Lateral Flow Assays Market

Updated on : February 15, 2023

The global lateral flow assays market in terms of revenue was estimated to be worth $20.5 billion in 2022 and is poised to reach $22.6 billion by 2027, growing at a CAGR of 2.0% from 2022 to 2027.

Increasing adoption of kits & reagents and lateral flow assay readers for infectious diseases testing, veterinary diagnostics, and drug of abuse testing, cardiac marker testing. Whereas most of lateral flow assays are having limitation of qualitative detection, lot to lot variation like factors may hinder the growth of global market during the forecast period.

Global Lateral Flow Assays Market Trends

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Impact of economic recession on Lateral Flow Assays Market

To assess the impact of economic recession and provide market forecasts, scenario-based approaches are considered.

There has been a sharp rise in the consumer price index (CPI) globally over the past year. According to an article published by the American Animal Hospital Association (AAHA), CPI has increased by 7.1% in the US since December 2020 (it has been the fastest annual rise since 1982). This increase in prices is affecting almost every business sector—including the medical device space, where inflation has led to increases in laboratory diagnostics and vendor fees, as much as 12% in some cases.

To counter the rising inflation, central banks across the world have increased their lending rates. But these counter-inflation measures could decrease the global GDP growth by 0.4%—settling down to 0.5% in 2023 (Source: World Bank)—which would meet the technical definition of a recession. This would impact health expenditure and thus negatively impact all healthcare product and service markets, including the lateral flow assay market.

Lateral Flow Assays Market Dynamics

DRIVERS: Need for rapid diagnostics testing for COVID-19

The need for rapid diagnosis for treatment will increase with the rising number of COVID-19 cases globally, and data collection is expected to accelerate the growth of the global market in the forecast period.

The advantages of lateral flow assay tests in detecting COVID-19 antibodies include their affordability, ease of interpretation, and speedy diagnosis (within 15 minutes). Since these tests can also be produced economically, all the major players in the lateral flow assay market launched COVID-19 tests in the past year. For instance,

• In October 2022, Roche Diagnostics launched the SARS-CoV-2 Rapid Antigen Test 2.01, SARS-CoV-2 Rapid Antigen Test 2.0 Nasal2, and SARS-CoV-2 Rapid Antigen Test 2.0 Nasal3.
• In September 2020, Abbott Laboratories (US) launched the PANBIO COVID-19 IgG/IgM Rapid Test Device in Europe.

Growing demand for point-of care testing

The the growing demand of point-of care testing uis mainly due to rising prevalence of chronic disease, technological advancements, and gowing people awareness. Major companies are focusing on developing a products with good sensitivity and performance for application such as pregnancy testing, COVID-19 testing, and cardiac marker testing.

Inconsistent results of lateral flow assays tests

Although easy to perform and more economical than laboratory tests, lateral flow assay tests have been observed to have lower accuracy. As per Mayo Clinic, while using pregnancy kits, false-positive results may happen if the patient had a pregnancy loss soon after the fertilized egg attached to the uterine lining (biochemical pregnancy); consequently, she has taken a pregnancy test too soon after taking a pregnancy test fertility drug that contains HCG. However, an ectopic pregnancy, menopause, or problems with ovaries also may contribute to misleading test results. These factors could restrain the growth of the global market during the forecast period.

OPPORTUNITIES: Omicron, new variant of concern, offers growth opportunities for players in lateral flow assays market

Omicron is a new variant of concern of SARS-Cov-2, the virus responsible for COVID-19. It was first reported to the WHO from South Africa on November 24, 2021. On October 24, 2022, the WHO designated it as “Omicron,” a variant of concern specifically XBB and its sublineages (indicated as XBB*), as well as BQ.1 and its sublineages (indicated as BQ.1*). The level of variation has resulted in concerns regarding its transmissibility, defects in the immune system, and vaccine resistance. Many countries are preventing the spread of the Omicron variant by increasing the capacity of daily tests. Also, pharmaceutical and medical device companies are focusing on developing lateral flow assay kits for the detection of this new variant. Growth in the number of cases due to new variants such as Omicron will increase the demand for lateral flow assays kits.

CHALLENGES: Difficulties in procuring quality raw materials for development of lateral flow assays tests

The procurement and qualification of antigens and antibodies, also referred to as essential reagents, is one of the difficult tasks involved in developing lateral flow assay tests. The accuracy, specificity, stability, and reproducibility of the antibodies to be employed in tests must be evaluated because any impurity in the reagent could lead to the assay's failure. More than 1,000 data points must be examined and verified in order for a single lot of reagents to be qualified.

Kits & reagents segment accounted for the largest share in the lateral flow assay market.

The global market is segmented into kits & reagents and lateral flow readers. In 2021, kits & reagents accounted for the larger share of the global market. The large share of kits & reagents is due to the increasing the adoption of kits & reagents for infectious disease testing.

Food Safety & Environmental Testing segment is expected to witness the fastest growth, in global lateral flow assays market, during the forecast period.

The global market is segmented into clinical testing, veterinary diagnostics, food safety & environmental testing, and drug development & quality testing based on the application. The food safety & environmental testing segment is expected to witness the fastest growth during the forecast period. The fastest of this segment can be attributed to the available LFA tests for identifying toxins and other contaminants in the food industry can potentially compete with other immunoassay methods, such as immuno-chips and immuno-sensors and other analytical methods. The food & beverage industry is shifting from lab-based conventional microbiology techniques to rapid LFA tests for faster result generation

Competitive assays technique accounted for the second largest share of lateral flow assays market in 2021

The global market is segmented into competitive assays, sandwich assays, and multiplex detection assays. In competitive assay technique, the absence of color at the test line indicates the presence of analytes, while the appearance of color at both the test and control lines indicates a negative result.

Others samples accounted for the largest share of lateral flow assays market in 2021

The global market is segmented into blood, urine, saliva, and others samples. Others samples accounted for the largest market share in 2021. The global market for others samples is likely to be driven by increased R&D and the need for more specific and accurate disease testing. Nasal swabs, throat swabs, and vaginal fluid have been considered as other samples in the study.

The Diagnostics laboratories segment accounted for the third largest share of lateral flow assays market in 2021

Based on end users, the market is segmented into hospitals & clinics, diagnostic laboratories, home care settings, pharmaceutical & biotechnology companies, and other end users. The diagnostics laboratories segment accounted for the third largest market share in 2021. The COVID-19 pandemic has resulted in an increased demand for rapid lateral flow-based diagnostic testing in laboratories. These tests may be conducted to gather data regarding the viral spread nationwide by government organizations and individuals for confirmation of symptomatic or asymptomatic cases with contact exposure.

North America accounted for the largest share of the lateral flow assays market in 2021

The lateral flow assay market is sub-segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa region. In 2021, North America accounted for the largest share of the lateral flow assay market, followed by Asia-Pacific, Europe, Latin America, and the Middle East & Africa. However, the APAC is expected to grow at the highest CAGR during the forecast period.

Geographic Snapshot: Lateral Flow Assays Market

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The prominent players in the global lateral flow assays market include Abbott Laboratories (US), Quidel Corporation (US), F. Hoffman-La Roche AG (Switzerland), Danaher Corporation (US), Siemens AG (Germany), BD (US), bioMérieux SA (France), Thermo Fisher Scientific, Inc. (US), PerkinElmer Inc. (US), Hologic Inc. (US), QIAGEN N.V. (Netherlands), and Merck KGaA (Germany).

Lateral Flow Assays Market Report Scope:

The research report categorizes Lateral Flow Assay Market into the following segments and sub-segments:

By Type

• Kits & Reagents
• Lateral Flow Readers

By Application

• Clinical Testing
• Veterinary Diagnostics
• Food Safety & Environmental Testing
• Drug Development & Quality Testing

By Technique

• Sandwich Assays
• Competitive Assays
• Multiplex Detection Assays

By Sample Type

• Blood Samples
• Urine Samples
• Saliva Samples
• Other Samples

By End User

• Hospitals & Clinics
• Diagnostics Laboratories
• Home Care Settings
• Pharmaceuticals & Biotechnology Companies
• Other End User

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • France
  • UK
  • Italy
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • Australia
  • Rest of APAC
• Latin America
  • Brazil
  • Mexico
  • Rest of LATAM
• Middle East and Africa

Recent Developments:

• In October 2022, F. Hoffmann-La Roche Ltd. (Switzerland)  a next-generation portfolio of SARS-CoV-2 rapid antigen test 2.01, SARS-CoV-2 Rapid Antigen Test 2.0 Nasal2, and SARS-CoV-2 Rapid Antigen Test 2.0 Nasal3
• In June 2021, Abbott Laboratories (US) received the CE approval for PanBio Rapid Antigen Self-test, opening access throughout Europe to fast, reliable COVID-19 testing

Frequently Asked Questions (FAQs):

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