Lateral Flow Assay Market - Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2031 - By Product, Technology, Grade, Application, End-user, Region: (North America, Europe, Asia Pacific, Latin America and Middle East and Africa)

The global lateral flow assay market, projected to reach US$ 8.9 billion by 2024, is set for substantial expansion with a compound annual growth rate (CAGR) of 6%. By 2031, it is expected to grow to US$ 13 billion. This growth is primarily fueled by rising incidences of sexually transmitted diseases (STDs) and the increasing need for quick and precise diagnostic solutions.

Increasing STD Incidence Driving Market Growth

The Centers for Disease Control and Prevention (CDC) has reported a concerning 30% increase in the number of sexually transmitted diseases. The World Health Organization (WHO) corroborates these findings, citing approximately 374 million new cases of sexually transmitted infections (STIs) in 2020. These infections include chlamydia, gonorrhea, syphilis, and trichomoniasis. Specifically, chlamydia accounted for 129 million cases, gonorrhea for 82 million, syphilis for 7.1 million, and trichomoniasis for 156 million cases. This surge in STD prevalence underscores the critical need for effective diagnostic solutions, thereby propelling the growth of the lateral flow assay market.

Government and Private Sector Efforts Boosting Market Expansion

To combat the rising STD rates, both government and private agencies are intensifying efforts to raise public awareness and promote self-testing policies. WHO estimates suggest that self-testing could help the U.S. achieve the target of diagnosing 90% of people with HIV. As a result, around 41 countries have adopted HIV self-testing protocols. Additionally, there is increasing funding to enhance the reach and effectiveness of HIV testing kits, services, and programs.

Manufacturers like Abbott are playing a pivotal role in supporting developing regions such as Africa. By collaborating with organizations like the African First Ladies Against HIV/AIDS (OAFLA), these companies aim to reduce the spread of HIV, significantly driving the demand for lateral flow assay tests across various regions.

Why Are Lateral Flow Assay Products Gaining Immense Popularity?

“Ease of Use, Cost-Effectiveness, & High Sensitivity of LFA Tests”

Lateral flow assay (LFA) tests have gained widespread acceptance across multiple sectors, including healthcare, animal health, food & feed testing, environmental testing, and plant disease testing. Beyond infectious disease and pregnancy testing, LFA tests are employed in food testing and drug abuse testing. Their ease of use, which reduces the need for hospital visits, has led to strong market penetration for testing seasonal and outbreak indications such as malaria and dengue.

Moreover, the veterinary sector's fast acceptance of LFA tests is contributing to the overall market growth. Lower-middle-income countries are anticipated to see significant adoption growth due to the economical pricing, easy availability, and high sensitivity of LFA tests in infectious disease testing.

Increasing R&D Efforts and Collaborative Initiatives

Research and development efforts are further boosting market growth. Emphasis on R&D for drugs and therapies targeting rare diseases such as malaria and salmonella is creating substantial opportunities for LFA product manufacturers. Collaborative efforts among leading pharmaceutical manufacturers, funding programs, and the presence of reimbursement policies are expected to supplement market expansion.

Challenges Facing the Lateral Flow Assay Market

“High Competition in Market Leading to Sub-Standard Products”

Despite the promising growth, the lateral flow assay market faces several challenges. One major issue is the poor reproducibility of results. LFA tests can yield different results when administered at different times to the same person. Additionally, the simultaneous analysis of multiple markers (multiplexing) remains difficult, and inaccurate sample volume can reduce result precision.

The market also suffers from pricing pressure due to the falling cost of manufacturing and the high volume, low-value nature of LFA kits. Vendors compete based on volume and pricing, leading to the availability of sub-standard products in the market.

Furthermore, LFAs are primarily qualitative tests that detect the presence of diseases. While they can provide semi-quantitative results based on color change, they are not suitable for quantifiable detection and cannot assess the severity of the condition being diagnosed. This limitation restricts their use to primary screening rather than detailed diagnostic applications.

Key Industry Players:

• Thermo Fisher Scientific Inc.
• F. Hoffmann-La Roche
• Abbott Laboratories
• Becton, Dickinson & Company
• PerkinElmer Inc.
• Siemens Healthineers
• QIAGEN N.V.
• bioMérieux SA
• Bio-Rad Laboratories, Inc.
• Maternova Inc.
• Quidel Corporation
• Healgen Scientific, LLC.
• Meridian Bioscience Inc.
• Abcam plc.
• Access Bio, Inc.
• Humasis Co. Ltd.
• DIALUNOX GmbH
• Detekt Biomedical LLC
• Guangzhou Wondfo Biotech Co., Ltd.
• Creative Diagnostics

Market Segmentation

By Product Type:

• LFA Readers
• Benchtop Readers
• Handheld Readers
• LFA Kits
• Test Strips
• Dipsticks
• Cassettes
• Lancets

By Application:

• Sexually Transmitted Diseases
• Human Deficiency Virus (HIV) Infection
• Gonorrhoea
• Syphilis
• Others
• Infectious Diseases
• Mosquito-Borne Diseases
• Streptococcus Infections
• Hepatitis Infection
• Gastrointestinal Infections
• Respiratory Tract Infections
• Others
• Diabetes
• Pregnancy and Fertility Testing
• Drug of Abuse Testing

By Distribution Channel:

• Hospital Pharmacies
• Retail Pharmacies
• Supermarkets/Hypermarkets
• e-Commerce

By Region

• North America
• GCC
• West Asia
• North Africa
• South Europe
• U.K.
• Rest of Europe
• Rest of Asia-Pacific
• Rest of Middle East & Africa