The lateral flow assays market is estimated to grow from USD 8.51 billion in 2025 to USD 12.52 billion by 2030 at a CAGR of 8.0%, during the forecast period.
Scope of the Report
Years Considered for the Study
2024-2030
Base Year
2024
Forecast Period
2025-2030
Units Considered
Value (USD billion)
Segments
Product, Application, Technique, Sample Type, and End User
Regions covered
North America, Europe, Asia Pacific, Latin America, the Middle East & Africa, and GCC Countries
This is due to the high prevalence of infectious diseases worldwide and the subsequent need for testing, rapid growth in the geriatric population, the rising use of home-based lateral flow assay devices, and the growing demand for POC testing, which are the major factors driving the growth of this market. However, inconsistent accuracy compared to other methods and the reluctance of doctors and patients to shift from traditional diagnostics restrain the growth of the lateral flow assays market.
"The clinical testing segment of the lateral flow assays market, by application, is estimated to hold the largest position during the forecast period."
The clinical testing segment is the largest application segment in the lateral flow assays market. Based on applications, the lateral flow assays market is segmented into clinical testing, veterinary diagnostics, food safety & environmental testing, and drug development & quality testing. The clinical testing segment accounted for the largest share of the lateral flow assays market in 2024. This trend is projected to continue during the study period. The large share of this application segment can be attributed to the rising prevalence of chronic diseases and infectious diseases worldwide, the growing geriatric population, increasing patient awareness about rapid test options, the growing pressure to reduce healthcare costs, and the increasing demand for patient-centric care.
"The hospitals & clinics segment accounted for the largest market share in the lateral flow assays market."
Based on end users, the LFA market is segmented into hospitals & clinics, diagnostic laboratories, home care settings, pharmaceutical & biotechnology companies, and others. The hospitals and clinics segment accounted for the largest market share in 2024. Technological advancements, increasing adoption of point-of-care testing, and the growing inclination toward fast and early diagnosis are driving the growth of the hospitals & clinics segment.
"North America segment of the lateral flow assays market, by region, is estimated to account for the largest share during the forecast period."
The global lateral flow assays market is segmented into six major regions: North America, Europe, Asia Pacific, Latin America, the Middle East & Africa, and GCC Countries. North America holds the leading position in this market, driven by advanced healthcare infrastructure, significant healthcare expenditure, and the strong presence of key manufacturers. The increasing aging population, rising prevalence of infectious and chronic diseases, and strong demand for home-use and self-test kits further support market growth in North America. This regional segment is expected to maintain its dominant position throughout the forecast period.
A breakdown of the primary participants referred to for this report is provided below:
By Company Type: Tier 1: 40%, Tier 2: 30%, and Tier 3: 35%
By Designation: C Level: 27%, Director Level: 18%, and Others: 55%
By Region: North America: 50%, Europe: 20%, Asia Pacific: 20%, Latin America: 7%, and Middle East & Africa: 3%
Note 1: Companies are classified into tiers based on their total revenue. As of 2024, Tier 1 = Greater than USD 10.00 billion, Tier 2 = USD 1.00 billion to USD 10.00 billion, and Tier 3 = Less than USD 1.00 billion.
Note 2: C-level primaries include CEOs, CFOs, COOs, and VPs.
Note 3: Other designations include sales managers, marketing managers, business development managers, product managers, distributors, and suppliers.
The major players operating in the lateral flow assays market are Abbott Laboratories (US), F. Hoffman-La Roche Ltd. (Switzerland), Danaher Corporation (US), Becton, Dickinson and Company (US), QuidelOrtho Corporation (US), Siemens AG (Germany), bioMerieux SA (France), Thermo Fisher Scientific, Inc. (US), Revvity, Inc. (US), Hologic Inc. (US), QIAGEN N.V. (Netherlands), Merck KGaA (Germany), Surmodics, Inc. (US), and OraSure Technologies Inc. (US).
Research Coverage
This report studies the lateral flow assays market based on product, application, technique, sample type, end user, and region. The report also studies factors (such as drivers, restraints, opportunities, and challenges) affecting market growth and provides details of the competitive landscape for market leaders. Furthermore, the report analyzes micro markets with respect to their individual growth trends. It forecasts the revenue of the market segments with respect to six major regions (and the respective countries in these regions).
Reasons to Buy the Report
The report will enable established firms as well as entrants/smaller firms to gauge the pulse of the market, which, in turn, would help them to gain a larger market share. Firms purchasing the report could use one or a combination of the strategies mentioned below to strengthen their market presence.
This report provides insights on the following points:
Analysis of key drivers (High prevalence of infectious diseases, Rising geriatric population, Growing use of home-based lateral flow assay devices, and Growing demand for POC testing), restraints (Inconsistent results of lateral flow assay tests), opportunities (Evolving applications of lateral flow assays and Rising demand for lateral flow assays in food & beverage industry), challenges (Limited reimbursements for lateral flow assay products and Difficulties in procuring quality raw materials to develop tests).
Market Penetration: Comprehensive information on the product portfolios offered by the top players in the lateral flow assays market
Product Development/Innovation: Detailed insights into the upcoming trends, R&D activities, and product launches in the lateral flow assays market
Market Development: Comprehensive information on lucrative emerging regions
Market Diversification: Exhaustive information about new products, growing geographies, and recent developments in the lateral flow assays market
Competitive Assessment: In-depth assessment of market segments, growth strategies, revenue analysis, and products of the leading market players
TABLE OF CONTENTS
1 INTRODUCTION
1.1 STUDY OBJECTIVES
1.2 MARKET DEFINITION
1.2.1 INCLUSIONS & EXCLUSIONS
1.3 MARKET SCOPE
1.3.1 MARKETS COVERED
1.3.2 YEARS CONSIDERED
1.4 CURRENCY CONSIDERED
1.5 STAKEHOLDERS
1.6 SUMMARY OF CHANGES
2 RESEARCH METHODOLOGY
2.1 RESEARCH DATA
2.1.1 SECONDARY DATA
2.1.1.1 Key data from secondary sources
2.1.2 PRIMARY DATA
2.1.2.1 Primary sources
2.1.2.2 Key industry insights
2.1.2.3 Key data from primary sources
2.1.2.4 Breakdown of primary interviews
2.2 MARKET SIZE ESTIMATION
2.2.1 BOTTOM-UP APPROACH
2.2.1.1 Approach 1: Company revenue estimation approach
2.2.1.2 Approach 2: Presentations of companies and primary interviews
2.2.1.3 Approach 3: Primary interviews
2.2.1.4 Approach 4: Growth Forecast
2.2.1.5 CAGR projections
2.2.2 TOP-DOWN APPROACH
2.3 MARKET BREAKDOWN & DATA TRIANGULATION
2.4 RESEARCH ASSUMPTIONS
2.4.1 STUDY-RELATED ASSUMPTIONS
2.4.2 GROWTH RATE ASSUMPTIONS
2.5 RISK ASSESSMENT
2.6 RESEARCH LIMITATIONS
3 EXECUTIVE SUMMARY
4 PREMIUM INSIGHTS
4.1 LATERAL FLOW ASSAYS MARKET OVERVIEW
4.2 ASIA PACIFIC: LATERAL FLOW ASSAYS MARKET, BY APPLICATION AND COUNTRY
4.3 LATERAL FLOW ASSAYS MARKET, BY COUNTRY
4.4 LATERAL FLOW ASSAYS MARKET: REGIONAL MIX
4.5 LATERAL FLOW ASSAYS MARKET: EMERGING ECONOMIES VS. DEVELOPED MARKETS
5 MARKET OVERVIEW
5.1 INTRODUCTION
5.2 MARKET DYNAMICS
5.2.1 DRIVERS
5.2.1.1 High prevalence of infectious diseases
5.2.1.2 Rise in geriatric population
5.2.1.3 Growing use of home-based lateral flow assay devices
5.2.1.4 Growth in demand for POC testing
5.2.2 RESTRAINTS
5.2.2.1 Inconsistent results of lateral flow assays
5.2.3 OPPORTUNITIES
5.2.3.1 Evolving applications of lateral flow assays
5.2.3.2 Rise in demand for lateral flow assays in food & beverage industry
5.2.4 CHALLENGES
5.2.4.1 Limited reimbursements for lateral flow assay products
5.2.4.2 Difficulties in procuring quality raw materials to develop tests
5.5.2 REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS
5.5.2.1 North America
5.5.2.2 Europe
5.5.2.3 Asia Pacific
5.5.2.4 Latin America
5.5.2.5 Rest of the world
5.6 PATENT ANALYSIS
5.7 TRADE ANALYSIS
5.7.1 IMPORT DATA (HS CODE 382200)
5.7.2 EXPORT DATA (HS CODE 382200)
5.8 PRICING ANALYSIS
5.8.1 INDICATIVE AVERAGE SELLING PRICE TREND, BY REGION
5.9 KEY CONFERENCES AND EVENTS
5.10 KEY STAKEHOLDERS AND BUYING CRITERIA
5.10.1 KEY STAKEHOLDERS IN BUYING PROCESS
5.10.2 BUYING CRITERIA
5.11 UNMET NEEDS/END-USER EXPECTATIONS IN LATERAL FLOW ASSAYS MARKET
5.12 VALUE CHAIN ANALYSIS
5.13 SUPPLY CHAIN ANALYSIS
5.14 IMPACT OF AI ON LATERAL FLOW ASSAYS MARKET
5.14.1 INTRODUCTION
5.14.2 MARKET POTENTIAL OF AI IN LATERAL FLOW ASSAYS MARKET
5.14.3 AI USE CASES
5.14.4 KEY COMPANIES IMPLEMENTING AI
5.14.5 FUTURE OF AI IN LATERAL FLOW ASSAYS MARKET
5.15 ECOSYSTEM ANALYSIS
5.16 CASE STUDY ANALYSIS
5.16.1 QUIDEL LAUNCHED NEW TEST WITH BROADER DETECTION WINDOW
5.16.2 ABINGTON OFFERED HIGH-SENSITIVITY TESTS FOR GREATER QUALITY
5.16.3 SIEMENS OFFERS HIGH-SENSITIVITY TROPONIN I ASSAY TO RAPIDLY DETECT ACUTE MYOCARDIAL INFARCTION
5.17 ADJACENT MARKETS FOR LATERAL FLOW ASSAYS MARKET
5.18 TRENDS/DISRUPTIONS IMPACTING CUSTOMER BUSINESS
5.19 INVESTMENT AND FUNDING SCENARIO
5.20 IMPACT OF US TARIFF REGULATION ON LATERAL FLOW ASSAYS MARKET
5.20.1 INTRODUCTION
5.20.2 KEY TARIFF RATES
5.20.3 PRICE IMPACT ANALYSIS
5.20.4 KEY IMPACTS ON COUNTRY/REGION
5.20.4.1 North America
5.20.4.2 Europe
5.20.4.3 Asia Pacific
5.20.5 IMPACT ON END-USE INDUSTRIES
5.20.5.1 Hospitals and Clinics
6 LATERAL FLOW ASSAYS MARKET, BY PRODUCT
6.1 INTRODUCTION
6.2 KITS & REAGENTS
6.2.1 RISE IN DEMAND FOR POC TESTING TO DRIVE MARKET
6.3 READERS
6.3.1 DIGITAL/HANDHELD READERS
6.3.1.1 Technological evolution and demand for accuracy to drive adoption
6.3.2 BENCHTOP READERS
6.3.2.1 Lower diagnosis cost per patient to drive segment
7 LATERAL FLOW ASSAYS MARKET, BY APPLICATION
7.1 INTRODUCTION
7.2 CLINICAL TESTING
7.2.1 INFECTIOUS DISEASE TESTING
7.2.1.1 Mosquito-borne diseases
7.2.1.1.1 Increase in incidence of dengue and introduction of more reliable test kits to drive market
7.2.1.2 Influenza
7.2.1.2.1 Rise in prevalence of influenza globally to boost market growth, despite lower sensitivity of lateral flow assays
7.2.1.3 Sexually transmitted infections
7.2.1.3.1 HIV
7.2.1.3.1.1 Growing need for early detection and awareness of HIV POC testing to drive market
7.2.1.3.2 HPV
7.2.1.3.2.1 Rapid HPV diagnostics and real-time PCR, covering broad range of genotypes, coupled with higher incidence of cervical cancer to drive segment
7.2.1.3.3 Chlamydia
7.2.1.3.3.1 Greater viability of advanced techniques to drive market
7.2.1.3.4 Gonorrhea
7.2.1.3.4.1 Rising incidence of gonorrhea and antimicrobial resistance to augment growth
7.2.1.3.5 Syphilis
7.2.1.3.5.1 Need for early and accessible diagnosis to fuel growth
7.2.1.3.6 Other sexually transmitted infections
7.2.1.4 Hepatitis
7.2.1.4.1 Nucleic acid hybridization-based LFAs to show strong potential in hepatitis testing
7.2.1.5 Tuberculosis
7.2.1.5.1 Rise in prevalence and growing focus on early diagnosis and treatment to propel market
7.2.1.6 Other infectious diseases
7.2.2 CARDIAC MARKER TESTING
7.2.2.1 Troponin I & T
7.2.2.1.1 Introduction of high-sensitivity troponin assays to support market growth
7.2.2.2 CK-MB
7.2.2.2.1 Growing applications of lateral flow tests in acute myocardial injuries to drive market
7.2.2.3 BNP & NT-proBNP
7.2.2.3.1 Increase in demand for cardiac biomarker tests to detect heart stress and damage to support growth
7.2.2.4 Myoglobin
7.2.2.4.1 Availability of new high-sensitivity cardiac troponin assays to restrict market growth
7.2.2.5 D-Dimer
7.2.2.5.1 Rising incidence of CVDs to drive market for D-dimer tests
7.2.2.6 Other cardiac marker testing
7.2.3 PREGNANCY & FERTILITY TESTING
7.2.3.1 Pregnancy testing
7.2.3.1.1 Pregnancy testing to hold larger market share but register slower growth
7.2.3.2 Fertility testing
7.2.3.2.1 Rise in infertility rates to drive demand for POC fertility testing kits
7.2.4 CHOLESTEROL/LIPID TESTING
7.2.4.1 Lifestyle changes, cardiovascular disorder incidence to drive segment
7.2.5 DRUGS-OF-ABUSE TESTING
7.2.5.1 Technological advancements and rising focus on workplace drug testing to drive market
7.2.6 OTHER CLINICAL TESTS
7.3 VETERINARY DIAGNOSTICS
7.3.1 INFECTIOUS DISEASE OUTBREAKS AND TESTS AVAILABLE FOR DIFFERENT SPECIES TO DRIVE FRAGMENTED MARKET
7.4 FOOD SAFETY & ENVIRONMENT TESTING
7.4.1 HIGH SENSITIVITY AND EASE OF USE TO BOOST DEMAND FOR ASSAYS TO CLEAR FOODS FOR MARKET AVAILABILITY
7.5 DRUG DEVELOPMENT & QUALITY TESTING
7.5.1 GREATER FOCUS ON PRODUCT SAFETY AND QUALITY ASSURANCE TO SUPPORT MARKET GROWTH
8 LATERAL FLOW ASSAYS MARKET, BY TECHNIQUE
8.1 INTRODUCTION
8.2 SANDWICH ASSAYS
8.2.1 WIDE RANGE OF APPLICATIONS IN CLINICAL TESTING TO SUPPORT MARKET GROWTH
8.3 COMPETITIVE ASSAYS
8.3.1 REDUCED SELECTIVITY AND SENSITIVITY COMPARED TO SANDWICH ASSAYS TO HAMPER GROWTH
8.4 MULTIPLEX DETECTION ASSAYS
8.4.1 HIGHER ADOPTION OF MULTI-ANALYTE ASSAYS AMONG CLINICIANS TO FUEL MARKET
9 LATERAL FLOW ASSAYS MARKET, BY SAMPLE TYPE
9.1 INTRODUCTION
9.2 BLOOD SAMPLES
9.2.1 SIGNIFICANT USE OF BLOOD SAMPLES FOR INFECTIOUS DISEASE TESTING TO DRIVE MARKET
9.3 URINE SAMPLES
9.3.1 GROWING USE OF URINE SAMPLES FOR PREGNANCY AND DRUGS-OF-ABUSE TESTING TO DRIVE MARKET
9.4 SALIVA SAMPLES
9.4.1 EASY AND LOW-COST COLLECTION, TRANSPORT, AND ANALYSIS OF SALIVA SAMPLES TO SUPPORT ADOPTION
9.5 OTHER SAMPLES
10 LATERAL FLOW ASSAYS MARKET, BY END USER
10.1 INTRODUCTION
10.2 HOSPITALS & CLINICS
10.2.1 HIGH DEMAND FOR DIAGNOSTICS ACROSS LARGE POOLS OF PATIENTS IN HOSPITALS TO DRIVE MARKET
10.3 HOME CARE SETTINGS
10.3.1 GROWING ACCEPTANCE OF REMOTE MONITORING TO PROPEL MARKET
10.4 DIAGNOSTIC LABORATORIES
10.4.1 LABORATORY TESTING LARGELY PREFERRED OVER PROFESSIONAL SETTINGS FOR URINE AND BLOOD TESTING
10.5 PHARMACEUTICAL & BIOTECHNOLOGY COMPANIES
10.5.1 INCREASE IN FOCUS ON PRODUCT SAFETY TO DRIVE ADOPTION OF LATERAL FLOW ASSAYS
10.6 OTHER END USERS
11 LATERAL FLOW ASSAYS MARKET, BY REGION
11.1 INTRODUCTION
11.2 NORTH AMERICA
11.2.1 MACROECONOMIC OUTLOOK FOR NORTH AMERICA
11.2.2 US
11.2.2.1 Large patient base to drive market growth
11.2.3 CANADA
11.2.3.1 Availability of research funding and implementation of favorable government initiatives to drive market
11.3 EUROPE
11.3.1 MACROECONOMIC OUTLOOK FOR EUROPE
11.3.2 GERMANY
11.3.2.1 Well-developed healthcare system and rise in geriatric population to fuel growth
11.3.3 UK
11.3.3.1 Growth in incidence of chronic conditions to propel market growth
11.3.4 FRANCE
11.3.4.1 High prevalence of age-related chronic diseases and infectious diseases to drive market
11.3.5 ITALY
11.3.5.1 Growth in initiatives toward decentralization of medical services to support market growth
11.3.6 SPAIN
11.3.6.1 Aging population and strong healthcare infrastructure to drive market
11.3.7 REST OF EUROPE
11.4 ASIA PACIFIC
11.4.1 MACROECONOMIC OUTLOOK FOR ASIA PACIFIC
11.4.2 JAPAN
11.4.2.1 Growing elderly population and well-developed healthcare system to drive market
11.4.3 CHINA
11.4.3.1 Modernized healthcare system to drive market
11.4.4 INDIA
11.4.4.1 Growth in healthcare concerns and rise in income levels to propel market growth, despite lack of reimbursement and insurance coverage for lateral flow assay products
11.4.5 AUSTRALIA
11.4.5.1 Rise in prevalence of infectious disease and healthcare expenditure to support growth
11.4.6 SOUTH KOREA
11.4.6.1 Growth in healthcare infrastructure to drive market
11.4.7 REST OF ASIA PACIFIC
11.5 LATIN AMERICA
11.5.1 MACROECONOMIC OUTLOOK FOR LATIN AMERICA
11.5.2 BRAZIL
11.5.2.1 High private healthcare expenditure and rise in geriatric population to drive market
11.5.3 MEXICO
11.5.3.1 Increase in demand for advanced medical equipment to drive market
11.5.4 ARGENTINA
11.5.4.1 Availability of health insurance to favor market growth
11.5.5 REST OF LATIN AMERICA
11.6 MIDDLE EAST & AFRICA
11.7 GCC COUNTRIES
11.7.1 RISE IN DEMAND FOR RAPID AND COST-EFFECTIVE DIAGNOSTICS TO DRIVE MARKET
12 COMPETITIVE LANDSCAPE
12.1 INTRODUCTION
12.2 KEY PLAYER STRATEGIES/RIGHT TO WIN
12.2.1 OVERVIEW OF STRATEGIES ADOPTED BY KEY PLAYERS IN LATERAL FLOW ASSAYS MARKET
12.3 REVENUE ANALYSIS, 2020-2024
12.4 MARKET SHARE ANALYSIS, 2024
12.5 COMPANY VALUATION AND FINANCIAL METRICS
12.6 BRAND/PRODUCT COMPARISON
12.7 COMPANY EVALUATION MATRIX: KEY PLAYERS, 2024
12.7.1 STARS
12.7.2 EMERGING LEADERS
12.7.3 PERVASIVE PLAYERS
12.7.4 PARTICIPANTS
12.7.5 COMPANY FOOTPRINT: KEY PLAYERS, 2024
12.7.5.1 Company footprint
12.7.5.2 Regional Footprint
12.7.5.3 Product Footprint
12.7.5.4 Technique Footprint
12.7.5.5 Application Footprint
12.7.5.6 Sample type Footprint
12.8 COMPANY EVALUATION MATRIX: STARTUPS/SMES, 2024