The report predicts that point-of-care biosensors will become a $33 billion market by 2027, with molecular diagnostic devices the main driver for this growth.
Biosensors are used to detect and quantify biological material associated with a disease state or health condition (biomarkers). Biosensors are therefore powerful tools for diagnosis and monitoring. As technological advances allow for such tests to be conducted faster and on smaller devices, these tests are moving out of specialised laboratories and closer to the patient at the point-of-care.
This report gives a complete analysis of the important trends in the field of medical biosensors, and lists the new technologies and devices which are likely to be highly disruptive to the in vitro diagnostics market.
Molecular diagnostics driving future growth
By definition, biosensors are formed of both biological and physical components. The biological component (bioreceptor) has the ability to recognise a biomarker. Binding between the biomarker and bioreceptor is converted into a readable signal by a transducer.
Glucose has been a very common biomarker to target because of its importance for diabetes management. Glucose test strips are the most common point-of-care biosensors on the market today.
However, the next step is direct DNA testing, which is commonly known as molecular diagnostics. It is already possible to perform DNA tests but these tends to be slow, and require highly trained personnel in laboratories. There is now effort to move DNA testing closer to the patient at the point-of-care. This trend is enabled by several advances in technologies includingdevice miniaturization and rapid nucleic acid amplification techniques.
Full analysis of all commercial applications
Medical biosensors can diagnose a wealth of diseases and health conditions, such as diabetes, cardiovascular issues, infectious diseases and cancer. Increasingly, biosensors are also being used to achieve targeted therapies in precision medicine and increase the efficacy of drugs through pharmacogenomics.
This report is the first to comprehensively look at all commercial applications for point-of-care biosensors. It gives you a complete picture of the types of biosensors, the key players on the market and the emerging technologies.
Key Topics Covered:
1. EXECUTIVE SUMMARY
1.1. Biosensors: Diagnosing and Monitoring Health States 1.2. Point-of-Care Testing: Both Rapid and Portable 1.3. POC vs. Centralised Testing: A Cost Comparison 1.4. Drivers of Point-of-Care Biosensors in Healthcare 1.5. Evolution of Biosensor Technologies at the Point-of-Care 1.6. Why POCT Now? Value and Complexity 1.7. The Rise of Point-of-Care Molecular Diagnostics 1.8. Pharmacogenomics At The Point-of-Care? 1.9. Impact of POC MDx on the In Vitro Diagnostics Market 1.10. Just Because We Can...Doesn't Mean We Will 1.11. Displacement of Incumbent Point-of-Care Technology 1.12. Lateral Flow Assays are Evolving 1.13. Key Trends: Multiplexing 1.14. Key Trends: Connectivity and Data Management 1.15. Give It Away...Now 1.16. Point-of-Care is a Sliding Scale, and Will Evolve 1.17. A Roadmap For Success in Point-of-Care Testing
2. INTRODUCTION TO BIOSENSORS 2.1. Defining Biosensors for Point-of-Care-Testing (POCT) 2.2. Applications for Biosensors in Healthcare 2.3. The Growing Market for In Vitro Diagnostics and Monitoring 2.4. Infectious Disease: A Ticking Bomb 2.5. Examples of Antimicrobial Resistance (AMR) 2.6. The Role of Biosensors in Healthcare 2.7. What Makes a Biosensor? 2.8. Biomarkers: Indicators of Disease and Health Conditions 2.9. Developing a Medical Biosensor: Considerations for Success 2.10. Biosensors: From Conception to Point-of-Care 2.11. Diagnostics are on the Move: New Markets are Emerging 2.12. The Value Point-of-Care Testing Offers 2.13. The Cost of Point-of-Care Testing 2.14. Key Characteristics of a Point-of-Care Biosensor 2.15. Desirable Characteristics in a Point-of-Care Biosensor 2.16. Characterising Different POC Biosensor Technologies
3. REGULATION OF MEDICAL BIOSENSORS 3.1. Regulatory Routes to Market Depend on the Target Market 3.2. EU Regulations for Medical Devices are Changing 3.3. Changing Regulations: Advice to Manufacturers 3.4. A Regulatory Road Map for Diagnostic Products in the US 3.5. US Regulations for Diagnostics: CLIA Categorizations
4. BIOSENSOR TECHNOLOGIES 4.1. Role of the Transducer 4.2. Most Common Transducers for Biosensors 4.3. Optical Transducers 4.4. Fluorescence Labelling 4.5. Electrochemical Transducers 4.6. Electrochemical Test Strips are Easy to Manufacture 4.7. Thin-Film vs Thick-Film Process 4.8. Importance of Immobilisation 4.9. The Industry Moves Toward CMOS Chips 4.10. Biosensors with Field Effect Transistors (FET) 4.11. Nanomaterials in Transducers 4.12. Electrodes with Graphene and Carbon Nanotubes 4.13. Nanowire Field Effect Transistor 4.14. Graphene Based FET Biosensor 4.15. Metal Nanoparticles 4.16. Quantum Dots as an Alternative to Fluorescent Labels 4.17. Advantages of QD Over Organic Dyes 4.18. Major Milestones in Academic Research for QD 4.19. Commercial Biosensor with Quantum Dots
5. LATERAL FLOW ASSAYS 5.1. Lateral Flow Assays (LFAs) 5.2. Key Players in the Lateral Flow Assay Market 5.3. Antigens and Antibodies: Lateral Flow Immunoassays 5.4. Mechanisms of Lateral Flow Immunoassays 5.5. Mechanisms of LFIAs: Signal Transduction & Detection 5.6. Mechanisms of LFIAs: Labels 5.7. Examples of Commercial Lateral Flow Assays 5.8. Materials and Manufacturing of Lateral Flow Test Strips 5.9. Advancements in LFIAs: Digital & Fluorescent Readers 5.10. Alere Reader 5.11. BD Veritor Plus Analyzer 5.12. Sofia 2 5.13. Advancements in Immunoassays: Smartphone Hardware 5.14. Advancements in LFIAs: Smartphone Software 5.15. Advancements in Labelling for LFIAs: Quantum Dots 5.16. Ellume Lab 5.17. Advancements in LFAs: Increasing Sensitivity 5.18. Disruption to the LFA Market: Molecular Diagnostics 5.19. Levels of Disruption by MDx in Key Segments of LFA Market 5.20. The Future of Lateral Flow Assays
6. ELECTROCHEMICAL TEST STRIPS 6.1. The four major POC electrochemical biosensors 6.2. Glucose monitoring as the key use of electrochemical test strips 6.3. Glucose biosensor mechanisms 6.4. Anatomy of a glucose test strip 6.5. Test strips always require an electronic reader 6.6. The business model of glucose monitoring 6.7. There is a large choice of glucometers available 6.8. Key diabetes businesses changing hands 6.9. Drivers and constraints to the disposable test strip industry 6.10. Blood is the best sample but there are alternatives 6.11. Continuous glucose monitoring (CGM) does not use blood samples 6.12. How CGM work 6.13. Anatomy of a CGM sensor 6.14. CGM sensor manufacture 6.15. Why blood tests are not going to disappear yet 6.16. Continuous vs Flash glucose monitoring 6.17. Abbott Libre 6.18. Abbott Libre glucose detection mechanism 6.19. Dexcom 6.20. Dexcom glucose monitoring mechanism 6.21. Medtronic 6.22. A new generation of glucose monitoring watches 6.23. Comparison of wearable/implanted glucose sensors 6.24. The potential for non-invasive testing 6.25. Google contact lens- an eye on glucose monitoring 6.26. Problems with a glucose contact lens 6.27. Non-invasive glucose monitoring- A first device to market 6.28. Past failure of non-invasive monitoring 6.29. Single use vs ambulatory monitoring: future directions 6.30. Will CGM systems replace test strips? 6.31. The future for glucose test strips 6.32. Advanced glucose monitoring leads to an artificial pancreas 6.33. Ketone monitoring 6.34. Electrochemical test strips are a more accurate method of ketone monitoring 6.35. Lactic acid monitoring for athletes 6.36. Traditional lactic acid monitors 6.37. Microneedles to analyse lactic acid in interstitial fluid 6.38. Electrochemical analysis in sweat 6.39. Cholesterol as an early indicator of cardiovascular disease 6.40. A real market for PoC cholesterol tests? 6.41. Key players in cholesterol biosensors 6.42. The future of electrochemical PoC biosensors
7. INTEGRATED CARTRIDGES 7.1. Integrated Cartridges 7.2. Adoption of Integrated Cartridges in Critical Care Settings 7.3. Components of Lab-on-a-Chip Systems 7.4. Driving the Movement of Fluids Within a Cartridge 7.5. Design and Manufacturing Concerns for Integrated Cartridges 7.6. Manufacturing Integrated Cartridges 7.7. i-STAT: A Commercial Success Story 7.8. i-STAT Mechanism of Action 7.9. epoc 7.10. Examples of Other Integrated Cartridge Devices 7.11. Biosensors as Alternatives to Cell Counting 7.12. The Future of Integrated Cartridges
8. MOLECULAR DIAGNOSTICS 8.1. An Introduction to Molecular Diagnostics (MDx) 8.2. The Central Dogma: DNA, RNA and Proteins 8.3. Genetic Mutations: What Are We Testing For? 8.4. Key Applications for Molecular Diagnostics 8.5. Key Players in Molecular Diagnostics 8.6. Molecular Diagnostics is Moving to Point-of-Care 8.7. What Constitutes a Point-of-Care MDx Test? 8.8. The Market for Molecular Diagnostics is Expanding 8.9. Market Drivers for Pushing MDx to the Point-of-Care 8.10. Barriers to Success for Point-of-Care MDx 8.11. What are the Benefits and Limitations of MDx? 8.12. The Varying Importance of Point-of-Care 8.13. The Impact of POC MDx on the Diagnostics Market 8.14. Importance of POC Impacts Take-Up for Different Applications 8.15. Multiple Techniques Exist for Molecular Testing 8.16. Enabling Technology: Nucleic Acid Extraction, Amplification & Detection 8.17. The First Step: Nucleic Acid Extraction and Purification 8.18. Nucleic Acid Amplification: Polymerase Chain Reaction (PCR) 8.19. Point-of-Care Enabling Technology: Advances in PCR 8.19.1. Examples of Isothermal Amplification Technologies I 8.19.2. Examples of Isothermal Amplification Technologies II 8.20. Which is the Future: Isothermal Amplification or PCR? 8.21. Enabling Technology: Combined Amplification and Detection 8.22. Considerations for Choosing a Signal Detection Method 8.23. Optical Detection: Fluorescence 8.24. Optical Detection: Colorimetric Hybridization 8.25. Electrochemical Detection 8.26. Examples of POC MDx on the Market or Coming Soon 8.27. Why Multiplex? 8.28. Multiplexing: Difficulties in Amplification and Detection 8.29. A Growing Demand for Connectivity and Data Management 8.30. Multiplexing and Costing of Cartridges for POC MDx Devices 8.31. POC MDx Devices Available and in the Pipeline 8.32. Additional Molecular Diagnostic Systems 8.33. Revenue From Point-of-Care Molecular Diagnostic Tests 8.34. Comparison of Point-of-Care Tests for Influenza A & B 8.35. Which Technology Wins At the Point-of-Care? LFA Vs. MDx 8.36. New Markets For Point-of-Care Molecular Diagnostics 8.37. The Future: Pharmacogenomics, and the Rise of CDx 8.38. The Future: Next Generation Sequencing (NGS) 8.39. What it Takes to Win in Point-of-Care Molecular Diagnostics
9. MARKET FORECASTS 9.1. Forecast Details and Assumptions 9.2. Point-of-Care Biosensor Revenue, 2017-2027 9.3. POC Biosensor Revenue by Technology, 2017-2027 9.4. POC Biosensor Revenue by Market Sector, 2017-2027 9.5. POC Biosensor Volume by Technology (without ETS), 2017-2027 9.6. POC Biosensor Volume by Market Sector (without glucose testing), 2017-2027 9.7. Genetic Testing Volume by Technology, 2017-2027 9.8. Lateral Flow Assay Volume by Market Sector, 2017-2027 9.9. Electrochemical Test Strip Volume by Market Sector, 2017-2027 9.10. Integrated Cartridge Volume by Market Sector, 2017-2027 9.11. Molecular Diagnostic Volume by Market Sector, 2017-2027 9.12. Infectious Disease Volume by Technology, 2017-2027 9.13. Infectious Disease Revenue by Technology, 2017-2027 9.14. Infectious Disease Revenue by Market Sector, 2017-2027