LATERAL FLOW ASSAY MARKET ANALYSIS
Global lateral flow assay market is estimated to be valued at USD 10.52 Bn in 2024 and is expected to reach USD 14.65 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 4.8% from 2024 to 2031.
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Rapid point-of-care testing and rising demand for home-based lateral flow assays can drive the market growth. Increasing incidence of infectious diseases and chronic illnesses can boost adoption of these testing kits globally.
The market is expected to witness steady growth over the forecast period due to increasing investments from leading players to develop innovative products. Technological advancements enabling multiplexing and automation has boosted lateral flow assay applications across various industries including food & beverage testing, clinical testing, and environmental monitoring. Growing need for easy-to-use testing solutions for conditions like COVID-19 can drive the market growth.
Increasing prevalence of infectious diseases
Rising prevalence of infectious diseases across the globe can drive the global lateral flow assay market growth. There has been increase in infectious diseases due to various factors like climate change, increased globalization, higher antimicrobial resistance, and evolving epidemiology of existing and new pathogens. As per the World Health Organization (WHO), infectious diseases account for around 17 million deaths globally every year, which is approximately one-third of all deaths worldwide. The occurrence of new strains of existing diseases like COVID-19, viral hemorrhagic fevers, and vector-borne illnesses due to factors like climate change, can exacerbate the situation. For example, in 2021, according to the WHO's World Malaria Report, malaria cases had increased globally to about 241 million cases in 2020 from 232 million cases in 2019. Growing threat posed by infectious diseases has boosted demand for rapid, cost-effective, and easy-to-use screening and diagnostic tests. Lateral flow assay tests meet all these requirements, and this leads to their increased adoption rate. Their ability to provide quick results without the need for laboratory infrastructure or specialized technicians has fueled their popularity in point-of-care testing. The lateral flow technique is highly favorable for screening large number of patients as it minimizes testing bottlenecks.
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Rising awareness and funding for disease screening and surveillance programs
Rising awareness about the importance of disease screening and surveillance globally can drive the market growth. Both developing and developed countries focuses on implementation of national screening programs for priority health issues to achieve early detection and treatment. This boosts demand for point-of-care testing devices. Moreover, there has been increase in government and private sector funding for infectious disease control, maternal and child healthcare programs. All these screening initiatives rely heavily on rapid, portable assays to decentralize testing and reach remote populations. Lateral flow assays are used in large surveillance programs due to their applicability in resource-limited field conditions and ability to provide timely results. These assays have been widely used in HIV, malaria and tuberculosis prevalence studies across Africa and Asia. Their usage grows further with more funding directed at expanding testing and vaccination coverage for communicable and non-communicable diseases. The portability and ease of use of lateral flow assays makes them a preferred technology for field healthcare camps, refugee camps and other temporary testing sites.
Key Takeaways from Analyst:
Global lateral flow assay market growth is driven by increasing demand for point-of-care testing. Growing prevalence of infectious diseases and chronic conditions worldwide can boost the adoption of lateral flow assay products for disease diagnosis. Furthermore, technological advancements leading to the development of more accurate and user-friendly lateral flow tests can boost their uptake in both hospital and home-care settings.
North America dominates the market, owing to rising healthcare expenditure and availability of advanced healthcare infrastructure. However, Asia Pacific is likely to emerge as the fastest-growing regional market with many countries looking to strengthen their healthcare systems. The market in the region will witness growth due to increasing healthcare needs of its large patient population.
Strict regulatory approvals and reimbursement policies can hamper the lateral flow assay market growth. Additional limitations include test accuracy concerns associated with some POC products. The presence of alternative mainstream diagnostics can also limit demand for lateral flow assays. With growing awareness, the technology will gain popularity worldwide over the forecast period.
Market Challenges: Stringent regulations for product approval
Stringent regulations for product approval ca hamper the global lateral flow assay market growth. Lateral flow assays are diagnostic tests used for clinical testing and medical diagnosis. These assays, being diagnostic devices, use biological samples such as blood, urine or saliva and hence regulatory approval for these assays is crucial. However, approval process has become extremely lengthy and complex in recent years. Regulatory bodies across the world like U.S. FDA and EU Notified Bodies have increased clinical trial requirements, improved review timeline and raised quality standards for approving lateral flow assays due to the COVID-19 pandemic. Factors like type of sample, claimed analyte, output format, and others also determine the level of clinical evaluation and documentation required, which further increases approval time. For example, U.S. FDA has been insisting on large sample clinical evaluations involving 700-1,000 patient samples for COVID-19 antigen and antibody lateral flow assays before granting Emergency Use Authorization, which has delayed their approval timeline significantly. This has demotivated many small diagnostic companies from innovating and launching new lateral flow assays. According to the World Health Organization Report in 2022, 59% of the 300 diagnostic companies surveyed stated that stringent regulations were the top challenge for commercializing their lateral flow-based point-of-care tests for diseases like TB, HIV and malaria. Many abandoned projects during clinical trials phase itself owing to regulatory uncertainty.
Market Opportunities: Outsourcing of Lateral Flow Assay Production
Outsourcing of lateral flow assay production can provide significant opportunities for growth of the global lateral flow assay market. As the demand for rapid, affordable COVID-19 and other infectious disease testing surged in recent years, the capacity of many medical device companies to produce lateral flow assays internally has been outpaced. By outsourcing non-core production functions to specialist contract manufacturers, medical device firms can maximize their production capacity and better meet rising global demand. This allows medical device companies to focus on their expertise in product development while leveraging the economies of scale of large-scale contract manufacturers. For example, contract manufacturers with dedicated lateral flow assay facilities can rapidly expand production lines and hire additional staff to accommodate quick ramp-ups when new outbreaks emerge. The contract manufacturers are also able to reduce costs through optimized automation, supply chain management, and their increased production volumes across multiple clients' products. These cost savings can be passed on to the medical device companies and healthcare systems, improving the accessibility of lateral flow technologies. As reliance on rapid at-home and point-of-care testing increases, outsourced production will be crucial to ensure a steady supply of affordable tests for infectious diseases globally. The COVID-19 pandemic underscored the need for scalable diagnostic manufacturing capacity.
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By Product Type - Reliability and ease of use can drive kits and reagents segment growth
In terms of product type, kits and reagents segment is estimated to contribute the highest market share of 55% in 2024, owing to their reliability and ease of use. Lateral flow assays based on kits and reagents provide consistent and standardized results without requiring specialized equipment or training to perform. The disposable nature of test strips and cassettes included in kits eliminates risks of contamination between tests. This reliability and convenience make kits and reagents well suited for point-of-care testing applications. Kits contain pre-measured and pre-packaged reagents along with all materials needed to complete the assay, simplifying the testing process. This simplification expands the range of settings where lateral flow tests can be administered. Kits empower healthcare workers and patients themselves to conduct tests in community healthcare centers, hospitals, homes, and even in field conditions. Their user-friendly design promotes adherence to testing protocols. The lack of complex instrumentation also makes kits accessible in resource-limited areas. Reagents form the key components of lateral flow strips and devices. Stable and optimized reagents maximize test sensitivity and specificity. Leading manufacturers leverage extensive research and development to formulate high performing reagents. Continuous refinement of reagents assists kit makers in enhancing lateral flow technologies. New innovations in labeling, detection, and stabilization of reagents further boosts reliability. The product lifecycle of kits also depends on the stability of constituent reagents during storage and use. Kits provide a standardized and simplified solution for lateral flow testing. Their user-friendliness and ease of access drives the segment growth.
By Technique - Multiplexing drives growth within detection assay segment
In terms of technique, multiplex detection assay segment is estimated to contribute the highest market share of 30% in 2024, owing to its ability to detect multiple analytes simultaneously. Unlike qualitative assays indicating only presence or absence, multiplex detection allows quantitative analysis of several targets in one reaction well. This multiplexing capability addresses a key limitation of conventional lateral flow tests, which typically only detect a single analyte. It empowers developers to design compact multi-parameter tests. This has applications in screening for co-infections like respiratory panels, cardiac marker panels, allergy tests, as well as research use. The possibility to detect a panel of biomarkers correlated to a disease enhances accuracy of diagnosis. It enables risk stratification, monitoring of disease progression, and guiding treatment decisions. Monitoring response to therapies requires analysis of multiple parameters. Furthermore, multiplexing conserves sample volume requirements and produces results faster than running individual single-plex tests serially. Technological advancements now allow development of assays with higher multiplexing abilities. Research into nanotechnology facilitated development of microarrays and nanowires with capabilities for 16-plex, 50-plex, and even 100-plex detection on a single cartridge. Continued innovations can scale up multiplex counts. This growing multiplexing potential of lateral flow drives its increasing utility.
By Application-Wide applicability drives clinical testing segment
In terms of application, clinical testing segment is estimated to contribute the highest market share of 35% in 2024, owing to the widespread use of lateral flow technology across various medical diagnostic applications. Currently, clinical testing constitutes more than half of the total lateral flow assay market. Lateral flow assays find diverse applications across various specialties like infectious disease testing, cardiac markers, toxicology, fertility, and others. Their ease of use and rapid results makes them suitable for point-of-care testing in physician offices and hospital settings. Furthermore, self-testing is growing for applications like pregnancy, fertility, and COVID-19 testing using home-use lateral flow kits. The ability to rapidly diagnose conditions influences patient management decisions. It allows proper isolation of infectious patients. Rapid results in emergency rooms facilitate quick triaging of patients. Bedside testing sustains continuous monitoring of patients. Lateral flow assays prove especially valuable in resource-limited primary healthcare centers in developing countries for basic screening and diagnosis.
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North America currently dominates the global lateral flow assay market with an estimated market share of 40.3% in 2024, led primarily by the U.S. With huge presence of leading diagnostics companies and robust healthcare infrastructure, the U.S. lateral flow assay market has grown steadily over the years. The region has established distribution channels and reimbursement structures in place, allowing for smooth adoption of new lateral flow technologies. High per capita healthcare spending provides lucrative growth opportunities for manufacturers. However, industry experts note pricing pressures due to payor initiatives like reference pricing can impact profits.
Asia Pacific region has emerged as the fastest growing market for lateral flow assays globally. Rapid economic development and rising affluence have boosted healthcare investments across developing nations like India and China. This has increased accessibility to diagnostic testing. Furthermore, tburgeoning geriatric population base that is more prone to chronic diseases boosts demand. With growing health awareness, preventive care has gained prominence, boding well for products detecting diseases early. Favorable regulations by regulatory bodies to fast-track new products are encouraging Western companies to tap into untapped markets. However, manufacturers will need to optimize supply chains and pricing strategies to succeed, given regional cost differences.
Lateral Flow Assay Market Report Coverage
| Report Coverage | Details | ||
|---|---|---|---|
| Base Year: | 2023 | Market Size in 2024: | US$ 10.52 Bn |
| Historical Data for: | 2019 to 2023 | Forecast Period: | 2024 to 2031 |
| Forecast Period 2024 to 2031 CAGR: | 4.8% | 2031 Value Projection: | US$ 14.65 Bn |
| Geographies covered: |
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| Companies covered: |
Abbott Laboratories , F. Hoffmann-La Roche AG, Thermo Fisher Scientific Inc., Quidel Corporation, Hologic Inc., bioMérieux SA, PerkinElmer Inc., Merck KGaA, QIAGEN NV, Becton, Dickinson and Company, Bio-Rad Laboratories Inc., Danaher Corporation, Access Bio Inc., Siemens AG, Chembio Diagnostic Systems Inc., Abcam PLC, Standard Diagnostics Inc., Eiken Chemical Co., Ltd. |
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*Definition: Global Lateral Flow Assay Market involves testing techniques used to detect the presence and concentration of analytes in samples without the need for specialized and expensive equipment. Lateral flow assays use commercial chromatography principles to separate analytes based on size and affinity to determine results either visually or with a meter. They offer rapid, low-cost testing solutions for various applications such as clinical diagnostics, food safety testing, and environmental monitoring on a global scale.
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About Author
Manisha Vibhute is a consultant with over 5 years of experience in market research and consulting. With a strong understanding of market dynamics, Manisha assists clients in developing effective market access strategies. She helps medical device companies navigate pricing, reimbursement, and regulatory pathways to ensure successful product launches.
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