ラテラルフローアッセイの世界市場：製品タイプ別、用途別、技術別、エンドユーザー別、地域別、規模と動向、COVID-19の影響の分析、予測（～2030年）

ラテラルフローアッセイ（LFA）は、ラテラルフローイムノクロマトグラフィーアッセイとしても知られ、サンプル（マトリクス）中の標的分析物の存在（または欠如）を検出するために使用される医療機器です。ラテラルフローアッセイ市場は、医療、医薬品、食品安全、環境検査、動物診断などのさまざまな産業や用途におけるラテラルフロー検査キット、試薬、コンポーネント、関連する装置や製品の開発、製造、流通に関連しています。感染症の増加、ポイントオブケア検査（POCT）の需要の高まり、COVID-19パンデミック後の感染予防・管理の重要性に対する意識の向上により、特に近年のパンデミック後、多くの診療所や病院でLFAの採用が増加しています。世界のラテラルフローアッセイの市場規模は、2024年に100億1,000万米ドルであり、2030年までに154億2,000万米ドルに達すると予測されています。

世界のラテラルフローアッセイ市場は一貫した成長を示しており、その主因は途上国と先進国の両方における感染症や慢性疾患の患者数の増加です。老年人口の拡大、予防医療への注目の高まり、病状の自己管理という考えの採用の増加、在宅医療キットの需要の急増、新興経済国における医療インフラの急速な拡大、在宅診断キットの高い消費は、世界のラテラルフローアッセイ市場の需要を引き続き押し上げるとみられます。さらに、ラテラルフローアッセイによって促進されるPOCTは、従来の検査施設へのアクセスが制限される遠隔地や十分な医療サービスを受けられない地域における医療へのアクセスを改善するというかたちで、診断をより患者に近づけるものであり、特に緊急事態や即時の支援を必要とする疾患に対して、タイムリーな診断と治療を患者に提供するものです。したがって、ポイントオブケア検査の人気が高まり、革新的なラテラルフローアッセイベースのPOC機器の開発に注力する企業が増加していることから、ラテラルフローアッセイに基づくポイントオブケア（POC）検査は、時間のかかる従来の検査法に取って代わり、予測期間の世界のラテラルフローアッセイ市場の成長を増大させ続ける見通しです。市場は、2025年～2030年の予測期間にCAGRで7.46%の成長が見込まれます。

当レポートでは、世界のラテラルフローアッセイ市場について調査分析し、市場力学、COVID-19の影響、競合情勢などの情報を提供しています。

目次

第1章 エグゼクティブサマリー

第2章 イントロダクション

• ラテラルフローアッセイ：概要
  • ラテラルフローアッセイの定義
  • ラテラルフローアッセイの利点
• ラテラルフローアッセイ市場のセグメンテーション
  • ラテラルフローアッセイ市場のセグメンテーション

第3章 世界市場の分析

• 世界のラテラルフローアッセイ市場：分析
  • 世界のラテラルフローアッセイ市場：概要
  • 世界のラテラルフローアッセイの市場規模
  • 世界のラテラルフローアッセイ市場：製品タイプ別（キット・試薬、ラテラルフローリーダー）
  • 世界のラテラルフローアッセイ市場：用途別（臨床検査、動物医療診断、食品安全・環境検査、医薬品開発・品質検査）
  • 世界のラテラルフローアッセイ市場：技術別（サンドイッチアッセイ、競合アッセイ、マルチプレックス検出アッセイ）
  • 世界のラテラルフローアッセイ市場：エンドユーザー別（病院・診療所、診断研究所、在宅ケア、製薬・バイオテクノロジー企業、その他）
  • ラテラルフローアッセイ市場：地域別（北米、欧州、アジア太平洋、その他の地域）
• 世界のラテラルフローアッセイ市場：製品タイプの分析
  • 世界のラテラルフローアッセイ市場：製品タイプ別、概要
  • 世界のラテラルフローアッセイキット・試薬の市場規模
  • 世界のラテラルフローアッセイリーダーの市場規模
• 世界のラテラルフローアッセイ市場：用途の分析
  • 世界のラテラルフローアッセイ市場：用途別、概要
  • 世界の臨床検査向けラテラルフローアッセイの市場規模
  • 世界の動物医療診断向けラテラルフローアッセイの市場規模
  • 世界の食品安全・環境検査向けラテラルフローアッセイの市場規模
  • 世界の医薬品開発・品質検査向けラテラルフローアッセイの市場規模
• 世界のラテラルフローアッセイ市場：技術の分析
  • 世界のラテラルフローアッセイ市場：技術別、概要
  • 世界のサンドイッチラテラルフローアッセイの市場規模
  • 世界の競合ラテラルフローアッセイの市場規模
  • 世界のマルチプレックス検出ラテラルフローアッセイの市場規模
• 世界のラテラルフローアッセイ市場：エンドユーザーの分析
  • 世界のラテラルフローアッセイ市場：エンドユーザー別、概要
  • 世界の病院・診療所向けラテラルフローアッセイの市場規模
  • 世界の診断研究所向けラテラルフローアッセイの市場規模
  • 世界の在宅ケア向けラテラルフローアッセイの市場規模
  • 世界の製薬・バイオテクノロジー企業向けラテラルフローアッセイの市場規模
  • 世界のその他のラテラルフローアッセイの市場規模

第4章 地域市場の分析

• 北米のラテラルフローアッセイ市場：分析
  • 北米のラテラルフローアッセイ市場：概要
  • 北米のラテラルフローアッセイの市場規模
  • 北米のラテラルフローアッセイ市場：製品タイプ別（キット・試薬、ラテラルフローリーダー）
  • 北米のラテラルフローアッセイ市場：技術別（サンドイッチアッセイ、競合アッセイ、マルチプレックス検出アッセイ）
  • 北米のラテラルフローアッセイ市場：地域別（米国、カナダ、メキシコ）
  • 米国のラテラルフローアッセイの市場規模
  • カナダのラテラルフローアッセイの市場規模
  • メキシコのラテラルフローアッセイの市場規模
• 欧州のラテラルフローアッセイ市場：分析
  • 欧州のラテラルフローアッセイ市場：概要
  • 欧州のラテラルフローアッセイの市場規模
  • 欧州のラテラルフローアッセイ市場：地域別（ドイツ、フランス、英国、イタリア、スペイン、その他の欧州）
  • ドイツのラテラルフローアッセイの市場規模
  • 英国のラテラルフローアッセイの市場規模
  • フランスのラテラルフローアッセイの市場規模
  • イタリアのラテラルフローアッセイの市場規模
  • スペインのラテラルフローアッセイの市場規模
  • その他の欧州のラテラルフローアッセイの市場規模
• アジア太平洋のラテラルフローアッセイ市場：分析
  • アジア太平洋のラテラルフローアッセイ市場：概要
  • アジア太平洋のラテラルフローアッセイの市場規模
  • アジア太平洋のラテラルフローアッセイ市場：地域別（中国、日本、インド、韓国、オーストラリア、その他のアジア太平洋）
  • 中国のラテラルフローアッセイの市場規模
  • 日本のラテラルフローアッセイの市場規模
  • インドのラテラルフローアッセイの市場規模
  • 韓国のラテラルフローアッセイの市場規模
  • オーストラリアのラテラルフローアッセイの市場規模
  • その他のアジア太平洋のラテラルフローアッセイの市場規模
• その他の地域のラテラルフローアッセイ市場：分析
  • その他の地域のラテラルフローアッセイ市場：概要
  • その他の地域のラテラルフローアッセイの市場規模

第5章 COVID-19の影響

• ラテラルフローアッセイ市場に対するCOVID-19の影響
• ラテラルフローアッセイ市場に対するCOVID-19後の影響

第6章 市場力学

• 成長促進要因
  • 高齢化
  • 感染症の増加
  • 家庭用アッセイキット・機器の採用の増加
  • ポイントオブケア検査の人気の高まり
• 課題
  • 診断結果の一貫性の欠如に起因する、厳しい規制要件
  • 代替診断技術との競合の激化
• 市場動向
  • AIとバイオセンサーの統合の拡大
  • デジタル技術の統合の高まり
  • ラテラルフローアッセイの新たな用途の進化
  • 個別化およびカスタマイズされたラテラルフローアッセイの需要の高まり

第7章 競合情勢

• 世界のラテラルフローアッセイ市場：競合情勢

第8章 企業プロファイル

• F. Hoffmann-La Roche Ltd
• Siemens Healthineers AG
• Thermo Fisher Scientific Inc.
• Abbott Laboratories
• Merck KGaA (MilliporeSigma)
• Bio-Rad Laboratories, Inc.
• Becton, Dickinson and Company (BD Biosciences)
• QuidelOrtho Corporation (Quidel Corporation)
• Access Bio, Inc.
• PerkinElmer, Inc.

List of Figures

• Figure 1: Lateral Flow Assay Segmentation
• Figure 2: Global Lateral Flow Assay Market by Value; 2020-2024 (US$ Billion)
• Figure 3: Global Lateral Flow Assay Market by Value; 2025-2030 (US$ Billion)
• Figure 4: Global Lateral Flow Assay Market by Product Type; 2024 (Percentage, %)
• Figure 5: Global Lateral Flow Assay Market by Application; 2024 (Percentage, %)
• Figure 6: Global Lateral Flow Assay Market by Technology; 2024 (Percentage, %)
• Figure 7: Global Lateral Flow Assay Market by End User; 2024 (Percentage, %)
• Figure 8: Global Lateral Flow Assay Market by Region; 2024 (Percentage, %)
• Figure 9: Global Kits and Reagents Lateral Flow Assay Market by Value; 2020-2024 (US$ Billion)
• Figure 10: Global Kits and Reagents Lateral Flow Assay Market by Value; 2025-2030 (US$ Billion)
• Figure 11: Global Lateral Flow Assay Readers Market by Value; 2020-2024 (US$ Billion)
• Figure 12: Global Lateral Flow Assay Readers Market by Value; 2025-2030 (US$ Billion)
• Figure 13: Global Clinical Testing Lateral Flow Assay Market by Value; 2020-2024 (US$ Billion)
• Figure 14: Global Clinical Testing Lateral Flow Assay Market by Value; 2025-2030 (US$ Billion)
• Figure 15: Global Veterinary Diagnostics Lateral Flow Assay Market by Value; 2020-2024 (US$ Million)
• Figure 16: Global Veterinary Diagnostics Lateral Flow Assay Market by Value; 2025-2030 (US$ Billion)
• Figure 17: Global Food Safety & Environment Testing Lateral Flow Assay Market by Value; 2020-2024 (US$ Million)
• Figure 18: Global Food Safety & Environment Testing Lateral Flow Assay Market by Value; 2025-2030 (US$ Billion)
• Figure 19: Global Drug Development & Quality Testing Lateral Flow Assay Market by Value; 2020-2024 (US$ Million)
• Figure 20: Global Drug Development & Quality Testing Lateral Flow Assay Market by Value; 2025-2030 (US$ Billion)
• Figure 21: Global Sandwich Lateral Flow Assay Market by Value; 2020-2024 (US$ Billion)
• Figure 22: Global Sandwich Lateral Flow Assay Market by Value; 2025-2030 (US$ Billion)
• Figure 23: Global Competitive Lateral Flow Assay Market by Value; 2020-2024 (US$ Billion)
• Figure 24: Global Competitive Lateral Flow Assay Market by Value; 2025-2030 (US$ Billion)
• Figure 25: Global Multiplex Detection Lateral Flow Assay Market by Value; 2020-2024 (US$ Billion)
• Figure 26: Global Multiplex Detection Lateral Flow Assay Market by Value; 2025-2030 (US$ Billion)
• Figure 27: Global Hospitals & Clinics Lateral Flow Assay Market by Value; 2020-2024 (US$ Billion)
• Figure 28: Global Hospitals & Clinics Lateral Flow Assay Market by Value; 2025-2030 (US$ Billion)
• Figure 29: Global Diagnostic Laboratories Lateral Flow Assay Market by Value; 2020-2024 (US$ Billion)
• Figure 30: Global Diagnostic Laboratories Lateral Flow Assay Market by Value; 2025-2030 (US$ Billion)
• Figure 31: Global Home Care Lateral Flow Assay Market by Value; 2020-2024 (US$ Billion)
• Figure 32: Global Home Care Lateral Flow Assay Market by Value; 2025-2030 (US$ Billion)
• Figure 33: Global Pharmaceutical & Biotechnology Companies Lateral Flow Assay Market by Value; 2020-2024 (US$ Million)
• Figure 34: Global Pharmaceutical & Biotechnology Companies Lateral Flow Assay Market by Value; 2025-2030 (US$ Billion)
• Figure 35: Global Others Lateral Flow Assay Market by Value; 2020-2024 (US$ Million)
• Figure 36: Global Others Lateral Flow Assay Market by Value; 2025-2030 (US$ Billion)
• Figure 37: North America Lateral Flow Assay Market by Value; 2020-2024 (US$ Billion)
• Figure 38: North America Lateral Flow Assay Market by Value; 2025-2030 (US$ Billion)
• Figure 39: North America Lateral Flow Assay Market by Product Type; 2024 (Percentage, %)
• Figure 40: North America Lateral Flow Assay Market by Technology; 2024 (Percentage, %)
• Figure 41: North America Lateral Flow Assay Market by Region; 2024 (Percentage, %)
• Figure 42: The US Lateral Flow Assay Market by Value; 2020-2024 (US$ Billion)
• Figure 43: The US Lateral Flow Assay Market by Value; 2025-2030 (US$ Billion)
• Figure 44: Canada Lateral Flow Assay Market by Value; 2020-2024 (US$ Million)
• Figure 45: Canada Lateral Flow Assay Market by Value; 2025-2030 (US$ Million)
• Figure 46: Mexico Lateral Flow Assay Market by Value; 2020-2024 (US$ Million)
• Figure 47: Mexico Lateral Flow Assay Market by Value; 2025-2030 (US$ Million)
• Figure 48: Europe Lateral Flow Assay Market by Value; 2020-2024 (US$ Billion)
• Figure 49: Europe Lateral Flow Assay Market by Value; 2025-2030 (US$ Billion)
• Figure 50: Europe Lateral Flow Assay Market by Region; 2024 (Percentage, %)
• Figure 51: Germany Lateral Flow Assay Market by Value; 2020-2024 (US$ Million)
• Figure 52: Germany Lateral Flow Assay Market by Value; 2025-2030 (US$ Million)
• Figure 53: UK Lateral Flow Assay Market by Value; 2020-2024 (US$ Million)
• Figure 54: UK Lateral Flow Assay Market by Value; 2025-2030 (US$ Million)
• Figure 55: France Lateral Flow Assay Market by Value; 2020-2024 (US$ Million)
• Figure 56: France Lateral Flow Assay Market by Value; 2025-2030 (US$ Million)
• Figure 57: Italy Lateral Flow Assay Market by Value; 2020-2024 (US$ Million)
• Figure 58: Italy Lateral Flow Assay Market by Value; 2025-2030 (US$ Million)
• Figure 59: Spain Lateral Flow Assay Market by Value; 2020-2024 (US$ Million)
• Figure 60: Spain Lateral Flow Assay Market by Value; 2025-2030 (US$ Million)
• Figure 61: Rest of Europe Lateral Flow Assay Market by Value; 2020-2024 (US$ Million)
• Figure 62: Rest of Europe Lateral Flow Assay Market by Value; 2025-2030 (US$ Million)
• Figure 63: Asia Pacific Lateral Flow Assay Market by Value; 2020-2024 (US$ Billion)
• Figure 64: Asia Pacific Lateral Flow Assay Market by Value; 2025-2030 (US$ Billion)
• Figure 65: Asia Pacific Lateral Flow Assay Market by Region; 2024 (Percentage, %)
• Figure 66: China Lateral Flow Assay Market by Value; 2020-2024 (US$ Million)
• Figure 67: China Lateral Flow Assay Market by Value; 2025-2030 (US$ Billion)
• Figure 68: Japan Lateral Flow Assay Market by Value; 2020-2024 (US$ Million)
• Figure 69: Japan Lateral Flow Assay Market by Value; 2025-2030 (US$ Million)
• Figure 70: India Lateral Flow Assay Market by Value; 2020-2024 (US$ Million)
• Figure 71: India Lateral Flow Assay Market by Value; 2025-2030 (US$ Million)
• Figure 72: South Korea Lateral Flow Assay Market by Value; 2020-2024 (US$ Million)
• Figure 73: South Korea Lateral Flow Assay Market by Value; 2025-2030 (US$ Million)
• Figure 74: Australia Lateral Flow Assay Market by Value; 2020-2024 (US$ Million)
• Figure 75: Australia Lateral Flow Assay Market by Value; 2025-2030 (US$ Million)
• Figure 76: Rest of Asia Pacific Lateral Flow Assay Market by Value; 2020-2024 (US$ Million)
• Figure 77: Rest of Asia Pacific Lateral Flow Assay Market by Value; 2025-2030 (US$ Million)
• Figure 78: Rest of the World Lateral Flow Assay Market by Value; 2020-2024 (US$ Million)
• Figure 79: Rest of the World Lateral Flow Assay Market by Value; 2025-2030 (US$ Billion)
• Figure 80: Global Total Population Aging 65 and above; 2020-2023 (Million)
• Figure 81: The US Tuberculosis Cases and Disease Incidence; 2019-2022 (Units)
• Figure 82: Global Artificial Intelligence in Healthcare Market Size; 2021-2025 (US$ Billion)
• Figure 83: Global Revenue in Healthcare IoT Market; 2022-2029 (US$ Billion)
• Figure 84: F. Hoffmann-La Roche Ltd Revenue by Operating Business; 2024 (Percentage, %)
• Figure 85: Siemens Healthineers AG Revenue by Segment; 2024 (Percentage, %)
• Figure 86: Thermo Fisher Scientific Inc. Revenues by Segment; 2023 (Percentage, %)
• Figure 87: Abbott Laboratories Net Sales by Segment; 2023 (Percentage, %)
• Figure 88: Merck KGaA Net Sales by Reportable Segment; 2023 (Percentage, %)
• Figure 89: Bio-Rad Laboratories, Inc. Net Sales by Segments; 2023 (Percentage, %)
• Figure 90: Becton, Dickinson and Company Revenue by Segment; 2024 (Percentage, %)
• Figure 91: QuidelOrtho Corporation Revenue by Operating Segment; 2023 (Percentage, %)

Lateral flow assays (LFA), also known as lateral flow immunochromatographic assays, is a medical device used to detect presence (or absence) of a target analyte in a sample (matrix). Lateral flow assay market is associated with development, manufacturing, and distribution of lateral flow test kits, reagents, components, and related equipment and products across various industries and applications, including healthcare, pharmaceuticals, food safety, environmental testing, veterinary diagnostics, etc. Due to increasing incidences of infectious diseases, rising demand for point-of-care testing (POCT), and increasing awareness about the importance of infection prevention & control after COVID-19 pandemic, there has been increasing adoption of LFAs by many clinics and hospitals, especially after recent pandemic. The global lateral flow assay market value stood at US$10.01 billion in 2024, and is expected to reach US$15.42 billion by 2030.

Global lateral flow assay market demonstrated a consistent growth, primarily driven by rising cases of infectious and chronic diseases in both developing and developed countries. Growing elderly population, increased focus on preventive healthcare, increasing adoption of the concept of self-management of person's medical conditions, surge in the demand for home based medical kits, rapidly expanding healthcare infrastructure in developing economies, and high consumption of home-based diagnostic kits, will continue to boost the demand of global lateral flow assay market. Moreover, POCT, facilitated by lateral flow assays, has brought diagnostics more closer to the patient in the form of improved accessibility to healthcare in remote or underserved areas where access to traditional laboratory facilities may be limited, providing individuals with timely diagnoses and treatment, particularly in emergency situations and for diseases that require immediate assistance. Therefore, with rising popularity of point-of-care testing and increasing number of companies focusing on developing innovative lateral flow assay-based POC devices, point-of-care (POC) tests based of lateral flow assay will continue to replace lengthy and conventional laboratory procedures, augmenting the growth of global lateral flow assay market in the forecasted period. The market is expected to grow at a CAGR of 7.46% over the projected period of 2025-2030.

Market Segmentation Analysis:

By Product Type: The report provides the bifurcation of the lateral flow assay market into two segments based on product type: kits and reagents, and lateral flow readers. Kits & reagents lateral flow assay is the largest segment of global lateral flow assay market owing to rising adoption of lateral flow tests in home care settings, ongoing development of cost effective and user friendly diagnostic kits, ongoing launch of new kits by major players in the market, increasing popularity of self-diagnosis, and rising application of kits and reagents in diagnostic testing of diseases, contaminants & allergens in food products, and environmental testing. Lateral flow assay readers is the fastest growing segment of global lateral flow assay market owing to constant advancements in reader technology, rising demand for portable and easy to use diagnostic devices, ongoing integration of smartphones and mobile applications with lateral flow readers for diagnostic testing, and increasing adoption of lateral flow assays in various fields such as clinical diagnostics, food safety testing, & environmental monitoring.

By Application: The report provides the bifurcation of the lateral flow assay market into four segments on the basis of application: clinical testing, veterinary diagnostics, food safety & environment testing, and drug development & quality testing. Clinical testing lateral flow assay market is the largest segment of global lateral flow assay market owing to growing patient population suffering from chronic diseases, rapidly expanding healthcare infrastructure in emerging economies, increase in the occurrence of infectious diseases, expanding geriatric population base, noninvasive nature of collecting specimen, growth in number of government initiatives promoting health awareness, and frequent employment of lateral flow assays in clinical laboratories, hospitals, & physician's office for quantitative & qualitative identification of specific antibodies, products of gene amplification, and antigens.

By Technology: The report provides the bifurcation of the lateral flow assay market into three segments on the basis of technology: sandwich assays, competitive assays, and multiplex detection assays. Sandwich lateral flow assay is the largest segment of global lateral flow assay market, owing to rising demand for point-of-care testing and home healthcare diagnostic devices, evolving applications of sandwich assays in medical testing settings, rising government approvals of lateral flow assay rapid detection kits based on the sandwich assay technique, increasing demand for sandwich assays in research and drug discovery applications, and better assay sensitivity & specificity provided by sandwich assays for the measurement of critical and larger analytes.

By End User: The report provides the bifurcation of the lateral flow assay market into five segments on the basis of end user: hospitals and clinics, diagnostic laboratories, home care, pharmaceutical & biotechnology companies, and others. Pharmaceutical & biotechnology companies lateral flow assay is the fastest growing segment, as a result of rising number of infectious diseases and research activities, increasing number of pharmaceutical companies putting extensive efforts in producing effective medicines & vaccines, growing demand for rapid and accurate diagnostic tests for drug development and quality testing, and increasing number of emerging market participants engaged in strategic efforts like mergers and acquisitions, product research, product approvals & launches to improve their lateral flow test products.

By Region: The report provides insight into lateral flow assay market based on the regions namely, Europe, North America, Asia Pacific, and rest of the world. North America is the largest region of global lateral flow assay market, owing to region's well-established healthcare and pharmaceutical sector, high per capita income, increasing prevalence of infectious diseases such as Lyme disease and tuberculosis, ongoing technological advancements and product innovations in the market, rising demand for point-of-care testing, increasing availability of lateral flow tests on online pharmacy platforms, and presence of a significant number of market players in the region including Thermo Fisher Scientific Inc., Bio-Rad Laboratories, Inc., etc.

Asia Pacific is the fastest growing region in the global lateral flow assay market, owing to region's vast population of low and middle-income countries being exposed to multiple infectious diseases, increasing public healthcare expenditure across APAC countries, region's large potential consumer base, expanding geriatric population, growing demand for rapid point-of-care testing, rising public health awareness campaigns, and rapidly developing lateral flow assay components & raw material manufacturing industry in India and China.

Market Dynamics:

Growth Drivers: The global lateral flow assay market has been rapidly growing over the past few years, due to factors such as aging population, rising cases of infectious diseases, growing adoption of home based assay kits and devices, rising popularity of point-of-care testing, etc. There has been an increase in the demand for rapid lateral flow assay diagnostic tests needed to accurately diagnose & monitor medical conditions associated with age-related diseases such as cystic fibrosis, cardiovascular ailments, hepatitis, diabetes, and certain types of cancer, etc., that are frequently caused by age-related physiological changes and metabolic problems. Lateral flow assay testing solutions offers convenience and accessibility to elderly patients that have mobility limitations by assisting them in managing and monitoring chronic condition, as well as allowing healthcare providers to assess the effectiveness of treatments through regular monitoring using lateral assay tests & make necessary medication adjustments. Therefore, the growing elderly population and rising patient pool for chronic illnesses will continue to create a positive demand for lateral flow tests and related products.

Challenges: However, the market growth would be negatively impacted by various challenges such as strict regulatory requirements due to inconsistent diagnostic results, and increased competition from alternative diagnostics technologies. The lateral flow assay kits are prone to depicting false results that can lead to false or no diagnosis, severely affecting patient's health. Therefore, lack of standardization, stringent regulatory requirements, & presence of lengthy approval procedures in industrialized nations is expected to negatively impact the growth of global lateral flow assay market.

Trends: The market is projected to grow at a fast pace during the forecasted period, due to increasing integration of artificial intelligence (AI) and biosensors, rising digital technology integration, evolving newer applications of lateral flow assays, rising demand for personalized and customized lateral flow assays, etc. Lateral flow assay testing has been widely used for infectious disease diagnosis, heart disease diagnosis, veterinary applications, and so on, however, in recent years, there has been an increase in the use of LFA kits and products in several newer applications, such as saliva diagnostics, behavioral health, agriculture (detection of genetically modified organisms and quality control of plants), biological warfare (detection of Bacillus anthracis), environmental testing (detection of contaminating enzymes in production facilities), food microbiology (E. coli Detection of O157, Salmonella, Listeria, and other food spoilage bacteria), etc., which is expected to accelerate the growth of lateral flow assay market in the upcoming years.

Impact Analysis of COVID-19 and Way Forward:

COVID-19 brought in many changes in the world in terms of reduced productivity, loss of life, business closures, closing down of factories and organizations, and shift to an online mode of work. The sudden outbreak of the COVID-19 pandemic was associated with an increase in the demand for simple, rapid, cost-effective, and point-of-care diagnostic devices, such as lateral flow assay kits and readers, needed by hospitals, clinics, airports, schools, and other workplaces for the detection and control of the SARS-CoV-2 virus as LFA test kits demonstrated the ability to detect both symptomatic and asymptomatic COVID-19 infections. The impact of the COVID-19 pandemic on the global lateral flow assay market turned out to be positive, as government organizations and healthcare associations increased their focus on mass population testing, infection prevention & control, and public awareness campaigns aimed at identifying the symptoms and creating patient awareness about the use of lateral flow assay COVID-19 kits.

Competitive Landscape:

The lateral flow assay market is relatively fragmented with increasing number of large and medium sized players accounting for the majority of market revenue. Major companies in the market have been implementing both organic (such as launches, expansion, and product approvals) and inorganic development strategies (such as product launches, partnerships, and collaborations) to expand their product portfolio and gain larger market share. For instance, on August 03, 2023, QuidelOrtho Corporation announced that the company had been granted a De Novo request from the U.S. Food and Drug Administration (FDA), allowing it to market its new Sofia 2 SARS Antigen+ FIA, a lateral flow immunofluorescent assay that is intended for the qualitative detection of the nucleocapsid protein antigen of SARS-CoV-2 in direct anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection.

The key players of the lateral flow assay market are:

F. Hoffmann-La Roche Ltd

Siemens Healthineers AG

Thermo Fisher Scientific Inc.

Abbott Laboratories

Merck KGaA (MilliporeSigma)

Bio-Rad Laboratories, Inc.

Becton, Dickinson and Company

QuidelOrtho Corporation (Quidel Corporation)

Access Bio, Inc.

PerkinElmer, Inc.

Table of Contents

1. Executive Summary

2. Introduction

• 2.1 Lateral Flow Assay: An Overview
  • 2.1.1 Definition of Lateral Flow Assay
  • 2.1.2 Benefits of Lateral Flow Assay
• 2.2 Lateral Flow Assay Market Segmentation
  • 2.2.1 Lateral Flow Assay Market Segmentation

3. Global Market Analysis

• 3.1 Global Lateral Flow Assay Market: An Analysis
  • 3.1.1 Global Lateral Flow Assay Market: An Overview
  • 3.1.2 Global Lateral Flow Assay Market by Value
  • 3.1.3 Global Lateral Flow Assay Market by Product Type (Kits and Reagents, and Lateral Flow Readers)
  • 3.1.4 Global Lateral Flow Assay Market by Application (Clinical Testing, Veterinary Diagnostics, Food Safety & Environment Testing, and Drug Development & Quality Testing)
  • 3.1.5 Global Lateral Flow Assay Market by Technology (Sandwich Assays, Competitive Assays, and Multiplex Detection Assays)
  • 3.1.6 Global Lateral Flow Assay Market by End User (Hospitals & Clinics, Diagnostic Laboratories, Home Care, Pharmaceutical & Biotechnology Companies, and Others)
  • 3.1.7 Global Lateral Flow Assay Market by Region (North America, Europe, Asia Pacific, and Rest of the World)
• 3.2 Global Lateral Flow Assay Market: Product Type Analysis
  • 3.2.1 Global Lateral Flow Assay Market by Product Type: An Overview
  • 3.2.2 Global Kits and Reagents Lateral Flow Assay Market by Value
  • 3.2.3 Global Lateral Flow Assay Readers Market by Value
• 3.3 Global Lateral Flow Assay Market: Application Analysis
  • 3.3.1 Global Lateral Flow Assay Market by Application: An Overview
  • 3.3.2 Global Clinical Testing Lateral Flow Assay Market by Value
  • 3.3.3 Global Veterinary Diagnostics Lateral Flow Assay Market by Value
  • 3.3.4 Global Food Safety & Environment Testing Lateral Flow Assay Market by Value
  • 3.3.5 Global Drug Development & Quality Testing Lateral Flow Assay Market by Value
• 3.4 Global Lateral Flow Assay Market: Technology Analysis
  • 3.4.1 Global Lateral Flow Assay Market by Technology: An Overview
  • 3.4.2 Global Sandwich Lateral Flow Assay Market by Value
  • 3.4.3 Global Competitive Lateral Flow Assay Market by Value
  • 3.4.4 Global Multiplex Detection Lateral Flow Assay Market by Value
• 3.5 Global Lateral Flow Assay Market: End User Analysis
  • 3.5.1 Global Lateral Flow Assay Market by End User: An Overview
  • 3.5.2 Global Hospitals & Clinics Lateral Flow Assay Market by Value
  • 3.5.3 Global Diagnostic Laboratories Lateral Flow Assay Market by Value
  • 3.5.4 Global Home Care Lateral Flow Assay Market by Value
  • 3.5.5 Global Pharmaceutical & Biotechnology Companies Lateral Flow Assay Market by Value
  • 3.5.6 Global Others Lateral Flow Assay Market by Value

4. Regional Market Analysis

• 4.1 North America Lateral Flow Assay Market: An Analysis
  • 4.1.1 North America Lateral Flow Assay Market: An Overview
  • 4.1.2 North America Lateral Flow Assay Market by Value
  • 4.1.3 North America Lateral Flow Assay Market by Product Type (Kits and Reagents, and Lateral Flow Readers)
  • 4.1.4 North America Lateral Flow Assay Market by Technology (Sandwich Assays, Competitive Assays, and Multiplex Detection Assays)
  • 4.1.5 North America Lateral Flow Assay Market by Region (The US, Canada, and Mexico)
  • 4.1.6 The US Lateral Flow Assay Market by Value
  • 4.1.7 Canada Lateral Flow Assay Market by Value
  • 4.1.8 Mexico Lateral Flow Assay Market by Value
• 4.2 Europe Lateral Flow Assay Market: An Analysis
  • 4.2.1 Europe Lateral Flow Assay Market: An Overview
  • 4.2.2 Europe Lateral Flow Assay Market by Value
  • 4.2.3 Europe Lateral Flow Assay Market by Region (Germany, France, UK, Italy, Spain and Rest of Europe)
  • 4.2.4 Germany Lateral Flow Assay Market by Value
  • 4.2.5 UK Lateral Flow Assay Market by Value
  • 4.2.6 France Lateral Flow Assay Market by Value
  • 4.2.7 Italy Lateral Flow Assay Market by Value
  • 4.2.8 Spain Lateral Flow Assay Market by Value
  • 4.2.9 Rest of Europe Lateral Flow Assay Market by Value
• 4.3 Asia Pacific Lateral Flow Assay Market: An Analysis
  • 4.3.1 Asia Pacific Lateral Flow Assay Market: An Overview
  • 4.3.2 Asia Pacific Lateral Flow Assay Market by Value
  • 4.3.3 Asia Pacific Lateral Flow Assay Market by Region (China, Japan, India, South Korea, Australia, and Rest of Asia Pacific)
  • 4.3.4 China Lateral Flow Assay Market by Value
  • 4.3.5 Japan Lateral Flow Assay Market by Value
  • 4.3.6 India Lateral Flow Assay Market by Value
  • 4.3.7 South Korea Lateral Flow Assay Market by Value
  • 4.3.8 Australia Lateral Flow Assay Market by Value
  • 4.3.9 Rest of Asia Pacific Lateral Flow Assay Market by Value
• 4.4 Rest of the World Lateral Flow Assay Market: An Analysis
  • 4.4.1 Rest of the World Lateral Flow Assay Market: An Overview
  • 4.4.2 Rest of the World Lateral Flow Assay Market by Value

5. Impact of COVID-19

• 5.1 Impact of COVID-19 on Lateral Flow Assay Market
• 5.2 Post COVID-19 Impact on Lateral Flow Assay Market

6. Market Dynamics

• 6.1 Growth Drivers
  • 6.1.1 Ageing Population
  • 6.1.2 Rising Cases Of Infectious Diseases
  • 6.1.3 Growing Adoption Of Home Based Assay Kits And Devices
  • 6.1.4 Rising Popularity Of Point-of-care Testing
• 6.2 Challenges
  • 6.2.1 Strict Regulatory Requirements Due to Inconsistent Diagnostic Results
  • 6.2.2 Increased Competition From Alternative Diagnostics Technologies
• 6.3 Market Trends
  • 6.3.1 Increasing Integration Of Artificial Intelligence (AI) And Biosensors
  • 6.3.2 Rising Digital Technology Integration
  • 6.3.3 Evolving Newer Applications Of Lateral Flow Assays
  • 6.3.4 Rising Demand For Personalized And Customized Lateral Flow Assays

7. Competitive Landscape

• 7.1 Global Lateral Flow Assay Market: Competitive Landscape

8. Company Profiles

• 8.1 F. Hoffmann-La Roche Ltd
  • 8.1.1 Business Overview
  • 8.1.2 Revenue by Operating Business
  • 8.1.3 Business Strategy
• 8.2 Siemens Healthineers AG
  • 8.2.1 Business Overview
  • 8.2.2 Operating Segments
  • 8.2.3 Business Strategy
• 8.3 Thermo Fisher Scientific Inc.
  • 8.3.1 Business Overview
  • 8.3.2 Operating Segments
  • 8.3.3 Business Strategy
• 8.4 Abbott Laboratories
  • 8.4.1 Business Overview
  • 8.4.2 Operating Segments
  • 8.4.3 Business Strategy
• 8.5 Merck KGaA (MilliporeSigma)
  • 8.5.1 Business Overview
  • 8.5.2 Operating Segments
  • 8.5.3 Business Strategy
• 8.6 Bio-Rad Laboratories, Inc.
  • 8.6.1 Business Overview
  • 8.6.2 Operating Segments
  • 8.6.3 Business Strategy
• 8.7 Becton, Dickinson and Company (BD Biosciences)
  • 8.7.1 Business Overview
  • 8.7.2 Operating Segments
  • 8.7.3 Business Strategy
• 8.8 QuidelOrtho Corporation (Quidel Corporation)
  • 8.8.1 Business Overview
  • 8.8.2 Operating Segments
  • 8.8.3 Business Strategy
• 8.9 Access Bio, Inc.
  • 8.9.1 Business Overview
• 8.10 PerkinElmer, Inc.
  • 8.10.1 Business Overview