Zika Virus Testing Market

How do the Historical Projections and Future Outlook Compare?

According to Future Market Insights, the zika virus testing market experienced moderate growth, registering a CAGR of over 2% until 2020. The market surpassed US$ 4 billion in value as government initiatives to contain the virus’s spread resulted in massive awareness campaigns which accelerated the frequency of infection diagnostics and testing.

As the intensity of the epidemic has waned, the incidence of testing has significantly dwindled. However, government and institutional level efforts are unceasing in terms of discovering possible new breakthroughs in the future. Furthermore, the existing COVID-19 pandemic has prompted individuals to screen for any possibility of viral strain presence as a precautionary measure, elevating growth prospects.

How are Increasing Epidemic Outbreaks contributing to Market Growth?

Since the dawn of the 21st century, the global healthcare community has been wrestling with countless epidemic outbreaks, which has significantly stretched existing infrastructure capabilities. Amongst all the pandemics and epidemics faced today, viral infections have acquired the topmost position, with diseases such as the Severe Acute Respiratory Syndrome (SARS), the Middle Eastern Respiratory Syndrome (MERS), Chikungunya, Swine Flu, Zika Virus and the COVID-19 pandemic being some examples.

Fortunately, numerous technological advancements has enabled the global healthcare industry to develop effective virology diagnostic and treatment procedures, leading to the introduction of highly advanced testing mechanisms. Multiple approaches, including viral culture, antigen detection, nucleic acid detection and serology. Viral isolation and a number of methods of detection of viral antigens, nucleic acids, and antibodies are at the core repertoire of techniques used for laboratory diagnosis of numerous viral infections.

All the aforementioned approaches have been extensively deployed to diagnose and contain the zika virus epidemic with largely successful results. Prominent laboratories are investing their funds in developing immunoglobulin testing and enzyme-linked immunosorbent assay (ELISA). Players such as LabCorp are at the forefront of the zika virus testing market, offering the Aptima® Zika Virus Assay and the ZIKV DetectTM IgM Capture ELISA which were authorized for emergency use initially. Such developments are further widening growth prospects in the future.

Why is Demand for Zika Virus Testing High for Pregnant Women?

Documented findings have established that the zika virus has a high possibility of being passed on from a pregnant woman to her fetus. Infection during pregnancy leads to microcephaly and other severe fetal brain defects. Additionally, it may result in neurodevelopmental abnormalities such as hearing and visual impairment, limited locomotion, seizures and other abnormalities.

Therefore, it has become imperative for women to undergo periodic screening for possible presence of the virus in their bloodstream. According to the World Health Organization, zika virus infection is also a trigger for Guillain-Barre syndrome, neuropathy and myelitis, particularly in adults and older children. Hence, it is highly advisable for women residing within zika intensive areas to undergo laboratory testing and other clinical care.

At the same time, clinicians are advocating a slew of preventive measures owing to the dearth of any vaccine or drug to treat the virus. As it is a vector borne disease, mostly through mosquitos, personal protection measures such as wearing light-colored clothing that covers as much of the body as possible. Furthermore, using physical barriers such as window screens and closed doors and windows and applying insect repellants are considered the best alternatives.

Key Challenges faced by the Zika Virus Testing Providers

A major factor impeding revenue growth of the zika virus testing market is the inefficiency of these tests in delivering results. While ELISA tests are said to provide relatively accurate results compared to IgG/IgM testing, yet companies are unable to deliver products owing to cross reactivity with other widely circulating virus strands such as Flavivirus, Dengue, Chikungunya and Japanese Encephalitis.

Furthermore, the outreach of zika virus testing is restricted to tropical regions, as these are the primary infection hotspots, thus restricting their growth scope. Fortunately, countries across the temperate regions are increasing uptake of various serological tests amid growing concerns of the epidemic’s spread by virtue of people frequenting tropical regions for tourism.

Country-wise Analysis

What Prospects are in Store for the US Zika Virus Testing Market?

Presently, as of 2021, there have been no documented instances of local zika virus transmission across the US. However, overseas territories have registered 7 active cases through presumed local mosquito-borne transmission. This number represents an impressive reduction as compared to 2019 levels wherein 28 active cases were reported, 27 in travelers returning from affected areas and 1 from laboratory exposure.

This reduction in cases is majorly credited to numerous regulatory approaches to facilitate active viral case load testing since the past few years. For instance, in May 2019, the Food & Drug Administration authorized marketing of the ZIKV Detect 2.0 IgM Capture ELISA to detect Zika virus Immunoglobulin (IgM) antibodies in human blood. This was the first diagnostic test permitted by the FDA to be commercially available.

Likewise, in July 2019, FDA cleared the ADVIA Center Zika test, making it the second major IgM antibody test to be commercially available. Earlier, this test was only permitted for emergency use by decree of the FDA’s emergency use authorization directive. Two other tests- the LIASION XL Zika Capture IgM Assay II and DPP Zika IgM Assay System were eventually granted approval subsequently. Attributed to these approvals, scope for the US market is increasing manifold.

Is Brazil Expected to Generate Revenue Streams for Prominent Players?

Prominent zika virus testing players are expected to find credible opportunities across the Brazilian market, given the fact it was the epicenter of the initial epidemic outbreak. The outbreak was first documented by the discovery of fetal microcephaly across northeastern Brazil in 2015. In view of the harmful consequence of microcephaly, in November 2015 the Ministry of Health declared a Public Health Emergency of National Concern.

To combat this menace, the Brazilian government introduced a massive nationwide operation to eliminate potential mosquito breeding sites and to educate the public about its role in combating spread of the disease. In the initial stages, health worker or members of the armed forces visited over 20 million homes, representing almost 30% of all the country’s private residences. Such unceasing efforts led to a nationwide improvement in the eradication efforts of the virus.

Presently, Brazilian authorities have taken crucial measures in a transparent and timely manner in line with the International Health Regulations, a legal instrument which is binding for all World Health Organization member states, for which the country has invested in purchasing essential materials such as laboratory reagents, insecticides and diagnostic kits. Moreover, the WHO is also assisting Brazil in strengthening integrated management of disease-carrying organisms in public health, including upscaling use of larvicides to inhibit breeding of the Aedes mosquitos, the main vectors responsible for the virus’ transmission.

How did Puerto Rico Generate High Ground for Zika Virus Testing?

According to the Centers for Disease Control and Prevention (CDC), zika virus is a major factor for microcephaly and other severe birth defects in babies born to women infected with the virus. Women living in Puerto Rico are especially at high risk of zika virus exposure due to local mosquito-borne transmission.

Beginning in 2016, healthcare providers in Puerto Rico were under administrative orders to provide counseling on zika virus risk-reduction strategies, assess patients for possible zika virus exposure during prenatal care visits and conduct prenatal testing for Zika virus. Additionally, the Puerto Rico Department of Health (PRDH) and the CDC worked together to conduct a population-based survey of women who gave birth to a live infant from August to December 2016.

The Pregnancy Risk Assessment Monitoring System - Zika Postpartum Emergency Response (PRAMS-ZPER) survey asked mothers about their use of recommended measures to prevent zika virus infection and their interactions with healthcare providers during their pregnancy. Most respondents replied that they received prenatal care in the 1st trimester (91%), while more than seven out of ten considered their healthcare provider to be the best source of information about the virus. Hence, regular diagnostic tests are administered to them to periodically check for any infections.

What are the Major Zika Virus Testing Guidelines in the UK?

According to Public Health England (PHE), testing for zika virus is available only through the Rare and Imported Pathogens Laboratory (RIPL) at PHE Porton. RIPL provides medical and laboratory specialist services to the National Health Service and other healthcare providers, covering advice and diagnosis of a wide range of unusual bacterial and viral infections, including zika virus infection.

As per UK law, zika virus infection is not a notifiable disease. Therefore, there is no statutory requirement to test for this infection if the result are expected to have a negligible impact on clinical management. Presently, testing services are inaccessible for asymptomatic individuals, including pregnant women, male travelers and couples who are attempting to conceive. Couples planning conception should be strongly advised to follow PHE guidance and delay conception for 3 months after return from a country or area with risk for zika, rather than pay for private zika tests that may not be fully validated for testing people who don’t have symptoms.   

With regard to investigating patients with previously suspected infection cases, clinicians can undertake testing for any patient who has had a rash illness or other symptoms suggestive of zika virus infection within 2 weeks of leaving any country suspected of having an outbreak. In such a case, patients have to submit serum or urine samples with an appropriate request form. Additionally, semen samples may also be tested in case of conceiving parents.

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Category-wise Insights

Why are ELISA based Tests Most Preferred?

By test type, ELISA-based zika virus testing is the most preferred, surpassing US$ 4 billion until 2020. ELISA tests are highly relied upon due to its high specificity and sensitivity. Additionally, they offer greater accuracy compared to other techniques such as radioimmunoassay (RIA) tests. Moreover, it does not require radioisotopes or costly radiation counters.

Simultaneously, demand for IgG/IgM testing is anticipated to remain equally strong, reaching US$ 26 million in valuation as of 2020. These tests have exhibited promising results due to minimal sample requirement and complications associated with their usage. These tests help in simultaneous detection and differentiation of the zika virus in human serum and plasma.

Demand for Testing Kits to Remain High across Commercial Laboratories?

By end-user, zika virus testing is likely to be extensively carried out by private commercial laboratories. Private laboratories often have more resources at their disposal, including finances for initiating new clinical trials, affordability of sophisticated lab equipment, and enhanced specimen storage capacities among other benefits. Prominent private commercial laboratories offering zika virus testing include Labcorp and ARUP Laboratories among others.

At the same time, government/publicly funded testing programs have experienced a significant incline. For example, in 2016, the US Congress allocated US$ 1.1 billion in supplemental funding to combat the zika virus to the Department of Health and Human Services (HHS), out of which US$ 394 million was allocated to CDC, US$ 152 million to NIH and US$ 387 million towards the public health and emergency fund.

Competitive Landscape

Prominent zika virus testing players are majorly emphasizing on incorporating advanced testing approaches to provide faster turn-around times and quicker results. This helps clinicians suggest the appropriate treatment approach to infected patients. They also rely on strategic collaborations with various institutions and companies to widen their market presence.

EUROIMMUN US is a prominent zika virus test provider, offering the anti-zika virus ELISA and indirect immunofluorescence test (IFA) formats which allows for detection of specific antibodies (IgM and IgG) in the blood of those who may be infected. In 2017, the company entered an optional agreement with Roche Diagnostics in which the latter gained access to intellectual property in zika virus immunodiagnostics assigned to EUROIMMUN.

Similarly, Creative Diagnostics offers the Recombinant Zika Virus Envelope protein test which contains Histidine tags. The protein reacts with both IgG and IgM to provide the desired result. Its purity score ranks above 85%, available in 1 mg vials. It also offers the Recombinant Zika Virus NS1 protein test.

Recently, in April 2021, Luminex Corporation has signed and acquisition agreement with DiaSorin S.p.A. wherein the latter has agreed to acquire the former. Luminex believes that this transaction will generate significant opportunities for both companies to gain access to broader assay portfolios, enhanced research tools and expanded support services. This collaboration will also drive new partnerships in the biopharmaceutical, academic and clinical spaces.

As per FMI’s analysis, the following players operate within the global zika virus testing market:

• EUROIMMUN US Inc.
• Creative Diagnostics
• Quest Diagnostics
• Artron Laboratories Inc.
• RapiGEN Inc.
• GenBody Inc.
• JAJ International Inc.
• LumiQuick Diagnostics Inc.
• Biocan Diagnostics Inc.
• NECTAR LIFESCIENCES LTD.
• Luminex Corporation
• ARUP Laboratories
• Abbott Molecular Inc.
• Hologic
• Vela Diagnostics

*This list is indicative - full details about prominent zika virus testing manufacturers is available upon request

Zika Virus Testing Market - Report Scope

Key questions answered in the report

• How will the zika virus testing market expand in the long-run?

  The global zika virus testing market is set to register credible gains through 2021 and beyond, registering a multi-billion dollar valuation amid extensive research and development to incorporate highly advanced diagnostic approaches which will help in timely detection and diagnosis of the virus

• Which region is likely to emerge as the most lucrative zika virus testing hub?

  As per FMI’s report, bulk of all zika virus testing is expected to occur across the tropical regions of the world, such as the Asian sub-continent, Caribbean and Central America respectively

• Which is the most prominent zika virus testing treatment approach by test type?

  ELISA based zika virus testing treatment will likely remain the most preferred approach in forthcoming years due to its immense promises in terms of higher accuracy and efficacy

• Which prominent players operate within the zika virus testing landscape?

  EUROIMMUN US Inc., Creative Diagnostics, Quest Diagnostics, Artron Laboratories Inc., RapiGEN Inc., GenBody Inc., JAJ International Inc., LumiQuick Diagnostics Inc., Biocan Diagnostics Inc., NECTAR LIFESCIENCES LTD., Luminex Corporation, ARUP Laboratories, Abbott Molecular Inc., Hologic and Vela Diagnostics are some prominent regenerative medicine players profiled by FMI’s report

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  Yes, the report has been compiled by expert analysts of Future Market Insights, through a combination of primary and secondary research. To know more about how the research was conducted, you can speak to a research analyst.

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Key Segments Covered

Test Type

• Rapid IgG/IgM Test
• ELISA Test

End-User

• Hospitals & Clinics
• Private Commercial Laboratories
• Government/Publicly Funded Programs

Region

• North America & Europe (US, UK, Germany, Spain, France, Italy and Rest of Europe)
• Latin America (Brazil, Mexico, Colombia  and Rest of LATAM)
• Central America (Costa Rica, Nicaragua, Guatemala and Rest of Central America)
• Caribbean (Puerto Rico and Rest of the Caribbean)
• South East Asia (Thailand, Singapore, Vietnam and Rest of South East Asia)
• Rest of the World (North Africa and South Africa)