BD unveiled BD Max last year as the first fully-automated molecular diagnostics analyzer with an open platform, signaling plans for a smartphone-style “app” business model for molecular diagnostics.

This article first appeared in Medtech Insight, October 2010.

The global economic downturn has put pressure on large, consumer-based in vitro diagnostic markets, such as diabetes glucose-testing, driving down sales, pricing, and profits. As a result, the IVD industry is actively seeking out higher growth opportunities to offset this impact-and it is finding solutions in several areas, branching into underserved emerging markets like China and India and targeting higher-growth clinical segments such as cancer, women's health, and infectious disease. But perhaps the biggest opportunity for future growth lies in the field of molecular diagnostics, particularly products that address the move toward more personalized care. Suppliers well positioned to take advantage of this opportunity are likely to experience strong growth ahead.

Highlights from the Q4 2009 review of medical device and in vitro diagnostics/research dealmaking: Medical device financings - again led by both early- and late-stage VC money, which made up 65% of the quarter's $745mm total - experienced a decline from the previous three-month period, which brought in over $1bn. The year overall fetched just $3.1bn, slightly less than 2008's $3.3bn aggregate. The biggest M&A was Ethicon Inc.'s $785mm takeover of Acclarent Inc. in December. Although Q4 M&A was $1bn higher than Q3, 2009 on the whole was the most dismal year for medtech acquisitions in over five years. On the in vitro diagnostics/research front, the $304mm in financings disappointed as it showed a significant dip from the $821mm done during Q3. Although Vermillion Inc.'s $43mm PIPE made up 19% of the quarter's pie, early- and late-stage VC financings again dominated, together accounting for 65% of Q4's aggregate dollar volume. Becton Dickinson & Co.'s $275mm October buy of molecular diagnostics firm HandyLab Inc. capped off a less-than-outstanding quarter of M&A activity with only five transactions totaling $468mm. For the entire year, in fact, this industry segment only managed to bring in $5.1bn through 21 M&A deals, a significant decrease over 2008's $9.6bn full-year amount.