体外診断薬（IVD）の品質管理の世界市場

世界の体外診断薬（IVD）の品質管理の市場規模は、2022年に12億米ドルになるとみられています。

同市場は、2022年～2027年の予測期間中に5.5%のCAGRで拡大し、2027年には16億米ドルに達すると予測されています。

当レポートでは、世界の体外診断薬（IVD）の品質管理市場について調査し、市場の概要とともに、検査タイプ別、メーカータイプ別、製品・サービス別、エンドユーザー業界別、地域別の動向、および市場に参入する企業のプロファイルなどを提供しています。

目次

第1章 イントロダクション

第2章 まとめとハイライト

第3章 市場の背景と技術

• 概要
• 品質管理材料の特徴

第4章 市場力学

• 市場の促進要因
• 市場の課題

第5章 市場の内訳、検査タイプ別

• 世界の体外診断薬（IVD）の品質管理市場
• 市場分析
• 免疫診断の品質管理
• 臨床化学の品質管理
• 分子診断の品質管理
• 血液学および止血の品質管理
• 微生物学の品質管理
• その他の品質管理

第6章 市場の内訳、メーカータイプ別

• 世界の体外診断薬（IVD）の品質管理市場、メーカータイプ別
• 第三者コントロール
• OEMコントロール

第7章 市場の内訳、製品・サービス別

• 世界の体外診断薬（IVD）の品質管理市場、製品・サービス別
• 体外診断薬（IVD）の品質管理製品
• 製品タイプに基づく世界の体外診断薬（IVD）品質管理製品
• 血清/血漿ベースの品質管理
• 全血ベースの品質管理
• 尿ベースの品質管理
• その他の品質管理
• データ管理サービス
• 品質保証サービス

第8章 市場の内訳、エンドユーザー別

• 世界の体外診断薬（IVD）の品質管理市場、エンドユーザー別
• 診断研究所
• 病院、クリニック
• ポイントオブケアセンター
• 研究機関
• その他

第9章 市場の内訳、地域別

• 世界の体外診断薬（IVD）の品質管理市場、地域別
• 北米
• 欧州
• アジア太平洋
• その他の地域

第10章 規制シナリオ

• 北米のIVD規制
• 欧州のIVD規制
• アジア太平洋のIVD規制
• その他の地域のIVD規制（ラテンアメリカ、アフリカ、中東）

第11章 COVID-19パンデミックの影響

第12章 競合情勢

第13章 企業プロファイル

• ABBOTT LABORATORIES
• BECTON, DICKINSON & CO.
• BIOMERIEUX SA
• BIO-RAD LABORATORIES INC.
• BIO-TECHNE CORP.
• DANAHER
• EKF DIAGNOSTICS HOLDINGS PLC
• LGC LTD.
• MICROBIOLOGICS INC.
• MINDRAY MEDICAL INTERNATIONAL LTD.
• QNOSTICS LTD.
• QUIDEL CORP.
• RANDOX LABORATORIES LTD.
• ROCHE DIAGNOSTICS CORP.
• SERO AS
• SIEMENS HEALTHINEERS AG
• SYSMEX
• THERMOFISHER SCIENTIFIC INC.
• ZEPTOMETRIX LLC

List of Tables

• Summary Table : Global Market for IVD Quality Controls, by Test Type, Through 2027
• Table 1 : Comparison Between Third-Party Controls and Original Equipment Manufacturer Controls
• Table 2 : Global Market for IVD Quality Controls, by Test Type, Through 2027
• Table 3 : Global Market for Immunodiagnostic Quality Controls, by Region, Through 2027
• Table 4 : Global Market for Clinical Chemistry Quality Controls, by Region, Through 2027
• Table 5 : Global Market for Molecular Diagnostic Quality Controls, by Region, Through 2027
• Table 6 : Global Market for Hematology Quality Controls, by Region, Through 2027
• Table 7 : Global Market for Microbiology Quality Controls, by Region, Through 2027
• Table 8 : Global Market for Other Types of Quality Controls, by Region, Through 2027
• Table 9 : Global Market for IVD Quality Controls, by Type of Manufacturer, Through 2027
• Table 10 : Global Market for Third-Party Controls, by Region, Through 2027
• Table 11 : Global Market for OEM Controls, by Region, Through 2027
• Table 12 : Global Market for IVD Quality Controls, by Product and Service, Through 2027
• Table 13 : Global Market for IVD Quality Control Products, by Region, Through 2027
• Table 14 : Global Market for IVD Quality Control Products, by Product Type, Through 2027
• Table 15 : Comparison Between Dipper and Dropper Style Urinalysis Quality Controls
• Table 16 : Global Market for Data Management Services of IVD Quality Controls, by Region, Through 2027
• Table 17 : Global Market for Quality Assurance Services of IVD Quality Controls, by Region, Through 2027
• Table 18 : Global Market for IVD Quality Controls, by End User, Through 2027
• Table 19 : Global Market for IVD Quality Controls Used in Diagnostic Laboratories, by Region, Through 2027
• Table 20 : Global Market for IVD Quality Controls Used in Hospitals and Clinics, by Region, Through 2027
• Table 21 : Global Market for IVD Quality Controls Used in Point-of-Care Centers, by Region, Through 2027
• Table 22 : Global Market for IVD Quality Controls Used in Research Institutions, by Region, Through 2027
• Table 23 : Global Market for IVD Quality Controls Used by Other End Users, by Region, Through 2027
• Table 24 : Global Market for IVD Quality Controls, by Region, Through 2027
• Table 25 : North American Market for IVD Quality Controls, by Country, Through 2027
• Table 26 : European Market for IVD Quality Controls, by Country, Through 2027
• Table 27 : Asia-Pacific Market for IVD Quality Controls, by Country, Through 2027
• Table 28 : Becton, Dickinson, and Co.: Product Portfolio
• Table 29 : Becton, Dickinson, and Co.: Key Developments
• Table 30 : Bio-Rad Laboratories Inc.: Products Portfolio
• Table 31 : Bio-Rad Laboratories Inc.: Recent Developments
• Table 32 : Bio-Techne Corp.: Product Portfolio
• Table 33 : EKF Diagnostics Holdings PLC: Product Portfolio
• Table 34 : EKF Diagnostics Holdings plc: Key Developments
• Table 35 : LGC Ltd.: Key Developments
• Table 36 : Microbiologics Inc.: Product Portfolio
• Table 37 : Mindray Medical International Ltd.: Product Portfolio
• Table 38 : Qnostics Ltd.: Product Portfolio
• Table 39 : Quidel Corp.: Product Portfolio
• Table 40 : Quidel Corp.: Key Developments
• Table 41 : Randox Laboratories Ltd.: Product Portfolio
• Table 42 : Roche Diagnostics Corp.: Key Developments
• Table 43 : Sero AS: Product Portfolio
• Table 44 : Siemens Healthineers: Key Developments
• Table 45 : Sysmex: Key Developments
• Table 46 : ThermoFisher Scientific Inc.: Product Portfolio
• Table 47 : ThermoFisher Scientific Inc.: Key Developments
• Table 48 : ZeptoMetrix LLC: Product Portfolio
• Table 49 : ZeptoMetrix LLC: Key Developments

List of Figures

• Summary Figure : Global Market for IVD Quality Controls, by Test Type, 2020-2027
• Figure 1 : Global Market Shares of IVD Quality Controls, by Test Type, 2021
• Figure 2 : Global Market for Immunodiagnostic Quality Controls, by Region, 2020-2027
• Figure 3 : Global Market Shares of Immunodiagnostic Quality Controls, by Region, 2021
• Figure 4 : Global Market for Clinical Chemistry Quality Controls, by Region, 2020-2027
• Figure 5 : Global Market Shares of Clinical Chemistry Quality Controls, by Region, 2021
• Figure 6 : Global Market for Molecular Diagnostic Quality Controls, by Region, 2020-2027
• Figure 7 : Global Market Shares of Molecular Diagnostic Quality Controls, by Region, 2021
• Figure 8 : Global Market for Hematology Quality Controls, by Region, 2020-2027
• Figure 9 : Global Market Shares of Hematology Quality Controls, by Region, 2021
• Figure 10 : Global Market for Microbiology Quality Controls, by Region, 2020-2027
• Figure 11 : Global Market Shares of Microbiology Quality Controls, by Region, 2021
• Figure 12 : Global Market for Other Types of Quality Controls, by Region, 2020-2027
• Figure 13 : Global Market Shares of Types of Other Quality Controls, by Region, 2021
• Figure 14 : Global Market Shares of IVD Quality Controls, by Type of Manufacturer, 2021
• Figure 15 : Global Market for Third-Party Quality Controls, 2020-2027
• Figure 16 : Global Market for OEM Controls, 2020-2027
• Figure 17 : Global Market Shares of IVD Quality Controls, by Product and Service, 2021
• Figure 18 : Global Market for IVD Quality Control Products, 2020-2027
• Figure 19 : Global Market Shares of IVD Quality Control Products, by Product Type, 2021
• Figure 20 : Global Market for Serum/Plasma Based Quality Controls, 2020-2027
• Figure 21 : Global Market for Whole Blood-Based Quality Controls, 2020-2027
• Figure 22 : Global Market for Urine-Based Quality Controls, 2020-2027
• Figure 23 : Global Market for Other Types of Product Quality Controls, 2020-2027
• Figure 24 : Global Market for Data Management Services of IVD Quality Controls, 2020-2027
• Figure 25 : Global Market for Quality Assurance Services of IVD Quality Controls, 2020-2027
• Figure 26 : Global Market Shares of IVD Quality Controls, by End User, 2021
• Figure 27 : Global Market for IVD Quality Controls, by End User, 2020-2027
• Figure 28 : Global Market for IVD Quality Controls Used in Diagnostics Laboratories, 2021-2027
• Figure 29 : Global Market for IVD Quality Controls Used in Hospitals and Clinics, 2020-2027
• Figure 30 : Global Market for IVD Quality Controls Used in Point-of-Care Centers, 2020-2027
• Figure 31 : Global Market for IVD Quality Controls Used in Research Institutions, 2020-2027
• Figure 32 : Global Market for IVD Quality Controls Used by Other End Users, 2021-2027
• Figure 33 : Global Market Shares of IVD Quality Controls, by Region, 2021
• Figure 34 : North American Market Shares of IVD Quality Controls, by Country, 2021
• Figure 35 : U.S. Market for IVD Quality Controls, 2020-2027
• Figure 36 : Canadian Market for IVD Quality Controls, 2020-2027
• Figure 37 : Mexican Market for IVD Quality Controls, 2020-2027
• Figure 38 : European Market Shares of IVD Quality Controls, by Country, 2021
• Figure 39 : German Market for IVD Quality Controls, 2020-2027
• Figure 40 : U.K. Market for IVD Quality Controls, 2020-2027
• Figure 41 : French Market for IVD Quality Controls, 2020-2027
• Figure 42 : Rest of the European Market for IVD Quality Controls, 2020-2027
• Figure 43 : Asia-Pacific Market Shares of IVD Quality Controls, by Country, 2021
• Figure 44 : Chinese Market for IVD Quality Controls, 2020-2027
• Figure 45 : Australian Market for IVD Quality Controls, 2020-2027
• Figure 46 : Japanese Market for IVD Quality Controls, 2020-2027
• Figure 47 : Rest of Asia-Pacific Market for IVD Quality Controls, 2020-2027
• Figure 48 : Rest of the World Market for IVD Quality Controls, 2020-2027
• Figure 49 : Abbott Laboratories: Annual Revenue, 2019-2021
• Figure 50 : Abbott Laboratories: Market Share, by Business Segment, 2021
• Figure 51 : Abbott Laboratories: Market Share of Diagnostics Segment, by Region, 2021
• Figure 52 : Abbott Laboratories: Market Share of Diagnostics Segment, by Business, 2021
• Figure 53 : Becton, Dickinson and Co.: Annual Revenue, 2019-2021
• Figure 54 : Becton, Dickinson, and Co.: Market Share, by Region, 2021
• Figure 55 : Becton, Dickinson, and Co.: Market Share, by Business Segment, 2021
• Figure 56 : BioMerieux SA, Annual Revenue, 2019-2021
• Figure 57 : BioMerieux SA: Market Share, by Business Segment, 2021
• Figure 58 : BioMerieux SA: Market Share, by Region, 2021
• Figure 59 : Bio-Rad Laboratories Inc.: Annual Revenue, 2019-2021
• Figure 60 : Bio-Rad Laboratories Inc.: Market Share, by Business Segment, 2021
• Figure 61 : Bio-Rad Laboratories Inc.: Revenue Share, by Region, 2021
• Figure 62 : Bio-Techne Corp., Annual Revenue, 2019-2021*
• Figure 63 : Bio-Techne Corp.: Market Share, by Region/Country, 2021
• Figure 64 : Bio-Techne Corp.: Market Share, by Segment, 2021
• Figure 65 : Danaher: Annual Revenue, 2019-2021
• Figure 66 : Danaher: Market Share of Diagnostics Segment, by Region, 2021
• Figure 67 : Danaher: Market Share, by Business Segment, 2021
• Figure 68 : EKF Diagnostics Holdings PLC: Annual Revenue, 2020 and 2021
• Figure 69 : EKF Diagnostics Holdings PLC: Market Share, by Region, 2021
• Figure 70 : EKF Diagnostics Holdings PLC: Market Share, by Business Segment, 2021
• Figure 71 : LGC Ltd.: Annual Revenue, 2019 and 2020*
• Figure 72 : LGC Ltd.: Market Share, by Region, 2020
• Figure 73 : LGC Ltd.: Market Share, by Business Segment, 2020
• Figure 74 : Quidel Corp.: Annual Revenue, 2019-2021
• Figure 75 : Quidel Corp.: Market Share, by Region, 2021
• Figure 76 : Quidel Corp.: Market Share, by Business Segment, 2021
• Figure 77 : Roche Diagnostics Corp.: Annual Revenue, 2020 and 2021
• Figure 78 : Roche Diagnostics Corp.: Market Share, by Region, 2021
• Figure 79 : Roche Diagnostics Corp.: Market Share, by Business Segment, 2021
• Figure 80 : Siemens Healthineers AG: Annual Revenue, 2020 and 2021
• Figure 81 : Siemens Healthineers: Market Share, by Business Segment, 2021
• Figure 82 : Siemens Healthineers: Market Share, by Region, 2021
• Figure 83 : Sysmex: Annual Revenue, 2019-2021
• Figure 84 : Sysmex: Market Share, by Region/Country, 2021
• Figure 85 : Sysmex: Revenue Share, by Business Segment, 2021
• Figure 86 : ThermoFisher Scientific Inc.: Annual Revenue, 2019-2021
• Figure 87 : ThermoFisher Scientific Inc.: Market Share, by Region, 2021
• Figure 88 : ThermoFisher Scientific Inc.: Market Share, by Business Segment, 2021
• Figure 89 : ThermoFisher Scientific Inc.: Market Share, by Product, 2021

Highlights:

The global in vitro diagnostic (IVD) quality controls market should reach $1.6 billion by 2027 from $1.2 billion in 2022 at a compound annual growth rate (CAGR) of 5.5% for the forecast period of 2022 to 2027.

The immunodiagnostics segment of the global IVD quality controls market is expected to grow from $365.1 million in 2022 to $457.4 million in 2027 at a CAGR of 4.6% for the forecast period of 2022 to 2027.

The molecular diagnostics segment of the global IVD quality controls market is expected to grow from $217.5 million in 2022 to $305.6 million in 2027 at a CAGR of 7.0% for the forecast period of 2022 to 2027.

Report Scope:

The current report provides detailed information regarding the in vitro diagnostics quality controls market. This report highlights the current and future market potential of in vitro diagnostics controls and a detailed analysis of the drivers and challenges in the market. The report also covers market projections to 2027 and market rank for key market players. It also covers the competitive environment and regulatory scenario. The report details the market share of IVD controls based on test type, products and services, manufacturer, application and end user.

Based on test type, the market is segmented into immunoassays, clinical chemistry, hematology and hemostasis, molecular diagnostics, microbiology and others. Based on products and services, controls are categorized into quality control products, data management solutions, and quality assurance services. Based on 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.

The report includes the company profiles of the key players with detailed information about their business segments, financials, product portfolios and recent developments. The report also includes impact of the COVID-19 pandemic on this market.

By geography, the market has been segregated into North America, Europe, Asia-Pacific and the Rest of the world. The North America region includes the U.S., Canada and Mexico. Europe includes Germany, U.K., Italy and Rest of Europe. Asia-Pacific includes China, India, Japan and the Rest of Asia-Pacific.

For market estimates, data has been provided for the 2020 as the historic year, 2021 as the base year and forecast for 2027.

Report Includes:

• 26 data tables and 24 additional tables
• An overview of the global market for in vitro diagnostics (IVD) quality controls market
• Estimation of the market size and analyses of global market trends, with data from 2021, estimates for 2022 with projections of compound annual growth rates (CAGRs) through 2027
• Highlights of the market potential for in vitro diagnostics (IVD) quality controls market, based on test type, manufacturer, products and services, end user, and region
• Identification of market drivers, restraints and other forces impacting the global market and evaluation of current market size and forecast
• Coverage of regulatory landscape, product recalls, pipeline products, and discussion on future perspective, strategies, and developments of the industry
• Market share analysis of the key companies of the industry and coverage of events like mergers & acquisitions, joint ventures, collaborations or partnerships, and other key market strategies and a relevant patent analysis
• Company profiles of major players, including Abbott Laboratories, Bio-Rad Laboratories Inc., LGC Ltd., Siemens Healthineers AG, and ThermoFisher Scientific Inc.

Table of Contents

Chapter 1 Introduction

• Study Goals and Objectives
• Reasons for Doing This Study
• Scope of This Report
• Methodology
• Geographic Breakdown
• Analyst's Credentials
• BCC Custom Research
• Related BCC Research Reports

Chapter 2 Summary and Highlights

• Highlights of the Market for IVD Quality Controls

Chapter 3 Market Background and Technology

• Overview
• Characteristics of Quality Control Materials

Chapter 4 Market Dynamics

• Market Drivers
• Growing Demand for Third-Party Controls
• Increasing Focus on Internal Quality Control in Point-of-Care Tests
• Rising Aging Population and Global Incidence of Chronic Diseases
• Market Challenges
• Matrix Effects with QC Materials
• Lack of Well-Defined Standards for Molecular QC Tests
• Packaging Challenges
• Stringent Regulatory Framework

Chapter 5 Market Breakdown by Test Type

• Global Market for In Vitro Diagnostic (IVD) Quality Controls
• Market Analysis
• Immunodiagnostic Quality Controls
• Clinical Chemistry Quality Controls
• Molecular Diagnostic Quality Controls
• Market Size and Forecast
• Hematology and Hemostasis Quality Controls
• Market Size and Forecast
• Microbiology Quality Controls
• Market Size and Forecast
• Other Quality Controls
• Market Size and Forecast

Chapter 6 Market Breakdown by Type of Manufacturer

• Global Market for IVD Quality Controls by Type of Manufacturer
• Third-Party Controls
• OEM Controls

Chapter 7 Market Breakdown by Product and Service

• Global Market for IVD Quality Controls by Product and Service
• IVD Quality Control Products
• Global Market for IVD Quality Control Products Based on Product Type
• Serum/Plasma-Based Quality Controls
• Whole Blood-Based Quality Controls
• Urine Based Quality Controls
• Other Quality Controls
• Data Management Services
• Quality Assurance Services

Chapter 8 Market Breakdown by End User

• Global Market for IVD Quality Controls by End User
• Diagnostic Laboratories
• Hospitals and Clinics
• Point-of-Care Centers
• Research Institutions
• Others

Chapter 9 Market Breakdown by Region

• Global Market for IVD Quality Controls by Region
• North America
• United States
• Canada
• Mexico
• Europe
• Germany
• United Kingdom
• France
• Rest of Europe
• Asia-Pacific
• China
• Australia
• Japan
• Rest of Asia-Pacific
• Rest of the World

Chapter 10 Regulatory Scenario

• IVD Regulations in North America
• United States
• Canada
• Mexico
• IVD Regulations in Europe
• IVD Regulations in Asia-Pacific
• Japan
• China
• India
• Australia and New Zealand
• Malaysia
• Singapore
• IVD Regulations in RoW (Latin America, Africa and Middle East)
• Brazil
• Israel
• Saudi Arabia
• South Africa

Chapter 11 Impact of the COVID-19 Pandemic

• Impact of COVID-19 on the IVD Quality Controls Market
• Increased Demand for Molecular and Immunoassay Assay Quality Controls
• Decreased Demand for Routine Diagnostic Testing
• Delays in the Implementation of Regulations
• Shortage of Raw Materials

Chapter 12 Competitive Landscape

• Overview
• Recent Developments of Key Market Players
• Growth Strategies

Chapter 13 Company Profiles

• ABBOTT LABORATORIES
• BECTON, DICKINSON & CO.
• BIOMERIEUX SA
• BIO-RAD LABORATORIES INC.
• BIO-TECHNE CORP.
• DANAHER
• EKF DIAGNOSTICS HOLDINGS PLC
• LGC LTD.
• MICROBIOLOGICS INC.
• MINDRAY MEDICAL INTERNATIONAL LTD.
• QNOSTICS LTD.
• QUIDEL CORP.
• RANDOX LABORATORIES LTD.
• ROCHE DIAGNOSTICS CORP.
• SERO AS
• SIEMENS HEALTHINEERS AG
• SYSMEX
• THERMOFISHER SCIENTIFIC INC.
• ZEPTOMETRIX LLC