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2050425

美國體外診斷市場：市場規模、佔有率和趨勢分析（2025-2032 年）

In Vitro Diagnostics Market Size, Share, & Trend Analysis | United States | 2025-2032 | Includes: Immunochemistry, Urinalysis, Molecular Diagnostics, and 5 more
出版日期: | 出版商: iData Research Inc. | 英文 323 Pages | 商品交期: 最快1-2個工作天內

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美國體外診斷市場報告（至2032年）

截至2025年，美國體外診斷市場規模為239億美元。預計該市場將以4.2%的年複合成長率成長，到2032年達到318億美元。

這份綜合報告涵蓋了美國體外診斷市場，包括免疫化學、尿液檢查、分子診斷、捐血者分子篩檢、血液學、止血、即時血氣診斷和即時血糖監測。

該分析包括銷售量、平均售價 (ASP)、市場規模、成長趨勢、市場促進因素和限制因素、截至 2032 年的市場預測以及截至 2022 年的歷史數據。它還涵蓋了近期併購、公司簡介、產品系列和主要參與者。

慢性病和感染疾病檢測需求的增加、技術創新、檢查室自動化以及分散式檢查的普及推動了這一成長。然而，價格壓力、成本限制以及聯邦保險體系的變化預計將在某些地區限制其應用。

市場概覽

美國體外診斷市場包括用於輔助檢測、監測和製定各種臨床疾病治療方案的診斷測試、分析儀、試劑和檢測試劑盒。這些產品應用於核心檢查室、醫院、捐血篩檢機構、照護現場（POC​​）場所和病患現場檢測點。

該市場涵蓋多個關鍵診斷類別，包括免疫化學、尿液檢查、分子診斷、分子捐血者篩檢、血液學、止血學、即時血氣分析和即時血糖監測。每個類別都滿足不同的檢測需求，從常規篩檢到特定疾病的檢測。

自動化仍然是後疫情時代診斷領域的核心趨勢。在疫情爆發後的幾年裡，各大醫院透過購買或租賃高通量整合系統，將化學檢測和免疫化學檢查整合到一個平台上，從而擴大了中心檢查室的檢測能力。

分散式檢查也在重塑市場格局。即時檢測（POC​​）和準專利系統使檢測更貼近患者，從而加快臨床決策速度並擴大檢測範圍。這在分子診斷、血氣分析、血糖監測和緊急傳染病檢查等領域尤其重要。

市場促進因素

慢性疾病和感染疾病的日益普遍是美國體外診斷市場的主要驅動力。糖尿病、心血管疾病、癌症和自體免疫疾病等疾病需要持續檢測，以進行診斷、後續觀察和治療方案製定。現有和新出現的感染疾病也持續推動對分子診斷和基於免疫化學的檢測的需求。

體外診斷（IVD）產品在常規和專科醫療中都發揮核心作用。檢測有助於臨床醫師早期發現疾病、監測治療反應並制定臨床決策。隨著患者群體不斷擴大，慢性病管理越來越依賴檢測，診斷產品在醫院、檢查室和照護現場（PoC）環境中仍然至關重要。

技術創新也在推動市場成長。分子診斷、次世代定序、PCR技術、自動化和即時檢測等領域的進步，正在提高檢測的速度、準確性和可及性。這些創新正在將診斷的覆蓋範圍從中心檢查室擴展到患者附近和家庭檢測環境。成熟的診斷公司正持續投資於研發和新產品發布，在多個體外診斷（IVD）領域中保持成長勢頭。

市場限制

預計醫療保險和醫療補助法案的變更將在預測期內抑制市場成長。 「一項全面的法案」對聯邦醫療保險計劃施加了新的限制。大規模非居民以及某些不符合特定就業要求的人員可能失去享有醫療保險和醫療補助的資格。

預計合格審查頻率的增加將導致約1000萬人失去醫療保險。 2026年至2032年間，聯邦醫療保險（Medicare）的資金削減預計將高達3,750億美元，這將迫使醫療系統收緊預算。隨著醫院和患者優先選擇必要的檢測途徑，優先順序較低的體外診斷（IVD）檢測的使用可能會減少。

價格壓力和成本限制也是限制因素。競爭和控制醫療成本的努力給診斷測試的價格帶來了下行壓力，這會擠壓利潤空間並限制對創新的再投資。最先進的設備、試劑和特殊測試可能很昂貴，這限制了預算緊張的小規模檢查室以及醫療資源匱乏地區的實驗室採用這些技術。

市場覆蓋範圍和數據範圍

  • 量化範圍：市場規模、市場佔有率、市場預測、市場成長率、銷售量、平均售價。
  • 定性範圍：市場促進因素和阻礙因素、市場規模和成長趨勢、近期併購、公司簡介、產品系列和主要競爭對手。
  • 目標時期：基準年為 2025 年，預測至 2032 年，歷史資料截至 2022 年。
  • 資料類型包括：銷售量、平均售價、市場規模和成長趨勢、市場促進因素和阻礙因素、到 2032 年的市場預測、歷史資料、近期併購、公司簡介和產品系列。
  • 方法注記：市場收入採用銷售量和平均售價計算，並採用細分市場來評估以下領域的需求：免疫化學、尿液檢查、分子診斷、捐血者分子篩檢、血液學、止血、即時血氣診斷和即時血糖監測。

本報告旨在幫助讀者評估慢性病檢測、感染疾病需求、自動化、即時檢測、報銷制度變化和價格壓力等因素如何影響美國體外診斷市場。

目標市場及區隔

免疫化學市場

  • 目標：核心和概念驗證。

尿液檢查市場

  • 技術：中央檢查室和即時檢測。

分子診斷市場

  • 市場類型：分子診斷設備、分子診斷試劑盒和患者端分子診斷。

捐血者分子篩檢市場

  • 市場類型：分析儀器和檢測試劑盒。

血液學市場

  • 市場類型：血液檢測分析儀和血液檢測試劑。

止血市場

  • 市場類型：止血分析儀和止血試劑。

即時血氣診斷市場

  • 產品類型：分析儀器和試劑。

即時血糖監測市場

  • 產品類型：分析儀器和試紙。

透過市場規模、市場佔有率、市場預測、市場成長率、銷售量和平均售價等相關定量指標對每個細分市場進行分析。

競爭分析

2025年，Cepheid公司成為美國體外診斷（IVD）市場的領導者。其GeneXpert®系統系列應用廣泛，因為它支援平台整合，並允許使用單一儀器進行多種檢測。該平台可實現長時間無人值守運行，從而提高檢查室效率並最佳化患者就診流程。

GeneXpert®產品線包含適用於照護現場和患者附近檢測的多種型號。這種柔軟性鞏固了Cefeid在該市場的領先地位，因為醫院和醫療機構正在尋求更快的檢測結果、更簡化的工作流程以及能夠處理多種檢測類別的診斷平台。

2025年，生物梅里埃是美國體外診斷（IVD）市場第二大公司。該公司擁有全面的分子診斷產品組合，包括即將獲得專利的FilmArray分析儀和SpotFire即時檢測（POC​​）分析儀。這些系統有助於加速傳染病檢查，並符合分子診斷分散化發展的大趨勢。

  • 雅培在2025年排名第三。本報告涵蓋兩個部門：雅培診斷和雅培實驗室。在核心免疫化學檢查市場，該公司提供Alinity ci系列和ARCHITECT平台，在高通量檢查室中佔據了穩固的地位。

科技和醫療治療的發展趨勢

檢查室自動化持續影響美國體外診斷市場。醫院和大型檢查室正在實施整合系統，將化學檢測和免疫化學檢查相結合，以提高處理能力、減少人工操作並支援更一致的工作流程。

隨著醫療服務提供者對更快的檢測結果和更便捷的檢測方式的需求日益成長，即時檢測（POC​​）正在迅速發展。即時血液氣體分析、即時血糖監測、尿液檢查和免疫化學檢查等，都受益於以病人為中心的快速決策模式。

分子診斷在患者身邊進行的重要性日益凸顯。能夠在傳統中心檢查室之外提供快速分子診斷結果的平台，有助於及時發現感染疾病，並減少治療決策的延遲。

分子診斷仍然是一個快速創新的領域。 PCR、檢測設計和次世代定序的進步正在擴大分子檢測在感染疾病、腫瘤學和其他專科領域的臨床應用。

捐血篩檢仍然是安全至關重要的環節。對分析儀器和檢測套組的需求反映了對捐血進行可靠篩檢的必要性，以及持續利用分子技術降低輸血相關風險的迫切需求。

成本控制正在影響技術的應用。雖然先進的平台能夠帶來臨床和工作流程的優勢，但小規模的檢查室和資源匱乏的地區可能會面臨高昂的資本投資成本、試劑價格和預算限制等障礙。

地區

本報告重點關注美國。

這份報告的意義

美國體外診斷市場規模有多大？預計到 2032 年將如何成長？

美國免疫化學、尿液檢查、分子診斷、捐血者分子篩檢、血液學、止血、即時血氣診斷和即時血糖監測的市場現況如何？

銷售量、平均售價和市場規模如何隨時間變化？

慢性病和感染疾病如何推動診斷檢測的需求？

自動化、整合測試平台和分散式檢查如何改變體外診斷工作流程？

分子診斷、PCR、NGS 和即時檢測 (POC) 如何拓展其臨床應用情境？

醫療保險和醫療補助計劃的改革、價格壓力和成本限制是如何限制市場成長的？

美國體外診斷 (IVD) 市場的主要參與者有哪些？ Cepheid、bioMerieux 和 Abbott 分別處於什麼位置？

iData Research 的《美國體外診斷市場報告》透過詳盡的市場規模、平均售價 (ASP) 趨勢、預測和競爭格局分析，解答了這些問題。該報告可用於評估市場需求、與主要競爭對手進行基準比較、評估技術應用情況，並制定美國體外診斷市場的整體成長策略。

目錄

美國體外診斷市場概覽

競爭分析

市場趨勢

市場趨勢

市場區隔

關鍵分析的最新進展

主要報告更新

版本歷史記錄

調查方法

  • 第一步：專案啟動與團隊組建
  • 步驟 2：準備資料系統並進行二次調查。
  • 步驟 3：設計和準備訪談和調查問卷。
  • 第四步：進行初步調查
  • 第五步：調查與分析：建立基準估計值
  • 第六步：市場預測與分析
  • 步驟 7：辨識策略機遇
  • 步驟 8：最終審核和市場推廣
  • 步驟九：客戶回饋與市場監測

全球關稅的影響

美國體外診斷市場概覽

  • 介紹
  • 市場概況及趨勢分析
  • 促進因素和抑制因素
  • 競爭性市佔率分析
  • 併購

免疫化學市場

  • 介紹
    • 免疫檢測
    • 臨床化學
  • 市場概覽
  • 市場分析與預測
    • 核心免疫化學市場
    • POC免疫化學市場
  • 促進因素和抑制因素
  • 競爭性市佔率分析

尿液檢查市場

  • 介紹
  • 市場概覽
  • 市場分析與預測
    • CoreLab尿液檢查市場
    • POC尿液檢查市場
  • 促進因素和抑制因素
  • 競爭性市佔率分析

分子診斷市場

  • 介紹
    • PCR
    • 凝膠電泳
  • 市場概覽
  • 市場分析與預測
    • 分子診斷設備市場
    • 分子診斷檢測試劑盒市場
  • 促進因素和抑制因素
  • 競爭性市佔率分析

分子血液捐贈者篩檢市場

  • 介紹
    • 人類免疫力缺乏病毒（HIV）
    • 西尼羅河病毒（WNV）
    • 乙型肝炎（HBV）
    • 丙型肝炎（HCV）
  • 市場概覽
  • 市場分析與預測
    • 分子血液捐贈者篩檢分析儀市場
    • 分子血液捐贈者篩檢檢測試劑盒市場
  • 促進因素和抑制因素
  • 競爭性市佔率分析

血液學市場

  • 介紹
  • 市場概覽
  • 市場分析與預測
    • 血液分析儀市場
    • 血液學試劑市場
  • 促進因素和抑制因素
  • 競爭性市佔率分析

止血市場

  • 介紹
    • 血栓症
    • 出血
    • A型血友病A和B
    • 抗磷脂症候群（APS）
    • 血管性血友病（VWD）
    • 診斷和監測
  • 市場概覽
  • 市場分析與預測
    • 止血分析儀市場
    • 止血劑市場
  • 促進因素和抑制因素
  • 競爭性市佔率分析

即時血氣診斷市場

  • 介紹
  • 市場概覽
  • 市場分析與預測
    • POC血氣診斷與分析設備市場
    • 即時檢驗血氣診斷劑市場
  • 促進因素和抑制因素
  • 競爭性市佔率分析

即時血糖值監測市場

  • 介紹
  • 市場概覽
  • 市場分析與預測
    • 即時血糖值監測與分析設備市場
    • POC血糖值監測試紙市場
  • 促進因素和抑制因素
  • 競爭性市佔率分析

簡稱

Product Code: iDATA_USIVD26_MS

U.S. In Vitro Diagnostics Market Report to 2032

The U.S. in vitro diagnostics market was valued at $23.9 billion in 2025. It is expected to grow at a compound annual growth rate (CAGR) of 4.2%, reaching $31.8 billion by 2032.

This comprehensive report covers the U.S. market for in vitro diagnostics, including immunochemistry, urinalysis, molecular diagnostics, molecular blood donor screening, hematology, hemostasis, POC blood gas diagnostics and POC blood glucose monitoring.

The analysis includes unit sales, average selling prices (ASPs), market size, growth trends, market drivers and limiters, market forecasts through 2032, and historical data back to 2022. It also includes recent mergers and acquisitions, company profiles, product portfolios and leading competitors.

Growth is supported by rising chronic and infectious disease testing needs, technological innovation, laboratory automation and decentralized testing. However, pricing pressure, cost constraints and federal insurance program changes are expected to limit some areas of utilization.

Market Overview

The U.S. in vitro diagnostics market includes diagnostic tests, analyzers, reagents and assay kits used to detect, monitor and support treatment decisions across a wide range of clinical conditions. These products are used in core laboratories, hospitals, blood donor screening settings, point-of-care environments and near-patient testing locations.

The market covers several major diagnostic categories, including immunochemistry, urinalysis, molecular diagnostics, molecular blood donor screening, hematology, hemostasis, POC blood gas diagnostics and POC blood glucose monitoring. Each category supports different testing needs, from routine screening to specialized disease detection.

Automation remains a central trend in the post-COVID diagnostic environment. In the years immediately after the pandemic, major hospitals expanded core laboratory capacity through purchases and rental agreements for high-throughput integrated systems that combined chemistry and immunochemistry on one platform.

Decentralized testing is also reshaping the market. Point-of-care and near-patient systems allow testing to move closer to the patient, supporting faster clinical decisions and broader access. This is especially important in areas such as molecular diagnostics, blood gas testing, glucose monitoring and urgent infectious disease testing.

Market Drivers

The rising prevalence of chronic and infectious diseases is a key driver of the U.S. in vitro diagnostics market. Conditions such as diabetes, cardiovascular disease, cancer and autoimmune disorders require ongoing testing for diagnosis, monitoring and treatment planning. Persistent and emerging infectious diseases also continue to support demand for molecular and immunochemistry-based testing.

IVDs play a central role in routine care and specialized medicine. Testing helps clinicians detect disease earlier, monitor treatment response and guide clinical decisions. As patient volumes increase and chronic disease management becomes more testing-dependent, diagnostic products remain essential across hospitals, laboratories and point-of-care settings.

Technological innovation is also supporting market growth. Advances in molecular diagnostics, next-generation sequencing, PCR technologies, automation and point-of-care testing improve speed, accuracy and access. These innovations expand diagnostic use from centralized laboratories into near-patient and home testing environments. Established diagnostics companies continue to invest in R&D and product launches, sustaining momentum across multiple IVD segments.

Market Limiters

Legislative changes to Medicare and Medicaid are expected to limit market growth over the forecast period. The One Big Beautiful Bill Act places new restrictions on federal health insurance programs. Sizeable groups of non-permanent residents and certain individuals who do not meet specific work requirements are expected to become ineligible for Medicare and Medicaid coverage.

With more frequent eligibility checks, an estimated 10 million people are expected to lose health insurance coverage. A projected reduction in Medicare funding of up to $375 billion between 2026 and 2032 is expected to force health systems to tighten budgets. Lower-priority IVD tests may be compressed in utilization as hospitals and patients prioritize essential testing pathways.

Pricing pressure and cost constraints are also limiting factors. Competitive pricing and healthcare cost containment efforts place downward pressure on diagnostic prices, which can squeeze margins and limit reinvestment in innovation. State-of-the-art instruments, reagents and specialized tests can be expensive, limiting adoption in smaller laboratories or underserved regions where budgets are tighter.

Market Coverage and Data Scope

  • Quantitative coverage: Market size, market shares, market forecasts, market growth rates, units sold and average selling prices.
  • Qualitative coverage: Market drivers and limiters, market size and growth trends, recent mergers and acquisitions, company profiles, product portfolios and leading competitors.
  • Time frame: Base year 2025, forecasts to 2032, and historical data back to 2022.
  • Data types included: Unit sales, average selling prices, market size and growth trends, market drivers and limiters, market forecasts through 2032, historical data, recent mergers and acquisitions, company profiles and product portfolios.
  • Method note: Market revenue is modeled using unit sales and average selling prices, with segmentation used to assess demand across immunochemistry, urinalysis, molecular diagnostics, molecular blood donor screening, hematology, hemostasis, POC blood gas diagnostics and POC blood glucose monitoring.

The report is designed to help readers evaluate how chronic disease testing, infectious disease demand, automation, point-of-care testing, reimbursement changes and pricing pressure are shaping the U.S. in vitro diagnostics market.

Markets Covered and Segmentation

Immunochemistry Market

  • Setting: Core and POC.

Urinalysis Market

  • Technology: Core lab and POC.

Molecular Diagnostics Market

  • Market type: Molecular diagnostics instrument, molecular diagnostics assay kit and near-patient molecular diagnostic.

Molecular Blood Donor Screening Market

  • Market type: Analyzer and assay kit.

Hematology Market

  • Market type: Hematology analyzer and hematology reagent.

Hemostasis Market

  • Market type: Hemostasis analyzer and hemostasis reagent.

POC Blood Gas Diagnostics Market

  • Product type: Analyzer and reagent.

POC Blood Glucose Monitoring Market

  • Product type: Analyzer and test strip.

Each segment is analyzed through relevant quantitative measures, including market size, market shares, market forecasts, market growth rates, units sold and average selling prices.

Competitive Analysis

Cepheid was the leading company in the U.S. IVD market in 2025. The company's GeneXpert(R) line of systems is widely used because it supports platform consolidation and enables a broad range of tests to be run on one machine. The platform provides high walk-away time, which is valuable for both laboratory efficiency and near-patient workflows.

The GeneXpert(R) portfolio includes models used in both point-of-care and near-patient settings. This flexibility supports Cepheid's leadership in a market where hospitals and healthcare providers are looking for faster results, simplified workflows and diagnostic platforms that can support multiple test categories.

bioMerieux was the second-largest company in the U.S. IVD market in 2025. The company has a significant molecular diagnostics portfolio, including the FilmArray near-patient analyzer and SpotFire POC analyzer. These systems support fast infectious disease testing and align with the broader shift toward decentralized molecular diagnostics.

  • Abbott ranked third in 2025. Abbott has two different departments represented in this report: Abbott Diagnostics and Abbott Laboratories. In the core immunochemistry market, the company offers the Alinity ci-series and ARCHITECT platforms, supporting its position across high-volume laboratory testing.

Technology and Practice Trends

Laboratory automation continues to shape the U.S. IVD market. Hospitals and large laboratories are adopting integrated systems that combine chemistry and immunochemistry testing to improve throughput, reduce manual steps and support more consistent workflows.

Point-of-care testing is expanding as providers seek faster results and more convenient testing access. POC blood gas diagnostics, POC blood glucose monitoring, urinalysis and immunochemistry testing all benefit from care models that prioritize rapid decision-making closer to the patient.

Near-patient molecular diagnostics continues to gain importance. Platforms that deliver fast molecular results outside the traditional core lab support timely infectious disease detection and help reduce delays in treatment decisions.

Molecular diagnostics remains an innovation-heavy category. Advances in PCR, assay design and next-generation sequencing are expanding the clinical role of molecular testing across infectious disease, oncology and other specialized applications.

Blood donor screening remains an important safety-focused segment. Analyzer and assay kit demand is tied to the need for reliable screening of donated blood and the continued use of molecular methods to reduce transfusion-related risk.

Cost containment is influencing technology adoption. While advanced platforms offer clinical and workflow benefits, smaller laboratories and underserved regions may face barriers due to capital equipment costs, reagent pricing and budget pressure.

Geography

This edition covers the United States.

Why This Report

How large is the U.S. in vitro diagnostics market, and how is it expected to grow through 2032?

How are immunochemistry, urinalysis, molecular diagnostics, molecular blood donor screening, hematology, hemostasis, POC blood gas diagnostics and POC blood glucose monitoring performing in the U.S. market?

How are unit sales, average selling prices and market values changing over time?

How are chronic diseases and infectious diseases driving demand for diagnostic testing?

How are automation, integrated laboratory platforms and decentralized testing reshaping IVD workflows?

How are molecular diagnostics, PCR, NGS and point-of-care testing expanding clinical use cases?

How are Medicare and Medicaid changes, pricing pressure and cost constraints limiting market growth?

Which companies lead the U.S. IVD market, and how are Cepheid, bioMerieux and Abbott positioned?

The U.S. In Vitro Diagnostics Market Report from iData Research answers these questions with detailed market sizing, ASP trends, forecasts and competitive share insights. Use it to evaluate demand, benchmark leading competitors, assess technology adoption and plan for growth across the U.S. in vitro diagnostics market.

TABLE OF CONTENT

U.S. In Vitro Diagnostics Market Overview

Competitive Analysis

Market Trends

Market Developments

Market Segmentation

Key Analysis Updates

Key Report Updates

Version History

Research Methodology

  • Step 1: Project Initiation & Team Selection
  • Step 2: Prepare Data Systems And Perform Secondary Research
  • Step 3: Preparation For Interviews & Questionnaire Design
  • Step 4: Performing Primary Research
  • Step 5: Research Analysis: Establishing Baseline Estimates
  • Step 6: Market Forecast And Analysis
  • Step 7: Identify Strategic Opportunities
  • Step 8: Final Review And Market Release
  • Step 9: Customer Feedback And Market Monitoring

Impact Of Global Tariffs

U.S. In Vitro Diagnostics Market Overview

  • 3.1 Introduction
  • 3.2 Market Overview & Trend Analysis
  • 3.3 Drivers And Limiters
    • 3.3.1 Market Drivers
    • 3.3.2 Market Limiters
  • 3.4 Competitive Market Share Analysis
  • 3.5 Mergers And Acquisitions

Immunochemistry Market

  • 4.1 Introduction
    • 4.1.1 Immunoassay
    • 4.1.2 Clinical Chemistry
  • 4.2 Market Overview
  • 4.3 Market Analysis And Forecast
    • 4.3.1 Core Immunochemistry Market
      • 4.3.1.1 Core Immunoassay Market
      • 4.3.1.1.1 Immunoassay Analyzer Market
      • 4.3.1.1.2 Immunoassay Reagent Market
      • 4.3.1.2 Clinical Chemistry Market
      • 4.3.1.2.1 Clinical Chemistry Analyzer Market
      • 4.3.1.2.2 Clinical Chemistry Reagent Market
      • 4.3.1.3 Integrated Immunochemistry Analyzer Market
    • 4.3.2 Poc Immunochemistry Market
      • 4.3.2.1 Poc Immunoassay Market
      • 4.3.2.1.1 Poc Immunoassay Analyzer Market
      • 4.3.2.1.2 Poc Immunoassay Reagent Market
      • 4.3.2.2 Poc Clinical Chemistry Market
      • 4.3.2.2.1 Poc Clinical Chemistry Analyzer Market
      • 4.3.2.2.2 Poc Clinical Chemistry Reagent Market
  • 4.4 Drivers And Limiters
    • 4.4.1 Market Drivers
    • 4.4.2 Market Limiters
  • 4.5 Competitive Market Share Analysis

Urinalysis Market

  • 5.1 Introduction
  • 5.2 Market Overview
  • 5.3 Market Analysis And Forecast
    • 5.3.1 Core Lab Urinalysis Market
      • 5.3.1.1 Core Lab Automated Urinalysis Analyzer Market
      • 5.3.1.2 Core Lab Automated Urinalysis Analyzer Reagent Market
    • 5.3.2 Poc Urinalysis Market
      • 5.3.2.1 Poc Urinalysis Analyzer Market
      • 5.3.2.2 Poc Urinalysis Test Strip Market
  • 5.4 Drivers And Limiters
    • 5.4.1 Market Drivers
    • 5.4.2 Market Limiters
  • 5.5 Competitive Market Share Analysis

Molecular Diagnostics Market

  • 6.1 Introduction
    • 6.1.1 Pcr
    • 6.1.2 Gel Electrophoresis
  • 6.2 Market Overview
  • 6.3 Market Analysis And Forecast
    • 6.3.1 Molecular Diagnostics Instrument Market
      • 6.3.1.1 Core Lab Molecular Diagnostics Analyzer Market
      • 6.3.1.2 Poc Molecular Diagnostics Analyzer Market
    • 6.3.2 Molecular Diagnostics Assay Kit Market
      • 6.3.2.1 Infectious Disease Molecular Diagnostics Assay Kit Market
      • 6.3.2.1.1 Blood Borne Virus Infection Disease Molecular Diagnostics Assay Kit Market
      • 6.3.2.1.2 Respiratory Infectious Disease Assay Molecular Diagnostics Market
      • 6.3.2.1.3 Women's Health Molecular Diagnostics Assay Kit Market
      • 6.3.2.1.4 Other Infectious Disease Molecular Diagnostics Assay Kit Market
      • 6.3.2.2 Pcr Molecular Diagnostics Assay Kit Market
      • 6.3.2.2.1 Lung Cancer Pcr Molecular Diagnostics Assay Kit Market
      • 6.3.2.2.2 Prostate Cancer Pcr Molecular Diagnostics Assay Kit Market
      • 6.3.2.2.3 Colorectal Cancer Pcr Molecular Diagnostics Assay Kit Market
      • 6.3.2.2.4 Myeloma Leukemia Molecular Diagnostics Assay Kit Market
      • 6.3.2.2.5 Thrombophilia Assay Molecular Diagnostics Kit Market
      • 6.3.2.3 Panel & Ngs Tests Molecular Diagnostic Assay Kit Market
      • 6.3.2.3.1 Oncology Cancer Panel & Ngs Tests Market
      • 6.3.2.3.2 Prostate Cancer Assay Market
      • 6.3.2.4 Near Patient Molecular Diagnostic Market
      • 6.3.2.4.1 Near Patient Molecular Diagnostic Analyzer Market
      • 6.3.2.4.2 Near Patient Molecular Diagnostic Reagent Market
  • 6.4 Drivers And Limiters
    • 6.4.1 Market Drivers
    • 6.4.2 Market Limiters
  • 6.5 Competitive Market Share Analysis

Molecular Blood Donor Screening Market

  • 7.1 Introduction
    • 7.1.1 Human Immunodeficiency Virus (Hiv)
    • 7.1.2 West Nile Virus (Wnv)
    • 7.1.3 Hepatitis B (Hbv)
    • 7.1.4 Hepatitis C (Hcv)
  • 7.2 Market Overview
  • 7.3 Market Analysis And Forecast
    • 7.3.1 Molecular Blood Donor Screening Analyzer Market
    • 7.3.2 Molecular Blood Donor Screening Assay Kit Market
      • 7.3.2.1 Wnv Molecular Blood Donor Screening Reagent Market
      • 7.3.2.2 Hiv Molecular Blood Donor Screening Reagent Market
      • 7.3.2.3 Hbv Molecular Blood Donor Screening Reagent Market
      • 7.3.2.4 Hcv Molecular Blood Donor Screening Reagent Market
      • 7.3.2.5 Multiplex (Hiv, Hbv, Hcv) Molecular Blood Donor Screening Reagent Market
  • 7.4 Drivers And Limiters
    • 7.4.1 Market Drivers
    • 7.4.2 Market Limiters
  • 7.5 Competitive Market Share Analysis

Hematology Market

  • 8.1 Introduction
  • 8.2 Market Overview
  • 8.3 Market Analysis And Forecast
    • 8.3.1 Hematology Analyzer Market
      • 8.3.1.1 High-End Hematology Analyzer Market
      • 8.3.1.2 Low-End Hematology Analyzer Market
    • 8.3.2 Hematology Reagent Market
  • 8.4 Drivers And Limiters
    • 8.4.1 Market Drivers
    • 8.4.2 Market Limiters
  • 8.5 Competitive Market Share Analysis

Hemostasis Market

  • 9.1 Introduction
    • 9.1.1 Thrombosis
    • 9.1.2 Hemorrhage
    • 9.1.3 Hemophilia A And B
    • 9.1.4 Antiphospholipid Syndrome (Aps)
    • 9.1.5 Von Willebrand Disease (Vwd)
    • 9.1.6 Diagnosis And Monitoring
  • 9.2 Market Overview
  • 9.3 Market Analysis And Forecast
    • 9.3.1 Hemostasis Analyzer Market
    • 9.3.2 Hemostasis Reagent Market
  • 9.4 Drivers And Limiters
    • 9.4.1 Market Drivers
    • 9.4.2 Market Limiters
  • 9.5 Competitive Market Share Analysis

Poc Blood Gas Diagnostics Market

  • 10.1 Introduction
  • 10.2 Market Overview
  • 10.3 Market Analysis And Forecast
    • 10.3.1 Poc Blood Gas Diagnostic Analyzer Market
      • 10.3.1.1 Handheld Poc Blood Gas Diagnostic Analyzer Market
      • 10.3.1.2 Decentralized Poc Blood Gas Diagnostic Analyzer Market
    • 10.3.2 Poc Blood Gas Diagnostic Reagent Market
      • 10.3.2.1 Single-Use Cartridge Poc Blood Gas Diagnostic Reagent Market
      • 10.3.2.2 Multi-Use Cartridge Poc Blood Gas Diagnostic Reagent Market
      • 10.3.2.3 Other Packaged Reagents And Electrode Poc Blood Gas Diagnostic Reagent Market
  • 10.4 Drivers And Limiters
    • 10.4.1 Market Drivers
    • 10.4.2 Market Limiters
  • 10.5 Competitive Market Share Analysis

Poc Blood Glucose Monitoring Market

  • 11.1 Introduction
  • 11.2 Market Overview
  • 11.3 Market Analysis And Forecast
    • 11.3.1 Poc Blood Glucose Monitoring Analyzer Market
    • 11.3.2 Poc Blood Glucose Monitoring Test Strip Market
  • 11.4 Drivers And Limiters
    • 11.4.1 Market Drivers
    • 11.4.2 Market Limiters
  • 11.5 Competitive Market Share Analysis

Abbreviations

LIST OF CHARTS

  • Chart 1-1: In Vitro Diagnostics Market By Segment, U.S., 2025 - 2032
  • Chart 1-2: In Vitro Diagnostics Market Overview, U.S., 2025 & 2032
  • Chart 3-1: In Vitro Diagnostics Market By Segment, U.S., 2022 - 2032
  • Chart 3-2: Leading Competitors, In Vitro Diagnostics Market, U.S., 2025
  • Chart 4-1: Immunochemistry Market By Segment, U.S., 2022 - 2032
  • Chart 4-2: Leading Competitors, Immunochemistry Market, U.S., 2025
  • Chart 5-1: Urinalysis Market By Segment, U.S., 2022 - 2032
  • Chart 5-2: Leading Competitors, Urinalysis Market, U.S., 2025
  • Chart 6-1: Molecular Diagnostics Market By Segment, U.S., 2022 - 2032
  • Chart 6-2: Leading Competitors, Molecular Diagnostics Market, U.S., 2025
  • Chart 7-1: Molecular Blood Donor Screening Market By Segment, U.S., 2022 - 2032
  • Chart 7-2: Leading Competitors, Hematology Market, U.S., 2025
  • Chart 8-1: Hematology Market By Segment, U.S., 2022 - 2032
  • Chart 8-2: Leading Competitors, Hematology Market, U.S., 2025
  • Chart 9-1: Hemostasis Market By Segment, U.S., 2022 - 2032
  • Chart 9-2: Leading Competitors, Hemostasis Market, U.S., 2025
  • Chart 10-1: Poc Blood Gas Diagnostics Market By Segment, U.S., 2022 - 2032
  • Chart 10-2: Leading Competitors, Poc Blood Gas Diagnostics Market, U.S., 2025
  • Chart 11-1: Poc Blood Glucose Monitoring Market By Segment, U.S., 2022 - 2032
  • Chart 11-2: Leading Competitors, Poc Blood Glucose Monitoring Market, U.S., 2025

LIST OF FIGURES

  • Figure 1-1: In Vitro Diagnostics Market Share Ranking By Segment, U.S., 2025 (1 Of 2)
  • Figure 1-2: In Vitro Diagnostics Market Share Ranking By Segment, U.S., 2025 (2 Of 2)
  • Figure 1-3: Companies Researched In This Report (1 Of 2)
  • Figure 1-4: Companies Researched In This Report (2 Of 2)
  • Figure 1-5: Factors Impacting The In Vitro Diagnostics Market By Segment, U.S. (1 Of 2)
  • Figure 1-6: Factors Impacting The In Vitro Diagnostics Market By Segment, U.S. (2 Of 2)
  • Figure 1-7: Recent Events In The In Vitro Diagnostics Market, U.S., 2022 - 2026 (1 Of 2)
  • Figure 1-8: Recent Events In The In Vitro Diagnostics Market, U.S., 2022 - 2026 (2 Of 2)
  • Figure 1-9: In Vitro Diagnostics Markets Covered (1 Of 3)
  • Figure 1-10: In Vitro Diagnostics Markets Covered (2 Of 3)
  • Figure 1-11: In Vitro Diagnostics Markets Covered (3 Of 3)
  • Figure 1-12: Key Analysis Updates
  • Figure 1-13: Key Report Updates
  • Figure 1-14: Version History
  • Figure 3-1: In Vitro Diagnostics Market By Segment, U.S., 2022 - 2032 (US$M) (1 Of 2)
  • Figure 3-2: In Vitro Diagnostics Market By Segment, U.S., 2022 - 2032 (US$M) (2 Of 2)
  • Figure 3-3: Leading Competitors, In Vitro Diagnostics Market, U.S., 2025 (1 Of 2)
  • Figure 3-4: Leading Competitors, In Vitro Diagnostics Market, U.S., 2025 (2 Of 2)
  • Figure 4-1: Immunochemistry Market By Segment, U.S., 2022 - 2032 (US$M)
  • Figure 4-2: Core Immunochemistry Market By Segment, U.S., 2022 - 2032 (US$M)
  • Figure 4-3: Core Immunoassay Market By Segment, U.S., 2022 - 2032
  • Figure 4-4: Immunoassay Analyzer Market By Segment, U.S., 2022 - 2032
  • Figure 4-5: Immunoassay Analyzer Market, U.S., 2022 - 2032
  • Figure 4-6: High Volume Immunoassay Analyzer Market, U.S., 2022 - 2032
  • Figure 4-7: Low-Mid Volume Immunoassay Analyzer Market, U.S., 2022 - 2032
  • Figure 4-8: Immunoassay Reagent Market, U.S., 2022 - 2032
  • Figure 4-9: Cardiovascular Immunoassay Reagent Market, U.S., 2022 - 2032
  • Figure 4-10: Cancer Immunoassay Reagent Market, U.S., 2022 - 2032
  • Figure 4-11: Infectious Disease Immunoassay Reagent Market, U.S., 2022 - 2032
  • Figure 4-12: Vitamin D Testing Immunoassay Reagent Market, U.S., 2022 - 2032
  • Figure 4-13: Endocrinology Immunoassay Reagent Market, U.S., 2022 - 2032
  • Figure 4-14: Reproductive And Fertility Immunoassay Reagent Market, U.S., 2022 - 2032
  • Figure 4-15: Autoimmune Immunoassay Reagent Market, U.S., 2022 - 2032
  • Figure 4-16: Clinical Chemistry Market By Segment, U.S., 2022 - 2032 (US$M)
  • Figure 4-17: Clinical Chemistry Analyzer Market By Segment, U.S., 2022 - 2032
  • Figure 4-18: High-Volume Laboratory Clinical Chemistry Analyzer Market, U.S., 2022 - 2032
  • Figure 4-19: Low Volume Laboratory Clinical Chemistry Analyzer Market, U.S., 2022 - 2032
  • Figure 4-20: Clinical Chemistry Reagent Market, U.S., 2022 - 2032
  • Figure 4-21: General Chemistry Clinical Chemistry Reagent Market, U.S., 2022 - 2032
  • Figure 4-22: Specific Protein Clinical Chemistry Reagent Market, U.S., 2022 - 2032
  • Figure 4-23: Therapeutic Drug Monitoring Clinical Chemistry Reagent Market, U.S., 2022 - 2032
  • Figure 4-24: Drugs Of Abuse / Toxicology Clinical Chemistry Reagent Market, U.S., 2022 - 2032
  • Figure 4-25: Special Chemistry Clinical Chemistry Reagent Market, U.S., 2022 - 2032
  • Figure 4-26: Integrated Immunochemistry Analyzer Market, U.S., 2022 - 2032
  • Figure 4-27: Poc Immunochemistry Market By Segment, U.S., 2022 - 2032
  • Figure 4-28: Poc Immunoassay Market By Segment, U.S., 2022 - 2032
  • Figure 4-29: Poc Immunoassay Analyzer Market, U.S., 2022 - 2032
  • Figure 4-30: Poc Immunoassay Reagent Market By Segment, U.S., 2022 - 2032
  • Figure 4-31: Poc Immunoassay Reagent Market, U.S., 2022 - 2032
  • Figure 4-32: Sars-Cov2 Poc Immunoassay Reagent Market, U.S., 2022 - 2032
  • Figure 4-33: Influenza Poc Immunoassay Reagent Market, U.S., 2022 - 2032
  • Figure 4-34: Multiplex Poc Immunoassay Reagent Market, U.S., 2022 - 2032
  • Figure 4-35: Cardiac Poc Immunoassay Reagent Market, U.S., 2022 - 2032
  • Figure 4-36: Poc Clinical Chemistry Market By Segment, U.S., 2022 - 2032
  • Figure 4-37: Poc Clinical Chemistry Analyzer Market, U.S., 2022 - 2032
  • Figure 4-38: Poc Clinical Chemistry Reagent Market, U.S., 2022 - 2032
  • Figure 4-39: Leading Competitors, Immunochemistry Market, U.S., 2025
  • Figure 5-1: Urinalysis Market By Segment, U.S., 2022 - 2032 (US$M)
  • Figure 5-2: Core Lab Urinalysis Market By Segment, U.S., 2022 - 2032
  • Figure 5-3: Core Lab Automated Urinalysis Analyzer Market, U.S., 2022 - 2032
  • Figure 5-4: Core Lab Automated Urinalysis Analyzer Reagent Market, U.S., 2022 - 2032
  • Figure 5-5: Poc Urinalysis Market By Segment, U.S., 2022 - 2032
  • Figure 5-6: Poc Urinalysis Analyzer Market, U.S., 2022 - 2032
  • Figure 5-7: Poc Urinalysis Test Strip Market, U.S., 2022 - 2032
  • Figure 5-8: Leading Competitors, Urinalysis Market, U.S., 2025
  • Figure 6-1: Molecular Diagnostics Market By Segment, U.S., 2022 - 2032 (US$M)
  • Figure 6-2: Molecular Diagnostics Instrument Market By Segment, U.S., 2022 - 2032
  • Figure 6-3: Molecular Diagnostics Instrument Market, U.S., 2022 - 2032
  • Figure 6-4: Core Lab Molecular Diagnostics Analyzer Market, U.S., 2022 - 2032
  • Figure 6-5: Poc Molecular Diagnostics Analyzer Market, U.S., 2022 - 2032
  • Figure 6-6: Molecular Diagnostics Assay Kit Market By Segment, U.S., 2022 - 2032
  • Figure 6-7: Molecular Diagnostics Assay Kit Market, U.S., 2022 - 2032
  • Figure 6-8: Infectious Disease Molecular Diagnostics Assay Kit Market By Segment, U.S., 2022 - 2032
  • Figure 6-9: Infectious Disease Molecular Diagnostics Assay Kit Market, U.S., 2022 - 2032
  • Figure 6-10: Blood Borne Virus Infection Disease Molecular Diagnostics Assay Kit Market By Segment, U.S., 2022 - 2032
  • Figure 6-11: Blood Borne Virus Infection Disease Molecular Diagnostics Market, U.S., 2022 - 2032
  • Figure 6-12: Hiv Molecular Diagnostics Assay Kit Market, U.S., 2022 - 2032
  • Figure 6-13: Hcv Molecular Diagnostics Assay Kit Market, U.S., 2022 - 2032
  • Figure 6-14: Hbv Molecular Diagnostics Assay Kit Market, U.S., 2022 - 2032
  • Figure 6-15: Respiratory Infectious Disease Assay Molecular Diagnostics Market, U.S., 2022 - 2032
  • Figure 6-16: Women's Health Molecular Diagnostics Assay Kit Market By Segment, U.S., 2022 - 2032
  • Figure 6-17: Women's Health Molecular Diagnostics Assay Kit Market, U.S., 2022 - 2032
  • Figure 6-18: Hpv Molecular Diagnostics Assay Kit Market, U.S., 2022 - 2032
  • Figure 6-19: Hsv Molecular Diagnostics Assay Kit Market, U.S., 2022 - 2032
  • Figure 6-20: Ct/Gc Molecular Diagnostics Assay Kit Market, U.S., 2022 - 2032
  • Figure 6-21: Other Infectious Disease Molecular Diagnostics Assay Kit Market By Segment, U.S., 2022 - 2032
  • Figure 6-22: Other Infectious Disease Molecular Diagnostics Assay Kit Market, U.S., 2022 - 2032
  • Figure 6-23: Mrsa Molecular Diagnostics Assay Kit Market, U.S., 2022 - 2032
  • Figure 6-24: C. Difficile Molecular Diagnostics Assay Kit Market, U.S., 2022 - 2032
  • Figure 6-25: Pcr Molecular Diagnostics Assay Kit Market By Segment, U.S., 2022 - 2032
  • Figure 6-26: Pcr Molecular Diagnostics Assay Kit Market, U.S., 2022 - 2032
  • Figure 6-27: Lung Cancer Pcr Molecular Diagnostics Assay Kit Market, U.S., 2022 - 2032
  • Figure 6-28: Prostate Cancer Pcr Molecular Diagnostics Assay Kit Market, U.S., 2022 - 2032
  • Figure 6-29: Colorectal Cancer Pcr Molecular Diagnostics Assay Kit Market, U.S., 2022 - 2032
  • Figure 6-30: Myeloma Leukemia Molecular Diagnostics Assay Kit Market, U.S., 2022 - 2032
  • Figure 6-31: Thrombophilia Assay Molecular Diagnostics Kit Market, U.S., 2022 - 2032
  • Figure 6-32: Panel & Ngs Tests Assay Kit Market By Segment, U.S., 2022 - 2032
  • Figure 6-33: Panel & Ngs Tests Assay Kit Market, U.S., 2022 - 2032
  • Figure 6-34: Oncology Cancer Panel & Ngs Tests Market, U.S., 2022 - 2032
  • Figure 6-35: Prostate Cancer Assay Market, U.S., 2022 - 2032
  • Figure 6-36: Near Patient Molecular Diagnostic Market By Segment, U.S., 2022 - 2032
  • Figure 6-37: Near Patient Molecular Diagnostic Analyzer Market, U.S., 2022 - 2032
  • Figure 6-38: Near Patient Molecular Diagnostic Reagent Market By Segment, U.S., 2022 - 2032
  • Figure 6-39: Near Patient Molecular Diagnostic Reagent Market, U.S., 2022 - 2032
  • Figure 6-40: Sars Cov2 Cartridge Market, U.S., 2022 - 2032
  • Figure 6-41: Multiplex Respiratory Market, U.S., 2022 - 2032
  • Figure 6-42: Influenza Cartridge Market, U.S., 2022 - 2032
  • Figure 6-43: Leading Competitors, Molecular Diagnostics Market, U.S., 2025
  • Figure 7-1: Molecular Blood Donor Screening Market By Segment, U.S., 2022 - 2032 (US$M)
  • Figure 7-2: Molecular Blood Donor Screening Analyzer Market, U.S., 2022 - 2032
  • Figure 7-3: Molecular Blood Donor Screening Reagent Market By Segment, U.S., 2022 - 2032 (US$M)
  • Figure 7-4: Total Molecular Blood Donor Screening Reagent Market, U.S., 2022 - 2032
  • Figure 7-5: Wnv Molecular Blood Donor Screening Reagent Market, U.S., 2022 - 2032
  • Figure 7-6: Hiv Molecular Blood Donor Screening Reagent Market, U.S., 2022 - 2032
  • Figure 7-7: Hbv Molecular Blood Donor Screening Reagent Market, U.S., 2022 - 2032
  • Figure 7-8: Hcv Molecular Blood Donor Screening Reagent Market, U.S., 2022 - 2032
  • Figure 7-9: Multiplex (Hiv, Hbv, Hcv) Molecular Blood Donor Screening Reagent Market, U.S., 2022 - 2032
  • Figure 7-10: Leading Competitors, Molecular Blood Donor Screening Market, U.S., 2025
  • Figure 8-1: Hematology Market By Segment, U.S., 2022 - 2032 (US$M)
  • Figure 8-2: Hematology Analyzer Market By Segment, U.S., 2022 - 2032 (US$M)
  • Figure 8-3: Total Hematology Analyzer Market, U.S., 2022 - 2032
  • Figure 8-4: High-End Hematology Analyzer Market, U.S., 2022 - 2032
  • Figure 8-5: Low-End Hematology Analyzer Market, U.S., 2022 - 2032
  • Figure 8-6: Hematology Reagent Market, U.S., 2022 - 2032
  • Figure 8-7: Leading Competitors, Hematology Market, U.S., 2025
  • Figure 9-1: Hemostasis Market By Segment, U.S., 2022 - 2032 (US$M)
  • Figure 9-2: Hemostasis Analyzer Market, U.S., 2022 - 2032
  • Figure 9-3: Hemostasis Reagent Market, U.S., 2022 - 2032
  • Figure 9-4: Leading Competitors, Hemostasis Market, U.S., 2025
  • Figure 10-1: Poc Blood Gas Diagnostics Market By Segment, U.S., 2022 - 2032 (US$M)
  • Figure 10-2: Poc Blood Gas Diagnostic Analyzer Market By Segment, U.S., 2022 - 2032 (US$M)
  • Figure 10-3: Total Poc Blood Gas Diagnostic Analyzer Market, U.S., 2022 - 2032
  • Figure 10-4: Handheld Poc Blood Gas Diagnostic Analyzer Market, U.S., 2022 - 2032
  • Figure 10-5: Decentralized Poc Blood Gas Diagnostic Analyzer Market, U.S., 2022 - 2032
  • Figure 10-6: Poc Blood Gas Diagnostic Reagent Market By Segment, U.S., 2022 - 2032 (US$M)
  • Figure 10-7: Total Poc Blood Gas Diagnostic Reagent Market, U.S., 2022 - 2032
  • Figure 10-8: Single-Use Cartridge Poc Blood Gas Diagnostic Reagent Market, U.S., 2022 - 2032
  • Figure 10-9: Multi-Use Cartridge Poc Blood Gas Diagnostic Reagent Market, U.S., 2022 - 2032
  • Figure 10-10: Other Packaged Reagents And Electrode Poc Blood Gas Diagnostic Reagent Market, U.S., 2022 - 2032
  • Figure 10-11: Leading Competitors, Poc Blood Gas Diagnostics Market, U.S., 2025
  • Figure 11-1: Poc Blood Glucose Monitoring Market By Segment, U.S., 2022 - 2032 (US$M)
  • Figure 11-2: Poc Blood Glucose Monitoring Analyzer Market, U.S., 2022 - 2032
  • Figure 11-3: Poc Blood Glucose Monitoring Test Strip Market, U.S., 2022 - 2032
  • Figure 11-4: Leading Competitors, Poc Blood Glucose Monitoring Market, U.S., 2025