分子品質控制市場機會、成長動力、產業趨勢分析及 2025-2034 年預測

2024 年全球分子品質控制市場價值為 2.152 億美元，預計 2025 年至 2034 年期間的複合年成長率為 6.8%。分子品質控制是分子診斷的重要參考材料，可確保測試結果的準確性、一致性和可靠性。這些控制在實驗室中發揮著至關重要的作用，有助於監控檢測性能、識別潛在錯誤並遵守嚴格的監管準則。隨著醫療保健提供者越來越依賴分子檢測來檢測傳染病、癌症檢測和基因分析，對精準診斷解決方案的需求不斷成長是推動市場擴張的主要因素。此外，傳染病和遺傳疾病發生率的不斷上升也增加了分子診斷持續進步的必要性。

2023 年，分子品質控制市場價值為 2.035 億美元。根據產品類型，市場分為獨立控制和儀器特定控制。獨立控制部門在 2024 年的收入為 1.167 億美元，預計到 2034 年的複合年成長率為 6.7%。獨立控制與測試套件分開製造，從而能夠客觀評估分子檢測性能。這些控制可協助實驗室檢測批次間差異、試劑不穩定性和儀器故障，確保結果可靠且一致。他們還支持外部品質評估計劃和能力測試，這對於滿足監管標準至關重要。

根據分析物類型，市場分為單分析物控制和多分析物控制。單一分析物控制部分在 2024 年佔據了 58.4% 的市場佔有率，創造了 1.257 億美元的收入。這些控制可以精確監測特定的目標分析物，最大限度地降低與多分析物控制相關的交叉反應風險。它們的高穩定性確保了長期一致的性能，減少了檢測的變異性並支持分子檢測的品質保證。

從應用角度來看，市場分為傳染病診斷、腫瘤檢測、基因檢測等領域。 2024 年，傳染病診斷領域佔了 48.2% 的市場。分子診斷在早期病原體檢測中發揮著至關重要的作用，甚至在症狀出現之前。分子品質控制作為潛在試劑分解或檢測失敗的早期檢測機制，對於確保這些快速檢測的長期準確性至關重要。

根據最終用途，市場分為醫院、診斷實驗室、學術和研究機構、合約研究組織和其他使用者。診斷實驗室部門佔 2024 年總收入的 34.5%。這些實驗室處理大量傳染病、腫瘤學和遺傳疾病的分子測試，使其成為分子品質控制的主要採用者。

2024 年，北美的收入為 8,710 萬美元，預計到 2034 年將達到 1.647 億美元。美國以 2023 年 7,550 萬美元的收入領先該地區。美國傳染病和癌症盛行率的上升是推動分子品質控制需求的關鍵因素，此外 FDA 的嚴格規定也確保了分子診斷測試的準確性。

目錄

第1章：方法論與範圍

第2章：執行摘要

第3章：行業洞察

• 產業生態系統分析
• 產業衝擊力
  • 成長動力
    • 癌症和傳染病發生率上升
    • 分子診斷的應用日益廣泛
    • 分子診斷技術進步
    • 對準確診斷測試的需求不斷成長
  • 產業陷阱與挑戰
    • 分子品管服務成本高
    • 有限的報銷政策
• 成長潛力分析
• 監管格局
• 技術格局
• 未來市場趨勢
• 波特的分析
• PESTEL 分析

第4章：競爭格局

• 介紹
• 公司市佔率分析
• 公司矩陣分析
• 主要市場參與者的競爭分析
• 競爭定位矩陣
• 策略儀表板

第5章：市場估計與預測：按產品，2021 年至 2034 年

• 主要趨勢
• 獨立控制
• 儀器專用控制
  • 聚合酶連鎖反應
  • DNA測序和NGS
  • 其他儀器專用控制

第6章：市場估計與預測：依分析物類型，2021 年至 2034 年

• 主要趨勢
• 單一分析物對照
• 多分析物控制

第7章：市場估計與預測：按應用，2021 年至 2034 年

• 主要趨勢
• 傳染病診斷
• 腫瘤學檢測
• 基因檢測
• 其他應用

第8章：市場估計與預測：依最終用途，2021 年至 2034 年

• 主要趨勢
• 醫院
• 診斷實驗室
• 學術和研究機構
• 合約研究組織
• 其他最終用途

第9章：市場估計與預測：按地區，2021 年至 2034 年

• 主要趨勢
• 北美洲
  • 美國
  • 加拿大
• 歐洲
  • 德國
  • 英國
  • 法國
  • 西班牙
  • 義大利
  • 荷蘭
• 亞太地區
  • 中國
  • 日本
  • 印度
  • 澳洲
  • 韓國
• 拉丁美洲
  • 巴西
  • 墨西哥
  • 阿根廷
• 中東和非洲
  • 南非
  • 沙烏地阿拉伯
  • 阿拉伯聯合大公國

第10章：公司簡介

• Anchor Molecular
• Bio-Rad Laboratories
• Bio-Techne Corporation
• Fortress Diagnostics
• Microbiologics
• Microbix Biosystems
• Maine Molecular Quality Controls
• Quidelortho Corporation
• Qiagen
• Randox Laboratories
• Seegene
• Thermo Fisher Scientific
• Zeptometrix

The Global Molecular Quality Controls Market was valued at USD 215.2 million in 2024 and is projected to expand at a CAGR of 6.8% from 2025 to 2034. Molecular quality controls serve as essential reference materials in molecular diagnostics, ensuring accuracy, consistency, and reliability in test results. These controls play a critical role in laboratories by helping monitor assay performance, identify potential errors, and comply with stringent regulatory guidelines. The rising demand for precise diagnostic solutions is a major factor fueling market expansion, as healthcare providers increasingly rely on molecular testing for infectious diseases, cancer detection, and genetic analysis. Additionally, the growing incidence of infectious diseases and genetic disorders has amplified the need for continuous advancements in molecular diagnostics.

In 2023, the molecular quality controls market was valued at USD 203.5 million. Based on product type, the market is categorized into independent controls and instrument-specific controls. The independent controls segment held USD 116.7 million in revenue in 2024 and is projected to grow at a CAGR of 6.7% through 2034. Independent controls are manufactured separately from test kits, enabling objective evaluation of molecular assay performance. These controls help laboratories detect batch-to-batch variations, reagent instability, and instrument malfunctions, ensuring reliable and consistent results. They also support external quality assessment programs and proficiency testing, which are crucial for meeting regulatory standards.

By analyte type, the market is segmented into single-analyte and multi-analyte controls. The single-analyte controls segment accounted for 58.4% of the market share in 2024, generating USD 125.7 million in revenue. These controls allow for precise monitoring of specific target analytes, minimizing cross-reactivity risks associated with multi-analyte controls. Their high stability ensures consistent performance over time, reducing assay variability and supporting quality assurance in molecular testing.

In terms of application, the market is divided into infectious disease diagnostics, oncology testing, genetic testing, and other areas. The infectious disease diagnostics segment held 48.2% of the market in 2024. Molecular diagnostics play a crucial role in early pathogen detection, even before symptoms manifest. Molecular quality controls are essential in ensuring the accuracy of these rapid assays over time by serving as an early detection mechanism for potential reagent degradation or assay failures.

Based on end use, the market is segmented into hospitals, diagnostic laboratories, academic and research institutes, contract research organizations, and other users. The diagnostic laboratories segment accounted for 34.5% of total revenue in 2024. These laboratories handle large volumes of molecular tests for infectious diseases, oncology, and genetic disorders, making them primary adopters of molecular quality controls.

North America accounted for USD 87.1 million in revenue in 2024 and is expected to reach USD 164.7 million by 2034. The US led the region with USD 75.5 million in revenue in 2023. The increasing prevalence of infectious diseases and cancer in the country is a key factor driving demand for molecular quality controls, alongside stringent FDA regulations ensuring the accuracy of molecular diagnostic tests.

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Market scope and definitions
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Base estimates and calculations
  • 1.3.1 Base year calculation
  • 1.3.2 Key trends for market estimation
• 1.4 Forecast model
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
  • 1.5.2 Data mining sources

Chapter 2 Executive Summary

• 2.1 Industry 360° synopsis

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Rising prevalence of cancers and infectious diseases
    • 3.2.1.2 Growing adoption of molecular diagnostics
    • 3.2.1.3 Technological advancements in molecular diagnostics
    • 3.2.1.4 Rising demand for accurate diagnostics testing
  • 3.2.2 Industry pitfalls and challenges
    • 3.2.2.1 High cost of molecular quality control services
    • 3.2.2.2 Limited reimbursement policies
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape
• 3.5 Technological landscape
• 3.6 Future market trends
• 3.7 Porter's analysis
• 3.8 PESTEL analysis

Chapter 4 Competitive Landscape, 2024

• 4.1 Introduction
• 4.2 Company market share analysis
• 4.3 Company matrix analysis
• 4.4 Competitive analysis of major market players
• 4.5 Competitive positioning matrix
• 4.6 Strategy dashboard

Chapter 5 Market Estimates and Forecast, By Product, 2021 – 2034 ($ Mn)

• 5.1 Key trends
• 5.2 Independent controls
• 5.3 Instrument-specific controls
  • 5.3.1 Polymerase chain reaction
  • 5.3.2 DNA sequencing and NGS
  • 5.3.3 Other instrument-specific controls

Chapter 6 Market Estimates and Forecast, By Analyte Type, 2021 – 2034 ($ Mn)

• 6.1 Key trends
• 6.2 Single-analyte controls
• 6.3 Multi-analyte controls

Chapter 7 Market Estimates and Forecast, By Application, 2021 – 2034 ($ Mn)

• 7.1 Key trends
• 7.2 Infectious disease diagnostics
• 7.3 Oncology testing
• 7.4 Genetic testing
• 7.5 Other applications

Chapter 8 Market Estimates and Forecast, By End Use, 2021 – 2034 ($ Mn)

• 8.1 Key trends
• 8.2 Hospitals
• 8.3 Diagnostic laboratories
• 8.4 Academic and research institutes
• 8.5 Contract research organizations
• 8.6 Other end use

Chapter 9 Market Estimates and Forecast, By Region, 2021 – 2034 ($ Mn)

• 9.1 Key trends
• 9.2 North America
  • 9.2.1 U.S.
  • 9.2.2 Canada
• 9.3 Europe
  • 9.3.1 Germany
  • 9.3.2 UK
  • 9.3.3 France
  • 9.3.4 Spain
  • 9.3.5 Italy
  • 9.3.6 Netherlands
• 9.4 Asia Pacific
  • 9.4.1 China
  • 9.4.2 Japan
  • 9.4.3 India
  • 9.4.4 Australia
  • 9.4.5 South Korea
• 9.5 Latin America
  • 9.5.1 Brazil
  • 9.5.2 Mexico
  • 9.5.3 Argentina
• 9.6 Middle East and Africa
  • 9.6.1 South Africa
  • 9.6.2 Saudi Arabia
  • 9.6.3 UAE

Chapter 10 Company Profiles

• 10.1 Anchor Molecular
• 10.2 Bio-Rad Laboratories
• 10.3 Bio-Techne Corporation
• 10.4 Fortress Diagnostics
• 10.5 Microbiologics
• 10.6 Microbix Biosystems
• 10.7 Maine Molecular Quality Controls
• 10.8 Quidelortho Corporation
• 10.9 Qiagen
• 10.10 Randox Laboratories
• 10.11 Seegene
• 10.12 Thermo Fisher Scientific
• 10.13 Zeptometrix