查看购物车
  • Traditional Chinese
  • English
  • Japanese
封面
市场调查报告书
商品编码
2024194

体外诊断（IVD）品管市场：策略与趋势，包括按检测类型、施行地点、产品、製造商和国家/地区分類的预测 -经营团队和咨询顾问的市场分析（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个工作天内

价格
简介目录

报告摘要：

体外诊断（IVD）品管产业曾面临疫情带来的挑战。如今，这个受经济衰退影响较小的成熟产业正蓬勃发展，充满新的机会。新技术和新兴领域正在推动产业爆发式成长。这份全面的报告将帮助您了解这些机会和挑战。

临床检查室品管（QC）是指用于确保临床检查室诊断检测结果的准确性、可靠性和一致性的系统、材料、软体工具和程序。由于诊断检测结果指南医疗决策、监测治疗效果并支持疾病诊断，因此品管是检查室运作的重要组成部分。检测误差可能导致错误的临床判断，因此，健全的品管流程对于病患安全和医疗保健系统的有效性至关重要。

临床检查室品管市场涵盖品管样品、校准参考物质、能力测试服务、品管软体以及用于监测检查室性能的数据分析工具。该市场预计在2025年达到13.9亿美元，并预计在2030年达到18.1亿美元，年复合成长率（CAGR）为5.4%。市场成长预计将与临床实验室检测总量的增加保持一致。

检查室品管产品和服务的需求受到以下因素的驱动：诊断测试技术的日益复杂化、分子和基因检测的扩展、检查室认证的监管要求以及医疗保健领域对品质保证的日益重视。

品管在临床试验中的作用

品管流程用于检验测试设备、试剂和工作流程是否正常运作并产生准确的结果。品管程序通常包括分析已知浓度的待测物对照样品，以确保测试结果在规定的性能范围内。

品管应用于广泛的检测领域，包括临床化学、免疫检测、血液学、血液凝固检验、微生物学、分子诊断和毒理学。

品质控制流程旨在检测由设备故障、试剂差异、校准问题或环境条件引起的分析误差。

检查室通常会同时实施内部品管和外部品质评估（EQA）。内部品质控制包括实验室性能的日常监测。外部品质评估则是利用标准化的能力测试样本，将本实验室的效能与其他实验室的效能进行比较。

认证机构和监管机构要求检查室维护有文件记录的品质管理计画。

市场组成部分

临床检查室品质控制市场包含多个产品和服务类别。

  • 品品管样品是含有已知浓度待测物的样品，用于检验测量性能。这些样本可用于多种临床检测。
  • 校准参考物质用于确定测量精度并确保测试结果的可追溯性。
  • 能力测试计划透过比较多个检查室的结果，对检查室的性能进行外部检验。
  • 品管软体平台使检查室能够追踪品质控制数据、监控设备性能并识别指示分析变异性的趋势。
  • 数据分析工具正越来越多地被用于支援统计品管方法。
  • QC产品适用于中心检查室、医院检查室和就地检验环境等各种场所。
  • 对品质控製材料的持续需求为供应商提供了稳定的收入来源。

市场驱动因素

推动临床检查室品管市场成长的因素有很多。

  • 随着诊断技术变得越来越复杂，对更先进的品质保证工具的需求也越来越大。
  • 随着分子诊断和基因检测的扩展，需要专门的品管材料和检验流程。
  • 检查室认证的监管要求日益重要，因此，有据可查的品管系统至关重要。
  • 随着检验次数的增加，对品质控製材料和服务的需求也在上升。
  • 医疗卫生系统越来越注重提高诊断准确率和减少医疗差错。
  • 检查室工作流程自动化需要一个整合的品管（QC）监控系统。
  • 随着就地检验的普及，对适用于分散式检查环境的品管解决方案的需求日益增长。
  • 随着临床试验日益全球化，整个检查室网路都需要标准化的品质保证流程。

科技趋势

技术创新正在影响临床检查室的品管市场。

  • 品质控制资料的收集和分析自动化提高了效率，减轻了手动建立文件的负担。
  • 中介软体平台整合了来自多个设备的QC数据，并提供集中式效能监控。
  • 统计品管工具能够检测分析中的趋势和效能波动。
  • 基于云端的品质控制管理平台可以远端监控检查室效能。
  • 检测设备与品管系统之间的数位化连接提高了结果的可追溯性。
  • 人工智慧工具正在被开发用于检测品质控制数据中的模式并识别潜在的分析问题。
  • 先进的分析技术可以用于创建预测性品管模型。
  • 将品质控制系统与检查室资讯系统整合起来，图提高工作流程效率。

市场区隔

临床检查室品质控制市场可以按产品类型、测试领域、最终用户和地区进行细分。

按检测领域划分，临床化学和免疫检测由于检测量大，占了很大比例。分子诊断和基因检测是成长迅速的领域，需要专门的品管解决方案。

最终用户包括医院检查室、参考实验室、诊所检查室和诊断测试网路。

  • 由于北美拥有完善的法律规范和先进的诊断基础设施，因此是最大的区域市场。
  • 欧洲已成为一个重要的市场，这得益于其检查室认证要求。
  • 由于医疗保健领域的投资增加和诊断测试数量的增长，亚太市场正在扩张。

竞争格局

临床检查室品管(QC) 市场包括专业 QC 材料製造商、诊断设备製造商、能力测试提供者和检查室资讯系统公司。

  • 竞争取决于 QC产品系列的广度、与主要诊断平台的兼容性以及支援多个测试领域的能力。
  • 供应商通常会开发专为特定诊断检测或仪器平台设计的品管材料。
  • 品质控制供应商与诊断设备製造商之间的策略伙伴关係可以影响产品的采用。
  • QC材料带来的持续收入提供了稳定的市场需求。
  • 质检材料的品质和可靠性是重要的竞争因素。
  • 对于供应商而言，合规性和可追溯性是重要的考虑因素。

未来展望

随着诊断检测技术变得越来越复杂，监管要求也越来越严格，临床检查室的品质控制市场预计将稳定成长。

  • 分子诊断和基因检测的扩展可能会增加对专用品管材料的需求。
  • 检查室工作流程自动化可能需要整合品管系统。
  • 检测设备与品质控制软体之间的数位化连接可以提高监控能力。
  • 引入人工智慧 (AI) 工具可以提高检测分析波动的准确性，并有可能增强预测性维护。
  • 分散式检查环境的普及可能会催生简化品管解决方案的需求。

总体而言，临床检查室品管是诊断检测基础设施的关键组成部分。随着检测技术的不断进步和对诊断准确性的日益重视，对品管产品和服务的需求预计将保持强劲。

目录

第一章 市集指南

  • 战略情势分析
  • 企业主管、行销负责人、销售负责人和业务拓展负责人。
  • 管理顾问和投资顾问指南
  • 人工智慧的影响

第二章：引言与市场定义

  • 什么是体外诊断（IVD）品管？
  • 机会的定义
  • 调查方法
  • 展望：医疗保健和体外诊断产业

第三章：动态市场概述

  • 参与企业充满活力的市场
    • 学术研究办公室
    • 诊断测试开发人员
    • 测量仪器供应商
    • 化学品/试剂供应商
    • 病理检测用品供应商
    • 独立临床实验室
    • 国家/地区公共研究机构
    • 医院检查室
    • 医师诊所检查室(POLS)
    • 审计机构
    • 认证机构
  • 细分——多种方法
  • 临床检测产业的结构
  • 国家和地区的多样性

第四章：推动市场变化的趋势

  • 成长的驱动力来自多个方面。
  • 导致市场萎缩的因素
  • 自动化和实验室的发展趋势

第五章：体外诊断医疗器材品管的最新趋势

第六章：主要企业概况

  • 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

第七章 体外诊断（IVD）品管的全球市场

  • 全球市场概览（按国家/地区划分）
  • 全球市场按检测类型划分 - 概述
  • 区域全球市场概览
  • 全球市场概览（按产品类别划分）
  • 全球製造商市场概览

第八章 全球体外诊断（IVD）品管市场－依检测类型划分

  • 化学
  • 微生物学
  • 血液学
  • 解剖病理学
  • 分子诊断
  • 神秘测试

第九章 全球体外诊断（IVD）品管市场－按施行地点

  • 医院
  • 门诊检查室
  • 实验室
  • 医生诊所检查室
  • 其他的

第十章：全球体外诊断（IVD）品管市场－依产品划分

  • 全血
  • 电浆
  • 尿
  • 其他的

第十一章：全球体外诊断（IVD）品管市场－按製造商划分

  • OEM
  • 第三方 -非专利
  • 第三方设备
  • 定制及其他

第十二章附录

表格一览

图表清单

简介目录
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