1. | EXECUTIVE SUMMARY |
1.1. | Report Scope |
1.2. | Growing market for in vitro diagnostics |
1.3. | The value of point-of-care testing versus conventional testing |
1.4. | Recent regulations updates |
1.5. | Biosensors |
1.6. | Biomarkers: indicators of disease and health |
1.7. | Bioreceptors |
1.8. | Bioreceptors: benefits and drawbacks of each type |
1.9. | Bioreceptors summary |
1.10. | Transducers |
1.11. | Optical transducers: benefits and drawbacks of each type |
1.12. | Electrochemical transducers: benefits and drawbacks of each type |
1.13. | Transducer conclusions |
1.14. | Format types |
1.15. | Minimalizing sample handling with integrated cartridges |
1.16. | Cartridge caveats |
1.17. | LFAs and cartridges: key points |
1.18. | Electrochemical test strips and CGMs: key points |
1.19. | Applications for biosensors at the point-of-care |
1.20. | COVID-19 |
1.21. | Diabetes |
1.22. | Infectious diseases |
1.23. | State of the Covid-19 diagnostics market in 2022 |
1.24. | POCT biosensors forecast: total revenue by application (2019-2032) |
1.25. | POCT biosensors: historic market share by application |
1.26. | POCT biosensors forecast: total revenue by format type (2019-2032) |
1.27. | POCT biosensors: diabetes revenue (2019-2032) |
1.28. | Conclusions and outlook |
2. | INTRODUCTION |
2.1. | In vitro diagnostics |
2.2. | Growing market for in vitro diagnostics |
2.3. | The value of point-of-care testing |
2.4. | In vitro diagnostics trending toward point-of-care testing (POCT) |
2.5. | Drivers of point-of-care testing in healthcare |
2.6. | The cost of point-of-care testing |
2.7. | POCT vs. centralised testing: a cost comparison |
2.8. | Biosensors |
2.9. | Designing biosensors for point-of-care testing |
2.10. | REASSURED: updated criterion for point-of-care biosensors |
2.11. | Other desirable characteristics in a point-of-care biosensor platform |
2.12. | The definition of POCT will evolve |
3. | REGULATION |
3.1. | Regulatory routes to regional markets |
3.2. | New regulations in the EU |
3.3. | EU IVD classification |
3.4. | IVDR performance evaluation report |
3.5. | IVDR post-market performance follow-up |
3.6. | Changing regulations: impact on manufacturers |
3.7. | FDA regulation in the US |
3.8. | US regulations for diagnostics: CLIA categorizations |
3.9. | FDA medical device classification |
3.10. | Elements of FDA review of medical devices |
3.11. | EUA for in vitro diagnostics for the COVID-19 Pandemic |
3.12. | New NMPA regulations in China for IVDs |
3.13. | Rest of World |
4. | BIORECEPTORS |
4.1. | Layout of a biosensor |
4.2. | Biomarkers: indicators of disease and health conditions |
4.3. | Bioreceptors |
4.4. | Protein bioreceptors |
4.5. | Enzymes |
4.6. | Commercial enzyme bioreceptors |
4.7. | Enzyme bioreceptors in glucose monitoring |
4.8. | Enzyme bioreceptors in glucose monitoring |
4.9. | Abbott FreeStyle Libre 2 glucose detection mechanism |
4.10. | Enzyme bioreceptors in cholesterol monitoring |
4.11. | Nanopore Sequencing |
4.12. | Immunoassays: antibodies and antigens |
4.13. | Different methods of immunoassay testing |
4.14. | Immunoassay analyzers for central laboratories |
4.15. | Lateral flow assays for point-of-care-testing |
4.16. | Colorimetrix: Pearl |
4.17. | Manufacturing Antibodies |
4.18. | Manufacturing Antigens |
4.19. | Nucleic acid bioreceptors |
4.20. | Nucleic Acids and the Central Dogma |
4.21. | Polymerase Chain Reaction |
4.22. | Primer design |
4.23. | Molecular diagnostics overview |
4.24. | Key enabling trend: the advance of DNA sequencing |
4.25. | LAMP |
4.26. | Loopamp™: Eiken Chemical Co. |
4.27. | NEAR |
4.28. | Abbott: ID NOW™ COVID-19 rapid test |
4.29. | Insulated Isothermal PCR |
4.30. | GeneReach: POCKIT COVID-19 test |
4.31. | Aptamers |
4.32. | Achiko: AptameX |
4.33. | CRISPR-Cas systems |
4.34. | Sherlock Biosciences: SHERLOCK |
4.35. | Comparing bioreceptors |
4.36. | Bioreceptors: benefits and drawbacks of each type |
4.37. | Bioreceptors summary |
5. | TRANSDUCERS |
5.1. | Layout of a biosensor |
5.2. | Optical transducers |
5.2.1. | Inorganic nanoparticles for colorimetry |
5.2.2. | Bioconjugation of nanoparticles |
5.2.3. | The LFA sandwich assay |
5.2.4. | Colorimetry and quantitative LFA |
5.2.5. | Label-free surface plasmon resonance is not ready for POCT |
5.2.6. | Fluorescence labelling |
5.2.7. | Most fluorescent biosensors use organic dyes |
5.2.8. | Quantum dots |
5.2.9. | Ellume |
5.2.10. | Fluorescence-based glucose detection |
5.2.11. | Senseonics |
5.2.12. | Senseonics: Financials and Partnerships |
5.2.13. | GluSense |
5.2.14. | Bioconjugation of fluorescent labels |
5.2.15. | Labelling for qPCR |
5.3. | Electrochemical transducers |
5.3.1. | Electrode deposition: screen printing vs sputtering |
5.3.2. | Biosensor field effect transistors (Bio-FET) |
5.3.3. | CMOS chip |
5.3.4. | Roswell Biotechnologies |
5.3.5. | Graphene-based bioFET |
5.3.6. | Cardea |
5.3.7. | Grapheal |
5.3.8. | Carbon nanotube-FETs and test strips |
5.3.9. | Hememics |
5.3.10. | Bioconjugation of carbon nanomaterials |
5.3.11. | Optical transducers: benefits and drawbacks of each type |
5.3.12. | Electrochemical transducers: benefits and drawbacks of each type |
5.3.13. | Conclusion |
6. | FORMAT AND FABRICATION |
6.1. | Lab-on-a-chip a concept for POCT |
6.2. | Lateral Flow Assays |
6.2.1. | Mechanism of the lateral flow assay |
6.2.2. | Materials and manufacturing of lateral flow assays |
6.2.3. | Sample and absorbent pad selection |
6.2.4. | Conjugate pad selection |
6.2.5. | Nitrocellulose membrane selection |
6.2.6. | Nitrocellulose membrane striping |
6.2.7. | Lateral flow assay assembly |
6.3. | Cartridges and Analyzers |
6.3.1. | Minimalizing sample handling with integrated cartridges |
6.3.2. | Cartridge fabrication |
6.3.3. | Thermoplastics analysis |
6.3.4. | Microfluidics |
6.3.5. | Cartridge fabrication chain |
6.3.6. | Format shape depends on function |
6.3.7. | Surface functionalisation |
6.3.8. | Cartridges for nucleic acid biosensors |
6.3.9. | cobas® Liat® system, Roche |
6.3.10. | Visby Medical |
6.3.11. | Spindiag |
6.3.12. | Cartridges for other bioreceptors |
6.3.13. | Epoc® blood analysis, Siemens |
6.3.14. | i-STAT®, Abbott: a commercial success story |
6.3.15. | i-STAT® mechanism of action |
6.3.16. | Nanoentek |
6.3.17. | SampinuteTM, Celltrion |
6.3.18. | BluSense Diagnostics |
6.3.19. | BluSense: Technology |
6.3.20. | Cartridge caveats |
6.3.21. | Conclusion |
6.4. | Electrochemical Strips |
6.4.1. | Glucose monitoring through test strips and associated readers |
6.4.2. | Test strips: business model |
6.4.3. | Electrode deposition: screen printing vs sputtering |
6.4.4. | Lifescan uses multiple manufacturing methods |
6.4.5. | Roche: Accu-Chek Guide |
6.4.6. | Abbott: coulometric methods for test strips |
6.4.7. | Innovation shifts from test strip development to increasing digitization |
6.5. | Continuous Monitors |
6.5.1. | Anatomy of a typical CGM device |
6.5.2. | CGM sensor manufacturing and anatomy |
6.5.3. | Sensor membranes are critical |
6.5.4. | CGM: Technology |
6.5.5. | Sensor filament structure |
6.5.6. | Foreign body responses to CGM devices |
6.5.7. | Dexcom: Sensor structure |
6.5.8. | Medtronic: Sensor structure |
6.5.9. | CGM markets in Asia |
6.5.10. | Outlook for smaller test strip companies |
6.5.11. | CGM reimbursement for type 2 is currently limited |
6.5.12. | CGM usage in hospitals |
7. | APPLICATIONS |
7.1. | Applications for biosensors at the point-of-care |
7.2. | Diagnostics and Monitoring |
7.3. | Diagnostics |
7.3.1. | Infectious diseases |
7.3.2. | Respiratory diseases |
7.3.3. | Tropical and vector diseases |
7.3.4. | Sexually transmitted infections |
7.3.5. | Infectious diseases: consider the infection load |
7.3.6. | Cancer diagnostics, how suitable for POCT? |
7.3.7. | POCT for cardiovascular disease |
7.3.8. | Cardiovascular markers for POCT in the emergency room |
7.4. | At-home Monitoring |
7.4.1. | Rising diabetes and rising costs press need for POCT and monitoring |
7.4.2. | Comparing test strip costs with CGM |
7.4.3. | Cholesterol as an early indicator of cardiovascular disease |
7.4.4. | Lactic acid monitoring for athletes |
7.4.5. | Fertility market grows, even as fertility rates fall |
8. | POCT FOR COVID-19 |
8.1. | COVID-19 is caused by the SARS-CoV-2 virus |
8.2. | COVID-19 Pandemic Crisis |
8.3. | State of the Covid-19 diagnostics market in 2022 |
8.4. | Covid-19 pandemic developments |
8.5. | Unstable Demand |
8.6. | Capacity in EU and US |
8.7. | EUA for in vitro diagnostics for the COVID-19 Pandemic |
8.8. | Assay target |
8.9. | Assay target over time |
8.10. | Performance comparison overview of COVID-19 diagnostics technologies |
8.11. | Conclusions for POCT for COVID-19 |
9. | MARKET ANALYSIS |
9.1. | Market dynamics |
9.2. | Value ecosystem of POCT devices |
9.3. | POCT biosensors: historic market share by application |
9.4. | POCT biosensors market overview |
9.5. | POCT biosensors market leading players, excluding diabetes in 2021 |
9.6. | POCT total market revenue by bioreceptor 2021 |
9.7. | POCT total market revenue by transducer 2021 |
9.8. | State of the Covid-19 diagnostics market in 2022 |
9.9. | Historic data: CGM continues to gain momentum |
9.10. | Leading players in diabetes continuous glucose monitors |
9.11. | Integrated cartridge & reader business model |
9.12. | Molecular diagnostics POCT players |
9.13. | POCT MDx by type |
9.14. | Competition and differentiation features for POCT molecular diagnostics |
9.15. | Reader instrument selling prices for molecular diagnostics |
10. | FORECASTS |
10.1. | Forecasting methodology |
10.2. | POCT biosensors forecast: total revenue by application (2019-2032) |
10.3. | POCT biosensors forecast: total revenue by application (2019-2032) |
10.4. | POCT biosensors forecast: total volume by application (2019-2032, excluding diabetes) |
10.5. | POCT biosensors: historic market share by application |
10.6. | POCT biosensors: key players (2021) |
10.7. | POCT biosensors forecast: effect of COVID-19 on market share |
10.8. | POCT biosensors forecast: total revenue by format type (2019-2032) |
10.9. | POCT biosensors forecast: total revenue by format type (2019-2032) |
10.10. | POCT biosensors forecast: total volume by format type (2019-2032) |
10.11. | POCT biosensors forecast: total volume by format type, excluding electrochemical test strips (2019-2032) |
10.12. | POCT biosensors forecast: lateral flow assay (LFA) revenue by application (2019-2032) |
10.13. | POCT biosensors forecast: cartridges revenue by application (2019-2032) |
10.14. | POCT biosensors: infectious diseases and COVID-19 revenue (2019-2032) |
10.15. | POCT Biosensors: cardiovascular diseases revenue (2019-2032) |
10.16. | POCT biosensors: fitness revenue (2019-2032) |
10.17. | POCT biosensors: cancer LFAs revenue (2019-2032) |
10.18. | Forecast assumptions for diabetes test strips and CGMs |
10.19. | POCT biosensors: diabetes revenue (2019-2032) |
10.20. | Test strip market forecast 2022-2032 |
10.21. | Historic data: CGM continues to gain momentum |