1. | EXECUTIVE SUMMARY |
1.1. | Biomedical diagnostics for point-of-care testing |
1.2. | Biosensors: diagnosing and monitoring health states |
1.3. | Applications for biosensors in healthcare |
1.4. | Evolution of biomedical diagnostics at the point-of-care |
1.5. | Point-of-care testing is a sliding scale, and will evolve |
1.6. | Give it away |
1.7. | Characterizing different point-of-care biosensor technologies |
1.8. | Biomedical diagnostics at point-of-care revenue |
1.9. | Biomedical diagnostics at POC revenue by technology |
1.10. | Biomedical diagnostics at POC revenue by market sector |
1.11. | Lab-on-a-chip is a key technique for point-of-care |
1.12. | Lab-on-a-chip applications for Point-of-Care |
1.13. | Electrochemical biosensors at point-of-care |
1.14. | Electrochemical biosensors: continuous vs flash glucose monitoring |
1.15. | Lateral flow assays (LFAs) at point-of-care |
1.16. | LFA market is disrupted by molecular diagnostics |
1.17. | Molecular diagnostics at point-of-care |
1.18. | Varying importance of molecular diagnostics and point-of-care |
1.19. | Clinical market for genomic testing is growing |
2. | INTRODUCTION TO BIOMEDICAL DIAGNOSTICS. BIOSENSORS AND POINT-OF-CARE |
2.1. | Biomedical diagnostics at point-of-care |
2.2. | Biosensor for biomedical diagnostics |
2.3. | History of biosensors |
2.4. | Biomedical diagnostics and vitro diagnostics |
2.5. | Applications for biomedical diagnostics |
2.6. | Growing market for biomedical diagnostics |
2.7. | Diagnostics move toward point-of-care testing |
2.8. | The value of point-of-care testing |
2.9. | Drivers of point-of-care biosensors in healthcare |
2.10. | The cost of point-of-care testing |
2.11. | POC vs. centralised testing: a cost comparison |
2.12. | Key characteristics of a point-of-care biosensor |
2.13. | Desirable characteristics in a point-of-care biosensor |
2.14. | A roadmap for success in point-of-care testing |
2.15. | Point-of-care testing is a sliding scale, and will evolve |
2.16. | Evolution of biosensor technologies at the point-of-care |
2.17. | Characterizing different point-of-care 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. | What is a biosensor? |
4.2. | Biomarkers: indicators of disease and health conditions |
4.3. | Bioreceptors: the key element for biosensors |
4.4. | Biotransducer: biological information to readable signal |
4.5. | Most common transducers for biosensors |
4.6. | Optical transducers |
4.7. | Fluorescence labelling |
4.8. | Electrochemical transducers |
4.9. | Electrochemical test strips are easy to manufacture |
4.10. | Thin-film vs thick-film process |
4.11. | Importance of immobilisation |
4.12. | The industry moves toward CMOS chips |
4.13. | Biosensors with field effect transistors (FET) |
4.14. | Nanomaterials in transducers |
4.15. | Electrodes with graphene and carbon nanotubes |
4.16. | Nanowire field effect transistor |
4.17. | Graphene based FET biosensor |
4.18. | Metal nanoparticles |
4.19. | Quantum dots as an alternative to fluorescent labels |
4.20. | Advantages of QD over organic dyes |
4.21. | Major milestones in academic research for QD |
4.22. | Commercial biosensor with quantum dots |
4.23. | Developing a medical Biosensor: considerations for success |
5. | LAB-ON-A-CHIP AND INTEGRATED CARTRIDGES |
5.1. | What is Lab-on-a-chip (LOC)? |
5.2. | History of Lab-on-a-chip |
5.3. | Lab-on-a-chip is a key technique for point-of-care |
5.4. | Ideal LOC devices for POC |
5.5. | Techniques for lab-on-a-chip: microfluidics |
5.6. | Sample preparation |
5.7. | Biocompatible photoresists |
5.8. | Bio-patterning |
5.9. | Photolithography bio-patterning |
5.10. | Microstamping bio-patterning |
5.11. | Microfluidic patterning |
5.12. | Self-assembly bio-patterning |
5.13. | Active flow control and digital microfluidics |
5.14. | Droplet microfluidics (digital microfluidics) |
5.15. | Example: the simple chip for low-cost, quantitative, and portable nucleic acid testing |
5.16. | Lab-on-a-chip applications for Point-of-Care |
5.17. | Lab-on-a-chip for digital polymerase chain reaction (dPCR) |
5.18. | Lab-on-a-chip for molecular diagnostics |
5.19. | Lab-on-a-chip for DNA sequencing |
5.20. | DNA sequencing devices |
5.21. | Lab-on-a-chip for chronic disease diagnosis |
5.22. | Lab-on-a-chip for diabetes diagnostics |
5.23. | Lab-on-a-chip for chronic kidney disease |
5.24. | Lab-on-a-chip for microfluidic immunoassays |
5.25. | Lab-on-a-chip devices: integrated cartridges |
5.26. | i-STAT®: a commercial success story |
5.27. | i-STAT® mechanism of action |
5.28. | Epoc® blood analysis |
5.29. | Alternatives to cell counting |
5.30. | Other Lab-on-a-chip devices |
5.31. | Design and manufacturing concerns |
5.32. | Future trends for Lab-on-a-chip |
6. | LATERAL FLOW ASSAYS |
6.1. | Lateral flow assays (LFAs) |
6.2. | Key players in the lateral flow assay market |
6.3. | Biomarker and bioreceptor: antigens and antibodies |
6.4. | Mechanisms of lateral flow immunoassays |
6.5. | Mechanisms of LFIAs: signal transduction & detection |
6.6. | Mechanisms of LFIAs: labels |
6.7. | Examples of commercial lateral flow assays |
6.8. | Materials and manufacturing of lateral flow assay strips |
6.9. | Advancements in LFAs: digital & fluorescent readers |
6.10. | Alere™ Reader |
6.11. | BD Veritor™ Plus Analyzer |
6.12. | Sofia 2 |
6.13. | Advancements: smartphone hardware |
6.14. | Advancements: smartphone software |
6.15. | Advancements: quantum dots |
6.16. | Ellume lab |
6.17. | Advancements in LFAs: increasing sensitivity |
6.18. | Disruption to the LFA market: molecular diagnostics |
6.19. | Levels of disruption by MDx in key segments of LFA market |
6.20. | The future of lateral flow assays |
7. | ELECTROCHEMICAL TEST STRIPS |
7.1. | The four major point-of-care electrochemical biosensors |
7.2. | Glucose monitoring as the key use of electrochemical test strips |
7.3. | Glucose biosensor mechanisms |
7.4. | Anatomy of a glucose test strip |
7.5. | Test strips always require an electronic reader |
7.6. | The business model of glucose monitoring |
7.7. | There is a large choice of glucometers available |
7.8. | Drivers and constraints to the disposable test strip industry |
7.9. | Blood is the best sample but there are alternatives |
7.10. | Continuous glucose monitoring (CGM) does not use |
7.11. | blood samples |
7.12. | How CGM work |
7.13. | Anatomy of a CGM sensor |
7.14. | CGM sensor manufacture |
7.15. | Why blood tests are not going to disappear yet |
7.16. | Continuous vs Flash glucose monitoring |
7.17. | Abbott Libre |
7.18. | Abbott Libre glucose detection mechanism |
7.19. | DexCom |
7.20. | Dexcom glucose monitoring mechanism |
7.21. | Medtronic |
7.22. | A new generation of glucose monitoring watches |
7.23. | Comparison of wearable/implanted glucose sensors |
7.24. | The potential for non-invasive testing |
7.25. | Google contact lens: an eye on glucose monitoring |
7.26. | Problems with glucose contact lens |
7.27. | Non-invasive glucose monitoring- first device to market |
7.28. | Past failure of non-invasive monitoring |
7.29. | Single use vs ambulatory monitoring: future directions |
7.30. | Will CGM systems replace test strips? |
7.31. | The future for glucose test strips |
7.32. | Advanced glucose monitoring leads to an artificial pancreas |
7.33. | Ketone monitoring |
7.34. | Electrochemical test strips are a more accurate method of ketone monitoring |
7.35. | Lactic acid monitoring for athletes |
7.36. | Traditional lactic acid monitors |
7.37. | Microneedles to analyse lactic acid in interstitial fluid |
7.38. | Electrochemical analysis in sweat |
7.39. | Cholesterol as an early indicator of cardiovascular disease |
7.40. | Key players in cholesterol biosensors |
7.41. | The future of electrochemical POC biosensors |
8. | MOLECULAR DIAGNOSTICS |
8.1. | What is molecular diagnostics (MDx) |
8.2. | The central dogma: DNA, RNA and Proteins |
8.3. | Molecular diagnostics is moving to point-of-care |
8.4. | Genetic mutations: what are we testing for? |
8.5. | Key applications for molecular diagnostics |
8.6. | Varying importance of molecular diagnostics and point-of-care |
8.7. | Key players in molecular diagnostics |
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 POC MDx |
8.11. | What are the benefits and limitations of MDx? |
8.12. | The impact of POC MDx on the diagnostics market |
8.13. | Multiple techniques exist for molecular testing |
8.14. | PCR: First Step of Nucleic Acid Extraction and Purification |
8.15. | PCR: amplification process |
8.16. | Advanced PCR for point-of-care |
8.17. | PCR: techniques and devices |
8.18. | Other devices of PCR |
8.19. | Which is the future: isothermal amplification or PCR? |
8.20. | Enabling technology: combined amplification and detection |
8.21. | Detection: fluorescence |
8.22. | Detection: colorimetric hybridization |
8.23. | Detection: electrochemical detection |
8.24. | Examples of POC MDx on the market or coming soon |
8.25. | Examples of disposable cartridge technologies I |
8.26. | Examples of disposable cartridge technologies II |
8.27. | Simultaneously detect multiple biomarkers: Multiplex |
8.28. | Key trends: multiplexing |
8.29. | Key trends: 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. | Devices: Atlas io® system |
8.33. | Devices: Cobas® Liat® |
8.34. | Devices: Alere™ i |
8.35. | Devices: Alere™ q Analyzer |
8.36. | Devices: GeneXpert® Omni |
8.37. | Devices: Spartan RX™ |
8.38. | Devices: Spartan Cube |
8.39. | Devices: FilmArray® 2.0 |
8.40. | Devices: PanNAT® molecular system and tests |
8.41. | Devices: Q-POC™ |
8.42. | Additional molecular diagnostic systems |
8.43. | Players: Atlas Genetics |
8.44. | Players: Roche molecular diagnostics |
8.45. | Players: Alere |
8.46. | Players: Cepheid |
8.47. | Players: Spartan Bioscience |
8.48. | Players: Scanogen |
8.49. | Revenue from point-of-care molecular diagnostic tests |
8.50. | Comparison of point-of-care tests for influenza A & B |
8.51. | LFA vs. MDx |
8.52. | New markets for point-of-care molecular diagnostics |
8.53. | The future: pharmacogenomics, and the rise of CDx |
8.54. | The future: next generation sequencing (NGS) |
8.55. | Direction for point-of-care molecular diagnostics |
9. | DNA SEQUENCING |
9.1. | What's DNA sequencing |
9.2. | History of DNA sequencing |
9.3. | What is DNA sequencing use for? |
9.4. | Applications of DNA sequencing in research and clinical use |
9.5. | Clinical market for genomic testing is growing |
9.6. | 2018: Watershed year for clinical genomics |
9.7. | Sanger sequencing, first generation of DNA sequencing and golden standard |
9.8. | Second generation sequencing (massively parallel) |
9.9. | Second generation sequencing workflows (Illumina) |
9.10. | Key players for second generation sequencing |
9.11. | 3rd generation sequencing (real time, single-molecule) |
9.12. | Key players for third generation sequencing |
9.13. | Cost to sequence whole human genome |
9.14. | Future trends and opportunities |
9.15. | DNA sequencing supply-chain |
9.16. | DNA sequencing service: research, clinics, direct-to-consumer |
9.17. | Cost of DNA sequencing service |
9.18. | Key player: Illumina |
9.19. | Key player: Thame Fisher Scientific |
9.20. | Key player: Pacific Biosciences |
9.21. | Key player: Nanopore, smallest device toward point-of-care |
9.22. | Key player: 23andme |
9.23. | Key player: Foundation Medicine |
10. | MARKET FORECASTS 2019-2029 |
10.1. | Forecast details and assumptions |
10.2. | Biomedical diagnostics at POC revenue |
10.3. | Biomedical diagnostics at POC volume |
10.4. | Biomedical diagnostics at POC revenue by technology |
10.5. | Biomedical diagnostics at POC volume by technology |
10.6. | Biomedical diagnostics at POC revenue by market sector |
10.7. | Biomedical diagnostics at POC volume by market sector |
10.8. | Lateral flow assay at POC by revenue |
10.9. | Lateral flow assay at POC by volume |
10.10. | Electrochemical test strip at POC by revenue |
10.11. | Electrochemical test strip at POC by volume |
10.12. | Molecular diagnostics at POC by revenue |
10.13. | Molecular diagnostics at POC by volume |