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The syphilis immunoassay diagnostics market size in the 7 major markets was valued at USD 411.4 million in 2023, driven by the incidence of syphilis cases in the major markets. The market is expected to grow at a CAGR of 3.0% during the forecast period of 2024-2032, with the values likely to rise from USD 423.6 million in 2024 to USD 534.9 million by 2032.
Syphilis immunoassay is a type of diagnostic method used to check if a patient is affected with syphilis. Syphilis is a bacterial infection. It is a sexually transmitted disease which spreads through oral, vaginal, or anal sexual contact. It may even pass down from a pregnant woman to the fetus.
The diagnosis is done via measuring certain antibody levels in the blood. It can be done through a blood test called rapid plasma regain (RPR) or through a blood or spinal fluid test called venereal disease research laboratory (VDRL) test.
Syphilis is the oldest known sexually transmitted disease, affecting a substantial portion of adults, falling in the age category of 15 to 49 years. Over the years, the incidence of Syphilis cases has increased by 32%. Therefore, there has been emphasis on diagnosing, preventing, and treating the disease. This has resulted in an increased syphilis immunoassay diagnostics market demand.
Syphilis is caused by the gram-negative bacterium Treponema pallidum. Currently, most of the syphilis detection is investigated through T. pallidum IgG chemiluminescence immunoassay (CLIA), which is a qualitative assay performed to detect the antibodies against the bacteria in the body. Owing to the array of CLIA applications, Fapon Biotech has developed around 80 different CLIA tests. The CLIA Analyzer Shine i8000/9000 produces high outputs for rapid and reliable clinical diagnosis. It does not require any extensive maintenance either. Therefore, the syphilis immunoassay diagnostics market value is certain to rise with such technologies.
As syphilis can also be transmitted to newborns via mother, there has been focus on preventing developing methods to detect congenital syphilis in children. The researchers from UTHealth Houston are developing a medical diagnostic test for the detection of congenital syphilis to facilitate early treatment. This method can turn out to be promising in the future as 60% of untreated syphilis infected infants suffer from neurodevelopmental issues.
Market Breakup by Product Type
Market Breakup by Technology
Market Breakup by End User
Market Breakup by Region
The United States is expected to lead the syphilis immunoassay diagnostics market share. As sexually transmitted diseases continue to rise in the region, the government has been setting several awareness campaigns to spread awareness and prevent the illness. ‘Girl, Get Tested’ is a notable public awareness campaign promoting syphilis screening in cisgender women. In addition, the United States also has prominent healthcare companies which continue to bring newer technologies.
The Asia Pacific region, especially Japan, is estimated to observe fastest growth, owing to the increasing prevalence of developing a well-equipped infrastructure for research and development. The syphilis immunoassay diagnostics market growth can be accredited to several awareness initiatives. For example, in March 2023, the Australian government initiated ‘Let your partners know’ syphilis awareness campaign envisioned to encourage contact tracing for people who have tested positive to syphilis. The aim is to ultimately increase syphilis testing and treatment.
The key features of the market report include patent analysis, grants analysis, clinical trials analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:
REPORT FEATURES | DETAILS |
Base Year | 2023 |
Historical Period | 2017-2023 |
Forecast Period | 2024-2032 |
Scope of the Report |
Historical and Forecast Trends, Industry Drivers and Constraints, Historical and Forecast Market Analysis by Segment:
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Breakup by Product Type |
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Breakup by Technology |
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Breakup by End User |
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Breakup by Region |
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Market Dynamics |
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Competitive Landscape |
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Companies Covered |
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*At Expert Market Research, we strive to always give you current and accurate information. The numbers depicted in the description are indicative and may differ from the actual numbers in the final EMR report.
1 Preface
1.1 Objectives of the Study
1.2 Key Assumptions
1.3 Report Coverage – Key Segmentation and Scope
1.4 Research Methodology
2 Executive Summary
3 Syphilis Disease Overview
3.1 Guidelines and Stages
3.2 Pathophysiology
3.3 Screening and Diagnosis
3.4 Treatment Pathway
4 Patient Profile
4.1 Patient Profile Overview
4.2 Patient Psychology and Emotional Impact Factors
4.3 Risk Assessment and Treatment Success Rate
5 Syphilis Disease Epidemiology Analysis – 7MM
5.1 7MM Epidemiology Scenario Overview (2017-2032)
5.2 United States Syphilis Disease Epidemiology Forecast (2017-2032)
5.3 EU-4 and United Kingdom Syphilis Disease Epidemiology Forecast (2017-2032)
5.3.1 Germany Syphilis Disease Epidemiology Forecast (2017-2032)
5.3.2 France Syphilis Disease Epidemiology Forecast (2017-2032)
5.3.3 Italy Syphilis Disease Epidemiology Forecast (2017-2032)
5.3.4 Spain Syphilis Disease Epidemiology Forecast (2017-2032)
5.3.5 United Kingdom Syphilis Disease Epidemiology Forecast (2017-2032)
5.4 Japan Syphilis Disease Epidemiology Forecast (2017-2032)
6 Syphilis Immunoassay Diagnostic Market Overview – 7MM
6.1 Syphilis Immunoassay Diagnostic Market Historical Value (2017-2023)
6.2 Syphilis Immunoassay Diagnostic Market Forecast Value (2024-2032)
7 Syphilis Immunoassay Diagnostic Market Landscape – 7MM
7.1 Syphilis Immunoassay Diagnostic: Developers Landscape
7.1.1 Analysis by Year of Establishment
7.1.2 Analysis by Company Size
7.1.3 Analysis by Region
7.2 Syphilis Immunoassay Diagnostic Product Landscape
7.2.1 Analysis by Product Type
7.2.2 Analysis by Technology
8 Syphilis Immunoassay Diagnostic Challenges and Unmet Needs
8.1 Treatment Pathway Challenges
8.2 Compliance and Drop-Out Analysis
8.3 Awareness and Prevention Gaps
9 Cost of Treatment
10 Syphilis Immunoassay Diagnostic Market Dynamics
10.1 Market Drivers and Constraints
10.2 SWOT Analysis
10.3 Porter’s Five Forces Model
10.4 Key Demand Indicators
10.5 Key Price Indicators
10.6 Industry Events, Initiatives, and Trends
10.7 Value Chain Analysis
11 Syphilis Immunoassay Diagnostic Market Segmentation – 7MM
11.1 Syphilis Immunoassay Diagnostic Market by Product Type
11.1.1 Market Overview
11.1.2 Analyzers
11.1.3 Kits
11.1.4 Reagents
11.2 Syphilis Immunoassay Diagnostic Market by Technology
11.2.1 Market Overview
11.2.2 CLIA
11.2.3 ELISA
11.2.4 Others
11.3 Syphilis Immunoassay Diagnostic Market by End User
11.3.1 Market Overview
11.3.2 Hospitals
11.3.3 Diagnostic Labs
11.3.4 Blood Banks
11.3.5 Others
11.4 Syphilis Immunoassay Diagnostic Market by Region
11.4.1 Market Overview
11.4.2 United States
11.4.3 EU-4 and the United Kingdom
11.4.3.1 Germany
11.4.3.2 France
11.4.3.3 Italy
11.4.3.4 Spain
11.4.3.5 United Kingdom
11.4.4 Japan
12 United States Syphilis Immunoassay Diagnostic Market
12.1 Syphilis Immunoassay Diagnostic Market Historical Value (2017-2023)
12.2 Syphilis Immunoassay Diagnostic Market Forecast Value (2024-2032)
12.3 Syphilis Immunoassay Diagnostic Market by Product Type
12.4 Syphilis Immunoassay Diagnostic Market by Technology
13 EU-4 and United Kingdom Syphilis Immunoassay Diagnostic Market
13.1 Syphilis Immunoassay Diagnostic Market Historical Value (2017-2023)
13.2 Syphilis Immunoassay Diagnostic Market Forecast Value (2024-2032)
13.3 Germany Syphilis Immunoassay Diagnostic Market Overview
13.3.1 Syphilis Immunoassay Diagnostic Market by Product Type
13.3.2 Syphilis Immunoassay Diagnostic Market by Technology
13.4 France Syphilis Immunoassay Diagnostic Market Overview
13.4.1 Syphilis Immunoassay Diagnostic Market by Product Type
13.4.2 Syphilis Immunoassay Diagnostic Market by Technology
13.5 Italy Syphilis Immunoassay Diagnostic Market Overview
13.5.1 Syphilis Immunoassay Diagnostic Market by Product Type
13.5.2 Syphilis Immunoassay Diagnostic Market by Technology
13.6 Spain Syphilis Immunoassay Diagnostic Market Overview
13.6.1 Syphilis Immunoassay Diagnostic Market by Product Type
13.6.2 Syphilis Immunoassay Diagnostic Market by Technology
13.7 United Kingdom Syphilis Immunoassay Diagnostic Market Overview
13.7.1 Syphilis Immunoassay Diagnostic Market by Product Type
13.7.2 Syphilis Immunoassay Diagnostic Market by Technology
14 Japan Syphilis Immunoassay Diagnostic Market
14.1 Syphilis Immunoassay Diagnostic Market Historical Value (2017-2023)
14.2 Syphilis Immunoassay Diagnostic Market Forecast Value (2024-2032)
14.3 Syphilis Immunoassay Diagnostic Market by Product Type
14.4 Syphilis Immunoassay Diagnostic Market by Technology
15 Regulatory Framework
15.1 Regulatory Overview
15.1.1 US FDA
15.1.2 EU EMA
15.1.3 JAPAN PMDA
16 Patent Analysis
16.1 Analysis by Type of Patent
16.2 Analysis by Publication year
16.3 Analysis by Issuing Authority
16.4 Analysis by Patent Age
16.5 Analysis by CPC Analysis
16.6 Analysis by Patent Valuation
16.7 Analysis by Key Players
17 Clinical Trials Analysis
17.1 Analysis by Trial Registration Year
17.2 Analysis by Trial Status
17.3 Analysis by Trial Phase
17.4 Analysis by Therapeutic Area
17.5 Analysis by Geography
18 Funding and Investment Analysis
18.1 Analysis by Funding Instances
18.2 Analysis by Type of Funding
18.3 Analysis by Funding Amount
18.4 Analysis by Leading Players
18.5 Analysis by Leading Investors
18.6 Analysis by Geography
19 Partnerships and Collaborations Analysis
19.1 Analysis by Partnership Instances
19.2 Analysis by Type of Partnership
19.3 Analysis by Leading Players
19.4 Analysis by Geography
20 Supplier Landscape
20.1 BioRad Laboratories Inc
20.1.1 Financial Analysis
20.1.2 Product Portfolio
20.1.3 Demographic Reach and Achievements
20.1.4 Mergers and Acquisitions
20.1.5 Certifications
20.2 Danaher Corporation
20.2.1 Financial Analysis
20.2.2 Product Portfolio
20.2.3 Demographic Reach and Achievements
20.2.4 Mergers and Acquisitions
20.2.5 Certifications
20.3 BECTON DICKINSON & COMPANY
20.3.1 Financial Analysis
20.3.2 Product Portfolio
20.3.3 Demographic Reach and Achievements
20.3.4 Mergers and Acquisitions
20.3.5 Certifications
20.4 F. Hoffmann-La Roche AG
20.4.1 Financial Analysis
20.4.2 Product Portfolio
20.4.3 Demographic Reach and Achievements
20.4.4 Mergers and Acquisitions
20.4.5 Certifications
20.5 Siemens Healthineers AG
20.5.1 Financial Analysis
20.5.2 Product Portfolio
20.5.3 Demographic Reach and Achievements
20.5.4 Mergers and Acquisitions
20.5.5 Certifications
20.6 Diasorin S.P.A
20.6.1 Financial Analysis
20.6.2 Product Portfolio
20.6.3 Demographic Reach and Achievements
20.6.4 Mergers and Acquisitions
20.6.5 Certifications
20.7 Abbott
20.7.1 Financial Analysis
20.7.2 Product Portfolio
20.7.3 Demographic Reach and Achievements
20.7.4 Mergers and Acquisitions
20.7.5 Certifications
20.8 Fujirebio
20.8.1 Financial Analysis
20.8.2 Product Portfolio
20.8.3 Demographic Reach and Achievements
20.8.4 Mergers and Acquisitions
20.8.5 Certifications
20.9 BioMerieux SA
20.9.1 Financial Analysis
20.9.2 Product Portfolio
20.9.3 Demographic Reach and Achievements
20.9.4 Mergers and Acquisitions
20.9.5 Certifications
20.10 Shenzhen New Industries Biomedical Engineering Co. Ltd
20.10.1 Financial Analysis
20.10.2 Product Portfolio
20.10.3 Demographic Reach and Achievements
20.10.4 Mergers and Acquisitions
20.10.5 Certifications
21 Syphilis Immunoassay Diagnostic Market- Distribution Model (Additional Insight)
21.1 Overview
21.2 Potential Distributors
21.3 Key Parameters for Distribution Partner Assessment
22 Key Opinion Leaders (KOL) Insights (Additional Insight)
23 Company Competitiveness Analysis (Additional Insight)
23.1 Very Small Companies
23.2 Small Companies
23.3 Mid-Sized Companies
23.4 Large Companies
23.5 Very Large Companies
24 Payment Methods (Additional Insight)
24.1 Government Funded
24.2 Private Insurance
24.3 Out-of-Pocket
*Additional insights provided are customisable as per client requirements.
The market attained a value of about USD 411.4 million in 2023, driven by the incidence of syphilis cases in the major markets.
The market is anticipated to grow at a CAGR of 3.0% during the forecast period of 2024-2032, likely to reach a market value of USD 534.9 million by 2032.
The growth of the market is driven by the rising emphasis on early detection of the diseases and the growing initiatives by the government.
The market has been flourished with new products that offer accurate and rapid results. For instance, Fapon Biotech has developed CLIA Analyzer Shine i8000/9000 for high outputs. It does not need any extra maintenance either.
The major regions of the market include United States, Japan, and EU-4 and the United Kingdom. EU-4 includes Germany, France, Italy, and Spain.
CLIA and ELISA, among others are different types of technologies available.
Products include analyzers, kits, and reagents.
Major end users include hospitals, diagnostic labs, and blood banks, among others.
Key players involved in the market are BioRad Laboratories Inc., Danaher Corporation, BECTON DICKINSON & COMPANY, F. Hoffmann-La Roche AG, Siemens Healthineers AG, Diasorin S.P.A, Abbott, Fujirebio, Shenzhen New Industries Biomedical Engineering Co. Ltd., and BioMerieux SA.
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