USD 22.94 Billion
Infectious Disease Diagnostics Market Size, Share, Growth Analysis, By Product & Service(Reagents, Kits, And Consumables, Instruments), By Type of Testing(Laboratory Testing, POC Testing), By Sample Type(Blood, Serum, and Plasma, Urine), By Disease Type(Hepatitis (Hepatitis B, Hepatitis C, Other Hepatitis Diseases), HIV), By Technology(Immunodiagnostics, Clinical Microbiology, Polymerase Chain Reaction, Isothermal Nucleic Acid Amplification Technology), By End User(Diagnostic Laboratories, Hospitals & Clinics, Academic Research Institutes, Other End Users), By Region - Industry Forecast 2025-2032
Report ID:
SQMIG35G2215 |
Region:
Global |
Published Date: September, 2024
Pages:
242
|Tables:
154
|Figures:
77
Infectious Disease Diagnostics Market Insights
Infectious Disease Diagnostics Market size was valued at USD 22.94 Billion in 2023 and is poised to grow from USD 24.82 Billion in 2024 to USD 46.62 Billion by 2032, growing at a CAGR of 8.20% during the forecast period (2025-2032).
Growing number of elderly people who are prone to infectious diseases, increasing awareness about early diagnosis, high demand for PoC diagnosis due to epidemics, rising infectious diseases are major factors driving the market in the forecast period.
The growing aging population worldwide and numerous untapped opportunities in developing countries are expected to boost the growth of the industry during the forecast period. According to World Bank Group estimates that in 2022 there were approximately 779 million people aged 65 & older worldwide. In addition, the number of individuals aged 80 and older is expected to more than double in 2050. The rise of infectious diseases is an important driver of rapid income. Moreover, it must be done routine screening of adults to avoid serious infections.
Increased regulatory scrutiny of the infectious disease diagnostics market as well. The regulatory framework for drug approval has always been one of the major inhibitors in the clinical research industry. The regulatory framework for the research sector is very strict in countries where the market has great potential for growth due to the large patient pool. Such sporadic and uncertain regulatory processes for in vitro diagnostics confuse manufacturers for commercial purposes.
There are very few direct alternatives to in vitro diagnostics products and services. The use of infectious imaging devices may restrain the Infectious Disease Diagnostics Market growth to some extent. However, IVD testing for infectious diseases outweighs the risk of alternatives due to its high accuracy and cost.
US Infectious Disease Diagnostics Market is poised to grow at a sustainable CAGR for the next forecast year.
Market snapshot - 2025-2032
Global Market Size
Largest Segment
Immunodiagnostics
Fastest Growth
Immunodiagnostics
Growth Rate
8.20% CAGR
Global Infectious Disease Diagnostics, Market 2021-2028 ($ Bn)
Country Share for North America Region- 2021 (%)
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Infectious Disease Diagnostics Market Segmental Analysis
Global Infectious Disease Diagnostics Market is segmented by Product & Service, Type of Testing, Sample Type, Disease Type, Technology, End User, and region. Based on Product & Service, the market is segmented into Reagents, Kits, And Consumables, Instruments, Software & Services. Based on Type of Testing, the market is segmented into Laboratory Testing, POC Testing. Based on Sample Type, the market is segmented into Blood, Serum, and Plasma, Urine, and Other Sample Types. Based on Disease Type, the market is segmented into Hepatitis, HIV, Hospital-acquired Infections, Mosquito-borne Diseases, HPV, Chlamydia Trachomatis, Neisseria Gonorrhea, Tuberculosis, Influenza, Syphilis, Other Infectious Diseases. Based on Technology, the market is segmented into Immunodiagnostics, Clinical Microbiology, Polymerase Chain Reaction, Isothermal Nucleic Acid Amplification Technology, DNA Sequencing & Next-generation Sequencing, DNA Microarray, Other Technologies. Based on End User, the market is segmented into Diagnostic Laboratories, Hospitals & Clinics, Academic Research Institutes, Other End Users. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & and Africa.
Analysis by Technology
Molecular diagnostic technology accounted for the largest Infectious Disease Diagnostics Market share of 35.76% in 2023. This can be attributed to the increased high accuracy of MDX technologies such as PCR, NGS, and its tests. Furthermore, key companies have participated the introduction of new devices for molecular diagnostics and the expansion of their product range. For example, in April 2023, ELITEchGroup published the roadmap for its upcoming innovation, the introduction of a high-throughput sample results in molecular-diagnostic tool. Immunodiagnostic technologies are expected to increase over the forecast period. The increasing demand for rapid research has led companies to focus on developing and commercializing antiviral drugs. For example, in October 2023, the widespread use of immunoassays for the diagnosis of various infectious diseases is expected to increase in the coming years.
The diagnostic laboratories segment plays an important role in the global infectious disease diagnostics market, serving as a key pillar in the identification, diagnosis and management of infectious diseases and delivery, respectively. A key strength of diagnostic laboratories is the ability to use advanced technologies such as polymer chain reaction (PCR), next-generation sequencing (NGS), and machine detection automated disease management to provide accurate and rapid detection of infectious agents. The scale at which diagnostic labs operate allows for comprehensive diagnostics, often serving hospitals, clinics and governments by providing centralized diagnostics for disease diagnosis and comprehensive diagnostic programs.
Analysis by Disease Type
The hepatitis segment plays an important role in the global infectious disease diagnostics market due to the high prevalence of hepatitis B (HBV) and hepatitis C (HCV) infections across the globe. The diagnosis of hepatitis is essential to identify and manage this chronic infection, which if left untreated can lead to severe liver disease including cirrhosis and liver cancer. The diagnosis of hepatitis is largely based on serological tests, which identify antibodies or antigens associated with the virus, and molecular tests such as PCR (Polymerase Chain Reaction), which indicate infection DNA or RNA in a patient’s blood. In addition, the increasing availability of clinical research in liver disease, especially in resource-limited settings, has provided diagnostic infrastructure, enabling comprehensive screening programs. The elimination of hepatitis as a public health threat has received increasing attention, as stated by the World Health Organization (WHO), which aims to eliminate vector-borne diseases by 2030, for funding greatly embedded in the diagnosis of liver disease.
The HIV segment is a keystone of the global infectious disease diagnostics market, with ongoing global efforts to prevent the spread of HIV/AIDS and manage the disease among infected persons. HIV diagnosis being critical provides early diagnosis, monitoring disease progression and guide treatment decisions occurs, especially with HIV. With an estimated 38 million people living with HIV worldwide, there is a demand for reliable and accessible diagnostic tools that can rapidly detect the virus, monitor viral load, and monitor drug response antiretroviral therapy (ART) is always effective. The technology for HIV detection has advanced dramatically, starting with enzyme-linked immunosorbent assays (ELISA) for the detection of HIV antibodies. Rapid diagnostic tests (RDTs) have been fundamentally revolutionary, providing results in minutes, which is essential for large-scale trials in manufactured environments and for low resources. RDTs extensive community-based self-testing programs, linked to clinic visits for HIV testing reducing stigma, and widespread use of testing, particularly in high-risk populations, have been achieved. This is especially important in settings where second-line treatment options are limited, making effective screening essential for better patient care. Furthermore, innovations in point-of-care HIV diagnosis are expanding.
Global Infectious Disease Diagnostics Market By Technology, 2021 (%)
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Infectious Disease Diagnostics Market Regional Insights
North America region in the infectious disease diagnostics market accounted for 38.49% of the global market in 2023. The industry is expected to keep expanding at lucrative growth during the forecast period with favorable & flexible regulatory framework. Presence of major manufacturers offering new IVD products, more testing and focus on disease management are the major factors driving the North America region. For example, in August 2023, the FDA provided a BD Vaginal Panel in the BD COR program to identify infectious agents that cause vaginal infections. The market for infectious diseases in the United States is expected to grow during the forecast period. The outbreak of COVID-19 dramatically changed the market landscape of diagnostics as companies engaged in test development with faster and more efficient turnaround times.
Asia Pacific is anticipated to witness significant Infectious Disease Diagnostics Market growth due to the high prevalence of infectious diseases, and the increasing demand for healthcare in emerging economies such as India and China are fueling the growth of the sector. The growing elderly population in countries such as Japan is also acting as a catalyst for the adoption of IVD screening. Rapid economic growth in the region and emerging market players are expected to drive the adoption of new diagnostic tests for infectious diseases in the community. The infectious diseases infectious disease diagnostics market in China is expected to grow during the forecast period. Increased need for early diagnosis, increased focus on new technology devices, and increasing levels of collaboration between leading partners & individual laboratories.
Global Infectious Disease Diagnostics Market By Geography, 2021-2028
- Largest
- Fastest
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Infectious Disease Diagnostics Market Dynamics
Infectious Disease Diagnostics Market Driver
Increasing Prevalence of Infectious Diseases
- The rise in infectious sicknesses which includes HIV, tuberculosis, hepatitis. COVID-19 is driving the demand for advanced diagnostics globally. These sicknesses require accurate, early diagnosis for powerful treatment, and wearable injectors, incorporated with diagnostic technologies, provide progressive solutions. Additionally, the increasing attention on disorder surveillance and outbreak monitoring has amplified the need for on-hand and speedy diagnostics, assisting marketplace expansion.
Technological Advancements in Diagnostics
- Another driver is the fast advancements in diagnostic technology, inclusive of molecular diagnostics and speedy diagnostics kits. These improvements enhance the accuracy and velocity of infectious disorder detection, presenting healthcare vendors better tools to deal with worldwide demanding health situations. Wearable injectors with diagnostic abilities are rising as a full-size device in dealing with infectious sicknesses, as they offer real-time data and enhance personalized remedy techniques.
Restraints
High Costs and Affordability Issues
- Despite technological improvements, the high cost of superior diagnostic equipment and wearable injectors remains a giant barrier. Many countries, especially in low- and middle-income areas, struggle with affordability and accessibility of those diagnostics, restricting their vast adoption. This economic barrier impacts Infectious Disease Diagnostics Market growth and exacerbates healthcare inequalities, especially in areas with restricted healthcare infrastructure.
Stringent Regulatory Approvals
- The infectious disease diagnostics marketplace faces stringent regulatory hurdles that gradual the introduction of innovative diagnostic answers, such as wearable injectors. These devices must bypass rigorous testing and gain approval from our bodies including the FDA, which prolongs time-to-marketplace and will increase prices. This regulatory burden in particular influences smaller organizations or startups which might be driving a great deal of the innovation in the zone.
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Infectious Disease Diagnostics Market Competitive Landscape
The competitive scenario of the infectious disease diagnostics market is characterized by established global players, emerging companies and local organizations all contributing to the growth of the industry by innovative a manufacture, partnerships and expansion of strategies. Major manufacturers such as Abbott Laboratories, Roche Diagnostics, Becton, Dickinson & Company (BD), and Biomeriex are market leaders, offering a range of diagnostic solutions from molecular diagnostics to point-of-care testing (POCT). These companies have strengthened their market positions through extensive divisions, strong R&D investments and global distribution networks.
Infectious Disease Diagnostics Market Top Player’s Company Profiles
- F. Hoffmann-La Roche Ltd. (Switzerland)
- Abbott (US)
- bioMérieux (France)
- Siemens Healthineers AG (Germany)
- Danaher (US)
- Thermo Fisher Scientific Inc. (US)
- Hologic, Inc. (US)
- Becton, Dickinson and Company (US)
- Revvity (US)
- Qiagen (Netherlands)
- Seegene Inc. (South Korea)
- QuidelOrtho Corporation (US)
- Grifols, S.A. (Spain)
- DiaSorin S.p.A. (Italy)
- Bio-Rad Laboratories, Inc. (US)
- Sysmex Corporation (Japan)
- OraSure Technologies (US)
- Co-Diagnostics, Inc. (US)
- Trinity Biotech (Ireland)
- Genetic Signatures Ltd. (Australia)
- Epitope Diagnostics, Inc. (US)
- Trivitron Healthcare (India)
- ELITech Group (France)
- Meril Life Sciences Pvt. Ltd. (India)
- InBios International, Inc. (US)
- Uniogen Oy (Finland)
- Vela Diagnostics (Singapore)
Infectious Disease Diagnostics Market Recent Developments
- In March 2024, SEKISUI Diagnostics, a global leader in the development of medical diagnostics, received an EUA license for the OSOM Flu SARS-CoV-2 Combo Test and has been approved for use in both commercial and home testing environments.
- In October 2023, Tangen Biosciences and SD Biosensors received an Early Use Authorization (EUA) from the US. at the FDA.
- In August 2023, BD will offer U.S. submitted a patent application with the Respiratory Viral Panel for the BD MAX System.
- In April 2023, EliTech announced plans to launch ELITE InGenius in 2024. EliVerse is an innovative high-performance molecular diagnostic device for more than 50 CE-IVD parameters.
Infectious Disease Diagnostics Key Market Trends
- Increase in Point-of-Care Testing (POCT): A major trend in the infectious disease diagnostics market is the rise of POCT. Changes in the decentralization of health care delivery and rapid on-demand analysis have led to the adoption of easy-to-use portable diagnostic kits. This trend does not appear to give rise to not only increases patient attendance but also reduces stress on hospitals by allowing outpatient testing.
- Expansion Of Molecular Diagnostics: The widespread use of molecular diagnostics in the diagnosis of infectious diseases is another major trend. This technology provides rapid and molecularly accurate results, enabling infection to be detected even before symptoms appear. Molecular analysis plays an increasingly important role in early detection, especially in preparing for and controlling outbreaks.
Infectious Disease Diagnostics Market SkyQuest Analysis
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
According to SkyQuest analysis, the global infectious disease detection market is driven by the increasing prevalence of infectious diseases and advancements in the diagnostic technologies. However, high costs and regulatory challenges hinder the growth of the market. Key trends such as increasing adoption of point-of-care testing, expansion of molecular diagnostics are shaping the future of the market where North America leads in terms of innovation and rapid adoption.
| Report Metric | Details |
|---|---|
| Market size value in 2023 | USD 22.94 Billion |
| Market size value in 2032 | USD 46.62 Billion |
| Growth Rate | 8.20% |
| Base year | 2024 |
| Forecast period | 2025-2032 |
| Forecast Unit (Value) | USD Billion |
| Segments covered |
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| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
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| Customization scope | Free report customization with purchase. Customization includes:-
|
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Table Of Content
Executive Summary
Market overview
- Exhibit: Executive Summary – Chart on Market Overview
- Exhibit: Executive Summary – Data Table on Market Overview
- Exhibit: Executive Summary – Chart on Infectious Disease Diagnostics Market Characteristics
- Exhibit: Executive Summary – Chart on Market by Geography
- Exhibit: Executive Summary – Chart on Market Segmentation
- Exhibit: Executive Summary – Chart on Incremental Growth
- Exhibit: Executive Summary – Data Table on Incremental Growth
- Exhibit: Executive Summary – Chart on Vendor Market Positioning
Parent Market Analysis
Market overview
Market size
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- SWOT Analysis
KEY MARKET INSIGHTS
- Technology Analysis
- (Exhibit: Data Table: Name of technology and details)
- Pricing Analysis
- (Exhibit: Data Table: Name of technology and pricing details)
- Supply Chain Analysis
- (Exhibit: Detailed Supply Chain Presentation)
- Value Chain Analysis
- (Exhibit: Detailed Value Chain Presentation)
- Ecosystem Of the Market
- Exhibit: Parent Market Ecosystem Market Analysis
- Exhibit: Market Characteristics of Parent Market
- IP Analysis
- (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
- Trade Analysis
- (Exhibit: Data Table: Import and Export data details)
- Startup Analysis
- (Exhibit: Data Table: Emerging startups details)
- Raw Material Analysis
- (Exhibit: Data Table: Mapping of key raw materials)
- Innovation Matrix
- (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
- Pipeline product Analysis
- (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
- Macroeconomic Indicators
COVID IMPACT
- Introduction
- Impact On Economy—scenario Assessment
- Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
- Revised Market Size
- Exhibit: Data Table on Infectious Disease Diagnostics Market size and forecast 2021-2027 ($ million)
- Impact Of COVID On Key Segments
- Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
- COVID Strategies By Company
- Exhibit: Analysis on key strategies adopted by companies
MARKET DYNAMICS & OUTLOOK
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- Regulatory Landscape
- Exhibit: Data Table on regulation from different region
- SWOT Analysis
- Porters Analysis
- Competitive rivalry
- Exhibit: Competitive rivalry Impact of key factors, 2021
- Threat of substitute products
- Exhibit: Threat of Substitute Products Impact of key factors, 2021
- Bargaining power of buyers
- Exhibit: buyers bargaining power Impact of key factors, 2021
- Threat of new entrants
- Exhibit: Threat of new entrants Impact of key factors, 2021
- Bargaining power of suppliers
- Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
- Competitive rivalry
- Skyquest special insights on future disruptions
- Political Impact
- Economic impact
- Social Impact
- Technical Impact
- Environmental Impact
- Legal Impact
Market Size by Region
- Chart on Market share by geography 2021-2027 (%)
- Data Table on Market share by geography 2021-2027(%)
- North America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- USA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Canada
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Europe
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Germany
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Spain
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- France
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- UK
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Europe
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Asia Pacific
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- China
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- India
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Japan
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Korea
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Asia Pacific
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Latin America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Brazil
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of South America
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Middle East & Africa (MEA)
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- GCC Countries
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Africa
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of MEA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
KEY COMPANY PROFILES
- Competitive Landscape
- Total number of companies covered
- Exhibit: companies covered in the report, 2021
- Top companies market positioning
- Exhibit: company positioning matrix, 2021
- Top companies market Share
- Exhibit: Pie chart analysis on company market share, 2021(%)
- Total number of companies covered
Methodology
For the Infectious Disease Diagnostics Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Infectious Disease Diagnostics Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Analyst Support
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Infectious Disease Diagnostics Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Infectious Disease Diagnostics Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
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