Monkeypox Testing Market Size & Share Analysis - Growth Trends and Forecast (2026 - 2031)

Global Monkeypox Testing Market Trends and Insights

Expansion of PCR-Based Test Approvals Across Private Reference Labs

Private reference laboratories now process a growing share of monkeypox specimens as streamlined FDA EUAs and WHO listings shrink regulatory hurdles. Quest Diagnostics received nationwide clearance in November 2024, enabling centralized throughput across coastal hubs^{[1]U.S. Food and Drug Administration, “FDA Authorizes First Home Collection Kit for Monkeypox Testing,” fda.gov}. Labcorp scaled from 500 to 25,000 weekly tests after its April 2024 home-collection EUA, leveraging COVID-era logistics. Cepheid’s Xpert Mpox gained WHO listing in October 2024, allowing procurement by UNICEF and the Global Fund. Price dispersion—USD 75 in U.S. insurance versus USD 12 in donor programs—pushes labs to juggle premium and budget kits, complicating inventory planning.

Funding Surges for Orthopoxvirus Surveillance in G-7 Public-Health Budgets

Aggregate allocations of roughly USD 450 million between 2024 and 2026 triple pre-2022 baselines, with the U.S. committing USD 180 million for diagnostics and stockpiles. The Pandemic Fund added USD 129 million for ten African and Asian labs, and the EU earmarked EUR 9.4 million to bolster Africa CDC networks. Multi-year contracts emerging from these budgets encourage manufacturers to open regional distribution hubs and invest in local cold-chain nodes.

WHO Target Product Profiles Accelerating POC Kit Development

Revised 2024 profiles require 60-minute time-to-result, ambient stability, and ≥95% sensitivity at 1 000 copies/mL. Start-ups respond with 15-minute recombinase polymerase amplification lateral-flow formats achieving 95.47% sensitivity. Dragonfly’s 1.2 kg battery unit removes thermocycler needs, fitting outreach clinics. Despite progress, WHO still advises against pure antigen devices after Congo trials showed ≤15.8% sensitivity.

Vendor Race to Multiplex Assays Bundling Mpox + HSV + VZV

QIAGEN’s Viral Vesicle panel runs on GeneXpert, detecting four viruses in 90 minutes and letting emergency rooms rule out alternatives without batching. A 2024 study showed multiplex serology improved diagnostic accuracy by 18 percentage points relative to sequential testing. Roche leverages its cobas 6800/8800 installed base to add mpox with minimal new capital, illustrating the reagent-lock model.

Post-Outbreak Demand Volatility Hurting Capacity-Planning ROI

The Democratic Republic of Congo tested only 37% of suspected cases in 2024 versus an 80% target, showing how stockpiled reagents can idle once incidence falls^{[2]Africa Centres for Disease Control and Prevention, “Unified Mpox Surveillance Protocol,” africacdc.org}. Labcorp’s utilization dropped below 10% three months after its April 2024 EUA despite 25 000-test capacity. Laboratories therefore prefer multiplex PCR or HSV bundles that backfill volume when mpox ebbs.

High Validation Costs for Clade-Specific Primers Under Evolving FDA EUA

A 2024 medRxiv preprint linked primer mismatches to missed positives in California and South Kivu isolates, prompting redesign expenses exceeding USD 500 000 per EUA filing^{[3]medRxiv, “Diagnostic Failures Due to Genomic Deletions in Monkeypox Virus,” medrxiv.org}. Smaller firms lacking bioinformatics teams face barriers, reinforcing scale advantages for Abbott and Roche.

Segment Analysis

By Test Type: Molecular Precision Anchors Market, Isothermal Platforms Gain Share

PCR assays held 48.55% of monkeypox testing market share in 2025 on the strength of eight FDA-cleared platforms and WHO listings that guarantee global procurement. Lateral-flow categories, boosted by emerging isothermal hybrids, are forecast for an 8.25% CAGR to 2031, the fastest among modalities. The recombinase polymerase amplification lateral-flow device serves as a bridge, reaching PCR-level sensitivity in 15 minutes. Serology remains niche due to vaccinia cross-reactivity, while CRISPR prototypes promise single-nucleotide differentiation but remain pre-commercial.

Growing adoption of multiplex viral rash panels further entrenches molecular platforms. Vendors with large analyzer fleets benefit from reagent lock-in, whereas open-platform entrants court volume by undercutting cartridge prices. As WHO Target Product Profiles emphasize 60-minute turnaround and ambient stability, isothermal formats should capture incremental share from centralized PCR without displacing it entirely, supporting steady expansion of the monkeypox testing market.

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

By End User: Diagnostic Laboratories Scale Fastest, Hospitals Retain Volume Share

Hospitals and clinics generated 36.53% of 2025 revenue, propelled by immediate patient access and bundled reimbursement. Diagnostic laboratories are on pace for a 9.55% CAGR through 2031, reflecting surge contracts during outbreaks and their use of broad test menus to preserve utilization. Public-health labs contribute vital genomic surveillance yet face budget ceilings, while research institutions remain small buyers focused on assay validation.

Home and community point-of-care testing will advance as Dragonfly-type devices win approvals, but centralized labs retain advantages during high-volume waves. Digital connectivity APIs that auto-report results into national databases strengthen the value proposition of reference labs that can integrate seamlessly, reinforcing their role within the monkeypox testing industry.

By Sample Type: Lesion Swabs Dominate, Respiratory Specimens Gain Traction

Lesion swabs delivered 54.23% of volume in 2025 due to viral loads 256-fold higher than respiratory sites, yielding earlier detection. Collection protocols mandate synthetic swabs to avoid inhibitors, with dual sampling from multiple lesions for redundancy. Oropharyngeal swabs should post a 9.85% CAGR, driven by asymptomatic contact tracing in Southeast Asia.

Scab material, although stable at room temperature for 30 days, suffers lower sensitivity late in the disease course. Blood and serum support seroprevalence studies but offer limited diagnostic utility. Vendors optimizing sample kits that pair lesion and throat swabs and include nucleic-acid stabilizers can improve result reliability, supporting the broader monkeypox testing market.

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

Geography Analysis

North America led revenue with a 39.55% stake in 2025 as FDA EUAs accelerated eight molecular launches and insurers reimbursed USD 75–150 per test. The United States sequenced 11% of confirmed cases, integrating diagnostics with genomic surveillance. Canada follows similar patterns, while Mexico blends public reference capacity with private outsourcing.

Asia-Pacific will expand at a 10.51% CAGR, the quickest globally, propelled by India’s Priority 2 designation for mpox and growing sequencing networks across ASEAN. Median genomic turnaround still sits at 18 days, signaling infrastructure gaps yet to be bridged. The region benefits from domestic cartridge production that lowers landed costs and from donor funds that smooth procurement cycles.

European demand stabilizes as outbreaks wane, though Spain’s cumulative 7,520 cases sustain baseline testing. EU4Health financing directs surplus capacity toward Africa CDC labs, diffusing European kit volumes into Sub-Saharan Africa. The Middle East showcases contrasting readiness: Saudi Arabia mandates 24-hour digital reporting while infrastructure-constrained neighbors depend on donor kits. Latin America’s need remains high after Brazil recorded 11,000 plus infections, but inconsistent reimbursement slows uptake. These contrasts shape a patchwork of opportunity for players in the monkeypox testing market.