Changes in Molecular Diagnostics Industry

Molecular Diagnostics Industry: We have seen the global molecular testing and diagnostics industry nearly double since 2007. Its valuation then was $3.7B. This year the projected valuation is going to be estimated at $6.3 B, according to some estimates. However, recent growing pains have caused some investors to question the vitality of this emerging  market.

PR-BG, in a recent article: “Factors such as reimbursement cuts and heavy hospital consolidation have massively affected the sale of equipment. Advanced technology applications like automatic stainers, microtomes and tissue processors require capital financing, and capital budgets are always a problem.”

Even though the industry will face some challenges in the future, such as the spending cuts, regulatory shifts and sales mentioned above, molecular diagnostics is the fastest-growing testing sector for in vitro diagnostics (IVD) manufacturers.  A recent report by Frost and Sullivan predicted a compounded annual growth rate of 11% year over year. Certain sub-segments, such as the HPV market are expecting growth rates as high as 20% through 2014. The four areas of molecular diagnostics that are expanding the fastest are genetic testing, prenatal diagnostics, cancer diagnostics, and near-patient applications.

Nine companies control more than 75% of the molecular diagnostics market. These include:

Roche Diagnostics, division of Roche Holdings (SIX: ROG.VX)
Gen-Probe Incorporated (NASDAQ: GPRO)
Abbott Diagnostics, (NYSE: ABT)
Siemens (NYSE: SI)
Becton Dickinson (NYSE: BDX)
Cepheid (NASDAQ: CPHD)
bioMerieux (EN Paris: BIM:FP)
Beckman Coulter (NYSE:DHR)
Roche is at the top of the list with a market share of 30%. Among the Roche products are molecular diagnostic tests for oncology, virology, microbiology, and blood screening.

Manufacturers are rapidly introducing molecular diagnostic tests for additional types of infectious disease. Following is a list of such tests that are relatively new to the market:

  • West Nile Virus
  • Clostridium difficile (C-diff)
  • methicillin-resistant Staphylococcus aureus (MRSA)
  • respiratory syncytial virus
  • influenza
  • pneumonia
  • Trichomonas vaginalis
  • genital mycoplasma
  • herpes simplex virus
  • norovirus
  • rotavirus
  • tuberculosis
  • meningitis.

Needless to say, the demand for expansion of molecular diagnostics tests and testing has created a great potential for rapid growth in the field. We expect to see many great opportunities for innovations in the near future.