Molecular Diagnostics Patent Landscape Report

Molecular Diagnostics Patent Landscape Report


Global Molecular Diagnostics Patent Landscape Report 2024 Global Molecular Diagnostics Industry Size The global molecular diagnostics market was valued at USD 15 billion in 2023. The market is expected to grow at a CAGR of 13.5% during the forecast period of 2024-2032, with the values likely to reach USD 46.8 billion by 2032. The patent landscape is expanding with the United States leading with over 7,500 patents focusing on advanced detection technologies such as PCR and sequencing. Patent Landscape Report Coverage This report provides a thorough analysis of the global patent landscape for molecular diagnostics. It explores patent trends, significant technological advancements, and emerging innovations in this field. The report includes detailed information on patent filings, grants, and the leading companies that are shaping the molecular diagnostics sector. Emphasising strategic developments and state-of-the-art technologies, this report is an essential resource for stakeholders aiming to grasp the intellectual property landscape and competitive environment of the molecular diagnostics industry. Global Molecular Diagnostics Patent Outlook • The molecular diagnostics patent landscape is driven by advancements in detection technologies such as PCR and next-generation sequencing. These technologies enhance sensitivity and specificity, facilitating early disease diagnosis and personalised treatment. Approximately 6,000 patents focus on these innovations, emphasizing the importance of precision medicine. • Leading companies such as Becton Dickinson Co. and Nanogen Inc. are pivotal in shaping the patent landscape. These companies are heavily investing in R&D, filing over 4,000 patents collectively to develop advanced assay technologies and integrate diagnostics with digital health platforms, enhancing accuracy and accessibility. • The United States leads with over 7,500 patents, focusing on regulatory compliance and advanced technologies. Europe, with over 5,000 patents, emphasizes integration with healthcare systems. The Asia-Pacific region, notably China and Japan, is emerging with 4,500 patents, focusing on scalable and cost-effective solutions to meet healthcare demands. Molecular Diagnostics Introduction Molecular diagnostics are at the forefront of precision medicine, enabling the detection and analysis of genetic material to diagnose and monitor diseases accurately. These diagnostics play a critical role in areas such as oncology, infectious diseases, and genetic testing, facilitating early detection and personalised treatment plans. The patent landscape for molecular diagnostics is driven by the need for advanced detection technologies, integration with digital platforms, and cost-effective solutions. • The pursuit of more accurate and reliable disease detection methods has led to a surge in innovations. With the rise of next-generation sequencing and PCR advancements, over 6,000 patents have been filed focusing on enhancing sensitivity and specificity. These technologies are crucial for early diagnosis and targeted therapy, helping clinicians detect diseases at their earliest stages and tailor treatments to individual patients' needs. • The growing importance of seamless healthcare delivery has spurred innovations in digital connectivity. Patents related to integrating diagnostics with health IT systems have seen significant growth, with approximately 4,500 patents filed. These innovations enable real-time data analysis and connectivity, improving clinical decision-making and patient management by facilitating the flow of diagnostic information between healthcare providers and systems. • The demand for accessible and affordable diagnostic tools has driven technological advancements aimed at reducing costs. Around 3,500 patents emphasize the development of miniaturised devices and automated systems that make diagnostics more affordable and accessible, particularly in resource-limited environments. These innovations ensure that high-quality diagnostic tools can reach a broader population, improving healthcare equity and outcomes. These drivers contribute to a robust patent landscape, fostering innovations that enhance the accuracy, accessibility, and integration of molecular diagnostics. Global Molecular Diagnostics Patent Segmentation Analysis The report provides an in-depth analysis of the patents in this field by the following segmentation – Analysis by Product and Service • Instruments • Reagents and Kits • Services and Software The patent segmentation based on product and service in molecular diagnostics landscape includes a variety of products and services crucial for accurate disease detection and monitoring. Among these, reagents and kits lead the patent landscape, with over 7,000 patents filed and 900 new filings recently. This dominance is driven by innovations in assay development and reagent formulations that enhance diagnostic accuracy and reliability. Advancements focus on multiplexing capabilities and automation, crucial for streamlining laboratory workflows and improving diagnostic throughput. Analysis by Test Location • Point-of-Care • Self-Test or Over the Counter • Central Laboratories In the patent segmentation based on test location, central laboratories dominate this segment, with over 6,500 patents filed and 850 new applications in the last year. These patents focus on high-throughput technologies and automated systems, which are essential for efficient and large-scale diagnostic testing. Innovations emphasize integration with laboratory information systems (LIS) to enhance data management and reporting accuracy. Analysis by Technology • Polymerase Chain Reaction (PCR) • In Situ Hybridization • Isothermal Nucleic Acid Amplification Technology (INAAT) • Chips and Microarrays • Mass Spectrometry • Sequencing • Transcription Mediated Amplification • Others In the patent segmentation based on technology, Polymerase Chain Reaction (PCR) technology leads with over 8,000 patents historically and 1,200 new patents recently. This dominance is due to advancements in real-time PCR and digital PCR, which enhance sensitivity and quantification accuracy. Innovations focus on multiplexing and rapid detection capabilities, making PCR a cornerstone in molecular diagnostics. Analysis by Application • Oncology o Breast Cancer o Colorectal Cancer o Lung Cancer o Prostate Cancer o Other Cancers • Pharmacogenomics • Infectious Diseases o Hepatitis o HIV o CT/NG o Hospital Acquired Infections (HAI) o HPV o Tuberculosis o Influenza o Other Infectious Diseases • Genetic Testing • Neurological Diseases • Cardiovascular Diseases • Microbiology • Others Molecular diagnostics applications span multiple areas of healthcare, addressing a wide array of diseases. Infectious disease applications lead the patent landscape with over 7,500 patents and 1,000 new filings recently. These patents focus on rapid and accurate detection methods for pathogens, crucial for controlling disease outbreaks. Innovations emphasize multiplex testing and point-of-care solutions that improve diagnostic speed and accessibility. Analysis by End User • Diagnostic Laboratories • Hospitals and Clinics • Others The end users patent segmentation of molecular diagnostics include various healthcare settings, each with specific needs and priorities. Diagnostic laboratories lead the patent landscape with over 6,000 patents historically and more than 800 new filings recently. This dominance is attributed to the development of advanced testing platforms and automated solutions that enhance testing efficiency and accuracy. Patents emphasize innovations in workflow integration and data management, aligning with the growing demand for high-quality diagnostics. Molecular Diagnostics Patent Jurisdiction Analysis The global patent landscape for molecular diagnostics exhibits diverse regional focuses and innovations. North America, particularly the United States, leads with over 7,500 patents, emphasizing advanced detection technologies and regulatory compliance. European countries, especially Germany and the UK, hold over 5,000 patents, focusing on integrating diagnostics with healthcare systems and enhancing test accuracy. The Asia-Pacific region, led by China and Japan, has filed over 4,500 patents, driven by the need for cost-effective and scalable diagnostic solutions to meet growing healthcare demands. Patent Profile of Key Companies The patent landscape for molecular diagnostics is shaped by several key companies driving innovation and securing intellectual property. Here is an overview of their patent activities: Becton Dickinson Co. Becton Dickinson Co., based in Franklin Lakes, New Jersey, holds over 2,500 patents related to molecular diagnostics, with approximately 300 patents in progress. The company focuses on innovations in assay development and automation, aiming to improve diagnostic accuracy and efficiency through strategic patent filings. Nanogen Inc Headquartered in San Diego, California, Nanogen Inc. has filed over 1,800 patents in the molecular diagnostics sector, with around 200 patents currently in progress. The company specialises in advanced detection technologies and point-of-care solutions, enhancing the accessibility and reliability of molecular diagnostics. Other key players in the industry include Wistron Corp, Almac Diagnostics Ltd, and Koninkl Philips Electronics Nv. Key Questions Answered in the Global Molecular Diagnostics Patent Landscape Report • What are the key drivers of impacting the patent landscape of molecular diagnostics? • How do patent trends vary across different regions in the molecular diagnostics landscape? • Which companies are leading in patent filings for molecular diagnostics? • What technological advancements are shaping the future of molecular diagnostics systems? • How is the demand for personalised healthcare solutions influencing patent activity? • What challenges face the development and implementation of molecular diagnostics? • How is regulatory compliance impacting the patent landscape for these devices? • What role do digital health platforms play in the molecular diagnostics patent landscape? • How are patents addressing the integration of diagnostics with healthcare systems? • What are the trends in patent filings for PCR and sequencing technologies? • How is the Asia-Pacific region contributing to the molecular diagnostics patent landscape? • \ • How are laboratory settings driving patent activity in molecular diagnostics? • How is AI influencing the design and functionality of molecular diagnostics? • What are the emerging opportunities for stakeholders in the molecular diagnostics industry? Reasons to Purchase this Report This report offers an in-depth analysis of the patent landscape, covering key trends, technological advancements, and regional insights. It provides detailed segmentation and highlights areas of significant innovation and activity. By examining leading companies' strategies and patent portfolios, the report elucidates competitive dynamics and emerging opportunities. Stakeholders will gain valuable information for strategic decision-making, ensuring they stay ahead in the evolving industry. This comprehensive coverage makes it an essential resource for understanding the industry's future direction.


1 Preface
1.1 Objectives of the Study
1.2 Key Assumptions
1.3 Report Coverage – Key Segmentation and Scope
1.4 Research Methodology
2 Executive Summary
3 Global Molecular Diagnostics Market Overview
3.1 Global Molecular Diagnostics Market Historical Value (2017-2023)
3.2 Global Molecular Diagnostics Market Forecast Value (2024-2032)
4 Global Molecular Diagnostics Market Landscape
4.1 Global Molecular Diagnostics: Developers Landscape
4.1.1 Analysis by Year of Establishment
4.1.2 Analysis by Type
4.1.3 Analysis by Indication
4.2 Global Molecular Diagnostics: Product Landscape
4.2.1 Analysis by Product & Service
4.2.2 Analysis by Technology
4.2.3 Analysis by Application
5 Global Molecular Diagnostics Market Dynamics
5.1 Market Drivers and Constraints
5.2 SWOT Analysis
5.2.1 Strengths
5.2.2 Weaknesses
5.2.3 Opportunities
5.2.4 Threats
5.3 Porter’s Five Forces Model
5.3.1 Bargaining Power of Suppliers
5.3.2 Bargaining Power of Buyers
5.3.3 Threat of New Entrants
5.3.4 Threat of Substitutes
5.3.5 Degree of Rivalry
5.4 Key Demand Indicators
5.5 Key Price Indicators
5.6 Industry Events, Initiatives, and Trends
5.7 Value Chain Analysis
6 Global Molecular Diagnostics Market Segmentation (2017-2032)
6.1 Global Molecular Diagnostics Market (2017-2032) by Product & Service
6.1.1 Market Overview
6.1.2 Instruments
6.1.3 Reagents & Kits
6.1.4 Services & Software
6.2 Global Molecular Diagnostics Market (2017-2032) by Test Location
6.2.1 Market Overview
6.2.2 Point-of-Care
6.2.3 Self-test or Over the Counter
6.2.4 Central Laboratories
6.3 Global Molecular Diagnostics Market (2017-2032) by Technology
6.3.1 Market Overview
6.3.2 Polymerase Chain Reaction (PCR)
6.3.3 In Situ Hybridization
6.3.4 Isothermal Nucleic Acid Amplification Technology (INAAT)
6.3.5 Chips and Microarrays
6.3.6 Mass Spectrometry
6.3.7 Sequencing
6.3.8 Transcription Mediated Amplification
6.3.9 Others
6.4 Global Molecular Diagnostics Market (2017-2032) by Application
6.4.1 Market Overview
6.4.2 Oncology
6.4.2.1 Breast Cancer
6.4.2.2 Colorectal Cancer
6.4.2.3 Lung Cancer
6.4.2.4 Prostate Cancer
6.4.2.5 Other Cancers
6.4.3 Pharmacogenomics
6.4.4 Infectious Diseases
6.4.4.1 Hepatitis
6.4.4.2 HIV
6.4.4.3 CT/NG
6.4.4.4 Hospital Acquired Infections (HAI)
6.4.4.5 HPV
6.4.4.6 Tuberculosis
6.4.4.7 Influenza
6.4.4.8 Other Infectious Diseases
6.4.5 Genetic Testing
6.4.6 Neurological Diseases
6.4.7 Cardiovascular Diseases
6.4.8 Microbiology
6.4.9 Others
6.5 Global Molecular Diagnostics Market (2017-2032) by End User
6.5.1 Market Overview
6.5.2 Diagnostic Laboratories
6.5.3 Hospitals & Clinics
6.5.4 Other End Users
6.6 Global Molecular Diagnostics Market (2017-2032) by Region
6.6.1 Market Overview
6.6.2 North America
6.6.3 Europe
6.6.4 Asia Pacific
6.6.5 Latin America
6.6.6 Middle East and Africa
7 North America Molecular Diagnostics Market (2017-2032)
7.1 North America Molecular Diagnostics Market (2017-2032) by Product and Service
7.1.1 Market Overview
7.1.1 Instruments
7.1.2 Reagents & Kits
7.1.3 Services & Software
7.2 North America Molecular Diagnostics Market (2017-2032) by Technology
7.2.1 Market Overview
7.2.2 Polymerase Chain Reaction (PCR)
7.2.3 In Situ Hybridization
7.2.4 Isothermal Nucleic Acid Amplification Technology (INAAT)
7.2.5 Chips and Microarrays
7.2.6 Mass Spectrometry
7.2.7 Sequencing
7.2.8 Transcription Mediated Amplification
7.2.9 Others
7.3 North America Molecular Diagnostics Market (2017-2032) by Country
7.3.1 United States of America
7.3.2 Canada
8 Europe Molecular Diagnostics Market (2017-2032)
8.1 Europe Molecular Diagnostics Market (2017-2032) by Product and Service
8.1.1 Market Overview
8.1.2 Instruments
8.1.3 Reagents & Kits
8.1.4 Services & Software
8.2 Europe Molecular Diagnostics Market (2017-2032) by Technology
8.2.1 Market Overview
8.2.2 Polymerase Chain Reaction (PCR)
8.2.3 In Situ Hybridization
8.2.4 Isothermal Nucleic Acid Amplification Technology (INAAT)
8.2.5 Chips and Microarrays
8.2.6 Mass Spectrometry
8.2.7 Sequencing
8.2.8 Transcription Mediated Amplification
8.2.9 Others
8.3 Europe Molecular Diagnostics Market (2017-2032) by Country
8.3.1 United Kingdom
8.3.2 Germany
8.3.3 France
8.3.4 Italy
8.3.5 Others
9 Asia Pacific Molecular Diagnostics Market (2017-2032)
9.1 Asia Pacific Molecular Diagnostics Market (2017-2032) by Product and Service
9.1.1 Market Overview
9.1.2 Instruments
9.1.3 Reagents & Kits
9.1.4 Services & Software
9.2 Asia Pacific Molecular Diagnostics Market (2017-2032) by Technology
9.2.1 Market Overview
9.2.2 Polymerase Chain Reaction (PCR)
9.2.3 In Situ Hybridization
9.2.4 Isothermal Nucleic Acid Amplification Technology (INAAT)
9.2.5 Chips and Microarrays
9.2.6 Mass Spectrometry
9.2.7 Sequencing
9.2.8 Transcription Mediated Amplification
9.2.9 Others
9.3 Asia Pacific Molecular Diagnostics Market (2017-2032) by Country
9.3.1 China
9.3.2 Japan
9.3.3 India
9.3.4 ASEAN
9.3.5 Australia
9.3.6 Others
10 Latin America Molecular Diagnostics Market (2017-2032)
10.1 Latin America Molecular Diagnostics Market (2017-2032) by Product and Service
10.1.1 Market Overview
10.1.2 Instruments
10.1.3 Reagents & Kits
10.1.4 Services & Software
10.2 Latin America Molecular Diagnostics Market (2017-2032) by Technology
10.2.1 Market Overview
10.2.2 Polymerase Chain Reaction (PCR)
10.2.3 In Situ Hybridization
10.2.4 Isothermal Nucleic Acid Amplification Technology (INAAT)
10.2.5 Chips and Microarrays
10.2.6 Mass Spectrometry
10.2.7 Sequencing
10.2.8 Transcription Mediated Amplification
10.2.9 Others
10.3 Latin America Molecular Diagnostics Market (2017-2032) by Country
10.3.1 Brazil
10.3.2 Argentina
10.3.3 Mexico
10.3.4 Others
11 Middle East and Africa Molecular Diagnostics Market (2017-2032)
11.1 Middle East and Africa Molecular Diagnostics Market (2017-2032) by Product and Service
11.1.1 Market Overview
11.1.2 Instruments
11.1.3 Reagents & Kits
11.1.4 Services & Software
11.2 Middle East and Africa Molecular Diagnostics Market (2017-2032) by Technology
11.2.1 Market Overview
11.2.2 Polymerase Chain Reaction (PCR)
11.2.3 In Situ Hybridization
11.2.4 Isothermal Nucleic Acid Amplification Technology (INAAT)
11.2.5 Chips and Microarrays
11.2.6 Mass Spectrometry
11.2.7 Sequencing
11.2.8 Transcription Mediated Amplification
11.2.9 Others
11.3 Middle East and Africa Molecular Diagnostics Market (2017-2032) by Country
11.3.1 Saudi Arabia
11.3.2 United Arab Emirates
11.3.3 Nigeria
11.3.4 South Africa
11.3.5 Others
12 Regulatory Framework
12.1 Regulatory Overview
12.1.1 US FDA
12.1.2 EU EMA
12.1.3 INDIA CDSCO
12.1.4 JAPAN PMDA
12.1.5 Others
13 Patent Analysis
13.1 Analysis by Type of Patent
13.2 Analysis by Publication Year
13.3 Analysis by Issuing Authority
13.4 Analysis by Patent Age
13.5 Analysis by CPC Analysis
13.6 Analysis by Patent Valuation
13.7 Analysis by Key Players
14 Grants Analysis
14.1 Analysis by Year
14.2 Analysis by Amount Awarded
14.3 Analysis by Issuing Authority
14.4 Analysis by Grant Application
14.5 Analysis by Funding Institute
14.6 Analysis by NIH Departments
14.7 Analysis by Recipient Organization
15 Clinical Trials Analysis
15.1 Analysis by Trial Registration Year
15.2 Analysis by Trial Status
15.3 Analysis by Trial Phase
15.4 Analysis by Therapeutic Area
15.5 Analysis by Geography
16 Funding and Investment Analysis
16.1 Analysis by Funding Instances
16.2 Analysis by Type of Funding
16.3 Analysis by Funding Amount
16.4 Analysis by Leading Players
16.5 Analysis by Leading Investors
16.6 Analysis by Geography
17 Partnership and Collaborations Analysis
17.1 Analysis by Partnership Instances
17.2 Analysis by Type of Partnership
17.3 Analysis by Leading Players
17.4 Analysis by Geography
18 Supplier Landscape
18.1 Market Share by Top 5 Companies
18.2 BioMérieux SA
18.2.1 Financial Analysis
18.2.2 Product Portfolio
18.2.3 Demographic Reach and Achievements
18.2.4 Mergers and Acquisition
18.2.5 Certifications
18.3 BD
18.3.1 Financial Analysis
18.3.2 Product Portfolio
18.3.3 Demographic Reach and Achievements
18.3.4 Mergers and Acquisition
18.3.5 Certifications
18.4 Bio-Rad Laboratories, Inc.
18.4.1 Financial Analysis
18.4.2 Product Portfolio
18.4.3 Demographic Reach and Achievements
18.4.4 Mergers and Acquisition
18.4.5 Certifications
18.5 Abbott
18.5.1 Financial Analysis
18.5.2 Product Portfolio
18.5.3 Demographic Reach and Achievements
18.5.4 Mergers and Acquisition
18.5.5 Certifications
18.6 Agilent Technologies, Inc.
18.6.1 Financial Analysis
18.6.2 Product Portfolio
18.6.3 Demographic Reach and Achievements
18.6.4 Mergers and Acquisition
18.6.5 Certifications
18.7 Hologic Inc.
18.7.1 Financial Analysis
18.7.2 Product Portfolio
18.7.3 Demographic Reach and Achievements
18.7.4 Mergers and Acquisition
18.7.5 Certifications
18.8 Danaher Corporation
18.8.1 Financial Analysis
18.8.2 Product Portfolio
18.8.3 Demographic Reach and Achievements
18.8.4 Mergers and Acquisition
18.8.5 Certifications
18.9 DiaSorin
18.9.1 Financial Analysis
18.9.2 Product Portfolio
18.9.3 Demographic Reach and Achievements
18.9.4 Mergers and Acquisition
18.9.5 Certifications
18.10 Illumina, Inc.
18.10.1 Financial Analysis
18.10.2 Product Portfolio
18.10.3 Demographic Reach and Achievements
18.10.4 Mergers and Acquisition
18.10.5 Certifications
18.11 Johnson & Johnson Services, Inc.
18.11.1 Financial Analysis
18.11.2 Product Portfolio
18.11.3 Demographic Reach and Achievements
18.11.4 Mergers and Acquisition
18.11.5 Certifications
18.12 QIAGEN N.V.
18.12.1 Financial Analysis
18.12.2 Product Portfolio
18.12.3 Demographic Reach and Achievements
18.12.4 Mergers and Acquisition
18.12.5 Certifications
18.13 F. Hoffmann-La Roche, Ltd.
18.13.1 Financial Analysis
18.13.2 Product Portfolio
18.13.3 Demographic Reach and Achievements
18.13.4 Mergers and Acquisition
18.13.5 Certifications
18.14 PerkinElmer, Inc.
18.14.1 Financial Analysis
18.14.2 Product Portfolio
18.14.3 Demographic Reach and Achievements
18.14.4 Mergers and Acquisition
18.14.5 Certifications
18.15 Siemens Healthineers
18.15.1 Financial Analysis
18.15.2 Product Portfolio
18.15.3 Demographic Reach and Achievements
18.15.4 Mergers and Acquisition
18.15.5 Certifications
18.16 Thermo Fisher Scientific Inc.
18.16.1 Financial Analysis
18.16.2 Product Portfolio
18.16.3 Demographic Reach and Achievements
18.16.4 Mergers and Acquisition
18.16.5 Certifications
19 Key Opinion Leaders (KOL) Insights (Additional Insight)
20 Company Competitiveness Analysis (Additional Insight)
20.1 Very Small Companies
20.2 Small Companies
20.3 Mid-Sized Companies
20.4 Large Companies
20.5 Very Large Companies
21 Payment Methods (Additional Insight)
21.1 Government Funded
21.2 Private Insurance
21.3 Out-of-Pocket
*Additional insights provided are customisable as per client requirements.
* The coverage of the Market Landscape section depends on the data availability and may cover a minimum of 80% of the total market. The EMR team strives to make this section as comprehensive as possible.

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