市场调查报告书
商品编码
1471102
横向流动化验组件市场:按类型、技术、应用和最终用途划分 – 2024-2030 年全球预测Lateral Flow Assay Components Market by Type (Membranes, Pads), Technique (Competitive Assays, Multiplex Detection Assays, Sandwich Assays), Application, End-Use - Global Forecast 2024-2030 |
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横向流动化验组件市场规模预计到 2023 年为 7.2215 亿美元,到 2024 年达到 7.6029 亿美元,预计到 2030 年将达到 10.336 亿美元,复合年增长率为 5.25%。
横向流动化验(LFA) 组件涵盖医疗保健诊断的一部分,其中包括用于构建横向流动化验的技术和材料,并用于检测目标分析物的存在或浓度。 LFA组件包括样本垫片、结合垫片、吸收垫片、硝酸纤维素膜、标记试剂等。这些组件对于增强 LFA 的功能(从医疗诊断到环境测试)至关重要。感染疾病的传播正在推动对快速诊断测试的需求,也是侧流检测(LFA)市场的基石。家庭检测和现场检测需求的不断增长是市场扩张的驱动力,进一步扩大了市场规模。与实验室测试相比,缺乏敏感性和特异性,导致假阴性和假阳性,市场成长受到阻碍。能够同时检测多种分析物的多重分析的市场不断开拓,以及它们与用于结果解释和资料管理的数位技术的集成,预计将创造市场成长机会。
主要市场统计 | |
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基准年[2023] | 72215万美元 |
预测年份 [2024] | 76029万美元 |
预测年份 [2030] | 10.336 亿美元 |
复合年增长率(%) | 5.25% |
横向流动化验(LFA) 膜越来越多地用于需要高灵敏度和特异性的测试。
侧向层析 (LFA) 膜是关键组件,可作为实际测试反应发生的平台。这些膜通常由硝化纤维或其他旨在表现出特定流动特性的材料製成。膜的选择会影响流速,进而影响测定的反应时间、敏感度和特异性。横向流动化验中的垫片包括样品垫片、结合垫片和吸收垫片,每种垫具有不同的功能。样品垫片用作测试样品的涂布点,通常包含化学物质以将测试样品保持在理想条件下。结合垫片含有化验特异性检测反应所需的试剂,吸收垫片在反应后吸收多余的样本液体并防止回流。
技术多重检测的重要性日益增加检测多个目标的检测
竞争性测定通常用于检测小分子。在这种测试形式中,样本抗原与标记抗原竞争有限数量的抗体结合位点。竞争测定适用于没有多个抗原决定位点的小分子,例如荷尔蒙、药物和生物标记物,因此无法透过夹心测定检测。多重检测分析旨在在一次测试中检测多个目标。结合不同的测试线同时评估多种分析物可以节省大量时间和样品量。三明治检测是最常见的蛋白质检测方法。其原理是将目标抗原夹在两种抗体之间。测试线是捕获抗体,结合垫片是标记的和游离的检测抗体。夹心测定法适用于检测大分子,例如蛋白质和大胜胜肽,它们呈现多个抗体结合表位。
应用横向流动化验的需求不断增加,以在药物开发和品质测试中提供定量且可靠的资料
临床检测是横向流动化验的重要市场,可快速诊断多种疾病,包括感染疾病、心臟标记、怀孕和药物滥用。该领域青睐能够快速提供结果的高度准确且用户友好的检测方法,从而能够及时做出临床决策。药物开发和品质测试依赖于药物动力学、药物筛检和治疗监测的横向流动化验。此领域青睐高度特异性的检测方法,可为药物开发过程定量提供可靠的资料。由于快速有效地检测病原体、过敏原和毒素等污染物的需求不断增加,食品安全和环境检测是横向流动化验的一个不断增长的市场。测试在该领域是首选,因为它们易于在现场使用,并且足够坚固,可以承受各种环境条件。兽医诊断是一个重要领域,利用横向流动化验来快速诊断动物疾病。测试是首选,因为它们快速、可靠且负担得起,并且可以在从诊所到现场工作的各种环境中使用。
扩大最终用途医疗设备製造商横向流动化验组件的潜力:维持其产品的品管
医疗设备契约製造製造商 (MDCM) 专门为各种医疗保健行业提供医疗设备契约製造。在横向流动化验组件方面,MDCM 透过以合约为基础製造产品,为品牌所有者提供量身定制的解决方案,通常协助监管流程。这些製造商在确保诊断设备(包括怀孕、传染病检查和药物检测套组)的持续供应方面发挥关键作用。医疗设备製造商以自有品牌设计、製造和销售产品。这些公司有能力生产全系列的医疗设备,包括横向流动化验。我们控制从研发到销售和分销的整个产品生命週期。医疗设备製造商喜欢此类组件,以便更好地控制其产品的品质和供应链。这个最终用户细分市场由具有强大市场地位、强大研发基础以及广泛销售和分销网络的大公司推动。
区域洞察
美洲的横向流动化验(LFA)组件市场已经成熟,尤其是在美国,医疗基础设施发达,消费者认知度较高。对研发的重视已在该地区获得多项专利。美国和加拿大的消费者更喜欢方便快速的诊断解决方案,这对基于 LFA 的测试产生了巨大的需求。随着这些北美国家努力将最尖端科技融入诊断医学,该领域的投资持续强劲。由于人口老化和家庭诊断测试的需求不断增加,欧盟国家对侧向层析检测的需求很高。欧洲消费行为倾向于青睐获得监管部门核准的优质产品,这反映在 LFA 组件的购买模式中。在中东和非洲 (MEA),感染疾病负担的增加和医疗保健行业的成长正在推动人们对照护现场诊断(包括横向流动化验)的兴趣日益浓厚。在中东和非洲国家,负担能力和可用性是决定客户购买行为的关键因素。该地区致力于解决公共卫生挑战,例如改善疾病监测和在偏远地区提供快速检测,这正在推动对 LFA 组件的需求。亚太地区是侧流检测快速成长的新兴市场。这得归功于政府推动医疗改革,加速了诊断领域的投资和技术创新,许多与新的LFA组件和检测方法相关的专利正在申请中。日本技术高度先进,并且积极引进新的医疗保健产品,代表成熟的 LFA 市场。
FPNV定位矩阵
FPNV 定位矩阵对于评估横向流动化验组件市场至关重要。我们检视与业务策略和产品满意度相关的关键指标,以对供应商进行全面评估。这种深入的分析使用户能够根据自己的要求做出明智的决策。根据评估,供应商被分为四个成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市场占有率分析
市场占有率分析是一种综合工具,可以对侧横向流动化验组件市场中供应商的现状进行深入而深入的研究。全面比较和分析供应商在整体收益、基本客群和其他关键指标方面的贡献,以便更好地了解公司的绩效及其在争夺市场占有率时面临的挑战。此外,该分析还提供了对该行业竞争特征的宝贵见解,包括在研究基准年观察到的累积、分散主导地位和合併特征等因素。详细程度的提高使供应商能够做出更明智的决策并制定有效的策略,从而在市场上获得竞争优势。
1. 市场渗透率:提供有关主要企业所服务的市场的全面资讯。
2. 市场开拓:我们深入研究利润丰厚的新兴市场,并分析其在成熟细分市场的渗透率。
3. 市场多元化:提供有关新产品发布、开拓地区、最新发展和投资的详细资讯。
4. 竞争评估和情报:对主要企业的市场占有率、策略、产品、认证、监管状况、专利状况和製造能力进行全面评估。
5. 产品开发与创新:提供对未来技术、研发活动和突破性产品开发的见解。
1.横向流动化验组件市场的市场规模与预测为何?
2.在横向流动化验组件市场的预测期间内,有哪些产品、细分市场、应用和领域需要考虑投资?
3.横向流动化验组件市场的技术趋势与法规结构是什么?
4.横向流动化验组件市场主要厂商的市场占有率为何?
5. 进入横向流动化验组件市场的适当型态和策略手段是什么?
[195 Pages Report] The Lateral Flow Assay Components Market size was estimated at USD 722.15 million in 2023 and expected to reach USD 760.29 million in 2024, at a CAGR 5.25% to reach USD 1,033.60 million by 2030.
Lateral flow assay (LFA) components encompass the segment of healthcare diagnostics that involves the technology and materials used to construct lateral flow assays, which are rapid diagnostic tests used for detecting the presence or concentration of a target analyte. LFA components include sample pads, conjugate pads, absorbent pads, nitrocellulose membranes, and labeling reagents. These components are essential for the functionality of LFAs in applications ranging from medical diagnostics to environmental testing. The increase in the prevalence of infectious diseases drives the demand for rapid diagnostic tests, subsequently creating a platform for the lateral flow assay (LFA) market. Growing demand for home-based and on-site testing fuels the market expansion further expanding the scope of the market. Lack of sensitivity and specificity compared to laboratory tests that lead to false negatives or positives are hampering the market growth. Expanding development of multiplex assays that can detect multiple analytes simultaneously and integration with digital technologies for result interpretation and data management are expected to create opportunities for market growth.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 722.15 million |
Estimated Year [2024] | USD 760.29 million |
Forecast Year [2030] | USD 1,033.60 million |
CAGR (%) | 5.25% |
Type: Growing usage of lateral flow assay (LFA) membranes for tests requiring high sensitivity and specificity
Lateral flow assay (LFA) membranes are crucial components that serve as the platform where the actual test reactions occur. These membranes typically consist of nitrocellulose or other materials engineered to exhibit specific flow characteristics. The choice of membrane affects the flow rate and, thus, the reaction time of the assay, as well as the sensitivity and specificity. Pads in lateral flow assays include sample pads, conjugate pads, and absorbent pads, each fulfilling distinct functions. The sample pad acts as the application point for the test sample and often includes chemicals that ensure the sample is in an ideal condition for testing. Conjugate pads contain the reagents necessary for the assay's specific detection reaction, while absorbent pads soak up excess sample fluid after the reaction takes place, preventing backflow.
Technique: Rising significance of multiplex detection Assays to detect multiple targets
Competitive assays are often utilized for the detection of small molecules. In this test format, the sample antigen competes with a labeled antigen for a limited number of antibody binding sites. Competitive assays are preferred for small molecules that cannot be detected using sandwich assay configurations due to the lack of multiple epitopes, such as hormones, drugs, and some biomarkers. Multiplex detection assays are designed to detect multiple targets in a single test. They can offer a substantial saving in time and sample volume as they assess several analytes simultaneously using a combination of different test lines. Sandwich assays are the most common format for protein detection. The principle involves capturing the target antigen between two antibodies: a capture antibody at the test line and a detection antibody that is labeled and free in the conjugate pad. Sandwich assays are preferred for the detection of larger molecules, such as proteins and large peptides, which present multiple epitopes for antibody binding.
Application: Increasing demand for lateral flow assays that quantify and provide reliable data during drug development & quality testing
Clinical testing represents a crucial market for lateral flow assays, providing rapid diagnostics for various conditions, including infectious diseases, cardiac markers, pregnancy, and drugs of abuse. The need-based preference in this segment leans towards highly accurate and user-friendly assays that can deliver immediate results, thereby enabling timely clinical decisions. Drug development & quality testing relies on lateral flow assays for pharmacokinetics, drug screening, and therapeutic monitoring. The preference in this segment leans toward highly specific assays that can quantify and provide reliable data for the drug development process. Food safety & environmental testing is an expanding market for lateral flow assays, as there is a growing need to detect contaminants, such as pathogens, allergens, and toxins, quickly and efficiently. The preference in this segment is for tests that are easy to use on-site and have the robustness to withstand various environmental conditions. Veterinary diagnostics is a vital area where lateral flow assays are employed to diagnose diseases in animals quickly. The preference is for rapid, reliable, and affordable tests that can be used in various settings, from clinics to fieldwork.
End-use: Growing potential of lateral flow assay components among medical device manufacturers to retain control over their product's quality
Medical device contract manufacturers (MDCMs) specialize in producing medical devices for various healthcare industries on a contractual basis. In the context of lateral flow assay components, MDCMs supply tailored solutions to brand owners by manufacturing products under contract and often assist with the regulatory processes. These manufacturers play a vital role in ensuring a continuous supply of diagnostic devices including pregnancies, infectious disease tests, and drug testing kits. Medical device manufacturers design, produce, and market their products under their brand name. These entities possess the capabilities to create full-range medical devices including lateral flow assays. They control the entire product lifecycle from R&D to sales and distribution. Medical device manufacturers prefer such components to retain more control over their product's quality and supply chain. This end-user segment is driven by large-scale companies that are well-established in the market, possess strong R&D foundations, and have a wide network for sales and distribution.
Regional Insights
The lateral flow assay (LFA) components market in the Americas is mature, particularly in the United States, owing to advanced healthcare infrastructure and high consumer awareness. There is a strong focus on research and development, which has led to several patents emerging from the region. Consumers in the U.S. and Canada demonstrate a preference for convenient and rapid diagnostic solutions, which creates a substantial demand for LFA-based tests. Investments in this sector remain robust as these North American countries strive to incorporate cutting-edge technology in diagnostic care. EU countries showcase a high demand for lateral flow assays, which is driven by an aging population and an increased need for home-based diagnostic testing. The consumer behavior in Europe tends to be inclined towards high-quality products with regulatory approval, which is reflected in their purchasing patterns for LFA components. The Middle East and Africa (MEA) have a rising interest in point-of-care diagnostics, including lateral flow assays, due to an increasing burden of infectious diseases and a growing healthcare sector. Affordability and accessibility are key determinants of customer purchasing behavior in MEA countries. Initiatives in the region focus on addressing public health challenges, such as improving disease monitoring and offering rapid tests in remote areas, thus propelling the demand for LFA components. The Asia Pacific region is recognized as a rapidly developing market for lateral flow assays due to the government's push for healthcare reforms, which has increased investments and innovation in the diagnostics sector, with numerous patents filed for novel LFA components and methods. Japan, with its advanced technology and consumer willingness to adopt new healthcare products, exhibits a sophisticated LFA market.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Lateral Flow Assay Components 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 Assay Components 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 Assay Components Market, highlighting leading vendors and their innovative profiles. These include Abcam PLC, ACON Laboratories, Inc., Agilent Technologies, Inc., Beckman Coulter, Becton, Dickinson and Company, Bio-Rad Laboratories, Inc., Biomerieux SA, DiaSorin S.p.A., EMD Millipore Corporation, Fujirebio Inc., GE Healthcare, Hoffmann-La Roche Ltd., Hologic, Inc., Horiba Ltd., Lonza Group, Luminex Corporation, Merck KGaA, Meridian Bioscience, Inc., Ortho Clinical Diagnostics, PerkinElmer Inc., Promega Corporation, QIAGEN GmbH, Randox Laboratories Ltd., Sartorius AG, Siemens Healthcare GmbH, Streck, Inc., Sysmex Corporation, Thermo Fisher Scientific, Inc., and Waters Corporation.
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 Assay Components Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Lateral Flow Assay Components Market?
3. What are the technology trends and regulatory frameworks in the Lateral Flow Assay Components Market?
4. What is the market share of the leading vendors in the Lateral Flow Assay Components Market?
5. Which modes and strategic moves are suitable for entering the Lateral Flow Assay Components Market?