IVD Market Presentation at BioMedDevice Boston 2019

IVD
Fast Growth New Products, Disruptive Trends

Detailed Market Studies in
In Vitro Diagnostics, Biotech
Advanced MedTech 30+ Studies a Year
About
Kalorama
IMV Medical Information: Imaging Markets
Strategic Directions International SDI
The Latest News for Lab Managers and Pathologists

The World Is Aging Faster
Not just Europe & U.S.
China – Soon larger aged pop. than Europe Latin America- Uruguay aging near
Europe, Japan
Africa –15x Aged Population this century

Why IVD?
Most advanced clinical decisions based on the use of a diagnostic test
Yet tests are just 3%
of the cost of healthcare

Why IVD?
Huge pipeline
Brisk M&A Activity Large R&D Spend

Why IVD?
Large Market
Strong Future Market Growth over US GDP Growth
3.5% vs. 2.9%

IVD’s Reach
IVD influences a $2.6 trillion market
CLINICAL LAB SERVICES ($125BN) HOSPITAL &
PHYSICIAN OFFICE MARKETS $1.1T
PHARMACEUTICAL
MARKET $1.2T IMAGING (IN VIVO)
MARKET $30BN
HEALTH CARE
IT
($85 BN)
OUTSOURCING IVD $12BN
INSTRUMENTS $75B
LIFE SCIENCES RESEARCH

IVD hits healthcare
pain points
IVD’s Reach
Emerging
Viruses durable and high sensitivity tests

Trend-AMR
Better use of IVD
reduces prescriptions

Trend-Tick Borne
•The Powassan virus (POWV) •Asian longhorned tick •Lyme
•Babesosis
Increasing Cases of Lyme
Increased Recognition and Demand
Likely Underreported – CDC Says
Possible 10x cases
.

Trend: DTC Tests
Consumers have the power.

Future: Wearable/Robot
•$4 Billion-Dollar Market for Personal Robotics
•How Long Before Robots Remind Users of Testing and/or Test Themselves
Demand for better, sensitive sensors, fingerstick probes.

EU IVD Regulations
General Increase in Regulation for IVDs
•Enhanced Regulation for Infectious Disease Tests, Blood Screens Where Public Safety Could Be Harmed. Also Enhanced for Companion/Cancer.
•New UIs, Quality Management, Serious Incident Reports, Clinical Studies, Post-Market Reqs, Incident Tracking of Your Device AND Others
Is Europe Ready?
NBs “will typically take 3-9 months to complete a product re-certification, and it is expected that it will take them even more time for new MDR certification,” Bernasconi said, pointing to a prediction that up to just 12 NBs will be designated by year’s end. “This is way too late, insufficient and gives no guarantee that NBs would have enough capacity to ensure continued regulatory approval of devices by May 2020.”

Contracting
IVD
Manufacturing Market
8,151
8,700
Reagents & Consumables
Instruments & Systems
Supplies & Accessories

What IVD Needs
•Non-Digital Capillary Tests
•Lower-cost Tubing
•Improved Microfluidics
•Systems That Can Report POC Results to EMR •IVD Quality Control Reagents
•Cardiac Troponin Point of Care
•C Reactive Protein Tests Point of Care •High-Temperature Performance Instruments •Apps That Can Help Consumers Understand Test Results

Impactful Trends
Population
Lyme Disease Chagas, Respiratory infections

Thank You!
www.kaloramainformation.com
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IMV Medical Information: Imaging Markets
The Latest News for Lab Managers and Pathologists
Strategic Directions International

APPENDIX
Market Statistics
Exclusive market sizing and segmentation from Kalorama Information’s
‘Worldwide Market for In Vitro Diagnostic Tests, 11th Edition and Contract Manufacturing in IVD Market Studies
For More Information: www.kaloramainformation.com

IVD Market

IVD Market
in 2018

Point of Care 14%
Molecular
2% Blood 4%
Microbiology* 24%
IVD Sectors
Others 17%
Clin Chem 13%
Glucose Metering 15%
Immunoassays 11%
* includes infectious disease immunoassays, molecular microbiology and ID/AST
65 Billion-Dollar Market: Kalorama Worldwide IVD Study

Professional Point of Care Point of Care Consumer Tests Continuous Glucose Mass Spectrometry Glucose Self-Testing Inherited Disease Molecular HPV, molecular Histology/Cytology Coagulation
Molecular Micro Micro ID/AST
Hematology HbA1c Immunoassays Drugs of Abuse Blood Bank Screening Other Immunoassays Infectious Immunoassays Clinical Chemistry