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Non Invasive Diagnostics Market for Fibrotic Diseases, 2020-2030: Focus on Liver, Pulmonary, Cystic and Other Types of Fibrosis

September 2020 | 330 pages | ID: N9677BF70424EN
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The non-invasive diagnostics market for fibrotic diseases is expected to reach USD 1.6 billion in 2020 and anticipated to grow at a CAGR of 10% during the forecast period 2020-2030.

The shifting lifestyle trends resulting in heightened occurrences of chronic conditions such as obesity and diabetes have significantly increased the global prevalence of fibrotic diseases. Liver fibrosis, for instance, often emerges as a secondary condition in individuals with metabolic or cholestatic ailments, excessive alcohol intake, or viral hepatitis. Non-alcoholic fatty liver disease (NAFLD), a primary catalyst for liver disease, impacted roughly 4.5 million adults in the US in 2018, progressing to nonalcoholic steatohepatitis (NASH). Similarly, idiopathic pulmonary fibrosis (IPF), a rare yet perilous lung ailment, is observed in persons exposed to pollutants, radiation, or certain medications. Despite its rarity, Europe witnesses approximately 40,000 new IPF cases annually. Early identification of fibrotic diseases is pivotal for effective management. However, diagnosing them presents challenges owing to the lack of conspicuous symptoms. When symptoms do appear, a tissue biopsy is typically advised for confirmation, yet this invasive procedure is both agonizing and traumatic, resulting in stigma. Furthermore, its invasive nature limits its application in monitoring disease progression or validating treatment efficacy.

Recent advancements in biotechnology have led to minimally invasive or non-invasive diagnostic techniques, encompassing imaging diagnostics and biomarker-based assays. Liquid biopsy, which examines biofluids like blood or urine, holds promise as a non-invasive method not only for cancer but also for detecting fibrosis. Genetic analyses, akin to those for cystic fibrosis, offer precise diagnoses and are substantiated by clinical data, indicating their relevance across various fibrotic conditions. These biomarker and genetic tests are positioned to supplant current invasive diagnostic methodologies in the future.

Report Coverage
  • The report comprehensively examines the non-invasive diagnostic market for fibrotic diseases based on criteria such as target fibrotic disease, end-user segments, and geographical regions.
  • It analyzes the market's growth influencers, including drivers, restraints, opportunities, and challenges.
  • Evaluation of advantages and obstacles within the market landscape is provided, along with insights into the competitive environment for leading market players.
  • Revenue forecasts are presented for market segments across five major regions.
  • An exhaustive assessment of the current market scenario for non-invasive fibrosis diagnostics involves analyzing crucial parameters. This includes product development status (available or in progress), product categorization (assay-kits, devices, software), applications (diagnostics, monitoring, screening, research), targeted fibrotic diseases (e.g., cardiac, cystic, liver, pulmonary, renal fibrosis), sample types (blood, saliva, mucus, buccal swabs), biomarker types, end-user categories (hospitals/clinics, research institutes, self-tests), turnaround times, and the necessity for medical intervention. It also encompasses information on device developers, including establishment year, company size, and headquarters location.
  • Detailed profiles of major players developing non-invasive fibrosis diagnostics are included, comprising company overviews, available financial data, comprehensive product portfolio descriptions, and insightful future perspectives.
  • The report presents an analysis of collaborations among stakeholders in the non-invasive diagnostics market for fibrotic diseases since 2016. This includes various agreements such as distribution, acquisitions, product development, joint ventures, licensing, utilization, clinical trials, and other relevant deals.
  • A thorough examination of completed, ongoing, and planned clinical studies related to non-invasive fibrotic disease diagnostics is conducted. Parameters considered include trial status, registration year, development phase, study design, focus, product types, targeted fibrotic diseases, enrolled patient populations, leading sponsors, popular products, and regional distribution of trials.
  • In-depth analysis of potential biomarkers for non-invasive liver fibrosis diagnosis is provided, considering biomarker types (physical/biological) and measurement indexes. This section highlights leading sponsors involved in clinically evaluating these biomarkers.
  • An extensive analysis of over 13,000 patents filed or granted for non-invasive fibrotic disease diagnostics until May 2020 is included. This analysis focuses on patent trends, including types, publication and application years, regional relevance, CPC symbols, emerging focus areas, top patent assignees in terms of filed or granted patents, and patent benchmarking and valuation.
Key Market Companies
  • BioPredictive
  • Echosens
  • ELITechGroup
  • Fibronostics
  • Fujirebio
  • GenPath Diagnostics
  • HepQuant
  • LabCorp
  • Luminex
  • Oasis Diagnostics
  • PerkinElmer
  • Yourgene Health
1. PREFACE

1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines

2. EXECUTIVE SUMMARY

3. INTRODUCTION

3.1. Chapter Overview
3.2. Overview of Fibrosis
3.3. Diagnostics of Fibrosis
3.4. Conventional Invasive Fibrosis Diagnostic Tests
  3.4.1. Biopsy
  3.4.2. Endoscopy
  3.4.3. Radiology
  3.4.4. Limitations of Conventional Diagnostics and Need for Non-Invasive Methods
3.5. Non-Invasive Diagnostic Techniques
  3.5.1. Diagnostic Biomarkers
    3.5.1.1 Biomarkers for Diagnosis of Liver Fibrosis
    3.5.1.2 Biomarkers for Diagnosis of Kidney Fibrosis
    3.5.1.3 Biomarkers for Diagnosis of Pulmonary Fibrosis
    3.5.1.4 Biomarkers for Diagnosis of Cardiac Fibrosis
  3.5.2. Imaging / Scanning Devices
3.6. Conclusion

4. CONCEPT OF NON-INVASIVE FIBROSIS SCREENING AND DIAGNOSTICS

4.1. Chapter Overview
4.2. Imaging / Scanning Based Diagnostics
  4.2.1. Computerized Tomography (CT) Scan
  4.2.2. Integrated Positron Emission Tomography (PET) -CT Scan
  4.2.3. Magnetic Resonance Imaging (MRI)
  4.2.4. Ultrasound
4.3. Screening Assays
  4.3.1. Biomarker Tests
  4.3.2. Digital Rectal Exam (DRE)
  4.3.3. Fecal Occult Blood Tests (FOBT)
4.4. Advanced Non-invasive Approaches
  4.4.1. Cytogenetic / Gene Expression Studies
  4.4.2. Liquid Biopsy
  4.4.3. Optical Biopsy
  4.4.4. Saliva-Based Oral Fibrosis Diagnostics
  4.4.5. Vital Staining

5. MARKET LANDSCAPE

5.1. Chapter Overview
5.2. Non-Invasive Diagnostics for Fibrotic Diseases: Overall Market Landscape
  5.2.1. Analysis by Status of Development
  5.2.2. Analysis by Type of Product
  5.2.3. Analysis by Application Area
  5.2.4. Analysis by Target Fibrotic Disease
  5.2.5. Analysis by Type of Product and Target Fibrotic Disease
  5.2.6. Analysis by Type of Sample
  5.2.7. Analysis by Type of Biomarker
  5.2.8. Analysis by End User
  5.2.9. Heat Map Analysis by Target Fibrotic Disease and End User
  5.2.10. Analysis by Turnaround Time
  5.2.11. Analysis by Requirement of Medical Assistance
5.4. Non-Invasive Diagnostics for Fibrotic Diseases: List of Developers
  5.4.1. Analysis by Year of Establishment
  5.4.2. Analysis by Company Size
  5.4.3. Analysis by Geographical Location
  5.4.4. Leading Developers: Analysis by Number of Products

6. COMPANY PROFILES

6.1. Chapter Overview
6.2. BioPredictive
  6.2.1. Company Overview
  6.2.2. Financial Information
  6.2.3. Non-Invasive Diagnostics Portfolio
  6.2.4. Recent Developments and Future Outlook
6.3. Echosens
  6.3.1. Company Overview
  6.3.2. Financial Information
  6.3.3. Non-Invasive Diagnostics Portfolio
  6.3.4. Recent Developments and Future Outlook
6.4. ELITechGroup
  6.4.1. Company Overview
  6.4.2. Financial Information
  6.4.3. Non-Invasive Diagnostics Portfolio
  6.4.4. Recent Developments and Future Outlook
6.5. Fibronostics
  6.5.1. Company Overview
  6.5.2. Financial Information
  6.5.3. Non-Invasive Diagnostics Portfolio
  6.5.4. Recent Developments and Future Outlook
6.6. Fujirebio
  6.6.1. Company Overview
  6.6.2. Financial Information
  6.6.3. Non-Invasive Diagnostics Portfolio
  6.6.4. Recent Developments and Future Outlook
6.7. GenPath Diagnostics
  6.7.1. Company Overview
  6.7.2. Financial Information
  6.7.3. Non-Invasive Diagnostics Portfolio
  6.7.4. Recent Developments and Future Outlook
6.8. HepQuant
  6.8.1. Company Overview
  6.8.2. Financial Information
  6.8.3. Non-Invasive Diagnostics Portfolio
  6.8.4. Recent Developments and Future Outlook
6.9. LabCorp
  6.9.1. Company Overview
  6.9.2. Financial Information
  6.9.3. Non-Invasive Diagnostics Portfolio
  6.9.4. Recent Developments and Future Outlook
6.10. Luminex
  6.10.1. Company Overview
  6.10.2. Financial Information
  6.10.3. Non-Invasive Diagnostics Portfolio
  6.10.4. Recent Developments and Future Outlook
6.11. Oasis Diagnostics
  6.11.1. Company Overview
  6.11.2. Financial Information
  6.11.3. Non-Invasive Diagnostics Portfolio
  6.11.4. Recent Developments and Future Outlook
6.12. PerkinElmer
  6.12.1. Company Overview
  6.12.2. Financial Information
  6.12.3. Non-Invasive Diagnostics Portfolio
  6.12.4. Recent Developments and Future Outlook
6.13. Yourgene Health
  6.13.1. Company Overview
  6.13.2. Financial Information
  6.13.3. Non-Invasive Diagnostics Portfolio
  6.13.4. Recent Developments and Future Outlook

7. PARNERSHIPS AND COLLABORATIONS

7.1. Chapter Overview
7.2. Partnership Models
7.3. Non-Invasive Diagnostics for Fibrotic Diseases: List of Partnerships and Collaborations
  7.3.1. Analysis by Year of Partnership
  7.3.2. Analysis by Type of Partnership
  7.3.3. Analysis by Type of Product
  7.3.4. Most Popular Products: Analysis by Number of Partnerships
  7.3.5. Analysis by Target Fibrotic Disease
  7.3.6. Analysis by Year of Partnership and Type of Partner
  7.3.7. Analysis by Type of Partnership and Type of Partner
  7.3.8. Most Active Players: Analysis by Number of Partnerships
7.4. Regional Analysis
  7.4.1. Intercontinental and Intracontinental Agreements

8. CLINICAL TRIAL ANALYSIS

8.1. Chapter Overview
8.2. Scope and Methodology
8.3. Non-Invasive Diagnostics for Fibrotic Diseases: Clinical Trial Analysis
  8.3.1. Analysis by Trial Registration Year
  8.3.2. Analysis by Trial Recruitment Status
  8.3.3. Analysis by Trial Registration Year and Number of Patients Enrolled
  8.3.4. Analysis by Study Design
  8.3.5. Analysis by Type of Sponsor / Collaborator
  8.3.6. Leading Players: Analysis by Number of Registered Trials
  8.3.7. Word Cloud: Key Focus Areas
  8.3.8. Analysis by Target Fibrotic Disease
  8.3.9. Popular Product Types: Analysis by Number of Registered Trials
  8.3.10. Popular Products: Analysis by Number of Registered Trials
  8.3.11. Heat Map Analysis by Target Fibrotic Disease and Product Type
  8.3.12. Geographical Analysis by Number of Registered Trials
  8.3.13. Geographical Analysis by Number of Patients Enrolled

9. CASE STUDY: BIOMARKER ANALYSIS FOR LIVER FIBROSIS

9.1. Chapter Overview
9.2. Scope and Methodology
9.3. Non-Invasive Diagnostics for Fibrotic Diseases: Biomarker Analysis for Liver Fibrosis
  9.3.1. Analysis by Type of Biomarker
  9.3.2. Analysis by Trial Phase and Type of Biomarker
  9.3.3. Analysis by Type of Liver Fibrosis
  9.3.4. Popular Biomarkers: Analysis by Number of Registered Trials
  9.3.5. Heat Map Analysis by Popular Biomarkers and Trial Phase
  9.3.6. Word Cloud Analysis: Popular and Emerging Biomarkers
  9.3.7. Leading Players: Analysis by Number of Registered Trials
  9.3.8. Heat Map Analysis by Popular Biomarkers and Leading Industry Players
  9.3.9. Heat Map Analysis by Popular Biomarkers and Leading Non-industry Players

10. PATENT ANALYSIS

10.1. Chapter Overview
10.2. Scope and Methodology
10.3. Non-Invasive Diagnostics for Fibrotic Diseases: Patent Analysis
  10.3.1. Analysis by Type of Patent
  10.3.2. Analysis by Publication Year
  10.3.3. Analysis by Issuing Authority / Patent Offices Involved
  10.3.4. Analysis by CPC Symbols
  10.3.5. Emerging Focus Areas
  10.3.6. Leading Players: Analysis by Number of Patents
10.4. Non-Invasive Diagnostics for Fibrotic Diseases: Patent Benchmarking Analysis
  10.4.1. Analysis by Patent Characteristics
10.5. Non-Invasive Diagnostics for Fibrotic Diseases: Patent Valuation Analysis
10.6. Leading Patents by Number of Citations

11. MARKET SIZING AND OPPORTUNITY ANALYSIS

11.1. Chapter Overview
11.2. Forecast Methodology and Key Assumptions
11.3. Global Non-Invasive Diagnostics for Fibrotic Diseases Market, 2020-2030
11.4. Global Non-Invasive Diagnostics for Fibrotic Diseases Market: Distribution by Target Fibrotic Disease
  11.4.1. Global Non-Invasive Diagnostics for Fibrotic Diseases Market for Cystic Fibrosis, 2020-2030
  11.4.2. Global Non-Invasive Diagnostics for Fibrotic Diseases Market for Liver Fibrosis, 2020-2030
  11.4.3. Global Non-Invasive Diagnostics for Fibrotic Diseases Market for Pulmonary Fibrosis, 2020-2030
11.5. Global Non-Invasive Diagnostics for Fibrotic Diseases Market: Distribution by End User, 2020-2030
  11.5.1. Global Non-Invasive Diagnostics for Fibrotic Diseases Market for Hospitals, 2020-2030
  11.5.2. Global Non-Invasive Diagnostics for Fibrotic Diseases Market for Research Institutes, 2020-2030
11.6. Global Non-Invasive Diagnostics for Fibrotic Diseases Market: Distribution by Region
  11.6.1. Non-Invasive Diagnostics for Fibrotic Diseases Market in North America, 2020-2030
  11.6.2. Non-Invasive Diagnostics for Fibrotic Diseases Market in Europe, 2020-2030
  11.6.3. Non-Invasive Diagnostics for Fibrotic Diseases Market in Asia Pacific, 2020-2030
  11.6.4. Non-Invasive Diagnostics for Fibrotic Diseases Market in Latin America, 2020-2030
  11.6.5. Non-Invasive Diagnostics for Fibrotic Diseases Market in Middle East and North Africa, 2020-2030

12. CONCLUDING REMARKS

12.1. Chapter Overview
12.2. Key Takeaways

13. EXECUTIVE INSIGHTS

13.1. Chapter Overview
13.2. Biorion
  13.2.1. Company Snapshot
  13.2.2. Interview Transcript: Herman Steen, Chief Executive Officer, Biorion
13.3. Glycotest
  13.3.1. Company Snapshot
  13.3.2. Interview Transcript: Lawrence Cohen, Chief Executive Officer and Charles Swindell, Chief Scientific Officer
13.4. Repeat Diagnostics
  13.4.1. Company Snapshot
  13.4.2. Interview Transcript: Garry de Jong, Chief Executive Officer, Repeat Diagnostics

14. APPENDIX 1: TABULATED DATA

15. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS


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