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Lateral Flow Assays Market - Strategic Insights and Forecasts (2025-2030)

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Market Size
See Report
by 2031
CAGR
CAGR during the forecast period
2026-2031
Base Year
2025
Forecast Period
2026-2031
Projection
Report OverviewSegmentationTable of ContentsCustomize Report

Report Overview

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Lateral Flow Assays Market Highlights

Driving POCT demand
Assays are enabling rapid diagnostics.
Boosting Asia-Pacific growth
Rising diseases are fueling adoption.
Enhancing infectious detection
Tests are addressing global outbreaks.
Advancing assay technology
Innovations are improving sensitivity.
Supporting clinical testing
Kits provide quick results.
Promoting home care
Devices are facilitating self-testing.
Expanding multiplex assays
Systems are detecting multiple targets.

Lateral Flow Assays Market Size:

The lateral flow assays market is expected to witness significant growth during the forecasted period.

Lateral Flow Assays Market Trends:

The market for lateral flow assays (LFAs) includes a broad range of simple diagnostic procedures that don't require specialized equipment and yield speedy results. Numerous industries, including healthcare, food safety, veterinary diagnostics, and environmental monitoring, use these tests. Their cost-effectiveness, simplicity, and speed make them invaluable in resource-constrained environments, remote locations, and point-of-care situations. Important uses include drug misuse screening, pregnancy testing, testing for infectious diseases, and, more recently, COVID-19 testing.

Market growth is fueled by things like rising rates of infectious diseases, rising need for quick diagnostics, and improvements in assay technology. Further factors driving market expansion include the growing demand for decentralized testing and the development of the healthcare infrastructure in emerging economies. Businesses in the LFA sector concentrate on innovation, product creation, and tactical alliances to stay competitive and meet changing global client demands.

Lateral Flow Assays Market Drivers:

  • Increasing demand for Point-of-care testing (POCT) products is anticipated to boost the lateral flow assays market.

The market for lateral flow assays has shown tremendous growth due to the growing demand for Point-of-Care Testing (POCT). The demand for lateral flow assays has increased as a result of POCT's broad adoption in a variety of healthcare settings and its quick and easy findings. These assays are especially well-suited for POCT applications because of their ease of use, speedy turnaround time, and simplicity. Rapid diagnostics have made them vital tools due to their capacity to provide on-the-spot diagnoses without the need for specialized equipment or laboratory facilities. This has led to continuing market growth and innovation in lateral flow assay technology to address increasing POCT needs.

In May 2022, in collaboration with Genes2Me Pvt. Ltd., Cipla Limited announced the launch of the "RT-Direct" multiplex COVID-19 RT PCR Test kit for sale in India. By doing this, Cipla can provide a wider range of sophisticated and cutting-edge diagnostic devices. Cipla has started supplying RT Direct kits and will be in charge of their distribution in India. This kit has been validated at a center accredited by the Indian Council of Medical Research (ICMR). It is based on the "gold standard RT-PCR method," which is far more advanced than others that just have one or two target genes and covers three target genes specific to SARS-COV-2 along with IC. The RT-PCR test's sensitivity is significantly raised by this.

  • The increasing incidence of infectious diseases is expected to boost the lateral flow assays market.

The need for quick and effective diagnostic solutions has increased due to the global rise in infectious illness cases, which has supported the lateral flow tests market. These tests are essential instruments in the diagnosis and treatment of a wide range of illnesses because they provide rapid and accurate detection of infectious agents. Because of their ease of use, portability, and quick turnaround times, they have established themselves as essential elements of diagnostic plans, particularly in situations with limited resources and during epidemics. The need for lateral flow assays is anticipated to endure as the burden of infectious diseases increases globally, propelling assay development, innovation, and market expansion.

According to the WHO, in 2023, Noncommunicable diseases (NCDs) account for 41 million annual deaths worldwide, or 74% of all fatalities. 17 million individuals die from NCDs before they become 70 years old every year; low- and middle-income nations account for 86% of these premature fatalities 77% of NCD-related deaths occur in low- and middle-income nations. The majority of NCD deaths,17.9 million annually, are caused by cardiovascular illnesses, which are followed by death by cancer (9.3 million), chronic respiratory diseases (4.1 million), and diabetes (2.0 million, including deaths from renal disease induced by diabetes).

  • Technological advancements are anticipated to boost the Lateral flow assays market.

Technological developments that improve sensitivity, specificity, and multiplexing capabilities have completely changed the lateral flow test market. More precise and trustworthy lateral flow assays can be created thanks to improved technologies, increasing their applicability to a wider range of medical illnesses and non-healthcare industries. Innovations that address changing consumer demands for quicker, more accurate, and easier-to-use diagnostic solutions—like smartphone integration for result interpretation, microfluidics for improved performance, and innovative detection techniques—fuel market expansion.

These developments encourage more research and development to push the limits of lateral flow assay technology, which in turn increases diagnostic accuracy and boosts market competitiveness. For example, Abcam provides the Universal Lateral Flow Assay Kit, which combines Ulfa-Tag kit technology with GOLD conjugation to enable the creation of unique sandwich assays. Such a kit's ability to function with any pair of detection and capture antibodies is one of its benefits. Thus, it is anticipated that the lateral flow assays market will develop as more cutting-edge sandwich assays become available.

Lateral Flow Assays Market Geographical Outlook:

  • Asia Pacific region is expected to grow significantly

The market for lateral flow assays is expanding significantly in the Asia-Pacific area. This expansion is being driven by factors like increased healthcare costs, an increase in the prevalence of infectious diseases, population growth, and growing awareness of early disease diagnosis. Technological developments and improvements in healthcare infrastructure are also driving market expansion.

The presence of major industry participants concentrating on strategic alliances and collaborations, in addition to the region's sizable and diversified population, supports the lateral flow assay market's strong expansion in the Asia-Pacific. This pattern is anticipated to persist as the need for quick and trustworthy diagnostic solutions keeps growing.

For example, the National Strategic Plan (NSP) for Malaria Elimination (2016–2030) of the Indian government aims to eradicate malaria by 2030 and raise awareness of the disease. The National Vector Borne Disease Control Programme, which falls under the purview of the country's National Health Mission, is expected to allocate USD 106.53 billion for this strategy.

Lateral Flow Assays Market Restraints:

  • Accuracy requirements could constrain the market for lateral flow assays.

The lack of sensitivity and specificity in lateral flow assays, especially when compared to laboratory-based diagnostic techniques, is a significant barrier to the market. Although lateral flow tests are simple to use and provide quick results, their accuracy may not always satisfy the demands of certain applications. For developers in the lateral flow assay market, overcoming this limitation through technological innovations targeted at improving sensitivity and specificity continues to be a top priority.

Lateral Flow Assays Market Developments:

  • December 2025: Amplifold secured an oversubscribed €5 million seed funding round to accelerate the commercialization of ultra-sensitive lateral flow diagnostic platforms targeting infectious diseases and point-of-care applications.
  • April 2025: Abingdon Health launched a full-service commercial office and laboratory in Madison, Wisconsin, USA, expanding its lateral flow assay development and manufacturing capacity for rapid diagnostics.
  • 2025: Major regulatory behavior—the US FDA issued a large number of 510(k) clearances and approvals for rapid point-of-care diagnostic tests (including lateral flow formats), driving broader market entry and adoption in 2025.
  • Oct-Dec 2025: Industry investment and capacity expansion notably increased across lateral flow assay manufacturing and component supply chains as companies sought to meet rising demand and onshore production needs.

Lateral Flow Assays Market Scope:

Report Metric Details
Growth Rate CAGR during the forecast period
Study Period 2021 to 2031
Historical Data 2021 to 2024
Base Year 2025
Forecast Period 2026 – 2031
Segmentation Technique, Product, Application, End-User
Geographical Segmentation North America, South America, Europe, Middle East and Africa, Asia Pacific
Companies
  • PerkinElmer Inc.
  • Merck KGaA
  • QIAGEN NV
  • Abbott Laboratories (Alere Inc.)
  • Quidel Corporation

Lateral Flow Assays Market Segmentation:

  • By Technique:
    • Sandwich Assay
    • Competitive Assay
    • Multiplex Assay
  • By Product:
    • Lateral Flow Readers
    • Kits and Reagents
  • By Application:
    • Clinical Testing
    • Drug Abuse Testing
    • Other Applications
  • By End-user: 
    • Home Car
    • Hospitals and Clinics
    • Other End Users
  • By geography:
    • North America
      • United States
      • Canada
      • Mexico
    • South America
      • Brazil
      • Argentina
      • Others
    • Europe
      • United Kingdom
      • Germany
      • France
      • Italy
      • Spain
      • Others
    • Middle East and Africa
      • Saudi Arabia
      • UAE
      • Others
    • Asia Pacific
      • Japan
      • China
      • India
      • South Korea
      • Taiwan
      • Thailand
      • Indonesia
      • Others

REPORT DETAILS

Report ID:KSI061616773
Published:Dec 2025
Pages:143
Format:PDF, Excel, PPT, Dashboard
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Frequently Asked Questions

Market growth is driven by rising demand for point-of-care testing (POCT), increasing infectious disease prevalence, technological advancements, and expanding decentralized and home-based diagnostic solutions.

The global rise in infectious diseases has increased the need for fast, reliable diagnostics, making lateral flow assays essential tools during outbreaks and in resource-limited settings.

Advancements include improved sensitivity and specificity, multiplex detection, smartphone-based result interpretation, microfluidics integration, and innovative detection chemistries.

The Asia Pacific region is expected to grow significantly due to rising healthcare investments, increasing infectious disease burden, population growth, and improved diagnostic awareness.

Accuracy limitations, particularly lower sensitivity and specificity compared to laboratory-based diagnostics, remain a key restraint for wider adoption in certain applications.

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