• by Aaron Hackle
  • December 6 2018


#BIOMEDevice2018: Kalorama Presents IVD Findings, Sums Up Best Opportunities in Testing, Biosensors and AI Discussed

#BIOMEDevice2018:  Kalorama Presents IVD Findings, Sums Up Best Opportunities in Testing, Biosensors and AI Discussed

BIOMEDevice meeting in San Jose, CA completed its first day yesterday, with hundreds of medtech companies in attendance and exhibiting products ranging from tubing, to sensors display systems, IVD tests, plastic casing and intricate components.  Kalorama presented the keynote speech at the meeting: 'IVD: Fast Growth, Market Opportunities, New Products and Disruptive Trends'   We identified how the $65 billion-dollar market is growing to $78 billion in 2023.  Which is a large market that has attracted competition.  But the actual size of the market belies a large influence the healthcare market as a whole, as IVD touches pharmaceuticals, hospital services, healthcare IT, biotech instrumentation and other markets. The market size and forecast came from Kalorama Information's The Worldwide Market for In Vitro Diagnostics, 11th Edition.

Kalorama Information's presentation focused on direct to consumer testing and the recent developments with Walgreens and Lab Corp's planned patient testing service centers, and Quest Diagnostics MyQuest online testing service.

"IVD Influences a 2.6 Trillion-Dollar Market when pharmaceuticals, healthcare delivery, IT and biotech instrumentation is considered."

-Kalorama Presentation @BIOMEDevice2018

IVD was noted for affecting key issues in the healthcare system, For instance, opioids may not seem like a problem solved by testing - but increasingly lab clinicians are being advised to work with physicians using DOA immunoassays or even advanced mass spectrometric-based tests that can identify specific substances and determine the best pain medication prescription strategy. Another issue is globilization and climate change that may influenced increase West Nile infections and the appearance of chikungunya virus for the first time in the United States several years ago.  In our presentation we focused on anti-microbial resistance.  Strategies aimed at getting faster test results and determining if an infection is truly present can reduce wasteful prescriptions of antibiotics for patients with viral infections.  There are many ways testing can combat anti-microbial testing; it is not always  the obivous search for a particular pathogen.  Tests for related pathogens and point of care molecular systems, in urgent care and retail clinic uses can also reduce errant prescriptions.  In addition, faster blood culture through improved automation systems (bioMerieux and BD offer representative time-reducing systems). 

"AMR represents a place where IVD can rightly place its flag.  It has a role in solving the problem and it is likely lack of testing that contributed to it."  

In other findings, Kalorama noted that point of care testing was in a 'slow burn' of adoption.  Some laboratories were using more, a median of 10% more, according to surveys of laboratories by sister company IMVInfo in a recent webinar: Disruptive Trends in the Lab Industry.

What IVD Needs

There will be between 60 and 80 significant technology acquisitions or M&As completed in the next year, Kalorama notes.  So what do mid to large IVD companies want from start ups, technology innovators and contractors?  There were a number of improvements the IVD industry needs from smaller innovators like those exhibiting and attending:

  • Durable microfluidics
  • PCR improvements: adaptive and touchdown methods
  • Histology testing automation
  • Non-fingerstick testing methods and innovative biosensors
  • Cardiac Troponin I for point of care
  • Point of care platforms for multiple tests
  • IT systems that can make labs more productive
  • Software that helps devices report to EMRs
  • Novel biomarker-based tests
  • Liquid biopsy improvements - error free targeting and sample collection/utilization
  • Amplified DNA probes
  • POC hbA1c testing
  • Apps that can help consumers interpret test results
  • Instruments that can withstand high temperatures
  • Lower-cost tubing, pipettes and IVD quality controls
  • Improvements (continued improvements) in miniturization


Biosensors A Meeting Focus


- Zimmer and Peacock's Sensor can work directly or continually, for varying applications -

Kalorama's presentation focused on, among several trends in the market, the need for better biosensors to make future diagnostics, wearable/IVD connections, and robotics-based work. This was also a focus of the BIOMEDevice meeting, where several innovative sensor products were on display: 


Sweat Sensors: Zimmer and Peacock's Glucose sensors can be used either for discrete measurements and disposed of after use, or it can be left in place for continuous measurement. The company offers potassium, pH, nitric oxide, lactate, oxygen and uric acid sensors,, among others.

"Noise Cancelling: for Sensors: Valencell developed wearable biosensors that continuously measures heart rate, VO2, energy expenditure, R-R interval, signal quality and other biometrics. The company said that their active signal characterization technology enables highly accurate biometrics in wearable devices even during vigorous activity. Active signal characterization is a term to describe the process of actively identifying and characterizing different types of raw signal data from the biometric sensors found on many wearable devices today.   According to the company, active signal characterization is similar to Active Noise Cancellation in headphones, but for biometric signals being generated by the sensors in wearables of all kinds, including smartwatches, wristbands, earbuds, or other systems.

Thin glass-based sensors: Samtec displayed its microelectronic systems consist of glass that is coated with a metalic layer. This helps miniturization and makes them highly reliable.   

Sensor companies were part of a "Hot Topics in Sensors" seminar held at the Center Stage at the meeting, which discussed the progress on sensoring technology and the challeges of powering systems. Implantable and 'Disappearable' Sensors were discussed.  Other seminars focused on unmet need in minimally invasive surgery, information technology in devices and AI-based medtech.

"How sensors might be powered, solar power or passive power, were discussed.  Moving from 'Implantable', which can have a negative connotation, to 'Disappearable' so it is seemless to the user was explored at the seminar. "

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LEARN MORE:

Kalorama Information's latest medical device report, The Global Market for Medical Devices, can be found here: https://www.kaloramainformation.com/Global-Medical-Devices-Edition-Specific-Device-Country-Forecasted-12046459/

Kalorama also publishes studies in contract manufacturing in IVD: https://www.kaloramainformation.com/Contract-Manufacturing-IVD-11536931/