Syphilis Immunoassay Diagnostics Market: Global Industry Analysis and Forecast (2023-2029)

Syphilis Immunoassay Diagnostics Market size was valued at USD 528.84 Million in 2022 and the total Syphilis Immunoassay Diagnostics revenue is expected to grow at a CAGR of 3.2% from 2022 to 2029, reaching nearly USD 659.31 Million.

The Syphilis immunoassay diagnostics market is expected to witness significant growth in the major markets during the forecast period. The increase in the disease burden of syphilis, rapid technological advancements, and high R&D investments by key players to introduce novel & innovative products such as genetic biomarkers for antibiotic-resistant strains of bacteria, multiplex Point-of-Care (PoC), & self-testing products in the market are expected to drive the syphilis immunoassay diagnostics market. In addition, the increased focus of government & nonprofit organizations on early diagnosis, growth in screening recommendations for the younger population, and rise in awareness campaigns are factors boosting the adoption of syphilis immunoassay diagnostics with the potential to improve the diagnosis scenario.To know about the Research Methodology :- Request Free Sample Report

Syphilis is caused by the bacteria Treponema pallidum and is transmitted through sexual contact. The rates of syphilis are rising among several demographics globally. In 2020, 133,945 new cases of syphilis (all stages) were reported in the United States, according to the Centers for Disease Control and Prevention (CDC). Syphilis in people with vaginas is rising slightly more than in people with penises, though both groups are seeing an uptick in cases overall.

Without treatment, syphilis causes serious health problems. It can permanently damage the heart, brain, muscles, bones, and eyes of the infected person. As a result, syphilis diagnostic tests are in high demand to treat syphilis across the world. Immunoassays are protein-based tests that function on the principle of detection and quantification of antigen–antibodies interactions. Immunoassay plays a vital role in disease diagnosis and treatment planning. As a result, an increase in the prevalence of syphilis has created high demand for immunoassays for diagnosis. This is expected to benefit the syphilis immunoassay diagnostics market growth.
Syphilis Immunoassay Diagnostics Market Dynamics:
Technological advancements in Syphilis diagnostics

Technological advancements related to accuracy, portability, and cost-effectiveness are expected to drive market growth during the forecast period. Key players are expanding their test portfolios, which include qPCR instruments, by investing in R&D to develop diagnostic kits that can identify emerging diseases or by entering into agreements with other kit manufacturing companies. In April 2021, F. Hoffmann-La Roche Ltd. acquired GenMark Diagnostics, Inc. at a price of USD 24.05 per share in cash and holds around 82.89% of the total shares of the company.

GenMark Diagnostics, Inc. has proprietary technologies, such as eSensor XT-8 and ePlex, which can be utilized in developing infectious disease tests, including bloodstream infections. Furthermore, the development and commercialization of advanced products, such as multiplex PCR products and next-generation HIV testing kits, enable physicians to timely distinguish & diagnose a range of Sexually Transmitted Infections such as syphilis and provide appropriate treatment. The availability of at-home collection and self-testing kits reduces patient visits to clinics and promotes the discretion of patients. These factors are expected to influence the syphilis immunoassay diagnostics market growth.

Increasing government initiatives encouraging early diagnosis and treatment

The government of developed economies is undertaking initiatives for promoting early diagnosis of Sexually Transmitted Infections (STIs) including syphilis is expected to be the major driving factor for the syphilis immunoassay diagnostics market growth. The Sexually Transmitted Infections National Strategic Plan is a groundbreaking, first-of-its-kind five-year plan aimed at reversing the recent rapid growth in STIs in the U.S. The STI Plan establishes a vision as well as objectives, goals, and methods for dealing with the STI crisis. Indicators with measurable targets are also included to track progress.

The STI Plan focuses on syphilis which has significant morbidity rates, the most persistent & pervasive STI inequities, and the biggest impact on the health of the people, according to the U.S. national data. This national plan focuses on increasing awareness about STIs and expanding high-quality affordable screening, diagnosis, and treatment of these STIs.

Similarly, in July 2019, the Canadian government launched Action Plan on Sexually Transmitted and Blood-Borne Infections (STBBI), which plans to accelerate efforts for diagnosis, treatment, and prevention of STBBI. The newly established Innovative Diagnostics Program at the Public Health Agency of Canada's National Microbiology Laboratory received USD 5 million in research funding over 5 years. As outlined in the United Nations' Sustainable Development Goals, the Joint United Nations Program on HIV/AIDS, and WHO's global healthcare strategies, the Canadian government is determined to end HIV and viral hepatitis epidemics and reduce the health impact of STIs by 2030.

High demand for point-of-care diagnostics

Applications of immunoassay-based diagnostics are significantly increasing globally. Public awareness campaigns aimed at identifying the symptoms of infectious diseases and ways to prevent them play an important role in controlling the disease epidemic. Thus, increased patient awareness has led to high demand for immunoassays. For instance, the advocacy program by the International Society for Infectious Diseases focuses on collaborating with clinicians, public health practitioners, & researchers globally and supporting the exchange of scientific knowledge & application of public health practices & evidence-based medicine.

In addition, growing awareness about infectious diseases & preventive measures has led to high demand for rapid diagnostic test products, thereby increasing sales. Based on a survey by WHO on the World malaria report 2018, manufacturers reported sales of 276 million for lateral flow assays in 2017. Genetic variation in hosts & pathogens, population pressure, and environmental changes are some of the factors responsible for the increase in the incidence of emerging diseases.

Several smartphone-based devices and associated tools have emerged as next-generation point-of-care diagnostics or testing devices, boosting the market growth. For instance, a smartphone application combined with the autonomous capillary microfluidic chip is used for rapid testing of cardiac troponin I in myocardial infarction. This platform can be easily used in resource-limited settings, providing test results within 12 minutes. Thus, novel technological advancements are expected to further drive the syphilis immunoassay diagnostics market growth.
Syphilis Immunoassay Diagnostics Market Segment Analysis:
Based on Product Type, the reagent and kits segment held the largest market share of 78% in the global syphilis immunoassay diagnostics market in 2022. The segment is expected to grow at a CAGR of xx% during the forecast period. Reagents and kits are used for the detection and measurement of small molecules that cause diseases. The reagents used incorporate antibodies and change the color for identifying analytes. Various types of reagents and kits needed to identify analytes include antigens for coating microtiter plate wells, antibodies, blocking reagents, anti-IgG species, and substrates, which react with the enzyme for producing a colored product.

The increasing prevalence of infectious diseases including syphilis has created a high demand for immunoassay reagents & kits, as a result driving the segment growth. Also, approval and launch of novel immunoassay kits and reagents to facilitate the diagnosis of life-threatening diseases are expected to support the segment's growth. In 2020, the U.S. FDA approved over 68 immunoassay test kits for commercial use, indicating the increase in the usage of immunoassay kits for the diagnosis of various infectious diseases. Similarly, Abbott’s AdviseDx SARS-CoV-2 IgM was also approved by the U.S. FDA under an Emergency Use Authorization (EUA) and has been directed to be used solely in laboratories. According to research at the University of Washington, the kit exhibited 100% sensitivity and 99.9% specificity in the detection of IgG antibodies in patients after 17 days of reporting symptoms.

By Technology, the Chemiluminescence Immunoassays (CLIA) segment dominated the syphilis immunoassay diagnostics market with the highest revenue share in 2021. The segment is further expected to maintain its dominance by 2029. Chemiluminescence Immunoassay (CLIA) is a type of enzyme-based immunoassay that makes use of immunochemical reactions with chemiluminescence and is performed for detecting hapten, hormones, enzymes, fatty acids, drugs, vitamins, or antigens.

This technique is the most recent and advanced technique for tracing small amounts of analytes. The rising success of this technique in pharmaceutical analysis is mainly due to low detection limit coupled with high performance and good precision. Moreover, CLIA is highly accurate and sensitive in comparison with other techniques, such as ELISA and fluorescence methods.

Some of its advantages are the high stability of reagents, low cost, high sensitivity, rapid detection, and wide detection range. Some of the common compounds by pharmaceutical importance analyzed using CLIA range from antiepileptics such as carbamazepine, phenobarbital, phenytoin, and valproic acid; bronchodilators such as salbutamol & clenbuterol; vitamin B12; hormones such as insulin, thyroxin, estradiol, estrone, & testosterone; and prostate-specific antigen tumor markers. An increase in the R&D activities associated with CLIA is expected to offer lucrative growth to the segment during the forecast period.
Syphilis Immunoassay Diagnostics Market Regional Insights:
North America held the largest market share of 37.51% of the syphilis immunoassay diagnostics market in 2022 and is expected to dominate the global market by 2029 holding a market share of 38.85%. The high prevalence rate of syphilis, increased healthcare expenditure, rapid technological advancements, proactive government initiatives, and rise in customer awareness about syphilis disease and its diagnosis tests are all factors responsible for regional dominance. In addition, the strong presence of the leading market players in the region is expected to be the major factor boosting the regional revenue share.

The increasing launch of multiplex PCR tests for the diagnosis of Sexually Transmitted Diseases (STDs), such as syphilis is expected to further drive market growth. The increasing number of government measures, such as the Antimicrobial Stewardship Project, to accelerate the development & implementation of rapid diagnostic methods is further expected to be the major driving factor. An increase in the number of partnerships between in vitro diagnostic companies and non-profit organizations for spreading awareness about SexuallTDs is creating lucrative opportunities for growth in the syphilis immunoassay diagnostics market.

The U.S. market is expected to hold the largest market share and dominate the market by 2029. The high disposable income, rise in consumer awareness, and increase in disease burden of Syphilis. According to CDC, the prevalence of syphilis increased by 74%, from 2015, accounting for 129,813 cases, respectively, in 2019. The increasing number of testing and screening procedures for diagnosis of Syphilis can be attributed to high awareness among people in the U.S. The increasing commercialization of diagnostic products coupled with growing strategic initiatives is expected to support market growth.

For instance, in May 2021, OraSure Technologies, Inc. along with its partners, including Insignia Federal Group, LLC, Building Healthy Online Communities (BHOC), and Emory University, was selected by CDC for distribution of 100,000 HIV self-test kits. In addition, partnerships with major distributors, such as Walgreens, are expected to contribute to the syphilis immunoassay diagnostics market growth during the forecast period.

The reimbursement structure associated with the use of Sexually Transmitted Diseases diagnostics is expected to drive market growth in the U.S. UnitedHealthcare reimbursement policies may use CMS and Current Procedural Terminology (CPT) or other coding guidelines. For molecular diagnostic tests, molecular pathology or MoPath codes provide guidance & framework to payers, such as private insurance companies & Medicare, to properly bill for services, and laboratories, thereby enabling them to label molecular diagnostic tests. To make it easy for payers to properly reimburse and identify molecular diagnostic tests, these codes are changed to analyte-specific codes. Despite having clinical validity, physicians generally do not adopt a diagnostic device without sufficient reimbursement.

The Asia-Pacific region is expected to grow at a CAGR of xx% during the forecast period. The increasing emphasis on preventive healthcare and improving the economy is expected to support regional growth. An increase in pro-health initiatives, a rise in the adoption of better technologies, and an increase in consumer awareness are further factors driving regional growth. In addition, the rising incidence of Sexually transmitted diseases including syphilis, increasing demand for cost-effective diagnostics, and growing population are significantly contributing to market growth. Asia Pacific markets such as China, Australia, Korea, and Taiwan already have a healthcare reimbursement system that provides coverage for in vitro diagnostic tests. The presence of untapped opportunities in the form of unmet medical needs, increasing initiatives for scientific research, and positive economic growth are some of the primary growth drivers of the syphilis immunoassay diagnostics market.

Moreover, improving the healthcare regulatory scenario in developing countries is expected to attract international players to invest and capitalize on available opportunities. Positive changes, such as healthcare benefits by the government, increased awareness among the population, and increasing willingness to avail of high-end medical treatment is also expected to drive market growth in the region. The launch of products by local players in new markets to increase their presence is expected to accelerate the syphilis immunoassay diagnostics market growth.
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Global Syphilis Immunoassay Diagnostics Market


Report Coverage
Details


Base Year:
2022
Forecast Period:
2023-2029


Historical Data:
2018 to 2022
Market Size in 2022:
US $ 528.84 Mn.


Forecast Period 2023 to 2029 CAGR:
3.2%
Market Size in 2029:
US $ 659.31 Mn.


 Segments Covered:
by Product Type
Analyzers
Reagents and Kits


by Technology
CLIA
ELISA


by End-Users
Blood Banks
Diagnostic Labs
Hospital
Others



Syphilis Immunoassay Diagnostics Market, by Region
North America (United States, Canada and Mexico)
Europe (UK, France, Germany, Italy, Spain, Sweden, Austria and Rest of Europe)
Asia Pacific (China, South Korea, Japan, India, Australia, Indonesia, Malaysia, Vietnam, Taiwan, Bangladesh, Pakistan and Rest of APAC)
Middle East and Africa (South Africa, GCC, Egypt, Nigeria and Rest of ME&A)
South America (Brazil, Argentina Rest of South America)
Key Players
1. Abbott Laboratories  (Illinois, United States)
2. Beckman Coulter (California, United States)
3. Becton, Dickinson, and Company (New Jersey, United States)
4. bioMerieux (Marcy-l'Étoile, France)
5. Bio-Rad Laboratories (California, United States)
6. Danaher (Beckman Coulter), (California, United States)
7. DiaSorin (Saluggia, Italy)
8. Fujirebio (Miraca Group), (Japan)
9. Gold Standard Diagnostics (California, United States)
10.Newmarket Biomedical (United Kingdom)
11.NuGenerex Diagnostics (United States)
12.Ortho Clinical Diagnostics (Carlyle Group), (United States)
13.Roche (Basel, Switzerland)
14.Shenzhen New Industries Biomedical Engineering (China)
15.Siemens Healthineers (Germany)
16.Thermo Fisher Scientific, Inc. (United States)

FAQs:

1. What are the growth drivers for the Syphilis Immunoassay Diagnostics market?
Ans. The increase in the disease burden of syphilis, rapid technological advancements, and high R&D investments by key players to introduce novel & innovative products such as genetic biomarkers for antibiotic-resistant strains of bacteria, multiplex Point-of-Care (PoC), & self-testing products are expected to be the major driver for the Syphilis Immunoassay Diagnostics market.

2. What is the lucrative growth opportunity for the Syphilis Immunoassay Diagnostics market growth?
Ans. The Technological advancements in immunoassays diagnostics kits are expected to offer lucrative growth opportunities for the Syphilis Immunoassay Diagnostics market growth.

3. Which region is expected to lead the global Syphilis Immunoassay Diagnostics market during the forecast period?
Ans. The North American market is expected to lead the global Syphilis Immunoassay Diagnostics market during the forecast period due to the increased number of production plants in the Asia-Pacific region increasing the demand for Syphilis Immunoassay Diagnostics products and eventually driving the market growth.

4. What is the projected market size & growth rate of the Syphilis Immunoassay Diagnostics Market?
Ans. The Syphilis Immunoassay Diagnostics Market size was valued at USD 528.84 Million in 2022 and the total Syphilis Immunoassay Diagnostics revenue is expected to grow at a CAGR of 3.2% from 2022 to 2029, reaching nearly USD 659.31 Million.

5. What segments are covered in the Syphilis Immunoassay Diagnostics Market report?
Ans. The segments covered in the Syphilis Immunoassay Diagnostics market report are Product Type, Technology, End-users, and Region.