Zika Virus Testing Market

Zika Virus Testing Market Outlook (2023 to 2033)

FMI forecasts the global Zika virus testing market is likely to grow from US$ 4.9 million in 2023 to US$ 6.8 million by 2033. During this forecast period, the market is expected to exhibit a CAGR of 3.4%. The key reason fueling the growing consumption of Zika virus testing over the projection period is the growing incidence of Zika virus infection.

Since the dawn of the 21st century, the global healthcare community has been wrestling with countless epidemic outbreaks. This has significantly stretched existing infrastructure capabilities. Amongst all the epidemics faced today, viral infections have acquired the topmost position like Severe Acute Respiratory Syndrome (SARS), Chikungunya, Swine Flu, and Zika Virus.

Demand for testing for Zika virus infections is growing by several important variables like the increased emergency authorization of POCT testing. The quick technological improvements and enhanced R&D in the domain of Zika virus RNA therapy are propelling the Zika virus therapeutics market.

Fortunately, numerous technological advances in diagnostic methods for Zika virus infection have enabled the healthcare industry to develop effective diagnostics and treatments. This leads to the introduction of highly advanced testing mechanisms. 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 testing for the Zika virus.

Technological Advancements are Creating Massive Opportunities for the Market Players

Healthcare providers are increasingly leaning towards ELISA and IgG/IgA whole-blood testing for the diagnosis of acute Zika virus mechanisms. The major reason behind this is their high throughput rates and enhanced accuracy degree. Prominent Zika virus testing players seek to leverage collaborations with government agencies and private laboratories to accelerate their research and development prospects.

The Zika virus testing market is being driven by the availability of serology kits for the qualitative diagnosis of infection. Its purpose is to detect the presence of IgM antibodies created by the body's natural immune system after exposure to the Zika virus. It is commonly used for Zika diagnostic testing in the US. During the projected period, these elements are likely to boost the Zika virus (ZIKV) diagnostics market.

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. They are offering the Aptima® Zika Virus Assay and the ZIKV DetectTM IgM Capture ELISA. These were authorized for emergency use initially. Such developments are further widening growth prospects in the future.

How do the Historical Projections and Future Outlook Compare?

According to Future Market Insights, the Zika virus testing market experienced slow-paced growth, registering a CAGR of over 2.7% until 2022. Key factors driving the market expansion are the intervention of national governments and international organizations like UNICEF in low-income developing regions. Additionally, the 2016 Zika virus epidemic has greatly aided the Zika virus testing market growth.

The market surpassed US$ 4.7 million in value as government initiatives to contain the virus’s spread resulted in massive awareness campaigns. This has accelerated the Zika virus (ZIKV) diagnostics market. Governmental and non-governmental efforts are unceasing in terms of discovering possible new breakthroughs in the future.

Short Term (2023 to 2026): As the intensity of the epidemic has waned, the incidence of testing has significantly dwindled. The development of the market is likely to be aided by elements like the scientific developments in Zika virus testing.

Medium Term (2026 to 2029): Diagnostic testing is expected to enter a new phase with the advent of constant viral pandemics and epidemic outbreaks. This is prompting clinicians and healthcare stakeholders to introduce highly advanced and precise testing solutions to ward off such threats.

Long Term (2029 to 2033): Infection with the Zika virus (ZIKV) is well recognized to be widespread throughout Southeast Asia and Africa. To lessen the morality, these nations are likely to improve their testing infrastructure for mosquito-borne public health problems.

The ever-exploding frequencies of viral epidemics have put the global healthcare fraternity at the cusp of significant technological revolutions. This has boded well for the market for Zika virus tests. On the back of these factors, sales in the Zika virus testing market are likely to increase reaching a valuation of US$ 4.9 million in 2023 and US$ 6.8 million by 2033.

Sabyasachi Ghosh

Principal Consultant

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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 the 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 for Zika virus 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 the 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 the uptake of various serological tests amid growing concerns of the epidemic’s spread by virtue of people frequenting tropical regions for tourism.

Regional Share in Zika Virus Testing Market

FMI has taken into account the epidemiological profiles of each nation to analyze the differential algorithm for the Zika virus diagnosis. The Zika virus testing market in North America held the biggest market share in 2022. It is anticipated to expand at a significant CAGR throughout the assessment period to hold its dominance.

According to statistics from the WHO updated in February 2022, Zika transmission continues in a number of countries but has been most prevalent at low levels from 2018 to the present. An outbreak in developed and developing nations resulted from the subsequent viral transmission over the Asia Pacific region. Massive Zika virus breakouts have also occurred in Latin American and Asia-Pacific nations.

Top Countries Driving Zika Virus Testing Market Growth

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

Presently, as of 2021, there have been no documented instances of local zika virus transmission across the USA. 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 over the past few years. For instance, in May 2019, the Food & Drug Administration authorized the 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, the scope of the US Zika virus testing market is increasing manifold.

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 in 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.

Why is the Mexico Zika Virus Testing Market Measured as Money-spinning?

An infected Aedes species mosquito is the main vector for the propagation of the Zika virus. Pregnancy-related contaminations lead to several birth idiosyncrasies. Prior to 2015, the Pan American Health Organization (PAHO) issued a warning about the first confirmed Zika virus infections in Brazil. Zika was previously found in Africa, Southeast Asia, and the Pacific Islands. Since then, the Zika virus has been found in several nations and areas of the Caribbean, Central America, South America, and 26 out of 32 states in Mexico.

Mexico confirmed 35 cases of the Zika virus infection in 2021, an increase from the 20 cases that were recorded in 2020. 2016 has more than 8,000 instances of Zika infections in North American nations. USA citizens, especially those of Mexican descent, travel to Mexico more often than any other country. This makes Zika preventative outreach and information a crucial aspect of the domestic approach. The expansion of blood donation screening utilizing individual donor NAAT tests to stop the spread of diseases linked to transfusions.

The Instituto Mexicano del Seguro Social conducted Zika virus test for around 80% of expectant Mexican women with potential Zika virus infection. The institute found the virus in about 27.8% of the women it tests. Hence, players are likely to find opportunities when it comes to testing for Zika virus infections in Mexico. The risk of Zika virus outbreak is very high in this country.

What is the Algorithm for Zika Virus Diagnosis in the Thailand Market?

Over the forecast period, the Asia-Pacific region is likely to hold a major share of the market. The major reason behind this is the rising prevalence of ZIKV in the nations, particularly in Thailand.

Growing infectious research and government measures to improve the healthcare system is very high in Thailand. Besides, increased awareness of the Zika virus and the advantages of early identification, as rising Research and Development (R&D) spending, are contributing to global revenue.

Since 2012, Thailand has documented ZIKV infections. According to a 2017 survey, approximately 70% of Thai people have ZIKV-neutralizing antibodies. Antibodies against mosquito-borne Flaviviridae can cross-react with Togaviridae viruses, according to a study of febrile patients in Thailand.

Five cases of the Zika virus infection have been recorded by medical professionals in the United Kingdom, Germany, and Israel. These are the individuals who visited Thailand between March 16 and June 2, 2022. These tourists had visited several places in Thailand which implies that the Zika virus is still being disseminated widely in the country.

What is the Development Status quo for Zika Virus Testing Market in Columbia?

65,726 instances of ZIKV have been recorded in Colombia in 2016, and 2485 (4%) of those cases had been verified. Overall, female patients had a reported incidence of ZIKV that was twice as high as male patients' in Colombia.

According to evaluations of Zika-affected women in Colombia, the infection is particularly harmful to women and is deeply connected to poverty. Another study found that mothers of children with congenital Zika disease felt guilty and had to bear uneven levels of childcare.

Is Brazil Expected to Generate Revenue Streams for Prominent Players?

Prominent zika virus testing players are expected to find credible opportunities across the Brazilian Zika virus testing 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 the spread of the disease. In the initial stages, health workers 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 that 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 the integrated management of disease-carrying organisms in public health, including upscaling the use of larvicides to inhibit the breeding of the Aedes mosquitos, the main vectors responsible for the virus’ transmission.

What are the Major Zika Virus Testing Guidelines in the United Kingdom?

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 the United Kingdom law, zika virus infection is not a notifiable disease. Therefore, there is no statutory requirement to test for this infection if the result is 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.

Zika Virus Testing Market Segment

Why are ELISA-based Tests Most Preferred?

By test type, ELISA-based zika virus testing is the most preferred, surpassing US$ 4 billion by 2020. ELISA tests are highly relied upon due to their 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 requirements and complications associated with their usage. These tests help in the simultaneous detection and differentiation of the zika virus in human serum and plasma.

Demand for Testing Kits to Remain High across Hospitals and Clinics?

By end-user, zika virus testing is likely to be extensively carried out by hospitals and clinics. Hospitals 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.

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.

Why are the Developments by Startups Highly in demand?

Keeping in mind the endemic of Zika virus, startups are making several developments in their testing kits and tools. They are integrating latest technological and clinical advancements in their products. They are also collecting additional funds and investing them in their research and developments.

LSK Technologies - Canada

Seray içek and Yuxiu (Livia) Guo, both graduates of the University of Toronto, formed LSK Technologies Inc. (LSK) alongside Professor Keith Pardee. They created their portable testing tools called PLUM to assist overburdened healthcare systems in isolated Latin American towns. It is going to help them to deal with the Zika virus threat.

Kineta Inc, - United States

Kineta, Inc. is a biotechnology startup. The business creates innovative immunotherapies to tackle autoimmune conditions, viral infections, and chronic pain. It has received funding to carry out more Zika virus testing on its broad spectrum innate immune antivirals. The National Institute of Allergy and Infectious Disease (NIAID) is providing this additional funds. The main aim is to assess lead wide range antivirals in preclinical models of Zika virus infection.

Market Players are Testing their Ability by Offering Advanced Testing Tools

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

EUROIMMUN USA is a prominent zika virus test provider, offering the anti-zika virus ELISA and indirect immunofluorescence test (IFA) formats which allow for the 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.

• In April 2021, Luminex Corporation has signed an acquisition agreement with DiaSorin S.p.A. wherein the latter 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. Previously, the USA FDA granted Emergency Use Authorization (EUA) to Luminex Corporation for a multiplex nucleic acid test. It was intended to identify Zika virus RNA in individuals who may be at risk of infection using their blood serum, plasma, or urine.
• In March 2022, The International Arbovirus Project was started by the World Health Organization. Initiated by the World Health Organization, the Global Arbovirus Initiative Zika, Dengue, Yellow fever, Chikungunya, and other Arboviruses are currently posing a danger to public health around the globe. By assembling a coalition of important partners, this integrated program is likely to improve the coordination, communication, capacity-building, research, readiness, and reaction required to reduce the rising risk of epidemics caused by these illnesses.

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

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