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市場調查報告書
商品編碼
2024194

體外診斷(IVD)品管市場:策略與趨勢,包括按檢測類型、施行地點、產品、製造商和國家/地區分類的預測 -經營團隊和諮詢顧問的市場分析(2026-2030 年)

In Vitro Diagnostic Quality Control Market. Strategy & Trends with Forecasts by Assay Type, by Place, by Product, by Manufacturer and by Country. Situation Analysis with Executive & Consultant Guides. 2026 to 2030

出版日期: | 出版商: Howe Sound Research | 英文 373 Pages | 商品交期: 最快1-2個工作天內

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簡介目錄

報告摘要:

體外診斷(IVD)品管產業曾面臨疫情帶來的挑戰。如今,這個受經濟衰退影響較小的成熟產業正蓬勃發展,充滿新的機會。新技術和新興領域正在推動產業爆發式成長。這份全面的報告將幫助您了解這些機會和挑戰。

臨床檢查室品管(QC)是指用於確保臨床檢查室診斷檢測結果的準確性、可靠性和一致性的系統、材料、軟體工具和程序。由於診斷檢測結果指南醫療決策、監測治療效果並支持疾病診斷,因此品管是檢查室運作的重要組成部分。檢測誤差可能導致錯誤的臨床判斷,因此,健全的品管流程對於病患安全和醫療保健系統的有效性至關重要。

臨床檢查室品管市場涵蓋品管樣品、校準參考物質、能力測試服務、品管軟體以及用於監測檢查室性能的數據分析工具。該市場預計在2025年達到13.9億美元,並預計在2030年達到18.1億美元,年複合成長率(CAGR)為5.4%。市場成長預計將與臨床實驗室檢測總量的增加保持一致。

檢查室品管產品和服務的需求受到以下因素的驅動:診斷測試技術的日益複雜化、分子和基因檢測的擴展、檢查室認證的監管要求以及醫療保健領域對品質保證的日益重視。

品管在臨床試驗中的作用

品管流程用於檢驗測試設備、試劑和工作流程是否正常運作並產生準確的結果。品管程序通常包括分析已知濃度的待測物對照樣品,以確保測試結果在規定的性能範圍內。

品管應用於廣泛的檢測領域,包括臨床化學、免疫檢測、血液學、血液凝固檢驗、微生物學、分子診斷和毒理學。

品質控制流程旨在檢測由設備故障、試劑差異、校準問題或環境條件引起的分析誤差。

檢查室通常會同時實施內部品管和外部品質評估(EQA)。內部品質控制包括實驗室性能的日常監測。外部品質評估則是利用標準化的能力測試樣本,將本實驗室的效能與其他實驗室的效能進行比較。

認證機構和監管機構要求檢查室維護有文件記錄的品質管理計畫。

市場組成部分

臨床檢查室品質控制市場包含多個產品和服務類別。

  • 品品管樣品是含有已知濃度待測物的樣品,用於檢驗測量性能。這些樣本可用於多種臨床檢測。
  • 校準參考物質用於確定測量精度並確保測試結果的可追溯性。
  • 能力測試計劃透過比較多個檢查室的結果,對檢查室的性能進行外部檢驗。
  • 品管軟體平台使檢查室能夠追蹤品質控制數據、監控設備性能並識別指示分析變異性的趨勢。
  • 數據分析工具正擴大被用於支援統計品管方法。
  • QC產品適用於中心檢查室、醫院檢查室和就地檢驗環境等各種場所。
  • 對品質控制材料的持續需求為供應商提供了穩定的收入來源。

市場促進因素

推動臨床檢查室品管市場成長的因素有很多。

  • 隨著診斷技術變得越來越複雜,對更先進的品質保證工具的需求也越來越大。
  • 隨著分子診斷和基因檢測的擴展,需要專門的品管材料和檢驗流程。
  • 檢查室認證的監管要求日益重要,因此,有據可查的品管系統至關重要。
  • 隨著檢驗次數的增加,對品質控制材料和服務的需求也在上升。
  • 醫療衛生系統越來越注重提高診斷準確率和減少醫療差錯。
  • 檢查室工作流程自動化需要一個整合的品管(QC)監控系統。
  • 隨著就地檢驗的普及,對適用於分散式檢查環境的品管解決方案的需求日益成長。
  • 隨著臨床試驗日益全球化,整個檢查室網路都需要標準化的品質保證流程。

科技趨勢

技術創新正在影響臨床檢查室的品管市場。

  • 品質控制資料的收集和分析自動化提高了效率,減輕了手動建立文件的負擔。
  • 中介軟體平台整合了來自多個設備的QC數據,並提供集中式效能監控。
  • 統計品管工具能夠檢測分析中的趨勢和效能波動。
  • 基於雲端的品質控制管理平台可以遠端監控檢查室效能。
  • 檢測設備與品管系統之間的數位化連接提高了結果的可追溯性。
  • 人工智慧工具正在被開發用於檢測品質控制數據中的模式並識別潛在的分析問題。
  • 先進的分析技術可以用於創建預測性品管模型。
  • 將品質控制系統與檢查室資訊系統整合起來,圖提高工作流程效率。

市場區隔

臨床檢查室品質控制市場可以按產品類型、測試領域、最終用戶和地區進行細分。

按檢測領域分類,臨床化學和免疫檢測由於檢測量大,佔了很大比例。分子診斷和基因檢測是成長迅速的領域,需要專門的品管解決方案。

最終用戶包括醫院檢查室、參考實驗室、診所檢查室和診斷測試網路。

  • 由於北美擁有完善的法律規範和先進的診斷基礎設施,因此是最大的區域市場。
  • 歐洲已成為一個重要的市場,這得益於其檢查室認證要求。
  • 由於醫療保健領域的投資增加和診斷測試數量的成長,亞太市場正在擴張。

競爭格局

臨床檢查室品管(QC) 市場包括專業 QC 材料製造商、診斷設備製造商、能力測試提供者和檢查室資訊系統公司。

  • 競爭取決於 QC產品系列的廣度、與主要診斷平台的兼容性以及支援多個測試領域的能力。
  • 供應商通常會開發專為特定診斷檢測或儀器平台設計的品管材料。
  • 品質控制供應商與診斷設備製造商之間的策略夥伴關係可以影響產品的採用。
  • QC材料帶來的持續收入提供了穩定的市場需求。
  • 質檢材料的品質和可靠性是重要的競爭因素。
  • 對於供應商而言,合規性和可追溯性是重要的考慮因素。

未來展望

隨著診斷檢測技術變得越來越複雜,監管要求也越來越嚴格,臨床檢查室的品質控制市場預計將穩定成長。

  • 分子診斷和基因檢測的擴展可能會增加對專用品管材料的需求。
  • 檢查室工作流程自動化可能需要整合品管系統。
  • 檢測設備與品質控制軟體之間的數位化連接可以提高監控能力。
  • 引入人工智慧 (AI) 工具可以提高檢測分析波動的準確性,並有可能增強預測性維護。
  • 分散式檢查環境的普及可能會催生簡化品管解決方案的需求。

總體而言,臨床檢查室品管是診斷檢測基礎設施的關鍵組成部分。隨著檢測技術的不斷進步和對診斷準確性的日益重視,對品管產品和服務的需求預計將保持強勁。

目錄

第1章 市集指南

  • 戰略情勢分析
  • 企業主管、行銷負責人、銷售負責人和業務拓展負責人。
  • 管理顧問和投資顧問指南
  • 人工智慧的影響

第2章:引言與市場定義

  • 什麼是體外診斷(IVD)品管?
  • 機會的定義
  • 調查方法
  • 展望:醫療保健和體外診斷產業

第3章:動態市場概述

  • 參與企業充滿活力的市場
    • 學術研究辦公室
    • 診斷測試開發人員
    • 測量儀器供應商
    • 化學品/試劑供應商
    • 病理檢測用品供應商
    • 獨立臨床實驗室
    • 國家/地區公共研究機構
    • 醫院檢查室
    • 醫師診所檢查室(POLS)
    • 審計機構
    • 認證機構
  • 細分——多種方法
  • 臨床檢測產業的結構
  • 國家和地區的多樣性

第4章:推動市場變化的趨勢

  • 成長的驅動力來自多個方面。
  • 導致市場萎縮的因素
  • 自動化和實驗室的發展趨勢

第5章:體外診斷醫療器材品管的最新趨勢

第6章:主要企業概況

  • Abbott Laboratories
  • Alpha-Tec Systems
  • Beckman Coulter Diagnostics(Danaher)
  • Becton, Dickinson and Company
  • BioFire Diagnostics(bioMerieux)
  • bioMerieux Diagnostics
  • Bio-Rad Laboratories, Inc
  • Bio-Techne
  • Danaher Corporation
  • Diasorin SpA
  • Fortress Diagnostics
  • Grifols
  • Helena Laboratories
  • Hologic
  • LGC Standards
  • Maine Molecular Quality Controls
  • Microbiologics
  • Microbix Systems
  • Novacyt
  • QuidelOrtho
  • Randox Toxicology
  • Seegene
  • SERO
  • Siemens Healthineers
  • Streck
  • Sun Diagnostics
  • Sysmex
  • Thermo Fisher Scientific
  • ZeptoMetrix

第7章 體外診斷(IVD)品管的全球市場

  • 全球市場概覽(按國家/地區分類)
  • 全球市場按檢測類型分類 - 概述
  • 區域全球市場概覽
  • 全球市場概覽(按產品類別分類)
  • 全球製造商市場概覽

第8章 全球體外診斷(IVD)品管市場-依檢測類型分類

  • 化學
  • 微生物學
  • 血液學
  • 解剖病理學
  • 分子診斷
  • 神秘測試

第9章 全球體外診斷(IVD)品管市場-按施行地點

  • 醫院
  • 門診檢查室
  • 實驗室
  • 醫生診所檢查室
  • 其他

第10章:全球體外診斷(IVD)品管市場-依產品分類

  • 全血
  • 電漿
  • 尿
  • 其他

第11章:全球體外診斷(IVD)品管市場-按製造商分類

  • OEM
  • 第三方 -非專利
  • 第三方設備
  • 客製化及其他

第12章附錄

表格一覽

圖表清單

簡介目錄
Product Code: CLINIVDQC 426

Report Overview:

The IVD Quality Control industry rose to the challenge of the pandemic. Now new opportunities abound in this established industry that is immune from recession. New technology and new segments are driving runaway growth. Understand the opportunities and the threats in this comprehensive report.

Clinical laboratory quality control (QC) refers to the systems, materials, software tools, and procedures used to ensure accuracy, reliability, and consistency of diagnostic test results generated by clinical laboratories. Quality control is an essential component of laboratory operations because diagnostic test results are used to guide medical decision-making, monitor treatment effectiveness, and support disease diagnosis. Errors in laboratory testing can lead to incorrect clinical decisions, making robust quality control processes critical for patient safety and healthcare system effectiveness.

The Clinical Laboratory Quality Control market includes quality control materials, calibration standards, proficiency testing services, quality management software, and data analytics tools used to monitor laboratory performance. The market is estimated to be USD 1.39 billion in 2025, growing to 1.81 Billion in 2030 at a CAGR of 5.4%. Growth is generally expected to track overall expansion in clinical laboratory testing volumes.

Demand for laboratory quality control products and services is driven by increasing complexity of diagnostic testing technologies, expansion of molecular diagnostics and genetic testing, regulatory requirements for laboratory accreditation, and growing emphasis on healthcare quality assurance.

Role of Quality Control in Laboratory Testing

Quality control processes are used to verify that laboratory instruments, reagents, and workflows are performing correctly and producing accurate results. QC procedures typically involve analysis of control samples with known analyte concentrations to ensure that test results fall within defined performance ranges.

Quality control is applied across a wide range of laboratory disciplines including clinical chemistry, immunoassay testing, hematology, coagulation testing, microbiology, molecular diagnostics, and toxicology.

QC processes are designed to detect analytical errors resulting from instrument malfunction, reagent variability, calibration issues, or environmental conditions.

Laboratories typically perform both internal quality control and external quality assessment (EQA). Internal QC involves routine monitoring of assay performance within a laboratory. External quality assessment involves comparison of laboratory performance with peer laboratories using standardized proficiency testing samples.

Accreditation bodies and regulatory agencies require laboratories to maintain documented quality control programs.

Market Components

The clinical laboratory QC market includes several product and service categories.

  • Quality control materials are samples containing known concentrations of analytes used to verify assay performance. These materials are available for a wide range of laboratory tests.
  • Calibration standards are used to establish measurement accuracy and ensure traceability of test results.
  • Proficiency testing programs provide external validation of laboratory performance by comparing results across multiple laboratories.
  • Quality management software platforms enable laboratories to track QC data, monitor instrument performance, and identify trends indicating analytical variation.
  • Data analytics tools are increasingly used to support statistical quality control methods.
  • QC products are used across centralized laboratories, hospital laboratories, and point-of-care testing environments.
  • Recurring demand for QC materials represents a stable revenue stream for suppliers.

Market Drivers

Several factors are supporting growth in the clinical laboratory quality control market.

  • Increasing complexity of diagnostic technologies is creating demand for more sophisticated quality assurance tools.
  • Expansion of molecular diagnostics and genetic testing requires specialized QC materials and validation processes.
  • Regulatory requirements for laboratory accreditation are increasing emphasis on documented quality management systems.
  • Growth in laboratory testing volumes is increasing demand for QC materials and services.
  • Healthcare systems are increasingly focused on improving diagnostic accuracy and reducing medical errors.
  • Automation of laboratory workflows requires integrated QC monitoring systems.
  • Expansion of point-of-care testing requires quality control solutions suitable for decentralized testing environments.
  • Globalization of clinical trials requires standardized quality assurance processes across laboratory networks.

Technology Trends

Technological innovation is influencing the clinical laboratory QC market.

  • Automation of QC data collection and analysis is improving efficiency and reducing manual documentation requirements.
  • Middleware software platforms integrate QC data from multiple instruments and provide centralized performance monitoring.
  • Statistical quality control tools enable detection of analytical trends and performance drift.
  • Cloud-based QC management platforms enable remote monitoring of laboratory performance.
  • Digital connectivity between laboratory instruments and quality management systems improves traceability of results.
  • Artificial intelligence tools are being developed to detect patterns in QC data and identify potential analytical issues.
  • Advanced analytics may enable predictive quality control models.
  • Integration of QC systems with laboratory information systems supports workflow efficiency.

Market Segmentation

The clinical laboratory QC market can be segmented by product type, laboratory discipline, end user, and geographic region.

By laboratory discipline, clinical chemistry and immunoassay testing represent large segments due to high test volumes. Molecular diagnostics and genetic testing represent growing segments requiring specialized QC solutions.

End users include hospital laboratories, reference laboratories, physician office laboratories, and diagnostic testing networks.

  • North America represents the largest regional market due to established regulatory frameworks and advanced diagnostic infrastructure.
  • Europe represents a significant market supported by laboratory accreditation requirements.
  • Asia-Pacific markets are expanding due to increasing healthcare investment and growing diagnostic testing volumes.

Competitive Landscape

The clinical laboratory QC market includes specialized QC material manufacturers, diagnostic instrument companies, proficiency testing providers, and laboratory informatics companies.

  • Competition is influenced by breadth of QC product portfolio, compatibility with major diagnostic platforms, and ability to support multiple laboratory disciplines.
  • Suppliers often develop QC materials designed for specific diagnostic assays or instrument platforms.
  • Strategic partnerships between QC suppliers and diagnostic instrument manufacturers may influence product adoption.
  • Recurring revenue from QC materials provides stable market demand.
  • Quality and reliability of QC materials are critical competitive factors.
  • Regulatory compliance and traceability are important considerations for suppliers.

Future Outlook

The clinical laboratory QC market is expected to experience steady growth as diagnostic testing technologies become more complex and regulatory expectations increase.

  • Expansion of molecular diagnostics and genetic testing may increase demand for specialized QC materials.
  • Automation of laboratory workflows may require integrated quality management systems.
  • Digital connectivity between laboratory instruments and QC software may improve monitoring capabilities.
  • Artificial intelligence tools may improve detection of analytical variation and enhance predictive maintenance.
  • Decentralized testing environments may create demand for simplified QC solutions.

Overall, clinical laboratory quality control represents a critical component of diagnostic testing infrastructure. Continued advances in laboratory technology and increasing emphasis on diagnostic accuracy are expected to support sustained demand for quality control products and services.

Table of Contents

1 Market Guides

  • 1.1 Strategic Situation Analysis
  • 1.2 Guide for Executives, Marketing, Sales and Business Development Staff
  • 1.3 Guide for Management Consultants and Investment Advisors
  • 1.4 Impact of Artificial Intelligence

2 Introduction and Market Definition

  • 2.1 What is IVD Quality Control?
  • 2.2 Defining the Opportunity
    • 2.2.1 Revenue Market Size
  • 2.3 Methodology
    • 2.3.1 Methodology
    • 2.3.2 Sources
    • 2.3.3 Authors
  • 2.4 Perspective: Healthcare and the IVD Industry
    • 2.4.1 Global Healthcare Spending
    • 2.4.2 Spending on Diagnostics
    • 2.4.3 Important Role of Insurance for Diagnostics

3 Overview of a Dynamic Market

  • 3.1 Players in a Dynamic Market
    • 3.1.1 Academic Research Lab
    • 3.1.2 Diagnostic Test Developer
    • 3.1.3 Instrumentation Supplier
    • 3.1.4 Chemical/Reagent Supplier
    • 3.1.5 Pathology Supplier
    • 3.1.6 Independent Clinical Laboratory
    • 3.1.7 Public National/regional Laboratory
    • 3.1.8 Hospital Laboratory
    • 3.1.9 Physicians Office Lab (POLS)
    • 3.1.10 Audit Body
    • 3.1.11 Certification Body
  • 3.2 Segmentation - Different Approaches
    • 3.2.1 Traditional Market Segmentation
    • 3.2.2 Laboratory Focus and Segmentation
  • 3.3 Structure of Clinical Testing Industry
    • 3.3.1 The Hospital Lab - Share of the Pie
    • 3.3.2 Key Role for Economies of Scale
    • 3.3.3 Physician Office Lab's are Still Here
    • 3.3.4 Physician's and POCT - Reviving Patient Service in China
  • 3.4 National and Regional Diversity

4 Trends Driving a Changing Market

  • 4.1 Growth Is Pushed from Many Sides
    • 4.1.1 Demographic Impacts on Consumption
    • 4.1.2 Alternative Suppliers
    • 4.1.3 Impact of POC
    • 4.1.4 Impact of Accreditation
    • 4.1.5 Genetic and Molecular Issues
  • 4.2 Factors at Work to Shrink the Market
    • 4.2.1 Where are Costs Going?
    • 4.2.2 Management Practices
    • 4.2.3 Cannabilization
    • 4.2.4 Point of Care
  • 4.3 Automation and Laboratory Trends
    • 4.3.1 Traditional Automation and Centralization
    • 4.3.2 The New Automation, Decentralization and Point Of Care
    • 4.3.3 Instruments Key to Market Share
    • 4.3.4 Bioinformatics Plays a Role
    • 4.3.5 PCR Takes Command
    • 4.3.6 Next Generation Sequencing Fuels a Revolution
    • 4.3.7 NGS Impact on Pricing
    • 4.3.8 Whole Genome Sequencing, A Brave New World
    • 4.3.9 Companion Diagnostics Blurs Diagnosis and Treatment
    • 4.3.10 Shifting Role of Diagnostics

5 IVD Quality Control Recent Developments

  • 5.1 Recent Developments - Importance and How to Use This Section
    • 5.1.1 Importance of These Developments
    • 5.1.2 How to Use This Section
  • 5.2 Lab Missteps Lead to Dismissed Charges
  • 5.3 bioMerieux Launches Diagnostic Solution for Food Industries
  • 5.4 Automation from Siemens Tackles Lab Challenges
  • 5.5 New FDA Quality Regulations Spark Questions
  • 5.6 Waters MassTrak Steroid Serum (IVD) Sets
  • 5.7 Cancer Test Harmonization Efforts Progress
  • 5.8 Bio-Techne Expanding With Ella Immunoassay Instrument
  • 5.9 ZeptoMetrix QC Products Receive IVDR Certification
  • 5.10 Coverage Criteria for Cancer Genetic Tests Creates Alarm
  • 5.11 IVDR Rollout Brings QC Hurdles for Clinical Labs
  • 5.12 LGC Clinical Diagnostics Acquires QC Product Maker Kova International
  • 5.13 FDA Probing Lab Test Quality in Cancer Care
  • 5.14 Sensible Diagnostics to Launch 10-Minute POC PCR System
  • 5.15 Streck Gets FDA Clearance for BioFire Sepsis Panel Control Material

6 Profiles of Key Companies

  • 6.1 Abbott Laboratories
  • 6.2 Alpha-Tec Systems
  • 6.3 Beckman Coulter Diagnostics (Danaher)
  • 6.4 Becton, Dickinson and Company
  • 6.5 BioFire Diagnostics (bioMerieux)
  • 6.6 bioMerieux Diagnostics
  • 6.7 Bio-Rad Laboratories, Inc
  • 6.8 Bio-Techne
  • 6.9 Danaher Corporation
  • 6.10 Diasorin S.p.A.
  • 6.11 Fortress Diagnostics
  • 6.12 Grifols
  • 6.13 Helena Laboratories
  • 6.14 Hologic
  • 6.15 LGC Standards
  • 6.16 Maine Molecular Quality Controls
  • 6.17 Microbiologics
  • 6.18 Microbix Systems
  • 6.19 Novacyt
  • 6.20 QuidelOrtho
  • 6.21 Randox Toxicology
  • 6.22 Seegene
  • 6.23 SERO
  • 6.24 Siemens Healthineers
  • 6.25 Streck
  • 6.26 Sun Diagnostics
  • 6.27 Sysmex
  • 6.28 Thermo Fisher Scientific
  • 6.29 ZeptoMetrix

7 The Global Market for IVD Quality Control

  • 7.1 Global Market Overview by Country
    • 7.1.1 Table - Global Market by Country
    • 7.1.2 Chart - Global Market by Country
  • 7.2 Global Market by Assay Type - Overview
    • 7.2.1 Table - Global Market by Assay Type
    • 7.2.2 Chart - Global Market by Assay Type - Base/Final Year Comparison
    • 7.2.3 Chart - Global Market by Assay Type - Base Year
    • 7.2.4 Chart - Global Market by Assay Type - End Year
    • 7.2.5 Chart - Global Market by Assay Type - Share by Year
    • 7.2.6 Chart - Global Market by Assay Type - Segments Growth
  • 7.3 Global Market by Place - Overview
    • 7.3.1 Table - Global Market by Place
    • 7.3.2 Chart - Global Market by Place - Base/Final Year Comparison
    • 7.3.3 Chart - Global Market by Place - Base Year
    • 7.3.4 Chart - Global Market by Place - End Year
    • 7.3.5 Chart - Global Market by Place - Share by Year
    • 7.3.6 Chart - Global Market by Place - Segments Growth
  • 7.4 Global Market by Product - Overview
    • 7.4.1 Table - Global Market by Product
    • 7.4.2 Chart - Global Market by Product - Base/Final Year Comparison
    • 7.4.3 Chart - Global Market by Product - Base Year
    • 7.4.4 Chart - Global Market by Product - End Year
    • 7.4.5 Chart - Global Market by Product - Share by Year
    • 7.4.6 Chart - Global Market by Product - Segments Growth
  • 7.5 Global Market by Manufacturer- Overview
    • 7.5.1 Table - Global Market by Manufacturer
    • 7.5.2 Chart - Global Market by Manufacturer - Base/Final Year Comparison
    • 7.5.3 Chart - Global Market by Manufacturer - Base Year
    • 7.5.4 Chart - Global Market by Manufacturer - End Year
    • 7.5.5 Chart - Global Market by Manufacturer - Share by Year
    • 7.5.6 Chart - Global Market by Manufacturer - Segments Growth

8 Global IVD Quality Control Markets - By Assay Type

  • 8.1 Chemistry
    • 8.1.1 Table Chemistry - by Country
    • 8.1.2 Chart - Chemistry Growth
  • 8.2 Microbiology
    • 8.2.1 Table Microbiology - by Country
    • 8.2.2 Chart - Microbiology Growth
  • 8.3 Hematology
    • 8.3.1 Table Hematology - by Country
    • 8.3.2 Chart - Hematology Growth
  • 8.4 Anatomic Pathology
    • 8.4.1 Table Anatomic Pathology - by Country
    • 8.4.2 Chart - Anatomic Pathology Growth
  • 8.5 Molecular Diagnostics
    • 8.5.1 Table Molecular Diagnostics - by Country
    • 8.5.2 Chart - Molecular Diagnostics Growth
  • 8.6 Esoteric
    • 8.6.1 Table Esoteric - by Country
    • 8.6.2 Chart - Esoteric Growth

9 Global IVD Quality Control Markets - By Place

  • 9.1 Hospital
    • 9.1.1 Table Hospital - by Country
    • 9.1.2 Chart - Hospital Growth
  • 9.2 Outpatient Laboratory
    • 9.2.1 Table Outpatient Laboratory - by Country
    • 9.2.2 Chart - Outpatient Laboratory Growth
  • 9.3 Research Laboratory
    • 9.3.1 Table Research Laboratory - by Country
    • 9.3.2 Chart - Research Laboratory Growth
  • 9.4 Physicians Office Laboratory
    • 9.4.1 Table Physicians Office Laboratory - by Country
    • 9.4.2 Chart - Physicians Office Laboratory Growth
  • 9.5 Other Laboratory
    • 9.5.1 Table Other Laboratory - by Country
    • 9.5.2 Chart - Other Laboratory Growth

10 Global IVD Quality Control Markets - By Product

  • 10.1 Whole Blood
    • 10.1.1 Table Whole Blood - by Country
    • 10.1.2 Chart - Whole Blood Growth
  • 10.2 Plasma
    • 10.2.1 Table Plasma - by Country
    • 10.2.2 Chart - Plasma Growth
  • 10.3 Urine
    • 10.3.1 Table Urine - by Country
    • 10.3.2 Chart - Urine Growth
  • 10.4 Control Material Other
    • 10.4.1 Table Control Material Other - by Country
    • 10.4.2 Chart - Control Material Other Growth

11 Global IVD Quality Control Markets - By Manufacturer

  • 11.1 Original Equipment Manufacturer
    • 11.1.1 Table Original Equipment Manufacturer - by Country
    • 11.1.2 Chart - Original Equipment Manufacturer Growth
  • 11.2 Third Party Generic
    • 11.2.1 Table Third Party Generic - by Country
    • 11.2.2 Chart - Third Party Generic Growth
  • 11.3 Third Party Instrument Specific
    • 11.3.1 Table Third Party Instrument Specific - by Country
    • 11.3.2 Chart - Third Party Instrument Specific Growth
  • 11.4 Custom Other
    • 11.4.1 Table Custom Other - by Country
    • 11.4.2 Chart - Custom Other Growth

12 Appendices

  • 12.1 Growth of Approved IVD Test Menu
  • 12.2 Growth of Approved Average IVD Test Fee
  • 12.3 The Most Used IVD Assays
  • 12.4 The Highest Grossing Assays
  • 12.5 Laboratory Fees Schedule

Table of Tables

  • Table 1 Market Players by Type
  • Table 2 Clinical Laboratory Departments and Segments
  • Table 3 Laboratory Management Focus - Different Approaches
  • Table 4 Key Segmentation Variables Going Forward
  • Table 5 Factors Affecting Local Clinical Testing Demand
  • Table 6 Seven Factors Driving Growth
  • Table 7 Six Factors Limiting Growth
  • Table 8 Seven Key Diagnostic Laboratory Technology Trends
  • Table 9 - Global Market by Region
  • Table 10 Global Market by Assay Type
  • Table 11 Global Market by Place
  • Table 12 Global Market by Product
  • Table 13 Global Market by Manufacturer
  • Table 14 Chemistry by Country
  • Table 15 Microbiology by Country
  • Table 16 Hematology by Country
  • Table 17 Anatomic Pathology by Country
  • Table 18 Molecular Diagnostics by Country
  • Table 19 Esoteric by Country
  • Table 20 Hospital by Country
  • Table 21 Outpatient Laboratory by Country
  • Table 22 Research Laboratory by Country
  • Table 23 Physicians Office Laboratory by Country
  • Table 24 Other Laboratory by Country
  • Table 25 Whole Blood by Country
  • Table 26 Plasma by Country
  • Table 27 Urine by Country
  • Table 28 Control Material Other by Country
  • Table 29 Original Equipment Manufacturer by Country
  • Table 30 Third Party Generic by Country
  • Table 31 Third Party Instrument Specific by Country
  • Table 32 Custom Other by Country
  • Table 33 The Most Common Assays
  • Table 34 Largest Revenue Assays
  • Table 35 Clinical Lab Fee Schedule

Table of Figures

  • Figure 1 Global Healthcare Spending
  • Figure 2 The Road to Diagnostics
  • Figure 3 The Changing Age of The World's Population
  • Figure 4 Health Care Consumption by Age
  • Figure 5 Cancer Incidence - Age at Diagnosis
  • Figure 6 Centralized vs. Decentralized Laboratory Service
  • Figure 7 A Highly Multiplexed Syndromic Testing Unit
  • Figure 8 The Real Cost to Sequence the Human Genome
  • Figure 9 The Codevelopment Process
  • Figure 10 Comparing MDx Diagnostic and Traditional Testing
  • Figure 11 Global Market Pareto Chart
  • Figure 12 Global Market by Assay Type - Base vs. Final
  • Figure 13 Global Market by Assay Type Base Year
  • Figure 14 Global Market by Assay Type End Year
  • Figure 15 Assay Type Share by Year
  • Figure 16 Assay Type Segments Growth
  • Figure 17 Global Market by Place - Base vs. Final
  • Figure 18 Global Market by Place Base Year
  • Figure 19 Global Market by Place End Year
  • Figure 20 Place Share by Year
  • Figure 21 Place Segments Growth
  • Figure 22 Global Market by Product - Base vs. Final
  • Figure 23 Global Market by Product Base Year
  • Figure 24 Global Market by Product End Year
  • Figure 25 Product Share by Year
  • Figure 26 Product Segments Growth
  • Figure 27 Global Market by Manufacturer - Base vs. Final
  • Figure 28 Global Market by Manufacturer Base Year
  • Figure 29 Global Market by Manufacturer End Year
  • Figure 30 Manufacturer Share by Year
  • Figure 31 Manufacturer Segments Growth
  • Figure 32 Chemistry Growth
  • Figure 33 Microbiology Growth
  • Figure 34 Hematology Growth
  • Figure 35 Anatomic Pathology Growth
  • Figure 36 Molecular Diagnostics Growth
  • Figure 37 Esoteric Growth
  • Figure 38 Hospital Growth
  • Figure 39 Out Patient Laboratory Growth
  • Figure 40 Research Laboratory Growth
  • Figure 41 Physicians Office Laboratory Growth
  • Figure 42 Other Laboratory Growth
  • Figure 43 Whole Blood Growth
  • Figure 44 Plasma Growth
  • Figure 45 Urine Growth
  • Figure 46 Control Material Other Growth
  • Figure 47 Original Equipment Manufacturer Growth
  • Figure 48 Third Party Generic Growth
  • Figure 49 Third Party Instrument Specific Growth
  • Figure 50 Custom Other Growth
  • Figure 51 IVD Test Menu Growth
  • Figure 52 IVD Test Average Fees - A Ten Year View