Lateral Flow Assays Market by Product (Kits, Readers), Application (Clinical Testing, Veterinary Diagnostics, Food Safety & Environmental Testing), Technique (Sandwich, Multiplex Detection Assay), End User (Hospitals, Home care) & Region - Global Forecast to 2027
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. The new research study consists of an industry trend analysis of the market. The new research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market.
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
DRIVER: 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.
OPPORTUNITY: 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.
CHALLENGE: 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. 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
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
The global market is segmented into blood, urine, saliva, and others samples. Others samples accounted for the largest market share. 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
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 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
The market is sub-segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa region. 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
Report Metric |
Details |
Market Revenue in 2022 |
$20.5 billion |
Projected Revenue by 2027 |
$22.6 billion |
Revenue Rate |
Poised to grow at a CAGR of 2.0% |
Market Driver |
Need for rapid diagnostics testing for COVID-19 |
Market Opportunity |
Omicron, new variant of concern, offers growth opportunities for players |
The research report categorizes Lateral Flow Assay Market to forecast revenue and analyze trends in each of the following submarkets:
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 (FAQ):
What is the projected market revenue value of the lateral flow assays market?
The lateral flow assays market boasts a total revenue value of $22.6 billion by 2027.
What is the estimated growth rate (CAGR) of the lateral flow assays market?
The global lateral flow assays market has an estimated compound annual growth rate (CAGR) of 2.0% and a revenue size in the region of $20.5 billion in 2022.
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This study involved four major approaches in estimating the current lateral flow assays market size. Extensive research was conducted to collect information on the market as well as its peer and parent markets. The next step was to validate these findings, assumptions, and sizing with industry experts across the value chain through primary research. Both top-down and bottom-up approaches were employed to estimate the value market. After that, market breakdown and data triangulation procedures were used to estimate the market size of segments and subsegments.
Secondary Research
This research study involved widespread secondary sources; directories; databases such as Bloomberg Business, Factiva, and Dun & Bradstreet; white papers; annual reports; company house documents; investor presentations; and SEC filings of companies. Secondary research was used to identify and collect information useful for the extensive, technical, market-oriented, and commercial study of the global market. It was also used to obtain important information about key players, market classification and segmentation according to industry trends to the bottom-most level, and key developments related to market and technology perspectives. A database of the key industry leaders was also prepared using secondary research.
Primary Research
In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. Primary sources from the supply side include industry experts such as CEOs, vice presidents, marketing and sales directors, technology and innovation directors, and related key executives from various key companies and organizations operating in the global market. Primary sources from the demand side include personnel from hospitals, diagnostic labs, pharma companies, and food & beverage companies.
Market Size Estimation
The total size of the lateral flow assays market was arrived at after data triangulation from four different approaches, as mentioned below.
Bottom-up Approach: Revenues of individual companies were gathered from public sources and databases. Shares of the lateral flow assays businesses of leading players were gathered from secondary sources to the extent available. In certain cases, the share of the business unit was ascertained after a detailed analysis of various parameters, including product portfolio, market positioning, selling price, and geographic reach and strength. Individual shares or revenue estimates were validated through expert interviews.
Country level Analysis: The size of the global market was obtained from the annual presentations of leading players and secondary data available in the public domain. The share of kits & reagents in the overall lateral flow assay market was obtained from secondary data and validated by primary participants to arrive at the total market. Primary participants further validated the numbers.
Primary Interviews: As a part of the primary research process, individual respondent insights on the market size and growth were taken during the interview (regional and global, as applicable). All the responses were collated, and a weighted average was taken to derive a probabilistic estimate of the market size and growth rate.
Geographic market assessment (by region & country): The geographic assessment was done using the following approaches:
Approach 1: Geographic revenue contributions/splits of leading players in the market (wherever available) and respective growth trends
Approach 2: Geographic adoption trends for individual product segments by end users and growth prospects for each of the segments (assumptions and indicative estimates validated from primary interviews)
At each point, the assumptions and approaches were validated through industry experts contacted during primary research. Considering the limitations of data available from secondary research, revenue estimates for individual companies (for the overall lateral flow assays market and geographic market assessment) were ascertained based on a detailed analysis of their respective product offerings, geographic reach/strength (direct or through distributors or suppliers), and the shares of the leading players in a particular region or country.
Breakdown of Primary Interviews
A breakdown of the primary respondents for lateral flow assays market (supply side) market is provided below:
* Note 1: Others include sales managers, marketing managers, and product managers.
Note 2: Tiers are defined based on a company’s total revenue. As of 2019, Tier 1 = >USD 1 billion, Tier 2 = USD 500 million to USD 1 billion, and Tier 3 = <USD 500 million.
To know about the assumptions considered for the study, download the pdf brochure
Data Triangulation
After arriving at the market size, the total market was divided into several segments and subsegments. To complete the overall market engineering process and arrive at the exact statistics for all segments and subsegments, data triangulation and market breakdown procedures were employed wherever applicable.
Approach to derive the market size and estimate market growth
The market rankings for leading players were ascertained after a detailed assessment of their revenues from the lateral flow assays business using secondary data available through paid and unpaid sources. Owing to data limitations, in certain cases, the revenue share was arrived at after a detailed assessment of the product portfolios of major companies and their respective sales performance. At each point, this data was validated through primary interviews with industry experts.
Objectives of the Study
- To define, describe, analyze, and forecast the lateral flow assays market by product, application, technique, sample type, end user, and region
- To provide detailed information about the major factors influencing the market growth (drivers, restraints, opportunities, and challenges)
- To analyze micromarkets with respect to individual growth trends, prospects, and contributions to the overall market
- To analyze market opportunities for stakeholders and provide details of the competitive landscape for key players
- To forecast the size of the global market in North America, Europe, the Asia Pacific, Latin America, and the Middle East & Africa
- To analyze the impact of the economic recession on the growth of the global market
- To strategically profile key players in the global market and comprehensively analyze their core competencies
- To track and analyze competitive developments such as product launches, expansions, acquisitions, partnerships, agreements, and other developments of leading players in the global market
Available Customizations
With the given market data, MarketsandMarkets offers customizations as per your company’s specific needs. The following customization options are available for the report:
Product Analysis
- Further breakdown of the kits & reagents segment of the global market
- Further segmentation of individual product segments by application and end user
Geographic Analysis
- Further breakdown of the Rest of Asia Pacific market into South Korea, Australia, New Zealand, and others
- Further breakdown of the Rest of Europe market into Belgium, Russia, the Netherlands, Switzerland, and others
Company Information
- Detailed analysis and profiling of additional market players (Up to 5)
Maket outlook for the top 10 for Antigen Test Market:
- Abbott Laboratories
- Becton, Dickinson and Company
- F. Hoffmann-La Roche Ltd
- Quidel Corporation
- LumiraDx
- Danaher Corporation
- Siemens Healthineers
- Bio-Rad Laboratories, Inc.
- GenBody Inc.
- Sysmex Corporation
The global antigen test market is expected to grow significantly due to the ongoing COVID-19 pandemic and the need for rapid testing. The market is also expected to be driven by the increasing prevalence of infectious diseases, rising demand for POC testing, and advancements in technology.
The COVID-19 pandemic has been a significant growth driver for the antigen test market, with increasing demand for rapid antigen tests for the diagnosis of COVID-19. As antigen tests are less expensive and quicker than molecular tests, they are being widely used for mass testing, screening, and surveillance programs.
Additionally, the market is also driven by the increasing prevalence of infectious diseases, such as HIV, hepatitis, and influenza. Antigen tests are being widely used for the detection of infectious diseases, as they provide rapid results and are more affordable than other tests.
Furthermore, the rising demand for POC testing is expected to drive the growth of the antigen test market. POC testing is widely used in clinics, hospitals, and emergency departments, and antigen tests are a popular choice due to their rapid results and ease of use.
However, the market may face challenges such as the high cost of development and manufacturing of antigen tests, lack of awareness and accessibility in certain regions, and stringent regulatory requirements.
In the future, antigen tests are expected to be used for the diagnosis of various diseases and conditions, including cancer, autoimmune diseases, and allergies. The market potential for antigen tests is significant, with increasing demand for rapid, accurate, and cost-effective diagnostic tests.
The risk in the market is mainly related to the uncertainty surrounding the COVID-19 pandemic, which may impact the demand for antigen tests. Additionally, competition among the top players in the market is expected to intensify, with companies investing in research and development to develop new and innovative antigen tests.
Growth drivers for Antigen Test Market from macro to micro
growth drivers for the Antigen Test Market are:
Increased demand due to COVID-19: The COVID-19 pandemic has created a huge demand for antigen tests as they are quick, cost-effective, and offer rapid results. As a result, the market for antigen tests has grown significantly during the pandemic.
Rising prevalence of infectious diseases: Antigen tests are useful in detecting various infectious diseases, including influenza, strep throat, and HIV. The growing prevalence of these diseases is expected to drive the demand for antigen tests in the coming years.
Technological advancements: Technological advancements in the field of diagnostic testing have led to the development of more accurate and reliable antigen tests, which is expected to drive market growth.
Increasing government support: Governments around the world are providing financial support and promoting the use of antigen tests to help contain the spread of COVID-19. This is expected to further boost market growth.
Growing need for point-of-care testing: Antigen tests are convenient and can be performed at the point of care, which eliminates the need for sending samples to a laboratory for testing. This has led to an increased demand for point-of-care testing, which is expected to drive market growth.
Micro factors driving growth in the Antigen Test Market include:
- Increased awareness among the general public about the benefits of early diagnosis and treatment.
- The availability of easy-to-use antigen test kits that can be administered by non-specialized healthcare professionals.
- The growing adoption of antigen tests by hospitals, clinics, and diagnostic centers.
- The increasing demand for accurate and reliable diagnostic tests.
- The cost-effectiveness of antigen tests compared to other diagnostic tests.
Hypothetic challenges of Antigen Test Market in future
Potential challenges that the Antigen Test Market may face in the future includes:
False negatives: Antigen tests are generally considered less accurate than PCR tests, and they can produce false negatives in some cases. This means that people who have the virus could receive a negative result and potentially spread it to others.
Quality control issues: Antigen tests are often less sensitive and specific than PCR tests, which means that they may produce more false positives and false negatives. Additionally, there is a risk that poorly manufactured or improperly stored tests could lead to inaccurate results.
Competition from other testing methods: As more testing methods become available, there is a risk that antigen tests could become less popular or lose market share to other options. For example, PCR tests and rapid molecular tests are also used to detect COVID-19.
Changes in testing protocols: As more is learned about COVID-19 and the best ways to control its spread, testing protocols may change. This could lead to a decrease in demand for antigen tests or a shift towards other testing methods.
Regulatory challenges: There may be challenges in obtaining regulatory approval for antigen tests, especially if they are produced by new or less established companies. Additionally, regulatory changes or inconsistencies across different countries or regions could impact the market.
Supply chain issues: The production and distribution of antigen tests may be impacted by supply chain issues, such as shortages of raw materials or difficulties in transporting and storing tests. This could lead to disruptions in the market and make it harder for companies to meet demand.
Future use cases of Antigen Test Market along with commentary of adaption, market potential, risk
potential future use cases of the antigen test market include:
Screening for infectious diseases: Antigen tests can be used to screen individuals for a wide range of infectious diseases, including respiratory viruses, bacterial infections, and sexually transmitted infections.
Testing at point-of-care: Antigen tests are easy to use and can be performed at the point-of-care, making them ideal for use in settings where rapid diagnosis is critical, such as emergency departments, urgent care centers, and primary care clinics.
Mass testing: Antigen tests are relatively inexpensive and can be used to conduct mass testing in populations where outbreaks occur, such as schools, workplaces, and nursing homes.
Surveillance: Antigen tests can be used for surveillance purposes to monitor the prevalence of infectious diseases in a population and to identify emerging outbreaks.
The adaptation and potential of the antigen test market are quite promising, especially in the current scenario where the COVID-19 pandemic has increased the demand for rapid and accurate diagnostic tests. The market potential is expected to grow as the technology for antigen tests continues to improve, making them more accurate and easier to use. However, there are also some potential risks associated with the antigen test market, such as false-positive or false-negative results, inadequate sensitivity, and specificity of the tests, which can lead to misdiagnosis and inappropriate treatment. Additionally, regulatory hurdles and reimbursement issues may impact the growth of the antigen test market.
Growth opportunities and latent adjacency in Lateral Flow Assays Market
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Which factors plays the vital role the global growth of Lateral Flow Assays Market?
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