全球分子診斷市場規模（按產品、應用、技術、地區、範圍和預測）

分子診斷的市場規模及預測

2024 年分子診斷市場規模價值為 190.8 億美元，預計到 2031 年將達到 332.8 億美元，2024 年至 2031 年的複合年增長率為 7.20%。分子診斷學是利用分子生物學研究疾病的領域。它檢查細胞和體液中的遺傳物質（DNA、RNA）和蛋白質。這項調查工作有助於診斷疾病、識別風險因素、甚至制定個人化治療方案。這是一個突破性的舉措，將使醫療保健從 "一刀切" 的做法轉向更具體的個人化策略。分子診斷具有多樣化、可改變醫療保健的應用。識別特定的病毒標記可以更好地診斷 COVID-19 等傳染病。它不僅可以檢測與傳染病相關的基因變異，還可以檢測與許多癌症相關的基因變異，從而實現早期發現和有針對性的治療。此外，該技術還可以確定某些疾病的易感性和身體對治療的反應，為個人化治療鋪平道路。

近年來，各種新技術被引進市場。散彈鎗宏基因組次世代定序是一種基於基因組的綜合診斷方法，可檢測患者樣本中所有已知微生物。每個樣本都會經過約 40,000 種微生物的檢測，包括細菌、病毒、寄生蟲和真菌。 MSI 分析系統可偵測與林奇症候群（一種顯性遺傳惡性腫瘤）相關的微衛星不穩定性 (MSI)。分子診斷領域的樣品製備技術正在不斷進步。

全球分子診斷市場動態

影響全球分子診斷市場的關鍵市場動態

主要市場驅動因子

技術進步：

技術進步：PCR、NGS、數位PCR等分子診斷技術的不斷突破，將有助於提高檢測的準確性、效率和可擴展性，從而推動市場擴張。這些進步將促進創新診斷檢測的發展，將分子診斷的範圍擴大到一系列疾病和病症。

慢性病和傳染病發生率不斷上升：

癌症、心血管疾病和糖尿病等慢性病和傳染病的發展正在推動對分子診斷的需求。這些測試能夠快速且準確地診斷疾病，實現早期介入、個人化治療和疾病管理，從而推動全球市場的成長。

個人化醫療需求不斷成長：

基因體學和精準醫療方法的進步推動了個人化醫療的趨勢，加速了分子診斷的使用。這些測試提供有關個人基因組成、疾病風險和治療反應的信息，幫助臨床醫生為患者確定最有效的治療方法。對個人化治療技術的日益重視凸顯了分子診斷在醫療保健中的重要性。

醫療支出與意識的提高：

醫療保健支出的增加以及對早期疾病檢測和預防保健益處的認識不斷提高，推動了分子診斷的採用。政府、醫療保健組織和患者都在投資新的診斷技術，以改善醫療保健結果並減輕疾病負擔。人們對醫療保健基礎設施的認識不斷提高以及投資不斷增加，正在增加全球獲得分子診斷測試的機會，從而推動市場擴張。

主要問題

監理障礙：

克服嚴格的監管障礙並獲得分子診斷測試的批准可能很困難且耗時。監管機構通常採用嚴格的標準來審查安全性、有效性和臨床有效性測試，從而延遲市場進入並增加製造商的合規成本。

實施成本高：

購買和維護分子診斷設備和技術的高成本是產業擴張的障礙。此外，需要專業人員來操作這些複雜的系統，這增加了總體成本並限制了可訪問性和可接受性，尤其是在資源受限的環境中。

傳統測試方法阻礙了：

由於熟悉度、成本效益或基礎設施限制，基於培養的技術和免疫測定等傳統診斷方法可能仍然比分子診斷方法更受歡迎。克服從傳統檢測轉向分子檢測的阻力對於市場滲透和廣泛接受度是一個課題。

資料解釋與標準化：

診斷測試產生的複雜分子數據可能難以解釋，並且在不同的實驗室中保持一致。測試方法、數據分析技術和報告標準的變化會導致不同的結果，從而降低分子診斷的可靠性和可比較性。為了解決這個問題，擁有強大的品質控制系統和一致的做法非常重要。

主要趨勢

即時檢定實作：

目前，人們越來越傾向於進行即時分子檢測，以便在病人床邊或社區環境中快速做出診斷和治療決策。這項變更將透過減少週轉時間來提高醫療保健效率，特別是在偏遠和資源有限的地區。

整合人工智慧與大數據分析：

人工智慧和大數據分析越來越多地被融入分子診斷程序中，從而能夠更準確地解釋複雜的分子數據並識別生物標記。這些技術提高了診斷準確性、加快了數據分析並實現了個人化的治療計劃。

擴大液體切片的應用：

液體切片檢查可以分析血液樣本中的循環腫瘤 DNA 和其他生物標記物，在分子診斷中越來越受歡迎。這種非侵入性方法可以實現早期癌症檢測、治療效果追蹤和微小殘留疾病的檢測，在癌症診斷中越來越被接受。

數位 PCR 與 NGS 技術的出現：

數位 PCR 和次世代定序 (NGS) 技術在分子診斷中的應用越來越廣泛，因為與傳統方法相比，它們具有更高的靈敏度、解析度和吞吐量。這些發展將實現更廣泛的基因分析、罕見突變的檢測和對疾病原因的更深入瞭解，從而影響分子診斷的未來。

目錄

第 1 章簡介

• 市場定義
• 市場區隔
• 研究方法

第 2 章執行摘要

• 主要發現 市場概況 市集亮點

第3章 市場概覽

• 市場規模與成長潛力
• 市場趨勢
• 市場推動因素
• 市場限制
• 市場機會
• 波特五力分析

第 4 章 分子診斷市場（依產品）

• 設備
• 試劑和耗材

第 5 章分子診斷市場：用途別

• 傳染病
• 腫瘤學
• 基因檢測
• 血液篩檢

第6章 分子診斷市場（依技術劃分）

• 聚合酶鍊式反應 (PCR) 新一代定序（NGS） 原位雜交（ISH）
• 微陣列 質譜法（MS）

第 7 章 區域分析

• 北美洲
• 美國
• 加拿大
• 墨西哥
• 歐洲
• 英國
• 德國
• 法國
• 義大利 亞太地區
• 中國
• 日本
• 印度
• 澳大利亞
• 拉丁美洲
• 巴西
• 阿根廷
• 智利
• 中東和非洲
• 南非
• 沙烏地阿拉伯
• 阿拉伯聯合大公國

第 8 章 市場動態

• 市場推動因素
• 市場限制
• 市場機會
• COVID-19 市場影響

第 9 章 競爭格局

• 大型公司
• 市佔率分析

第10章 公司簡介

• 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 市場展望與機會

• 新興技術
• 未來市場趨勢
• 投資機會

第 12 章附錄

• 縮寫列表
• 來源與參考文獻

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