• The Pertussis Infection Testing Market is growing due to rising incidence of whooping cough and increased demand for accurate, timely diagnostics that improve patient outcomes and support public health monitoring.

• Polymerase Chain Reaction (PCR) and other molecular testing methods are widely adopted for pertussis diagnosis, offering high sensitivity and specificity to ensure rapid and reliable detection of Bordetella pertussis infections.

• North America is a key market, driven by advanced healthcare infrastructure, high disease awareness, and strong adoption of point-of-care testing solutions for early detection and outbreak control.

• Technological innovations, including rapid diagnostic tests and portable testing kits, are enhancing accessibility and reducing turnaround time, which is expanding use in clinics, hospitals, and remote healthcare settings.

• Government initiatives and public health campaigns focused on vaccination coverage and early detection programs are driving adoption of pertussis testing and supporting more effective disease surveillance.

• Challenges such as regulatory requirements, integration with existing healthcare systems, and the need for continuous product innovation remain, pushing companies to invest in R&D and advanced diagnostic technologies.

• Key market players are leveraging strategic partnerships, collaborations, and product innovation to expand reach, introduce new testing solutions, and enhance competitiveness in the growing pertussis diagnostics landscape.

In this report, the Pertussis Infection Testing Market has been segmented by Product Type, End User, Technology, Application and Geography.

Pertussis Infection Testing Market, Segmentation by Product Type

The market by Product Type captures the variety of diagnostic modalities used to detect Pertussis (whooping cough) infection. Available test types include Serological Tests, PCR Tests, Culture Tests, and Rapid Antigen Tests. Each test type addresses different clinical needs — from early detection to retrospective confirmation, and from high‑sensitivity diagnostics to rapid screening — affecting demand, laboratory workflows, and public‑health surveillance strategies. Variation in performance, turnaround time, and suitability for different stages of infection drives adoption patterns across regions and care settings.

• Serological Tests

  Serological tests detect antibodies against the pertussis pathogen, useful particularly when testing occurs later in the disease course or for retrospective diagnosis. They help identify past or recent infection — especially valuable in adolescents or adults where classic symptoms may be muted. Their utility supports surveillance, outbreak confirmation, and epidemiological studies, expanding the market beyond acute diagnosis.

• PCR Tests

  PCR tests (nucleic acid–based assays) offer rapid and sensitive detection of the pathogen’s genetic material, enabling early diagnosis. Because PCR does not require live bacteria, it is highly suitable shortly after symptom onset. Its speed and sensitivity make it a preferred method in many clinical settings for confirming pertussis, supporting prompt treatment and infection control measures.

• Culture Tests

  Culture tests remain the traditional “gold‑standard” diagnostic method, capable of isolating live bacteria to confirm pertussis with high specificity. Although slower and more resource‑intensive, culture enables strain identification and antimicrobial susceptibility testing, maintaining a critical role in diagnostics, especially in research and outbreak‑investigation contexts.

• Rapid Antigen Tests

  Rapid antigen tests provide the potential for quick, point‑of‑care screening through detection of pathogen antigens. While not as widely established for pertussis compared to PCR or serology, they represent a segment with growth potential — especially for initial screening, resource‑limited settings, or outbreak‑screening scenarios where speed and accessibility are critical.

Pertussis Infection Testing Market, Segmentation by End User

The End User segmentation reflects the diverse healthcare and diagnostic settings where pertussis testing is performed. Major end users include Hospitals, Diagnostic Laboratories, Clinics, and Home Care Settings. Variation in infrastructure, resource availability, and patient demographics across these settings influences adoption of different test types and technologies. End‑user segmentation helps predict where demand for rapid tests, PCR diagnostics, or retrospective serology is most likely to concentrate.

• Hospitals

  Hospitals are primary users of pertussis diagnostic tests, especially for acute cases requiring immediate diagnosis and treatment. Their laboratory infrastructure supports PCR and culture testing, and they play a key role in outbreak management and infection control protocols. High patient volume and diagnostic demand position hospitals as a major segment driving market consumption.

• Diagnostic Laboratories

  Standalone diagnostic laboratories — public or private — serve clinics, general practices, and community health centers by offering PCR, serological, and culture‑based pertussis testing. Their role is critical for enabling widespread access to diagnostics beyond hospital settings, supporting surveillance, screening, and epidemiological monitoring.

• Clinics

  Clinics, including outpatient and primary‑care centers, often rely on accessible, faster diagnostic formats such as PCR tests or rapid screening tools. For mild or early presentations of cough, clinics provide the first contact point and drive demand for convenient, cost‑effective testing solutions suitable for outpatient settings.

• Home Care Settings

  Home care settings may increasingly become relevant for pertussis testing — particularly with the growth of point‑of‑care diagnostics and rapid tests that allow sampling outside traditional facilities. This end‑user segment supports decentralized testing models, improving access in remote areas and reducing burden on hospitals and labs.

Pertussis Infection Testing Market, Segmentation by Technology

Under the Technology segmentation, the market is classified according to diagnostic methodology: Polymerase Chain Reaction (PCR), Enzyme‑Linked Immunosorbent Assay (ELISA/Serology), Nucleic Acid Amplification (beyond standard PCR), and Immunofluorescence/related methods. This axis highlights technological evolution, detection sensitivity, diagnostic turnaround, and suitability for different stages of infection. The diversity of technology routes enables testing providers and manufacturers to tailor offerings depending on clinical, epidemiological or resource‑driven needs.

• Polymerase Chain Reaction (PCR)

  PCR is widely adopted due to its high sensitivity and rapid turnaround, allowing detection of Bordetella pertussis DNA in nasopharyngeal specimens. It is especially useful in early stages of infection, facilitating timely diagnosis and initiation of treatment. PCR’s role as a core technology underpins much of current pertussis diagnostic demand globally.

• Enzyme‑Linked Immunosorbent Assay (ELISA / Serology)

  Serological assays detect antibodies generated in response to pertussis infection, offering a tool for diagnosis beyond the acute phase and for retrospective confirmation. ELISA‑based serology supports outbreak investigations, population surveillance, and diagnosis in patients presenting later after symptom onset. This technology adds depth to diagnostic strategies when PCR or culture are no longer effective.

• Nucleic Acid Amplification (non‑standard PCR)

  Advanced nucleic acid amplification methods beyond conventional PCR — including multiplex assays targeting multiple gene loci — enhance specificity and the ability to differentiate among Bordetella species. These technologies support improved diagnostic accuracy, especially in settings with co‑circulating pathogens or history of vaccination. Their adoption reflects growing demand for high‑precision diagnostic solutions.

• Immunofluorescence & Other Methods

  Immunofluorescence‑based tests or other antigen/antibody detection techniques serve as supplementary or preliminary diagnostic options, useful in settings with limited molecular diagnostics. While less sensitive or specific compared to PCR or culture, they provide additional flexibility — particularly in resource‑constrained or remote settings where rapid or low‑cost diagnostics are required.

Pertussis Infection Testing Market, Segmentation by Application

The Application segmentation captures the different use cases for pertussis testing, reflecting demographic, epidemiologic and public‑health needs. The key application segments are Pediatric Testing, Adult Testing, Outbreak Investigation, and Routine Screening. Each application influences demand for specific test types — early detection tools like PCR for acute cases, serology for retrospective confirmation, and rapid/point‑of‑care tests for mass screening — shaping market structure and growth opportunities.

• Pediatric Testing

  Testing in children is critical due to higher risk and severity of pertussis in young age groups. Pediatric testing demands sensitive, rapid diagnostics to enable early detection and reduce transmission risk. High demand in this segment supports growth of PCR and culture tests in pediatric care settings.

• Adult Testing

  Adult pertussis cases may present atypically, with milder or non‑specific symptoms, increasing the need for accurate diagnostics. Growing recognition of pertussis in adolescents and adults drives demand for serological assays and molecular diagnostics to guide diagnosis, treatment, and surveillance in older age groups.

• Outbreak Investigation

  During outbreaks — in communities, schools or care facilities — there is high demand for rapid, reliable testing to confirm cases and contain spread. This application segment favors use of PCR, multiplex nucleic acid assays, and sometimes serology for retrospective confirmation, driving institutional demand for diversified testing capabilities.

• Routine Screening

  Routine screening programs — for surveillance or epidemiological monitoring — require cost‑effective, scalable diagnostic solutions. In such contexts, serological testing or antigen/rapid tests may play a role, supporting broader population‑level surveillance and early warning systems for pertussis resurgence.

Pertussis Infection Testing Market, Segmentation by Geography

The geographic segmentation divides the global market into North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. Differential regional factors — including disease burden, public‑health surveillance infrastructure, laboratory capacity, regulatory environment and healthcare access — influence test adoption, technology preference, and market growth. Geographic analysis helps stakeholders identify priority markets for expansion, region‑specific product demand, and strategic allocation of diagnostic resources.

North America

North America is a mature market for pertussis infection testing, characterized by well‑established public‑health surveillance systems, broad laboratory capacity, and widespread use of advanced diagnostics such as PCR and multiplex nucleic acid assays. High awareness of pertussis, strong regulatory frameworks, and investment in diagnostic infrastructure support consistent demand across hospitals, diagnostic labs, and outpatient settings. This region often leads in adopting novel testing technologies and plays a central role in outbreak response and routine surveillance efforts.

Europe

Europe exhibits strong adoption of both molecular diagnostics and serological assays for pertussis detection, supported by integrated healthcare systems, surveillance programs, and regulatory oversight. Demand is driven by routine screening, outbreak investigations, and adult testing programs. High quality standards, combined with increasing public‑health emphasis on immunization and disease monitoring, foster stable demand for diversified testing modalities across the region.

Asia Pacific

Asia Pacific presents significant growth potential in the pertussis testing market due to large and diverse population, rising demand for improved diagnostics, increasing healthcare infrastructure investment, and growing awareness of respiratory diseases. Expansion of diagnostic laboratory networks and increasing access to PCR and rapid testing — particularly in urban centers — are expected to drive market growth. The region’s heterogeneity in healthcare access also offers opportunities for point‑of‑care testing and decentralized diagnostic solutions to reach underserved populations.

Middle East & Africa

The Middle East & Africa region is emerging as a developing market for pertussis diagnostics, with growing demand for infection testing due to rising public‑health awareness and improving laboratory infrastructure. Limited but increasing access to molecular and serological diagnostics, along with growing need for outbreak surveillance and routine screening, supports gradual market expansion. Opportunities exist for cost‑effective and rapid diagnostic solutions to address regional healthcare constraints and improve disease detection coverage.

Latin America

Latin America demonstrates growing demand for pertussis infection testing as awareness of vaccine‑preventable diseases increases, and diagnostic capacities expand in both urban and semi‑urban areas. Adoption of PCR, serology, and rapid tests is expected to rise with strengthening public‑health programs, outbreak preparedness, and expanding access to diagnostic laboratories. The region offers potential for both volume testing and introduction of advanced diagnostic technologies to improve pertussis detection and surveillance coverage.

This report provides an in depth analysis of various factors that impact the dynamics of Pertussis Infection Testing Market. These factors include; Market Drivers, Restraints and Opportunities Analysis.

Drivers, Restraints and Opportunity Analysis

Drivers:

• Rising Incidence of Pertussis Outbreaks
• Demand for Early and Accurate Diagnosis

• Advancements in Diagnostic Technologies- The Pertussis Infection Testing Market is being driven by advancements in diagnostic technologies, which have significantly enhanced the ability to detect pertussis more accurately and efficiently. Over the past few years, there has been a shift toward more rapid and precise testing methods. The introduction of polymerase chain reaction (PCR) technology has been a game-changer in pertussis diagnosis. PCR allows for the detection of Bordetella pertussis DNA in patient samples, even in the early stages of infection when traditional diagnostic methods, such as culture tests, might fail to detect the pathogen. PCR-based tests are highly sensitive and specific, enabling clinicians to diagnose pertussis quickly and with greater accuracy, which is crucial for effective treatment and reducing transmission.

  In addition to PCR, molecular diagnostics such as FluoroType Bordetella have emerged as another significant advancement. This technology utilizes fluorescence-based PCR techniques, offering even faster results compared to traditional PCR, making it ideal for point-of-care (POC) settings. These innovations have improved the turnaround time for results, allowing for quicker diagnosis, which is particularly important in hospitals and emergency settings where time-sensitive decisions are necessary. The ability to conduct tests more rapidly also facilitates better patient management and reduces the burden on healthcare systems, making diagnostic procedures more efficient and less expensive over time.

  The growing adoption of serological tests and rapid antigen detection tests has also contributed to advancements in pertussis diagnosis. While these methods are not as sensitive as PCR, they offer several advantages, such as affordability, simplicity, and the ability to be used in remote or resource-limited areas. These tests can quickly detect antibodies or antigens related to Bordetella pertussis in patients, providing valuable information for epidemiological surveillance and outbreak management. The continued innovation and refinement of these diagnostic technologies ensure that healthcare providers have a wider array of tools at their disposal to detect pertussis more effectively, ultimately driving the growth of the pertussis infection testing market. As these technologies continue to evolve, they will likely make testing even more accessible, improving both the speed and accuracy of pertussis diagnoses across various healthcare settings.

Restraints:

• High Cost of Advanced Diagnostic Tests
• Lack of Standardization in Diagnostic Methods

• Shortage of Skilled Labor and Infrastructure in Developing Regions- The growth of the Pertussis Infection Testing Market faces significant barriers due to a shortage of skilled labor and inadequate healthcare infrastructure in developing regions. Many low- and middle-income countries struggle to build and sustain the necessary systems required for advanced diagnostic testing. Although molecular diagnostic technologies such as PCR assays and serological tests have transformed pertussis detection, these methods demand specialized equipment and highly trained personnel. Unfortunately, healthcare systems in several developing areas often lack sufficient laboratory facilities, diagnostic tools, and funding, leading to delays in the timely identification and treatment of pertussis infections. Consequently, the adoption of advanced testing technologies in these regions lags behind that of developed markets, hindering market expansion.

  The shortage of skilled labor further compounds the issue. Conducting accurate pertussis testing—particularly through PCR and other molecular diagnostic techniques—requires trained laboratory technicians and healthcare professionals proficient in operating complex diagnostic instruments and interpreting results. However, a significant gap in properly trained professionals exists across many developing countries. Issues such as brain drain, where qualified healthcare workers migrate to developed nations for better career prospects, worsen the shortage. This lack of expertise often results in suboptimal test quality, misdiagnosis, or the complete absence of available diagnostic services. Without sufficient skilled labor, the ability to deliver accurate, timely pertussis diagnoses diminishes, limiting effective intervention strategies and slowing the overall growth of the pertussis infection testing market in these regions.

  Inadequate healthcare infrastructure, particularly in rural and remote areas, presents another major challenge. Even in countries with advanced urban medical facilities, rural regions often experience limited access to pertussis diagnostic tests. The absence of necessary elements such as diagnostic laboratories, reliable power supplies, and proper cold-chain systems for reagent storage makes widespread testing difficult. These infrastructure deficiencies not only impact the use of complex molecular diagnostics but also hinder the deployment of more accessible alternatives like rapid antigen detection tests and point-of-care (POC) diagnostic solutions. As a result, the growing burden of pertussis infections in underserved regions remains unmet by sufficient diagnostic capabilities, reducing the impact of technological innovations and slowing global market growth. Addressing the infrastructure and workforce shortages will be critical to unlocking the full potential of the pertussis infection testing market in developing areas.

Opportunities:

• Growth in Point-of-Care (POC) and Home-Based Testing Solutions
• Technological Innovations in PCR and Molecular Testing

• Increase in Vaccination and Monitoring Programs- The growth of the Pertussis Infection Testing Market is strongly driven by the rise in vaccination campaigns and enhanced disease monitoring programs aimed at controlling pertussis outbreaks and improving public health surveillance. As governments and healthcare organizations increasingly recognize the critical need to prevent pertussis, there has been a notable push for comprehensive vaccination efforts targeting infants, adolescents, and vulnerable populations. These expanded vaccination initiatives not only help lower the incidence of pertussis but also heighten public awareness about the disease, consequently fueling the demand for accurate diagnostic testing. As vaccination rates improve, there is greater emphasis on tracking vaccine effectiveness and identifying emerging outbreaks, boosting the need for efficient and reliable diagnostic solutions to detect the presence of Bordetella pertussis across different communities.

  The expansion of national and international surveillance programs is creating significant growth opportunities for the pertussis infection testing market. Countries worldwide are adopting more rigorous disease monitoring systems, integrating routine screening for pertussis both in clinical environments and during broader epidemiological studies. This surge in surveillance efforts enables early detection of outbreaks and rapid intervention by health authorities, underscoring the critical role of diagnostic testing in modern public health strategies. Especially in regions where vaccination coverage remains suboptimal or where pertussis outbreaks are frequent, the increasing scope of monitoring initiatives is driving steady demand for accurate and scalable testing methods.

  The growing focus on surveillance is fostering innovation in diagnostic technology. Governments and public health bodies are increasingly collaborating with diagnostic companies to develop cost-effective, rapid, and point-of-care (POC) solutions that can be deployed in resource-limited settings. Advances such as rapid antigen tests, molecular diagnostics, and digital health platforms are opening new avenues for real-time disease tracking and more accessible diagnostic services. The integration of diagnostic testing within vaccination and monitoring frameworks ensures that testing becomes a routine part of public health management, extending its reach beyond traditional clinical settings. This synergistic relationship between vaccination drives, disease surveillance, and diagnostic innovations will continue to be a major catalyst for the growth of the pertussis infection testing market, particularly in regions with high disease burdens or expanding immunization programs.

Pertussis Infection Testing Market is witnessing heightened competitiveness as diagnostic accuracy and rapid detection become critical priorities for healthcare systems. Around 40% of providers are focusing on specialized strategies to strengthen their portfolios, while nearly 30% are enhancing partnerships with laboratories and hospitals. Continuous innovation in molecular testing and strategic merger activities are driving consistent growth across this segment.

Market Structure and Concentration
The industry reflects moderate concentration, with leading diagnostic companies accounting for nearly 55% of revenues. Over 20% of structural changes have resulted from merger and acquisitions, reinforcing dominance in molecular testing. About 25% of emerging firms adopt niche strategies in point-of-care solutions. Enhanced collaboration across healthcare ecosystems continues to sustain competitive growth and service expansion.

Brand and Channel Strategies
Manufacturers are implementing multi-channel strategies, combining direct sales to hospitals with distributor-led networks. More than 60% of revenues are driven by long-term partnerships with healthcare providers, while nearly 35% come from regional expansion. Strong collaboration with diagnostic labs ensures broad adoption, while brand-led initiatives reinforce growth in both developed and emerging healthcare markets.

Innovation Drivers and Technological Advancements
More than 45% of R&D spending is directed toward innovation in PCR-based testing, multiplex assays, and rapid immunoassays. Technological advancements in automation and digital platforms are enhancing accuracy and reducing turnaround times. Producers are integrating smart strategies to improve accessibility. These innovation drivers accelerate growth, establishing competitive advantages in next-generation infectious disease testing.

Regional Momentum and Expansion
North America accounts for nearly 35% of demand, supported by strong partnerships with diagnostic labs and public health agencies. Asia-Pacific records over 25% annual growth, driven by healthcare infrastructure expansion. Europe demonstrates nearly 18% collaboration through advanced clinical programs. Regional strategies strengthen market presence and reinforce competitiveness across diverse diagnostic environments.

Future Outlook
The future outlook signals strong growth, with nearly 50% of companies preparing significant expansion initiatives. Increased collaboration with healthcare authorities and diagnostic service providers will accelerate adoption. Continuous innovation in molecular and point-of-care testing will shape industry benchmarks. Strategic partnerships and technological advancements are expected to secure long-term competitiveness in pertussis infection testing.

Key players in Pertussis Infection Testing Market include:

• Merck & Co., Inc.
• Sanofi
• GlaxoSmithKline
• Pfizer Inc.
• Novartis AG
• Johnson & Johnson Services Inc.
• Serum Institute of India Pvt. Ltd.
• Mitsubishi Tanabe Pharma Corporation
• China National Biotec Group
• Beijing Institute of Biological Products
• Cansino Bio
• Aurobindo Pharma
• Sun Pharmaceutical Industries Ltd.
• ILiAD Biotechnologies
• Bharat Biotech

In this report, the profile of each market player provides following information:

• Market Share Analysis
• Company Overview and Product Portfolio
• Key Developments
• Financial Overview
• Strategies
• Company SWOT Analysis