Host Response Diagnostics Markets 2027–2031

Host Response Diagnostics Markets: Market Forecast, Competitive Landscape, Technology and Policy Outlook, 2027–2031

Global forecasts by application, technology, care setting, test format and product, for 14 countries and regions, with 26 company profiles. Sepsis, bacterial vs viral and severity testing, beyond procalcitonin and routine inflammatory markers.

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Our Take

Host-response tests read the patient's immune response instead of searching for the pathogen, and they answer the question clinicians face first: whether to treat, not what to treat. In 2026 the field became a market, with at least eight FDA-cleared or authorised products, its own billing codes and a Medicare add-on payment. It grows from $180.0 million in 2026 to $720.0 million in 2031, at 32.0% a year, as the same signatures move onto core-laboratory analysers, near-patient cartridges and fingerstick readers.

Market Size 2026: USD $180M Market Size 2031: USD $720M CAGR: 32.0%

Situation Analysis: what is really happening

• The test leaves the emergency department. Beckman Coulter's Access MeMed BV won a CE mark under the IVDR in April 2026, putting a bacterial versus viral test on core-laboratory analysers.
• Point-of-care arrives. Lumos Diagnostics' FebriDx fingerstick test received a CLIA waiver and was live at 265 US sites by October; MeMed's BV Flex fingerstick test gained Breakthrough Device designation.
• Payment is in place. MeMed BV, IntelliSep and TriVerity carry their own billing codes, paid at $260.50, $444.08 and $760.00 under the 2026 Medicare fee schedule, and TriVerity earns a new-technology add-on payment of up to $243.75 per case.
• Gene expression takes the lead. Host Gene Expression grows 36.8% a year and overtakes Host Protein Signatures in 2029; Near-Patient Cartridges add $350.1 million by 2031.
• The guidelines lag the market. The 2026 Surviving Sepsis Campaign guidelines found the evidence for novel host-response tests insufficient, so outcome studies decide who wins.
• Government money matters. Prenosis paired a $20 million Series A with a $20 million BARDA contract, and the US Department of Defense sought host-based diagnostics for acute infection.

Company Analysis: who is positioned, who is exposed

• Inflammatix, Cytovale, MeMed and Immunexpress: Leaders with FDA-cleared sepsis and bacterial versus viral tests.
• Beckman Coulter, DiaSorin, Roche, Cepheid and Biocartis: Platform partners that put host-response tests on installed analysers and cartridge systems.
• bioMérieux and Thermo Fisher: Incumbents whose procalcitonin tests are the price benchmark host-response tests must beat.
• Lumos Diagnostics, Abionic, Prenosis, SphingoTec, PHC and Bluejay Diagnostics: Point-of-care tests, AI scores and novel single markers.
• Biomeme, Presymptom Health, Asep Medical, GNOMX, Loop Diagnostics, QuantuMDx, Cytomics and Endpoint Health: Emerging developers in the US, Europe and Asia.
• Bayesian Health: AI sepsis software that competes for the same triage decision without a specimen.

In all, 26 company profiles, each one to two pages with a fact box covering website, headquarters, ownership, revenue, employees and key products.

Questions this report answers

• How large is the host-response diagnostics market, and how fast will it grow?
• Which applications grow fastest: sepsis identification, bacterial versus viral, severity and prognosis, or TB?
• Will gene-expression, protein, cellular or algorithm-based tests win, and on which test format?
• What do billing codes, add-on payments, SEP-1 and the 2026 guidelines mean for adoption?
• Which companies are best placed, and which depend on partners or new funding?
• How large is each country market, and where is growth fastest?

What's inside

• 292 pages, 23 chapters, 63 tables and 54 figures
• Forecasts for 2027–2031 from a 2026 base year, by application, technology, care setting, test format and product, for 14 countries and regions
• Sepsis identification and triage, bacterial versus viral differentiation, severity and prognosis, and technology platforms and test formats
• Care settings including military and TB triage, regulation, reimbursement and policy, international markets, and clinical evidence and health economics
• 10 market-moving developments from 2026, SWOT, Porter's Five Forces and strategic recommendations
• 26 company profiles
• Download the Table of Contents (PDF)

Who buys this report

• Diagnostic companies and business development teams: size the market, choose formats and find partners for host-response tests.
• Laboratory and health-system leaders: judge where host-response testing fits beside procalcitonin, culture and syndromic panels.
• Investors and analysts: model a young, fast-growing market and the companies that depend on new funding.
• Antimicrobial stewardship and public health programmes: plan tests that cut unnecessary antibiotics.

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ABOUT THE LEAD AUTHOR

Mr. Greg Powell, B.Sc., M.B.A., is the President of Howe Sound Research. His education includes:

Finance for Senior Executives - Harvard Business School

Market Research - Burke Institute

M.B.A. (Finance and Policy) - University of British Columbia

B.Sc. (Chemistry) - University of British Columbia

He is an experienced business and clinical professional. He is co-author of the paper "The Radioimmunoassay of Angiotensinogen by Antibody Trapping." He has worked in laboratory testing and management for over 20 years.