Lateral Flow Assays Market - Global Outlook & Forecast 2023-2028

The global lateral flow assays market is expected to grow at a CAGR of 2.89% from 2022 to 2028. The market is one of the major segments in the global point of care or the rapid diagnostics market and is growing steadily and is anticipated to grow at a similar pace during the forecast period. Further, the growth in the market is attributed to the increasing prevalence/incidence of various infectious and chronic diseases. In addition, malaria is still a cause of death in a few regions. For instance, according to the WHO, malaria is one of the leading causes of death in the Middle East & Africa.

MARKET TRENDS & OPPORTUNITIES

Smartphone and AI Integration in Lateral Flow Immunoassay

The use of smartphones as biosensors in many applications (e.g., optical-based methods such as absorption, reflection, fluorescence, etc.) is particularly important for improving diagnostics, healthcare, medical, food, and environmental monitoring. It has the potential as a portable, low-cost POC platform and provides treatment in remote low-income areas. The Cambridge-based startup, PocDoc, has received CE mark approval for a digital reader powered with artificial intelligence (AI) for lateral flow testing. The cloud-based system turns any smartphone or tablet into a universal digital reader, enabling healthcare organizations to perform large-scale lateral flow testing for any disease or marker. An AI-driven innovation that can read a COVID-19 lateral flow diagnostic test using a user's smartphone has received special use approval from the Medicines and Healthcare Products Regulatory Agency (MHRA).

Evolving New Application of Lateral Flow Assays

Lateral flow testing is widely used for infectious disease diagnosis, heart disease diagnosis, and veterinary applications but has seen increased use in recent years in several new applications. For example, saliva diagnostics, behavioral health, agriculture (detection of genetically modified organisms and quality control of plants), biological warfare (detection of Bacillus anthracis), environmental testing (detection of contaminating enzymes in production facilities), food microbiology (E. coli Detection of O157, Salmonella, Listeria, and other food spoilage bacteria) has emerged as a new application area in the lateral flow assays market.

Saliva is a new biological fluid with many studies and clinical applications. OraSure Technologies, based in the US, is one of the largest lateral flow saliva testing vendors. Salivary LFAs have also infiltrated the market for applications such as substance abuse testing, and several systems have been cleared for sale by the FDA. However, the tests remain largely qualitative.

Growing Adoption of Home-Based Lateral Flow Assay Devices

Home tests (also called self-tests or home tests) are typically sold over the counter and allow users to test self-collected samples and obtain results without the assistance of a trained medical professional. The home-use lateral flow assay device plays an important role in the treatment of cardiovascular disease and infectious diseases. These devices could also be very useful for testing pregnancy and stigmatized diseases such as HIV, allowing patients to perform self-tests at home. Therefore, the increasing incidence of these diseases and the growing adoption of lateral flow assay testing in home healthcare are expected to propel the lateral flow assays market growth. During COVID-19, many companies have introduced at-home lateral flow assays for COVID-19 testing. This is because people feared rushing to a diagnostic lab or hospital for testing has created a demand for at-home lateral flow assays.

Some of the introduced tests for home use were:

• In August 2020, BinaxNOW COVID-19 Ag Card and Panbio rapid COVID-19 test in September 2020
• In September 2020, Roche launched the SARS-CoV-2 Rapid Antigen test
• Quidel launched during the COVID-19, Sofia 2 Flu+ SARS Antigen FIA
• In June 2022, Siemens Healthineers launched the CLINITEST Rapid COVID-19 Antigen test and
• BD has launched the BD Veritor SARS CoV-2 Test

SEGMENTATION INSIGHTS

INSIGHTS BY PRODUCT

The kits & reagents are expected to be the largest product segment in the global lateral flow assays market in 2022, accounting for a share of 82.24%. These kits & reagents predominantly include biomarkers, assay kits, and reagents, including substrates, enzymes, specific proteins, lipids, and other test kits. The awareness of rapid and POC testing for various infectious diseases is one of the key factors driving the demand for rapid testing. The large market share of the segment is also attributed to the use of consumables reoccurring in nature, and the consumables segment generates continuous revenue for vendors. As a result, many renowned vendors are manufacturing consumables required for analyzers. This growth is attributable to the growing use of rapid tests in several points of care (POC) sites, such as emergency care, physician offices, ambulatory settings, nursing homes, and by individuals for diagnosing several diseases such as infectious diseases, diabetes, cancer, and other metabolic diseases.

Segmentation by Product

• Kits & Reagents
• Readers

INSIGHTS BY APPLICATION

The global lateral flow assays market is segmented into clinical diagnostics, food safety, veterinary diagnostics, and others. Clinical application accounted for the global market's highest share, 46.50%, in 2022. Rapid infectious disease diagnostic tests are critical for diagnosing diseases for early detection and biosurveillance and improving global health. For instance, the Health and Human Services (HHS), the National Institutes of Health (NIH), the US Centers for Disease Control and Prevention (CDC), and the US Department of Defense (DoD) consider rapid and early detection a keyway to reduce the impact on the population. The POC provides multiple advantages over other diagnostics to diagnose infectious diseases, especially for rapid testing scenarios. For instance, Chembio, a leading lateral flow assay market company, is offering FDA-approved LFA HIV tests, SURE CHECK HIV 1/2 Assay, which combines a patented plastic barrel device that houses the lateral flow strip.

The global lateral flow assays market by food safety is expected to reach USD 3.83 billion by 2028. The lateral flow test is a very convenient immunoassay for detecting foodborne pathogens. The test covers the most important pathogens, acts as a minilab, and includes built-in control reactions for optimized pathogen testing. There are many leading and local players offering LFA testing for food testing, including Sigma-Aldrich, a subsidiary of Merck kGaA, Perkinelmer, R- Biopharma, Abingdon Health, and creative diagnostics.

Segmentation by Application

• Clinical Diagnostics
• Food Safety
• Veterinary Diagnostics
• Others

INSIGHTS BY TECHNIQUE

The sandwich assays held the most significant technique segment share in the global lateral flow assays market in 2022 at 61.36%. The first type of LFA assay is a non-competitive or sandwich assay. It is used for macromolecular analytes with two antigen-binding sites: which bind to the target and has a binder that does not interfere with each other. If the target is present in the sample, the signal at the test line will increase. The LFA vendor uses the sandwich technique to market their product; the best-known examples of this format are the over-the-counter pregnancy tests. The sandwich assays account for a larger share of the technique segment, also growing with a high growth rate of 3.39% in the market. At the same time, the competitive segment accounted for 38.64% of the global lateral flow assays market.

Segmentation by Technique

• Sandwich Assays
• Competitive Assays

INSIGHTS BY END USERS

The global lateral flow assays market is segmented into hospitals & clinics, individuals, diagnostic laboratories, food & beverage companies (FBC), pharma & biotech companies (PBC), and others by end-users. The hospitals & clinics held the largest end-users market share at 25.32% in 2022. Hospitals perform more rapid tests than other end-users and form the first point of contact for infections and diseases. The diagnosis is used for the initial patient screening, thereby contributing to the larger use of rapid testing in hospitals. Moreover, hospitals establish contracts with multiple vendors for procuring rapid test kits, POC analyzers, and related consumables. In addition, hospital laboratories are unique entities in hospitals. Around 92% of the hospitals operate with their laboratories. Hospitals are one of the largest end-users of infectious disease diagnosis, which perform a wide range of diagnostics per the requirement.

Segmentation by End-Users

• Hospitals & Clinics
• Individuals
• Diagnostic Laboratories
• Food & Beverage Companies
• Pharma & Biotech Companies
• Others

GEOGRAPHICAL INSIGHTS

a) North America accounted for the highest share of 28.57% in the global lateral flow assays market in 2022. The region is dominating among all the regions due to several factors, such as the increase in the prevalence of infectious diseases such as COVID-19, influenza, HIV, chronic conditions & lifestyle diseases, easy availability, and the high affordability of technologically advanced LFAs, presence of key vendor for the LFAs. Moreover, the presence of advanced healthcare infrastructure and the availability of government funding for research will likely augment the expansion of the LFA market for LFAs in this region. For instance, In July 2020, the NIH invested USD 248.7 million in developing new technologies to deal with the challenges associated with the testing of COVID-19.

b) Europe's lateral flow assays market was valued at USD 2.58 billion in 2022. The region has developed healthcare infrastructure with the availability of advanced lateral flow assay devices coupled with the high prevalence of infectious and chronic diseases, which has significantly contributed to the overall growth of the lateral flow assay market. Moreover, the region is affected by the increasing prevalence of infectious diseases, which include HIV, Haemophilus influenzae, Meningococcal disease, Streptococcus pneumoniae, etc., contributing to the growth of the market.

Segmentation by Geography

• North America
• US
• Canada
• Europe
• UK
• Germany
• France
• Italy
• Russia
• Spain
• APAC
• China
• Japan
• India
• South Korea
• Australia
• Philippines
• Latin America
• Brazil
• Mexico
• Argentina
• Middle East & Africa
• South Africa
• Saudi Arabia
• Turkey

VENDOR LANDSCAPE

The global lateral flow assay market is highly dynamic, with several global and local players offering various instruments/analyzers and reagents for diagnosing various clinical testing, food safety, Veterinary Diagnostics, drug testing, etc. The industry is consolidated with global players accounting for dominant shares. Abbott, Danaher, F. Hoffmann-La Roche, Quidel, and Siemens Healthineers are the leading players and account for significant global lateral flow assays market share.

Key Company Profiles

• Abbott
• F. Hoffmann-La Roche
• Siemens Healthineers
• Thermo Fisher Scientific
• Quidel

Other Prominent Vendors

• BD
• Abaxis
• Abingdon Health
• Access BIO
• Arbor Vita
• Assure Tech
• Atomo Diagnostics
• AccuBioTech
• BIOMÉRIEUX
• bioLytical Laboratories
• BIO-RAD Laboratories
• Biosynex
• Cupid
• DIALAB
• HUMAN Gesellschaft für Biochemica und Diagnostica mbH
• INTEC
• J. Mitra & Co. Pvt. Ltd.
• Meril Life Sciences
• MP Biomedicals
• Medsource Ozone Biomedicals
• Nanjing Synthgene Medical Technology
• OraSure Technologies
• Premier Medical
• QIAGEN
• SD Biosensor
• Rega Biotechnology
• KHB
• Türklab A.S.
• Trinity Biotech
• Wondfo
• PerkinElmer
• Merck KGaA

KEY QUESTIONS ANSWERED:

1. How big is the lateral flow assays market?
2. What is the growth rate of the lateral flow assays market?
3. Which are the key companies in the global lateral flow assays market?
4. Which region holds the most significant global lateral flow assays market share?
5. What are the rising trends in the lateral flow assay market?