Lateral Flow Assays Market Size, Share and Growth Report, 2035

Global Lateral Flow Assays Market Size, Forecast, and Trend Highlights Over 2023 – 2035

Lateral Flow Assays Market size is estimated to garner a revenue of ~USD 23 billion by the end of 2035 by growing at a CAGR of ~6.40% over the forecast period, i.e., 2023 – 2035. Further, the market generated a revenue of ~USD 11 billion in the year 2023. The market growth is mainly owing to the increasing prevalence of infectious diseases, the growing demand for point-of-care testing, and the development of innovative lateral flow assay products. According to the World Health Organization (WHO), infectious diseases are the world's leading cause of death, accounting for approximately 25% of all deaths worldwide. Some of the key applications of lateral flow assays include infectious disease testing, pregnancy testing, drug testing, and food safety testing. The lateral flow assays refer to the diagnostic testing products that utilize lateral flow technology, also known as immune chromatography. Lateral flow assays are simple and portable diagnostic devices that can be used in a wide range of settings, including clinics, hospitals, and homes.

In addition to this, in 2020, the COVID-19 pandemic resulted in over 266 million confirmed cases and 5.2 million deaths globally. Other infectious diseases that continue to pose a significant public health threat include HIV/AIDS, tuberculosis, malaria, hepatitis, and sexually transmitted infections. In the year 2019, there were an estimated 38 million people living with HIV/AIDS worldwide, with 1.5 million new infections and 690,000 deaths. Tuberculosis (TB) remains one of the top 10 causes of death worldwide, with an estimated 10 million new cases and 1.4 million deaths in the year 2019. Malaria caused an estimated 229 million cases and 409,000 deaths worldwide in 2019, with the majority of cases occurring in sub-Saharan Africa. Hence, this is estimated to be an important factor to boost the growth of the global lateral flow assays market.

Global Lateral Flow Assays Market: Growth Drivers and Challenges

Growth Drivers

Increasing Incidence of Infectious Diseases: Tuberculosis (TB) is a bacterial infection that primarily affects the lungs. According to the WHO, there were an estimated 10 million cases of TB worldwide in 2020, with 1.5 million deaths. The COVID-19 pandemic has significantly impacted the world, with over 466 million confirmed cases and over 6.1 million deaths globally as of November 2021, according to the World Health Organization (WHO). Human immunodeficiency virus (HIV) is a virus that attacks the immune system, and acquired immunodeficiency syndrome (AIDS) is the most advanced stage of HIV infection. According to UNAIDS, there were approximately 38 million people living with HIV/AIDS globally in 2020, with 680,000 deaths.
Rise in Research Spending – Growth in the global market during the forecast period can be further attributed to increased investment in research and development activities to continuously find more viable solutions for biological safety cabinets. Research reports show that global R&D spending has more than tripled in real terms since 2000, rising from about USD 680 billion to more than USD 2.5 trillion in the year 2019.
Spiking Healthcare Spending – According to the latest spending data, global healthcare spending has increased over the past two decades, effectively doubling from 8.5% in the year 2000 to USD 8.5 trillion in the year 2019, increasing GDP reached 9.8%. The boom will continue during the forecast period.
Growing Demand for Point-of-Care Testing: Point-of-care testing (POCT) has become increasingly important in recent years due to its ability to provide rapid and accurate results in a variety of settings. According to a report, the global POCT industry size accounted for nearly USD 22 billion in the year 2020. Lateral flow assays are well-suited for POCT due to their simplicity, portability, and ease of use.
Increasing Demand for Food Safety Testing: The demand for food safety testing is increasing globally, driven by factors such as the growing incidence of foodborne illnesses, changing food safety regulations, and increasing consumer awareness about the safety and quality of the food they consume. According to a report, the industry is expected to reach nearly USD 25 billion by 2026. Lateral flow assays are widely used for food safety testing due to their ease of use, rapid turnaround time, and ability to detect a wide range of contaminants such as pathogens, toxins, and allergens. This is expected to drive demand for lateral flow assays in the food safety testing market in the coming years.

Challenges

Lack of sensitivity and specificity: Lateral flow assays are known to have limitations in terms of sensitivity and specificity compared to other diagnostic methods, such as PCR or ELISA. This can lead to false-positive or false-negative results, which can be a significant challenge in certain applications.
Competition from alternative technologies
Regulatory challenges

Global Lateral Flow Assays Market Segmentation

The lateral flow assays market is segmented and analyzed for demand and supply by end users into hospitals, diagnostic laboratories, pharmaceutical companies, and others. Out of the five types of end users, the hospital segment is estimated to gain the largest market share of about ~35% in the year 2035. The growth of the segment can be accredited to the large number of patients present in hospital facilities for treatment. The number of hospitals is also notably growing. For instance, by the year 2022, there were noted to be approximately 6,100 hospitals in the United States. Hospitals provide a wide range of medical care. Physicians, called hospital doctors, typically specialize in internal medicine, pediatrics, or general practice. They have the knowledge to solve common problems and the resources to solve more complex medical problems. Hospitals may also offer specialized care, such as neurology, obstetrics and gynecology, and oncology. By definition of a hospital, a county hospital is typically a primary medical facility in a region with numerous intensive care and mobile beds for patients requiring long-term care.

The lateral flow assays market is also segmented and analyzed for demand and supply by-products into kits & reagents, and lateral flow readers. Amongst these two segments, the kits & reagents segment is expected to garner a significant share of around ~60% in the year 2035. The growth of the segment can be accredited to the increasing demand for rapid and point-of-care testing. The growing demand for rapid and point-of-care testing is driving demand for lateral flow assay kits and reagents. These products are widely used in various settings, such as clinics, hospitals, and home-based testing, due to their simplicity, ease of use, and rapid turnaround time. The development of new and innovative lateral flow assay technologies, such as digital and smartphone-based lateral flow assays, is driving demand for kits and reagents. These technologies require specialized kits and reagents that are designed to work with specific lateral flow assay platforms, driving demand for these products. Ongoing investments in research and development are driving the development of new and improved lateral flow assay kits and reagents. These products are designed to offer higher sensitivity, specificity, and accuracy, driving demand for new and improved kits and reagents.

Our in-depth analysis of the global lateral flow assays market includes the following segments:

By End User

Hospitals
Diagnostic Laboratories
Pharmaceutical Companies
Others

By Product

Kits & Reagents
Lateral Flow Readers

Global Lateral Flow Assays Market Regional Synopsis

The lateral flow assays in the Asia Pacific region, amongst the market in all the other regions, is projected to hold the largest market share of about ~35% by the end of 2035. The regional growth can majorly be attributed to the increasing prevalence of infectious diseases in the region. The Asia Pacific region has a high burden of infectious diseases, which is driving demand for lateral flow assays for rapid and accurate diagnosis. For example, according to a report by the World Health Organization (WHO), tuberculosis (TB) incidence rates in the Asia Pacific region are among the highest in the world, accounting for around 60% of global cases in 2019. The increasing prevalence of TB, as well as other infectious diseases such as dengue and malaria, is expected to drive demand for lateral flow assays in the region. The demand for point-of-care testing is increasing in the Asia Pacific region, driven by factors such as the need for rapid diagnosis and the limited availability of laboratory infrastructure in certain areas. Several countries in the Asia Pacific region, such as China and India, are investing heavily in healthcare infrastructure, which is expected to drive demand for lateral flow assays. The Asia Pacific region has a large and growing population, which is expected to drive demand for lateral flow assays.

The lateral flow assays in the North America region, amongst the market in all the other regions, is projected to hold the second largest share of about ~24% during the forecast period. The growth of the market in this region can primarily be attributed to growing prevalence of chronic diseases. The North America region has a high burden of chronic diseases, such as diabetes, cardiovascular disease, and cancer, which is driving demand for lateral flow assays for early detection and monitoring. According to the Centers for Disease Control and Prevention (CDC), chronic diseases account for 6 out of 10 deaths in the United States, and the burden is expected to increase in the coming years. The demand for point-of-care testing is increasing in North America, driven by factors such as the need for rapid diagnosis, convenience, and cost-effectiveness. North America is a hub of technological advancements, which is driving the development of new and innovative lateral flow assay technologies.

Further, the lateral flow assays in the Europe region, amongst the market in all the other regions, is projected to hold a majority of the share by the end of 2035. The growth of the market can be attributed majorly to the increasing demand for rapid diagnostic tests. The demand for rapid diagnostic tests is increasing in Europe, driven by factors such as the need for early diagnosis and treatment of infectious diseases, and the increasing prevalence of chronic diseases. Europe is a hub of technological advancements, which is driving the development of new and innovative lateral flow assay technologies. For example, the development of digital and smartphone-based lateral flow assays is driving demand for specialized kits and reagents that are designed to work with these platforms. The demand for point-of-care testing is increasing in Europe, driven by factors such as the need for rapid diagnosis, convenience, and cost-effectiveness. The governments in Europe are actively supporting lateral flow assay development and commercialization. For instance, the European Commission has launched several initiatives to support the development of point-of-care testing technologies, including lateral flow assays, for the rapid diagnosis of infectious diseases.

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Top Featured Companies Dominating the Global Lateral Flow Assays Market

Abbott Laboratories
- Company Overview
- Business Strategy
- Key Product Offerings
- Financial Performance
- Key Performance Indicators
- Risk Analysis
- Recent Development
- Regional Presence
- SWOT Analysis
Becton, Dickinson, and Company
Bio-Rad Laboratories, Inc.
Danaher Corporation
F. Hoffmann-La Roche AG
QIAGEN N.V.
Siemens Healthineers AG
Thermo Fisher Scientific, Inc.
Merck KGaA

In The News

Abbott Laboratories: Abbott announced the launch of a new lateral flow antigen test called the BinaxNOW COVID-19 Ag Card home test. This test is intended for non-prescription, and over-the-counter use, and provides results in 15 minutes. It is the first COVID-19 test authorized for non-prescription use by the US Food and Drug Administration (FDA).
Becton, Dickinson and Company: BD announced the acquisition of a lateral flow and clinical diagnostics company, Inflammatix. Inflammatix's technology enables rapid diagnosis and triage of patients with suspected infectious or inflammatory conditions. The acquisition is expected to enhance BD's diagnostic capabilities and expand its presence in the infectious disease market.

Global Economic Impact

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Despite Inflation & Fearing Recession, Businesses Across the Globe Expected to Do Better in 2023:

In 2023, market players might incur losses due to huge gap in currency translation followed by contracting revenues, shrinking profit margins & cost pressure on logistics and supply chain.
Controlling Inflation has become the first priority for global economies from last quarter of 2022 and to be followed in 2023. With skewed economic situations, rise in interest rate by governments to control spending and inflation, spiked oil and gas prices, high inflation, geo-political issues including U.S. & China trade war, Russia-Ukraine conflict to intensify the global economic issues.
The interest rates in the U.S. may be less sensitive in 2023 as compared to 2022; sigh of relief for businesses. Positive business sentiments, healthy business balance sheets, growth in construction spending (private construction value in 2022 stood at $1,429.2 billion, 11.7 percent (±1.0 percent) above the $1,279.5 billion spent in 2021, Residential construction in 2022 was $899.1 billion, up by 13.3 percent (±2.1 percent) from $793.7 billion in 2021, non-residential construction touched $530.1 billion, 9.1 percent (±1.0 percent) above the $485.8 billion in 2021.) showcases minimal impact of recession in the country.
Similarly, spiked spending in the European and major Asia economics including, India, China & Japan to showcase less impact on the global demand.

Key Questions Answered in the Report

1) What are the major factors driving the growth of the lateral flow assays market?

Ans: Increasing prevalence of infectious diseases, and the growing demand for point-of-care testing are the major factors driving the market growth.

2) What would be the CAGR of lateral flow assays market over the forecast period?

Ans: The market size of lateral flow assays is anticipated to attain a CAGR of ~6.40% over the forecast period, i.e., 2023 – 2035.

3) What are the challenges affecting the lateral flow assays market growth?

Ans: The competition from alternative technologies is estimated to be the growth hindering factor for the market expansion.

4) Which region will provide more business opportunities for growth of lateral flow assays market in future?

Ans: The market in the Asia Pacific region is projected to hold the largest market share by the end of 2035 and provide more business opportunities in the future.

5) Who are the major players dominating the lateral flow assays market?

Ans: The major players in the market are QIAGEN N.V., Siemens Healthineers AG, Thermo Fisher Scientific, Inc., Merck KGaA, PerkinElmer, Inc., and others.

6) How are the company profiles selected?

Ans: The company profiles are selected based on the revenues generated from the product segment, and the geographical presence of the company, which determines the revenue-generating capacity as well as the new products being launched into the market by the company.

7) What are the segments in the lateral flow assays market?

Ans: The market is segmented by product, end user, and by region.

8) Which segment captures the largest market size in the end user segment in the lateral flow assays market?

Ans: The hospital segment is anticipated to garner the largest market size by the end of 2035 and display significant growth opportunities.

Base Year	2022
Forecast Year	2023-2035
CAGR	~6.40%
Base Year Market Size (2023)	~ USD 11 Billion
Forecast Year Market Size (2035)	~ USD 23 Billion
Regional Scope	North America (U.S., and Canada) Latin America (Mexico, Argentina, Rest of Latin America) Asia-Pacific (Japan, China, India, Indonesia, Malaysia, Australia, Rest of Asia-Pacific) Europe (U.K., Germany, France, Italy, Spain, Russia, NORDIC, Rest of Europe) Middle East and Africa (Israel, GCC North Africa, South Africa, Rest of Middle East and Africa)