Infectious Diseases Preliminary Screening Tests Market, Global Outlook and Forecast 2025-2032

MARKET INSIGHTS

Global Infectious Diseases Preliminary Screening Tests market size was valued at USD 1.45 billion in 2024. The market is projected to grow from USD 1.62 billion in 2025 to USD 2.95 billion by 2032, exhibiting a CAGR of 10.9% during the forecast period.

Infectious diseases preliminary screening tests are rapid diagnostic tools used for early detection of pathogens through bodily fluids like saliva or blood. These tests serve as initial indicators before confirmatory laboratory testing, covering diseases such as HIV, hepatitis, influenza, malaria, and emerging viral threats. The industry categorizes these tests into over-the-counter and professional rapid test products.

The market growth is driven by multiple factors, including the rising global burden of infectious diseases, with WHO reporting over 17 million deaths annually from communicable diseases. However, challenges remain in test accuracy and regulatory approvals. Key developments include Abbott's 2023 launch of Influenza A/B & COVID-19 combo rapid test and Roche's 2024 FDA clearance for a multiplex respiratory panel. Leading players like Quidel Corporation and BD are expanding their portfolios through strategic acquisitions and technological innovations in lateral flow assay and PCR-based rapid testing.

MARKET DYNAMICS

MARKET DRIVERS

Rising Prevalence of Infectious Diseases to Fuel Market Growth

The global infectious disease burden has increased significantly, with emerging pathogens and antimicrobial resistance posing critical public health challenges. Recent data indicates that infectious diseases account for approximately 17 million deaths annually worldwide, creating substantial demand for rapid screening solutions. The COVID-19 pandemic demonstrated the critical need for efficient preliminary testing, accelerating regulatory approvals and adoption of novel screening technologies. This shift toward decentralized testing models, where rapid results enable timely clinical decisions, continues driving market expansion across healthcare settings.

Technological Advancements in Rapid Diagnostics Boosting Adoption

Innovations in lateral flow assays, molecular diagnostics, and microfluidic technologies are transforming preliminary screening capabilities. Modern tests now deliver laboratory-quality results in under 30 minutes with sensitivity exceeding 90% for many pathogens. The integration of artificial intelligence for test interpretation and smartphone connectivity for result reporting further enhances clinical utility. Leading manufacturers are investing heavily in multiplex platforms that can simultaneously detect multiple pathogens from single samples, creating opportunities in both professional and consumer markets.

➤ The recent global health crisis saw emergency use authorizations for over 400 COVID-19 rapid tests alone, establishing new benchmarks for regulatory flexibility and rapid test deployment during outbreaks.

Furthermore, growing health awareness and self-testing trends among consumers, particularly for sexually transmitted infections and respiratory illnesses, continue expanding market accessibility beyond traditional clinical settings.

MARKET RESTRAINTS

Regulatory Complexities and Reimbursement Challenges Limit Growth Potential

While demand grows, the infectious disease screening market faces significant regulatory barriers. Diagnostic tests must navigate varying approval requirements across regions, with some jurisdictions mandating extensive clinical validations that can take 12-18 months to complete. Reimbursement policies frequently lag behind technological advances, creating financial disincentives for healthcare providers to adopt newer screening methods. These factors particularly impact smaller manufacturers who lack resources for prolonged regulatory processes, potentially stifling innovation in the long term.

Additionally, professional guidelines often emphasize confirmatory testing for positive rapid results, creating operational complexities for healthcare systems already facing resource constraints.

MARKET CHALLENGES

Accuracy Limitations and False Result Risks Present Clinical Concerns

Despite technological improvements, preliminary screening tests inherently carry higher false-negative rates compared to laboratory-based diagnostics. Studies indicate rapid influenza tests may miss 20-30% of positive cases, potentially delaying critical treatments. This performance gap creates clinician hesitancy in relying exclusively on screening results, particularly for diseases requiring immediate intervention. The industry also faces ongoing challenges in maintaining test accuracy against rapidly mutating pathogens, requiring continuous assay reformulations that strain R&D budgets.

Additional Operational Challenges

Supply Chain Vulnerabilities
The diagnostics industry remains susceptible to reagent shortages and manufacturing disruptions, as witnessed during recent global health crises. Dependence on specialized components from limited suppliers creates production bottlenecks when demand surges unexpectedly.

User Error Variables
Improper specimen collection or test interpretation by untrained users accounts for approximately 15-20% of inaccurate results in decentralized testing environments, undermining confidence in screening programs.

MARKET OPPORTUNITIES

Emerging Markets and Point-of-Care Expansion Offer Significant Growth Potential

Developing regions with limited laboratory infrastructure present substantial opportunities for high-quality screening tests. The Asia-Pacific market alone is projected to grow at 14.2% CAGR through 2032, fueled by healthcare modernization initiatives. Meanwhile, non-traditional settings like pharmacies, workplaces, and schools are adopting screening tests for infectious disease management, creating new distribution channels. Strategic partnerships between diagnostics companies and retail health providers are accelerating this expansion, making testing more accessible to broader populations.

Advancements in biomarker discovery also enable development of novel screening panels for emerging pathogens, while AI-powered diagnostic decision support systems enhance the clinical value of rapid test results in resource-limited settings.

Segment Analysis:

By Type

Professional Rapid Test Product Segment Leads Due to High Accuracy and Clinical Reliability

The market is segmented based on type into:

• Over-the-Counter Rapid Test Product

• Professional Rapid Test Product

By Application

Infectious Diseases Segment Dominates with Rising Prevalence of Global Pandemics

The market is segmented based on application into:

• Infectious Diseases

• Hepatitis

• Influenza

• Malaria

• HIV

• Other

By End User

Hospitals & Clinics Account for Major Market Share Due to High Patient Inflow

The market is segmented based on end user into:

• Hospitals & Clinics

• Diagnostic Laboratories

• Home Care Settings

• Research Institutes

COMPETITIVE LANDSCAPE

Key Industry Players

Diagnostic Giants and Emerging Innovators Vie for Market Share

The global infectious disease preliminary screening tests market exhibits a dynamic competitive landscape, characterized by the presence of established diagnostic multinationals and agile specialty players. Abbott Laboratories currently leads the market, leveraging its extensive distribution network and portfolio of rapid tests for HIV, hepatitis, and respiratory infections. The company's recent acquisition of Alere in 2017 significantly strengthened its position in point-of-care testing.

F. Hoffmann-La Roche Ltd and Quidel Corporation are maintaining strong market positions through continuous innovation. Roche's cobas® Liat PCR system and Quidel's Sofia® immunoassay platform have become industry standards for rapid, accurate testing. Both companies are investing heavily in multiplex testing capabilities to address the growing demand for comprehensive pathogen detection.

The market has seen notable expansion from mid-sized players like Meridian Bioscience and OraSure Technologies, who are carving out specialized niches. Meridian's expertise in gastrointestinal pathogen testing and OraSure's oral fluid collection technologies demonstrate how focused product strategies can succeed despite competing with larger corporations.

Emerging trends show that companies are increasingly forming strategic alliances with academic institutions and government agencies. BD (Becton Dickinson) recently partnered with several public health organizations to develop next-generation screening tests for antimicrobial resistant pathogens, reflecting the industry's shift toward collaborative innovation models.

List of Major Infectious Disease Screening Test Companies

• Abbott Laboratories (U.S.)

• BD (Becton, Dickinson and Company) (U.S.)

• Bio-Rad Laboratories, Inc. (U.S.)

• Cepheid (U.S.)

• Hologic, Inc. (U.S.)

• Meridian Bioscience, Inc. (U.S.)

• OraSure Technologies, Inc. (U.S.)

• QuidelOrtho Corporation (U.S.)

• F. Hoffmann-La Roche Ltd (Switzerland)

• Siemens Healthineers (Germany)

• Luminex Corporation (U.S.)

• QIAGEN (Netherlands)

Market competition is intensifying as companies expand their test menus to cover emerging pathogens while improving the sensitivity and specificity of existing assays. The recent COVID-19 pandemic demonstrated how quickly market dynamics can shift, with companies like Cepheid and Mesa Biotech gaining significant market share through their rapid SARS-CoV-2 tests. Established players are now accelerating their preparedness for future pandemic scenarios through enhanced R&D pipelines and manufacturing flexibility.

INFECTIOUS DISEASES PRELIMINARY SCREENING TESTS MARKET TRENDS

Rapid Technological Advancements Driving Market Growth

The infectious diseases preliminary screening tests market is experiencing transformative growth due to rapid advancements in diagnostic technologies. Innovations such as point-of-care testing (POCT) devices and molecular diagnostic platforms have significantly reduced testing times while improving accuracy. For instance, recent data indicates that lateral flow assays can now deliver results in under 15 minutes with over 95% sensitivity for diseases like influenza and HIV. Furthermore, the integration of artificial intelligence in test interpretation has enhanced detection capabilities for emerging pathogens, allowing healthcare providers to respond more effectively to outbreaks. These technological leaps are expected to contribute to the market's projected CAGR of 10.9% through 2032.

Other Trends

Global Health Preparedness Initiatives

The increasing frequency of infectious disease outbreaks has prompted governments and global health organizations to invest heavily in screening infrastructure. Following the COVID-19 pandemic, over 75 countries have established national surveillance programs incorporating rapid screening tests for early outbreak detection. This trend is particularly evident in developing regions where laboratory capacity is limited, creating substantial demand for portable, easy-to-use screening solutions. The World Health Organization's recent guidelines emphasizing decentralized testing strategies have further accelerated adoption rates across primary healthcare settings worldwide.

Shift Toward Over-the-Counter Testing Solutions

A significant market evolution is the growing consumer preference for self-testing kits, particularly for sexually transmitted infections and respiratory diseases. The over-the-counter segment now accounts for nearly 35% of total market revenue, driven by increased health awareness and the convenience of at-home testing. Manufacturers are responding with user-friendly designs featuring smartphone connectivity for result interpretation and digital reporting. However, this trend presents regulatory challenges as health authorities work to balance accessibility with test accuracy standards, creating an evolving landscape for product approvals and post-market surveillance.

Regional Analysis: Infectious Diseases Preliminary Screening Tests Market

North America
The North American market leads in adoption of infectious disease screening tests due to advanced healthcare infrastructure, regulatory support, and heightened awareness of disease surveillance. The U.S. dominates with over 60% regional market share, fueled by FDA approvals for rapid diagnostic tests (RDTs) and substantial public health spending ($4.3 trillion in 2022). However, reimbursement policy inconsistencies between private and public payers create adoption barriers for newer technologies. The COVID-19 pandemic accelerated demand for point-of-care testing, with companies like Abbott and Quidel launching CLIA-waived molecular tests that deliver results in 15 minutes. Expect sustained growth as healthcare shifts toward decentralized testing models.

Europe
Europe maintains the second-largest market position, with Germany and France collectively accounting for 45% of regional revenues. The EU's In Vitro Diagnostic Regulation (IVDR) framework ensures test quality but increases compliance costs for manufacturers. Recent outbreaks of mpox (formerly monkeypox) and antimicrobial-resistant infections have driven demand for multiplex screening panels. Notably, the UK's National Health Service allocated £2.3 billion in 2023 for diagnostic capacity expansion, including point-of-care infectious disease testing. While Western Europe shows maturity, Eastern Europe presents untapped potential with increased healthcare modernization efforts.

Asia-Pacific
APAC exhibits the highest growth rate (projected 13.2% CAGR) due to massive populations, rising healthcare expenditure, and frequent infectious disease outbreaks. China's centralized procurement policies make it a price-sensitive market, favoring local manufacturers like Wantai Biological. India's diagnostics market expansion (valued at $10 billion in 2023) focuses on affordable rapid tests for diseases like dengue and tuberculosis. Southeast Asian countries battle resource limitations but show increasing adoption of malaria/HIV combo tests through WHO-backed programs. Japan and South Korea lead innovation, with Tokyo launching AI-powered screening kiosks in 2023 for early respiratory pathogen detection.

South America
Market growth in South America remains constrained by economic instability, though Brazil demonstrates resilience with its robust public health system (SUS). The region saw increased test utilization during Zika and yellow fever outbreaks, revealing infrastructure gaps. Argentina's recent $200 million investment in laboratory networks signals progress, while Colombia utilizes mobile testing units for hard-to-reach populations. Regulatory frameworks vary significantly by country, creating supply chain complexities for multinational manufacturers. The high disease burden (particularly for arboviruses) continues driving demand for low-cost rapid diagnostic solutions.

Middle East & Africa
The MEA region presents dichotomy: Gulf Cooperation Council (GCC) countries invest heavily in cutting-edge molecular screening technologies, while Sub-Saharan Africa relies on donor-funded rapid test kits. Saudi Arabia's Vision 2030 allocates $50 billion for healthcare transformation, including disease surveillance upgrades. By contrast, malaria-endemic African nations depend on Global Fund-distributed RDTs, though local production capabilities are emerging in Senegal and South Africa. Political instability in some areas disrupts testing supply chains, while urbanization and pandemic preparedness initiatives create long-term opportunities. Multiplex tests capable of detecting neglected tropical diseases show particular promise across the region.

Report Scope

This market research report offers a holistic overview of global and regional markets for the forecast period 2025–2032. It presents accurate and actionable insights based on a blend of primary and secondary research.

Key Coverage Areas:

• ✅ Market Overview

  • Global and regional market size (historical & forecast)

  • Growth trends and value/volume projections

• ✅ Segmentation Analysis

  • By product type or category

  • By application or usage area

  • By end-user industry

  • By distribution channel (if applicable)

• ✅ Regional Insights

  • North America, Europe, Asia-Pacific, Latin America, Middle East & Africa

  • Country-level data for key markets

• ✅ Competitive Landscape

  • Company profiles and market share analysis

  • Key strategies: M&A, partnerships, expansions

  • Product portfolio and pricing strategies

• ✅ Technology & Innovation

  • Emerging technologies and R&D trends

  • Automation, digitalization, sustainability initiatives

  • Impact of AI, IoT, or other disruptors (where applicable)

• ✅ Market Dynamics

  • Key drivers supporting market growth

  • Restraints and potential risk factors

  • Supply chain trends and challenges

• ✅ Opportunities & Recommendations

  • High-growth segments

  • Investment hotspots

  • Strategic suggestions for stakeholders

• ✅ Stakeholder Insights

  • Target audience includes manufacturers, suppliers, distributors, investors, regulators, and policymakers

FREQUENTLY ASKED QUESTIONS:

What is the current market size of Global Infectious Diseases Preliminary Screening Tests Market?

-> The Global Infectious Diseases Preliminary Screening Tests market was valued at USD 1.45 billion in 2024 and is projected to reach USD 2.95 billion by 2032.

Which key companies operate in Global Infectious Diseases Preliminary Screening Tests Market?

-> Key players include Abbott, F. Hoffmann-La Roche Ltd, BD, Quidel Corporation, and Siemens Healthcare Private Limited, among others.

What are the key growth drivers?

-> Key growth drivers include rising infectious disease prevalence, increasing healthcare spending, and government initiatives for rapid testing adoption.

Which region dominates the market?

-> North America currently leads the market, while Asia-Pacific is projected as the fastest-growing region.

What are the emerging trends?

-> Emerging trends include point-of-care testing advancements, AI-powered diagnostics, and multiplex testing technologies.