体外诊断品质控制市场 - 全球产业规模、份额、趋势、机会和预测，按类型、应用、最终用途区域和竞争细分，2020-2030 年预测

2024 年全球体外诊断品质控制市场价值为 11.4 亿美元，预计到 2030 年将达到 12.5 亿美元，预测期内复合年增长率为 1.55%。全球体外诊断品质控制市场代表了更广泛的医疗保健产业中一个充满活力且重要的领域，专注于确保人体外部进行的诊断测试的准确性和可靠性。体外诊断（IVD）品质控制在确保临床实验室结果的准确性方面发挥关键作用，进而影响患者的诊断和治疗决策。该市场的特点是提供多样化的产品和服务，旨在监测诊断仪器、试剂和测试系统的性能，最终提高患者安全和医疗保健结果。全球体外诊断品质控制市场成长的关键驱动因素包括慢性病盛行率的上升、老年人口的增加以及对先进诊断技术的需求的不断增长。实验室和医疗机构面临着满足严格的监管要求和维持最高准确度标准的压力，这促使他们投资于品质控制解决方案。

市场参与者包括成熟的 IVD 品质控制供应商，以及利用创新技术和方法的新兴公司。品质控制产品涵盖广泛的产品，包括品质控製材料、软体解决方案和资料管理系统。这些工具使实验室能够即时检测错误、标准化程序和解决问题，从而提高诊断结果的品质。

美国临床实验室协会表示，美国每年进行超过70亿次实验室测试，80%的临床决策都是在实验室测试后做出的。根据国际糖尿病联盟（IDF）公布的数据，2021年全球约有5.37亿人患有糖尿病，预计到2030年这一数字将达到6.43亿左右，到2045年将达到7.83亿。服务提供者数量的增加和对临床诊断测试的需求不断增长，导致IVD QC产品的使用量增加。

主要市场驱动因素

慢性病盛行率上升

主要市场挑战

监管的复杂性和严格性

主要市场趋势

即时诊断（POC）检测的兴起

目录

第 1 章：产品概述

第 2 章：研究方法

第 3 章：执行摘要

第四章：全球体外诊断品质控制市场展望

• 市场规模和预测
  • 按价值
• 市场占有率和预测
  • 按类型（品质控制、资料管理解决方案、品质保证服务）
  • 依应用（免疫测定、血液学、临床化学、分子诊断、凝血、微生物学、其他）
  • 依最终用途（医院和诊所、门诊手术中心、其他）
  • 按地区
  • 按公司分类（2024）
• 市场地图
  • 按类型
  • 按应用
  • 按最终用途
  • 按地区

第 5 章：亚太地区体外诊断品质控制市场展望

• 市场规模和预测
  • 按价值
• 市场占有率和预测
  • 按类型
  • 按应用
  • 按最终用途
  • 按国家
• 亚太地区：国家分析
  • 中国
  • 印度
  • 澳洲
  • 日本
  • 韩国

第六章：欧洲体外诊断品质管制市场展望

• 市场规模和预测
• 市场占有率和预测
• 欧洲：国家分析
  • 德国
  • 西班牙
  • 义大利
  • 英国

第 7 章：北美体外诊断品质控制市场展望

• 市场规模和预测
• 市场占有率和预测
• 北美：国家分析
  • 墨西哥
  • 加拿大

第 8 章：南美洲体外诊断品质控制市场展望

• 市场规模和预测
• 市场占有率和预测
• 南美洲：国家分析
  • 阿根廷
  • 哥伦比亚

第 9 章：中东和非洲体外诊断品质控制市场展望

• 市场规模和预测
• 市场占有率和预测
• MEA：国家分析
  • 沙乌地阿拉伯
  • 阿联酋

第 10 章：市场动态

• 驱动程式
• 挑战

第 11 章：市场趋势与发展

• 最新动态
• 产品发布
• 合併与收购

第 12 章：全球体外诊断品质控制市场：SWOT 分析

第 13 章：波特五力分析

• 产业竞争
• 新进入者的潜力
• 供应商的力量
• 顾客的力量
• 替代产品的威胁

第 14 章：竞争格局

• F. Hoffmann-La Roche Ltd.
• Alere, Inc.
• Abbott Laboratories Inc.
• Hologic, Inc. (Gen-Probe)
• Qiagen NV
• Bio-Rad Laboratories, Inc.
• Quidel Corp.
• bioMerieux, Inc.
• Sysmex Corporation
• Thermo Fisher Scientific, Inc.

第 15 章：策略建议

第16章调查会社について・免责事项

Global In Vitro Diagnostics Quality Control Market was valued at USD 1.14 billion in 2024 and is expected to reach USD 1.25 billion by 2030 with a CAGR of 1.55% during the forecast period. The Global In Vitro Diagnostics Quality Control Market represents a dynamic and essential sector within the broader healthcare industry, focused on ensuring the accuracy and reliability of diagnostic tests conducted outside the human body. In vitro diagnostics (IVD) quality control plays a pivotal role in guaranteeing the precision of clinical laboratory results, which, in turn, influences patient diagnoses and treatment decisions. This market is characterized by a diverse range of products and services designed to monitor the performance of diagnostic instruments, reagents, and test systems, ultimately enhancing patient safety and healthcare outcomes. Key drivers behind the growth of the Global In Vitro Diagnostics Quality Control Market include the increasing prevalence of chronic diseases, a rising geriatric population, and the growing demand for advanced diagnostic technologies. Laboratories and healthcare institutions are under constant pressure to meet stringent regulatory requirements and maintain the highest standards of accuracy, prompting them to invest in quality control solutions.

Market participants include established IVD quality control providers, as well as emerging companies leveraging innovative technologies and methodologies. Quality control products encompass a wide array of offerings, including quality control materials, software solutions, and data management systems. These tools enable laboratories to detect errors, standardize procedures, and troubleshoot issues in real-time, thereby improving the quality of diagnostic results.

The American Clinical Laboratory Association stated that more than 7 billion lab tests are performed in the U.S. annually, and 80% of clinical decisions are taken after laboratory testing. As per the information published by the International Diabetes Federation (IDF), in 2021, approximately 537 million people worldwide had diabetes, and this number is expected to reach around 643 million by 2030 and 783 million by 2045. The increasing number of service providers and rising demand for clinical diagnostic tests are leading to an increase in the usage of IVD QC products.

Key Market Drivers

Rising Prevalence of Chronic Diseases

The rising prevalence of chronic diseases is a compelling driver behind the growing prominence of the Global In Vitro Diagnostics Quality Control Market. Chronic diseases, such as diabetes, cardiovascular conditions, cancer, and respiratory ailments, are becoming increasingly prevalent worldwide. These conditions necessitate frequent diagnostic testing, which is fundamental to disease management, early detection, and treatment evaluation. In this context, the demand for quality control solutions has surged, driven by the imperative need to maintain the integrity of diagnostic tests.

As the global population continues to age and lifestyles become increasingly sedentary, the incidence of chronic diseases has skyrocketed. The elderly population, in particular, faces a higher risk of chronic ailments, and they require routine diagnostic tests to monitor their health status and manage their conditions effectively. Reliable and accurate diagnostic results are non-negotiable for the elderly, who often have complex healthcare needs, further underscoring the significance of quality control in ensuring consistent and dependable diagnostic outcomes.

Key Market Challenges

Regulatory Complexity and Stringency

The Global In Vitro Diagnostics Quality Control Market plays a vital role in ensuring the accuracy and reliability of diagnostic tests, serving as a linchpin in the healthcare system. However, a significant challenge that hampers its growth and effectiveness is the regulatory complexity and stringency that surrounds the in vitro diagnostics (IVD) industry.

Regulations governing IVD quality control are multifaceted, intricate, and subject to continual evolution. This complexity is primarily rooted in the need to safeguard patient safety by ensuring that diagnostic tests meet rigorous standards of accuracy and reliability. While stringent regulations are undoubtedly essential, they can present a myriad of challenges for manufacturers and stakeholders in the IVD quality control market.

One of the primary issues is the extensive documentation and reporting requirements that regulatory bodies impose on IVD quality control providers. The approval process for new quality control products can be time-consuming and expensive, involving rigorous testing and validation procedures. The stringent compliance measures necessitate substantial resources and expertise, contributing to the overall high cost of quality control solutions.

Furthermore, regulatory variations exist not only between countries but also between different regions within countries. This lack of uniformity complicates the global landscape, making it challenging for manufacturers to develop and maintain quality control solutions that adhere to the specific requirements of various markets. These disparities can result in delays, additional costs, and increased complexities for quality control providers, which in turn impact their ability to serve a global clientele efficiently.

Key Market Trends

Rise of Point-of-Care (POC) Testing

The rise of Point-of-Care (POC) testing is a significant trend that is strongly boosting the Global In Vitro Diagnostics Quality Control Market. POC testing has gained momentum in recent years as it enables rapid, on-site diagnostic assessments, delivering results in real time and often at the patient's bedside. This trend is reshaping the landscape of healthcare delivery, and with it, the demand for specialized quality control solutions that cater to the unique needs of decentralized testing environments.

POC testing offers several advantages, such as reduced turnaround times for results, increased accessibility, and the potential for immediate medical decision-making. However, these benefits come with the inherent challenge of maintaining the accuracy and reliability of diagnostic tests performed outside the controlled environment of a central laboratory.

Quality control is paramount in POC testing to ensure that test results are consistent, precise, and dependable. The stringent requirements for quality control in POC testing are driven by the need to guarantee the accuracy of medical decisions made at the point of care, whether for diagnosing infectious diseases, monitoring chronic conditions, or evaluating the effectiveness of treatments.

To meet these quality control demands, the In Vitro Diagnostics Quality Control Market has adapted by developing a range of products and services tailored to the unique aspects of POC testing. These include specialized quality control materials and software designed to validate the performance of POC devices and maintain the integrity of testing processes.

The global prevalence of POC testing is expected to continue its ascent, driven by the need for rapid diagnostics, especially in scenarios where immediate medical decisions are crucial, such as emergency departments, ambulances, and remote or resource-limited settings. This growth in POC testing will, in turn, fuel the demand for quality control solutions that can effectively ensure the reliability of these decentralized tests.

Key Market Players

• F. Hoffmann-La Roche Ltd
• Alere, Inc.
• Abbott Laboratories Inc.
• Hologic, Inc. (Gen-Probe)
• Qiagen N.V.
• Bio-Rad Laboratories, Inc.
• Quidel Corp.
• bioMerieux, Inc.
• Sysmex Corporation
• Thermo Fisher Scientific, Inc.

Report Scope:

In this report, the Global In Vitro Diagnostics Quality Control Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

In Vitro Diagnostics Quality Control Market, By Type:

• Quality Controls
• Data Management Solutions
• Quality Assurance Services

In Vitro Diagnostics Quality Control Market, By Application:

• Immunoassay
• Hematology
• Clinical Chemistry
• Molecular Diagnostics
• Coagulation
• Microbiology
• Others

In Vitro Diagnostics Quality Control Market, By End-use:

• Hospitals & Clinics
• Ambulatory Surgical Centers
• Others

In Vitro Diagnostics Quality Control Market, By Region:

• North America
  • United States
  • Canada
  • Mexico
• Europe
  • France
  • United Kingdom
  • Italy
  • Germany
  • Spain
• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global In Vitro Diagnostics Quality Control Market.

Available Customizations:

Global In Vitro Diagnostics Quality Control Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, Trends

4. Global In Vitro Diagnostics Quality Control Market Outlook

• 4.1. Market Size & Forecast
  • 4.1.1. By Value
• 4.2. Market Share & Forecast
  • 4.2.1. By Type (Quality Controls, Data Management Solutions, Quality Assurance Services)
  • 4.2.2. By Application (Immunoassay, Hematology, Clinical Chemistry, Molecular Diagnostics, Coagulation, Microbiology, Others)
  • 4.2.3. By End-use (Hospitals & Clinics, Ambulatory Surgical Centers, Others)
  • 4.2.4. By Region
  • 4.2.5. By Company (2024)
• 4.3. Market Map
  • 4.3.1. By Type
  • 4.3.2. By Application
  • 4.3.3. By End-use
  • 4.3.4. By Region

5. Asia Pacific In Vitro Diagnostics Quality Control Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Type
  • 5.2.2. By Application
  • 5.2.3. By End-use
  • 5.2.4. By Country
• 5.3. Asia Pacific: Country Analysis
  • 5.3.1. China In Vitro Diagnostics Quality Control Market Outlook
    • 5.3.1.1. Market Size & Forecast
      • 5.3.1.1.1. By Value
    • 5.3.1.2. Market Share & Forecast
      • 5.3.1.2.1. By Type
      • 5.3.1.2.2. By Application
      • 5.3.1.2.3. By End-use
  • 5.3.2. India In Vitro Diagnostics Quality Control Market Outlook
    • 5.3.2.1. Market Size & Forecast
      • 5.3.2.1.1. By Value
    • 5.3.2.2. Market Share & Forecast
      • 5.3.2.2.1. By Type
      • 5.3.2.2.2. By Application
      • 5.3.2.2.3. By End-use
  • 5.3.3. Australia In Vitro Diagnostics Quality Control Market Outlook
    • 5.3.3.1. Market Size & Forecast
      • 5.3.3.1.1. By Value
    • 5.3.3.2. Market Share & Forecast
      • 5.3.3.2.1. By Type
      • 5.3.3.2.2. By Application
      • 5.3.3.2.3. By End-use
  • 5.3.4. Japan In Vitro Diagnostics Quality Control Market Outlook
    • 5.3.4.1. Market Size & Forecast
      • 5.3.4.1.1. By Value
    • 5.3.4.2. Market Share & Forecast
      • 5.3.4.2.1. By Type
      • 5.3.4.2.2. By Application
      • 5.3.4.2.3. By End-use
  • 5.3.5. South Korea In Vitro Diagnostics Quality Control Market Outlook
    • 5.3.5.1. Market Size & Forecast
      • 5.3.5.1.1. By Value
    • 5.3.5.2. Market Share & Forecast
      • 5.3.5.2.1. By Type
      • 5.3.5.2.2. By Application
      • 5.3.5.2.3. By End-use

6. Europe In Vitro Diagnostics Quality Control Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Type
  • 6.2.2. By Application
  • 6.2.3. By End-use
  • 6.2.4. By Country
• 6.3. Europe: Country Analysis
  • 6.3.1. France In Vitro Diagnostics Quality Control Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Type
      • 6.3.1.2.2. By Application
      • 6.3.1.2.3. By End-use
  • 6.3.2. Germany In Vitro Diagnostics Quality Control Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Type
      • 6.3.2.2.2. By Application
      • 6.3.2.2.3. By End-use
  • 6.3.3. Spain In Vitro Diagnostics Quality Control Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Type
      • 6.3.3.2.2. By Application
      • 6.3.3.2.3. By End-use
  • 6.3.4. Italy In Vitro Diagnostics Quality Control Market Outlook
    • 6.3.4.1. Market Size & Forecast
      • 6.3.4.1.1. By Value
    • 6.3.4.2. Market Share & Forecast
      • 6.3.4.2.1. By Type
      • 6.3.4.2.2. By Application
      • 6.3.4.2.3. By End-use
  • 6.3.5. United Kingdom In Vitro Diagnostics Quality Control Market Outlook
    • 6.3.5.1. Market Size & Forecast
      • 6.3.5.1.1. By Value
    • 6.3.5.2. Market Share & Forecast
      • 6.3.5.2.1. By Type
      • 6.3.5.2.2. By Application
      • 6.3.5.2.3. By End-use

7. North America In Vitro Diagnostics Quality Control Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Type
  • 7.2.2. By Application
  • 7.2.3. By End-use
  • 7.2.4. By Country
• 7.3. North America: Country Analysis
  • 7.3.1. United States In Vitro Diagnostics Quality Control Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Type
      • 7.3.1.2.2. By Application
      • 7.3.1.2.3. By End-use
  • 7.3.2. Mexico In Vitro Diagnostics Quality Control Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Type
      • 7.3.2.2.2. By Application
      • 7.3.2.2.3. By End-use
  • 7.3.3. Canada In Vitro Diagnostics Quality Control Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Type
      • 7.3.3.2.2. By Application
      • 7.3.3.2.3. By End-use

8. South America In Vitro Diagnostics Quality Control Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Type
  • 8.2.2. By Application
  • 8.2.3. By End-use
  • 8.2.4. By Country
• 8.3. South America: Country Analysis
  • 8.3.1. Brazil In Vitro Diagnostics Quality Control Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Type
      • 8.3.1.2.2. By Application
      • 8.3.1.2.3. By End-use
  • 8.3.2. Argentina In Vitro Diagnostics Quality Control Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Type
      • 8.3.2.2.2. By Application
      • 8.3.2.2.3. By End-use
  • 8.3.3. Colombia In Vitro Diagnostics Quality Control Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Type
      • 8.3.3.2.2. By Application
      • 8.3.3.2.3. By End-use

9. Middle East and Africa In Vitro Diagnostics Quality Control Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Type
  • 9.2.2. By Application
  • 9.2.3. By End-use
  • 9.2.4. By Country
• 9.3. MEA: Country Analysis
  • 9.3.1. South Africa In Vitro Diagnostics Quality Control Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Type
      • 9.3.1.2.2. By Application
      • 9.3.1.2.3. By End-use
  • 9.3.2. Saudi Arabia In Vitro Diagnostics Quality Control Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Type
      • 9.3.2.2.2. By Application
      • 9.3.2.2.3. By End-use
  • 9.3.3. UAE In Vitro Diagnostics Quality Control Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Type
      • 9.3.3.2.2. By Application
      • 9.3.3.2.3. By End-use

10. Market Dynamics

• 10.1. Drivers
• 10.2. Challenges

11. Market Trends & Developments

• 11.1. Recent Developments
• 11.2. Product Launches
• 11.3. Mergers & Acquisitions

12. Global In Vitro Diagnostics Quality Control Market: SWOT Analysis

13. Porter's Five Forces Analysis

• 13.1. Competition in the Industry
• 13.2. Potential of New Entrants
• 13.3. Power of Suppliers
• 13.4. Power of Customers
• 13.5. Threat of Substitute Product

14. Competitive Landscape

• 14.1. F. Hoffmann-La Roche Ltd.
  • 14.1.1. Business Overview
  • 14.1.2. Company Snapshot
  • 14.1.3. Products & Services
  • 14.1.4. Financials (In case of listed)
  • 14.1.5. Recent Developments
  • 14.1.6. Key Personnel Details
  • 14.1.7. SWOT Analysis
• 14.2. Alere, Inc.
• 14.3. Abbott Laboratories Inc.
• 14.4. Hologic, Inc. (Gen-Probe)
• 14.5. Qiagen N.V.
• 14.6. Bio-Rad Laboratories, Inc.
• 14.7. Quidel Corp.
• 14.8. bioMerieux, Inc.
• 14.9. Sysmex Corporation
• 14.10. Thermo Fisher Scientific, Inc.

15. Strategic Recommendations

16. About Us & Disclaimer