A look at the IVD kit market for Zika, Ebola and the market considerations of emerging infectious disease tests.

1. Based on Information From Kalorama Information’s Report –
World Molecular Diagnostics Market
Molecular Test
Approaches to Zika,
Ebola and Other
Infectious Diseases
The development of molecular tests has been prioritized for all
recent disease threats, notably Ebola and Zika virus. While
immunoassays are preferred for routine screening and by cost-
constrained labs, molecular tests offer optimal sensitivity and
specificity key to public health response, diagnosis, and
targeted treatment. Infectious diseases range from the common
flu to antimicrobial resistant inpatient infections and engage all
levels of healthcare and thus represent the largest market for
molecular diagnostics. Excellent sensitivity has made nucleic acid tests (NATs) the predominant
screening method for transfusion transmitted infections (TTIs) in donated blood including
hepatitis viruses, human immunodeficiency virus (HIV), and other pathogens. With complete
penetration of established national blood programs in the developed world, NAT blood screening
or molecular transfusion diagnostics has few remaining prospects for market growth. Declining
transfusion rates in developed healthcare systems are a result of advances in medicine and new
practices in surgery, and have caused regional NAT blood screening markets to contract.
Remaining opportunities for market growth are found primarily in blood screening conversion
from serology to NATs as taking place in China.
The future of the molecular diagnostics market lies with nucleic acid amplification tests and
sequencing-based tests. Time to results for real-time PCR and isothermal amplification are
crucial for several infectious disease testing applications including respiratory testing, hospital-
Infectious disease is projected to
account for 60% of the global
molecular diagnostics market by
2021 or roughly $5.9 billion in
sales.

2. Based on Information From Kalorama Information’s Report –
World Molecular Diagnostics Market
acquired infections, bloodstream infections, and molecular point-of-care tests. Superior
sensitivity and non-invasive sampling will make qPCR and next-generation sequencing the
future methods of choice for cancer testing and prenatal screening.
Despite competitive displacement in cytogenetics, new cancer tests and blood culture tests, in
situ hybridization will retain application markets in cancer testing and comprise 47% of the total
molecular diagnostics market for cancer in 2021.
Infectious disease is projected to account for 60% of the global molecular diagnostics market by
2021 or roughly $5.9 billion in sales. The market segment is defined by test decentralization with
the introduction of NAAT platforms able to be operated in hospital labs and near-patient points
of care such as physician office labs (POLs) and outpatient clinics. Integrated design from
sample preparation to results analysis and user friendly features are just as appealing to larger
clinical labs to free up personnel. Menu expansion on integrated analyzers has been the
predominant focus of competitors in molecular infectious disease diagnostics. Market share and
client retention depend on the ability of one platform to perform all routine infectious disease
tests.
In the United States, blood transfusion rates continue to decline from an estimated 40
transfusions per 1,000 population in 2011, to 35 per 1,000 in 2014, and 32 per 1,000 in 2016
according to the American Red Cross. Transfusion demand has fallen as a result of new practices
in surgery, blood salvaging, and hospital blood management. Blood demand is expected to
stabilize eventually in the United States with declines in related testing revenue expected to
moderate. Other market developments for U.S. NAT blood screening include the U.S. Food and
Drug Administration recommendation that all donated blood be screened for Zika by 2016 and
the introduction of molecular blood typing.1
IVD Vendors responded to the Ebola Crisis in the United States and Blood screening assay
vendors and regulators have swiftly responded to the Zika virus outbreak in the Americas. In
early February 2016, only four public health labs were able to perform Zika virus testing in the
United States. Several Emergency Use Authorizations (EUA) were granted by the U.S. FDA
during the year. Development of Zika virus diagnostics has also proceeded quickly in Brazil,
where the government has partnered with domestic industry and health organizations to meet
domestic testing demand. Beyond public health lab testing for confirmation of Zika virus
infections, the outbreak has impacted the IVD market by generating demand among Latin
American and some U.S. blood banks for Zika virus NAT blood screening assays.
1
Widespread implementation of Zika virus screening of donated blood is unlikely within the recommended time
frame. AABB, America’s Blood Centers and the American Red Cross have voiced dissatisfaction with the most
recent FDA guidance and questioned returned value on the cost of nationwide Zika screening.

3. Based on Information From Kalorama Information’s Report –
World Molecular Diagnostics Market
 In March 2016, Roche’s cobas Zika NAT was granted FDA Investigational New Drug
(IND) designation for use in Puerto Rican blood centers. The assay can be performed on
Roche cobas 6800/8800 analyzers for core molecular testing and blood screening.
Grifols’ Procleix Zika NAT for the Procleix Panther system was provided FDA IND
designation in June 2016. The protocol allows blood centers in newly endemic areas of
the southern United States to perform blood screening for the Zika virus.
 In August 2016, the U.S. FDA recommended Zika virus screening of all donated blood
and blood products in the United States in order to prevent transfusion-transmitted
infections of the virus. Blood and blood component collection establishments in Florida
and Puerto Rico were recommended to begin screening immediately; establishments in
Alabama, Arizona, California, Georgia, Hawaii, Louisiana, Mississippi, New Mexico,
New York, South Carolina and Texas within four weeks; and remaining U.S.
establishments within 12 weeks. Blood industry association and organizations in the
United States – AABB, America’s Blood Centers and the American Red Cross – issued a
joint statement in November 2016 criticizing the scope of the recommendation, lack of
formal risk assessment for the recommended measures, and lack of consultation with
stakeholders. Yet, AABB has reported that measures have been undertaken in line with
the FDA recommendation including NAT screening in Puerto Rico, Florida (since July
2016), and 10 other southern states.2
 Rapid Ebola Virus Triage Test – developed with Janssen Diagnostics and the Institute for
Tropical Medicine in Antwerp for the Idylla platform; granted U.S. FDA Emergency Use
Authorization (EUA) in June 2016 and following studies conducted with live Ebola
viruses at the U.S. National Institutes of Health (NIH)
 October 2014, BioFire received Emergency Use Authorization (EUA) from the FDA for
its FilmArray Ebola test.
 Cepheid has developed assays for critical infections such as enterovirus (EV) meningitis,
Ebola virus (FDA Emergency Use Authorization), and MTB/RIF testing. Internationally,
Cepheid also sells an Xpert assay for HCV viral load monitoring under its virology
portfolio that also includes the company’s HIV tests.
2
AABB Association Bulletin #16-07, September 28, 2016