• by Bruce Carlson
  • November 26 2018


Kalorama To Present IVD Market Findings at BIOMEDevice

Kalorama To Present IVD Market Findings at BIOMEDevice

In many ways, the IVD market of today does not resemble the market five years ago.  2018 appears to be the year where a number of trends that had been discussed began to gel.  With that in mind, Kalorama Information will be on hand for UBM's BIOMedDevice Convention in San Jose, CA next month.   In vitro diagnostics represents a 65 billion-dollar market, according to Kalorama Information's latest report on the worldwide diagnostic industry.  That makes it a large, competitive and growing market.  But the significance of in vitro diagnostics goes beyond the market numbers.  IVD really is significant because of its reach: testing reaches touches clinical lab services, hospital care provision, pharmaceuticals. These add up to a multi-trillion dollar "Influence Market" for IVD.  

Among many trends that Kalorama will discuss at the meeting:

  • Direct-to-consumer testing was a scattered array of projects and small startups prior to 2018.  Now, it is a real factor in the business.  With both Lab Corp and Quest making direct to patient pitches, and 23 and Me's FDA approval for its consumer-ordered BRCA test, there is an actual market for these products.  
  • There are nearly 10,000 locations where a patient now can walk in and secure a healthcare visit with no appointment.  
  • Novel biomarkers are being discovered.  The track record of PCT in sepsis treatment and and high-sensitivity troponin markers in detecting heart attacks has been evident from their migration on to large analyzer systems.  This year saw developments in tests for traumatic brain injury and Alzheimer's Disease, including two FDA approvals for microRNA biomarkers for the latter disease.  
  • Sequencing: Clinical systems were introduced and smaller footprint instruments have been developed.  Simplified (NGS in a Box) systems have made gains.   How sequencing will fit into clinical diagnostics is still being determined, but it is clear it will have some impact.  

There are many factors causing an increase in the rise of diagnostic services to monitor health, which in turn is stoking the growth of the IVD market. Trends such as technological advancements, rising end-user awareness, and miniaturization is driving the demand for point-of-care products and have increased the access to diagnostic tests near patient site. But with growth comes new regulations and implementation dates put forth for medical device manufacturers active in Europe. Compliance deadlines for 2020 and 2022 are looming. 

With this in mind, Kalorama announces that Publisher Bruce Carlson will speak at the BIOMedDevice convention in San Jose, CA, December 4-6th, 2018.  The keynote speech:

The IVD Market Opportunity: Fast-Growth Markets, New Products, Disruptive Trends ( https://bmsj18.mapyourshow.com/7_0/sessions/session-details.cfm?ScheduleID=11 ) will be held on December 5th.  

Topics covered include:

  • Retail clinics, Direct-to-Consumer marketing, accelerated aging and trends driving new product development in the IVD space
  • Point-of-Care, digital capillary testing, wearable, and other products moving IVD diagnostics forward
  • Medicare Part B Cuts and New FDA Proposals
  • New European IVDR affecting 80% of IVD products – what you need to know
  • Market Statistics for In Vitro Diagnostics and Contract Manufacturing for In Vitro Diagnostics