Lateral Flow Readers/Assays - Market Insights, Competitive Landscape, and Market Forecast - 2030

Lateral Flow Readers/Assay Market by Product (Readers [Bench-top Readers, Digital/Mobile Readers], and Kits & Reagents), Technique (Sandwich Assays, Competitive Assays, and Multiplex Detection Assays), Application (Clinical Testing [Pregnancy Testing, Infectious Diseases Testing, Cardiac Marker Testing, and Others], Drug Development & Quality Testing, and Others), End-User (Hospitals & Clinics, Home Care, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to advance at a substantial CAGR forecast till 2030 owing to the growing instances of infectious diseases and rising product developmental activities worldwide

The lateral flow readers/assay market was valued at USD 8.64 billion in 2023, growing at a CAGR of 5.41% during the forecast period from 2024 to 2030 to reach USD 12.15 billion by 2030. The lateral flow readers/assay market is experiencing significant growth due to the increasing cases of infectious diseases including HIV, hepatitis B & C, and influenza, the introduction of new and innovative products by key players, and others that are acting as major factors contributing to the overall growth of the lateral flow readers/assay market during the forecast period from 2024 to 2030.

Lateral Flow Readers/Assay Market Dynamics:

As per the World Health Organization (WHO) 2024, nearly 39 million people were living with HIV infection in 2022, globally. The source also stated that nearly 37.5 million were adults (aged 15 and above) and approximately 1.5 million people were children, aged less than 15 years. Infectious disease diagnostics are crucial in identifying HIV infection, enabling early detection, treatment monitoring, and preventing transmission. Lateral flow readers/assays are essential tools in HIV diagnostics, offering rapid, point-of-care detection of HIV antibodies or antigens. They enable early identification of infection, allowing for timely intervention and treatment monitoring.

Data from the WHO 2024, stated that 304 million people were infected by hepatitis B and C across the world in the year 2022. The same source further stated that out of these 254 million were afflicted by hepatitis B and 50 million were affected by hepatitis C. Lateral flow readers/assays are used to quickly and efficiently diagnose hepatitis B and C by detecting specific antigens or antibodies in blood or serum samples. These tests provide rapid results at the point of care, enabling early detection and monitoring of infections, particularly in resource-limited settings.

Additionally, the introduction of new and innovative products by market players are pushing forward the market share for same. For example, in February 2023, Thermo Fisher introduced real-time PCR kits in India for the detection of infectious diseases. The Applied Biosystems TaqPath PCR kits are designed to provide confidence and reliability in diagnostic development and testing for conditions like Multi-Drug Resistant Tuberculosis (MDR-TB), M. Tuberculosis complex (MTB), Hepatitis B (HBV), Hepatitis C (HCV), HIV, and for genetic analysis such as HLA-B27.

Hence, the interplay of all the above-mentioned factors is expected to drive the lateral flow readers/assay market during the given forecast period from 2024 to 2030.

However, challenges in the development of accurate diagnostic tests and equipment, and the availability of alternative procedures, among others may restrict the market growth for the lateral flow readers/assay market.

Lateral Flow Readers/Assay Market Segment Analysis:

Lateral Flow Readers/Assay Market by Product (Readers [Bench-top Readers, Digital/Mobile Readers], and Kits & Reagents), Technique (Sandwich Assays, Competitive Assays, and Multiplex Detection Assays), Application (Clinical Testing [Pregnancy Testing, Infectious Diseases Testing, Cardiac Marker Testing, and Others], Drug Development & Quality Testing, and Others), End-User (Hospitals & Clinics, Home Care, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)

In the product segment of the lateral flow readers/assay market, the kits & reagents category is expected to have a significant revenue share in the year 2023. The rapid growth of the kits & reagents of lateral flow readers/assay is due to its widely utilized approach that offers several distinctive features and benefits, making it a preferred option for people.

These kits typically include the lateral flow test strips, reagents for sample preparation, and sometimes buffers or diluents necessary for running the assay. The distinctive features of these kits and reagents lie in their simplicity, convenience, and versatility. Designed for point-of-care use, they do not require complex laboratory infrastructure, which makes them ideal for rapid testing in various settings such as clinics, hospitals, and even home diagnostics.

A key feature of lateral flow kits and reagents is their ability to detect specific biomarkers, antigens, or antibodies, making them suitable for diagnosing infectious diseases (such as COVID-19, HIV, or malaria), monitoring chronic conditions (like diabetes through glycated hemoglobin detection), and assessing cardiac events (e.g., detecting troponin levels in heart attack cases). Moreover, these kits are typically pre-configured for a specific target, meaning they are highly specific to the condition being tested for. However, sensitivity can vary depending on the design and quality of the reagents used.

Therefore, owing to the factors mentioned earlier, the demand for the kits & reagents category upsurges, thereby the category is expected to witness considerable growth eventually contributing to the overall growth of the lateral flow readers/assay market during the forecast period from 2024 to 2030.

North America is expected to dominate the overall lateral flow readers/assay market:

Among all the regions, North America is estimated to hold a significant revenue share in the lateral flow readers/assay market. This domination is due to the growing burden of infectious diseases including tuberculosis, outbreaks of influenza, emerging pathogens, growing product developmental activities, presence of key manufacturers, among others that are expected to fuel the lateral flow readers/assay market in the region during the forecast period from 2024 to 2030.

Public Health Agency of Canada (2024), stated that in 2022, there were 1,971 active tuberculosis cases in Canada. Lateral flow readers/assays are used in tuberculosis diagnostics to provide rapid, point-of-care detection of TB antigens or antibodies. These tests help identify active TB cases by detecting Mycobacterium tuberculosis-specific proteins, aiding in early diagnosis and timely treatment.

Advancements in technology, such as the development of rapid diagnostic tests and molecular assays, enhance the accuracy and speed of diagnoses, making testing more accessible. The increase in point-of-care testing is also contributing to the market, allowing immediate results in clinical settings.

Rising product developmental activities by regulatory bodies in the region are likely to push forward the revenue shares for the same. For example, in November 2023, Abbott announced that it received the U.S. Food and Drug Administration (FDA) approval for its human papillomavirus or HPV screening solution.

Therefore, the interplay of all the factors mentioned above would provide a conducive growth environment for the North America region in the lateral flow readers/assay market during the forecast period from 2024 to 2030.

Lateral Flow Readers/Assay Market key players:

Some of the key market players operating in the lateral flow readers/assay market include Abbott, Quidel Corporation, Danaher Corporation, Siemens Healthineers, F. Hoffman-La Roche AG, LumiraDx, BD, Eurofins Technologies, bioMerieux SA, Bio-Rad Laboratories, Inc., Thermo Fisher Scientific, Hologic, Inc., PerkinElmer Inc., QIAGEN, Merck KGaA, OPERON, Abingdon Health, DIALUNOX, 3B BlackBio Biotech India Ltd., ADS Biotec Inc., and others.

Recent Developmental Activities in the Lateral Flow Readers/Assay Market:

• In January 2021, LumiraDx announced multinational approvals of its SARS-CoV-2 Antigen Test. With approvals in Japan and Brazil, the fast, accurate LumiraDx SARS-CoV-2 Antigen Test was made available to patients in more than 30 nations worldwide.
• In January 2021, ADS Biotec announced the European launch and immediate availability of its COVID-19 Rapid Antigen Test. The company obtained a CE mark for the industry's first Rapid Antigen Test that works with both nasal swabs and blood serum, using proven fluorescence immunochromatographic lateral flow technology, providing an easy-to-use test for COVID-19 infection within 15 minutes.

Key takeaways from the Lateral Flow Readers/Assay market report study

• Market size analysis for current lateral flow readers/assay market size (2023), and market forecast for 6 years (2024 to 2030)
• Top key product/services developments, mergers, acquisitions, partnerships, and joint ventures happened for the last 3 years
• Key companies dominating the lateral flow readers/assay market
• Various opportunities available for the other competitors in the lateral flow readers/assay market space
• What are the top-performing segments in 2023? How these segments will perform in 2030?
• Which are the top-performing regions and countries in the current lateral flow readers/assay market scenario?
• Which are the regions and countries where companies should have concentrated on opportunities for lateral flow readers/assay market growth in the coming future?

Target audience who can be benefited from this Lateral Flow Readers/Assay market report study

• Lateral flow readers/assay device providers
• Research organizations and consulting companies
• Lateral flow readers/assay related organizations, associations, forums, and other alliances
• Government and corporate offices
• Start-up companies, venture capitalists, and private equity firms
• Distributors and traders dealing in lateral flow readers/assay
• Various end-users who want to know more about the lateral flow readers/assay market and the latest developments in the lateral flow readers/assay market

Frequently Asked Questions for the Lateral Flow Readers/Assay Market:

1. What are Lateral Flow Readers/Assay?

• The lateral flow readers/assay are simple diagnostic devices that are used to confirm the presence or absence of a target analyte, such as pathogens or biomarkers in humans or animals, or contaminants in water supplies, foodstuffs, or animal feeds. The most commonly known type of lateral flow rapid test strip is the pregnancy test.

2. What is the market for Lateral Flow Readers/Assay?

• The lateral flow readers/assay market was valued at USD 8.64 billion in 2023, growing at a CAGR of 5.41% during the forecast period from 2024 to 2030 to reach USD 12.15 billion by 2030.

3. What are the drivers for the Lateral Flow Readers/Assay market?

• The lateral flow readers/assay market is experiencing significant growth due to the increasing cases of infectious diseases including HIV, hepatitis B & C, and influenza, the introduction of new and innovative products by key players, and others that are acting as major factors contributing to the overall growth of the lateral flow readers/assay market during the forecast period from 2024 to 2030.

4. Who are the key players operating in the Lateral Flow Readers/Assay market?

• Some of the major market key players operating in the lateral flow readers/assay market include Abbott, Quidel Corporation, Danaher Corporation, Siemens Healthineers, F. Hoffman-La Roche AG, LumiraDx, BD, Eurofins Technologies, bioMerieux SA, Bio-Rad Laboratories, Inc., Thermo Fisher Scientific, Hologic, Inc., PerkinElmer Inc., QIAGEN, Merck KGaA, OPERON, Abingdon Health, DIALUNOX, 3B BlackBio Biotech India Ltd., ADS Biotec Inc., and others.

5. Which region has the highest share in the Lateral Flow Readers/Assay market?

Among all the regions, North America is estimated to hold a significant revenue share in the lateral flow readers/assay market. This domination is due to the growing burden of infectious diseases including tuberculosis, outbreaks of influenza, emerging pathogens, growing product developmental activities, presence of key manufacturers, among others that are expected to fuel the lateral flow readers/assay market in the region during the forecast period from 2024 to 2030.