The global lateral flow assays market size is anticipated to exceed USD 12.1 billion by 2028, with the emergence of new diseases and the trend of at-home testing.

Each year billions of test strips are used for diagnosing various healthcare conditions. LFA technology enables practitioners and healthcare settings to conduct tests for pregnancy and fertility, STDs, mosquito-borne diseases, tuberculosis, drugs of abuse, hepatitis, cardiac markers, veterinary diagnostics, and food safety, amongst others. Especially in the research community, point-of-care (POC) diagnosis using LFAs has been gaining grip for the development of platforms that can evaluate biological markers in bodily fluids such as saliva and urine.

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Lateral flow assays (LFAs) are gaining popularity as a standard point-of-care testing platform across both developed and developing countries. These disposable diagnostic devices are simple to use, affordable, and are significantly faster in delivering test results. The help in identifying biomarkers in samples such as saliva, urine, blood, and food and are most commonly used for at-home pregnancy tests.

In 2022, Canon Virginia, Inc. announced a new collaboration with Maxim Biomedical to assemble ClearDetect COVID-19 Antigen Test Kits that utilizes LFA technology that can easily be used at home. While the U.S. NIH’s Rapid Acceleration of Diagnostics (RADx) initiative announced that it has issued contract awards of around $77.7 million to develop and manufacture 12 new rapid diagnostic tests for SARS-CoV-2. 

Cases of infertility on a rise worldwide 

The rate of pregnancy and fertility is steadily declining across the world. The World Health Organization claims that around 48 million couples and 186 million individuals in the world are suffering from infertility. Some of the common causes of this growing catastrophe are obesity, alcohol consumption, pollution, and stress among others.  

With that said, the sale of at-home pregnancy tests — commonly based on LSA— is expected to record huge demand in countries like the U.S that are experiencing a surge in infertility rate. According to the U.S. Centers for Disease Control and Prevention (CDC), about 1 in 5 (19%) women aged 15 to 49 years with no prior births are unable to get pregnant due to infertility.

Meanwhile, China is expected to emerge as a lucrative lateral flow assays market as the demand for pregnancy kits is expected to spike in the coming years. Recently, the Chinese government announced that it will allow couples to have up to three children after census data indicated a steep decline in birth rates. A survey published on South China Morning Post further revealed that China saw its infertility rate spike up to 18% in 2020 in contrast to 12% in 2007.

New developments in manufacturing technology and process control will allow pregnancy kit manufacturers to meet this emerging demand. In 2020, Swiss medtech firm Bloom Diagnostics launched its testing device after securing USD 10.88 million in Series B round that will be used for additional R&D and expansion in the U.S. and Europe.

Diagnostic laboratories to favor LFA market growth

Diagnostic centers today have several tests to offer, of which lateral flow assays is one. LFA represents high potential healthcare monitoring and screening applications. They offer a promising alternative to preliminary diagnosis for laboratory instruments which are notoriously costly, time-consuming, and require trained personnel to operate.

Early detection of diseases using LFA-based tests can help patients in the long run. It is a medically proven fact that diseases such as diabetes, cancer, and tumor if detected at an early stage can be treated or managed effectively.

Reportedly, the demand for LFA-based testing prevailed during the COVID-19 pandemic, with huge footfall across diagnostic centers to test reports. With advancements in technology and medical science, manufacturers are expected to come up with new testing tools that can be used across diagnostic centers over the coming years.

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UK evaluating new point-of-care lateral flow tests

The UK Government is evaluating multiple rapid point-of-care tests, including lateral flow tests to validate the diagnosis of various diseases. Cases of STDs have elevated significantly in recent years across the UK, claims a report by the Health Protection Agency. Apparently, the rate of Chlamydia rose from 121,791 (2007) to over 123,000 last year in the region.

Early detection is vital for both men and women experiencing chlamydia and gonorrhea which can lead to complications and permanent damage such as infertility. The conception rate for women under 18 years has also decreased for the 11th year in a row, the longest slope ever since records began. In view of such a scenario, the manufacturing and supply of diagnostics kits that are based on LSA technology might prevail in the UK through the coming years. 

To sum up, low development costs and ease of production of LFAs is expected to expand the product application scope into multiple fields that demand rapid tests. Widely used in hospitals, diagnostics centers, and clinical laboratories for quantitative and qualitative detection of specific antigens and antibodies will favor lateral flow assays market outlook in the future too.

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