Syphilis Immunoassay Diagnostics Market (Product: Analyzers, Kits & Reagents; Technology: ELISA, CLIA, Others; End User: Hospitals, Diagnostic Labs, Blood Banks, Others) - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2019 - 2030

Advanced Analyzers Provide High-quality Solutions in Syphilis Immunoassay Diagnostics

New innovations in syphilis analyzers are becoming increasingly mainstream in the syphilis immunoassay diagnostics market. As such, companies are launching new technologies in analyzers. For instance, in April 2019, Gold Standard Diagnostics - a provider of comprehensive diagnostic solutions, revealed the launch of its proprietary technology with a U.S. patent, which performs serological testing for syphilis.

Advancements in analyzer technologies are creating incremental opportunities for healthcare companies in the syphilis immunoassay diagnostics market space. There is increasing demand for advanced analyzers in hospitals and blood banks due to increase in the spending capacity of patients with STDs. Companies in the syphilis immunoassay diagnostics market are innovating in new technologies with the help of dedicated machines to automate rapid plasma regain (RPR) assays. They are improving testing capabilities for laboratories with the help of new software developments to enhance outcomes in patients.

Novel approaches of technological automation and machine learning are being adopted to develop first-of-its-kind diagnostics systems. The combination of approaches is helping clinical laboratories offer high-quality solutions for syphilis testing.

On-the-spot Testing Solutions Help Perform Immunoassays in ELISA

The growing trend of on-the-spot testing solutions has led to improvements in the syphilis immunoassay diagnostics landscape. For instance, clinical diagnostics company MBio, announced the launch of the LightDeck® platform, an innovative analytical technology that performs quantitative immunoassays and cell based assays. With the help of on-the-spot testing, companies in the syphilis immunoassay diagnostics market can tap into new business models, such as providing analytical testing services to the veterinary, food, military sectors.

Companies in the syphilis immunoassay diagnostics market are focused on expanding their product portfolios. They are increasing efforts to manufacture and sell instruments by acquiring licensing for the same. By these efforts, they are supporting the global OEM supply business model associated with various assays and their applications.

Healthcare industries are developing multiplexed immunoassay systems by experimenting on planar waveguide technology and fluorescence imaging. These efforts are being made to support outcomes in the ELISA (enzyme-linked immunosorbent assay) test, since ELISA currently accounts for the highest revenue in the syphilis immunoassay diagnostics market.

Recent advancements in molecular biology have led to the popularity of molecular diagnosis, such as the polymerase chain reaction (PCR), in the syphilis immunoassay diagnostics ecosystem. PCR technology is playing a crucial role in diagnosing syphilis. Healthcare industries in the syphilis immunoassay diagnostics market are developing various PCR methodologies that can be easily adapted in the clinical and laboratory environment. PCR is being increasingly associated with widespread application and deep exploration in the healthcare space.

Fast developments in PCR have led to advancements in real-time PCR, nested PCR, and multiplex PCR. The high sensitivity and specificity of PCR is well-suited for the diagnosis of early-stage syphilis. On the other hand, routine PCR is well-received in secondary syphilis. Healthcare companies in the syphilis immunoassay diagnostics market are increasing R&D to detect atypical cases of vertebral, ocular, and tonsillar syphilis with the help of molecular biology. Real-time PCR is gaining increased popularity for its ability to calculate the sum of pathogens that reveal the severity of the infection.

Companies Improve Access to Testing Technologies in LMICs to Prevent Maternal Syphilis

The issue of maternal and child mortality due to syphilis and HIV/AIDS is distinctly prevalent in low- and middle-income countries (LMICs). This is why, healthcare industries in the syphilis immunoassay diagnostics market are increasing efforts to improve child and maternal health through antenatal care.

At the same time, companies in the syphilis immunoassay diagnostics space are innovating in point of care diagnostic services. Although healthcare industries are making progress in the prevention of mother-to-child transmission, several new cases of pediatric infections are still being reported. Thus, companies in the syphilis immunoassay diagnostics market should improve access to new testing technologies that will reduce the incidence of syphilis infection in LMICs. Along with testing for syphilis, companies should offer convenient testing options such as the dual HIV/syphilis rapid diagnostics test to help patients assess the prevalence of any other bacterial infections.

Companies in the syphilis immunoassay diagnostics ecosystem are also increasing the availability of antenatal rapid syphilis testing in LMICs. Undiagnosed and untreated maternal syphilis has catalyzed the demand for antenatal rapid syphilis testing.

Analysts’ Viewpoint

Kits and reagents are projected for high growth in the syphilis immunoassay diagnostics market. Apart from manual testing, healthcare companies are turning toward automating high-quality syphilis test kits with the use of state-of-the-art machines. FDA-cleared automated analyzers are also triggering market growth.

Healthcare providers are increasingly replacing labor-intensive reading with full automatic results that meet the 'results-per-hour' demand. However, the transmission of syphilis during blood donation poses a huge risk for healthcare providers. Hence, companies should educate healthcare providers about thorough health consultation and screening of high-risk groups before blood donation. Companies should invest in developing robust clinical chemistry analyzers that provide automation-ready immunoassays.

Syphilis Immunoassay Diagnostics Market and Report Description

Syphilis is a sexually transmitted disease caused by a bacteria called Treponema pallidum. The most common route of transmission is through contact with an infected person’s sore during sexual activity. The syphilis immunoassay diagnostics market is likely to expand significantly, as syphilis continues to be a global concern.

Syphilis immunoassay diagnostic tests are vital to ascertain an infection. According to CDC and IUSTI guidelines, blood serological tests for syphilis remain the diagnostic standard. At least one treponemal antigen test (syphilis immunoassay diagnostics) and one non-treponemal antigen test is sufficient to confirm syphilis.

The global syphilis immunoassay diagnostics market was valued at ~US$ 310 Mn in 2018, and is projected to reach ~US$ 380 Mn by 2027.

The global syphilis immunoassay diagnostics market is projected to expand at a CAGR of ~2% during the forecast period of 2019 to 2027.

Syphilis Immunoassay Diagnostics Market: Drivers

Sexually transmitted diseases (STDs) have reached become an epidemic across the world. According to 2016 World Health Organizations (WHO) research findings, more than 1 million people acquire sexually transmitted infections (STI), every day, globally.

Research findings also suggest that, every year, 350 million new cases of one of four (chlamydia, gonorrhea, syphilis, and trichomoniasis) curable sexually transmitted infections (STIs) occur each year, and out of that, 6 million new cases are found. This is estimated to offer significant opportunities to the syphilis immunoassay diagnostic market.

Mother-to-child and gestational syphilis is a global concern, and affects more than 1 million pregnant women, globally. This is likely to drive the demand for syphilis immunoassay diagnostics.

Syphilis is primarily transmitted through sexual activity, and it remains a significant public health issue, worldwide. STDs are caused due to social, economic, and biological factors. STDs disproportionately affect disenfranchised people and people in social networks, in which high-risk sexual behavior is commonly observed, especially when either access to healthcare or health-seeking behavior is compromised. Therefore, socioeconomic factors are also likely to boost the global syphilis immunoassay diagnostic market.

Global Syphilis Immunoassay Diagnostics Market: Key Segments

The global syphilis immunoassay diagnostics market has been bifurcated into product, technology, and end user.

Increasing number of tests and one time uses of reagents are projected to boost the demand for kits & reagents at a high CAGR in the syphilis immunoassay diagnostics market.

In terms of end user, diagnostic labs held a dominant share of the global syphilis immunoassay diagnostic market; however, mandatory tests of blood donors is boosting the blood banks segment across the globe.

Higher efficiency of CLIA technology and low turnaround time as compared to that offered by ELISA technology are projected to drive the demand for CLIA technology in the syphilis immunoassay diagnostics market during the forecast period.

Global Syphilis Immunoassay Diagnostics Market: Trends

Preparing reagents for testing is a time-consuming job. Ready-to-use reagents offer several advantages as compared to that offered by preparing reagents.

Ready-to use reagents avoid wastage of time taken for dilutions, calculation, pipetting, and prevents contamination. So, the demand for these reagents is high in hospitals and clinical laboratories, thereby boosting the syphilis immunoassay diagnostics market.

Moreover, technological advancements are closing the gaps for effective diagnosis by providing better diagnostics procedures. Hospitals and labs in emerging economies in Asia Pacific are able to carry larger number of tests for syphilis through advanced analyzers and offer proper treatment options to eradicate syphilis infection. For instance, in June 2016, Thailand became the first country in Asia to eliminate mother-to-child transmission of syphilis, after it successfully reduced transmission rates to less than 2%.

Global Syphilis Immunoassay Diagnostics Market: Major Players

Key players analyzed in this report on the syphilis immunoassay diagnostics market are -

• Bio-Rad Laboratories, Inc.
• Danaher (Beckman Coulter, Inc.)
• Becton
• Dickinson and Company
• F. Hoffmann-La Roche Ltd
• Siemens Healthineers AG
• DiaSorin S.p.A.
• Abbott Laboratories
• Ortho Clinical Diagnostics (a part of Carlyle Group)
• Shenzhen New Industries Biomedical Engineering Co., Ltd.
• bioMérieux SA
• Fujirebio (Miraca Group)

Strategic mergers & acquisitions, new product launches, and emphasis on research & development are key strategies adopted by major players in the global syphilis immunoassay diagnostics market.

On October 03, 2017, Abbott announced the acquisition of Alere Inc., a provider of diagnostic devices and services, for nearly US$ 5,300.0 Mn.

In June 2017, Bio-Rad Laboratories, Inc. received FDA approval for its BioPlex 2200 syphilis total & RPR assay, a novel testing method for the diagnosis of syphilis infection.

Major players in the syphilis immunoassay diagnostics market such as Abbott, Siemens Healthineers AG, F. Hoffmann-La Roche Ltd, and DiaSorin S.p.A. hold more than 50% share of the global syphilis immunoassay diagnostics market.

Key Questions Answered in Syphilis Immunoassay Diagnostics Market Report

• What is the sales/revenue expected to be generated by each product type across all regions during the forecast period?
• What are the opportunities in the global syphilis immunoassay diagnostics market?
• What are the major drivers, restraints, opportunities, and threats in the syphilis immunoassay diagnostics market?
• Which region is likely to expand at the fastest CAGR during the forecast period?
• Which syphilis immunoassay diagnostics and technology segments are expected to generate the highest revenue, globally, in 2027? Which segment is projected to expand at the highest CAGR during the forecast period?
• What was the market share or position of different companies operating in the global syphilis immunoassay diagnostics market in 2018?

Global Syphilis Immunoassay Diagnostics Market - Segmentation

Product

• Analyzers
• Kits & Reagents

Technology

• ELISA
• CLIA
• Others

End User

• Hospitals  
• Diagnostic Labs
• Blood Banks
• Others

Region

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa

1. Preface

    1.1. Market Definition and Scope

    1.2. Market Segmentation

    1.3. Key Research Objectives

    1.4. Research Highlights

2. Assumptions and Research Methodology

3. Executive Summary : Global Syphilis Immunoassay Diagnostics Market

4. Market Overview

    4.1. Introduction

        4.1.1. Class Definition

        4.1.2. Industry Evolution / Developments

    4.2. Overview

    4.3. Market Dynamics

        4.3.1. Drivers

        4.3.2. Restraints

        4.3.3. Opportunities

    4.4. Global Syphilis Immunoassay Diagnostics Market Analysis and Forecast, 2017–2027

        4.4.1. Market Revenue Projections (US$ Mn)

5. Market Outlook

    5.1. Technological Advancement

    5.2. Key Merger & Acquisition

    5.3. Top Three Players- Analysis

    5.4. Number of Syphilis Diagnostic Test, by Technology (2018)

    5.5. Pricing Analysis by Technology

    5.6. Disease Prevalence & Incidence Rate

6. Global Syphilis Immunoassay Diagnostics Market Analysis and Forecast, by Product, 2017-2027 

    6.1. Introduction & Definition

    6.2. Key Findings / Developments

    6.3. Market Value Forecast, by Product, 2017–2027

        6.3.1. Analyzers

        6.3.2. Kits & Reagents

    6.4. Global Syphilis Immunoassay Diagnostics Market Attractiveness, by Product 

7. Global Syphilis Immunoassay Diagnostics Market Analysis and Forecast, by Technology, 2017-2027 

    7.1. Introduction & Definition

    7.2. Key Findings / Developments

    7.3. Global Syphilis Immunoassay Diagnostics Market Value Forecast, by Technology, 2017–2027

        7.3.1. ELISA

        7.3.2. CLIA

        7.3.3. Others

    7.4.  Market Attractiveness, by Technology 

8. Global Syphilis Immunoassay Diagnostics Market Analysis and Forecast, by End-user

    8.1. Introduction & Definition

    8.2. Key Findings / Developments

    8.3. Global Syphilis Immunoassay Diagnostics Market Value Forecast, by End-user, 2017–2027

        8.3.1. Hospitals

        8.3.2. Diagnostics Labs

        8.3.3. Blood Banks

        8.3.4. Others

    8.4. Global Syphilis Immunoassay Diagnostics Market Attractiveness, by End-user

9. Global Syphilis Immunoassay Diagnostics Market Analysis and Forecast, by Region, 2017-2027

    9.1. Key Findings

    9.2. Market Value Forecast, by Region

        9.2.1. North America 

        9.2.2. Europe 

        9.2.3. Asia Pacific 

        9.2.4. Latin America 

        9.2.5. Middle East & Africa 

    9.3. Global Syphilis Immunoassay Diagnostics Market Attractiveness, by Region

10. North America Syphilis Immunoassay Diagnostics Market Analysis and Forecast, 2017-2027

    10.1. Introduction

        10.1.1. Key Findings

    10.2. North America Syphilis Immunoassay Diagnostics Market Value Forecast, by Product, 2017–2027

        10.2.1. Analyzers

        10.2.2. Kits & Reagents

    10.3. North America Syphilis Immunoassay Diagnostics Market Value Forecast, by Technology, 2017-2027

        10.3.1. ELISA

        10.3.2. CLIA

        10.3.3. Others

    10.4. North America Syphilis Immunoassay Diagnostics Market Value Forecast, by End-user, 2017-2027

        10.4.1. Hospitals

        10.4.2. Diagnostics Labs

        10.4.3. Blood Banks

        10.4.4. Others

    10.5. North America Syphilis Immunoassay Diagnostics Market Value Forecast, by Country, 2017-2027 

        10.5.1. U.S.

        10.5.2. Canada

    10.6. North America Syphilis Immunoassay Diagnostics Market Attractiveness Analysis 

        10.6.1. By Product 

        10.6.2. By Technology 

        10.6.3. By End-user

        10.6.4. By Country

11. Europe Syphilis Immunoassay Diagnostics Market Analysis and Forecast, 2017-2027

    11.1. Introduction

        11.1.1. Key Finding

    11.2. Europe Syphilis Immunoassay Diagnostics Market Value Forecast, by Product, 2017-2027

        11.2.1. Analyzers

        11.2.2. Kits & Reagents 

    11.3. Europe Syphilis Immunoassay Diagnostics Market Value Forecast, by Technology, 2017-2027

        11.3.1. ELISA

        11.3.2. CLIA

        11.3.3. Others

    11.4. Europe Syphilis Immunoassay Diagnostics Market Value Forecast, by End-user, 2017-2027

        11.4.1. Hospitals

        11.4.2. Diagnostic Labs

        11.4.3. Blood Banks

        11.4.4. Others

    11.5. Europe Syphilis Immunoassay Diagnostics Market Value Forecast, by Country/Sub-region, 2017-2027

        11.5.1. Germany

        11.5.2. U.K.

        11.5.3. France

        11.5.4. Italy

        11.5.5. Spain

        11.5.6. Russia

        11.5.7. Turkey

        11.5.8. Eastern Europe

        11.5.9. Rest of Europe

    11.6. Europe Syphilis Immunoassay Diagnostics Market Attractiveness Analysis 

        11.6.1. By Product 

        11.6.2. By Technology 

        11.6.3. By End-user

        11.6.4. By Country/Sub-region

12. Asia Pacific Syphilis Immunoassay Diagnostics Market Analysis and Forecast, 2017-2027

    12.1. Introduction

        12.1.1. Key Finding

    12.2. Asia Pacific Syphilis Immunoassay Diagnostics Market Value Forecast, by Product, 2017-2027

        12.2.1. Analyzers

        12.2.2. Kits & Reagents 

    12.3. Asia Pacific Syphilis Immunoassay Diagnostics Market Value Forecast, by Technology, 2017-2027

        12.3.1. ELISA

        12.3.2. CLIA

        12.3.3. Others

    12.4. Asia Pacific Syphilis Immunoassay Diagnostics Market Value Forecast, by End-user, 2017-2027

        12.4.1. Hospitals

        12.4.2. Diagnostic Labs

        12.4.3. Blood Banks

        12.4.4. Others

    12.5. Asia Pacific Syphilis Immunoassay Diagnostics Market Value Forecast, by Country/Sub-region, 2017-2027

        12.5.1. China

        12.5.2. Japan

        12.5.3. India

        12.5.4. Australia & New Zealand

        12.5.5. South Korea

        12.5.6. Vietnam

        12.5.7. Rest of Asia Pacific

    12.6. Asia Pacific Syphilis Immunoassay Diagnostics Market Attractiveness Analysis 

        12.6.1. By Product 

        12.6.2. By Technology 

        12.6.3. By End-user

        12.6.4. By Country/Sub-region

13. Latin America Syphilis Immunoassay Diagnostics Market Analysis and Forecast, 2017-2027

    13.1. Introduction

        13.1.1. Key Finding

    13.2. Latin America Syphilis Immunoassay Diagnostics Market Value Forecast, by Product, 2017-2027

        13.2.1. Analyzers

        13.2.2. Kits & Reagents

    13.3. Latin America Syphilis Immunoassay Diagnostics Market Value Forecast, by Technology, 2017-2027

        13.3.1. ELISA

        13.3.2. CLIA

        13.3.3. Others

    13.4. Latin America Syphilis Immunoassay Diagnostics Market Value Forecast, by End-user, 2017-2027

        13.4.1. Hospitals

        13.4.2. Diagnostic Labs

        13.4.3. Blood Banks

        13.4.4. Others

    13.5. Latin America Syphilis Immunoassay Diagnostics Market Value Forecast by Country/Sub-region, 2017-2027

        13.5.1. Brazil

        13.5.2. Mexico

        13.5.3. Argentina

        13.5.4. Rest of Latin America

    13.6. Latin America Syphilis Immunoassay Diagnostics Market Attractiveness Analysis 

        13.6.1. By Product 

        13.6.2. By Technology 

        13.6.3. By End-user

        13.6.4. By Country/Sub-region

14. Middle East & Africa Syphilis Immunoassay Diagnostics Market Analysis and Forecast, 2017-2027

    14.1. Introduction

        14.1.1. Key Finding

    14.2. Middle East & Africa Syphilis Immunoassay Diagnostics Market Value Forecast, by Product, 2017-2027

        14.2.1. Analyzers

        14.2.2. Kits & Reagents

    14.3. Middle East & Africa Syphilis Immunoassay Diagnostics Market Value Forecast, by Technology, 2017-2027

        14.3.1. ELISA

        14.3.2. CLIA

        14.3.3. Others

    14.4. Middle East & Africa Syphilis Immunoassay Diagnostics Market Value Forecast, by End-user, 2017-2027

        14.4.1. Hospitals

        14.4.2. Diagnostic Labs

        14.4.3. Blood Banks

        14.4.4. Others

    14.5. Middle East & Africa Syphilis Immunoassay Diagnostics Market Value Forecast, by Country/Sub-region, 2017-2027

        14.5.1. GCC Countries

        14.5.2. South Africa

        14.5.3. Maghreb

        14.5.4. Rest of Middle East & Africa

    14.6. Middle East & Africa Syphilis Immunoassay Diagnostics Market Attractiveness Analysis 

        14.6.1. By Product 

        14.6.2. By Technology 

        14.6.3. By End-users

        14.6.4. By Country/Sub-region

15. Competition Landscape

    15.1. Market Player - Competition Matrix (By Tier and Size of companies)

    15.2. Market Share Analysis by Company (2018)

    15.3. Company Profiles

        15.3.1. F. Hoffmann-La Roche AG

                15.3.1.1. Company Overview (HQ, Business Segments, Employee Strength)

                15.3.1.2. Company Financials

                15.3.1.3. Growth Strategies

                15.3.1.4. SWOT Analysis

        15.3.2. Bio-Rad Laboratories, Inc.

                15.3.2.1. Company Overview (HQ, Business Segments, Employee Strength)

                15.3.2.2. Company Financials

                15.3.2.3. Growth Strategies

                15.3.2.4. SWOT Analysis

        15.3.3. BD

                15.3.3.1. Company Overview (HQ, Business Segments, Employee Strength)

                15.3.3.2. Company Financials

                15.3.3.3. Growth Strategies

                15.3.3.4. SWOT Analysis

        15.3.4. Siemens Healthineers AG

                15.3.4.1. Company Overview (HQ, Business Segments, Employee Strength)

                15.3.4.2. Company Financials

                15.3.4.3. Growth Strategies

                15.3.4.4. SWOT Analysis

        15.3.5. DiaSorin S.p.A.

                15.3.5.1. Company Overview (HQ, Business Segments, Employee Strength)

                15.3.5.2. Company Financials

                15.3.5.3. Growth Strategies

                15.3.5.4. SWOT Analysis

        15.3.6. Abbott

                15.3.6.1. Company Overview (HQ, Business Segments, Employee Strength)

                15.3.6.2. Company Financials

                15.3.6.3. Growth Strategies

                15.3.6.4. SWOT Analysis

        15.3.7. Ortho Clinical Diagnostics (a part of Carlyle Group)

                15.3.7.1. Company Overview (HQ, Business Segments, Employee Strength)

                15.3.7.2. Company Financials

                15.3.7.3. Growth Strategies

                15.3.7.4. SWOT Analysis

        15.3.8. Shenzhen New Industries Biomedical Engineering Co., Ltd.

                15.3.8.1. Company Overview (HQ, Business Segments, Employee Strength)

                15.3.8.2. Company Financials

                15.3.8.3. Growth Strategies

                15.3.8.4. SWOT Analysis

        15.3.9. bioMérieux SA

                15.3.9.1. Company Overview (HQ, Business Segments, Employee Strength)

                15.3.9.2. Company Financials

                15.3.9.3. Growth Strategies

                15.3.9.4. SWOT Analysis

        15.3.10. Fujirebio (Miraca Group) (Miraca Group)

                15.3.10.1. Company Overview (HQ, Business Segments, Employee Strength)

                15.3.10.2. Company Financials

                15.3.10.3. Growth Strategies

                15.3.10.4. SWOT Analysis

        15.3.11. Fujirebio (Miraca Group)

                15.3.11.1. Company Overview (HQ, Business Segments, Employee Strength)

                15.3.11.2. Company Financials

                15.3.11.3. Growth Strategies

                15.3.11.4. SWOT Analysis

        15.3.12. Danaher (Beckman Coulter, Inc.)

                15.3.12.1. Company Overview (HQ, Business Segments, Employee Strength)

                15.3.12.2. Company Financials

                15.3.12.3. Growth Strategies

                15.3.12.4. SWOT Analysis