The Global Lateral Flow Assays Market is projected to reach USD 12.6 billion by 2026, at a CAGR of 2.0% during the forecast period. The high prevalence of infectious diseases worldwide, rapid growth in the geriatric population, growing demand for point-of-care testing, and rising use of home-based lateral flow assay devices are the major factors driving the growth of this market. On the other hand, reluctance among doctors and patients to change existing diagnostic procedures and the low accuracy of lateral flow assays are the key restraints.
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Key Market Players:
Abbott Laboratories (US), Quidel Corporation (US), F. Hoffman-La Roche AG (Switzerland), Danaher Corporation (US), Siemens AG (Germany), BD (US), bioMérieux SA (France), Bio-Rad Laboratories (US), Thermo Fisher Scientific, Inc. (US), PerkinElmer Inc. (US), Hologic Inc. (US), QIAGEN N.V. (Netherlands), and Merck KGaA (Germany)
Difficulties in procuring quality raw materials for the development of lateral flow assays tests
One of the challenging aspects of developing lateral flow assay tests is the procurement and qualification of antigens and antibodies, known as critical reagents. Antibodies to be used in assays must be tested for accuracy, specificity, stability, and reproducibility, as any defects in the reagent can result in failure of the assay. The qualification of a single lot of reagents requires more than 1,000 data points to be checked and verified. Another challenge is related to the stability testing of assays once an antibody or antibody pair is identified. For an assay to qualify as a commercial product, it should have a stable shelf life of 6 months, preferably extending to 18 24 months. Additional time, resources, and costs are involved in the correction of assays that fail stability testing. Consequently, this would result in creating a delayed time-to-market. These factors pose a challenge to the growth of the lateral flow assays market in the forecast period.
Kits & Reagents segment accounted for the largest share in the lateral flow assays market.
The lateral flow assays market is segmented into kits & reagents and lateral flow readers. In 2020, kits & reagents accounted for the larger share of the global market. The large share of this segment can be attributed to the increasing application of lateral flow kits & reagents for POC testing, during the forecast period.
Clinical Testing segment is expected to witness the fastest growth in the forecast period.
The lateral flow assays market is segmented into clinical testing, veterinary diagnostics, food safety & environmental testing, and drug development & quality testing based on the application. The clinical testing segment accounted for the largest share of the market in 2020. The large share of this segment can be attributed to the rising prevalence of chronic diseases and the increasing demand for patient-centric care.
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Sandwich assays technique accounted for the largest share of lateral flow assays market in 2020
The lateral flow assay kits & reagents market is segmented into competitive assays, sandwich assays, and multiplex detection assays. The sandwich assays technique dominated the lateral flow assays market with a share in 2020. The large share of this segment can be attributed to its better assay sensitivity and specificity.
Blood samples accounted for the largest share of lateral flow assays market in 2020
The clinical testing lateral flow assays market is segmented into blood, urine, saliva, and other samples. Blood samples accounted for the largest market share in 2020. The use of blood samples in lateral flow tests for infectious diseases such as malaria, HIV, and syphilis; the rising awareness of rapid testing solutions; and easy detection of disease antibodies from blood samples are factors for the largest share of this segment.
The hospitals & Clinics segment accounted for the largest share of lateral flow assays industry in 2020
Based on end users, the lateral flow assays market is segmented into hospitals & clinics, diagnostic laboratories, home care settings, pharmaceutical & biotechnology companies, and other end users. The hospitals & clinics segment accounted for the largest market share in 2020. Technological advancements, the increasing adoption of point-of-care testing and growing patient inclination toward fast and early diagnosis are driving the growth of the hospitals & clinics segment.
North America accounted for the largest share of the lateral flow assays industry in 2020
The North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. In 2020, North America accounted for the largest share of the lateral flow assays market, followed by Europe, the Asia Pacific, Latin America, and the Middle East & Africa. However, the APAC is expected to grow at the highest CAGR during the forecast period. The rapidly developing healthcare industry in China and India, growth in the aging population reasons for high growth rate in the market in this region.
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