$4450
$3560
The infectious disease in vitro diagnostics market size is projected to reach US$ 76.71 billion by 2031 from US$ 45.69 billion in 2024. The market is expected to register a CAGR of 7.7% during 2025–2031. Technological advancements are likely to bring new trends in the infectious disease in vitro diagnostics market.
Infectious Disease In vitro Diagnostics Market Analysis
The infectious disease in vitro diagnostics market is witnessing substantial growth due to the rising global burden of infectious diseases—including HIV, tuberculosis, COVID?19, and emerging zoonotic threats—which has intensified demand for early, accurate detection. Technological innovation also plays a pivotal role: advances in molecular diagnostics such as PCR, next-generation sequencing, microfluidics, and AI-enhanced platforms are enabling faster, more precise, and multiplex testing capabilities. Another major growth driver is the expansion of point?of?care and home testing, bolstered by telemedicine and consumer preference for rapid, at?home diagnostics. Demographic trends, notably an aging global population susceptible to infections, further support market expansion.
Infectious Disease In vitro Diagnostics Market Overview
The global infectious disease in vitro diagnostics market is accelerating owing to the aging global population that magnifies this need, as immunosenescence increases susceptibility to infections, thereby fueling demand for reliable diagnostic tools. A mounting burden of infectious diseases—including long?standing threats like HIV, tuberculosis, malaria, and emerging ones such as COVID?19, Ebola, and Zika—is sustaining demand for rapid, accurate diagnostics. Rapid technological innovation is a critical catalyst. Next?generation molecular diagnostics—PCR, NAAT, and NGS—along with advanced immunoassays, lab-on-a-chip systems, and point-of-care devices are boosting sensitivity, specificity, and speed. Integration of AI, machine learning, and automation further enhances diagnostic accuracy and efficiency, streamlining workflows and enabling predictive surveillance. Together, these factors are synergistically propelling the global market forward.
Customize Research To Suit Your Requirement
We can optimize and tailor the analysis and scope which is unmet through our standard offerings. This flexibility will help you gain the exact information needed for your business planning and decision making.
Infectious Disease In vitro Diagnostics Market: Strategic Insights
Mrinal
Have a question?
Mrinal will walk you through a 15-minute call to present the report’s content and answer all queries if you have any.
Speak to Analyst
Customize Research To Suit Your Requirement
We can optimize and tailor the analysis and scope which is unmet through our standard offerings. This flexibility will help you gain the exact information needed for your business planning and decision making.
Infectious Disease In vitro Diagnostics Market: Strategic Insights
Mrinal
Have a question?
Mrinal will walk you through a 15-minute call to present the report’s content and answer all queries if you have any.
Speak to Analyst
Infectious Disease In vitro Diagnostics Market Drivers and Opportunities
Increasing Prevalence of Infectious Diseases Bolsters Market
As per the World Health Organization (WHO), tuberculosis (TB) affects 10 million people globally each year. Even though TB can be both prevented and cured, it still claims 1.5 million lives annually, making it among the leading infectious causes of death worldwide. The majority of TB cases occur in low- and middle-income countries, though the disease is found across the globe. Nearly half of all TB cases are recorded in the following eight countries: Bangladesh, China, India, Indonesia, Nigeria, Pakistan, the Philippines, and South Africa.
In alignment with global health trends, the prevalence of HIV continues to escalate worldwide. According to data from the World Health Organization, an estimated 39.9 million individuals were living with HIV as of the end of 2023, with projections ranging from 36.1 to 44.6 million. Approximately 0.6% of the global adult population aged 15–49 years is affected, although the magnitude and implications of the epidemic vary substantially across different countries and regions.
Furthermore, increasing fungal infections are one of the major concerns among a large population base globally, affecting millions. According to the Global Action Fund for Fungal Infections (GAFFI) 2024, more than 80 million people are at high risk of developing fungal disease every year, and approximately 6.55 million patients develop life-threatening fungal infections, of which 3.75 million people die annually. Thus, the growing cases of infectious diseases create a significant need for in vitro diagnosis to detect diseases and infections before proceeding with the desired treatment. Further, the escalating prevalence of HIV, hepatitis, tuberculosis, influenza, and new viral infections has intensified the demand for rapid and precise diagnostic solutions. Innovations in molecular diagnostics, better point-of-care testing, and greater emphasis on early detection and disease surveillance are collectively driving the adoption of in vitro diagnostic methodologies across both developed and emerging healthcare markets.
Government Initiatives to Increase Awareness Regarding Infectious Diseases to Create Growth Opportunities
Government efforts to raise awareness on infectious diseases, as well as their diagnosis, hold a major opportunity in the infectious disease in vitro diagnostics market. Initiatives focused on early detection, disease management, and strengthening the health system are fueling the demand for diagnostic products worldwide.
Public health initiatives such as immunization campaigns, school-based education programs, and community-level screenings are raising public awareness and utilization of diagnostic tests. Disease-control national programs for diseases such as tuberculosis, HIV, hepatitis, malaria, and dengue incorporate a mass screening element into the program, leading to sustained demand for centralized and point-of-care diagnostic platforms.
Governments are also backing diagnostic innovation with R&D investments, regulatory expediting, and public-private collaborations. The US NIH's RADx program and equivalents in the EU and Asia have intensified the development and deployment process of rapid and molecular tests. In lower- and middle-income economies, WHO's Essential Diagnostics List (EDL) and programs such as FIND and the Global Fund are supporting high-burden disease diagnostics priority setting and funding. Also, through the Nigerian Center for Disease Control (NCDC) and the Ministry of Health, the government promotes public health campaigns targeting malaria, HIV/AIDS, and tuberculosis. These campaigns emphasize early detection, prevention, and management, encouraging more people to seek diagnostic testing. As awareness grows, healthcare providers and diagnostic centers increasingly adopt advanced IVD technologies to meet the rising demand for reliable and rapid tests. Nationwide HIV screening programs supported by government initiatives have increased the need for efficient in vitro diagnostic kits. Similarly, in 2023, under the National Health Mission, the Indian government launched the Free Diagnostics Service Initiative (FDSI) to provide accessible and affordable diagnostics, reducing out-of-pocket expenses on healthcare. Further, in December 2024, Mexico's Ministry of Health's National Institute of Respiratory Diseases (INER) "Ismael Cosío Villegas" launched its first infectious disease diagnostic equipment, based on T2 Magnetic Resonance (T2MR) technology. The technology will help combat antimicrobial resistance (AMR) and speed up diagnosis.
Additionally, greater investment in national preparedness strategies and disease surveillance, particularly after the COVID-19 pandemic, has placed infectious disease diagnosis at the forefront. These efforts not only increase testing infrastructure but also create favorable regulatory and funding conditions, setting government-led awareness campaigns as a primary opportunity for growth within the IVD market.
Partnerships with international health organizations and government subsidies help improve access to these diagnostic tools, especially in rural and underserved areas. This supportive environment attracts investments from diagnostic companies aiming to develop and distribute innovative testing solutions tailored to the needs of a specific country or region. Overall, government-driven awareness campaigns are expected to create lucrative opportunities in the infectious disease IVD market by creating sustained demand for diagnostic innovations.
Infectious Disease In vitro Diagnostics Market Report Segmentation Analysis
Key segments that are the foundation of the infectious disease in vitro diagnostics market analysis are application and end user.
- Based on application, the infectious disease in vitro diagnostics market is segmented into HIV/AIDS, Tuberculosis, Hepatitis B & C, Malaria, and Others. The Hepatitis B & C segment held the largest share of the market in 2024.
- In terms of end user, the infectious disease in vitro diagnostics market is categorized into hospitals and clinics, diagnostics laboratories, blood bank, and others. The hospitals and clinics segment dominated the market in 2024.
Infectious Disease In vitro Diagnostics Market Share Analysis by Geography
The geographical scope of the infectious disease in vitro diagnostics market report is divided into five regions: North America, Asia Pacific, Europe, the Middle East and Africa, and South and Central America.
North America held a significant share of the market in 2024. The increasing acceptance of technologically advanced products, rising research and development activities, and growing use of in vitro diagnostics kits for infectious disease diagnosis, as well as the presence of large healthcare businesses, are among the key factors propelling the growth of the infectious diseases in vitro diagnostics market in North America. The region is experiencing an increasing prevalence of infectious diseases and multiple product launches for its diagnosis by key players. Additionally, growing awareness among patients and healthcare providers about the importance of early disease detection supports market expansion. Government initiatives and funding aimed at strengthening disease surveillance and preparedness further bolster the sector. The presence of leading diagnostic companies and favorable regulatory frameworks from agencies like the FDA facilitates the quick approval and commercialization of new tests. Moreover, an aging population, which is more vulnerable to infections, is increasing the need for regular diagnostic screening.
Infectious Disease In vitro Diagnostics Market Report Scope
Infectious Disease In vitro Diagnostics Market News and Recent Developments
The infectious disease in vitro diagnostics market is evaluated by gathering qualitative and quantitative data post primary and secondary research, which includes important corporate publications, association data, and databases. A key development in the market is listed below:
- bioMérieux, a world leader in the field of in vitro diagnostics, announced the launch of its WATCHFIRE molecular testing solution. The WATCHFIRE Respiratory (R) Panel, targeting 22 pathogens, will run on the BIOFIRE FILMARRAY TORCH instrument, integrated with FIREWORKS software, to deliver real-time trending of viruses and bacteria present in wastewater samples. (Source: bioMerieux SA, Press Release, April 2025)
- Roche received FDA approval for the first molecular test to screen for malaria in blood donors in the US. Roche's cobas Malaria test was approved by the FDA for use on the cobas 6800/8800 Systems. The test identifies infected blood units, making the blood supply safer. The test screens for the five main species of Plasmodium parasites that cause human infection. It can be used to screen blood, organ, and tissue donors, improving blood safety and availability. (Source: F. Hoffmann-La Roche Ltd, Press Release, March 2024)
Infectious Disease In vitro Diagnostics Market Report Coverage and Deliverables
The "Infectious Disease In vitro Diagnostics Market Size and Forecast (2021–2031)" report provides a detailed analysis of the market covering below areas:
- Infectious disease in vitro diagnostics market size and forecast at global, regional, and country levels for all the key market segments covered under the scope
- Infectious disease in vitro diagnostics market trends and market dynamics, such as drivers, restraints, and key opportunities
- Detailed PEST and SWOT analysis
- Infectious disease in vitro diagnostics market analysis covering key market trends, global and regional framework, major players, regulations, and recent market developments
- Industry landscape and competition analysis covering market concentration, heat map analysis, prominent players, and recent developments in the infectious disease in vitro diagnostics market
- Detailed company profiles
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
This text is related
to segments covered.
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
This text is related
to country scope.
Frequently Asked Questions
North America dominated the market in 2024.
The increasing prevalence of infectious diseases and strategic developments by key players contribute to market growth.
The market is expected to reach US$ 76.71 billion by 2031.
Abbott Laboratories, F. Hoffmann-La Roche Ltd., Becton Dickinson and Co., Sysmex Corp., bioMerieux SA, Bio-Rad Laboratories Inc., QIAGEN NV, QuidelOrtho Corp., and Bruker Corp are among the key players operating in the infectious disease in vitro diagnostics market.
The market is estimated to register a CAGR of 7.7% during the forecast period.
The List of Companies - Infectious Disease In-vitro Diagnostics Market
- Abbott Laboratories
- F. Hoffmann-La Roche Ltd.
- Becton Dickinson and Co
- Sysmex Corp
- bioMerieux SA
- Bio-Rad Laboratories Inc
- QIAGEN NV
- QuidelOrtho Corp
- Bruker Corp.
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
- Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
- Validates and strengthens in-house secondary research findings
- Develops the analysis team’s expertise and market understanding
Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:
- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
- Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.
Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- 3.1 Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- 3.2 Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- 3.3 Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- 3.4 Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.
Trends and growth analysis reports related to Infectious Disease In vitro Diagnostics Market
Jul 2025
Infectious Disease In vitro Diagnostics Market
Size and Forecast (2021-2031), Global and Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: Application (HIV or AIDS, Tuberculosis, Hepatitis B and C, Malaria, and Others), End User (Hospitals and Clinics, Diagnostic Laboratories, Blood Bank, and Others), and Geography
Jul 2025
Donor Blood Components Market
Size and Forecast (2021–2031), Global and Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: Blood Component (Red Blood Cells, White Blood Cells, Platelets, Plasma, and Others), Indication (Immunosuppression and Oncology), Application (Anemia Management, Thrombocytopenia Treatment, Coagulopathy Correction, Supportive Care During Chemotherapy, Surgery, and Others), Age Group (Adult and Child), End User (Hospitals, Oncology Centers, Transplant Centers, Ambulatory Surgical Centers, and Others), and Geography
Jul 2025
Aesthetic Injectable Devices Market
Size and Forecast (2021-2031), Global and Regional Share, Trend, and Growth Opportunity Analysis Report Coverage:Â Product (Dermal Filler, Botulinum Toxin and Others), Dermal Fillers (Calcium Hydroxylapatite, Hyaluronic Acid, Collagen, Poly-L-Lactic Acid, Polymethylmethacrylate, Fat Fillers, and Others), Device Type (Microcannulas, Pre-Filled Syringes, Mesotherapy Guns, and Others), Application (Facial Line Correction, Face Lift, Lip Treatment, Anti-Ageing and Wrinkle Treatment, Acne and Scar Treatment, Stretch Marks, and Others), Age Group (Up to 30, 31-40, 41-50, 51-60, and More Than 60), Gender (Female and Male), End User (Medical Spas, Dermatology Clinics, Hospitals, and Others), and Geography
Jul 2025
ECG Monitoring Equipment Market
Size and Forecast (2021-2031), Global and Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: By Product (Resting ECG, Stress ECG, Holter Monitors, and Cardiopulmonary Stress Testing Monitors), Lead Type (12-Lead ECG, 3–6 Lead ECG, and Single Lead), Technology [Portable (Wired) ECG System and Wireless ECG System], End User (Hospital and Clinics, Ambulatory Surgical Centers, Cardiac Centers, and Others), and Geography (North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America)
Jul 2025
Prescription Drugs Market
Size and Forecast (2021-2031), Global and Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: Product Type (Branded and Generics), Drug Type (Small Molecule and Biologics and Biosimilar), Therapeutic Area (Oncology, Cardiovascular Diseases, Neurological Diseases, Metabolic Diseases, Respiratory Diseases, Immunology, and Others), Route Of Administration (Oral, Injectable, Topical, and Others), Distribution Channel (Hospital Pharmacies, Retail Pharmacies and Online Pharmacies), and Geography (North America, Europe, Asia Pacific, Middle East & Africa, and South & Central America)
Jul 2025
Regenerative Dentistry Market
Size and Forecast (2021 - 2031), Global and Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: By Type (Natural and Synthetic), Technology (Tissue Engineering, Stem Cell Therapy, and Others), Application (Periodontal Regeneration, Endodontic Regeneration, Tooth Reconstruction, Bone Regeneration, and Others), Age Group (Adult and Pediatric), End User (Dental Clinics, Hospital, and Others), and Geography
Jul 2025
Wound Closure Devices Market
Size and Forecast (2021 - 2031), Global and Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: By Product (Sutures, Adhesives, Staplers, Strips, and Others), Wound Type (Chronic Wound and Acute Wound), End User (Hospitals, Clinics, Ambulatory Surgery Centers, and Others), and Geography
Jul 2025
Cell and Gene Therapy Contract Development and Manufacturing Organization Market
Size and Forecast (2021 - 2031), Global and Regional Share, Trend, and Growth Opportunity Analysis Report Coverage: By Service Type (Drug Development and Manufacturing, Testing and Regulatory Services, and Others), Product Type (Gene Therapy and Cell Therapy), End User (Pharmaceutical Companies, Biopharmaceutical Companies, and Others), and Geography