体外診断品質管理の世界市場 - 戦略と動向、アッセイタイプ別、場所別、製品タイプ別、メーカー別、国別予測 - エグゼクティブコンサルタントガイド付き（2024年～2028年）

体外診断品質管理業界はパンデミックという課題に立ち向かっています。不況とは無縁のこの業界には今、新たなチャンスがあふれています。

臨床検査は、バイオテクノロジー、特にゲノミクスの爆発的な発展から直接恩恵を受ける立場にあります。様々なダイナミックな動向が市場の成長と企業の評価を押し上げています。品質管理産業は利益を得る立場にあります。

当レポートは、世界の体外診断品質管理市場について調査し、市場の概要とともに、アッセイタイプ別、場所別、製品タイプ別、メーカー別、国別動向、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 市場ガイド

第2章 イントロダクションと市場の定義

• 体外診断品質管理とは何か
• 機会の定義
• 調査手法
• 視点：ヘルスケアとIVD業界

第3章 ダイナミックな市場の概要

• 市場参入組織
  • 学術研究機関
  • 診断試験開発者
  • 計装サプライヤー
  • 薬品・試薬メーカー
  • 病理サプライヤー
  • 独立系臨床検査室
  • 公共の国立/地域研究所
  • 病院検査室
  • 臨床検査室
  • 監査機関
  • 認証機関
• セグメンテーション- さまざまなアプローチ
• 臨床検査業界の構造
• 国と地域の多様性

第4章 変化する市場推進動向

• 成長は多くの側面から推進される
• 市場縮小の要因
• 自動化と研究室の動向

第5章 体外診断品質管理の最近の動向

第6章 主要企業のプロファイル

• Abbott Laboratories
• Alpha-Tec Systems
• Beckman Coulter Diagnostics（Danaher）
• Becton, Dickinson and Company
• BioFire Diagnostics（bioMerieux）
• bioMerieux Diagnostics
• Bio-Rad Laboratories, Inc
• Bio-Techne
• Danaher Corporation
• Diasorin S.p.A.
• Fortress Diagnostics
• Grifols
• Helena Laboratories
• Hologic
• LGC Standards
• Maine Molecular Quality Controls
• Microbiologics
• Microbix Systems
• Novacyt
• QuidelOrtho
• Randox Toxicology
• Seegene
• SERO
• Siemens Healthineers
• Streck
• Sun Diagnostics
• Sysmex
• Thermo Fisher Scientific
• ZeptoMetrix

第7章 体外診断品質管理の世界市場

• 国別世界市場概要
• アッセイタイプ別世界市場概要
• 地域別世界市場概要
• 製品別世界市場概要
• メーカー別世界市場- 概要

第8章 世界の体外診断品質管理市場- アッセイタイプ別

• 化学
• 微生物学
• 血液学
• 解剖病理学
• 分子診断
• 難解

第9章 世界の体外診断品質管理市場- 場所別

• 病院
• 外来検査室
• 研究室
• 診療所検査室
• その他の研究室

第10章 世界の体外診断品質管理市場- 製品別

• 全血
• 血漿
• 尿
• その他

第11章 世界の体外診断品質管理市場- メーカー別

• オリジナル機器メーカー
• サードパーティのジェネリック
• サードパーティの機器
• カスタムその他

第12章 付録

Table of Tables

• Table 1 Market Players by Type
• Table 2 Clinical Laboratory Departments and Segments
• Table 3 Laboratory Management Focus - Different Approaches
• Table 4 Key Segmentation Variables Going Forward
• Table 5 Factors Affecting Local Clinical Testing Demand
• Table 6 Seven Factors Driving Growth
• Table 7 Six Factors Limiting Growth
• Table 8 Seven Key Diagnostic Laboratory Technology Trends
• Table 9-Global Market by Region
• Table 10 Global Market by Assay Type
• Table 11 Global Market by Place
• Table 12 Global Market by Product
• Table 13 Global Market by Manufacturer
• Table 14 Chemistry by Country
• Table 15 Microbiology by Country
• Table 16 Hematology by Country
• Table 17 Anatomic Pathology by Country
• Table 18 Molecular Diagnostics by Country
• Table 19 Esoteric by Country
• Table 20 Hospital by Country
• Table 21 Outpatient Laboratory by Country
• Table 22 Research Laboratory by Country
• Table 23 Physicians Office Laboratory by Country
• Table 24 Other Laboratory by Country
• Table 25 Whole Blood by Country
• Table 26 Plasma by Country
• Table 27 Urine by Country
• Table 28 Control Material Other by Country
• Table 29 Original Equipment Manufacturer by Country
• Table 30 Third Party Generic by Country
• Table 31 Third Party Instrument Specific by Country
• Table 32 Custom Other by Country
• Table 33 The Most Common Assays
• Table 34 Largest Revenue Assays
• Table 35 Clinical Lab Fee Schedule

Table of Figures

• Figure 1 Global Healthcare Spending
• Figure 2 The Road to Diagnostics
• Figure 3 The Changing Age of The World's Population
• Figure 4 Health Care Consumption by Age
• Figure 5 Cancer Incidence - Age at Diagnosis
• Figure 6 Centralized vs. Decentralized Laboratory Service
• Figure 7 A Highly Multiplexed Syndromic Testing Unit
• Figure 8 The Real Cost to Sequence the Human Genome
• Figure 9 The Codevelopment Process
• Figure 10 Comparing MDx Diagnostic and Traditional Testing
• Figure 11 Global Market Pareto Chart
• Figure 12 Global Market by Assay Type-Base vs. Final
• Figure 13 Global Market by Assay Type Base Year
• Figure 14 Global Market by Assay Type End Year
• Figure 15 Assay Type Share by Year
• Figure 16 Assay Type Segments Growth
• Figure 17 Global Market by Place-Base vs. Final
• Figure 18 Global Market by Place Base Year
• Figure 19 Global Market by Place End Year
• Figure 20 Place Share by Year
• Figure 21 Place Segments Growth
• Figure 22 Global Market by Product-Base vs. Final
• Figure 23 Global Market by Product Base Year
• Figure 24 Global Market by Product End Year
• Figure 25 Product Share by Year
• Figure 26 Product Segments Growth
• Figure 27 Global Market by Manufacturer-Base vs. Final
• Figure 28 Global Market by Manufacturer Base Year
• Figure 29 Global Market by Manufacturer End Year
• Figure 30 Manufacturer Share by Year
• Figure 31 Manufacturer Segments Growth
• Figure 32 Chemistry Growth
• Figure 33 Microbiology Growth
• Figure 34 Hematology Growth
• Figure 35 Anatomic Pathology Growth
• Figure 36 Molecular Diagnostics Growth
• Figure 37 Esoteric Growth
• Figure 38 Hospital Growth
• Figure 39 Out Patient Laboratory Growth
• Figure 40 Research Laboratory Growth
• Figure 41 Physicians Office Laboratory Growth
• Figure 42 Other Laboratory Growth
• Figure 43 Whole Blood Growth
• Figure 44 Plasma Growth
• Figure 45 Urine Growth
• Figure 46 Control Material Other Growth
• Figure 47 Original Equipment Manufacturer Growth
• Figure 48 Third Party Generic Growth
• Figure 49 Third Party Instrument Specific Growth
• Figure 50 Custom Other Growth
• Figure 51 IVD Test Menu Growth
• Figure 52 IVD Test Average Fees - A Ten Year View

OVERVIEW:

The IVD Quality Control industry rose to the challenge of the pandemic. Now new opportunities abound in this established industry that is immune from recession. New technology and new segments are driving runaway growth. Understand the opportunities and the threats in this comprehensive report.

The fundamentals are still here. Clinical laboratory testing is positioned to directly benefit from the explosion in biotechnology, especially genomics. A range of dynamic trends are pushing market growth and company valuations. The Quality Control industry stands to gain.

The report provides data that analysts and planners can use. Hundreds of pages of information including detailed information on clinical laboratory trends and the role of IVD. Forecast demand for new testing regimes or technologies.

The report includes detailed breakouts for 15 Countries and 4 Regions. A detailed breakout for any country in the world is available to purchasers of the report.

All report data is available in Excel format on request.

Make investment decisions and valuations with confidence using the latest data.

ABOUT THE LEAD AUTHOR:

Mr. Greg Powell, B.SC., M.B.A is the President of Howe Sound Research. He is an experienced business and clinical professional. He is co-author of the paper "The Radioimmunoassay of Angiotensinogen by Antibody Trapping." He has worked in laboratory testing and management for over 20 years. Mr. Powell's education includes:

• B.Sc. (Chemistry) University of BC
• M.B.A. (Finance and Policy) University of BC
• Market Research Seminar - Burke Institute
• Finance for Senior Executives - Harvard Business School

Table of Contents

1 Market Guides

• 1.1 Strategic Situation Analysis
• 1.2 Guide for Executives, Marketing, Sales and Business Development Staff
• 1.3 Guide for Management Consultants and Investment Advisors

2 Introduction and Market Definition

• 2.1 What is IVD Quality Control?
• 2.2 Defining the Opportunity
  • 2.2.1 Revenue Market Size
• 2.3 Methodology
  • 2.3.1 Methodology
  • 2.3.2 Sources
  • 2.3.3 Authors
• 2.4 Perspective: Healthcare and the IVD Industry
  • 2.4.1 Global Healthcare Spending
  • 2.4.2 Spending on Diagnostics
  • 2.4.3 Important Role of Insurance for Diagnostics

3 Overview of a Dynamic Market

• 3.1 Players in a Dynamic Market
  • 3.1.1 Academic Research Lab
  • 3.1.2 Diagnostic Test Developer
  • 3.1.3 Instrumentation Supplier
  • 3.1.4 Chemical/Reagent Supplier
  • 3.1.5 Pathology Supplier
  • 3.1.6 Independent Clinical Laboratory
  • 3.1.7 Public National/regional Laboratory
  • 3.1.8 Hospital Laboratory
  • 3.1.9 Physicians Office Lab (POLS)
  • 3.1.10 Audit Body
  • 3.1.11 Certification Body
• 3.2 Segmentation - Different Approaches
  • 3.2.1 Traditional Market Segmentation
  • 3.2.2 Laboratory Focus and Segmentation
• 3.3 Structure of Clinical Testing Industry
  • 3.3.1 The Hospital Lab - Share of the Pie
  • 3.3.2 Key Role for Economies of Scale
  • 3.3.3 Physician Office Lab's are Still Here
  • 3.3.4 Physician's and POCT - Reviving Patient Service in China
• 3.4 National and Regional Diversity

4 Trends Driving a Changing Market

• 4.1 Growth Is Pushed from Many Sides
  • 4.1.1 Demographic Impacts on Consumption
  • 4.1.2 Alternative Suppliers
  • 4.1.3 Impact of POC
  • 4.1.4 Impact of Accreditation
  • 4.1.5 Genetic and Molecular Issues
• 4.2 Factors at Work to Shrink the Market
  • 4.2.1 Where are Costs Going?
  • 4.2.2 Management Practices
  • 4.2.3 Cannabilization
  • 4.2.4 Point of Care
• 4.3 Automation and Laboratory Trends
  • 4.3.1 Traditional Automation and Centralization
  • 4.3.2 The New Automation, Decentralization and Point Of Care
  • 4.3.3 Instruments Key to Market Share
  • 4.3.4 Bioinformatics Plays a Role
  • 4.3.5 PCR Takes Command
  • 4.3.6 Next Generation Sequencing Fuels a Revolution
  • 4.3.7 NGS Impact on Pricing
  • 4.3.8 Whole Genome Sequencing, A Brave New World
  • 4.3.9 Companion Diagnostics Blurs Diagnosis and Treatment
  • 4.3.10 Shifting Role of Diagnostics

5 IVD Quality Control Recent Developments

• 5.1 Recent Developments - Importance and How to Use This Section
  • 5.1.1 Importance of These Developments
  • 5.1.2 How to Use This Section
• 5.2 New FDA Quality Regulations Spark Questions
• 5.3 Waters MassTrak Steroid Serum (IVD) Sets
• 5.4 Cancer Test Harmonization Efforts Progress
• 5.5 Bio-Techne Expanding With Ella Immunoassay Instrument
• 5.6 ZeptoMetrix QC Products Receive IVDR Certification
• 5.7 Coverage Criteria for Cancer Genetic Tests Creates Alarm
• 5.8 IVDR Rollout Brings QC Hurdles for Clinical Labs
• 5.9 LGC Clinical Diagnostics Acquires QC Product Maker Kova International
• 5.10 FDA Probing Lab Test Quality in Cancer Care
• 5.11 Sensible Diagnostics to Launch 10-Minute POC PCR System
• 5.12 Streck Gets FDA Clearance for BioFire Sepsis Panel Control Material

6 Profiles of Key Companies

• 6.1 Abbott Laboratories
• 6.2 Alpha-Tec Systems
• 6.3 Beckman Coulter Diagnostics (Danaher)
• 6.4 Becton, Dickinson and Company
• 6.5 BioFire Diagnostics (bioMerieux)
• 6.6 bioMerieux Diagnostics
• 6.7 Bio-Rad Laboratories, Inc
• 6.8 Bio-Techne
• 6.9 Danaher Corporation
• 6.10 Diasorin S.p.A.
• 6.11 Fortress Diagnostics
• 6.12 Grifols
• 6.13 Helena Laboratories
• 6.14 Hologic
• 6.15 LGC Standards
• 6.16 Maine Molecular Quality Controls
• 6.17 Microbiologics
• 6.18 Microbix Systems
• 6.19 Novacyt
• 6.20 QuidelOrtho
• 6.21 Randox Toxicology
• 6.22 Seegene
• 6.23 SERO
• 6.24 Siemens Healthineers
• 6.25 Streck
• 6.26 Sun Diagnostics
• 6.27 Sysmex
• 6.28 Thermo Fisher Scientific
• 6.29 ZeptoMetrix

7 The Global Market for IVD Quality Control

• 7.1 Global Market Overview by Country
  • 7.1.1 Table - Global Market by Country
  • 7.1.2 Chart-Global Market by Country
• 7.2 Global Market by Assay Type-Overview
  • 7.2.1 Table - Global Market by Assay Type
  • 7.2.2 Chart - Global Market by Assay Type - Base/Final Year Comparison
  • 7.2.3 Chart - Global Market by Assay Type - Base Year
  • 7.2.4 Chart - Global Market by Assay Type - End Year
  • 7.2.5 Chart - Global Market by Assay Type - Share by Year
  • 7.2.6 Chart - Global Market by Assay Type - Segments Growth
• 7.3 Global Market by Place-Overview
  • 7.3.1 Table - Global Market by Place
  • 7.3.2 Chart - Global Market by Place - Base/Final Year Comparison
  • 7.3.3 Chart - Global Market by Place - Base Year
  • 7.3.4 Chart - Global Market by Place - End Year
  • 7.3.5 Chart - Global Market by Place - Share by Year
  • 7.3.6 Chart - Global Market by Place - Segments Growth
• 7.4 Global Market by Product-Overview
  • 7.4.1 Table - Global Market by Product
  • 7.4.2 Chart - Global Market by Product - Base/Final Year Comparison
  • 7.4.3 Chart - Global Market by Product - Base Year
  • 7.4.4 Chart - Global Market by Product - End Year
  • 7.4.5 Chart - Global Market by Product - Share by Year
  • 7.4.6 Chart - Global Market by Product - Segments Growth
• 7.5 Global Market by Manufacturer- Overview
  • 7.5.1 Table - Global Market by Manufacturer
  • 7.5.2 Chart - Global Market by Manufacturer - Base/Final Year Comparison
  • 7.5.3 Chart - Global Market by Manufacturer - Base Year
  • 7.5.4 Chart - Global Market by Manufacturer - End Year
  • 7.5.5 Chart - Global Market by Manufacturer - Share by Year
  • 7.5.6 Chart - Global Market by Manufacturer - Segments Growth

8 Global IVD Quality Control Markets - By Assay Type

• 8.1 Chemistry
  • 8.1.1 Table Chemistry - by Country
  • 8.1.2 Chart-Chemistry Growth
• 8.2 Microbiology
  • 8.2.1 Table Microbiology - by Country
  • 8.2.2 Chart-Microbiology Growth
• 8.3 Hematology
  • 8.3.1 Table Hematology - by Country
  • 8.3.2 Chart-Hematology Growth
• 8.4 Anatomic Pathology
  • 8.4.1 Table Anatomic Pathology - by Country
  • 8.4.2 Chart-Anatomic Pathology Growth
• 8.5 Molecular Diagnostics
  • 8.5.1 Table Molecular Diagnostics - by Country
  • 8.5.2 Chart-Molecular Diagnostics Growth
• 8.6 Esoteric
  • 8.6.1 Table Esoteric - by Country
  • 8.6.2 Chart-Esoteric Growth

9 Global IVD Quality Control Markets - By Place

• 9.1 Hospital
  • 9.1.1 Table Hospital - by Country
  • 9.1.2 Chart-Hospital Growth
• 9.2 Outpatient Laboratory
  • 9.2.1 Table Outpatient Laboratory - by Country
  • 9.2.2 Chart - Outpatient Laboratory Growth
• 9.3 Research Laboratory
  • 9.3.1 Table Research Laboratory - by Country
  • 9.3.2 Chart-Research Laboratory Growth
• 9.4 Physicians Office Laboratory
  • 9.4.1 Table Physicians Office Laboratory - by Country
  • 9.4.2 Chart-Physicians Office Laboratory Growth
• 9.5 Other Laboratory
  • 9.5.1 Table Other Laboratory - by Country
  • 9.5.2 Chart-Other Laboratory Growth

10 Global IVD Quality Control Markets - By Product

• 10.1 Whole Blood
  • 10.1.1 Table Whole Blood- by Country
  • 10.1.2 Chart - Whole Blood Growth
• 10.2 Plasma
  • 10.2.1 Table Plasma - by Country
  • 10.2.2 Chart - Plasma Growth
• 10.3 Urine
  • 10.3.1 Table Urine - by Country
  • 10.3.2 Chart -Urine Growth
• 10.4 Control Material Other
  • 10.4.1 Table Control Material Other - by Country
  • 10.4.2 Chart-Control Material Other Growth

11 Global IVD Quality Control Markets - By Manufacturer

• 11.1 Original Equipment Manufacturer
  • 11.1.1 Table Original Equipment Manufacturer - by Country
  • 11.1.2 Chart - Original Equipment Manufacturer Growth
• 11.2 Third Party Generic
  • 11.2.1 Table Third Party Generic - by Country
  • 11.2.2 Chart - Third Party Generic Growth
• 11.3 Third Party Instrument Specific
  • 11.3.1 Table Third Party Instrument Specific - by Country
  • 11.3.2 Chart - Third Party Instrument Specific Growth
• 11.4 Custom Other
  • 11.4.1 Table Custom Other - by Country
  • 11.4.2 Chart - Custom Other Growth

12 Appendices

• 12.1 Growth of Approved IVD Test Menu
• 12.2 Growth of Approved Average IVD Test Fee
• 12.3 The Most Used IVD Assays
• 12.4 The Highest Grossing Assays
• 12.5 Laboratory Fees Schedule