Lateral Flow Assays Market

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:

Driver:

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.

Restraint:

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.

Opportunity:

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.

Threat:

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 UAE
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