市場調查報告書
商品編碼
1471102
橫向流動化驗組件市場:按類型、技術、應用和最終用途分類 – 2024-2030 年全球預測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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橫向流動化驗組件市場規模預計到 2023 年為 7.2215 億美元,到 2024 年達到 7.6029 億美元,預計到 2030 年將達到 10.336 億美元,複合年成長率為 5.25%。
橫向流動化驗(LFA) 組件涵蓋醫療保健診斷的一部分,其中包括用於構建橫向流動化驗的技術和材料,並用於檢測目標分析物的存在或濃度。 LFA組件包括樣本墊片、結合墊片、吸收墊片、硝酸纖維素膜、標記試劑等。這些組件對於增強 LFA 的功能(從醫療診斷到環境測試)至關重要。感染疾病的傳播正在推動對快速診斷測試的需求,也是側流檢測(LFA)市場的基石。家庭檢測和現場檢測需求的不斷成長是市場擴張的驅動力,進一步擴大了市場規模。與實驗室測試相比,缺乏敏感性和特異性,導致假陰性和假陽性,市場成長受到阻礙。能夠同時檢測多種分析物的多重分析的市場不斷開拓,以及它們與用於結果解釋和資料管理的數位技術的整合,預計將創造市場成長機會。
主要市場統計 | |
---|---|
基準年[2023] | 72215萬美元 |
預測年份 [2024] | 76029萬美元 |
預測年份 [2030] | 10.336 億美元 |
複合年成長率(%) | 5.25% |
橫向流動化驗(LFA) 膜擴大用於需要高靈敏度和特異性的測試。
側向層析 (LFA) 膜是關鍵組件,可作為實際測試反應發生的平台。這些膜通常由硝化纖維或其他旨在表現出特定流動特性的材料製成。膜的選擇會影響流速,進而影響測定的反應時間、敏感度和特異性。橫向流動化驗中的墊片包括樣品墊片、結合墊片和吸收墊片,每種墊具有不同的功能。樣品墊片用作測試樣品的塗布點,通常包含化學物質以將測試樣品保持在理想條件下。結合墊片含有化驗特異性檢測反應所需的試劑,吸收墊片在反應後吸收多餘的樣本液體並防止回流。
技術多重檢測的重要性日益增加檢測多個目標的檢測
競爭性測定通常用於檢測小分子。在這種測試形式中,樣本抗原與標記抗原競爭有限數量的抗體結合位點。競爭測定適用於沒有多個抗原決定位點的小分子,例如荷爾蒙、藥物和生物標記物,因此無法透過夾心測定檢測。多重檢測分析旨在在一次測試中檢測多個目標。結合不同的測試線同時評估多種分析物可以節省大量時間和樣品量。三明治檢測是最常見的蛋白質檢測方法。其原理是將目標抗原夾在兩種抗體之間。測試線是捕獲抗體,結合墊片是標記的和遊離的檢測抗體。夾心測定法適用於檢測大分子,例如蛋白質和大勝胜肽,它們呈現多個抗體結合表位。
應用橫向流動化驗的需求不斷增加,以在藥物開發和品質測試中提供定量且可靠的資料
臨床檢測是橫向流動化驗的重要市場,可快速診斷多種疾病,包括感染疾病、心臟標記、懷孕和藥物濫用。該領域青睞能夠快速提供結果的高度準確且方便用戶使用的檢測方法,從而能夠及時做出臨床決策。藥物開發和品質測試依賴於藥物動力學、藥物篩檢和治療監測的橫向流動化驗。此領域青睞高度特異性的檢測方法,可為藥物開發過程定量提供可靠的資料。由於快速有效地檢測病原體、過敏原和毒素等污染物的需求不斷增加,食品安全和環境檢測是橫向流動化驗的一個不斷成長的市場。測試在該領域是首選,因為它們易於在現場使用,並且足夠堅固,可以承受各種環境條件。獸醫診斷是一個重要領域,利用橫向流動化驗來快速診斷動物疾病。測試是首選,因為它們快速、可靠且負擔得起,並且可以在從診所到現場工作的各種環境中使用。
擴大最終用途醫療設備製造商橫向流動化驗組件的潛力:維持其產品的品管
醫療設備契約製造製造商 (MDCM) 專門為各種醫療保健行業提供醫療設備契約製造。在橫向流動化驗組件方面,MDCM 透過以合約為基礎製造產品,為品牌所有者提供量身定做的解決方案,通常協助監管流程。這些製造商在確保診斷設備(包括懷孕、傳染病檢查和藥物檢測套組)的持續供應方面發揮關鍵作用。醫療設備製造商以自有品牌設計、製造和銷售產品。這些公司有能力生產全系列的醫療設備,包括橫向流動化驗。我們控制從研發到銷售和分銷的整個產品生命週期。醫療設備製造商喜歡此類組件,以便更好地控制其產品的品質和供應鏈。這個最終用戶細分市場由具有強大市場地位、強大研發基礎以及廣泛銷售和分銷網路的大公司推動。
區域洞察
美洲的橫向流動化驗(LFA)組件市場已經成熟,尤其是在美國,醫療基礎設施發達,消費者認知度較高。對研發的重視已在該地區獲得多項專利。美國和加拿大的消費者更喜歡方便快速的診斷解決方案,這對基於 LFA 的測試產生了巨大的需求。隨著這些北美國家努力將最尖端科技融入診斷醫學,該領域的投資持續強勁。由於人口老化和家庭診斷測試的需求不斷增加,歐盟國家對側向層析檢測的需求很高。歐洲消費行為傾向於青睞獲得監管部門核准的優質產品,這反映在 LFA 組件的購買模式中。在中東和非洲 (MEA),感染疾病負擔的增加和醫療保健行業的成長正在推動人們對照護現場診斷(包括橫向流動化驗)的興趣日益濃厚。在中東和非洲國家,負擔能力和可用性是決定客戶購買行為的關鍵因素。該地區致力於解決公共衛生挑戰,例如改善疾病監測和在偏遠地區提供快速檢測,這正在推動對 LFA 組件的需求。亞太地區是側流檢測快速成長的新興市場。這得歸功於政府推動醫療改革,加速了診斷領域的投資和技術創新,許多與新的LFA組件和檢測方法相關的專利正在申請中。日本技術高度先進,並且積極引進新的醫療保健產品,代表成熟的 LFA 市場。
FPNV定位矩陣
FPNV 定位矩陣對於評估橫向流動化驗組件市場至關重要。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,可以對側橫向流動化驗組件市場中供應商的現狀進行深入而深入的研究。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。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. 競爭評估和情報:對主要企業的市場佔有率、策略、產品、認證、監管狀況、專利狀況和製造能力進行全面評估。
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.橫向流動化驗組件市場的市場規模與預測為何?
2.在橫向流動化驗組件市場的預測期間內,有哪些產品、細分市場、應用和領域需要考慮投資?
3.橫向流動化驗組件市場的技術趨勢與法規結構是什麼?
4.橫向流動化驗組件市場主要廠商的市場佔有率為何?
5. 進入橫向流動化驗組件市場的適當型態和策略手段是什麼?
[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?