Global Bordetella Pertussis Test Kit Industry: ELISAs and Rapid Tests for Pertussis Laboratory Confirmation – Strategic Outlook 2026-2032

Global Leading Market Research Publisher QYResearch announces the release of its latest report “Bordetella Pertussis Test Kit – Global Market Share and Ranking, Overall Sales and Demand Forecast 2026-2032″. Based on current situation and impact historical analysis (2021-2025) and forecast calculations (2026-2032), this report provides a comprehensive analysis of the global Bordetella Pertussis Test Kit market, including market size, share, demand, industry development status, and forecasts for the next few years.

The global market for Bordetella Pertussis Test Kit was estimated to be worth US45millionin2025andisprojectedtoreachUS45millionin2025andisprojectedtoreachUS70 million by 2032, growing at a CAGR of 6.5% from 2026 to 2032. For clinical laboratory managers, infectious disease specialists, and public health epidemiologists, the core business imperative lies in utilizing Bordetella pertussis test kits that address the critical need for accurate laboratory confirmation of pertussis (whooping cough), a highly contagious respiratory disease caused by Bordetella pertussis and Bordetella parapertussis. Serological assays detect human antibodies (IgA, IgG, IgM) against Bordetella pertussis antigens (pertussis toxin (PT), filamentous hemagglutinin (FHA), pertactin (PRN), fimbriae (FIM)) in serum or plasma for diagnosis of recent infection, past infection, or vaccination response. Test formats include quantitative ELISA (enzyme-linked immunosorbent assay) and qualitative rapid immunochromatographic tests. The Bordetella pertussis IgA, IgG, and IgM test is a quantitative and qualitative immunoassay for detection of human antibodies against Bordetella pertussis and Bordetella parapertussis. Applications: medical (clinical diagnosis of pertussis in infants, children, adults with persistent cough; outbreak investigation; vaccine response monitoring), scientific research (seroepidemiology, vaccine trials, immune response studies), and others (public health surveillance). Types: diagnostic kits (CE-IVD marked, FDA cleared) and research use only (RUO) kits.

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https://www.qyresearch.com/releases/5985648/bordetella-pertussis-test-kit

The Bordetella Pertussis Test Kit market is segmented as below:
Serion Diagnostics
Medline
Igenex
GeneProof
Thermo Fisher Scientific
Everlywell
Cortez Diagnostics
Pyramid
Abcam
LetsGetChecked
Fujirebio

Segment by Type
Bordetella Pertussis Test Kit for Diagnostics
Bordetella Pertussis Test Kit for Research

Segment by Application
Medical
Scientific Research
Others

1. Market Drivers: Pertussis Resurgence, Serological Surveillance, and Vaccine Efficacy

Several powerful forces are driving the Bordetella pertussis test kit market:

Pertussis resurgence in developed countries – Despite vaccination, pertussis cases increasing (US 10,000-20,000 annually, UK, Australia). Waning immunity (acellular vaccines). Serological diagnosis (IgG anti-PT) for adolescents, adults.

Serological surveillance and outbreak response – Public health labs monitor pertussis incidence, antibody prevalence. Pertussis seroepidemiology studies using commercial kits. CDC, WHO, ECDC.

Vaccine clinical trials and immune response – New pertussis vaccines (maternal immunization, adult boosters, recombinant) require serological testing (anti-PT IgG). Research kits.

Recent market data (December 2025): According to Global Info Research analysis, diagnostic kits (CE-IVD, FDA) dominate with approximately 75% revenue share (clinical labs, hospitals, public health). Research kits 25% share (vaccine trials, academic). Medical (clinical diagnosis) largest application (70% share). Scientific research (seroepidemiology, vaccine studies) 25% share. Others 5%. North America (US CDC surge) largest market (40% share). Europe 30% share. Asia-Pacific 20% share.

2. Test Kit Types and Specifications

Type Format Antibodies Detected Antigens Quantitative Clinical Use Price (per kit) Share
Diagnostic ELISA, rapid test IgG, IgM, IgA (individual or combined) PT, FHA, PRN, FIM Yes (ELISA) Clinical diagnosis, public health US$200-500 (96T) ~75%
Research ELISA IgG, IgA (mostly PT) PT (main), FHA Yes Vaccine trials, research US$300-600 ~25%

Key specifications: Antibody isotype (IgG (current/past infection), IgM (recent infection), IgA (mucosal response)). Antigen (PT (pertussis toxin) most specific and sensitive for diagnosis). Quantitative (calibrated against WHO International Standard (IS) for pertussis antiserum (06/140, 06/142)). Cutoff values (≥100 IU/mL for acute infection, 50-100 borderline). Turnaround time (ELISA 2-4 hours, rapid test 15-20 minutes). Positive control (human serum).

Exclusive observation (Global Info Research analysis): Bordetella pertussis serology is dominated by anti-PT (pertussis toxin) IgG ELISA, most specific and reliable marker for diagnosis of pertussis in adolescents, adults (since nasopharyngeal PCR <3 weeks cough). IgA testing less sensitive. IgM unreliable. European CDC, Public Health England recommend single serum anti-PT IgG. Commercial kits: Euroimmun (not listed) market leader. Serion Diagnostics, Thermo Fisher (Oxoid), Igenex, GeneProof.

User case – adult pertussis diagnosis (December 2025): Clinical lab (US) receives serum sample from 35-year-old with persistent cough (2 weeks). Performs anti-PT IgG ELISA (Serion Diagnostics or Euroimmun). Result: 120 IU/mL (positive >100). Confirms pertussis. PCR negative (late presentation). Report to local health department.

User case – serosurveillance (January 2026): Public health lab (Europe) conducts population serosurvey for pertussis antibody prevalence (1000 samples). Anti-PT IgG ELISA (Thermo Fisher, Oxoid). Results used for vaccine policy (adult booster, maternal immunization).

3. Technical Challenges

Interpretation of single serum IgG – Distinguishing recent infection from past infection or vaccination. Paired sera (acute/convalescent) ideal but rarely collected. High anti-PT IgG (>100 IU/mL) indicative of recent infection (<12 months).

Cross-reactivity with Bordetella parapertussis – B. parapertussis causes milder illness, but anti-PT specific (PT not produced by B. parapertussis). Anti-FHA cross-reacts.

Technical difficulty – lack of standardized cutoffs: Different commercial kits use different cutoffs (IU/mL vs arbitrary units (AU)). Harmonization needed.

Technical development (October 2025): WHO established International Standard (IS) for Bordetella pertussis antiserum (NIBSC 06/140, 06/142). Kits calibrated to WHO standard enable comparison.

4. Competitive Landscape

Key players include: Serion Diagnostics (Germany – Serion ELISA classic), Medline (US – distributor), Igenex (US – Lyme, pertussis), GeneProof (Czech Republic – PCR, not serology), Thermo Fisher Scientific (US – Oxoid ELISA), Everlywell (US – DTC (Direct-to-Consumer) home test kit), Cortez Diagnostics (US), Pyramid (US – home test), Abcam (UK – antibodies, not complete kit), LetsGetChecked (US – DTC home test), Fujirebio (Japan – ELISA). Euroimmun (not listed, Germany (PerkinElmer)) market leader.

Regional dynamics: Germany (Serion Diagnostics, Euroimmun). US (Thermo Fisher, Igenex, Everlywell, LetsGetChecked). Japan (Fujirebio). DTC home kits (Everlywell, LetsGetChecked) finger prick sample, mail-in.

5. Outlook

Bordetella pertussis test kit market will grow at 6.5% CAGR to US$70 million by 2032, driven by pertussis resurgence, seroepidemiology studies, and vaccine trials. Technology trends: multiplex (IgG+IgA+IgM), point-of-care rapid test (15 minutes), and harmonization WHO standards. DTC home testing (collection kit, mail-in) emerging. Asia-Pacific growth 7-8% CAGR.


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カテゴリー: 未分類 | 投稿者huangsisi 15:31 | コメントをどうぞ

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