Global Lateral Flow Assay Market: Analysis By Product Type, By Application, By Technology, By End User, By Region Size and Trends with Impact of COVID-19 and Forecast up to 2028

Lateral flow assays (LFA), also known as lateral flow immunochromatographic assays, is a medical device used to detect presence (or absence) of a target analyte in a sample (matrix). Lateral flow assay market is associated with development, manufacturing, and distribution of lateral flow test kits, reagents, components, and related equipment and products across various industries and applications, including healthcare, pharmaceuticals, food safety, environmental testing, veterinary diagnostics, etc. Due to increasing incidences of infectious diseases, rising demand for point-of-care testing (POCT), and increasing awareness about the importance of infection prevention & control after COVID-19 pandemic, there has been increasing adoption of LFAs by many clinics and hospitals, especially after recent pandemic. The global lateral flow assay market value stood at US$8.55 billion in 2022, and is expected to reach US$12.10 billion by 2028.

Global lateral flow assay market demonstrated a consistent growth, primarily driven by rising cases of infectious and chronic diseases in both developing and developed countries. Growing elderly population, increased focus on preventive healthcare, increasing adoption of the concept of self-management of person's medical conditions, surge in the demand for home based medical kits, rapidly expanding healthcare infrastructure in developing economies, and high consumption of home-based diagnostic kits, will continue to boost the demand of global lateral flow assay market. Moreover, POCT, facilitated by lateral flow assays, has brought diagnostics more closer to the patient in the form of improved accessibility to healthcare in remote or underserved areas where access to traditional laboratory facilities may be limited, providing individuals with timely diagnoses and treatment, particularly in emergency situations and for diseases that require immediate assistance. Therefore, with rising popularity of point-of-care testing and increasing number of companies focusing on developing innovative lateral flow assay-based POC devices, point-of-care (POC) tests based of lateral flow assay will continue to replace lengthy and conventional laboratory procedures, augmenting the growth of global lateral flow assay market in the forecasted period of 2023-2028.

Market Segmentation Analysis:

By Product Type: The report provides the bifurcation of the lateral flow assay market into two segments based on product type: kits and reagents, and lateral flow readers. Kits & reagents lateral flow assay is the largest segment of global lateral flow assay market owing to rising adoption of lateral flow tests in home care settings, ongoing development of cost effective and user friendly diagnostic kits, ongoing launch of new kits by major players in the market, increasing popularity of self-diagnosis, and rising application of kits and reagents in diagnostic testing of diseases, contaminants & allergens in food products, and environmental testing. Lateral flow assay readers is the fastest growing segment of global lateral flow assay market owing to constant advancements in reader technology, rising demand for portable and easy to use diagnostic devices, ongoing integration of smartphones and mobile applications with lateral flow readers for diagnostic testing, and increasing adoption of lateral flow assays in various fields such as clinical diagnostics, food safety testing, & environmental monitoring.

By Application: The report provides the bifurcation of the lateral flow assay market into four segments on the basis of application: clinical testing, veterinary diagnostics, food safety & environment testing, and drug development & quality testing. Clinical testing lateral flow assay market is the largest segment of global lateral flow assay market owing to growing patient population suffering from chronic diseases, rapidly expanding healthcare infrastructure in emerging economies, increase in the occurrence of infectious diseases, expanding geriatric population base, noninvasive nature of collecting specimen, growth in number of government initiatives promoting health awareness, and frequent employment of lateral flow assays in clinical laboratories, hospitals, & physician's office for quantitative & qualitative identification of specific antibodies, products of gene amplification, and antigens.

By Technology: The report provides the bifurcation of the lateral flow assay market into three segments on the basis of technology: sandwich assays, competitive assays, and multiplex detection assays. Sandwich lateral flow assay is the largest segment of global lateral flow assay market, owing to rising demand for point-of-care testing and home healthcare diagnostic devices, evolving applications of sandwich assays in medical testing settings, rising government approvals of lateral flow assay rapid detection kits based on the sandwich assay technique, increasing demand for sandwich assays in research and drug discovery applications, and better assay sensitivity & specificity provided by sandwich assays for the measurement of critical and larger analytes.

By End User: The report provides the bifurcation of the lateral flow assay market into five segments on the basis of end user: hospitals and clinics, diagnostic laboratories, home care, pharmaceutical & biotechnology companies, and others. Pharmaceutical & biotechnology companies lateral flow assay is the fastest growing segment, as a result of rising number of infectious diseases and research activities, increasing number of pharmaceutical companies putting extensive efforts in producing effective medicines & vaccines, growing demand for rapid and accurate diagnostic tests for drug development and quality testing, and increasing number of emerging market participants engaged in strategic efforts like mergers and acquisitions, product research, product approvals & launches to improve their lateral flow test products.

By Region: The report provides insight into lateral flow assay market based on the regions namely, Europe, North America, Asia Pacific, and rest of the world. North America is the largest region of global lateral flow assay market, owing to region's well-established healthcare and pharmaceutical sector, high per capita income, increasing prevalence of infectious diseases such as Lyme disease and tuberculosis, ongoing technological advancements and product innovations in the market, rising demand for point-of-care testing, increasing availability of lateral flow tests on online pharmacy platforms, and presence of a significant number of market players in the region including Thermo Fisher Scientific Inc., Bio-Rad Laboratories, Inc., etc.

Asia Pacific is the fastest growing region in the global lateral flow assay market, owing to region's vast population of low and middle-income countries being exposed to multiple infectious diseases, increasing public healthcare expenditure across APAC countries, region's large potential consumer base, expanding geriatric population, growing demand for rapid point-of-care testing, rising public health awareness campaigns, and rapidly developing lateral flow assay components & raw material manufacturing industry in India and China.

Market Dynamics:

Growth Drivers: The global lateral flow assay market has been rapidly growing over the past few years, due to factors such as aging population, rising cases of infectious diseases, growing adoption of home based assay kits and devices, rising popularity of point-of-care testing, etc. There has been an increase in the demand for rapid lateral flow assay diagnostic tests needed to accurately diagnose & monitor medical conditions associated with age-related diseases such as cystic fibrosis, cardiovascular ailments, hepatitis, diabetes, and certain types of cancer, etc., that are frequently caused by age-related physiological changes and metabolic problems. Lateral flow assay testing solutions offers convenience and accessibility to elderly patients that have mobility limitations by assisting them in managing and monitoring chronic condition, as well as allowing healthcare providers to assess the effectiveness of treatments through regular monitoring using lateral assay tests & make necessary medication adjustments. Therefore, the growing elderly population and rising patient pool for chronic illnesses will continue to create a positive demand for lateral flow tests and related products.

Challenges: However, the market growth would be negatively impacted by various challenges such as strict regulatory requirements due to inconsistent diagnostic results, and increased competition from alternative diagnostics technologies. The lateral flow assay kits are prone to depicting false results that can lead to false or no diagnosis, severely affecting patient's health. Therefore, lack of standardization, stringent regulatory requirements, & presence of lengthy approval procedures in industrialized nations is expected to negatively impact the growth of global lateral flow assay market.

Trends: The market is projected to grow at a fast pace during the forecasted period, due to increasing integration of artificial intelligence (AI) and biosensors, rising digital technology integration, evolving newer applications of lateral flow assays, rising demand for personalized and customized lateral flow assays, etc. Lateral flow assay testing has been widely used for infectious disease diagnosis, heart disease diagnosis, veterinary applications, and so on, however, in recent years, there has been an increase in the use of LFA kits and products in several newer applications, such as saliva diagnostics, behavioral health, agriculture (detection of genetically modified organisms and quality control of plants), biological warfare (detection of Bacillus anthracis), environmental testing (detection of contaminating enzymes in production facilities), food microbiology (E. coli Detection of O157, Salmonella, Listeria, and other food spoilage bacteria), etc., which is expected to accelerate the growth of lateral flow assay market in the upcoming years.

Impact Analysis of COVID-19 and Way Forward:

COVID-19 brought in many changes in the world in terms of reduced productivity, loss of life, business closures, closing down of factories and organizations, and shift to an online mode of work. The sudden outbreak of the COVID-19 pandemic was associated with an increase in the demand for simple, rapid, cost-effective, and point-of-care diagnostic devices, such as lateral flow assay kits and readers, needed by hospitals, clinics, airports, schools, and other workplaces for the detection and control of the SARS-CoV-2 virus as LFA test kits demonstrated the ability to detect both symptomatic and asymptomatic COVID-19 infections. The impact of the COVID-19 pandemic on the global lateral flow assay market turned out to be positive, as government organizations and healthcare associations increased their focus on mass population testing, infection prevention & control, and public awareness campaigns aimed at identifying the symptoms and creating patient awareness about the use of lateral flow assay COVID-19 kits.

Competitive Landscape:

The lateral flow assay market is relatively fragmented with increasing number of large and medium sized players accounting for the majority of market revenue. Major companies in the market have been implementing both organic (such as launches, expansion, and product approvals) and inorganic development strategies (such as product launches, partnerships, and collaborations) to expand their product portfolio and gain larger market share. For instance, on October 12, 2022, F. Hoffmann-La Roche Ltd, announced the launch of company's next-generation portfolio SARS-CoV-2 rapid antigen tests ("2.0") for self-testing and professional use in countries accepting the CE Mark, where ARS-CoV-2 Antigen Self Test Nasal is a lateral flow test for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in human nasal samples.

The key players of the lateral flow assay market are:

F. Hoffmann-La Roche Ltd

Siemens Healthineers AG

Thermo Fisher Scientific Inc.

Abbott Laboratories

Merck KGaA (MilliporeSigma)

Bio-Rad Laboratories, Inc.

Becton, Dickinson and Company

QuidelOrtho Corporation (Quidel Corporation)

Access Bio, Inc.

PerkinElmer, Inc.