市場調查報告書
商品編碼
1470917
橫向流動化驗的全球市場:按產品類型、技術、測試類型、應用和最終用戶 - 預測 2024-2030Lateral Flow Assays Market by Product (Kits & Reagents, Lateral Flow Readers), Technique (Competitive Assays, Multiplex Detection Assays, Sandwich Assays), Test Type, Application, End-User - Global Forecast 2024-2030 |
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預計2023年全球橫向流動化驗市場規模為96.5億美元,2024年達到100.3億美元,預計2030年將達到129.6億美元,複合年成長率為4.30%。
橫向流動化驗(LFA) 是一種快速診斷測試,用於檢測複雜混合物中是否存在目標分析物。由於其成本效益、易用性和快速結果,這些檢測方法被廣泛應用於各個領域,包括醫療診斷、環境監測和食品安全中的就地檢驗和家庭檢測。 LFA 利用毛細管作用將樣本抽取到含有特定抗體或抗原的試紙上,通常在幾分鐘內提供視覺上可觀察到的訊號。包括 COVID-19、流感和 HIV 在內的全球感染疾病負擔日益加重,更需要 LFA 等快速且易於使用的診斷工具,以促進早期檢測和管理。醫療保健的分散化以及對即時檢測便利性的日益成長的需求正在支持 LFA 在各種醫療保健環境中的採用。然而,更靈敏和定量技術的存在對 LFA 構成了競爭威脅,特別是在高靈敏度很重要的應用中。此外,LAF 的技術局限性,例如靈敏度和特異性降低,以及由於交叉反應或不當使用而可能出現假陽性/陰性的可能性,引發了對其準確性和可靠性的擔憂。然而,主要相關人員正在探索數位和定量 LAF 的開發及其與智慧型手機技術的整合,以進行資料分析和共用,以克服性能問題並提高 LAF 的準確性和效率。材料科學和生物技術的進步有可能提高 LFA 的敏感度、特異性和多重功能,從而擴大其在各個領域的效用和採用。
主要市場統計 | |
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基準年[2023] | 96.5億美元 |
預測年份 [2024] | 100.3億美元 |
預測年份 [2030] | 129.6億美元 |
複合年成長率(%) | 4.30% |
改進產品套件和試劑的功能、性能和適用性的新進展
LFA中包含的套件和試劑在醫療保健、食品和飲料、環境監測和農業等領域中發揮著至關重要的作用。這些組件預製在硝化纖維膜上,並裝在塑膠外殼內。為了檢驗測定性能,將發生反應的一條或多條測試線與控制線整合在一起。試劑包括對目標分析物特異性的抗體或抗原,並與膠體金或其他顆粒綴合以表達訊號。套件提供檢測所需的所有組件,並確保易用性和可靠性,這使得它們對於就地檢驗、現場測試和品管流程至關重要。側向流讀取儀是先進的儀器,旨在以高精度和可靠性定量或定性解釋 LFA 結果。與傳統的目視檢查方法不同,這些閱讀器利用先進的光學系統來準確檢測和測量測試和控制線。量化測試線的強度大大提高了檢測的靈敏度和特異性,並提供客觀的分析。側向流讀取儀適合實驗室和現場使用,提供資料管理和可追溯性的連接選項,這對於臨床診斷、食品安全通訊協定和環境監測至關重要。桌上型側向流讀取儀是一款專為實驗室使用而設計的先進儀器,透過量化世界橫向流動化驗測試線的強度來提供高度準確的結果。這些儀器通常用於臨床診斷、研究和開發以及品管過程,與多種檢測格式相容。桌上型讀碼器可提供準確且可重複的結果,通常可以與實驗室資訊管理系統 (LIMS) 整合,以儲存資料並簡化工作流程和資料分析。數位或手持式側向流讀取儀為現場診斷測試提供了可攜式解決方案,非常適合現場使用、照護現場設置以及無法訪問完整測試設施的偏遠地區。這些緊湊的設備透過解釋世界範圍內的橫向流動化驗中的測試和控制線來提供快速、定性和定量分析。行動或智慧型手機閱讀器是橫向流動化驗技術的創新飛躍,利用智慧型手機的普遍性和先進功能來執行和解釋測試。這些讀取器利用智慧型手機的攝影機和運算能力,結合專用的應用程式和軟體來分析試紙。這種方法將使診斷測試民主化,並提高其對廣大用戶的可近性和便利性。
應用臨床測試需要快速、準確且易於使用的解決方案
橫向流動化驗(LFA) 在臨床檢測中發揮著至關重要的作用,可提供快速、經濟高效且使用者友好的診斷解決方案。 LFA 廣泛用於檢測感染疾病、懷孕和藥物濫用,並促進即時檢測,無需複雜的設備或訓練有素的人員。奈米技術與先進生物辨識元件的融合,進一步提高了LFA的敏感度和特異性,使其成為臨床診斷不可或缺的一部分。在藥物開發和品質檢測領域,LFA 是快速篩檢、生物有效性和生物等效性測試的寶貴工具。 LFA 在藥物試驗的藥物動力學分析中發揮關鍵作用,為安全性和有效性評估提供及時的資料。此外,LFA 用於檢測污染物並確保藥品質量,從而保護公眾健康並保持法規遵循。 LFA技術在食品安全和環境檢測中的應用是檢測病原體、毒素、農藥和其他有害物質的快速實用的方法。 LFA 易於使用且減少了樣品製備的需要,使其成為現場測試的一個有吸引力的選擇,以確保食品安全和品質並監測環境污染物。多重檢測的發展使得同時檢測多個目標成為可能,為公共衛生和安全做出了重大貢獻。 LFA廣泛應用於獸醫診斷,為各種動物疾病的檢測提供快速結果。其簡單性、成本效益高、對技術設備和環境要求低,特別適合在野外和資源有限的環境中使用。無論是家庭寵物、家養動物或野生動物,LFA 都有助於疾病的早期發現和管理,有助於動物健康並預防潛在的人畜共通感染疾病。
區域洞察
以美國和加拿大為中心的美洲地區是橫向流動化驗領域高度先進的市場,擁有高額醫療保健支出、先進的醫療保健基礎設施以及對研發的高度重視。感染疾病的快速診斷測試和藥物測試是值得注意的應用。最近的專利強調了檢測靈敏度和特異性方面的進步。許多新興企業和老牌公司正在投資開發新應用並擴大其產品範圍。在強而有力的法律規範和醫療基礎設施的支持下,歐盟國家橫向流動化驗的全球採用率很高。該地區的著名研究和專利主要集中在資料分析和與行動裝置整合的複用功能。歐盟層級的舉措旨在提高診斷測試的負擔能力和取得機會,特別是在服務不足的地區。在旨在改善醫療保健和對抗感染疾病的政府舉措的推動下,亞太地區是橫向流動化驗領域快速成長的地區。重點放在本地生產和研究上,以減少對進口商品的依賴。日本市場的特點是技術創新水準高,消費者願意採用先進的診斷方法。人口老化進一步增加了慢性病管理中快速檢測的需求。由於人們對就地檢驗及其在管理感染疾病和慢性病方面的好處的認知不斷增強,印度的需求正在迅速成長。最近的舉措旨在加強當地製造能力和分銷網路,以改善全國範圍內獲得診斷測試的機會。
FPNV定位矩陣
FPNV定位矩陣對於評估全球橫向流動化驗市場至關重要。我們檢視與業務策略和產品滿意度相關的關鍵指標,以對供應商進行全面評估。這種深入的分析使用戶能夠根據自己的要求做出明智的決策。根據評估,供應商被分為四個成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市場佔有率分析
市場佔有率分析是一種綜合工具,可以對全球橫向流動化驗市場中供應商的現狀進行深入而詳細的研究。全面比較和分析供應商在整體收益、基本客群和其他關鍵指標方面的貢獻,以便更好地了解公司的績效及其在爭奪市場佔有率時面臨的挑戰。此外,該分析還提供了對該行業競爭特徵的寶貴見解,包括在研究基準年觀察到的累積、分散主導地位和合併特徵等因素。這種詳細程度的提高使供應商能夠做出更明智的決策並制定有效的策略,從而在市場上獲得競爭優勢。
1. 市場滲透率:提供有關主要企業所服務的市場的全面資訊。
2. 市場開拓:我們深入研究利潤豐厚的新興市場,並分析其在成熟細分市場的滲透率。
3. 市場多元化:提供有關新產品發布、開拓地區、最新發展和投資的詳細資訊。
4.競爭評估與資訊:對主要企業的市場佔有率、策略、產品、認證、監管狀況、專利狀況、製造能力等進行全面評估。
5. 產品開發與創新:提供對未來技術、研發活動和突破性產品開發的見解。
1. 全球橫向流動化驗市場的市場規模與預測為何?
2.在全球橫向流動化驗市場的預測期間內,有哪些產品、細分市場、應用和領域需要考慮投資?
3. 全球橫向流動化驗市場的技術趨勢和法規結構是什麼?
4.全球橫向流動化驗市場主要廠商的市場佔有率為何?
5. 進入全球橫向流動化驗市場的適當型態和策略手段是什麼?
[193 Pages Report] The Lateral Flow Assays Market size was estimated at USD 9.65 billion in 2023 and expected to reach USD 10.03 billion in 2024, at a CAGR 4.30% to reach USD 12.96 billion by 2030.
Lateral flow assays (LFAs) are rapid diagnostic tests used for detecting the presence or absence of a target analyte in complex mixtures. These assays are widely utilized in medical diagnostics for point-of-care testing and home testing and in various fields such as environmental monitoring and food safety due to their cost-effectiveness, ease of use, and rapid results. LFAs rely on the principle of capillary action to draw a sample across a test strip that contains specific antibodies or antigens, leading to a visually observable signal, typically within minutes. The growing global burden of infectious diseases, including COVID-19, influenza, and HIV, drives the need for rapid, easy-to-use diagnostic tools like LFAs, facilitating early detection and management. The growing need for decentralized healthcare and the convenience of point-of-care testing supports the increased adoption of LFAs across various healthcare settings. However, the presence of more sensitive and quantitative technologies poses a competitive threat to LFAs, especially in applications where high sensitivity is crucial. Furthermore, technical limitations of the LAFs, such as reduced sensitivity and specificity and the potential for false positives/negatives due to cross-reactivity or improper use, can raise concerns about their accuracy and reliability. However, key players are exploring the development of digital and quantitative LFAs and integration with smartphone technology for data analysis and sharing to overcome performance issues and improve LAFs' accuracy and efficiency. Advances in materials science and biotechnology hold the potential to enhance the sensitivity, specificity, and multiplexing capabilities of LFAs, thereby broadening their utility and adoption in various sectors.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 9.65 billion |
Estimated Year [2024] | USD 10.03 billion |
Forecast Year [2030] | USD 12.96 billion |
CAGR (%) | 4.30% |
Product: Emerging advancements to improve the functionality, performance, and applicability of kits and reagents
The kits and reagents involved in LFAs play a pivotal role in the healthcare, food and beverage, environmental monitoring, and agricultural sectors, among others. These components come prefabricated on a nitrocellulose membrane and housed within a plastic casing. They integrate one or multiple test lines where reactions occur alongside control lines to validate the assay's performance. The reagents include antibodies or antigens specific to the analyte of interest, conjugated with colloidal gold or other particles for signal development. The kits provide all necessary components for the assay, ensuring ease of use and reliability, making them essential for point-of-care testing, field testing, and quality control processes. Lateral flow readers are sophisticated devices designed to quantitatively or qualitatively interpret the results of LFA with high precision and reliability. Unlike the traditional visual inspection method, these readers utilize advanced optical systems to accurately detect and measure the test and control lines. They significantly enhance the assay's sensitivity and specificity by quantifying the intensity of the test line, thus providing an objective analysis. Suitable for both laboratory and field use, lateral flow readers offer connectivity options for data management and traceability, which is pivotal for clinical diagnostics, food safety protocols, and environmental monitoring. Benchtop lateral flow readers are sophisticated instruments designed for laboratory use, providing high-accuracy results by quantifying the test line's intensity on lateral flow assays. These devices, often employed in clinical diagnostics, research and development laboratories, and quality control processes, support a wide range of assay formats. Benchtop readers deliver precise, reproducible results and can often store data and integrate with laboratory information management systems (LIMS) to streamline workflow and data analysis. Digital or handheld lateral flow readers offer a portable solution for on-the-spot diagnostic testing, making them ideal for field use, point-of-care settings, and remote locations where access to full laboratory facilities is limited. These compact devices provide rapid, qualitative, and quantitative analyses by interpreting the test and control lines on lateral flow assays. Mobile or smartphone readers represent an innovative leap in lateral flow assay technology, leveraging the ubiquity and advanced capabilities of smartphones to perform and interpret tests. These readers utilize a smartphone's camera and computational power, coupled with specialized apps or software, to analyze test strips. This approach democratizes diagnostic testing, enhancing accessibility and convenience for a wide user base.
Application: Need for rapid, accurate, and accessible solutions in clinical testing
Lateral flow assays (LFA) hold a pivotal role in clinical testing, offering rapid, cost-effective, and user-friendly diagnostic solutions. They are widely utilized for the detection of infectious diseases, pregnancy, and drug abuse testing and facilitate point-of-care testing without the need for sophisticated equipment or highly trained personnel. The integration of nanotechnologies and advanced biorecognition elements has further enhanced their sensitivity and specificity, making LFAs indispensable in clinical diagnostics. In the realm of drug development and quality testing, LFAs offer valuable tools for rapid screening, bioavailability, and bioequivalence studies. They serve crucially in the pharmacokinetic analysis of drug trials, providing timely data that is essential for safety and efficacy assessments. Additionally, LFAs are employed to detect contaminants and ensure the quality of pharmaceutical products, thereby safeguarding public health and maintaining regulatory compliance. The application of LFA technology in food safety and environmental testing represents a fast and practical approach to detecting pathogens, toxins, pesticides, and other harmful agents. Its ease of use and the minimal requirement for sample preparation make LFA an attractive option for on-site testing, ensuring the safety and quality of food products and monitoring environmental pollutants. The development of multiplexed assays has enabled the simultaneous detection of multiple targets, significantly benefitting public health and safety. LFAs are extensively applied in veterinary diagnostics, providing rapid results for the detection of various animal diseases. Their simplicity, cost-effectiveness, and the minimal need for technical equipment or environments make them especially suited for use in field conditions or in resource-limited settings. Whether for domestic pets, livestock, or wildlife, LFAs help in the early detection and management of diseases, contributing to animal health and preventing potential zoonotic transmissions to humans.
Regional Insights
The Americas region, particularly the U.S. and Canada, represents a highly advanced market for lateral flow assays, driven by high healthcare expenditure, advanced healthcare infrastructure, and a strong focus on research and development. Rapid diagnostic testing for infectious diseases and drug testing are prominent applications. Recent patents emphasize advancements in the sensitivity and specificity of assays. Numerous startups and established companies are investing in the development of new applications and the expansion of product range. EU countries show a high adoption rate for lateral flow assays, favored by a strong regulatory framework and healthcare infrastructure. Notable research and patents in the region focus on multiplexing capabilities and integration with mobile devices for data analysis. Initiatives at the EU level aim to improve affordability and access to diagnostic testing, particularly in underserved areas. APAC is a rapidly growing region for lateral flow assays, driven by government initiatives aimed at improving healthcare access and combating infectious diseases. There is a significant focus on local production and research to reduce dependency on imports. Japan's market is characterized by high innovation and consumer willingness to adopt advanced diagnostic methods. Aging population dynamics further fuel the need for rapid testing in chronic disease management. The demand in India is rapidly increasing due to rising awareness about point-of-care testing and its benefits in managing infectious diseases and chronic conditions. Recent initiatives aim to enhance local manufacturing capabilities and distribution networks to improve access to diagnostic tests across the country.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Lateral Flow Assays Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Market Share Analysis
The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Lateral Flow Assays Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
Key Company Profiles
The report delves into recent significant developments in the Lateral Flow Assays Market, highlighting leading vendors and their innovative profiles. These include Abbott Laboratories, Inc., Abcam PLC, BBI Solutions, Becton, Dickinson and Company, Bio-Rad Laboratories, Inc., Bio-Techne Corp., BioFluidix GmbH by Hamilton Company, BioMerieux SA, BioPorto Diagnostics A/S, BOC Sciences, Cytodiagnostics Inc., Danaher Corporation, Elabscience Biotechnology Inc., F. Hoffmann-La Roche AG, Fortis Life Sciences, Hologic, Inc., Leinco Technologies, Merck KGaA, Microcoat Biotechnologie GmbH, Milenia Biotec GmbH, PerkinElmer Inc., Porex Filtration Group, QIAGEN GmbH, Quidel Corporation, R-Biopharm AG, Rockland Immunochemicals, Inc., Shenzhen SEKBIO Co., Ltd., Siemens AG, Tetracore, Inc., Thermo Fisher Scientific, Inc., and VDO Biotech Co., Ltd..
Market Segmentation & Coverage
1. Market Penetration: It presents comprehensive information on the market provided by key players.
2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.
1. What is the market size and forecast of the Lateral Flow Assays Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Lateral Flow Assays Market?
3. What are the technology trends and regulatory frameworks in the Lateral Flow Assays Market?
4. What is the market share of the leading vendors in the Lateral Flow Assays Market?
5. Which modes and strategic moves are suitable for entering the Lateral Flow Assays Market?