分子品質管理の世界市場：製品タイプ別、分析物タイプ別、用途別、エンドユーザー別、地域別

世界の分子品質管理の市場規模は、2025年には2億2,330万米ドルと推定され、2032年には3億6,590万米ドルに達すると予測され、2025年～2032年のCAGRは7.3%で成長する見込みです。

図.分子品質管理市場シェア（%）、2025年、地域別

分子品質管理には、サンプル、試薬、バリデーション手順を通じて分子診断薬の品質を評価・モニタリングすることが含まれます。世界の分子品質管理市場は、分子技術の進歩とポイントオブケア（POC）検査の採用拡大により大きく成長しています。個別化医療に対する需要の高まりと、世界のラボ検査の集中化により、分子品質保証ソリューションの需要が高まる可能性があります。さらに、検査結果の正確性と信頼性を確保するために、分子検査手順の標準化と調和に重点を置く傾向が強まっていることも、さまざまな分子品質管理製品やサービスの普及を後押ししています。

市場力学

世界の分子品質管理市場の成長は、臨床上の意思決定に分子検査を取り入れる動きが活発化していることと相まって、さまざまな疾患領域で分子診断の応用が拡大していることが主因となっています。PCRや次世代シーケンシングなどの分子技術における急速な技術進歩が、その応用範囲を拡大しています。感染症、がん、遺伝性疾患の有病率の増加は、分子アッセイの強固な品質評価を必要とします。米国のCLIA（Clinical Laboratory Improvement Amendments）のようなガイドラインが施行され、分子診断ラボの認定とバリデーションが義務付けられたことは、品質管理の採用をさらに後押ししています。しかし、新興国の臨床検査室には予算上の制約があり、市場開拓の課題となっています。さらに、複雑な規制の枠組みや熟練した専門家の不足が市場成長の妨げとなっています。一貫性と再現性を強化した新しい分子品質管理の開発が進んでおり、近い将来、多くの有利な機会がもたらされる見通しです。

本調査の主な特徴

この調査レポートは、世界の分子品質管理市場を詳細に分析し、2024年を基準年とした予測期間（2025～2032年）の市場規模とCAGR%を掲載しています。

異なるセグメントにわたる潜在的な収益機会を解明し、この市場の魅力的な投資提案のマトリックスについて説明しています。

また、市場促進要因、抑制要因、機会、新製品の上市や承認、市場動向、地域別の展望、主要企業が採用する競争戦略などに関する重要な考察も提供しています。

世界の分子品質管理市場における主要企業を、企業ハイライト、製品ポートフォリオ、主要ハイライト、財務実績、戦略などのパラメータに基づいてプロファイルしています。

本調査の対象となる主要企業には、Thermo Fisher Scientific Inc.、Bio-Rad Laboratories, Inc.、Microbiologics, Inc.、ZeptoMetrix Corporation、F. Hoffmann-La Roche Ltd.、Abbott Laboratories、Quidel Corporation、Qnostics、Maine Molecular Quality Controls, Inc.、Danaher Corporation、Helena Biosciences Europe、SERO AS、Technopath Clinical Diagnostics、Randox Laboratories Ltd.、Hologic, Inc.などがあります。

本レポートからの洞察により、マーケティング担当者や企業の経営陣は、将来の製品発売、タイプアップグレード、市場拡大、マーケティング戦術に関する情報に基づいた意思決定を行うことができます。

分子品質管理の世界市場レポートは、投資家、サプライヤー、製品メーカー、流通業者、新規参入者、財務アナリストなど、この業界のさまざまな利害関係者に対応しています。

利害関係者は、世界の分子品質管理市場の分析に使用される様々な戦略マトリックスを通じて、意思決定が容易になります。

目次

第1章 調査の目的と前提条件

• 調査目的
• 前提条件
• 略語

第2章 市場の展望

• レポートの説明
  • 市場の定義と範囲
• エグゼクティブサマリー

第3章 市場力学、規制、動向分析

• 市場力学
• 影響分析
• 主な発展
• 規制シナリオ
• 製品の発売/承認
• PEST分析
• ポーターの分析
• 合併と買収のシナリオ
• 業界動向

第4章 世界の分子品質管理市場：製品タイプ別（2020年～2032年）

• 独立制御
• 機器固有の制御
• DNAシーケンシングと次世代シーケンシング

第5章 世界の分子品質管理市場：分析物タイプ別（2020年～2032年）

• 単一分析物コントロール
• 多重分析象コントロール

第6章 世界の分子品質管理市場：用途別（2020年～2032年）

• 感染症診断
• 腫瘍学検査
• 遺伝子検査
• 微生物学
• その他の用途（組織型判定など）

第7章 世界の分子品質管理市場：エンドユーザー別（2020年～2032年）

• 臨床および診断研究室
• 病院と診療所
• 学術研究機関
• 契約研究機関
• その他

第8章 世界の分子品質管理市場：地域別（2020年～2032年）

• 北米
• ラテンアメリカ
• 欧州
• アジア太平洋
• GCC諸国
• イスラエル
• その他中東
• アフリカ

第9章 競合情勢

• Thermo Fisher Scientific Inc.
• Bio-Rad Laboratories, Inc.
• Microbiologics, Inc.
• ZeptoMetrix Corporation
• Hoffmann-La Roche Ltd.
• Abbott Laboratories
• Quidel Corporation
• Qnostics
• Maine Molecular Quality Controls, Inc.
• Danaher Corporation
• Helena Biosciences Europe
• SERO AS
• Technopath Clinical Diagnostics
• Randox Laboratories Ltd.
• Hologic, Inc.

第10章 アナリストの推奨事項

• 運命の輪
• アナリストの見解
• Coherent Opportunity Map（COM）

第11章 参考文献と調査手法

• 参考文献
• 調査手法
• 出版社について

Global Molecular Quality Control Market is estimated to be valued at USD 223.3 Mn in 2025 and is expected to reach USD 365.9 Mn by 2032, growing at a compound annual growth rate (CAGR) of 7.3% from 2025 to 2032.

Figure. Molecular Quality Control Market Share (%), By Region 2025

Molecular quality control involves assessing and monitoring the quality of molecular diagnostics through samples, reagents, and validation procedures. Global molecular quality control market has witnessed significant growth due to advancements in molecular technology and growing adoption of point-of-care (POC) testing. Rising demand for personalized medicine and centralized lab testing worldwide can boost demand for molecular quality assurance solutions. Moreover, increasing focus on standardizing and harmonizing molecular testing procedures to ensure accuracy and reliability of test results boosts uptake of various molecular quality control products and services.

Market Dynamics

Global molecular quality control market growth is primarily driven by growing molecular diagnostics applications across different disease areas coupled with increasing incorporation of molecular testing in clinical decision making. Rapid technological advancement in molecular techniques such as PCR and Next-Gen sequencing has expanded their scope of applications. Rising prevalence of infectious diseases, cancer and genetic disorders necessitates robust quality assessment of molecular assays. Implemented guidelines like CLIA (Clinical Laboratory Improvement Amendments) in U.S mandating accreditation and validation of molecular diagnostic labs further boosts adoption of quality controls. However, budgetary constraints of clinical laboratories in developing nations poses challenge for market players. Moreover, complex regulatory frameworks and lack of skilled professionals hampers the market growth. Ongoing development of novel molecular quality controls with enhanced consistency and reproducibility presents numerous lucrative opportunities in the near future.

Key features of the study

This report provides in-depth analysis of the global molecular quality control market, and provides market size (USD Million) and compound annual growth rate (CAGR%) for the forecast period (2025-2032), considering 2024 as the base year

It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market

This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends, regional outlook, and competitive strategies adopted by key players

It profiles key players in the global molecular quality control market based on the following parameters - company highlights, products portfolio, key highlights, financial performance, and strategies

Key companies covered as a part of this study include Thermo Fisher Scientific Inc., Bio-Rad Laboratories, Inc., Microbiologics, Inc., ZeptoMetrix Corporation, F. Hoffmann-La Roche Ltd., Abbott Laboratories, Quidel Corporation, Qnostics, Maine Molecular Quality Controls, Inc., Danaher Corporation, Helena Biosciences Europe, SERO AS, Technopath Clinical Diagnostics, Randox Laboratories Ltd., and Hologic, Inc.

Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics

Global molecular quality control market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts

Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global molecular quality control market.

Market Segmentation

• By Product Type Insights (Revenue, USD Mn, 2019 - 2032)
  • Independent Control
  • Instrument Specific Control
  • DNA Sequencing and Next-Generation Sequencing
  • Polymerase Chain Reaction
  • Others
• By Analyte Type Insights (Revenue, USD Mn, 2019 - 2032)
  • Single-Analyte Controls
  • Multi-Analyte Controls
• By Application Insights (Revenue, USD Mn, 2019 - 2032)
  • Infectious Disease Diagnostics
  • Oncology Testing
  • Genetic Testing
  • Microbiology
  • Other Applications (Tissue Typing, etc.)
• By End Users Insights (Revenue, USD Mn, 2019 - 2032)
  • Clinical & Diagnostic Laboratories
  • Hospitals and Clinics
  • Academic and Research Institutes
  • Contract Research Organizations
  • Others
• Regional Insights (Revenue, USD Mn, 2019 - 2032)
  • North America
  • U.S.
  • Canada
  • Latin America
  • Brazil
  • Argentina
  • Mexico
  • Rest of Latin America
  • Europe
  • Germany
  • U.K.
  • Spain
  • France
  • Italy
  • Russia
  • Rest of Europe
  • Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
  • ASEAN
  • Rest of Asia Pacific
  • Middle East
  • GCC Countries
  • Israel
  • Rest of Middle East
  • Africa
  • South Africa
  • North Africa
  • Central Africa
• Key Players Insights
  • Thermo Fisher Scientific Inc.
  • Bio-Rad Laboratories, Inc.
  • Microbiologics, Inc.
  • ZeptoMetrix Corporation
  • Hoffmann-La Roche Ltd.
  • Abbott Laboratories
  • Quidel Corporation
  • Qnostics
  • Maine Molecular Quality Controls, Inc.
  • Danaher Corporation
  • Helena Biosciences Europe
  • SERO AS
  • Technopath Clinical Diagnostics
  • Randox Laboratories Ltd.
  • Hologic, Inc.

Table of Contents

1. Research Objectives and Assumptions

• Research Objectives
• Assumptions
• Abbreviations

2. Market Purview

• Report Description
  • Market Definition and Scope
• Executive Summary
  • Global Molecular Quality Control Market, By Product Type
  • Global Molecular Quality Control Market, By Analyte Type
  • Global Molecular Quality Control Market, By Application
  • Global Molecular Quality Control Market, By End Users
  • Global Molecular Quality Control Market, By Region

3. Market Dynamics, Regulations, and Trends Analysis

• Market Dynamics
  • Driver
  • Restraint
  • Opportunity
• Impact Analysis
• Key Developments
• Regulatory Scenario
• Product Launches/Approvals
• PEST Analysis
• PORTER's Analysis
• Merger and Acquisition Scenario
• Industry Trends

4. Global Molecular Quality Control Market, By Product Type, 2020-2032, (USD Mn)

• Introduction
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Independent Control
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Instrument Specific Control
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• DNA Sequencing and Next-Generation Sequencing
  • Polymerase Chain Reaction
  • Others

5. Global Molecular Quality Control Market, By Analyte Type, 2020-2032, (USD Mn)

• Introduction
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Single-Analyte Controls
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Multi-Analyte Controls
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)

6. Global Molecular Quality Control Market, By Application, 2020-2032, (USD Mn)

• Introduction
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Infectious Disease Diagnostics
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Oncology Testing
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Genetic Testing
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Microbiology
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Other Applications (Tissue Typing, etc.)
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)

7. Global Molecular Quality Control Market, By End Users, 2020-2032, (USD Mn)

• Introduction
  • Market Share Analysis, 2025 and 2032 (%)
  • Y-o-Y Growth Analysis, 2021 - 2032
  • Segment Trends
• Clinical & Diagnostic Laboratories
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Hospitals and Clinics
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Academic and Research Institutes
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Contract Research Organizations
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)
• Others
  • Introduction
  • Market Size and Forecast, and Y-o-Y Growth, 2020-2032, (USD Mn)

8. Global Molecular Quality Control Market, By Region, 2020 - 2032, (USD Mn)

• Introduction
  • Market Share (%) Analysis, 2025, 2028 & 2032, (USD Mn)
  • Market Y-o-Y Growth Analysis (%), 2021 - 2032, (USD Mn)
  • Regional Trends
• North America
  • Introduction
  • Market Size and Forecast, By Product Type, 2020 - 2032, USD Mn)
  • Market Size and Forecast, By Analyte Type, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Application, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By End Users, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Country, 2020 - 2032, (USD Mn)
    • U.S.
    • Canada
• Latin America
  • Introduction
  • Market Size and Forecast, By Product Type, 2020 - 2032, USD Mn)
  • Market Size and Forecast, By Analyte Type, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Application, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By End Users, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Country, 2020 - 2032, (USD Mn)
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
• Europe
  • Introduction
  • Market Size and Forecast, By Product Type, 2020 - 2032, USD Mn)
  • Market Size and Forecast, By Analyte Type, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Application, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By End Users, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Country, 2020 - 2032, (USD Mn)
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
• Asia Pacific
  • Introduction
  • Market Size and Forecast, By Product Type, 2020 - 2032, USD Mn)
  • Market Size and Forecast, By Analyte Type, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Application, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By End Users, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Country, 2020 - 2032, (USD Mn)
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
    • Middle East
  • Introduction
  • Market Size and Forecast, By Product Type, 2020 - 2032, USD Mn)
  • Market Size and Forecast, By Analyte Type, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Application, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By End Users, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Country, 2020 - 2032, (USD Mn)

• GCC Countries
• Israel
• Rest of Middle East
• Africa
  • Introduction
  • Market Size and Forecast, By Product Type, 2020 - 2032, USD Mn)
  • Market Size and Forecast, By Analyte Type, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Application, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By End Users, 2020 - 2032, (USD Mn)
  • Market Size and Forecast, By Country/Region, 2020 - 2032, (USD Mn)
    • South Africa
    • North Africa
    • Central Africa

9. Competitive Landscape

• Thermo Fisher Scientific Inc.
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Bio-Rad Laboratories, Inc.
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Microbiologics, Inc.
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• ZeptoMetrix Corporation
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Hoffmann-La Roche Ltd.
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Abbott Laboratories
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Quidel Corporation
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Qnostics
  • Company Highlights
  • Product Portfolio
  • Key Developments
  • Financial Performance
  • Strategies
• Maine Molecular Quality Controls, Inc.
• Danaher Corporation
• Helena Biosciences Europe
• SERO AS
• Technopath Clinical Diagnostics
• Randox Laboratories Ltd.
• Hologic, Inc.

10. Analyst Recommendations

• Wheel of Fortune
• Analyst View
• Coherent Opportunity Map

11. References and Research Methodology

• References
• Research Methodology
• About us