体外診断品質管理市場- 世界の産業規模、動向、機会、予測、タイプ別、用途別、最終用途、地域別セグメント、競合、2020年～2030年

体外診断品質管理の世界市場規模は2024年に11億4,000万米ドル、予測期間中のCAGRは1.55%で、2030年には12億5,000万米ドルに達すると予測されています。

世界の体外診断品質管理市場は、より広範なヘルスケア産業において、人体外で実施される診断検査の正確性と信頼性を確保することに焦点を当てた、ダイナミックで不可欠なセクターです。体外診断薬（IVD）の品質管理は、臨床検査結果の精度を保証する上で極めて重要な役割を果たしており、ひいては患者の診断や治療方針の決定に影響を与えます。この市場は、診断機器、試薬、検査システムの性能をモニターし、最終的に患者の安全性とヘルスケアの成果を向上させるために設計された多様な製品とサービスによって特徴付けられます。世界の体外診断品質管理市場成長の主な促進要因には、慢性疾患の蔓延、高齢者人口の増加、高度な診断技術に対する需要の高まりなどがあります。検査機関やヘルスケア機関は、厳しい規制要件を満たし、最高水準の精度を維持しなければならないというプレッシャーに常にさらされており、品質管理ソリューションへの投資を促しています。

市場参入企業には、既存のIVD品質管理プロバイダーに加え、革新的な技術や手法を活用する新興企業も含まれます。品質管理製品には、品質管理材料、ソフトウェア・ソリューション、データ管理システムなど、幅広い製品が含まれます。これらのツールは、検査室がエラーを検出し、手順を標準化し、問題をリアルタイムでトラブルシューティングすることを可能にし、それによって診断結果の質を向上させる。

米国臨床検査協会（American Clinical Laboratory Association）は、米国では年間70億件以上の臨床検査が実施され、臨床判断の80％は臨床検査後に下されると述べています。国際糖尿病連合（IDF）が発表した情報によると、2021年には世界で約5億3,700万人が糖尿病を患っており、この数は2030年には約6億4,300万人、2045年には7億8,300万人に達すると予想されています。サービスプロバイダーの増加や臨床診断検査に対する需要の高まりが、IVD QC製品の使用量の増加につながっています。

市場促進要因

慢性疾患の有病率の上昇

主な市場課題

規制の複雑さと厳しさ

主な市場動向

ポイントオブケア（POC）検査の台頭

目次

第1章 概要

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 世界の体外診断品質管理市場展望

• 市場規模・予測
  • 金額別
• 市場シェア・予測
  • タイプ別（品質管理、データ管理ソリューション、品質保証サービス）
  • 用途別（免疫測定、血液学、臨床化学、分子診断、凝固、微生物学、その他）
  • 最終用途別（病院・診療所、外来手術センター、その他）
  • 地域別
  • 企業別（2024）
• 市場マップ
  • タイプ別
  • 用途別
  • 最終用途別
  • 地域別

第5章 アジア太平洋地域の体外診断品質管理市場展望

• 市場規模・予測
  • 金額別
• 市場シェア・予測
  • タイプ別
  • 用途別
  • 最終用途別
  • 国別
• アジア太平洋地域：国別分析
  • 中国
  • インド
  • オーストラリア
  • 日本
  • 韓国

第6章 欧州の体外診断品質管理市場展望

• 市場規模・予測
• 市場シェア・予測
• 欧州：国別分析
  • フランス
  • ドイツ
  • スペイン
  • イタリア
  • 英国

第7章 北米の体外診断品質管理市場展望

• 市場規模・予測
• 市場シェア・予測
• 北米：国別分析
  • 米国
  • メキシコ
  • カナダ

第8章 南米の体外診断品質管理市場展望

• 市場規模・予測
• 市場シェア・予測
• 南米：国別分析
  • ブラジル
  • アルゼンチン
  • コロンビア

第9章 中東・アフリカの体外診断品質管理市場展望

• 市場規模・予測
• 市場シェア・予測
• 中東・アフリカ：国別分析
  • 南アフリカ
  • サウジアラビア
  • アラブ首長国連邦

第10章 市場力学

• 促進要因
• 課題

第11章 市場動向と発展

• 最近の動向
• 製品上市
• 合併と買収

第12章 世界の体外診断品質管理市場：SWOT分析

第13章 ポーターのファイブフォース分析

• 業界内の競合
• 新規参入の可能性
• サプライヤーの力
• 顧客の力
• 代替品の脅威

第14章 競合情勢

• 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.

第15章 戦略的提言

第16章 調査会社について・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