IVD Market $54 Billion: Kalorama's 9th Edition Report

 The world market for diagnostics is estimated at $54.6 billion in 2013, according to Kalorama Information.   Kalorama revealed the market estimate in its biennial survey of the IVD industry, The Worldwide Market for In Vitro Diagnostic Tests, 9th Edition.   Aside this article is a Wordle of the entire text of the report, which provides some indication of the topics that are most often discussed in its pages.   The survey can be obtained at http://www.kaloramainformati

Recent FDA Guidance Benefits IVD Companies in Companion Diagnostics

The majority of the companion diagnostics market is held by LDTs developed in reference or commercial laboratories and able to compete in the market without the clinical trials and product registration required for companion diagnostic (or “companion device”) products sold by IVD companies. Coupled with a tightened grip on LDTs competing in the U.S. companion diagnostics market, the FDA’s preferential treatment of “contemporaneously” developed pharmaceuticals and companion IVDs under its recently released guidance is expected to benefit non-LDT pharmacodiagnostic leaders such as Roche (and confirm Roche’s bullish outlook on the U.S. IVD market).

Cerner-Siemens AG Deal Shakes Up EMR Market

Cerner Corporation and Siemens AG's announcement that Cerner will acquire the assets of Siemens’ health information technology business unit, Siemens Health Services, for $1.3 billion creates scale for future industry innovation, given the combined $650 million annual R&D investment the deal entails.  As covered in our EMR market report earlier this year, Siemens is one of the companies that has moved away from electronic medical records in favor of other systems.   The move should help Cerner build its pl

Grassroots Molecular – How AACC Exhibitors Addressed the New Frontier in POC and Decentralized Testing

Even after a relatively disappointing year for molecular diagnostics overall in 2013, industry remains poised to capitalize on remaining underserved areas of demand. One such area is molecular point-of-care (POC) diagnostics or molecular tests performed outside of a central or reference lab. The number of systems showcased at AACC for decentralized and field molecular testing indicates how crowded a once nascent field has become.

Expensive Drugs: Only At First Glance

We concur with a recent article by Peter J. Pitts, a former FDA associate commissioner ("Why ‘Pricey’ Drugs Save Money — and Lives," in the New York Post.  In that article Pitts argues against expensive new drugs as the culprit to rising US health-care costs.

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