IVD品質管理市場規模、シェア、成長分析：製品・サービス別、技術別、メーカータイプ別、エンドユーザー別、地域別 - 産業予測 2025～2032年

IVD品質管理の世界市場規模は2023年に11億1,000万米ドルと評価され、2024年の11億6,000万米ドルから2032年には15億9,000万米ドルに成長し、予測期間（2025-2032年）のCAGRは4.1％で成長する見通しです。

世界のIVD（体外診断薬）品質管理市場は、高齢者人口の増加、外部品質評価プログラムに対する需要の高まり、先進地域におけるポイントオブケア（POC）機器の採用などの要因によって、大きな成長を遂げています。感染症、HIV、がんの増加により、効果的な治療と厳格な品質モニタリングのための革新的な診断薬が必要とされています。例えば、2019年現在、約2,450万人がHIVの抗レトロウイルス療法を受けており、迅速診断システムの必要性が浮き彫りになっています。とはいえ、検査室への負担増、IVD検査に対する不利な償還シナリオ、多くの新興市場における強制的な認定規制の欠如など課題は残っており、市場の進展を妨げる可能性があります。

目次

イントロダクション

• 調査の目的
• 調査範囲
• 定義

調査手法

• 情報調達
• 二次と一次データの方法
• 市場規模予測
• 市場の前提条件と制限

エグゼクティブサマリー

• 世界市場の見通し
• 供給と需要の動向分析
• セグメント別機会分析

市場力学と見通し

• 市場概要
• 市場規模
• 市場力学
  • 促進要因と機会
  • 抑制要因と課題
• ポーターの分析

主な市場の考察

• 重要成功要因
• 競合の程度
• 主な投資機会
• 市場エコシステム
• 市場の魅力指数（2024年）
• PESTEL分析
• マクロ経済指標
• バリューチェーン分析
• 価格分析

IVD品質管理市場規模：製品・サービス別& CAGR（2025-2032）

• 市場概要
• 品質管理製品
  • 血清/血漿ベースのコントロール
  • 全血ベースのコントロール
  • 尿検査
  • その他のコントロール
• データ管理ソリューション
  • 検査情報管理システム（LIMS）
  • スタンドアロンソフトウェア
• 品質保証サービス

IVD品質管理市場規模：技術別& CAGR（2025-2032）

• 市場概要
• 免疫化学
• 臨床化学
  • 電解質とミネラル
  • 腎機能
  • 肝機能
  • タンパク質と酵素
  • 心臓マーカー
  • その他
• 分子診断
  • 核酸増幅検査
  • DNA配列解析
  • 遺伝子検査
  • その他
• 微生物学
• 血液学
• 凝固/止血
• その他の技術

IVD品質管理市場規模：メーカータイプ別& CAGR（2025-2032）

• 市場概要
• サードパーティのコントロール
  • 独立したコントロール
  • 楽器固有のコントロール
• オリジナル機器メーカーによる管理

IVD品質管理市場規模：エンドユーザー別& CAGR（2025-2032）

• 市場概要
• 病院
• 臨床検査室
• 学術研究機関
• その他のエンドユーザー

IVD品質管理市場規模：地域別& CAGR（2025-2032）

• 北米
  • 米国
  • カナダ
• 欧州
  • ドイツ
  • スペイン
  • フランス
  • 英国
  • イタリア
  • その他欧州地域
• アジア太平洋地域
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋地域
• ラテンアメリカ
  • ブラジル
  • その他ラテンアメリカ地域
• 中東・アフリカ
  • GCC諸国
  • 南アフリカ
  • その他中東・アフリカ

競合情報

• 上位5社の比較
• 主要企業の市場ポジショニング（2024年）
• 主な市場企業が採用した戦略
• 最近の市場動向
• 企業の市場シェア分析（2024年）
• 主要企業の企業プロファイル
  • 企業の詳細
  • 製品ポートフォリオ分析
  • 企業のセグメント別シェア分析
  • 収益の前年比比較（2022-2024）

主要企業プロファイル

• Thermo Fisher Scientific（United States）
• Danaher Corporation（United States）
• Sysmex Corporation（Japan）
• Tecan Group Ltd.（Switzerland）
• Eurofins Scientific（France）
• Intertek Group plc（United Kingdom）
• Bio-Rad Laboratories（United States）
• Roche Diagnostics（Switzerland）
• Siemens Healthineers（Germany）
• Abbott Laboratories（United States）
• Becton, Dickinson and Company（United States）
• Agilent Technologies（United States）
• PerkinElmer（United States）
• bioMerieux（France）
• DiaSorin（Italy）
• Ortho Clinical Diagnostics（United States）
• Quidel Corporation（United States）
• Hologic, Inc.（United States）
• Qiagen N.V.（Netherlands）

結論と提言

Global IVD Quality Control Market size was valued at USD 1.11 billion in 2023 and is poised to grow from USD 1.16 billion in 2024 to USD 1.59 billion by 2032, growing at a CAGR of 4.1% during the forecast period (2025-2032).

The global in vitro diagnostics (IVD) quality control market is experiencing significant growth, driven by factors such as the rising elderly population, an uptick in demand for external quality assessment programs, and the adoption of point-of-care (POC) instruments in developed regions. The increase in infectious diseases, HIV, and cancers necessitates innovative diagnostics for effective treatment and stringent quality monitoring. For instance, as of 2019, approximately 24.5 million individuals were receiving antiretroviral therapy for HIV, highlighting the need for rapid diagnostic systems. Nevertheless, challenges remain, including added burdens on laboratories, unfavorable reimbursement scenarios for IVD tests, and a lack of mandatory accreditation regulations in many emerging markets, which may hinder market progression.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Ivd Quality Control market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Ivd Quality Control Market Segments Analysis

Global IVD Quality Control Market is segmented by Product and Service, Technology, Manufacturer Type, End User and region. Based on Product and Service, the market is segmented into Quality control products, Data Management Solutions and Quality Assurance Services. Based on Technology, the market is segmented into Immunochemistry, Clinical Chemistry, Molecular Diagnostics, Microbiology, Hematology, Coagulation/ Hemostasis and Other Technologies. Based on Manufacturer Type, the market is segmented into Third-party controls and Original Equipment Manufacturer controls. Based on End User, the market is segmented into Hospitals, Clinical Laboratories, Academic and Research Institutes and Other End users. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Ivd Quality Control Market

The rise in the prevalence of various diseases has led to an increase in laboratory testing, driving growth in the global IVD quality control market. With the surge in demand for diagnostic testing due to the COVID-19 pandemic that began in December 2019, both public and private laboratories have expanded significantly. Governments around the world have responded by establishing additional laboratories to enhance testing capacity and meet the growing need for accurate diagnostics. This increase in laboratory infrastructure and testing capabilities has been a key factor propelling the market forward, as the demand for reliable quality control in diagnostics continues to escalate.

Restraints in the Global Ivd Quality Control Market

The global IVD quality control market faces significant restraints due to the high costs associated with establishing quality control (QC) procedures in hospitals and clinical laboratories. Implementing effective QC requires both substantial investment and specialized expertise, which can be a barrier, especially for clinical laboratories that operate with low volume QC processes. Additionally, many hospitals and laboratories are constrained by tight budgets, which further hampers the implementation and adoption of these crucial QC procedures. Consequently, these financial and resource challenges can lead to slower growth and limited utilization of quality control systems in the IVD market.

Market Trends of the Global Ivd Quality Control Market

The Global IVD Quality Control market is experiencing significant growth, driven by the rising prevalence of chronic diseases and an increased focus on precision medicine. Medical device companies are investing in the development of innovative, technologically advanced diagnostic devices to enhance testing accuracy and efficiency. Concurrently, hospitals and laboratories are increasingly adopting point-of-care testing solutions, facilitating immediate access to real-time data for better clinical decision-making. This shift towards rapid diagnostics, combined with stringent regulatory standards for quality control, is propelling market expansion. As healthcare's demand for reliability and speed continues to rise, the IVD quality control sector is poised for robust growth.

Table of Contents

Introduction

• Objectives of the Study
• Scope of the Report
• Definitions

Research Methodology

• Information Procurement
• Secondary & Primary Data Methods
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Global Market Outlook
• Supply & Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Overview
• Market Size
• Market Dynamics
  • Drivers & Opportunities
  • Restraints & Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of substitute
  • Bargaining power of buyers
  • Threat of new entrants
  • Bargaining power of suppliers

Key Market Insights

• Key Success Factors
• Degree of Competition
• Top Investment Pockets
• Market Ecosystem
• Market Attractiveness Index, 2024
• PESTEL Analysis
• Macro-Economic Indicators
• Value Chain Analysis
• Pricing Analysis

Global IVD Quality Control Market Size by Product and Service & CAGR (2025-2032)

• Market Overview
• Quality control products
  • Serum/ Plasma based controls
  • Whole blood based controls
  • Urine based controls
  • Other controls
• Data Management Solutions
  • Laboratory information management systems (LIMS)
  • Standalone software
• Quality Assurance Services

Global IVD Quality Control Market Size by Technology & CAGR (2025-2032)

• Market Overview
• Immunochemistry
• Clinical Chemistry
  • Electrolytes and minerals
  • Renal function
  • Liver function
  • Proteins and enzymes
  • Cardiac markers
  • Others
• Molecular Diagnostics
  • Nucleic acid amplification tests
  • DNA sequencing
  • Genetic testing
  • Others
• Microbiology
• Hematology
• Coagulation/ Hemostasis
• Other Technologies

Global IVD Quality Control Market Size by Manufacturer Type & CAGR (2025-2032)

• Market Overview
• Third-party controls
  • Independent controls
  • Instrument specific controls
• Original Equipment Manufacturer controls

Global IVD Quality Control Market Size by End User & CAGR (2025-2032)

• Market Overview
• Hospitals
• Clinical Laboratories
• Academic and Research Institutes
• Other End users

Global IVD Quality Control Market Size & CAGR (2025-2032)

• North America (Product and Service, Technology, Manufacturer Type, End User)
  • US
  • Canada
• Europe (Product and Service, Technology, Manufacturer Type, End User)
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific (Product and Service, Technology, Manufacturer Type, End User)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America (Product and Service, Technology, Manufacturer Type, End User)
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Product and Service, Technology, Manufacturer Type, End User)
  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2024
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2024
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2022-2024)

Key Company Profiles

• Thermo Fisher Scientific (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Danaher Corporation (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sysmex Corporation (Japan)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Tecan Group Ltd. (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Eurofins Scientific (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Intertek Group plc (United Kingdom)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Bio-Rad Laboratories (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Roche Diagnostics (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Siemens Healthineers (Germany)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Abbott Laboratories (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Becton, Dickinson and Company (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Agilent Technologies (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• PerkinElmer (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• bioMerieux (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• DiaSorin (Italy)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Ortho Clinical Diagnostics (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Quidel Corporation (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Hologic, Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Qiagen N.V. (Netherlands)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations