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Akshat Heera Chhabra
Akshat Heera Chhabra
Presented by
Akshat Heera Chhabra
MBA PM-12
Introduction
• Most physicians are used to the role of
diagnostic tests to clarify and support their
clinical decision making. Professional
Regulators associates Patient
(FDA/EMA, advocacy
• When it comes to Rheumatoid Arthritis (RA), C-
AMA, etc.) organization
reactive protein (commonly known as CRP) is a
popular ordered blood test for diagnosis and s
treatment monitoring
For diagnosis of RA, CRP is ordered for 100%
suspected cases of RA Stakeholders
For treatment monitoring of RA, CRP is ordered that
for 80% of total RA diagnosed patients influence
diagnosis
• Guidelines recommend doctors to check CRP
development
levels every 3 months each year
Competitive Assessment
• Competitive landscape of CRP testing
market in USA is moderately fragmented
with several key players operating on
global and regional levels.
• Key players:
• Thermo Fisher Scientific, Inc.
• F. Hoffmann-La Roche Ltd.
• Danaher
• Quest Diagnostics Incorporated
• Siemens
• Abbott Laboratories
• Merck KGaA
Estimation of total number of CRP tests ordered by the doctors in the USA
• More than 7 billion clinical lab tests are performed in the U.S. each year, providing critical data
for a relatively small expenditure in more than 200,000 Clinical Laboratory Improvement
Amendment (CLIA)-certified laboratories [2, 4, 5]
• Out of them around 2.6% tests are specific to CRP subjected to various conditions
• (Grand View Research, 2021)
• CRP tests have also become an early marker to predict risk for severity of COVID ‐19.
Therefore, CRP tests have been on a rise
• So, the total number of CRP tests ordered by the doctors in the USA could estimated at around:
• ~ 200 million per year (for diagnosis), and
• ~ 160 million per year (treatment monitoring)
Global In-vitro Diagnostics (IVD) Market Outlook
• Other major disadvantages include the long detection time, lower sensitivity, low
stability, cross reactivity with the serum proteins, lack of miniaturization and on-site
analysis
• This could be an opportunity for the MNC to develop a new biosensor-based assay
kit to penetrate the market
Other tests for diagnosing RA
• With growing cases of RA, the demand of biomarker testing will also increase.
• MNC could leverage the drawbacks of CRP testing and develop a new biosensor-based
assay kit, that would be accurate, to penetrate the market
• After successfully gaining an edge over CRP testing, the cost of newly developed biomarker
test could be priced lesser than CRP testing (~ USD 6) for further penetration
Thank You…