體外診斷品質控制市場 - 全球產業規模、佔有率、趨勢、機會和預測，按類型、應用、最終用途區域和競爭細分，2020-2030 年預測

2024 年全球體外診斷品質控制市場價值為 11.4 億美元，預計到 2030 年將達到 12.5 億美元，預測期內複合年成長率為 1.55%。全球體外診斷品質控制市場代表了更廣泛的醫療保健產業中一個充滿活力且重要的領域，專注於確保人體外部進行的診斷測試的準確性和可靠性。體外診斷（IVD）品質控制在確保臨床實驗室結果的準確性方面發揮關鍵作用，進而影響患者的診斷和治療決策。該市場的特點是提供多樣化的產品和服務，旨在監測診斷儀器、試劑和測試系統的性能，最終提高患者安全和醫療保健結果。全球體外診斷品質控制市場成長的關鍵促進因素包括慢性病盛行率的上升、老年人口的增加以及對先進診斷技術的需求的不斷成長。實驗室和醫療機構面臨著滿足嚴格的監管要求和維持最高準確度標準的壓力，這促使他們投資於品質控制解決方案。

市場參與者包括成熟的 IVD 品質控制供應商，以及利用創新技術和方法的新興公司。品質控制產品涵蓋廣泛的產品，包括品質控制材料、軟體解決方案和資料管理系統。這些工具使實驗室能夠即時檢測錯誤、標準化程序和解決問題，從而提高診斷結果的品質。

美國臨床實驗室協會表示，美國每年進行超過70億次實驗室測試，80%的臨床決策都是在實驗室測試後做出的。根據國際糖尿病聯盟（IDF）公佈的數據，2021年全球約有5.37億人患有糖尿病，預計到2030年這一數字將達到6.43億左右，到2045年將達到7.83億。服務提供者數量的增加和對臨床診斷測試的需求不斷成長，導致IVD QC產品的使用量增加。

主要市場促進因素

慢性病盛行率上升

主要市場挑戰

監管的複雜性和嚴格性

主要市場趨勢

即時診斷（POC）檢測的興起

目錄

第 1 章：產品概述

第 2 章：研究方法

第 3 章：執行摘要

第4章：全球體外診斷品質控制市場展望

• 市場規模和預測
  • 按價值
• 市場佔有率和預測
  • 按類型（品質控制、資料管理解決方案、品質保證服務）
  • 依應用（免疫測定、血液學、臨床化學、分子診斷、凝血、微生物學、其他）
  • 依最終用途（醫院和診所、門診手術中心、其他）
  • 按地區
  • 按公司分類（2024）
• 市場地圖
  • 按類型
  • 按應用
  • 按最終用途
  • 按地區

第 5 章：亞太地區體外診斷品質控制市場展望

• 市場規模和預測
  • 按價值
• 市場佔有率和預測
  • 按類型
  • 按應用
  • 按最終用途
  • 按國家
• 亞太地區：國家分析
  • 中國
  • 印度
  • 澳洲
  • 日本
  • 韓國

第6章：歐洲體外診斷品質管制市場展望

• 市場規模和預測
• 市場佔有率和預測
• 歐洲：國家分析
  • 德國
  • 西班牙
  • 義大利
  • 英國

第 7 章：北美體外診斷品質控制市場展望

• 市場規模和預測
• 市場佔有率和預測
• 北美：國家分析
  • 墨西哥
  • 加拿大

第 8 章：南美洲體外診斷品質控制市場展望

• 市場規模和預測
• 市場佔有率和預測
• 南美洲：國家分析
  • 阿根廷
  • 哥倫比亞

第 9 章：中東和非洲體外診斷品質控制市場展望

• 市場規模和預測
• 市場佔有率和預測
• MEA：國家分析
  • 沙烏地阿拉伯
  • 阿拉伯聯合大公國

第 10 章：市場動態

• 驅動程式
• 挑戰

第 11 章：市場趨勢與發展

• 最新動態
• 產品發布
• 合併與收購

第 12 章：全球體外診斷品質控制市場：SWOT 分析

第 13 章：波特五力分析

• 產業競爭
• 新進入者的潛力
• 供應商的力量
• 顧客的力量
• 替代產品的威脅

第 14 章：競爭格局

• 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：策略建議

第16章調查會社について,免責事項

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