Lateral Flow Assays Market

Lateral Flow Assays Market

Lateral Flow Assays Market Forecasts to 2028 – Global Analysis By Test (Lateral Flow Immuno Assay and Nucleic Acid Lateral Flow Assay), Product (Kits, Readers and Other Products), Technique, Application, End User and By Geography

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Published: 2023 ID: SMRC23098

This report covers the impact of COVID-19 on this global market

Years Covered


Estimated Year Value (2022)

US $8.29 BN

Projected Year Value (2028)

US $11.11 BN

CAGR (2022 - 2028)


Regions Covered

North America, Europe, Asia Pacific, South America, and Middle East & Africa

Countries Covered

US, Canada, Mexico, Germany, UK, Italy, France, Spain, Japan, China, India, Australia, New Zealand, South Korea, Rest of Asia Pacific, South America, Argentina, Brazil, Chile, Middle East & Africa, Saudi Arabia, UAE, Qatar, and South Africa

Largest Market

North America

Highest Growing Market

Asia Pacific

According to Stratistics MRC, the Global Lateral Flow Assays Market is accounted for $8.29 billion in 2022 and is expected to reach $11.11 billion by 2028 growing at a CAGR of 5.0% during the forecast period. Lateral Flow Assays, often referred to as lateral flow immune chromatographic assays, are methods for determining if a target analyse is present (or absent) in a sample (matrix). These assays are widely used for the qualitative and quantitative identification of certain antigens and antibodies. They enable the testing method to analyze several analyses independently and effectively. They aid in the detection of multiple targets due to their flexibility and functionality. It provides speedy diagnosis and enables ease of interpretation.

According to the report of United States Department of Health & Human Services, published in January 2020, about 37,832 people in the United States were diagnosed with HIV in 2018, and 38,000 new HIV infections still occur in the United States.

Market Dynamics:


Rising shift towards self-testing

The demand for lateral flow assay kits has skyrocketed due to a move toward self-testing. A quick read-out from lateral flow tests, which can identify analyses in a range of samples, enables self-testing and decentralized diagnosis. It delivers results in minutes, both quantitatively and qualitatively. The popularity of self-diagnosis among the general population has led to a sharp rise in the usage of lateral flow assay tests performed at home.


Strict regulations

Lateral flow tests are subject to strict requirements. These gadgets must undergo drawn-out review processes and time-consuming documentation in order to be authorized. Healthcare organizations like the U.S. FDA have classified them as Class II devices. If these restrictions are flouted or ignored, there is a significant chance that the manufacturer would be hit with hefty fines, which will slow the expansion of the industry.


Rising demand for point-of care testing

Any tests that are carried out on or close to a patient are included in point-of-care testing. It offers quick test results so that the proper course of therapy may be followed. The need for point-of-care testing was mostly driven up by the growing prevalence of chronic illness. Major corporations are concentrating on creating devices with high sensitivity and performance for applications including COVID-19 testing, cardiac marker testing, and pregnancy testing. The need was raised by ongoing technical developments and rising public awareness.


No accuracy in results

LFAs have trouble reproducing their findings. The outcomes of LFA tests performed on the same subject at various intervals might be very different. Additionally, multiplexing the simultaneous examination of many markers is challenging. The accuracy of the results might be affected by inaccurate sample volume. Based on color change, they can only offer a maximum of semi-quantitative data. Since lateral flow tests do not give quantitative detection, they are only suitable for primary screening and cannot be used to gauge the severity of a problem that is being diagnosed.

Covid-19 Impact

The COVID-19 pandemic has significantly increased demand for lateral flow tests (LFA). The ability of LFA test kits to identify both symptomatic and asymptomatic infections has led to the widespread adoption of lateral flow assay-based diagnostics for the diagnosis of COVID infections. Many healthcare firms concentrated on creating lateral flow assay instruments that can identify COVID-19 viral antigens or patient antibodies (IgG and IgM) in blood samples obtained by finger pricking, saliva sampling, or nose fluid swabs. The epidemic had rose the market growth drastically.

The sandwich assays segment is expected to be the largest during the forecast period

The sandwich assays segment is estimated to have a lucrative growth owing to its high sensitivity. The sandwich assays test captures antibodies from blood samples towards specific foods or other typical allergens. It can detect antibodies in blood or serum against viruses and allergen proteins in food products for quality control. Its benefits such as low overall density, high strength and stiffness to weight ratio, good thermal insulation and uniform energy absorption capacity are flourishing the segment’s growth.

The diagnostic laboratories segment is expected to have the highest CAGR during the forecast period

The diagnostic laboratories segment is anticipated to witness the fastest CAGR growth during the forecast period. The diagnostic laboratories use lateral flow assays for quick and accurate tests for specific target molecules and gene expression. They test a variety of samples like urine, blood, saliva, sweat, serum, and other fluids. They help the diagnostic laboratories for rapid delivery of qualitative diagnostic results.

Region with largest share:

North America is projected to hold the largest market share during the forecast period owing to the rise in various infections. This region has the presence of various infectious and chronic diseases, such as Lyme disease and tuberculosis. It is also facing huge mortality rate associated with HIV/AIDS. The presence of a high patient pool and affordability with increasing disposable income is boosting the market growth in this region.

Region with highest CAGR:

Asia Pacific is projected to have the highest CAGR over the forecast period. Due to its enormous and dense population, China is projected to be the most opportune area among the others. Due to a lack of preventative healthcare measures, the region's low- and middle-income population is vulnerable to a number of infectious illnesses. Unmet needs in the area provide private market businesses a large market opportunity. Also the expense of public healthcare is increasing drastically which accelerates market expansion.

Key players in the market

Some of the key players profiled in the Lateral Flow Assays Market include Thermo Fisher Scientific Inc, Abbott Laboratories, Siemens Healthineers, Hologic Inc, Bio-Rad Laboratories Inc, PerkinElmer Inc, Merck KGaA, F. Hoffmann-La Roche AG, Danaher Corporation, Quidel Corporation, QIAGEN N.V., Abingdon Health, bioMerieux SA, Bioeasy Biotechnology Inc, OPERON S.A., Maternova Inc, Creative Diagnostics, Access Bio Inc, Healgen Scientific LLC and Becton, Dickinson & Company.

Key Developments:

In September 2022, Thermo Fisher Scientific Inc., the world leader in serving science unveiled the Thermo Scientific™ DynaSpin™ Single-Use Centrifuge system at the BioProcess International annual conference in Boston, MA. The system is specifically designed to provide an optimal single-use solution for large-scale cell culture harvesting.

In January 2021, Abbott announced that it had received CE Mark for two new uses of its Panbio COVID-19 Ag Rapid Test Device to detect the SARS-CoV-2 virus for asymptomatic screening and self-administered sample collection with a nasal swab.

Tests Covered:
• Lateral Flow Immuno Assay
• Nucleic Acid Lateral Flow Assay

Products Covered:
• Kits
• Readers
• Other Products

Techniques Covered:
• Sandwich Assays
• Competitive Assays
• Multiplex Detection Assays
• Other Techniques

Applications Covered:
• Cardiac Marker Testing
• Infectious Disease Testing
• Pregnancy Testing
• Fertility Testing
• Cholesterol Testing
• Drug-of-Abuse (DoA) Testing
• Food Safety & Environmental Testing
• Drug Development & Quality Testing
• Mosquito-Borne Disease Testing
• Other Applications

End Users Covered:
• Diagnostic Laboratories
• Homecare settings
• Hospital & Clinics
• Pharmaceutical & Biotechnology Companies
• Other End Users

Regions Covered:
• North America
o US
o Canada
o Mexico
• Europe
o Germany
o UK
o Italy
o France
o Spain
o Rest of Europe
• Asia Pacific
o Japan
o China
o India
o Australia
o New Zealand
o South Korea
o Rest of Asia Pacific
• South America
o Argentina
o Brazil
o Chile
o Rest of South America
• Middle East & Africa
o Saudi Arabia
o Qatar
o South Africa
o Rest of Middle East & Africa

What our report offers:
- Market share assessments for the regional and country-level segments
- Strategic recommendations for the new entrants
- Covers Market data for the years 2020, 2021, 2022, 2025, and 2028
- Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
- Strategic recommendations in key business segments based on the market estimations
- Competitive landscaping mapping the key common trends
- Company profiling with detailed strategies, financials, and recent developments
- Supply chain trends mapping the latest technological advancements

Free Customization Offerings:
All the customers of this report will be entitled to receive one of the following free customization options:
• Company Profiling
o Comprehensive profiling of additional market players (up to 3)
o SWOT Analysis of key players (up to 3)
• Regional Segmentation
o Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
o Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances

Table of Contents

1 Executive Summary

2 Preface
2.1 Abstract
2.2 Stake Holders
2.3 Research Scope
2.4 Research Methodology
2.4.1 Data Mining
2.4.2 Data Analysis
2.4.3 Data Validation
2.4.4 Research Approach
2.5 Research Sources
2.5.1 Primary Research Sources
2.5.2 Secondary Research Sources
2.5.3 Assumptions

3 Market Trend Analysis
3.1 Introduction
3.2 Drivers
3.3 Restraints
3.4 Opportunities
3.5 Threats
3.6 Product Analysis
3.7 Application Analysis
3.8 End User Analysis
3.9 Emerging Markets
3.10 Impact of Covid-19

4 Porters Five Force Analysis
4.1 Bargaining power of suppliers
4.2 Bargaining power of buyers
4.3 Threat of substitutes
4.4 Threat of new entrants
4.5 Competitive rivalry

5 Global Lateral Flow Assays Market, By Test
5.1 Introduction
5.2 Lateral Flow Immuno Assay
5.3 Nucleic Acid Lateral Flow Assay

6 Global Lateral Flow Assays Market, By Product
6.1 Introduction
6.2 Kits
6.3 Readers
6.4 Other Products

7 Global Lateral Flow Assays Market, By Technique
7.1 Introduction
7.2 Sandwich Assays
7.3 Competitive Assays
7.4 Multiplex Detection Assays
7.5 Other Techniques

8 Global Lateral Flow Assays Market, By Application
8.1 Introduction
8.2 Cardiac Marker Testing
8.3 Infectious Disease Testing
8.4 Pregnancy Testing
8.5 Fertility Testing
8.6 Cholesterol Testing
8.7 Drug-of-Abuse (DoA) Testing
8.8 Food Safety & Environmental Testing
8.9 Drug Development & Quality Testing
8.10 Mosquito-Borne Disease Testing
8.11 Other Applications

9 Global Lateral Flow Assays Market, By End User
9.1 Introduction
9.2 Diagnostic Laboratories
9.3 Homecare settings
9.4 Hospital & Clinics
9.5 Pharmaceutical & Biotechnology Companies
9.6 Other End Users

10 Global Lateral Flow Assays Market, By Geography
10.1 Introduction
10.2 North America
10.2.1 US
10.2.2 Canada
10.2.3 Mexico
10.3 Europe
10.3.1 Germany
10.3.2 UK
10.3.3 Italy
10.3.4 France
10.3.5 Spain
10.3.6 Rest of Europe
10.4 Asia Pacific
10.4.1 Japan
10.4.2 China
10.4.3 India
10.4.4 Australia
10.4.5 New Zealand
10.4.6 South Korea
10.4.7 Rest of Asia Pacific
10.5 South America
10.5.1 Argentina
10.5.2 Brazil
10.5.3 Chile
10.5.4 Rest of South America
10.6 Middle East & Africa
10.6.1 Saudi Arabia
10.6.2 UAE
10.6.3 Qatar
10.6.4 South Africa
10.6.5 Rest of Middle East & Africa

11 Key Developments
11.1 Agreements, Partnerships, Collaborations and Joint Ventures
11.2 Acquisitions & Mergers
11.3 New Product Launch
11.4 Expansions
11.5 Other Key Strategies

12 Company Profiling
12.1 Thermo Fisher Scientific Inc
12.2 Abbott Laboratories
12.3 Siemens Healthineers
12.4 Hologic Inc
12.5 Bio-Rad Laboratories Inc
12.6 PerkinElmer Inc
12.7 Merck KGaA
12.8 F. Hoffmann-La Roche AG
12.9 Danaher Corporation
12.10 Quidel Corporation
12.11 QIAGEN N.V.
12.12 Abingdon Health
12.13 bioMerieux SA
12.14 Bioeasy Biotechnology Inc
12.15 OPERON S.A.
12.16 Maternova Inc
12.17 Creative Diagnostics
12.18 Access Bio Inc
12.19 Healgen Scientific LLC
12.20 Becton, Dickinson & Company

List of Tables
1 Global Lateral Flow Assays Market Outlook, By Region (2020-2028) ($MN)
2 Global Lateral Flow Assays Market Outlook, By Test (2020-2028) ($MN)
3 Global Lateral Flow Assays Market Outlook, By Lateral Flow Immuno Assay (2020-2028) ($MN)
4 Global Lateral Flow Assays Market Outlook, By Nucleic Acid Lateral Flow Assay (2020-2028) ($MN)
5 Global Lateral Flow Assays Market Outlook, By Product (2020-2028) ($MN)
6 Global Lateral Flow Assays Market Outlook, By Kits (2020-2028) ($MN)
7 Global Lateral Flow Assays Market Outlook, By Readers (2020-2028) ($MN)
8 Global Lateral Flow Assays Market Outlook, By Other Products (2020-2028) ($MN)
9 Global Lateral Flow Assays Market Outlook, By Technique (2020-2028) ($MN)
10 Global Lateral Flow Assays Market Outlook, By Sandwich Assays (2020-2028) ($MN)
11 Global Lateral Flow Assays Market Outlook, By Competitive Assays (2020-2028) ($MN)
12 Global Lateral Flow Assays Market Outlook, By Multiplex Detection Assays (2020-2028) ($MN)
13 Global Lateral Flow Assays Market Outlook, By Other Techniques (2020-2028) ($MN)
14 Global Lateral Flow Assays Market Outlook, By Application (2020-2028) ($MN)
15 Global Lateral Flow Assays Market Outlook, By Cardiac Marker Testing (2020-2028) ($MN)
16 Global Lateral Flow Assays Market Outlook, By Infectious Disease Testing (2020-2028) ($MN)
17 Global Lateral Flow Assays Market Outlook, By Pregnancy Testing (2020-2028) ($MN)
18 Global Lateral Flow Assays Market Outlook, By Fertility Testing (2020-2028) ($MN)
19 Global Lateral Flow Assays Market Outlook, By Cholesterol Testing (2020-2028) ($MN)
20 Global Lateral Flow Assays Market Outlook, By Drug-of-Abuse (DoA) Testing (2020-2028) ($MN)
21 Global Lateral Flow Assays Market Outlook, By Food Safety & Environmental Testing (2020-2028) ($MN)
22 Global Lateral Flow Assays Market Outlook, By Drug Development & Quality Testing (2020-2028) ($MN)
23 Global Lateral Flow Assays Market Outlook, By Mosquito-Borne Disease Testing (2020-2028) ($MN)
24 Global Lateral Flow Assays Market Outlook, By Other Applications (2020-2028) ($MN)
25 Global Lateral Flow Assays Market Outlook, By End User (2020-2028) ($MN)
26 Global Lateral Flow Assays Market Outlook, By Diagnostic Laboratories (2020-2028) ($MN)
27 Global Lateral Flow Assays Market Outlook, By Homecare settings (2020-2028) ($MN)
28 Global Lateral Flow Assays Market Outlook, By Hospital & Clinics (2020-2028) ($MN)
29 Global Lateral Flow Assays Market Outlook, By Pharmaceutical & Biotechnology Companies (2020-2028) ($MN)
30 Global Lateral Flow Assays Market Outlook, By Other End Users (2020-2028) ($MN)

Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.

List of Figures


Research Methodology

We at Stratistics opt for an extensive research approach which involves data mining, data validation, and data analysis. The various research sources include in-house repository, secondary research, competitor’s sources, social media research, client internal data, and primary research.

Our team of analysts prefers the most reliable and authenticated data sources in order to perform the comprehensive literature search. With access to most of the authenticated data bases our team highly considers the best mix of information through various sources to obtain extensive and accurate analysis.

Each report takes an average time of a month and a team of 4 industry analysts. The time may vary depending on the scope and data availability of the desired market report. The various parameters used in the market assessment are standardized in order to enhance the data accuracy.

Data Mining

The data is collected from several authenticated, reliable, paid and unpaid sources and is filtered depending on the scope & objective of the research. Our reports repository acts as an added advantage in this procedure. Data gathering from the raw material suppliers, distributors and the manufacturers is performed on a regular basis, this helps in the comprehensive understanding of the products value chain. Apart from the above mentioned sources the data is also collected from the industry consultants to ensure the objective of the study is in the right direction.

Market trends such as technological advancements, regulatory affairs, market dynamics (Drivers, Restraints, Opportunities and Challenges) are obtained from scientific journals, market related national & international associations and organizations.

Data Analysis

From the data that is collected depending on the scope & objective of the research the data is subjected for the analysis. The critical steps that we follow for the data analysis include:

  • Product Lifecycle Analysis
  • Competitor analysis
  • Risk analysis
  • Porters Analysis
  • PESTEL Analysis
  • SWOT Analysis

The data engineering is performed by the core industry experts considering both the Marketing Mix Modeling and the Demand Forecasting. The marketing mix modeling makes use of multiple-regression techniques to predict the optimal mix of marketing variables. Regression factor is based on a number of variables and how they relate to an outcome such as sales or profits.

Data Validation

The data validation is performed by the exhaustive primary research from the expert interviews. This includes telephonic interviews, focus groups, face to face interviews, and questionnaires to validate our research from all aspects. The industry experts we approach come from the leading firms, involved in the supply chain ranging from the suppliers, distributors to the manufacturers and consumers so as to ensure an unbiased analysis.

We are in touch with more than 15,000 industry experts with the right mix of consultants, CEO's, presidents, vice presidents, managers, experts from both supply side and demand side, executives and so on.

The data validation involves the primary research from the industry experts belonging to:

  • Leading Companies
  • Suppliers & Distributors
  • Manufacturers
  • Consumers
  • Industry/Strategic Consultants

Apart from the data validation the primary research also helps in performing the fill gap research, i.e. providing solutions for the unmet needs of the research which helps in enhancing the reports quality.

For more details about research methodology, kindly write to us at

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