The “human biotechnolgy” segment of the greater Biotechnology has been one of the most appealing industries to follow from an editor's perspective. No other field has had a greater impact on healthcare and pharmaceutical development; however, over the past two years, public market equity evaporated, company market values sank and biotech was tossed into its current phase of redefining itself.
What's emerging from this fog is an industry that's possibly as strong as its ideas are revolutionary.
Once considered the ideal pharma/bio situation—the fully integrated pharmaceutical company where a “big pharma” invests heavily in biotech-start-up ideas—now appears attainable only by the world's largest companies.
Today, we're seeing biotechs either going it alone or incorporating virtual integration and other creative alliances with pharmas in an effort to push the “closest” product through FDA trials. These innovative arrangements rely on key partners to share essential tasks, such as regulatory and clinical expertise, to speed time-to-market.
Combine this newer, leaner business model with an undying entrepreneurial spirit, true attention to core competencies and automated technological advances in R&D, and we get 22 biotech-based products and indication approvals granted by the FDA this year—with another 371 in the pipeline at various stages of testing.
And according to Resilience: Americas Biotechnology Report 2003, Ernst & Young's recently released annual market report, it's this new mode that's driving this critical segment of Biotechnology toward actual profitability in the next five years, and bringing with it a forecasted clean lab and production cleanroom space crunch.
This month, readers in our ever-intensifying life sciences circulation base will be receiving the third installment of the CleanRooms supplement entitled Advancing Life Science Environments. It's designed to give readers an overview of pharmaceutical and biotechnology markets and offer technical insight into the most advanced materials and technologies available to solve production-level contamination control concerns.
My forecast is that pharmaceutical and biotech companies, no matter what size, will remain inexorably linked, will continue to tap into core competencies where feasible and ultimately learn from one another. Once everyone's in the game, we'll witness a whole new set of growing pains.
Michael A. Levans