Summary
この調査レポートでは、IDTechExがポイントオブケアバイオセンサの成長、業界内の新たなトレンド、新技術がもたらす機会について詳細に調査・分析しています。
主な掲載内容（目次より抜粋）
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規制
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バイオレセプタ
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トランスデューサー
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フォーマットとファブリケーション
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予測
Report Summary
The market for medical diagnostics is shifting from conventional, laboratory-based testing towards testing directly at the point of care. No time has this shift been so vital as now, during the COVID-19 pandemic. In this report, IDTechEx discusses the growth of point-of-care biosensors, the emerging trends within the industry and what opportunities new technologies will present. We forecast the trajectory that these will take the industry.
Point-of-care testing (POCT) refers to diagnostics at the bedside or near the patient. This can be in hospital wards, physician's offices, retail clinics, and at home. By providing rapid results, POCT allows faster clinical action to be taken. By eliminating the need to send samples to conventional laboratories for testing, POCT solves the clinical issues around follow-ups and resources/time commitment. Furthermore, at-home testing allows patients to directly test for disease/health conditions without the need to visit a physician, which is critical for monitoring chronic diseases such as diabetes.
What is driving the growth of point-of-care testing?
Our changing population demographics are increasing the pressure on healthcare systems. Today, healthcare spending makes up about 14% of the world GDP. In developed economies, there are rising cases of chronic diseases, driven by the aging population, and by more sedentary lifestyles. The demand for healthcare in emerging economies grows too, accelerated by an expanding population size. The need to bring diagnostics to resource limited settings drives POCT in these regions. Overall, cases of infectious disease and the frequency of emerging epidemics are growing too, driven by increasing urban density and a warming climate. Together, these factors are driving the point-of-care biosensor industry to grow towards $29.5 billion by 2032.
Impact of COVID-19 on the point-of-care diagnostics industry
With the onset of COVID-19, the diagnostics industry ramped up manufacturing capacity for COVID-19 test products. Testing has been critical to tracking an infection which is asymptomatic for most of the population, allowing people to manage the spread of the virus. While conventional testing using PCR within the laboratory remains the gold-standard of testing accuracy, the emergence of at-home COVID-19 tests has increased testing accessibility and allowed individuals to use it at a higher frequency. In 2021, the US government invested $1 billion in increasing the supply of at-home tests, enabling the rise of production volume to approximately 200 million tests per month. This opportunity has been a key booster on several fronts for the industry. Cue Health, who developed a molecular COVID-19 at-home test, received a $400m contract from the US Department of Defense in 2021; versus a total revenue of $23m the year before. For POCT cartridge products, install-base has grown massively: BD's Veritor device almost tripled its USA install base, to 70,000, in six months, while Quidel's Sofia similarly installed over 75,000 units in 2021. This established user base facilitates future market expansion. The virus has also allowed start-ups to seed the market by pivoting the platforms they were developing into COVID-19 testing applications, such as Visby Medical who have developed a single-use, miniaturized PCR for the point-of-care.
Trends in biosensor technologies
In this report, IDTechEx divides the POC biosensor into its components of bioreceptors and transducers to explore the key and novel technologies within these segments. We analyse the techniques designed to miniaturize nucleic acid amplification and bring it towards point-of-care, such as PCR, LAMP, and NEAR. The report also explores emerging approaches to transducing biological signals, including the use of graphene and carbon nanotubes in electrochemical transduction, and the use of fluorescent organic dyes and quantum dots in optical transducers.
However, many of the biosensor technologies at point-of-care are mature with limited innovation. Lateral flow tests have been commercialised for half a century, yet they remain limited by the accuracy of their readings. Part of this problem is being resolved by a growing trend of using readers and smartphone-camera readers to digitalize and connect the results of these tests, eliminating inaccuracy such as misinterpreting faint lines by eye. Yet, the technology is fundamentally limited by the sensitivity and the specificity of their bioreceptors, which are usually antibodies.
Despite the excitement around many emerging technologies for biosensing, there are still several problems to solve. While the properties of CRIPSR/Cas make it good for diagnostics, with potential for excellent accuracy, the reality is that the technology is still immature. The technology does not see many players for a point-of-care diagnostics application, with many more focused on other applications such as therapeutics. Similarly, we ask what constraints are limiting carbon-based nanomaterials from their commercialization in transducers today, despite their suitability.
10-year market forecast segmented by format and application
The report segments and discusses the market by applications, looking at the drivers and constraints of each segment, as well as the key diseases and disease biomarkers that industry players target. We also segment by the format of the biosensor and evaluate the importance of formats to bring different biosensors to the point-of-care. These segments are extrapolated in our 10-year forecast, to explore the make-up of applications and formats and how they might change in time.
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Table of Contents
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|
1. |
EXECUTIVE SUMMARY |
|
1.1. |
Report Scope |
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1.2. |
Growing market for in vitro diagnostics |
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1.3. |
The value of point-of-care testing versus conventional testing |
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1.4. |
Recent regulations updates |
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1.5. |
Biosensors |
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1.6. |
Biomarkers: indicators of disease and health |
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1.7. |
Bioreceptors |
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1.8. |
Bioreceptors: benefits and drawbacks of each type |
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1.9. |
Bioreceptors summary |
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1.10. |
Transducers |
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1.11. |
Optical transducers: benefits and drawbacks of each type |
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1.12. |
Electrochemical transducers: benefits and drawbacks of each type |
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1.13. |
Transducer conclusions |
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1.14. |
Format types |
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1.15. |
Minimalizing sample handling with integrated cartridges |
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1.16. |
Cartridge caveats |
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1.17. |
LFAs and cartridges: key points |
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1.18. |
Electrochemical test strips and CGMs: key points |
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1.19. |
Applications for biosensors at the point-of-care |
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1.20. |
COVID-19 |
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1.21. |
Diabetes |
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1.22. |
Infectious diseases |
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1.23. |
State of the Covid-19 diagnostics market in 2022 |
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1.24. |
POCT biosensors forecast: total revenue by application (2019-2032) |
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1.25. |
POCT biosensors: historic market share by application |
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1.26. |
POCT biosensors forecast: total revenue by format type (2019-2032) |
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1.27. |
POCT biosensors: diabetes revenue (2019-2032) |
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1.28. |
Conclusions and outlook |
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2. |
INTRODUCTION |
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2.1. |
In vitro diagnostics |
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2.2. |
Growing market for in vitro diagnostics |
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2.3. |
The value of point-of-care testing |
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2.4. |
In vitro diagnostics trending toward point-of-care testing (POCT) |
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2.5. |
Drivers of point-of-care testing in healthcare |
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2.6. |
The cost of point-of-care testing |
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2.7. |
POCT vs. centralised testing: a cost comparison |
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2.8. |
Biosensors |
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2.9. |
Designing biosensors for point-of-care testing |
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2.10. |
REASSURED: updated criterion for point-of-care biosensors |
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2.11. |
Other desirable characteristics in a point-of-care biosensor platform |
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2.12. |
The definition of POCT will evolve |
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3. |
REGULATION |
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3.1. |
Regulatory routes to regional markets |
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3.2. |
New regulations in the EU |
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3.3. |
EU IVD classification |
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3.4. |
IVDR performance evaluation report |
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3.5. |
IVDR post-market performance follow-up |
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3.6. |
Changing regulations: impact on manufacturers |
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3.7. |
FDA regulation in the US |
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3.8. |
US regulations for diagnostics: CLIA categorizations |
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3.9. |
FDA medical device classification |
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3.10. |
Elements of FDA review of medical devices |
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3.11. |
EUA for in vitro diagnostics for the COVID-19 Pandemic |
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3.12. |
New NMPA regulations in China for IVDs |
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3.13. |
Rest of World |
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4. |
BIORECEPTORS |
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4.1. |
Layout of a biosensor |
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4.2. |
Biomarkers: indicators of disease and health conditions |
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4.3. |
Bioreceptors |
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4.4. |
Protein bioreceptors |
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4.5. |
Enzymes |
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4.6. |
Commercial enzyme bioreceptors |
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4.7. |
Enzyme bioreceptors in glucose monitoring |
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4.8. |
Enzyme bioreceptors in glucose monitoring |
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4.9. |
Abbott FreeStyle Libre 2 glucose detection mechanism |
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4.10. |
Enzyme bioreceptors in cholesterol monitoring |
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4.11. |
Nanopore Sequencing |
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4.12. |
Immunoassays: antibodies and antigens |
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4.13. |
Different methods of immunoassay testing |
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4.14. |
Immunoassay analyzers for central laboratories |
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4.15. |
Lateral flow assays for point-of-care-testing |
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4.16. |
Colorimetrix: Pearl |
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4.17. |
Manufacturing Antibodies |
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4.18. |
Manufacturing Antigens |
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4.19. |
Nucleic acid bioreceptors |
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4.20. |
Nucleic Acids and the Central Dogma |
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4.21. |
Polymerase Chain Reaction |
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4.22. |
Primer design |
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4.23. |
Molecular diagnostics overview |
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4.24. |
Key enabling trend: the advance of DNA sequencing |
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4.25. |
LAMP |
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4.26. |
Loopamp™: Eiken Chemical Co. |
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4.27. |
NEAR |
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4.28. |
Abbott: ID NOW™ COVID-19 rapid test |
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4.29. |
Insulated Isothermal PCR |
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4.30. |
GeneReach: POCKIT COVID-19 test |
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4.31. |
Aptamers |
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4.32. |
Achiko: AptameX |
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4.33. |
CRISPR-Cas systems |
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4.34. |
Sherlock Biosciences: SHERLOCK |
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4.35. |
Comparing bioreceptors |
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4.36. |
Bioreceptors: benefits and drawbacks of each type |
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4.37. |
Bioreceptors summary |
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5. |
TRANSDUCERS |
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5.1. |
Layout of a biosensor |
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5.2. |
Optical transducers |
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5.2.1. |
Inorganic nanoparticles for colorimetry |
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5.2.2. |
Bioconjugation of nanoparticles |
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5.2.3. |
The LFA sandwich assay |
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5.2.4. |
Colorimetry and quantitative LFA |
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5.2.5. |
Label-free surface plasmon resonance is not ready for POCT |
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5.2.6. |
Fluorescence labelling |
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5.2.7. |
Most fluorescent biosensors use organic dyes |
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5.2.8. |
Quantum dots |
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5.2.9. |
Ellume |
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5.2.10. |
Fluorescence-based glucose detection |
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5.2.11. |
Senseonics |
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5.2.12. |
Senseonics: Financials and Partnerships |
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5.2.13. |
GluSense |
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5.2.14. |
Bioconjugation of fluorescent labels |
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5.2.15. |
Labelling for qPCR |
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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 |
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5.3.7. |
Grapheal |
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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 |
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6.2.3. |
Sample and absorbent pad selection |
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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. |
FORECASTS |
|
9.1. |
Forecasting methodology |
|
9.2. |
POCT biosensors forecast: total revenue by application (2019-2032) |
|
9.3. |
POCT biosensors forecast: total revenue by application (2019-2032) |
|
9.4. |
POCT biosensors forecast: total volume by application (2019-2032, excluding diabetes) |
|
9.5. |
POCT biosensors: historic market share by application |
|
9.6. |
POCT biosensors: key players (2021) |
|
9.7. |
POCT biosensors forecast: effect of COVID-19 on market share |
|
9.8. |
POCT biosensors forecast: total revenue by format type (2019-2032) |
|
9.9. |
POCT biosensors forecast: total revenue by format type (2019-2032) |
|
9.10. |
POCT biosensors forecast: total volume by format type (2019-2032) |
|
9.11. |
POCT biosensors forecast: total volume by format type, excluding electrochemical test strips (2019-2032) |
|
9.12. |
POCT biosensors forecast: lateral flow assay (LFA) revenue by application (2019-2032) |
|
9.13. |
POCT biosensors forecast: cartridges revenue by application (2019-2032) |
|
9.14. |
POCT biosensors: infectious diseases and COVID-19 revenue (2019-2032) |
|
9.15. |
POCT Biosensors: cardiovascular diseases revenue (2019-2032) |
|
9.16. |
POCT biosensors: fitness revenue (2019-2032) |
|
9.17. |
POCT biosensors: cancer LFAs revenue (2019-2032) |
|
9.18. |
Forecast assumptions for diabetes test strips and CGMs |
|
9.19. |
POCT Biosensors: diabetes revenue (2019-2032) |
|
9.20. |
Test strip market forecast 2022-2032 |
|
9.21. |
Historic data: CGM continues to gain momentum |
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