体外診断 (IVD) の品質管理：世界市場

世界の体外診断 (IVD) の品質管理の市場規模は、2024年の15億米ドルから、予測期間中はCAGR 7.8%で推移し、2029年末には21億米ドルの規模に達すると予測されています。

免疫診断の部門は、2024年の4,142億米ドルから、CAGR 8.6％で推移し、2029年末には6,257億米ドルに達すると予測されています。また、血液学の部門は、2024年の2億8,930万米ドルから、CAGR 8.5%で推移し、2029年末には4,351億米ドルに達すると予測されています。

当レポートでは、世界の体外診断 (IVD) の品質管理の市場を調査し、市場概要、市場影響因子および市場機会の分析、新興技術および技術開発の動向、市場規模の推移・予測、各種区分・地域別の詳細分析、競合情勢、主要企業のプロファイルなどをまとめています。

目次

第1章 エグゼクティブサマリー

• 市場見通し
• 調査範囲
• 市場概要

第2章 市場と技術の背景

• 概要
• IVDエレメントの分類
• IVD品質管理の重要性
• 規則
• 各国におけるIVD製品の規制

第3章 市場力学

• 市場促進要因
• 市場抑制要因
• 市場機会

第4章 新興技術と開発

• AI
• 古いIVD技術の優先性
• IVDデバイスの自動化
• IVDにおける新たな動向
• FDA承認
• 個別化医療の需要増加

第5章 市場セグメンテーション分析

• セグメンテーションの内訳
• 市場内訳：テストタイプ別
• 免疫診断
• 臨床化学
• 血液学
• 分子診断
• 微生物学
• その他
• 市場内訳：製造業者別
• サードパーティコントロール
• ODMコントロール
• 市場内訳：製品・サービス別
• 品質管理製品
• データ管理ソリューション
• 品質保証サービス
• 市場内訳：エンドユーザー別
• 診断ラボ
• 病院・診療所
• ポイントオブケアセンター
• 研究機関
• その他
• 地理的内訳
• 市場内訳：地域別
• 北米
• 欧州
• アジア太平洋
• その他の地域

第6章 競合情報

• 企業ランキング
• 協定、協力、パートナーシップ
• IVDの開発と新興企業

第7章 持続可能性

• IVD業界におけるESGの重要性
• IVD業界におけるESGの実践
• 環境パフォーマンス
• 社会的パフォーマンス
• ガバナンスパフォーマンス
• ケーススタディ
• BCCによる見解

第8章 付録

• 調査手法
• 参考文献
• 企業プロファイル
• ABBOTT
• BD
• BIOMERIEUX
• BIO-RAD LABORATORIES INC.
• BIO-TECHNE
• DANAHER CORP.
• F. HOFFMANN-LA ROCHE LTD.
• MICROBIOLOGICS
• QUIDELORTHO CORP.
• SIEMENS HEATHNIEERS AG
• SYSMEX CORP.
• THERMO FISHER SCIENTIFIC INC.

List of Tables

• Summary Table : Global Market for In Vitro Diagnostics Quality Controls, by Test Type, Through 2029
• Table 1 : Global Market for In Vitro Diagnostics Quality Controls, by Test Type, Through 2029
• Table 2 : Global Market for Immunodiagnostics, by Region, Through 2029
• Table 3 : Global Market for Clinical Chemistry, by Region, Through 2029
• Table 4 : Global Market for Hematology, by Region, Through 2029
• Table 5 : Global Market for Molecular Diagnostics, by Region, Through 2029
• Table 6 : Global Market for Microbiology, by Region, Through 2029
• Table 7 : Global Market for Other Test Types, by Region, Through 2029
• Table 8 : Global Market for In Vitro Diagnostics Quality Controls, by Type of Manufacturer, Through 2029
• Table 9 : Global Market for Third-party Controls, by Region, Through 2029
• Table 10 : Global Market for ODM Controls, by Region, Through 2029
• Table 11 : Global Market for In Vitro Diagnostics Quality Controls, by Type of Product and Service, Through 2029
• Table 12 : Global Market for Quality Control Products, by Region, Through 2029
• Table 13 : Global Market for Serum/Plasma-Based Controls, by Region, Through 2029
• Table 14 : Global Market for Whole Blood-Based Controls, by Region, Through 2029
• Table 15 : Global Market for Urine-based Controls, by Region, Through 2029
• Table 16 : Global Market for Other Quality Control Products, by Region, Through 2029
• Table 17 : Global Market for Data Management Solutions, by Region, Through 2029
• Table 18 : Global Market for Quality Assurance Services, by Region, Through 2029
• Table 19 : Global Market for In Vitro Diagnostics Quality Controls, by End User, Through 2029
• Table 20 : Global Market for IVD Quality Controls in Diagnostic Laboratories, by Region, Through 2029
• Table 21 : Global Market for IVD Quality Controls in Hospitals and Clinics, by Region, Through 2029
• Table 22 : Global Market for IVD Quality Controls in Point-of-Care Centers, by Region, Through 2029
• Table 23 : Global Market for IVD Quality Controls in Research Institutions, by Region, Through 2029
• Table 24 : Global Market for Other End Users, by Region, Through 2029
• Table 25 : Global Market for In Vitro Diagnostics Quality Controls, by Region, Through 2029
• Table 26 : North American Market for In Vitro Diagnostics Quality Controls, by Country, Through 2029
• Table 27 : European Market for In Vitro Diagnostics Quality Controls, by Country, Through 2029
• Table 28 : Asia-Pacific Market for In Vitro Diagnostics Quality Controls, by Country, Through 2029
• Table 29 : Rest of the World Market for In Vitro Diagnostics Quality Controls, by Country/Sub-Region, Through 2029
• Table 30 : ESG Practices: Environmental Performance
• Table 31 : ESG Practices: Social Performance
• Table 32 : ESG Practices: Governance Performance
• Table 33 : Abbott: Company Snapshot
• Table 34 : Abbott: Financial Performance, FY2022 and 2023
• Table 35 : Abbott: Product Portfolio
• Table 36 : Abbott: News/Key Developments, 2021 and 2022
• Table 37 : BD: Company Snapshot
• Table 38 : BD: Financial Performance, FY 2022 and 2023
• Table 39 : BD: Product Portfolio
• Table 40 : BD: News/Key Developments, 2023 and 2024
• Table 41 : bioMerieux: Company Snapshot
• Table 42 : bioMerieux: Financial Performance, FY 2022 and 2023
• Table 43 : bioMerieux: Product Portfolio
• Table 44 : bioMerieux: News/Key Developments, 2023
• Table 45 : Bio-Rad Laboratories Inc.: Company Snapshot
• Table 46 : Bio-Rad Laboratories Inc.: Financial Performance, FY 2022 and 2023
• Table 47 : Bio-Rad Laboratories Inc.: Product Portfolio
• Table 48 : Bio-Rad Laboratories Inc.: News/Key Developments, 2021-2024
• Table 49 : Bio-Techne: Company Snapshot
• Table 50 : Bio-Techne: Financial Performance, FY 2022 and 2023
• Table 51 : Bio-Techne: Product Portfolio
• Table 52 : Bio-Techne: News/Key Developments, 2022 and 2023
• Table 53 : Danaher Corp.: Company Snapshot
• Table 54 : Danaher Corp.: Financial Performance, FY 2022 and 2023
• Table 55 : Danaher Corp.: Product Portfolio
• Table 56 : Danaher Corp.: News/Key Developments, 2021-2023
• Table 57 : F. Hoffmann-La Roche Ltd.: Company Snapshot
• Table 58 : F. Hoffmann-La Roche Ltd.: Financials, FY 2022 and 2023
• Table 59 : F. Hoffmann-La Roche Ltd.: Product Portfolio
• Table 60 : F. Hoffmann-La Roche Ltd.: News/Key Developments, 2022-2024
• Table 61 : Microbiologics: Company Snapshot
• Table 62 : Microbiologics: Product Portfolio
• Table 63 : Microbiologics: News/Key Developments, 2022
• Table 64 : QuidelOrtho Corp.: Company Snapshot
• Table 65 : QuidelOrtho Corp.: Financial Performance, FY 2022 and 2023
• Table 66 : QuidelOrtho Corp.: Product Portfolio
• Table 67 : QuidelOrtho Corp.: News/Key Developments, 2021-2024
• Table 68 : Siemens Healthineers AG: Company Snapshot
• Table 69 : Siemens Healthineers AG: Financial Performance, FY 2022 and 2023
• Table 70 : Siemens Healthineers AG: Product Portfolio
• Table 71 : Siemens Healthineers AG: News/Key Developments, 2021-2023
• Table 72 : Sysmex Corp.: Company Snapshot
• Table 73 : Sysmex Corp.: Financial Performance, FY 2021 and 2022
• Table 74 : Sysmex Corp.: Product Portfolio
• Table 75 : Sysmex Corp.: News/Key Developments, 2022 and 2023
• Table 76 : Thermo Fisher Scientific Inc.: Company Snapshot
• Table 77 : Thermo Fisher Scientific Inc.: Financial Performance, FY 2022 and 2023
• Table 78 : Thermo Fisher Scientific Inc.: Product Portfolio
• Table 79 : Thermo Fisher Scientific Inc.: News/Key Developments, 2022 and 2023

List of Figures

• Summary Figure : Global Market Shares of In Vitro Diagnostics Quality Controls, by Test Type, 2023
• Figure 1 : In Vitro Diagnostics (IVD) Quality Controls Global Market: Market Dynamics
• Figure 2 : Elderly Population (Aged 65 and above), by Top Countries, 2022
• Figure 3 : Comparison Between Third-Party Controls and Original Equipment Manufacturer Controls
• Figure 4 : Global Market Shares of In Vitro Diagnostics Quality Controls, by Test Type 2023
• Figure 5 : Global Market Shares of In Vitro Diagnostics Quality Control, by Type of Manufacturer 2023
• Figure 6 : Global Market Shares of In Vitro Diagnostics Quality Controls, by Type of Product and Service, 2023
• Figure 7 : Global Market Shares of In Vitro Diagnostics Quality Controls, by Type of Quality Control Product, 2023
• Figure 8 : Global Market Shares of In Vitro Diagnostics Quality Controls, by End-user, 2023
• Figure 9 : Global Market Shares of In Vitro Diagnostics Quality Controls, by Region, 2023
• Figure 10 : North American Market Shares of In Vitro Diagnostics Quality Controls, by Test Type, 2023
• Figure 11 : North American Market Shares of In Vitro Diagnostics Quality Controls, by Type of Manufacturer, 2023
• Figure 12 : North American Market Shares of In Vitro Diagnostics Quality Controls, by Product and Service, 2023
• Figure 13 : North American Market Shares of In Vitro Diagnostics Quality Control Products, by Type of Product, 2023
• Figure 14 : North American Market Shares of In Vitro Diagnostics Quality Controls, by End User, 2023
• Figure 15 : North American Market Shares of In Vitro Diagnostics Quality Controls, by Country, 2023
• Figure 16 : European Market Shares of In Vitro Diagnostics Quality Controls, by Test Type, 2023
• Figure 17 : European Market Shares of In Vitro Diagnostics Quality Controls, by Type of Manufacturer, 2023
• Figure 18 : European Market Shares of In Vitro Diagnostics Quality Controls, by Product and Service, 2023
• Figure 19 : European Market Shares of In Vitro Diagnostics Quality Control Products, by Type of Product, 2023
• Figure 20 : European Market Shares of In Vitro Diagnostics Quality Controls, by End User, 2023
• Figure 21 : European Market Shares of In Vitro Diagnostics Quality Controls, by Country, 2023
• Figure 22 : Asia-Pacific Market Shares of In Vitro Diagnostics Quality Controls, by Test Type, 2023
• Figure 23 : Asia-Pacific Market Shares of In Vitro Diagnostics Quality Controls, by Type of Manufacturer, 2023
• Figure 24 : Asia-Pacific Market Shares of In Vitro Diagnostics Quality Controls, by Product and Service, 2023
• Figure 25 : Asia-Pacific Market Shares of In Vitro Diagnostics Quality Control Products, by Type of Product, 2023
• Figure 26 : Asia-Pacific Market Shares of In Vitro Diagnostics Quality Controls, by End User, 2023
• Figure 27 : Asia-Pacific Market Shares of In Vitro Diagnostics Quality Controls, by Country, 2023
• Figure 28 : Rest of World Market Shares of In Vitro Diagnostics Quality Controls, by Test Type, 2023
• Figure 29 : Rest of World Market Shares of In Vitro Diagnostic Quality Controls, by Type of Manufacturer, 2023
• Figure 30 : Rest of World Market Shares of In Vitro Diagnostics Quality Controls, by Product and Service, 2023
• Figure 31 : Rest of World Market Shares of In Vitro Diagnostics Quality Control Products, by Type of Product, 2023
• Figure 32 : Rest of World Market Shares of In Vitro Diagnostics Quality Controls, by End User, 2023
• Figure 33 : Rest of the World Market Shares of In Vitro Diagnostics Quality Controls, by Country/Sub-Region, 2023
• Figure 34 : Global Market Ranking of In Vitro Diagnostics Quality Controls, by Company, 2023
• Figure 35 : Snapshot: Key ESG Trends in the In Vitro Diagnostics Industry
• Figure 36 : Abbott: Revenue Shares, by Business Unit, FY 2023
• Figure 37 : Abbott: Revenue Shares, by Country/Region, FY 2023
• Figure 38 : BD: Revenue Shares, by Country/Region, FY 2023
• Figure 39 : BD: Revenue Shares, by Business Unit, FY 2023
• Figure 40 : bioMerieux: Revenue Shares, by Country/Region, FY 2023
• Figure 41 : bioMerieux: Revenue Shares, by Business Unit, FY 2023
• Figure 42 : Bio-Rad Laboratories Inc.: Revenue Shares, by Business Unit, FY 2023
• Figure 43 : Bio-Rad Laboratories Inc.: Revenue Shares, by Country/Region, FY 2023
• Figure 44 : Bio-Techne: Revenue Shares, by Business Unit, FY 2023
• Figure 45 : Bio-Techne: Revenue Shares, by Country/Region, FY 2023
• Figure 46 : Danaher Corp.: Revenue Shares, by Business Unit, FY 2023
• Figure 47 : Danaher Corp.: Revenue Shares, by Country/Region, FY 2023
• Figure 48 : F. Hoffmann-La Roche Ltd.: Revenue Shares, by Business Unit, FY 2023
• Figure 49 : F. Hoffmann-La Roche Ltd.: Revenue Shares, by Country/Region, FY 2023
• Figure 50 : QuidelOrtho Corp.: Revenue Shares, by Business Unit, FY 2023
• Figure 51 : QuidelOrtho Corp.: Revenue Shares, by Country/Region, FY 2023
• Figure 52 : Siemens Healthineers AG: Revenue Shares, by Business Unit, FY 2023
• Figure 53 : Siemens Healthineers AG: Revenue Shares, by Country/Region, FY 2023
• Figure 54 : Sysmex Corp.: Revenue Shares, by Business Unit, FY 2022
• Figure 55 : Sysmex Corp.: Revenue Shares, by Country/Region, FY 2022
• Figure 56 : Thermo Fisher Scientific Inc.: Revenue Shares, by Business Unit, FY 2023
• Figure 57 : Thermo Fisher Scientific Inc.: Revenue Shares, by Country/Region, FY 2023

The global market for In Vitro diagnostics quality controls is expected to grow from $1.5 billion in 2024 and is projected to reach $2.1 billion by the end of 2029, at a compound annual growth rate (CAGR) of 7.8% during the forecast period of 2024 to 2029.

The immunodiagnostics market for In Vitro diagnostics quality controls is expected to grow from $414.2 billion in 2024 and is projected to reach $625.7 billion by the end of 2029, at a CAGR of 8.6% during the forecast period of 2024 to 2029.

The hematology market for In Vitro diagnostics quality controls is expected to grow from $289.3 million in 2024 and is projected to reach $435.1 billion by the end of 2029, at a CAGR of 8.5% during the forecast period of 2024 to 2029.

Report Scope

This report provides details about the market for in vitro diagnostics quality controls used in checking the in vitro diagnostic devices present in labs, clinics and hospitals. This report will also highlight the current and future market potentiality of in vitro diagnostics quality controls, with a detailed analysis of the competitive environment between companies. Drivers, restraints, opportunities, prevalence or incidence of chronic diseases, and a regulatory scenario assessment will be covered in the current report. The report includes market projections for 2029 and market shares for key players.

Based on test type, the market is segmented into immunodiagnostics, clinical chemistry, hematology and hemostasis, molecular diagnostics, microbiology, and others. Based on products and services, the market is categorized into quality control products, data management solutions and quality assurance services. Based on type of manufacturer, the market is segmented into third-party controls and OEM controls. Based on end users, the market is segmented into hospitals, diagnostic laboratories and academic institutions.

By geographical region, the market has been segmented into North America, Europe, Asia-Pacific, and Rest of the World. Detailed analyses of major countries such as the U.S., Germany, the U.K., Italy, France, Spain, Japan, China, India, Brazil, Mexico, and GCC countries are covered within the regional segments. For market estimates, data will be provided for 2023 as the base year, with estimates for 2024 and forecast value for 2029.

Report Includes

• 40 data tables and 40 additional tables
• An overview of the global market for in vitro diagnostics (IVD) quality controls
• Analysis of global market trends, featuring revenue data for 2021-2023, estimated figures for 2024, and projected CAGRs through 2029
• Evaluation of the current market's size and revenue growth prospects, along with a market share analysis by test type, manufacturer, product/services, end user and region
• Discussion of market drivers and restraints and other dynamics
• Assessment of the regulatory landscape, including product recalls
• Analysis of the key companies' market shares, recent M&A activity, acquisitions, joint ventures, partnerships, and patents
• Company profiles,including Abbott, bioMerieux, F. Hoffmann-La Roche Ltd., Siemens Healthineers, and Thermo Fisher Scientific Inc.

Table of Contents

Chapter 1 Executive Summary

• Market Outlook
• Scope of Report
• Market Summary

Chapter 2 Market and Technology Background

• Introduction
• Overview
• Classification of In Vitro Diagnostics Elements
• Importance of In Vitro Diagnostics Quality Control
• Regulations
• Regulation of IVD products in Different countries

Chapter 3 Market Dynamics

• Market Drivers
• Rise in the Aging Population and Dependency on Frequent Diagnosis Procedures
• Rising Demand for Third-Party Quality Control Products
• Rising Incidence of Chronic Disease Cases
• Strengthening Clinical Laboratories
• Improving the Quality of Point-of-Care Testing
• Market Restraints
• Challenges for Quality Control Product Packaging
• Increases in Shipping Costs or Service Issues
• Improper Operation and Maintenance of Laboratory Equipment and Consumables
• Market Opportunities
• Rise in Home Care Testing Devices
• Demand for Point-of-Care (POC) Testing Units

Chapter 4 Emerging Technologies and Developments

• Artificial Intelligence
• Prioritizing Old IVD Techniques
• Automating In-Vitro Diagnostic Devices
• Emerging Trends in In Vitro Diagnostics
• FDA Approval
• Rise in Demand for Personalized Medicine

Chapter 5 Market Segmentation Analysis

• Segmentation Breakdown
• Market Breakdown by Test Type
• Immunodiagnostics
• Clinical Chemistry
• Hematology
• Molecular Diagnostics
• Microbiology
• Other Test Types
• Market Breakdown by Type of Manufacturer
• Third-party Controls
• ODM Controls
• Market Breakdown by Products and Services
• Quality Control Products
• Data Management Solutions
• Quality Assurance Services
• Market Breakdown by End User
• Diagnostic Laboratories
• Hospitals and Clinics
• Point-of-Care Centers
• Research Institutions
• Other End Users
• Geographic Breakdown
• Market Analysis by Region
• North America
• Market Size and Forecast
• U.S.
• Canada
• Mexico
• Europe
• Market Size and Forecast
• Germany
• France
• U.K.
• Italy
• Spain
• Rest of Europe
• Asia-Pacific
• Market Size and Forecast
• Japan
• China
• India
• Australia and New Zealand
• Rest of Asia-Pacific
• Rest of the World
• Market Size and Forecast
• Brazil
• GCC Countries
• Rest of the World Countries

Chapter 6 Competitive Intelligence

• Introduction
• Global Analysis of Company Market Ranking
• Agreements, Collaborations and Partnerships
• In Vitro Diagnostics Developments and Startups, 2021-2023

Chapter 7 Sustainability

• Importance of ESG in the In Vitro Diagnostics Industry
• ESG Practices in the In Vitro Diagnostics Industry
• Environmental Performance
• Social Performance
• Governance Performance
• Case Studies
• BCC Research Viewpoint

Chapter 8 Appendix

• Research Methodology
• References
• Company Profiles
• ABBOTT
• BD
• BIOMERIEUX
• BIO-RAD LABORATORIES INC.
• BIO-TECHNE
• DANAHER CORP.
• F. HOFFMANN-LA ROCHE LTD.
• MICROBIOLOGICS
• QUIDELORTHO CORP.
• SIEMENS HEATHNIEERS AG
• SYSMEX CORP.
• THERMO FISHER SCIENTIFIC INC.