Market opportunity for a

new blood test for

Rheumatoid Arthritis in
the USA

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

• Global IVD Total Value: 100.2 Billion

USD (2020); 133.8 Billion USD (2025),
CAGR: 6.0%

• The global C-reactive protein testing

(for RA) market size was estimated at
USD 1.7 billion in 2019 and is
expected to register a CAGR of 1.3%
over the forecast period, in the USA

• (Grand View Research, 2021)

Drawbacks of CRP test w.r.t to RA diagnosis/treatment monitoring

• CRP testing is more sensitive to cardiovascular conditions rather than other

conditions like RA

• 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

• Thus, in recent years, various biosensor-based detection systems have been

attempted for quick, sensitive and on-site detection of CRP

• 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

• Other biomarker tests are also used for

diagnosing RA, like:
• the rheumatoid factor (RF) and,
• the anti-cyclic citrullinated peptide (anti-
CCP)

• Since 2010, new biomarkers were

discovered and proved useful in identifying
RA in early stages, like
• 14-3-3 eta protein
• Anti-CarP
Strategies and action points
• The new product should be targeted and promoted to all stakeholders in USA that influence
a physician’s diagnosis development. For example,
 Clinics, Hospitals, laboratories, etc.
 regulators (FDA/EMA, American Medical Association, etc.)
 professional associates (pathologists, pharmacists, etc.)
 patient advocacy groups, etc.

• 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…