全球分子诊断市场规模（按产品、应用、技术、地区、范围和预测）

分子诊断的市场规模及预测

2024 年分子诊断市场规模价值为 190.8 亿美元，预计到 2031 年将达到 332.8 亿美元，2024 年至 2031 年的复合年增长率为 7.20%。分子诊断学是利用分子生物学研究疾病的领域。它检查细胞和体液中的遗传物质（DNA、RNA）和蛋白质。这项调查工作有助于诊断疾病、识别风险因素、甚至制定个人化治疗方案。这是一个突破性的举措，将使医疗保健从 "一刀切" 的做法转向更具体的个人化策略。分子诊断具有多样化、可改变医疗保健的应用。识别特定的病毒标记可以更好地诊断 COVID-19 等传染病。它不仅可以检测与传染病相关的基因变异，还可以检测与许多癌症相关的基因变异，从而实现早期发现和有针对性的治疗。此外，该技术还可以确定某些疾病的易感性和身体对治疗的反应，为个人化治疗铺平道路。

近年来，各种新技术被引进市场。散弹鎗宏基因组次世代定序是一种基于基因组的综合诊断方法，可检测患者样本中所有已知微生物。每个样本都会经过约 40,000 种微生物的检测，包括细菌、病毒、寄生虫和真菌。 MSI 分析系统可侦测与林奇症候群（一种显性遗传恶性肿瘤）相关的微卫星不稳定性 (MSI)。分子诊断领域的样品製备技术正在不断进步。

全球分子诊断市场动态

影响全球分子诊断市场的关键市场动态

主要市场驱动因子

技术进步：

技术进步：PCR、NGS、数位PCR等分子诊断技术的不断突破，将有助于提高检测的准确性、效率和可扩展性，从而推动市场扩张。这些进步将促进创新诊断检测的发展，将分子诊断的范围扩大到一系列疾病和病症。

慢性病和传染病发生率不断上升：

癌症、心血管疾病和糖尿病等慢性病和传染病的发展正在推动对分子诊断的需求。这些测试能够快速且准确地诊断疾病，实现早期介入、个人化治疗和疾病管理，从而推动全球市场的成长。

个人化医疗需求不断成长：

基因体学和精准医疗方法的进步推动了个人化医疗的趋势，加速了分子诊断的使用。这些测试提供有关个人基因组成、疾病风险和治疗反应的信息，帮助临床医生为患者确定最有效的治疗方法。对个人化治疗技术的日益重视凸显了分子诊断在医疗保健中的重要性。

医疗支出与意识的提高：

医疗保健支出的增加以及对早期疾病检测和预防保健益处的认识不断提高，推动了分子诊断的采用。政府、医疗保健组织和患者都在投资新的诊断技术，以改善医疗保健结果并减轻疾病负担。人们对医疗保健基础设施的认识不断提高以及投资不断增加，正在增加全球获得分子诊断测试的机会，从而推动市场扩张。

主要问题

监理障碍：

克服严格的监管障碍并获得分子诊断测试的批准可能很困难且耗时。监管机构通常采用严格的标准来审查安全性、有效性和临床有效性测试，从而延迟市场进入并增加製造商的合规成本。

实施成本高：

购买和维护分子诊断设备和技术的高成本是产业扩张的障碍。此外，需要专业人员来操作这些复杂的系统，这增加了总体成本并限制了可访问性和可接受性，尤其是在资源受限的环境中。

传统测试方法阻碍了：

由于熟悉度、成本效益或基础设施限制，基于培养的技术和免疫测定等传统诊断方法可能仍然比分子诊断方法更受欢迎。克服从传统检测转向分子检测的阻力对于市场渗透和广泛接受度是一个课题。

资料解释与标准化：

诊断测试产生的复杂分子数据可能难以解释，并且在不同的实验室中保持一致。测试方法、数据分析技术和报告标准的变化会导致不同的结果，从而降低分子诊断的可靠性和可比较性。为了解决这个问题，拥有强大的品质控制系统和一致的做法非常重要。

主要趋势

即时检定实作：

目前，人们越来越倾向于进行即时分子检测，以便在病人床边或社区环境中快速做出诊断和治疗决策。这项变更将透过减少週转时间来提高医疗保健效率，特别是在偏远和资源有限的地区。

整合人工智慧与大数据分析：

人工智慧和大数据分析越来越多地被融入分子诊断程序中，从而能够更准确地解释复杂的分子数据并识别生物标记。这些技术提高了诊断准确性、加快了数据分析并实现了个人化的治疗计划。

扩大液体切片的应用：

液体切片检查可以分析血液样本中的循环肿瘤 DNA 和其他生物标记物，在分子诊断中越来越受欢迎。这种非侵入性方法可以实现早期癌症检测、治疗效果追踪和微小残留疾病的检测，在癌症诊断中越来越被接受。

数位 PCR 与 NGS 技术的出现：

数位 PCR 和次世代定序 (NGS) 技术在分子诊断中的应用越来越广泛，因为与传统方法相比，它们具有更高的灵敏度、解析度和吞吐量。这些发展将实现更广泛的基因分析、罕见突变的检测和对疾病原因的更深入瞭解，从而影响分子诊断的未来。

目录

第 1 章简介

• 市场定义
• 市场区隔
• 研究方法

第 2 章执行摘要

• 主要发现 市场概况 市集亮点

第3章 市场概览

• 市场规模与成长潜力
• 市场趋势
• 市场推动因素
• 市场限制
• 市场机会
• 波特五力分析

第 4 章 分子诊断市场（依产品）

• 设备
• 试剂和耗材

第 5 章分子诊断市场：用途别

• 传染病
• 肿瘤学
• 基因检测
• 血液筛检

第6章 分子诊断市场（依技术划分）

• 聚合酶炼式反应 (PCR) 新一代定序（NGS） 原位杂交（ISH）
• 微阵列 质谱法（MS）

第 7 章 区域分析

• 北美洲
• 美国
• 加拿大
• 墨西哥
• 欧洲
• 英国
• 德国
• 法国
• 义大利 亚太地区
• 中国
• 日本
• 印度
• 澳大利亚
• 拉丁美洲
• 巴西
• 阿根廷
• 智利
• 中东和非洲
• 南非
• 沙乌地阿拉伯
• 阿拉伯联合大公国

第 8 章 市场动态

• 市场推动因素
• 市场限制
• 市场机会
• COVID-19 市场影响

第 9 章 竞争格局

• 大型公司
• 市占率分析

第10章 公司简介

• Abbott Laboratories
• Roche Diagnostics
• Thermo Fisher Scientific
• Bio-Rad Laboratories
• QIAGEN
• Siemens Healthineers
• Becton
• Dickinson and Company（BD）
• Hologic, Inc.
• Danaher Corporation
• Agilent Technologies

第 11 章 市场展望与机会

• 新兴技术
• 未来市场趋势
• 投资机会

第 12 章附录

• 缩写列表
• 来源与参考文献

Molecular Diagnostics Market Size And Forecast

Molecular Diagnostics Market size was valued at USD 19.08 Billion in 2024 and is projected to reach USD 33.28 Billion by 2031 , growing at a CAGR of 7.20% from 2024 to 2031. Molecular diagnostics is a field that uses molecular biology to study diseases. It investigates genetic material (DNA, RNA) and proteins in cells or fluids. This investigative work aids in disease diagnosis, risk factor identification, and even personalized treatment regimens. It's a game-changing instrument that is moving medicine away from a one-size-fits-all approach and toward a more specific and tailored strategy. Molecular diagnostics has a diverse set of applications that are transforming medicine. It excels at diagnosing infectious disorders like COVID-19 by identifying specific viral markers. Beyond infection, it can detect genetic changes associated with many cancers, allowing for early detection and targeted treatments. Furthermore, this technology can determine a person's susceptibility to particular diseases or how their body will react to treatments, paving the path for tailored therapy.

In recent years, various new technologies have been introduced to the market. Shotgun metagenomic next-generation sequencing is a comprehensive genomics-based diagnostic that detects all known microorganisms in a patient's sample. Each sample is examined for around 40,000 microorganisms, which include bacteria, viruses, parasites, and fungus. The MSI Analysis System detects microsatellite instability (MSI), which is associated with Lynch Syndrome, a dominant hereditary malignancy. Sample preparation techniques have advanced in the field of molecular diagnostics.

Global Molecular Diagnostics Market Dynamics

The key market dynamics that are shaping the global molecular diagnostics market include:

Key Market Drivers:

Advancements in Technology:

Continuous breakthroughs in molecular diagnostic technologies, including as PCR, NGS, and digital PCR, propel market expansion by boosting test accuracy, efficiency, and scalability. These advancements allow for the development of innovative diagnostic assays and broaden the application range of molecular diagnostics to a variety of diseases and situations.

Increased prevalence of chronic and infectious diseases:

The growing prevalence of chronic diseases such as cancer, cardiovascular disease, and diabetes, as well as developing infectious diseases, is driving the demand for molecular diagnostics. These tests diagnose diseases quickly and accurately, allowing for early intervention, individualized therapy, and disease management, driving global market growth.

Increasing Demand for Personalized Medicine:

The trend to customized medicine, fueled by advances in genomics and precision medicine approaches, accelerates the use of molecular diagnostics. These tests provide information about individuals' genetic makeup, disease risk, and treatment response, assisting clinicians in identifying the most effective therapy for patients. The increased emphasis on personalized treatment techniques highlights the importance of molecular diagnostics in healthcare delivery.

Increasing Healthcare Spending and Awareness:

Rising healthcare spending, combined with growing knowledge of the benefits of early disease identification and preventive care, is driving the adoption of molecular diagnostics. Governments, healthcare organizations, and patients are all investing in new diagnostic technology to enhance healthcare outcomes and lower illness burdens. Growing awareness and investment in healthcare infrastructure drives market expansion by increasing access to molecular diagnostic testing worldwide.

Key Challenges:

Regulatory hurdles:

Navigating rigorous regulatory hurdles and securing permission for molecular diagnostic tests can be difficult and time-consuming. Regulatory bodies frequently use severe criteria to examine the safety, effectiveness, and clinical validity of these tests, causing delays in market entrance and increasing compliance costs for producers.

High Implementation Costs:

The high cost of purchasing and maintaining molecular diagnostic equipment and technologies is a barrier to industry expansion. Furthermore, the necessity for specialized staff to operate these advanced systems raises the overall cost, restricting accessibility and acceptance, particularly in resource-constrained environments.

Interference from Traditional Testing Methods:

Traditional diagnostic procedures, such as culture-based techniques or immunoassays, may still be favored over molecular diagnostics for reasons of familiarity, cost-effectiveness, or infrastructural restrictions. Overcoming opposition to switching from conventional to molecular testing poses a challenge to market penetration and widespread acceptance.

Data Interpretation and Standardization:

Interpreting complicated molecular data produced by diagnostic testing and ensuring consistency among laboratories can be difficult. Variability in testing methodologies, data analysis techniques, and reporting standards can lead to variations in results, reducing the reliability and comparability of molecular diagnostics. To overcome this issue, it is critical to establish strong quality control systems and consistent norms.

Key Trends:

Implementation of Point-of-Care Testing:

There is a growing trend toward point-of-care molecular testing, which allows for rapid diagnosis and treatment decisions at the patient's bedside or in community settings. This change shortens turnaround times and improves healthcare efficiency, particularly in distant or resource-limited places.

Integration of AI and Big Data Analytics:

AI and big data analytics are increasingly being integrated into molecular diagnostic procedures, enabling for more accurate interpretation of complex molecular data and biomarker identification. These technologies improve diagnosis accuracy, speed data analysis, and enable individualized treatment plans.

Expansion of Liquid Biopsy Applications:

Liquid biopsy, which analyzes circulating tumor DNA or other biomarkers in blood samples, is gaining popularity in molecular diagnostics. This non-invasive approach allows for early cancer identification, treatment response tracking, and minimal residual disease detection, which is pushing its acceptance in oncology diagnostics.

Emergence of Digital PCR and NGS technologies:

Digital PCR and next-generation sequencing (NGS) technologies are increasingly being used in molecular diagnostics, as they provide improved sensitivity, resolution, and throughput than previous approaches. These developments allow for extensive genetic analysis, the detection of rare mutations, and a better knowledge of disease causes, influencing the future of molecular diagnostics.

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Global Molecular Diagnostics Market Regional Analysis

Here is a more detailed regional analysis of the global molecular diagnostics market:

North America:

Several significant reasons contribute to North America's dominance in the Molecular Diagnostics market. For starters, the region has modern healthcare infrastructure and facilities, which makes molecular diagnostic technology more widely available. This infrastructure facilitates efficient testing processes and provides prompt and accurate diagnosis, which contributes to North America's market leadership.

North America is home to a variety of major pharmaceutical and biotechnology companies that make significant investments in research and development. These investments spur innovation in molecular diagnostics, resulting in the creation of new testing procedures and diagnostic tools. Continuous technological developments strengthen North America's position as a global leader in molecular diagnostics.

In North America, strong regulatory standards and guidelines ensure that molecular diagnostic products are of high quality and safe. The strict regulatory system gives healthcare professionals and patients trust in the reliability and precision of diagnostic tests, promoting wider usage. This regulatory environment promotes a favorable market environment, attracting investments and driving market growth in North America.

The prevalence of chronic diseases and infectious outbreaks in North America emphasizes the role of molecular diagnostics in disease management and surveillance. The region's high healthcare expenditures and emphasis on precision medicine fuel demand for innovative diagnostic solutions. As a result, North America remains at the forefront of the Molecular Diagnostics Market, dominating innovation, acceptance, and market share.

Asia Pacific:

Healthcare expenditure in the Asia Pacific region is rapidly increasing, owing to rising incomes, growing middle-class populations, and improved healthcare infrastructure. This increasing spending provides better access to new diagnostic technologies, such as molecular diagnostics, resulting in a boom in demand for these tests throughout the region.

The Asia Pacific region is seeing a huge increase in the prevalence of chronic diseases such as cancer, cardiovascular disease, and diabetes, as well as new infectious diseases. Molecular diagnostics provide reliable and quick detection of various disorders, which drives their use in clinical settings. As the region's disease burden increases, so does the demand for molecular diagnostics.

Government activities aiming at improving healthcare access, illness surveillance, and preventative healthcare measures are pushing molecular diagnostics usage across Asia Pacific. Healthcare reforms and regulations that encourage the development and implementation of sophisticated diagnostic technologies drive market growth, creating a favorable environment for investment and innovation.

The growing awareness among healthcare professionals and patients about the benefits of personalized and precision medicine is pushing the adoption of molecular diagnostics in Asia Pacific. With an emphasis on personalized treatment approaches based on genetic profiles and illness characteristics, molecular diagnostics is critical in guiding medication selection and improving patient outcomes.

Global Molecular Diagnostics Market Segmentation Analysis

The Global Molecular Diagnostics Market is Segmented on the basis of Product, Application, Technology, And Geography.

Molecular Diagnostics Market, By Product

• Instruments
• Reagents & Consumables

Based on Product, the market is bifurcated into Instruments and Reagents & Consumables. Reagents and consumables dominate the Molecular Diagnostics industry, outperforming devices. Two major elements contribute to this supremacy. For starters, unlike devices with lengthy lifespans, reagents such as test kits and enzymes are utilized and must be replaced on a regular basis to perform diagnostic tests. Second, the segment offers a broader range of test kits for a number of applications, including infectious disease testing and genetic analysis, as opposed to the more limited instrument category. However, the tide may be turning. Advancements in equipment, such as next-generation sequencing platforms, and rising need for automation may push their market share higher in the future.

Molecular Diagnostics Market, By Technology

• Polymerase Chain Reaction (PCR)
• Next-Generation Sequencing (NGS)
• In Situ Hybridization (ISH)
• Microarrays
• Mass Spectrometry (MS)

Based on Technology, the market is bifurcated into Polymerase Chain Reaction (PCR), Next-Generation Sequencing (NGS), In Situ Hybridization (ISH), Microarrays, and Mass Spectrometry (MS). The Polymerase Chain Reaction (PCR) segment dominates the Molecular Diagnostics Market because to its well-established technology, high sensitivity and specificity, and versatility across a wide range of diagnostic applications. PCR's capacity to accurately amplify tiny DNA or RNA samples makes it essential for detecting infectious illnesses, genetic abnormalities, and cancer. Continuous advancements, such as real-time and digital PCR, have improved its efficiency and accuracy, firmly establishing its market leadership.

Molecular Diagnostics Market, By Application

• Infectious Diseases
• Oncology
• Genetic Testing
• Blood Screening

Based on Application, the market is segmented into Infectious Diseases, Oncology, Genetic Testing, and Blood Screening. The Infectious Diseases segment dominates the Molecular Diagnostics Market due to the substantial need for speedy and accurate diagnostic tests that can detect a wide spectrum of pathogens. The worldwide spread of infectious diseases, particularly new and re-emerging infections, highlights the need for reliable diagnostic treatments. Molecular diagnostics have excellent sensitivity and specificity, making them critical for early detection, treatment, and outbreak control. Furthermore, continued advances in molecular technology and an increased emphasis on infectious disease control contribute to this segment's dominant position.

Molecular Diagnostics Market, By Geography

• North America
• Europe
• Asia Pacific
• Rest of the World
• On the basis of regional analysis, the Global Molecular Diagnostics Market is classified into North America, Europe, Asia Pacific, and the Rest of the world. North America leads the Global Molecular Diagnostics Market due to its advanced healthcare infrastructure, significant investment in R&D, and widespread use of cutting-edge technologies. The region benefits from the existence of top molecular diagnostics companies, as well as a strong regulatory framework that allows innovative diagnostic tests to be approved and commercialized quickly. Furthermore, the growing prevalence of chronic and infectious diseases, combined with rising healthcare costs, pushes demand for molecular diagnostics.

Key Players

• The "Global Molecular Diagnostics Market" study report will provide valuable insight with an emphasis on the global market. The major players in the market are
• Abbott Laboratories, Roche Diagnostics, Thermo Fisher Scientific, Bio-Rad Laboratories, QIAGEN, Siemens Healthineers, Becton, Dickinson and Company (BD), Hologic, Inc., Danaher Corporation, and Agilent Technologies.
• are all prominent players in the healthcare and diagnostics industry. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.

• Molecular Diagnostics Market Recent Developments
• In February 2023, Thermo Fisher Scientific Inc. (US) purchased Binding Site Group (UK), an international leader in specialised diagnostics, expanding Thermo Fisher's current specialty diagnostics portfolio with pioneering innovation in multiple myeloma diagnosis and monitoring.
• In October 2022, F. Hoffmann-La Roche Ltd. (Switzerland) gained 510(k) approval from the US FDA for the cobas SARS-CoV-2 Qualitative PCR test for use with the entirely computerized cobas 6800 and cobas 8800 systems.
• In May 2022, F. Hoffmann-La Roche Ltd. (Switzerland) collaborated with the Global Fund to help countries with low or middle incomes develop vital diagnostics infrastructure.
• In December 2021, Hologic, Inc. (US) introduced Panther Trax for large quantities of molecular testing.
• In March 2021, Abbott Laboratories (US) received Emergency Use Authorization (EUA) from the FDA for Alinity m Resp-4-Plex molecular assay, a laboratory PCR assay that detects and distinguishes between SARS-COV-2, flu A, flu B, and RSV in a single test.

TABLE OF CONTENTS

1. Introduction

• Market Definition
• Market Segmentation
• Research Methodology

2. Executive Summary

• Key Findings
• Market Overview
• Market Highlights

3. Market Overview

• Market Size and Growth Potential
• Market Trends
• Market Drivers
• Market Restraints
• Market Opportunities
• Porter's Five Forces Analysis

4. Molecular Diagnostics Market, By Product

• Instruments
• Reagents & Consumables

5. Molecular Diagnostics Market, By Application

• Infectious Diseases
• Oncology
• Genetic Testing
• Blood Screening

6. Molecular Diagnostics Market, By Technology

• Polymerase Chain Reaction (PCR)
• Next-Generation Sequencing (NGS)
• In Situ Hybridization (ISH)
• Microarrays
• Mass Spectrometry (MS)

7. Regional Analysis

• North America
• United States
• Canada
• Mexico
• Europe
• United Kingdom
• Germany
• France
• Italy
• Asia-Pacific
• China
• Japan
• India
• Australia
• Latin America
• Brazil
• Argentina
• Chile
• Middle East and Africa
• South Africa
• Saudi Arabia
• UAE

8. Market Dynamics

• Market Drivers
• Market Restraints
• Market Opportunities
• Impact of COVID-19 on the Market

9. Competitive Landscape

• Key Players
• Market Share Analysis

10. Company Profiles

• Abbott Laboratories
• Roche Diagnostics
• Thermo Fisher Scientific
• Bio-Rad Laboratories
• QIAGEN
• Siemens Healthineers
• Becton
• Dickinson and Company (BD)
• Hologic, Inc.
• Danaher Corporation
• Agilent Technologies

11. Market Outlook and Opportunities

• Emerging Technologies
• Future Market Trends
• Investment Opportunities

12. Appendix

• List of Abbreviations
• Sources and References