Lateral Flow Assays Market - By Product (Kits, Readers), By Application (Infectious Disease Testing, Cardiac Metabolic Testing, Cholesterol Testing, Drug of Abuse), By Technique (Sandwich Assays, Competitive Assays, Multiplex Detection Assays), By End-use & Forecast, 2023-2032

Lateral Flow Assays Market Size

Lateral Flow Assays Market size was valued at more than USD 8.75 billion in 2022 and is anticipated to record over 4.5% CAGR between 2023 and 2032. Increasing demand for point-of-care testing and effective diagnostic solutions will influence market growth.
 

High prevalence of infectious diseases and the growing adoption rate of home-based point-of-care (POC) testing solutions would fuel market progress. Lateral flow POC testing is preferred over traditional laboratory testing methods due to its cost efficiency and accuracy. Simpler sample requirements and fast specimen handling are some of the benefits of POC testing model that make it a popular choice among practitioners and patients.
 

Mounting need for affordable diagnostic tools across low-income and developing countries would boost the demand for point-of-care (POC) testing for the diagnosis of diseases like HIV and tuberculosis. New research and development (R&D) activities on POCT along with advancements in Internet of Medical Things (IOMT) should complement industry expansion.
 

The strict regulatory requirements by healthcare agencies like the U.S. FDA and convoluted approval processes could hinder the lateral flow assays market landscape. Classified as Class II devices, lateral flow assays require premarket notification, or 510(k) process before they can be marketed to the public. Due to strict regulations, these devices are not approved easily and are required to go through lengthy review procedures and laborious documentation. In case these laws are stalled or not followed, there are high chances of heavy fines imposed on the manufacturer.
 

Lateral Flow Assays Market Analysis

Lateral flow assays market share from the multiplex detection assays is expected to cross USD 3.9 billion by 2032. Multiplex detection assays aid in the detection of multiple targets due to their flexibility and functionality. This enables the testing method to analyze several analytes independently and effectively. Multiplex detection assays also offer statistical precision as it collects data using several beads for each ligand. The cost-effectiveness and quicker turnaround time that comes with using these tests is anticipated to drive its application across research and clinical laboratories in the coming years.
 

The cardiac marker testing application accounted for nearly 26.4% share of the lateral flow assays market in 2022. These tests are gaining high popularity owing to the increase in cases of cardiovascular disease as well as the globally expanding geriatric population base. Older individuals are often prone to chronic diseases like heart attack, stroke, and coronary artery disease due to their weakened immune systems. As per the Centers for Disease Control and Prevention (CDC), most people with heart disease are 65 years or older and almost 17% of adults above the age of 65 were reported to have coronary heart disease. As a result, there is a growing need for diagnostic tools like lateral flow assays that can detect cardiac disease and recommend the best course of therapy.
 

Lateral flow assays market share from the hospital & clinics end-use segment will observe a 4.8% CAGR between 2023 and 2032. Lateral flow diagnostics are used across hospitals and clinics as they offer quick and accurate results. During the COVID-19 pandemic, many hospitals and clinical institutions utilized lateral flow immunoassay to detect the infection on a large scale. The requirement for advanced diagnostic solutions in clinical settings will facilitate product penetration over the forthcoming years.
 

Europe lateral flow assays market is expected to be worth USD 4.6 billion by end of 2032. In many western European countries, point of care testing (POCT) which includes lateral flow assays as well as lateral flow-based platforms or technology, is commonly employed in healthcare settings. Based on estimates, more than 25% of laboratory tests are carried out in POC settings by academic institutions and hospitals in nations like Belgium and Germany, among others. This type of testing is carried out in pharmacies, home visits, and other outpatient nursing facilities in Germany. It is anticipated that widespread adoption of lateral flow tests in numerous European nations will spur regional market progress.
 

Lateral Flow Assays Market Share

Some of the key industry participants in the global lateral flow assays market include

• Bioeasy Biotechnology Inc.
• Abingdon Health
• Quidel Corporation
• Abbott
• Bio-Rad Laboratories
• Hologic Inc.
• Thermo Fischer Scientific
• F. Hoffmann La Roche
• OPERON, S.A.
• bioMerieux SA.

Companies are trying to launch new products and cater to the immediate need of the healthcare sector. For instance, in January 2022, Roche Diagnostics India launched its new lateral flow immunoassay diagnostic solution – the COVID-19 At-Home Test - to improve the detection of the nucleocapsid protein antigen from SARS-CoV-2.
 

Impact of the COVID-19 pandemic 

The COVID-19 pandemic had a positive impact on the lateral flow assays industry revenue. The use of lateral flow test kits helped practitioners to detect COVID-19 cases even in low-resource situations like home-care settings. The U.S. FDA and European Commission approved the use of several quick lateral flow tests to prevent the spread of the virus. As a result, many cutting-edge diagnostic solutions were introduced to the market to meet the growing testing requirements. The use of lateral flow assays in laboratory settings is estimated to grow further with the emergence of new strains of COVID-19 worldwide.
 

The lateral flow assays market research report includes in-depth coverage of the industry with estimates & forecasts in terms of revenue in USD from 2018 to 2032, for the following segments:

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By Product

• Kits
• Readers

By Application

• Infectious disease testing
  • Influenza
  • Sexually transmitted disease (STD)
  • Hepatitis
  • Tuberculosis
  • Others
• Cardiac marker testing
  • Creatine kinase-MB (CK-MB)
  • Myoglobin
  • D-dimer
  • Troponin I
  • Others
• Pregnancy & fertility testing
  • Pregnancy testing
  • Fertility testing
• Cholesterol testing
• Drug of abuse testing
• Others

By Technique

• Sandwich assays
• Competitive assays
• Multiplex detection assays

By End-use

• Hospital & clinics
• Diagnostic laboratories
• Homecare settings
• Others

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Poland
  • Switzerland
  • Netherlands
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
  • Indonesia
  • Thailand
• Latin America
  • Brazil
  • Mexico
  • Argentina
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE