Drug development and product introductions continue to escalate as the impact of generics, outsourcing and development partnerships shorten product cycles and reduce time-to-market. For injectables, the pace of new drug application approvals varies widely across therapeutic classes, market segments and application types (BLA, NDA, ANDA). This environment is putting pressure on the product planning process and forcing planners to innovate.

Several companies dominate selected injectables market segments. Examples include Amgen in injectables for treating neutropenia and anemia, Genentech in immunotherapeutics and Actavis in oncology. Amgen and Genentech also account for a significant share of biological license applications (BLA) due to the nature of the drugs they develop and produce. On the generics side, major players include Mylan, Hikma and Fresenius.

Injectables competition influencing strategic planning methodsAn analysis of the total number of new injectable drug applications that have been approved over the last ten years produces a list of companies that is heavily represented by the generic drug segment. Several of these players are quite large and have mastered the business of rapidly bringing products into global distribution channels once an ANDA has been approved.

Generic drug suppliers are also utilizing the secondary market to acquire ANDAs as a way to speed product portfolio growth. The divestiture and subsequent acquisition of ANDAs was virtually nonexistent ten years ago, but as companies become more adept at valuing their generic products, ANDA divestiture has become a standard tool for adjusting drug product assets.

Oncology continues to be the fastest growing market segment in terms of drug application approvals for injectables/infusibles. Antibiotics and anti-infectives continue to exhibit year-on-year application growth but activity is almost entirely in the generics space.

While injectables competition is influencing strategic planning methods, the multinational pharmaceutical organizations continue to lead in terms of new drug formulations and NCEs as measure the BLA/NDA approvals and pipeline activity. However, under the hood the new drug development segment is vastly different than it was twenty years ago, as the innovators continue to reduce development costs and risk through numerous, often complex development agreements. Outsourcing key skills and technology requirements is the linchpin of this strategy as companies manage their operations to avoid the risk of organically developing a new drug product internally.