for being first-in-class just got stronger. Class leaders have more flexibility to "sit it out" until the timing is right. At any rate, one thing is sure: Uncertainty in FDA review calls for greater agility—and that comes from more fluid forecasting and more comprehensive planning.