The global Lateral Flow Assay Components market size was estimated at USD 345 million in 2022 and is expected to surpass around USD 820 million by 2030 and poised to grow at a compound annual growth rate (CAGR) of 9.3% during the forecast period 2022 to 2030. The growth of the market may due to the high prevalence of infectious diseases worldwide, rapid growth in the geriatric population, the growing demand for point-of-care testing, the increased demand for lateral flow assay components due to COVID-19, and the rising use of home-based lateral flow assay devices.
On the other hand, the availability of conventional substitutes such as alternative diagnostics may restrict the growth of the lateral flow assay components market during the forecast period.
Impact of Covid-19 on Lateral Flow Assays Market
To assess the impact of COVID-19 and provide market forecasts, scenario-based approaches are considered.
To assess the impact of COVID-19 and provide market forecasts, scenario-based approaches are considered. The lateral flow assay components market has been positively impacted by the COVID-19 pandemic, as the need for the rapid diagnosis of the coronavirus infection has been the focus since the inception of the pandemic outbreak in December 2019. As the number of cases increased across regions, most major lateral flow assay market players invested in R&D, as well as entered into partnerships and agreements with other industry players and government agencies.
Report Scope of the Lateral Flow Assay Components Market
Lateral Flow Assay Components Market Dynamics:
DRIVERS: Growing demand for lateral flow assay kits due to the COVID-19 pandemic
During COVID-19, many companies launched home-based lateral flow assays for COVID-19 testing as people were afraid to get tested at diagnostic laboratories or hospitals, which supported the demand for home-based lateral flow assays. This led to the launches of several home-based assays. For example:
- The BinaxNOW COVID-19 Ag Card was launched in August 2020, and the Panbio Rapid COVID-19 test was launched in September 2020.
- Roche Diagnostics launched the SARS-CoV-2 Rapid Antigen test in September 2020.
- Other tests launched during COVID-19 include Sofia 2 Flu+ SARS Antigen FIA (Quidel Corporation), CLINITEST Rapid COVID-19 Antigen test (Danaher Corporation), and BD Veritor SARS CoV-2 Test (BD).
The pandemic also promoted cooperation between local manufacturers of lateral flow assay components and key market players to increase the supply of components to meet the increased demand for lateral flow assay kits.
Growing Usage of home-based lateral flow assay devices
Home-based lateral flow assay devices play a important role in diagnosis of cardiovascular and infectious diseases. These devices are also useful in testing pregnancy and stigmatized conditions such as HIV as they potentially empower patients to perform self-tests in their homes. Hence, the increasing incidence of these diseases and the higher adoption of lateral flow assay tests in home care settings are expected to boost the demand for lateral flow assay components in the coming years.
Growing demand for point-of-care testing
Lateral flow assay-based point-of-care (POC) tests are increasingly being adopted to replace lengthy, conventional laboratory procedures. POC diagnostic tests do not require complex infrastructures and training, owing to which the cost of these tests is lower than conventional laboratory diagnostic procedures. POC testing is anticipated to hold the greatest share in the lateral flow assays market because of its importance in combating the growing disease burden.
The rising prevalence of chronic diseases, technological advancements in diagnostic instruments, and growing patient awareness are other key factors driving the demand for lateral flow assays and lateral flow assay components. Many companies are increasingly focusing on developing innovative lateral flow assay-based POC devices for applications such as pregnancy (using hCG levels) and ovulation confirmation, infectious disease and drugs-of-abuse screening, and the measurement of protein markers in the blood. In 2019, Abbott Laboratories (US) developed its ARCHITECT STAT Troponin I Blood Test, while Siemens AG developed the CLINITEK Microalbumin 2 strips for clinical diagnostics.
The rising demand for POC testing and the increasing focus on using lateral flow assay-based POC testing devices to achieve greater portability are expected to boost the growth of the lateral flow assay components market during the forecast period.
Increasing public and private investment to develop lateral flow assayss
Medical device companies use lateral flow membranes in rapid diagnostic test kit manufacturing, enabling reproducible results due to their consistent quality and optimized properties. Rapid test kits are used for a variety of applications, including infectious disease testing (COVID-19, HIV, influenza, and malaria), as well as in women’s health, biomarker detection, drug testing, food safety, and animal health. Due to the continuously increasing demand for lateral flow membranes, public and private investors are investing in developing lateral flow assays and their components. These investments may improve the manufacturing capacity of assay components, leading to growth in the lateral flow assay components market during the forecast period. For instance:
- In December 2021, Merck invested €121 million (132.8 USD million) to construct a lateral flow membrane production facility at Sheboygan, Wisconsin, US.
- In January 2021, a UK-based diagnostics firm received an investment of USD 2.6 million from public and commercial buyers from both the US and the UK.
RESTRAINTS: Availability of alternative diagnostics technologies
Although lateral flow assay kits have many advantages like low cost, rapid detection, stability over a wide range of environmental conditions, and a very long shelf life, they are also associated with a number of disadvantages. These kits are mostly qualitative or semi-quantitative, reproducibility varies from lot to lot, they suffer from low biomolecule affinity toward analytes, the tendency of cross-reactivity, and the occasional requirement of pretreatment of samples which is time-consuming. Once a sample is applied to a strip, capillary action cannot be decreased or sped up, and the analysis time is also dependent on the nature of the sample itself, i.e., viscosity or surface tension. This limits the adoption of lateral flow assay kits to a greater extent, affecting the demand for lateral flow assay components.
OPPORTUNITY: Evolving application of lateral flow assays
The lateral flow tests are widely used for infectious disease diagnostics, the diagnosis of cardiac diseases, and veterinary applications, their use has increased in several new applications over the last few years. For instance, saliva diagnostics, behavioral health, agriculture (genetically modified organism detection and crop quality testing), biowarfare (anthrax detection), environmental testing (detection of contaminating enzymes in manufacturing plants), and food microbiology (detection of E. coli O157, Salmonella, Listeria, and other food spoilage organisms) have emerged as new application areas for lateral flow assays.
Atlas Link Technologies Co., Ltd. (China) provides the FASPIT SARS-CoV-2 Saliva Test, a saliva-based lateral flow assay kit for COVID-19. Salivary LFIAs have also penetrated the market for applications such as drugs-of-abuse testing, and several systems have been FDA-cleared for marketing; however, testing remains largely qualitative.
Due to the increasing adoption of lateral flow assays in different application areas, the demand for components will also increase.
CHALLENGES: Requirement of specialized storage and shipping facilities for membrane
Nitrocellulose membranes are biological membranes made up of nitrocellulose and have a different grade of pore size. The performance of lateral flow assay kits depends on the quality of the nitrocellulose membrane used. Nitrocellulose membranes must be stored properly to ensure maximum shelf life. These components need to be stored away from room temperature or chemical vapors, which may partially dissolve the nitrocellulose and thereby disrupt the pore structure. These are a challenges to the growth of the lateral flow assay components market in the forecast period.
Membranes segment accounted for the largest share in the lateral flow assay components market.
The lateral flow assay components market is segmented into membranes, pads, and others. In 2021, membranes accounted for the largest share of the global lateral flow assay components market. The large share of this segment can be attributed to the increasing applications of lateral flow assay kits & reagents for POC testing, and their convenience and ease of use.
The lateral flow assay membranes market is further bifurcated into nitrocellulose and other membranes. In 2021, the nitrocellulose membranes segment accounted for the largest share of the global lateral flow assay membranes market. Nitrocellulose membranes are mainly used to make lateral flow immunoassays.
The lateral flow assay pads market is further bifurcated into sample pads, conjugate pads, and absorbent pads. In 2021, the sample pads segment accounted for 56.4% of the lateral flow assay pads market.
Clinical Testing segment is expected to witness the fastest growth in the forecast period.
The lateral flow assay components market is segmented into clinical testing, veterinary diagnostics, food safety & environmental testing, and drug development & quality testing based on the application type. The clinical testing segment accounted for the largest share of the lateral flow assay components market in 2021. The large share of this segment can be attributed to the rising prevalence of chronic diseases and the increasing demand for patient-centric care.
Sandwich assays technique accounted for the largest share of lateral flow assay components market in 2021”
The lateral flow assay components market is segmented into competitive assays, sandwich assays, and multiplex detection assays. Sandwich assays dominated the lateral flow assay components market in 2021. The large share of this segment can be attributed to its better assay sensitivity and specificity as well as its extensive applications in the measurement of critical analytes
The medical device manufacturing company accounted for the largest share of lateral flow assays components market in 2021
The lateral flow assay components market is segmented into medical device manufacturing companies and medical device contract manufacturing companies. Medical device manufacturing companies accounted for the largest market share of the lateral flow assay components market in 2021. The COVID-19 pandemic has also increased the demand for point-of-care testing in professional healthcare settings, which increases the demand for lateral flow assay components among medical device manufacturing companies.
North America accounted for the largest share of the lateral flow assay components market in 2021
In 2021, North America accounted for the largest share of the lateral flow assay components market, followed by Europe, the Asia Pacific, Latin America, and the Middle East & Africa. However, the APAC region is expected to grow at the highest CAGR during the forecast period. The rapidly developing raw material industry in China and India, the growing number of local manufacturers for lateral flow assay components, increasing investments in the region by key market players, are the key factors driving market growth in the APAC.
Some of the prominent players in the Lateral Flow Assay Components Market include: Danaher Corporation (Cytiva Life Science and Pall Corporation) (US), Merck KGaA (Germany), Sartorius Stedim Biotech (Germany), Ahlstrom-Munksjö (Finland), Advanced Microdevice Pvt. Ltd. (India), Hangzhou Cobetter Filtration System Co., Ltd. (China), Axiva-Axiflow Group (India), Nupore Filtration (India), DCN Diagnostics (US), and Ballya Bio (China).
Segments Covered in the Report
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2030. For this study, Nova one advisor, Inc. has segmented the global Lateral Flow Assay Components market
By Type
By Application
- Clinical Testing
- Veterinary Diagnostics
- Food Safety & Environmental Testing
- Drug Development & Quality Testing
By Technique
- Sandwich Assays
- Competitive Assays
- Multiplex Detection Assays
By End User
- Medical Device Manufacturing Company
- Medical Device Contract Manufacturing Company
By Geography
North America
Europe
- Germany
- France
- United Kingdom
- Rest of Europe
Asia Pacific
- China
- Japan
- India
- Southeast Asia
- Rest of Asia Pacific
Latin America
- Brazil
- Rest of Latin America
Middle East & Africa (MEA)
- GCC
- North Africa
- South Africa
- Rest of Middle East & Africa
Key Points Covered in Lateral Flow Assay Components Market Study:
- Growth of Lateral Flow Assay Components in 2022
- Market Estimates and Forecasts (2017-2030)
- Brand Share and Market Share Analysis
- Key Drivers and Restraints Shaping Market Growth
- Segment-wise, Country-wise, and Region-wise Analysis
- Competition Mapping and Benchmarking
- Recommendation on Key Winning Strategies
- COVID-19 Impact on Demand for Lateral Flow Assay Components and How to Navigate
- Key Product Innovations and Regulatory Climate
- Lateral Flow Assay Components Consumption Analysis
- Lateral Flow Assay Components Production Analysis
- Lateral Flow Assay Components and Management
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