Infectious Disease In Vitro Diagnostics Market (By Product; By Technology; By Application; By Test Location) - Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2025-2034

Infectious Disease In Vitro Diagnostics Market Size, Share, Report 2025-2034

The global infectious disease in vitro diagnostics market size was valued at USD 24.35 billion in 2024 and is expected to grow from USD 24.98 billion in 2025 to around USD 31.48 billion by 2034, expanding at a CAGR of 2.6% during the forecast period. The rising geriatric population is susceptible to infectious diseases, increased awareness and patient care, and rising demand for rapid and accurate diagnostics, and innovation in technology fuel the market growth. 

Key Pointers

• By region, North America region dominated the market with highest share of 40% in 2024.
• By region, the Asia Pacific Infectious Disease In Vitro Diagnostics market is estimated to expand at the fastest CAGR from 2025 to 2034.
• By product, the reagents segment held the largest market revenue share of 68% in 2024.
• By technology, the immunoassay technology segment captured the maximum market share of 36% in 2024.
• By technology, the microbiology technology segment is estimated to expand the fastest CAGR during the forecast period.
• By application, the COVID-19 application generated the maximum market share of 15% in 2024.
• By application, the HIV segment is expected to grow at the fastest CAGR from 2025 to 2034.
• By test location, the central laboratories segment held the largest share in 2024, accounting for 49% of the market. 

Infectious Disease In Vitro Diagnostics Market Overview

Infectious Disease In Vitro Diagnostics (IVD) are medical devices and reagents used to detect, identify, and monitor infectious pathogens, such as bacteria, viruses, fungi, and parasites, in biological samples like blood, tissue, urine, or saliva. The term in vitro, meaning "in glass," refers to tests performed outside of a living organism, typically in a laboratory or near a patient. 

The global in vitro diagnostic market growth is driven by the increasing worldwide prevalence of various infectious diseases, including viral, bacterial, and parasitic infections, necessitating the use of IVD for early detection and control. Healthcare systems are increasingly focused on rapid, precise diagnostic methods to enable timely and targeted treatment decisions, which is fueled by the capabilities of IVD solutions.

Rising Burden of Infectious Diseases Market Growth:

The increasing global prevalence of various infectious diseases, including viral, bacterial, and parasitic infections, necessitates the use of IVD for early detection and control. Early detection is crucial for monitoring disease progression, reducing transmission, and improving patient outcomes. 
This necessitates a growing demand for efficient diagnostic tools. Government-led health programs and public awareness initiatives encourage diagnostic testing, further driving the demand for IVD solutions.

Report Scope of the Infectious Disease In Vitro Diagnostics Market

Infectious Disease In Vitro Diagnostics Market Trends

• Rising Prevalence of Chronic Diseases: The ongoing threat of outbreaks and the consistent burden of endemic diseases drive the demand for effective diagnostics. Events such as the COVID-19 pandemic significantly boosted the IVD market through rapid test innovation, emphasizing the critical role of diagnostics and leading to continued investment in surveillance. 
• Persistent diseases: like HIV and TB also contribute to a steady market, with millions globally affected. Additionally, emerging outbreaks like Mpox and the H5 avian influenza necessitate the development of new diagnostic tests. 

Infectious Disease In Vitro Diagnostics Market Opportunity

Technological Advancement for the Infectious Disease In Vitro Diagnostics Market

Continuous innovations in diagnostic technologies, including molecular diagnostics, point-of-care testing (POCT), and next-generation sequencing (NGS), enhance the speed, specificity, and sensitivity of infectious disease diagnostics. Artificial Intelligence (AI) and Machine Learning (ML) are being integrated into diagnostics to improve accuracy and efficiency. MDx offers high sensitivity and specificity for identifying pathogens and can detect them even before symptoms appear, which is crucial for early intervention and personalized treatment. Technologies like RT-PCR became widely used for diseases like COVID-19 and tuberculosis, leading to a decentralization of such tests from large referral labs to smaller setups.

Infectious Disease In Vitro Diagnostics Market Challenge

Unfavourable Reimbursements in the Infectious Disease In Vitro Diagnostics Market

The inadequate and inconsistent reimbursement policies from payers, whether public or private, limit coverage and rates for advanced diagnostic tests. This financial gap hinders healthcare providers' adoption of innovative IVD technologies and can restrict patient access, particularly in cost-sensitive settings.

Regional Insights

Which Region Dominated the Infectious Disease In Vitro Diagnostics Market?

North America dominated the infectious disease in vitro diagnostics market share 40% in 2024, and the region is expected to sustain the position during the forecast period. The region has well-established healthcare systems that support the widespread integration of innovative diagnostic technologies into patient care. The ongoing prevalence of infectious and chronic diseases necessitates the demand for effective IVD solutions for diagnosis and monitoring. Supportive government regulations and reimbursement policies in countries like the US and Canada encourage the adoption and development of IVD devices.

• In August 2024, Quest Diagnostics acquired Canada-based LifeLabs, increasing diagnostic testing capacity. (Source: Quest Diagnostics)

United States Infectious Disease In Vitro Diagnostics Market Trends

The rising disease prevalence, demand for rapid testing, and technological advancements like molecular diagnostics and point-of-care solutions. Key trends include the increasing adoption of molecular testing, expansion of POC testing, and a shift towards home-based diagnostics. However, challenges such as the high cost of instruments, stringent regulations, and a shortage of skilled professionals could impact market progression. 

Why is the Asia Pacific Significantly Growing in the Infectious Disease In Vitro Diagnostics Market?

Asia Pacific expects significant growth in the Infectious Disease In Vitro Diagnostics market during the forecast period. The high burden of infectious diseases and increasing awareness for early diagnosis. Technological advancements like molecular diagnostics and point-of-care testing are key growth drivers. Significant healthcare expenditure and an aging population also contribute to market expansion. Despite challenges like unequal access, the region's focus on innovation and healthcare investment points towards continued strong growth.

• In August 2024, Sysmex Corporation bolstered its direct operations in India to improve market access and support for IVD solutions. (Source: EXPRESS HELTHCARE)

Segmental Insights

Product Insights

Why did the Reagents Segment Dominate the Infectious Disease In Vitro Diagnostics Market?

The reagents dominated the market, accounting for 68% of the global revenue share in 2024. They are consumable items that are essential for performing every diagnostic test. Unlike expensive, long-lasting instruments, reagents generate consistent, recurring revenue due to their high-volume usage. This continuous demand is driven by the global prevalence of infectious diseases and increasing adoption of molecular and immunoassay technologies, which are highly dependent on specific reagents for detection. The reagents segment's dominance is further reinforced by frequent product innovations and the expanding applications of personalized medicine.

Rapid innovation continues to play a crucial role in gaining a competitive advantage in the market. A study published in February 2024 by Diagnostic Microbiology and Infectious Disease highlighted how advanced molecular techniques have revolutionized the identification and diagnosis of pathogenic microorganisms and viruses in clinical microbiology laboratories. Next-generation sequencing (NGS), which enables nucleic acid detection and genetic profiling, has notably transformed infectious agent identification.

Technology Insights

How the Immunoassay Technology Segment hold the Largest Share in the Infectious Disease In Vitro Diagnostics Market?

The immunoassay technology held the largest share of revenue, accounting for 36% of the total market in 2024. Its high sensitivity, specificity, and rapid results are essential for infectious disease diagnosis. Versatile and adaptable, these tests work across multiple sample types and testing environments, from centralized labs to point-of-care. Ongoing innovations, including automation and multiplexing, further enhance accuracy and efficiency for managing infectious diseases. This combination of speed, accuracy, and broad application meets the pressing global demand for effective infectious disease diagnostics.

The microbiology technology segment is experiencing the fastest growth in the market during the forecast period. Advancements like automated systems and pathogen identification are addressing the global burden of infectious diseases and antimicrobial resistance. Additionally, the rising demand for rapid, accurate diagnostics and increased investments by key players will fuel the microbiology segment's expansion. Thus, its growing innovation and integration with other technologies will secure a rapid growth trajectory.

Application Insights

How the COVID-19 Application Segment hold the Largest Share in the Infectious Disease In Vitro Diagnostics Market?

The COVID-19 application held the largest share of market revenue, accounting for 15% in 2024. The unprecedented demand for testing kits during the pandemic. Government initiatives and rapid product innovation drove mass testing and accelerated regulatory approvals for various diagnostics. This surge eclipsed testing for other infectious diseases but has since declined as the pandemic subsided. The pandemic's long-term legacy includes heightened investment in rapid, point-of-care, and multiplex testing technologies.

The HIV segment is experiencing the fastest growth in the market during the forecast period. The rising global HIV prevalence and heightened awareness of early diagnosis. This is supported by significant technological advancements, particularly rapid, point-of-care, and self-testing kits that improve accessibility and convenience. Additionally, strong government initiatives and international funding programs expand testing availability and reduce social stigma, driving market momentum towards accessible and accurate diagnostic solutions.

Test Location Insights

How the Central Laboratories Segment hold the Largest Share in the Infectious Disease In Vitro Diagnostics Market?

The central laboratories segment held the largest share in 2024, accounting for 49% of the market. Their sophisticated technologies and automated systems facilitate high-throughput, high-precision testing necessary for the large volumes of samples often required for infectious disease diagnosis. Handling a large volume of tests allows central laboratories to achieve lower per-unit costs, making them cost-effective for high-volume testing. Central laboratories are vital in public health surveillance and outbreak response, contributing to their high testing volumes. 

The point of care segment is experiencing the fastest growth in the market during the forecast period. The rising worldwide burden of infectious diseases and emerging viral threats like monkeypox creates a constant demand for rapid and effective diagnostic solutions. The growing trend towards decentralized healthcare models, moving testing closer to patients in clinics, physicians' offices, urgent care centers, and even homes, further fuels the demand for convenient and accessible POC solutions. Growing awareness about the importance of early disease detection and prevention encourages individuals to seek diagnostic testing, including readily available POC options.

The Infectious Disease In Vitro Diagnostics Market-Value Chain Analysis

• R&D: The infectious disease in vitro diagnostics market focuses on creating and improving tests and devices that detect diseases, conditions, and infections by analyzing biological samples (like blood or tissue) outside the body (in glass).
• Patient Support and Services: The infectious disease in vitro diagnostics market involves comprehensive range of activities, technologies, and support systems that facilitate the entire IVD process for patients, from initial testing to post-diagnostic care.
• Distribution to Hospitals, Pharmacies: The central and hospital laboratories, point-of-care and retail pharmacies, and at-home and over-the-counter testing. 

Recent Developments

• In February 2025, Roche's Sequencing by Expansion (SBX) technology is a next-generation sequencing method utilizing an "Xpandomer" molecule, significantly longer than the original DNA/RNA, to boost the signal-to-noise ratio for higher accuracy. The technology aims to provide rapid speed, high accuracy, flexibility, and scalability for various sequencing applications. (Source: Roche)
• In December 2024, OraSure Technologies announced its acquisition of Sherlock Biosciences to strengthen its position in the diagnostics market, particularly for point-of-need and home testing. The acquisition includes Sherlock's molecular diagnostics platform and a molecular self-test for Chlamydia Trachomatis and Neisseria Gonorrhoeae, which is undergoing clinical studies and targeting FDA submission by late. (Source: OraSure Technologies, Inc.)

Top Companies in Infectious Disease In Vitro Diagnostics Market

• Roche Diagnostics
• Abbott Laboratories
• Siemens Healthineers
• bioMérieux SA
• Thermo Fisher Scientific Inc.
• Hologic, Inc.
• Qiagen N.V.
• Becton, Dickinson and Company (BD)
• Luminex Corporation
• Danaher Corporation

Infectious Disease In Vitro Diagnostics Market Segmentation

By Product 

• Instruments
  • MRSA
  • Streptococcus
  • Clostridium difficile
  • VRE
  • CRE
  • Respiratory Virus
  • Candida
  • TB and drug-resistant TB
  • Gastro-intestinal panel testing
  • Chlamydia
  • Gonorrhea
  • HPV
  • HIV
  • Hepatitis C
  • Hepatitis B
  • COVID-19
  • Other Infectious Diseases
• Reagents
  • MRSA
  • Streptococcus
  • Clostridium difficile
  • VRE
  • CRE
  • Respiratory Virus
  • Candida
  • TB and drug-resistant TB
  • Gastro-intestinal panel testing
  • Chlamydia
  • Gonorrhea
  • HPV
  • HIV
  • Hepatitis C
  • Hepatitis B
  • COVID-19
  • Other Infectious Diseases
• Software
  • MRSA
  • Streptococcus
  • Clostridium difficile
  • VRE
  • CRE
  • Respiratory Virus
  • Candida
  • TB and drug-resistant TB
  • Gastro-intestinal panel testing
  • Chlamydia
  • Gonorrhea
  • HPV
  • HIV
  • Hepatitis C
  • Hepatitis B
  • COVID-19
  • Other Infectious Diseases

By Technology 

• Immunoassay
• Molecular diagnostics
• Microbiology
• Others

By Application 

• MRSA
• Streptococcus
• Clostridium difficile
• VRE
• CRE
• Respiratory Virus
• Candida
• TB and drug-resistant TB
• Gastro-intestinal panel testing
• Chlamydia
• Gonorrhea
• HPV
• HIV
• Hepatitis C
• Hepatitis B
• COVID-19
• Other Infectious Diseases

By Test Location 

• Point of Care
• Central Laboratories
• Others

By Regional 

• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • Spain
  • France
  • Italy
  • Denmark
  • Sweden
  • Norway
• Asia Pacific
  • Japan
  • China
  • India
  • South Korea
  • Australia
  • Thailand
• Latin America
  • Brazil
  • Argentina
• Middle East and Africa (MEA)
  • South Africa
  • Saudi Arabia
  • UAE
  • Kuwait