分子诊断市场规模、份额和成长分析（按产品类型、检测类型、检体类型、技术、应用、最终用户和地区划分）－2026-2033年产业预测

全球分子诊断市场规模预计在 2024 年达到 191 亿美元，从 2025 年的 204.9 亿美元成长到 2033 年的 360.1 亿美元，在预测期（2026-2033 年）内复合年增长率为 7.3%。

受精准医疗和疾病早期检测需求不断增长的推动，全球分子诊断市场正经历强劲增长。推动这项扩张的关键因素是全球感染疾病的日益流行，这需要快速、准确的诊断技术。即时PCR、次世代定序和微阵列等创新技术正在提高病原体和基因突变的识别速度和准确性。伴随诊断在标靶癌症治疗中的日益普及也推动了市场发展。此外，就地检验和家庭诊断的趋势正在加速对使用者友善平台的投资。然而，除非解决高昂的检测成本、复杂的监管和资料隐私问题等挑战，否则市场的成长潜力将无法充分发挥。

全球分子诊断市场驱动因素

全球分子诊断市场正经历显着成长，这主要得益于聚合酵素链锁反应(PCR)、次世代定序(NGS) 和微阵列技术的进步。这些创新彻底改变了分子诊断领域，显着提高了检测的准确性、灵敏度和速度。随着这些技术的不断发展，整体诊断流程的有效性不断提升，最终推动了市场扩张。为了满足日益增长的精准快速医疗检测需求，先进诊断设备的持续研发在推动该领域的进一步成长中发挥关键作用。

全球分子诊断市场面临的限制因素

分子诊断检测以其高准确性和有效性着称，但其成本可能成为一大障碍，尤其是在医疗机构预算有限的发展中地区。购置必要的设备和试剂，以及聘请专业人员进行检测，往往会给这些机构带来沉重的经济负担。因此，分子诊断的成本效益仍然是一个挑战，阻碍了其广泛应用，并最终限制了整个分子诊断市场的成长。因此，解决这些经济限制因素对于提高分子诊断的可近性和扩大市场覆盖范围至关重要。

全球分子诊断市场趋势

全球分子诊断市场正经历着向就地检验（POC​​T）的显着转变，这主要受诊所、急诊和救护车等各种医疗机构对快速诊断解决方案和有效治疗监测的需求所驱动。这一趋势的特点是小型化和携带式分子诊断设备的创新，这些设备能够在传统检查室之外进行即时检测。对即时结果的重视不仅有助于改善患者照护，还有助于提高整体医疗效率，这反映了医疗解决方案向分散化方向发展的趋势。因此，分子诊断领域也在不断发展，以应对现代医疗保健的挑战。

目录

介绍

• 调查目标
• 调查范围
• 定义

调查方法

• 资讯收集
• 二手资料和一手资料方法
• 市场规模预测
• 市场假设与限制

执行摘要

• 全球市场展望
• 供需趋势分析
• 细分市场机会分析

市场动态与展望

• 市场规模
• 市场动态
  • 驱动因素和机会
  • 限制与挑战
• 波特分析

关键市场考察

• 关键成功因素
• 竞争程度
• 关键投资机会
• 市场生态系统
• 市场吸引力指数（2025）
• PESTEL 分析
• 总体经济指标
• 价值链分析
• 定价分析

全球分子诊断市场规模（依产品/服务划分）及复合年增长率（2026-2033 年）

• 试剂和试剂盒
• 装置
• 服务和软体

全球分子诊断市场规模（按检测类型和复合年增长率划分）（2026-2033 年）

• 实验室检测
• 即时检测

全球分子诊断市场规模（依检体类型划分）及复合年增长率（2026-2033 年）

• 血液、血清和血浆
• 尿
• 其他检体类型

全球分子诊断市场规模（依技术及复合年增长率划分）（2026-2033 年）

• 聚合酵素链锁反应
• 恒温核酸增幅技术
• DNA定序与次世代定序
• 原位杂合反应
• DNA微阵列
• 其他技术

全球分子诊断市场规模（按应用领域划分）及复合年增长率（2026-2033 年）

• 感染疾病诊断
  • 肝炎
  • B型肝炎
  • C型肝炎
  • 其他肝炎疾病
  • HIV
  • CT/NG
  • HAI
  • HPV
  • 结核
  • 流感
  • 其他感染疾病
• 肿瘤检测
  • 乳癌
  • 大肠直肠癌
  • 肺癌
  • 摄护腺癌
  • 其他癌症
• 基因检测
• 其他用途

全球分子诊断市场规模（依最终用户划分）及复合年增长率（2026-2033 年）

• 诊断检查室
• 医院和诊所
• 其他最终用户

全球分子诊断市场规模及复合年增长率（2026-2033）

• 北美洲
  • 美国
  • 加拿大
• 欧洲
  • 德国
  • 西班牙
  • 法国
  • 英国
  • 义大利
  • 其他欧洲地区
• 亚太地区
  • 中国
  • 印度
  • 日本
  • 韩国
  • 亚太其他地区
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲地区
• 中东和非洲
  • 海湾合作委员会国家
  • 南非
  • 其他中东和非洲地区

竞争资讯

• 前五大公司对比
• 主要企业的市场定位（2025 年）
• 主要市场参与者所采取的策略
• 近期市场趋势
• 公司市占率分析（2025 年）
• 主要企业公司简介
  • 公司详情
  • 产品系列分析
  • 依业务板块进行公司股票分析
  • 2023-2025年营收年比比较

主要企业简介

• F. Hoffmann-La Roche Ltd.（Switzerland）
• Hologic, Inc.（US）
• Abbott Laboratories（US）
• Illumina, Inc.（US）
• Thermo Fisher Scientific Inc.（US）
• bioMerieux（France）
• QIAGEN（Netherlands）
• Becton Dickinson And Company（US）
• Grifols SA（Spain）
• Bio-Rad Laboratories, Inc.（US）
• Sysmex Corporation（Japan）
• Quidel Corporation（US）
• Biocartis（Belgium）
• DiaSorin（Italy）
• Myriad Genetics（US）
• Revvity（US）
• MDxHealth（Belgium）
• OncoCyte Corporation（US）

结论与建议

Global Molecular Diagnostics Market size was valued at USD 19.1 Billion in 2024 and is poised to grow from USD 20.49 Billion in 2025 to USD 36.01 Billion by 2033, growing at a CAGR of 7.3% during the forecast period (2026-2033).

The Global Molecular Diagnostics Market is experiencing robust growth, driven by a heightened demand for precision medicine and early disease detection. Key factors fueling this expansion include the increasing prevalence of infectious diseases and cancers globally, necessitating rapid and accurate diagnostic technologies. Innovations like real-time PCR, next-generation sequencing, and microarray methods enhance the speed and accuracy of identifying pathogens and genetic mutations. The market is also bolstered by the rising use of companion diagnostics in targeted oncology treatments. Furthermore, the trend towards point-of-care testing and at-home diagnostics is accelerating investments in user-friendly platforms. However, challenges such as high testing costs, complex regulations, and data privacy issues must be addressed to fully capitalize on the market's growth potential.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Molecular Diagnostics 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 Molecular Diagnostics Market Segments Analysis

Global Molecular Diagnostics Market is segmented by Product, Test Type, Sample Type, Technology, Application, End User and region. Based on Product, the market is segmented into Reagents & Kits, Instruments and Services & Software. Based on Test Type, the market is segmented into Lab Tests and POC Tests. Based on Sample Type, the market is segmented into Blood, Serum, And Plasma, Urine and Other Sample Types. Based on Technology, the market is segmented into Polymerase Chain Reaction, Isothermal Nucleic Acid Amplification Technology, DNA Sequencing & Next-Generation Sequencing, In Situ Hybridization, DNA Microarrays and Other Technologies. Based on Application, the market is segmented into Infectious Disease Diagnostics, Oncology Testing, Genetic Testing and Other Applications. Based on End User, the market is segmented into Diagnostic Laboratories, Hospitals & Clinics 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 Molecular Diagnostics Market

The Global Molecular Diagnostics market is experiencing significant growth driven by advancements in technologies such as PCR (Polymerase Chain Reaction), NGS (Next-Generation Sequencing), and microarray techniques. These innovations have transformed the landscape of molecular diagnostics, leading to improvements in accuracy, sensitivity, and speed of testing. As these technologies continue to evolve, they enhance the overall efficacy of diagnostic procedures, ultimately driving the expansion of the market. The ongoing development of sophisticated diagnostic equipment plays a crucial role in meeting the increasing demand for precise and timely medical testing, thereby fostering further growth within the sector.

Restraints in the Global Molecular Diagnostics Market

While molecular diagnostic tests are known for their high accuracy and effectiveness, their cost can be a significant barrier, particularly in developing regions where healthcare facilities operate on limited budgets. The expenses associated with the necessary equipment and reagents, along with the need for trained professionals to conduct the tests, often place undue financial pressure on these facilities. As a result, the affordability of molecular diagnostics remains a challenge, impeding widespread adoption and ultimately hindering the overall growth of the molecular diagnostics market. Hence, addressing these economic constraints is crucial for enhancing accessibility and expanding the market's reach.

Market Trends of the Global Molecular Diagnostics Market

The Global Molecular Diagnostics market is experiencing a notable shift towards point-of-care testing, fueled by the demand for swift diagnostic solutions and effective treatment monitoring across diverse healthcare environments such as clinics, emergency departments, and ambulances. This trend is characterized by the innovation of miniaturized and portable molecular diagnostic devices, which facilitate real-time testing beyond conventional laboratory confines. The emphasis on immediate results not only enhances patient care but also improves overall healthcare efficiency, reflecting a broader movement toward decentralized healthcare solutions. Consequently, the molecular diagnostics landscape is evolving to meet the challenges of modern medical demands.

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, 2025
• PESTEL Analysis
• Macro-Economic Indicators
• Value Chain Analysis
• Pricing Analysis

Global Molecular Diagnostics Market Size by Product & Service & CAGR (2026-2033)

• Market Overview
• Reagents & Kits
• Instruments
• Services & Software

Global Molecular Diagnostics Market Size by Test Type & CAGR (2026-2033)

• Market Overview
• Lab Tests
• POC Tests

Global Molecular Diagnostics Market Size by Sample Type & CAGR (2026-2033)

• Market Overview
• Blood, Serum, And Plasma
• Urine
• Other Sample Types

Global Molecular Diagnostics Market Size by Technology & CAGR (2026-2033)

• Market Overview
• Polymerase Chain Reaction
• Isothermal Nucleic Acid Amplification Technology
• DNA Sequencing & Next-Generation Sequencing
• In Situ Hybridization
• DNA Microarrays
• Other Technologies

Global Molecular Diagnostics Market Size by Application & CAGR (2026-2033)

• Market Overview
• Infectious Disease Diagnostics
  • Hepatitis
  • Hepatitis B
  • Hepatitis C
  • Other Hepatitis Diseases
  • HIV
  • CT/NG
  • HAI
  • HPV
  • Tuberculosis
  • Influenza
  • Other Infectious Diseases
• Oncology Testing
  • Breast Cancer
  • Colorectal Cancer
  • Lung Cancer
  • Prostate Cancer
  • Other Cancer Types
• Genetic Testing
• Other Applications

Global Molecular Diagnostics Market Size by End User & CAGR (2026-2033)

• Market Overview
• Diagnostic Laboratories
• Hospitals & Clinics
• Other End Users

Global Molecular Diagnostics Market Size & CAGR (2026-2033)

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

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2025
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2025
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2023-2025)

Key Company Profiles

• F. Hoffmann-La Roche Ltd. (Switzerland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Hologic, Inc. (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Abbott Laboratories (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Illumina, Inc. (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Thermo Fisher Scientific Inc. (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• bioMerieux (France)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• QIAGEN (Netherlands)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Becton Dickinson And Company (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Grifols S.A. (Spain)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Bio-Rad Laboratories, Inc. (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Sysmex Corporation (Japan)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Quidel Corporation (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Biocartis (Belgium)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• DiaSorin (Italy)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Myriad Genetics (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Revvity (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• MDxHealth (Belgium)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• OncoCyte Corporation (US)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations