Lateral Flow Assay Market
Medical Device

Lateral Flow Assay Market – How to Outperform the Competition

Lateral flow assay (LFA), known as lateral flow immunochromatographic assay, is a simple paper-based device intended for detecting the presence or absence of a target analyte in a liquid sample (matrix) without the need for specialized or costly equipment. The lateral flow assay is used for medical diagnostics, home testing, point-of-care testing, and laboratory use. The lateral flow assay market is presumed to account for the highest CAGR from 2023 to 2028. The growth is attributable to the growing usage of home-based lateral flow assay devices and growing demand for point-of-care testing.

Abbott Laboratories and Danaher Corp – Notable Market Players in Lateral Flow Assay Market 

Key factors that are driving the growth of the lateral flow assay market are the increasing use of home-based assay kits and rising popularity of point-of-care testing drives the growth of the lateral flow assays market. However, the market is likely to get impacted by the inconsistent assay results due to procedural limitations during the forecast period.

The lateral flow assay market is majorly comprised of top players involving F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific Inc, Abbott Laboratories, Merck KGaA; Hologic Inc; Qiagen NV; bioMerieux SA; Bio-Rad Laboratories Inc; Access Bio Inc; Danaher Corp; among others.

The companies listed above are implementing various strategies such as product launches, acquisitions, mergers, and partnerships, which have resulted in the company’s growth and, in turn, have brought about various changes in the worldwide market. Additionally, the companies have adopted several inorganic and organic strategies for accelerating their growth and improving their market position.

Below is the list of the growth strategies done by the players operating in the lateral flow assay market:

Year

News

Mar-2023

Roche announced that the FDA approved the Ventana PD-L1 (SP263) assay
to identify patients with non-small cell lung cancer who are eligible for treatment
with Libtayo, a PD-1 inhibitor therapy developed by Regeneron).

Dec-2022

Roche announced FDA 510(k) clearance of its Elecsys Beta-Amyloid (1-42) CSF II (Abeta42)
and Elecsys Phospho-Tau (181P) CSF (pTau181) assays. The assays measure beta-amyloid
(1-42) and phospho-tau (181P) concentrations in cerebrospinal fluid in adults 55 and older who
are being evaluated for Alzheimer’s disease and other causes of cognitive impairment to generate
a pTau181/Abeta42 ratio value. The assays can detect Alzheimer’s pathology in earlier stages of disease
when changes in these biomarker levels occur

Jun-2021

Thermo Fisher Scientific launched its CE-IVD-marked TaqPath COVID-19 Fast PCR Combo Kit 2.0.
The kit compensates for current and emerging variants. The first generation TaqPath COVID-19 CE-IVD RT PCR Kit
and the TaqPath COVID-19 Combo Kit, using a different assay design, respectively, received CE-IVD certification and
emergency use authorization in March 2020.

May-2022

Abbott received FDA clearance for its Alinity m STI assay. The test simultaneously detects and differentiates
four sexually transmitted infections—Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis,
and Mycoplasma genitalium—from one swab sample or urine sample collected in a health care setting
by either a clinician or the patient

Ded-2021

Merck announced that its Life Science business sector for the construction of a
lateral flow membrane production facility at the company’s U.S. site in Sheboygan,
Wisconsin had been awarded a €121 million contract award. With this agreement, Merck will construct
a state-of-the-art lateral flow membrane production facility providing global in-vitro diagnostic (IVD)
manufacturing customers greater flexibility and security of supply of Hi-Flow Plus lateral flow membranes

Jul-2021

Hologic obtained a CE Mark for the use of saliva samples with the
Aptima SARS-CoV-2 assay in Europe. The Aptima SARS-CoV-2 test
is a molecular diagnostic assay which detects the genetic material of the
pathogen causing COVID-19. The test runs on the fully automated Panther system.