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Syphilis Immunoassay Diagnostics Global Market Report 2025
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Syphilis immunoassay diagnostics refer to laboratory tests designed to detect antibodies or antigens associated with the bacterium treponema pallidum, the causative agent of syphilis. These diagnostics utilize immunoassay techniques to detect specific immune responses present in the blood. The primary objective of syphilis immunoassay diagnostics is to accurately diagnose syphilis infections, facilitating prompt and effective treatment.

Key products in syphilis immunoassay diagnostics include analyzers, reagents, kits, and related items. Analyzers are devices employed in laboratories to analyze samples for the presence of syphilis. Various technologies utilized include chemiluminescence immunoassay (CLIA), enzyme-linked immunosorbent assay (ELISA), among others. These diagnostics cater to applications in both men and women and serve diverse end-users such as hospitals, blood banks, diagnostic laboratories, and others.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sharp rise in U.S. tariffs and the resulting trade tensions in spring 2025 are having a significant impact on the healthcare sector, especially in the supply of essential medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are grappling with higher costs for imported surgical tools, imaging systems, and consumables like syringes and catheters, many of which have limited domestic substitutes. These escalating expenses are putting pressure on healthcare budgets, prompting some providers to delay equipment upgrades or pass increased costs on to patients. Furthermore, tariffs on raw materials and components are disrupting the manufacturing of vital drugs and devices, leading to supply chain delays. In response, the industry is adopting diversified sourcing strategies, expanding local production where feasible, and pushing for tariff exemptions on critical medical products.

The syphilis immunoassay diagnostics market research report is one of a series of new reports from The Business Research Company that provides syphilis immunoassay diagnostics market statistics, including the syphilis immunoassay diagnostics industry global market size, regional shares, competitors with syphilis immunoassay diagnostics market share, detailed syphilis immunoassay diagnostics market segments, market trends, and opportunities, and any further data you may need to thrive in the syphilis immunoassay diagnostics industry. These syphilis immunoassay diagnostics market research reports deliver a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

The syphilis immunoassay diagnostics market size has grown strongly in recent years. It will grow from $31.25 billion in 2024 to $33.5 billion in 2025 at a compound annual growth rate (CAGR) of 7.2%. The growth in the historic period can be attributed to rise in socioeconomic factors such as STDs, increasing percentage of unidentified sex, growing incidences of fatal syphilis diseases, growing initiatives by the government, and rising emphasis on early detection of the diseases.

The syphilis immunoassay diagnostics market size is expected to see strong growth in the next few years. It will grow to $44.26 billion in 2029 at a compound annual growth rate (CAGR) of 7.2%. The growth in the forecast period can be attributed to rapid growth of high-risk population, increasing awareness about partner notification programs, rise in the prevalence, increase awareness of syphilis immunoassay diagnostics, and surge in government expenditure on healthcare. Major trends in the forecast period include adoption of innovative technologies, development of rapid point-of-care tests, growing demand for home test kits, advancements in laboratory testing methods, and expansion of the diagnostic laboratory techniques.

The forecast of 7.2% growth over the next five years reflects a modest reduction of 0.5% from the previous estimate for this market. This reduction is primarily due to the impact of tariffs between the US and other countries. Tariff barriers are expected to hamper Sexually Transmitted Disease screening by increasing the cost of rapid treponemal test kits and automated analyzers sourced from Germany and Spain, thereby slowing diagnosis and elevating public health laboratory expenditures. The effect will also be felt more widely due to reciprocal tariffs and the negative effect on the global economy and trade due to increased trade tensions and restrictions.

The increasing prevalence of sexually transmitted diseases (STDs) is expected to drive the growth of the syphilis immunoassay diagnostics market in the coming years. STDs, or sexually transmitted infections (STIs), are primarily spread through sexual contact, including vaginal, anal, and oral sex. The rise in STDs can be attributed to factors such as reduced condom use, antibiotic resistance, lack of sexual education, changes in social and behavioral patterns, stigma, reduced funding for STD prevention programs, and greater travel. Syphilis immunoassay diagnostics play a critical role in the detection and management of STDs by providing accurate and timely identification of syphilis infections, which enables appropriate treatment and preventive measures. For example, in June 2024, the UK-based Terrence Higgins Trust reported that data from the UK Health Security Agency (UKHSA) indicated 401,800 STIs were reported in England in 2023, a 5% increase from the previous year. As a result, the growing incidence of STDs is fueling the demand for syphilis immunoassay diagnostics.

Major companies in the syphilis immunoassay diagnostics market are prioritizing the development of innovative solutions, including rapid syphilis tests, to enhance the efficiency and accuracy of syphilis detection. Rapid syphilis tests are user-friendly, point-of-care tools that detect syphilis antibodies in blood or bodily fluids within minutes, facilitating prompt diagnosis and early treatment. For example, in February 2023, Chembio Diagnostics Inc., a US-based company specializing in point-of-care diagnostics for infectious diseases, received a CLIA waiver from the FDA for its DPP HIV-Syphilis System. This dual rapid test is designed to simultaneously detect antibodies to HIV 1/2 and Treponema pallidum, the bacterium that causes syphilis. Conducted in just 15 minutes, this test aims to enhance diagnostic accuracy and treatment efficacy, particularly in preventing mother-to-child transmission of syphilis and reducing the risk of HIV transmission among individuals with syphilis.

In April 2023, Biosynex SA, a France-based company specializing in syphilis immunoassay diagnostics, acquired Chembio Diagnostics, Inc. for $17.2 million. This strategic acquisition aims to bolster Biosynex's market footprint in North America by leveraging Chembio's established portfolio of FDA-approved products and expertise in rapid diagnostic tests. Chembio Diagnostics Inc., based in the United States, is renowned for its focus on point-of-care diagnostics for infectious diseases, including syphilis.

Major companies operating in the syphilis immunoassay diagnostics market are F. Hoffmann-La Roche Ltd., Thermo Fisher Scientific Inc., Abbott Laboratories, Siemens Healthineers, Becton Dickinson and Company, bioMerieux SA, Bio-Rad Laboratories Inc., Meril Life Sciences Pvt. Ltd., Randox Laboratories Ltd., SEKISUI Diagnostics, Bloodworks Northwest, LetsGetChecked, Everlywell Inc., ACON Laboratories Inc., Trinity Biotech, Fujirebio, CTK Biotech Inc., bioLytical Laboratories Inc., AdvaCare Pharma, MyBioSource.com, Gold Standard Diagnostics Frankfurt GmbH, Newmarket Biomedical Ltd, InTec PRODUCTS INC., NuGenerex Diagnostics LLC

North America was the largest region in the syphilis immunoassay diagnostics market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the syphilis immunoassay diagnostics market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

The countries covered in the syphilis immunoassay diagnostics market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The syphilis immunoassay diagnostics market consists of revenues earned by entities by providing services such as sample collection services, laboratory testing services, point-of-care testing services, and consultation and follow-up services. The market value includes the value of related goods sold by the service provider or included within the service offering. The syphilis immunoassay diagnostics market also consists of sales of rapid plasma reagin (RPR) tests, fluorescent treponemal antibody absorption (FTA-ABS) tests, point-of-care (POC) tests, western blot assays, and multiplex immunoassays. Values in this market are 'factory gate' values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

Syphilis Immunoassay Diagnostics Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses on syphilis immunoassay diagnostics market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.

Reasons to Purchase

Where is the largest and fastest growing market for syphilis immunoassay diagnostics ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The syphilis immunoassay diagnostics market global report from the Business Research Company answers all these questions and many more.

The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.

The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.

Scope

Table of Contents

1. Executive Summary

2. Syphilis Immunoassay Diagnostics Market Characteristics

3. Syphilis Immunoassay Diagnostics Market Trends And Strategies

4. Syphilis Immunoassay Diagnostics Market - Macro Economic Scenario Including The Impact Of Interest Rates, Inflation, Geopolitics, Trade Wars and Tariffs, And Covid And Recovery On The Market

5. Global Syphilis Immunoassay Diagnostics Growth Analysis And Strategic Analysis Framework

6. Syphilis Immunoassay Diagnostics Market Segmentation

7. Syphilis Immunoassay Diagnostics Market Regional And Country Analysis

8. Asia-Pacific Syphilis Immunoassay Diagnostics Market

9. China Syphilis Immunoassay Diagnostics Market

10. India Syphilis Immunoassay Diagnostics Market

11. Japan Syphilis Immunoassay Diagnostics Market

12. Australia Syphilis Immunoassay Diagnostics Market

13. Indonesia Syphilis Immunoassay Diagnostics Market

14. South Korea Syphilis Immunoassay Diagnostics Market

15. Western Europe Syphilis Immunoassay Diagnostics Market

16. UK Syphilis Immunoassay Diagnostics Market

17. Germany Syphilis Immunoassay Diagnostics Market

18. France Syphilis Immunoassay Diagnostics Market

19. Italy Syphilis Immunoassay Diagnostics Market

20. Spain Syphilis Immunoassay Diagnostics Market

21. Eastern Europe Syphilis Immunoassay Diagnostics Market

22. Russia Syphilis Immunoassay Diagnostics Market

23. North America Syphilis Immunoassay Diagnostics Market

24. USA Syphilis Immunoassay Diagnostics Market

25. Canada Syphilis Immunoassay Diagnostics Market

26. South America Syphilis Immunoassay Diagnostics Market

27. Brazil Syphilis Immunoassay Diagnostics Market

28. Middle East Syphilis Immunoassay Diagnostics Market

29. Africa Syphilis Immunoassay Diagnostics Market

30. Syphilis Immunoassay Diagnostics Market Competitive Landscape And Company Profiles

31. Syphilis Immunoassay Diagnostics Market Other Major And Innovative Companies

32. Global Syphilis Immunoassay Diagnostics Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Syphilis Immunoassay Diagnostics Market

34. Recent Developments In The Syphilis Immunoassay Diagnostics Market

35. Syphilis Immunoassay Diagnostics Market High Potential Countries, Segments and Strategies

36. Appendix

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