医療現場（ポイントオブケア [POC]） における生物学的診断製品の世界市場2019-2029：技術、用途、成長予測: IDTechEx
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医療現場（ポイントオブケア [POC]） における生物学的診断製品の世界市場2019-2029：技術、用途、成長予測
バイオセンサー、マイクロ流体ラブオンチップ、ラテラルフロー・アッセイ、電子化学的検査紙、分子診断および DNA シークエンシングを含む
製品情報
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当レポートは、医療現場でのバイオセンサー生体医学診断の高度な技術に焦点を当てています。技術的には、マイクロフルイディクス、ラボオンチップ、ラテラルフローアッセイ、電気化学試験片、分子診断および、DNAシーケンスが挙げられます。これらの技術とデバイスは、遺伝子疾患、感染症、心血管代謝、妊娠と受胎能、糖尿病と癌の診断に使用されます。バイオメディカル診断の市場は、2029年までに430億ドルに達すると予測しています。これは、主に今後数年間の分子診断の急速な成長に牽引されます
Biomedical diagnostics refers to the use of biosensor devices which provide information associated with a specific health condition or disease. Medical biosensors can diagnose a wealth of diseases and health conditions, such as diabetes, cardiovascular issues, infectious diseases, and cancer.
The market for biomedical diagnostics is expected to grow steadily, reaching $43 billion by 2029, due to a growing and aging global population increasing health expenditure and more prevalent lifestyle ailments such as obesity, cancer and cardiovascular diseases. Millions of people in emerging markets such as China and India are entering the middle class and pushing up the demand for a high standard of healthcare.
Traditionally, biomedical diagnosis is mainly performed by sending collected samples (blood, urine, or genetic samples) to an off-site analytical laboratory. This approach has been fundamentally changed by point-of-care biosensor devices, which allow biomedical diagnosis at the time and place of patient care. Trillions of dollars have been poured into the innovation of advanced biosensor devices that are small, sensitive, and have a fast sample-to-answer response.
This report gives a comprehensive study and complete analysis of the important trends in the field of biomedical biosensors, and lists the new technologies and devices which are likely to be highly disruptive to the in vitro diagnostics market. It includes five categories:
- Lab-on-a-chip: A large portion of point-of-care biosensors are based on microfluidic techniques and are integrated into one device. This technique simplifies the steps of testing, automates the process and enables the miniaturisation of biomedical devices. This report surveys the techniques, focussing on integrated cartridges.
- Lateral flow assays: Biomedical diagnostic devices using capillary technology for broad applications such as pregnancy testing. This report highlights the recent advancements and trends as well as the coming years.
- Electrochemical test strips: This report goes beyond the traditional glucose testing strips, and searches for non-blood diabetic management, such as continuous glucose monitoring. It also includes monitoring of lactic acid and cholesterol.
- Molecular Diagnostics: This report provides a comprehensive study of molecular diagnostics which assesses an individual's health at the molecular level by detecting genetic information in DNA, RNA or protein.
- DNA sequencing: An emerging and advanced technique entering biomedical diagnostics market, which is considered as a possible ultimate solution for healthcare in the future.
In addition, the report gives a 10-year market forecast segmented by the following applications:
- Infectious disease
- Glucose testing
- Cancer
- Cardiometabolic
- Pregnancy & fertility
- Genetic testing
- DNA sequencing
We provide a list and analysis of the main players. We also give a comprehensive study of both currently available and incoming devices that are using biosensors for biomedical diagnostics. This report will be useful to any company wishing to know the biomedical diagnostics market, advanced techniques and biosensor devices, current market size and future tendency.
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アイディーテックエックス株式会社 (IDTechEx日本法人)
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担当: 村越美和子 m.murakoshi@idtechex.com
| 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 |
レポート概要
| スライド | 270 |
|---|---|
| フォーキャスト | 2029 |