Thursday, March 8, 2012

How New is "Personalized Medicine?"

Not as new as you think.  If we define personalized medicine as 'using testing to develop and individual therapy for a patient,' then there are all sorts of diagnostic products that fit the category of 'personalized.' or as we say PMx testing.   This broad scope is used by our analyst Shara Rosen in her latest report, Personalized Medicine Diagnostics.   

Glucose testing, antimicrobial susceptibility testing (AST), blood typing, transplant typing,
HbA1c testing, coagulation testing.  These are among the tests already on the market and in routine clinical practice that can be said to do the same thing that any novel companion diagnostic test does: align a treatment strategy to the individual characteristics of the patient.   Another way of stating this broad scope in lay language perhaps is: tests to decide if a patient gets Treatment X, Treatment Y, both Treatment X and Y, or no treatment at all.  It's almost always applying to drugs but could in future applications apply to radiology or surgery. 

With all of these testing methods considered, and the new tissue diagnostics and tumor marker studies considered, Kalorama estimates a 28 billion-dollar market for tests that are personalized to a patient.  The primary growth drivers in the market for PMx tests, are the continued discovery of protein and genetic markers with proven clinical utility, the increasing adoption of these diagnostic tests as markers for personalized medicine, and the expansion of reimbursement programs to include a greater number of companion diagnostic tests. 

 Our recent report states in it's methodology section that "In accordance with a broad application of PMx, the market estimate in this report covers tests that can also provide therapy decision-making information that is tailored to the individual in the following ways:

  • Tests that identify a population in which the therapeutic product will achieve greater (or little) effectiveness.
  •  Tests that identify a patient population that should not receive a particular therapeutic product due to the possibility for therapy-related serious adverse events.
  •  Tests that identify the characteristics of a disease, condition, or disorder to specifically determine what type of treatment is appropriate.  This area of disease stratification is one of the fastest growing areas of personalized medicine.  It includes tests for: tumor aggressiveness, risk of tumor reoccurrence, aggressive rheumatoid arthritis, pathways for severe cardiac disease and many others. 
  •  Tests that are the basis for selecting a safe and efficacious therapeutic dose.  This is probably the oldest application of PMx that has been in use in clinical laboratories for at least 50 years. "
Our report details specific market estimates but overall it makes it clear that PMx testing is on an upswing; the number of assays introduced has been growing at a remarkable clip.  The expanding menu of PMx tests can be attributed in part to the publication of the human genome project and advances in functional proteomics, bioinformatics, miniaturization and microelectronics.