Hepatitis E Diagnostic Tests Market Size & Share Analysis - Growth Trends and Forecast (2026 - 2031)

Global Hepatitis E Diagnostic Tests Market Trends and Insights

Rising Incidence of HEV Outbreaks in Endemic Regions

Waterborne outbreaks in refugee camps across Chad and Namibia shifted sporadic testing to year-round procurement of rapid IgM strips, with more than 5,000 confirmed cases reported between 2024 and 2025 alone^{[2]World Health Organization, “WHO Essential Diagnostics List 2023,” WHO.INT}. Monsoon flooding in India’s Bihar and Odisha states produced localized surges that overwhelmed municipal laboratories, prompting emergency tenders for shelf-stable diagnostics that do not require electricity or refrigeration. The World Health Organization’s 2023 Essential Diagnostics List now prequalifies rapid HEV assays from Wantai and MP Diagnostics, validating field performance above 82% sensitivity and near-perfect specificity. Manufacturers capable of delivering single-use cartridges in fewer than 15 minutes have captured most outbreak-response budgets, narrowing opportunities for batch-processed ELISA kits in low-resource settings. The trend is expected to keep first-line testing focused on lateral-flow strips, while confirmatory workloads shift to regional hubs equipped with NAT instruments.

Growing Blood-Safety Screening Mandates in Europe

The European Union’s Regulation 2024/1938 now obliges blood establishments to validate assays against WHO International Standards covering HEV genotypes 1-4^{[3]European Commission, “Regulation (EU) 2024/1938 on Substances of Human Origin,” EUR-LEX.EUROPA.EU}. The United Kingdom, France, and Spain already run universal donor screening; Germany and Poland are piloting selective protocols for high-risk recipients. Roche’s Elecsys and Grifols’ Procleix systems dominate these high-throughput environments by delivering multiplex results in 18 minutes or less and reducing false-positive callbacks^{[4]Roche Diagnostics, “Elecsys Anti-HEV IgM and IgG Assays,” ROCHE.COM}. Compliance costs are likely to push smaller regional blood banks toward outsourcing NAT or joining consortia that share analyzer capacity. Consequently, the Hepatitis E Diagnostic Tests market is expected to see sustained instrument placements through 2028, even as per-test margins tighten under bulk-purchase contracts.

Technological Advances in Molecular Diagnostics

Pocket-sized analyzers are shrinking the infrastructure gap between ELISA and PCR. Northwestern University’s DASH prototype delivered a 15-minute HEV PCR using microfluidics and smartphone readout in December 2025. The FDA’s June 2024 clearance of Cepheid’s Xpert HCV set a predicate for point-of-care viral-load approvals, encouraging similar submissions for HEV. Digital droplet PCR and RT-LAMP are being adopted for wastewater monitoring, enabling municipalities to forecast spikes days before clinical presentation. Vendors that integrate extraction, amplification, and detection into sealed cartridges can sidestep the skilled-technician bottleneck that constrains NAT penetration in district hospitals.

Adoption of HEV Testing in Xenotransplantation Research

Vertical transmission studies in swine herds showed persistent HEV RNA in newborn piglets, forcing academic transplant programs to schedule serial NAT screens across breeding colonies. The FDA’s draft xenotransplantation guidance and similar European frameworks require validated, genotype-specific assays for donor animals, leading niche laboratories to pay premium list prices. Although test volumes are modest, per-sample revenues are 5 to 8 times higher than in routine clinical diagnostics, creating a profitable niche for assay makers with R&D bandwidth to customize panels.

Low Awareness and Under-Reporting in Endemic Areas

In many endemic nations, clinicians still default to hepatitis A presumptions when confronted with acute jaundice, leading to test rates that capture fewer than 20% of suspected HEV cases during outbreaks. The absence of compulsory HEV case reporting disrupts data feedback loops that might otherwise justify budget lines for diagnostics. Until national medical curricula differentiate HEV genotypes and transmission routes, test-volume growth will trail true disease incidence, trimming roughly 0.7 percentage points off the forecast CAGR.

Price Sensitivity and Limited Reimbursement

Aetna’s 2024 bulletin limits HEV PCR reimbursement to antibody-positive patients, excludes routine prenatal or transplant screening, and forces U.S. labs to bill under generic viral-load codes, which are often denied. In LMICs, a USD 10 ELISA outprices the daily earnings of many at-risk households, and public budgets prioritize HIV, malaria, and tuberculosis diagnostics. Manufacturers face tightening margins as they juggle high-price, low-volume molecular sales in high-income markets against commodity-priced rapid-test tenders.

Segment Analysis

By Test Type: Molecular Assays Gain Ground Despite ELISA Dominance

ELISA continued to account for 43.55% of the Hepatitis E Diagnostic Tests market revenue in 2025, supported by hospital laboratories that batch-process high sample volumes at low variable costs. Roche’s Elecsys Anti-HEV IgM delivers 18-minute results on an installed base of more than 8,000 cobas analyzers worldwide, giving incumbent suppliers substantial channel reach. Grifols’ Procleix NAT assay is expanding its presence in blood centers, and its ability to detect HEV RNA alongside HIV, HBV, and HCV is accelerating multiplex uptake at an 8.25% CAGR. Rapid lateral-flow kits remain indispensable for outbreak response: Wantai’s WHO-listed strip produces a visual readout in 15 minutes and retails near USD 1.50 for bulk orders.

Pressure is mounting for ELISA manufacturers to innovate. Digital ELISA platforms that amplify signals via nanoparticle conjugates promise a four-fold increase in sensitivity, enabling earlier detection after exposure; however, capital costs near USD 200,000 per analyzer limit uptake to tertiary centers. The Hepatitis E Diagnostic Tests industry is therefore bifurcating: molecular vendors chase high-margin transfusion accounts, while lateral-flow specialists compete on cost and shelf life for humanitarian tenders. The “Others” category—Western blot confirmation and RUO genotyping kits—retains relevance in reference virology laboratories but commands less than 5% of the value pool

Note: Segment shares of all individual segments available upon report purchase

By Sample Type: Stool Testing Emerges as Fastest-Growing Segment

Serum and plasma accounted for 70.53% of the Hepatitis E Diagnostic Tests market in 2025, aligning with standard acute hepatitis workflows. ELISA and chemiluminescence assays integrate seamlessly into existing serum analyzers, keeping variable cost per test below USD 5 in high-volume settings. Stool testing is the fastest-growing segment, expanding at 9.85% CAGR as municipalities add HEV RNA to wastewater dashboards that already track poliovirus and norovirus. Food-safety laboratories are also embracing fecal-matrix PCR to certify pork and shellfish batches under tightened EU and USDA guidelines.

Advances in nucleic-acid stabilization media now allow stool samples to remain analyzable for up to 72 hours at ambient temperature, a game-changer for rural clinics without cold-chain infrastructure. The Hepatitis E Diagnostic Tests market, therefore, stands to benefit from cross-sector demand, as environmental programs procure the same extraction cartridges used in clinical virology. Saliva and urine remain investigational matrices, but early data suggest sensitivity comparable to serum within the first week of symptom onset, hinting at future self-collection kits for telehealth workflows.

By End User: Blood Banks Accelerate Adoption Amid Transfusion-Safety Mandates

Hospitals and clinics remained the top revenue generators, with a 45.23% share in 2025, leaning heavily on batch ELISA formats that exploit existing immunochemistry automation. However, blood banks and transfusion centers exhibited the fastest trajectory, marching at an 8.55% CAGR as jurisdictions from Japan to Ireland enforce universal NAT screening. The shift obliges centers to install high-throughput analyzers and secure stable reagent pipelines, favoring multinational vendors that can bundle service contracts and integrate LIMS remotely.

Diagnostic reference laboratories occupy a resilient mid-tier, capturing send-out testing that smaller hospitals cannot perform in-house. ARUP and Mayo Clinic Laboratories manage complex genotyping and viral-load quantification, tapping into transplant-recipient and chronic-infection niches. Environmental and food-testing labs form the “Other End Users” bucket, a small but growing cohort spurred by European Food Safety Authority mandates to certify pork supply chains against HEV contamination. 

Note: Segment shares of all individual segments available upon report purchase

Geography Analysis

Asia-Pacific retained leadership with 38.13% of global revenues in 2025, propelled by China’s extensive ELISA base and Japan’s universal donor NAT screening. Wantai’s WHO-prequalified kits dominate governmental procurements, while BGI Genomics leverages NGS panels to win contracts at provincial CDCs. India’s endemic burden is high but underdiagnosed; fewer than 20% of suspected acute hepatitis cases received HEV serology in 2025, signaling latent demand once awareness programs mature.

Europe ranked second, underpinned by the United Kingdom's blood services that detect approximately 1 HEV-positive unit per 10,000 donations. The new Regulation 2024/1938 raises assay-validation costs, but harmonizes NAT quality across member states, fostering a predictable reimbursement climate. Germany and France apply selective donor screening, focusing on immunocompromised recipients, while Spain and Ireland run universal programs.

The Middle East and Africa segment is the growth engine, forecasting a 10.81% CAGR through 2031 as refugee-camp outbreaks compel Ministries of Health to stockpile rapid strips. South Africa’s National Health Laboratory Service is upgrading provincial PCR capacity in response to urban clusters linked to informal settlements. Gulf Cooperation Council states report imported genotype-1 cases among expatriate workers, leading private hospitals to adopt multiplex travel panels.

North America remains smaller, as the United States lacks universal donor screening and HEV incidence stays low outside genotype-3 zoonotic exposures in pork consumers. Canada is reviewing cost-benefit scenarios for selective screening of immunosuppressed patients, but no mandates exist yet. Latin America sees episodic activity; Brazil’s health authorities deploy HEV IgM strips during flood-related outbreaks, while Argentina integrates HEV PCR into sentinel surveillance at abattoirs.