全球分子品管市場：按產品類型、按分析物類型、按應用、按最終用戶、按地區

2025 年全球分子品管市場價值估計為 2.233 億美元，預計到 2032 年將達到 3.659 億美元，2025 年至 2032 年的複合年成長率為 7.3%。

數字。 2025 年分子品管市場佔有率（%），依地區分類

分子品管涉及透過樣品、試劑和驗證程序評估和監測分子診斷的品質。由於分子技術的進步和照護現場（POC）檢測的日益普及，全球分子品管市場正在經歷顯著成長。個人化醫療需求的不斷成長和全球實驗室測試的集中化可能會推動對分子品質保證解決方案的需求。此外，為了確保檢測結果的準確性和可靠性，人們越來越重視分子檢測程序的標準化和協調，這也推動了一系列分子品管產品和服務的激增。

市場動態

全球分子品管市場的成長主要得益於分子診斷在各個疾病領域的應用不斷擴大以及分子檢測在臨床決策中的應用日益增加。 PCR和次世代定序等分子技術的快速進步正在擴大其應用範圍。感染疾病、癌症和遺傳疾病的發生率日益上升，需要對分子檢測進行嚴格的品質評估。美國《臨床實驗室改進修正案》（CLIA）等指南的實施，要求對分子診斷實驗室進行認證和驗證，進一步推動了品管的採用。然而，新興國家的臨床實驗室面臨預算限制，使得市場開發面臨挑戰。此外，複雜的法律規範和熟練專業人員的短缺也阻礙了市場的成長。正在開發具有增強的一致性和可重複性的新型分子品管，這將在不久的將來提供許多有利可圖的機會。

本研究的主要特點

本研究報告對全球分子品管市場進行了詳細分析，並以 2024 年為基準年，給出了預測期（2025-2032 年）的市場規模和複合年成長率。

它揭示了不同領域的潛在商機並解釋了該市場的有吸引力的投資提案矩陣。

它還提供了對市場促進因素、限制因素、機會、新產品發布和核准、市場趨勢、區域前景以及主要企業採用的競爭策略的重要見解。

全球分子品管市場的主要企業根據公司亮點、產品系列、關鍵亮點、財務績效和策略等參數進行分析。

研究中介紹的主要企業包括賽默飛世爾科技公司 (Thermo Fisher Scientific Inc.)、Bio-Rad Laboratories, Inc.、Microbiologics, Inc.、ZeptoMetrix Corporation、F. Hoffmann-La Roche Ltd.、雅培 Qualdott Laboratories)、Quidel Corporation、Qnostics、Manel Corporation、Qnoscan、Controla） O AS、Technopath Clinical Diagnostics、Randox Laboratories Ltd. 和 Hologic, Inc.

本報告的見解將使負責人和公司經營團隊能夠就未來的產品發布、類型升級、市場擴張和行銷策略做出明智的決策。

全球分子品管市場報告迎合了該行業的各個相關人員，例如投資者、供應商、產品製造商、經銷商、新進入者和金融分析師。

相關人員將透過用於分析全球分子品管市場的各種策略矩陣來做出決策。

目錄

第1章 調查目的與前提條件

• 研究目標
• 先決條件
• 簡稱

第2章 市場展望

• 報告描述
  • 市場定義和範圍
• 執行摘要

第3章市場動態、法規與趨勢分析

• 市場動態
• 影響分析
• 主要進展
• 監管情景
• 產品發布/核准
• PEST分析
• 波特的分析
• 併購情景
• 產業趨勢

4. 全球分子品管市場依產品類型分類（2020-2032 年）

• 獨立控制
• 設備特定控制
• DNA定序與次世代定序

5. 全球分子品管市場依分析物類型分類（2020-2032 年）

• 單一分析物對照
• 多重分析控制

6. 全球分子品管市場按應用分類（2020-2032 年）

• 感染疾病診斷
• 腫瘤學檢測
• 基因檢測
• 微生物學
• 其他用途（如組織分型）

7. 全球分子品管市場依最終用戶分類（2020-2032 年）

• 臨床和診斷實驗室
• 醫院和診所
• 學術研究所
• 合約研究組織
• 其他

8. 全球分子品管市場按地區分類（2020-2032 年）

• 北美洲
• 拉丁美洲
• 歐洲
• 亞太地區
• 海灣合作理事會國家
• 以色列
• 其他中東地區
• 非洲

第9章 競爭格局

• 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 章分析師建議

• 命運之輪
• 分析師觀點
• Coherent Opportunity Map（COM）

第 11 章 參考文獻與調查方法

• 參考
• 調查方法
• 關於出版商

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