分子診断の世界市場規模：製品別、用途別、技術別、地域別、範囲および予測

分子診断の市場規模と予測

分子診断の市場規模は、2024年に190億8,000万米ドルと評価され、2031年には332億8,000万米ドルに達すると予測され、2024年から2031年までのCAGRは7.20%で成長します。分子診断学は、分子生物学を利用して病気を研究する分野です。細胞や体液中の遺伝物質（DNA、RNA）やタンパク質を調査します。この調査作業は、病気の診断、危険因子の特定、さらには個別化された治療レジメンの助けとなります。これは、医療を画一的なアプローチから、より具体的で個別化された戦略へと移行させる、画期的な手段です。分子診断学には、医療を一変させる多様な応用分野があります。特定のウイルス・マーカーを特定することで、COVID-19のような感染症の診断に優れています。感染症にとどまらず、多くのがんに関連する遺伝子の変化を検出することができ、早期発見と標的治療を可能にします。さらにこの技術は、特定の病気に対する感受性や、治療に対する身体の反応を判定し、オーダーメイド治療への道を開くことができます。

近年、さまざまな新技術が市場に導入されています。ショットガンメタゲノム次世代シーケンサーは、患者のサンプルに含まれる既知の微生物をすべて検出する、包括的なゲノムベースの診断法です。各サンプルは、細菌、ウイルス、寄生虫、真菌を含む約40,000の微生物について検査されます。MSI分析システムは、優性遺伝性悪性腫瘍であるリンチ症候群に関連するマイクロサテライト不安定性（MSI）を検出します。分子診断の分野ではサンプル調製技術が進歩しています。

世界の分子診断市場力学

世界の分子診断市場を形成している主な市場力学

主な市場促進要因

技術の進歩：

技術の進歩：PCR、NGS、デジタルPCRなど、分子診断技術における継続的なブレークスルーは、検査精度、効率性、拡張性を高めることで市場拡大を後押しします。これらの進歩は革新的な診断アッセイの開発を可能にし、分子診断の適用範囲を様々な疾患や状況にまで広げます。

慢性疾患および感染症の流行増加：

がん、心血管疾患、糖尿病などの慢性疾患や感染症の開発が、分子診断に対する需要を押し上げています。これらの検査は疾病を迅速かつ正確に診断し、早期介入、個別化治療、疾病管理を可能にし、世界市場の成長を牽引しています。

個別化医療への需要の高まり：

ゲノミクスと精密医療アプローチの進歩に後押しされた個別化医療の動向は、分子診断の使用を加速させています。これらの検査は、個人の遺伝的体質、疾病リスク、治療反応に関する情報を提供し、臨床医が患者に最も効果的な治療法を特定するのに役立ちます。個別化治療技術の重視の高まりは、ヘルスケア提供における分子診断学の重要性を浮き彫りにしています。

ヘルスケア支出と意識の高まり：

ヘルスケア支出の増加と、疾病の早期発見と予防医療の利点に関する知識の高まりが、分子診断の採用を後押ししています。政府、医療機関、患者はいずれも、ヘルスケアの成果を高め、疾病負担を軽減するために新しい診断技術に投資しています。ヘルスケア・インフラに対する認識と投資の高まりは、分子診断検査へのアクセスを世界的に増加させ、市場拡大の原動力となっています。

主な課題

規制上のハードル：

厳しい規制のハードルを乗り越え、分子診断検査の許可を得ることは困難で時間のかかることです。規制機関はしばしば厳しい基準で検査の安全性、有効性、臨床的妥当性を審査するため、市場参入が遅れ、製造業者のコンプライアンスコストが増大します。

高い実施コスト：

分子診断装置や技術の購入・維持にかかる高コストは、業界拡大の障壁となっています。さらに、これらの高度なシステムを操作するためには専門スタッフが必要であるため、全体的なコストが上昇し、特に資源に制約のある環境では、利用しやすさと受容性が制限されます。

従来の検査方法による妨害：

培養に基づく技術や免疫測定法などの従来の診断法は、親しみやすさ、費用対効果、あるいはインフラの制約などの理由から、分子診断法よりも依然として好まれている可能性があります。従来の検査法から分子検査法への切り替えに対する反対を克服することは、市場への浸透と広く受け入れられるための課題となります。

データの解釈と標準化：

診断検査で得られた複雑な分子データの解釈や検査施設間の一貫性の確保は困難です。検査手法、データ解析技術、報告基準のばらつきが結果のばらつきにつながり、分子診断の信頼性と比較可能性を低下させる。この問題を克服するためには、強固な品質管理システムと一貫した規範を確立することが重要です。

主な動向

ポイントオブケア検査の実施：

患者のベッドサイドや地域環境で迅速な診断と治療方針の決定を可能にするポイントオブケア分子検査への動向が高まっています。この変化により、特に遠隔地や資源が限られた場所での所要時間が短縮され、ヘルスケアの効率が向上します。

AIとビッグデータ分析の統合：

AIとビッグデータ解析の分子診断手順への統合が進んでおり、複雑な分子データのより正確な解釈とバイオマーカーの同定が可能になっています。これらの技術は診断精度を向上させ、データ解析を迅速化し、個別の治療計画を可能にします。

リキッドバイオプシー応用の拡大：

血液サンプル中の循環腫瘍DNAやその他のバイオマーカーを分析するリキッドバイオプシーは、分子診断学で人気を集めています。この非侵襲的なアプローチにより、がんの早期発見、治療効果の追跡、最小残存病変の検出が可能となり、がん診断における受け入れが進んでいます。

デジタルPCRとNGS技術の出現：

デジタルPCRと次世代シークエンシング（NGS）技術は、従来のアプローチよりも感度、分解能、スループットが向上しているため、分子診断においてますます使用されるようになっています。これらの開発により、広範な遺伝子解析、希少変異の検出、疾患の原因に関するより深い知識が可能となり、分子診断の将来に影響を与えます。

目次

第1章 イントロダクション

• 市場の定義
• 市場セグメンテーション
• 調査手法

第2章 エグゼクティブサマリー

• 主な調査結果
• 市場概要
• 市場ハイライト

第3章 市場概要

• 市場規模と成長の可能性
• 市場動向
• 市場促進要因
• 市場抑制要因
• 市場機会
• ポーターのファイブフォース分析

第4章 分子診断市場：製品別

• 機器
• 試薬・消耗品

第5章 分子診断市場：用途別

• 感染症
• 腫瘍学
• 遺伝子検査
• 血液スクリーニング

第6章 分子診断市場：技術別

• ポリメラーゼ連鎖反応（PCR）
• 次世代シーケンシング（NGS）
• インサイチュハイブリダイゼーション（ISH）
• マイクロアレイ
• 質量分析（MS）

第7章 地域分析

• 北米
• 米国
• カナダ
• メキシコ
• 欧州
• 英国
• ドイツ
• フランス
• イタリア
• アジア太平洋
• 中国
• 日本
• インド
• オーストラリア
• ラテンアメリカ
• ブラジル
• アルゼンチン
• チリ
• 中東・アフリカ
• 南アフリカ
• サウジアラビア
• アラブ首長国連邦

第8章 市場力学

• 市場促進要因
• 市場抑制要因
• 市場機会
• COVID-19の市場への影響

第9章 競合情勢

• 主要企業
• 市場シェア分析

第10章 企業プロファイル

• 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 市場の展望と機会

• 新興技術
• 今後の市場動向
• 投資機会

第12章 付録

• 略語リスト
• 出典と参考文献

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