Lateral Flow Assays Market 101

 

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)

Lateral Flow Assays Industry Dynamics:

DRIVERS: High prevalence of infectious disease across the globe

Despite significant improvements in sanitation and medicine, the global prevalence of infectious diseases is still high. Although non-communicable diseases are the leading cause of morbidity and mortality, infectious diseases remain a major public health concern across the globe. The high prevalence of infectious diseases, such as HIV and malaria, coupled with the underdeveloped healthcare infrastructural facilities and increasing public awareness in developing countries, is expected to drive the adoption of lateral flow assay tests in these countries.

The high prevalence of infectious diseases, such as HIV and malaria, coupled with the underdeveloped healthcare infrastructural facilities and increasing public awareness in developing countries, is expected to drive the adoption of lateral flow assay tests in these countries. In addition, recent outbreaks of infectious diseases from the spread of viruses (such as Ebola, H1N1, and Zika) have highlighted the need for early disease detection capabilities, which is also expected to drive market growth. The current COVID-19 pandemic has resulted in high demand for rapid diagnostic testing through lateral flow technology, supporting the growth of this market in the coming year.

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Growing usage of home-based lateral flow assays devices

Home-based lateral flow assay devices play a vital role in the management of cardiovascular and infectious diseases. These devices are also very useful in testing pregnancy and stigmatized conditions such as HIV as they potentially empower patients to perform self-tests in their homes. Hence, the increasing incidence of these diseases and the higher adoption of lateral flow assay tests in home care settings are expected to boost the demand for lateral flow assays.

During COVID-19, many companies launched home-based lateral flow assays for COVID-19 testing as people were afraid to get tested at diagnostic laboratories or hospitals due to the high rush, which supported the demand for home-based lateral flow assays.

This led to the launches of several home-based assays. For example:

·         BinaxNOW COVID-19 Ag Card in August 2020 and Panbio rapid COVID-19 test in September 2020

·         Roche Diagnostics launched the SARS-CoV-2 Rapid Antigen test in September 2020.

·         Other tests launched during the COVID-19 include Sofia 2 Flu+ SARS Antigen FIA (Quidel Corporation), CLINITEST Rapid COVID-19 Antigen test (Danaher Corporation), and BD Veritor SARS CoV-2 Test (BD).

CHALLENGES: Limited reimbursements for lateral flow assay product

Owing to reimbursement issues, lateral flow assay-based diagnostic tests have witnessed limited adoption in several countries across the globe. The rise in healthcare expenditure is compelling insurance payers to question and analyze the necessity of new diagnostic tests. Also, payers are moving from fee-for-service reimbursement systems towards fee-for-value-based reimbursement systems. As a result, a diagnostic test that enables a clinician to decide whether to go for a particular treatment does not receive adequate reimbursement and is abandoned or underinvested.

Reimbursement issues are plaguing the growth of the lateral flow assay-based diagnostics industry in many countries. For instance, the National Health Service (NHS) accounts for ~75% of healthcare reimbursements throughout the UK. Within primary care in the NHS, reimbursement is available only for prescribed lateral flow assay devices, such as the CrAg lateral flow assays used to diagnose cryptococcosis. There is no separate policy for reimbursing non-prescribed lateral flow assay kits (such as cardiac markers and pregnancy kits).

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Recent Developments:

·         In August 2021, Becton, Dickinson and Company got approval for the OTC rapid antigen test using the Scanwell Health Mobile App.

·         In April 2021, Becton, Dickinson and Company partnered with USA Track & Filed (USATF) (US) to provide rapid COVID-19 testing for athletes using the BD veritor plus system.

·         In September 2020, Qiagen N.V. (Netherlands) acquired NeuMoDx Molecular, Inc. (US) to broaden Qiagen’s diagnostics instrument product portfolio and strengthen its automated molecular testing market position.

·         In July 2020, Merck KGaA (Germany) announced its expansion of a new manufacturing facility worth USD 21 million in Buchs (Switzerland).

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