分子診斷市場規模、佔有率和成長分析（按產品類型、檢測類型、檢體類型、技術、應用、最終用戶和地區分類）－2026-2033年產業預測

全球分子診斷市場規模預計在 2024 年達到 191 億美元，從 2025 年的 204.9 億美元成長到 2033 年的 360.1 億美元，在預測期（2026-2033 年）內複合年成長率為 7.3%。

受精準醫療和疾病早期檢測需求不斷成長的推動，全球分子診斷市場正經歷強勁成長。推動這項擴張的關鍵因素是全球感染疾病的日益流行，這需要快速、準確的診斷技術。即時PCR、次世代定序和微陣列等創新技術正在提高病原體和基因突變的識別速度和準確性。伴隨診斷在標靶癌症治療中的日益普及也推動了市場發展。此外，就地檢驗和家庭診斷的趨勢正在加速對使用者友善平台的投資。然而，除非解決高昂的檢測成本、複雜的監管和資料隱私問題等挑戰，否則市場的成長潛力將無法充分發揮。

全球分子診斷市場促進因素

全球分子診斷市場正經歷顯著成長，這主要得益於聚合酵素鏈鎖反應(PCR)、次世代定序(NGS) 和微陣列技術的進步。這些創新徹底改變了分子診斷領域，顯著提高了檢測的準確性、靈敏度和速度。隨著這些技術的不斷發展，整體診斷流程的有效性不斷提升，最終推動了市場擴張。為了滿足日益成長的精準快速醫療檢測需求，先進診斷設備的持續研發在推動該領域的進一步成長中發揮關鍵作用。

全球分子診斷市場面臨的限制因素

分子診斷檢測以其高準確性和有效性著稱，但其成本可能成為一大障礙，尤其是在醫療機構預算有限的發展中地區。購置必要的設備和試劑，以及聘請專業人員進行檢測，往往會給這些機構帶來沉重的經濟負擔。因此，分子診斷的成本效益仍然是一個挑戰，阻礙了其廣泛應用，並最終限制了整個分子診斷市場的成長。因此，解決這些經濟限制因素對於提高分子診斷的可近性和擴大市場覆蓋範圍至關重要。

全球分子診斷市場趨勢

全球分子診斷市場正經歷著向就地檢驗（POC​​T）的顯著轉變，這主要受診所、急診和救護車等各種醫療機構對快速診斷解決方案和有效治療監測的需求所驅動。這一趨勢的特點是小型化和攜帶式分子診斷設備的創新，這些設備能夠在傳統檢查室之外進行即時檢測。對即時結果的重視不僅有助於改善患者照護，還有助於提高整體醫療效率，這反映了醫療解決方案向分散化方向發展的趨勢。因此，分子診斷領域也在不斷發展，以應對現代醫療保健的挑戰。

目錄

介紹

• 調查目標
• 調查範圍
• 定義

調查方法

• 資訊收集
• 二手資料和一手資料方法
• 市場規模預測
• 市場假設與限制

執行摘要

• 全球市場展望
• 供需趨勢分析
• 細分市場機會分析

市場動態與展望

• 市場規模
• 市場動態
  • 促進因素和機遇
  • 限制與挑戰
• 波特分析

關鍵市場考察

• 關鍵成功因素
• 競爭程度
• 關鍵投資機會
• 市場生態系統
• 市場吸引力指數（2025）
• PESTEL 分析
• 總體經濟指標
• 價值鏈分析
• 定價分析

全球分子診斷市場規模（依產品/服務分類）及複合年成長率（2026-2033 年）

• 試劑和試劑盒
• 裝置
• 服務和軟體

全球分子診斷市場規模（按檢測類型和複合年成長率分類）（2026-2033 年）

• 實驗室檢測
• 即時檢測

全球分子診斷市場規模（依檢體類型分類）及複合年成長率（2026-2033 年）

• 血液、血清和血漿
• 尿
• 其他檢體類型

全球分子診斷市場規模（依技術及複合年成長率分類）（2026-2033 年）

• 聚合酵素鏈鎖反應
• 恒溫核酸增幅技術
• DNA定序與次世代定序
• 原位雜合反應
• DNA微陣列
• 其他技術

全球分子診斷市場規模（按應用領域分類）及複合年成長率（2026-2033 年）

• 感染疾病診斷
  • 肝炎
  • B型肝炎
  • C型肝炎
  • 其他肝炎疾病
  • HIV
  • CT/NG
  • HAI
  • HPV
  • 結核
  • 流感
  • 其他感染疾病
• 腫瘤檢測
  • 乳癌
  • 大腸直腸癌
  • 肺癌
  • 攝護腺癌
  • 其他癌症
• 基因檢測
• 其他用途

全球分子診斷市場規模（依最終用戶分類）及複合年成長率（2026-2033 年）

• 診斷檢查室
• 醫院和診所
• 其他最終用戶

全球分子診斷市場規模及複合年成長率（2026-2033）

• 北美洲
  • 美國
  • 加拿大
• 歐洲
  • 德國
  • 西班牙
  • 法國
  • 英國
  • 義大利
  • 其他歐洲地區
• 亞太地區
  • 中國
  • 印度
  • 日本
  • 韓國
  • 亞太其他地區
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲地區
• 中東和非洲
  • 海灣合作理事會國家
  • 南非
  • 其他中東和非洲地區

競爭資訊

• 前五大公司對比
• 主要企業的市場定位（2025 年）
• 主要市場參與者所採取的策略
• 近期市場趨勢
• 公司市佔率分析（2025 年）
• 主要企業公司簡介
  • 公司詳情
  • 產品系列分析
  • 依業務板塊進行公司股票分析
  • 2023-2025年營收年比比較

主要企業簡介

• 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）

結論與建議

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