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1. | EXECUTIVE SUMMARY |
1.1. | Molecular diagnostics (MDx) |
1.2. | Drivers for the MDx markets |
1.3. | What are the benefits and limitations of MDx? |
1.4. | Working flow of MDx devices |
1.5. | Key technologies for MDx: overview |
1.6. | Market forecast for MDx technologies from 2020-2030 |
1.7. | DNA microarray: high-throughput analysis of target regions in the genome |
1.8. | Synthesis of DNA microarrays |
1.9. | Key players for DNA microarrays |
1.10. | Market share of DNA microarrays in 2019 |
1.11. | Market forecast for microarrays devices from 2020-2030 |
1.12. | Polymerase chain reaction (PCR): Process |
1.13. | Real-Time PCR/ Quantitative PCR (qPCR) |
1.14. | Digital PCR (dPCR) |
1.15. | Key players for PCR devices |
1.16. | Key players for PCR reagents/consumables |
1.17. | Market share for PCR equipment in 2019 |
1.18. | Market forecast for PCR devices from 2020-2030 |
1.19. | DNA sequencing technology: first generation |
1.20. | Next generation sequencing (NGS) |
1.21. | 3rd generation sequencing |
1.22. | Future trends and opportunities |
1.23. | Market share for DNA sequencers in 2019 |
1.24. | Market forecast for DNA sequencers from 2020-2030 |
1.25. | Miniaturized devices enable molecular diagnostics at point-of-care |
1.26. | Market drivers for pushing MDx to the point-of-care |
1.27. | Examples of POC MDx devices |
1.28. | Cost of cartridges for POC MDx devices |
1.29. | Key applications for molecular diagnostics |
1.30. | MDx applications are divided into two categories |
1.31. | Key players for Human Genetic Tests |
1.32. | Key players for Microbial Tests |
1.33. | Market forecast for MDx market segments from 2020-2030 |
1.34. | Market forecast for molecular diagnostics for infectious diseases |
1.35. | Market forecast for molecular diagnostics for direct-to-consumer |
1.36. | Market forecast for molecular diagnostics for cancer diagnostics and liquid biopsy |
1.37. | Market forecast for molecular diagnostics for companion diagnostics |
2. | INTRODUCTION TO MOLECULAR DIAGNOSTICS |
2.1.1. | Global healthcare trend |
2.1.2. | US, Europe and Asia are the key markets |
2.1.3. | Why the healthcare market is growing |
2.1.4. | Molecular diagnostics (MDx) |
2.1.5. | The central dogma: DNA, RNA and Proteins |
2.1.6. | Key technologies for MDx: overview |
2.1.7. | Drivers for the MDx markets |
2.1.8. | Key applications for molecular diagnostics |
2.1.9. | Clinical market for genomic testing is expanding |
2.1.10. | All disease is a result of genes interacting with the environment |
2.1.11. | Testing genetic mutations |
2.1.12. | Biomarker development in the precision medicine era |
2.1.13. | What are the benefits and limitations of MDx? |
2.1.14. | 2018: Turning point for MDx |
2.2. | Genetic Data |
2.2.1. | Applications of genetic data |
2.2.2. | Race to build up genetic database and the dilemma for privacy |
2.2.3. | Global Genetics projects |
2.2.4. | Population sequencing: backing by governments |
2.2.5. | Moral and ethical concerns |
2.3. | Regulations |
2.3.1. | Regulatory routes to market depend on the target market |
2.3.2. | EU regulations for medical devices are changing |
2.3.3. | Changing regulations: Advice to manufacturers |
2.3.4. | A regulatory road map for diagnostic products in the US |
2.3.5. | US regulations for diagnostics: CLIA categorizations |
3. | TECHNOLOGIES OF MOLECULAR DIAGNOSTICS |
3.1.1. | Introduction to Genome |
3.1.2. | Genotyping |
3.1.3. | Gene expression |
3.1.4. | Genotyping and SNP Analysis |
3.1.5. | Working flow of MDx devices |
3.1.6. | Extraction and purification |
3.1.7. | Amplification: PCR or isothermal amplification |
3.1.8. | Detection: DNA sequencing vs. DNA probe |
3.1.9. | Detection methods are being used commercially |
3.1.10. | Optical detection: fluorescence |
3.1.11. | Optical detection: colorimetric |
3.1.12. | Electrochemical detection: with label |
3.1.13. | Electrochemical detection: label free |
3.1.14. | The industry moves toward CMOS chips |
3.2. | Technology: DNA microarrays |
3.2.1. | DNA microarray: high-throughput analysis of target regions in the genome |
3.2.2. | Key players for DNA microarrays |
3.2.3. | Substrate for DNA microarray |
3.2.4. | Synthesis of DNA microarrays |
3.2.5. | Synthesis of DNA microarrays: printed methods |
3.2.6. | Synthesis of DNA microarrays: In-situ synthesis |
3.2.7. | Synthesis of DNA microarrays: microbeads/ self assembled arrays |
3.2.8. | Research trend in DNA microarrays: Microfluidic DNA Microarrays |
3.2.9. | GeneChip® microarrays (Affymetrix, Thermal Fishers) |
3.2.10. | NimbleGen (Roche): Maskless Array Synthesis |
3.2.11. | SurePrint technology (Agilent Technologies) |
3.2.12. | BeadArray Microarray Technology (Illumina) |
3.2.13. | DualChip (Eppendorf) |
3.2.14. | NanoChip electronic microarray (Savyon Diagnostics ) |
3.2.15. | DNA microarrays for DNA sequence (exome sequencing) |
3.2.16. | Limitation of DNA microarray |
3.2.17. | Revenue of DNA microarrays from 2010 to 2018 |
3.2.18. | Market share of DNA microarrays in 2019 |
3.2.19. | Market forecast for microarrays devices from 2020-2030 |
3.3. | Technology: Polymerase chain reaction (PCR) |
3.3.1. | Polymerase chain reaction (PCR): Introduction |
3.3.2. | Polymerase chain reaction (PCR): Process |
3.3.3. | Trend for PCR technology |
3.3.4. | Various PCR technologies |
3.3.5. | Multiplex polymerase chain reaction (mPCR) |
3.3.6. | Real-Time PCR/ Quantitative PCR (qPCR) |
3.3.7. | Labelling for qPCR |
3.3.8. | QuantStudio (Thermal Fisher Scientific): smart PCR |
3.3.9. | Digital PCR (dPCR) |
3.3.10. | Digital PCR devices |
3.3.11. | Droplet Digital PCR (ddPCR, Bio-Rad) |
3.3.12. | Key players for PCR devices |
3.3.13. | Key players for PCR reagents/consumables |
3.3.14. | Isothermal amplification of nucleic acids techniques |
3.3.15. | Which is the future: isothermal amplification or PCR? |
3.3.16. | Revenue of PCR devices from 2010 to 2018 |
3.3.17. | Market share for PCR equipment in 2019 |
3.3.18. | Market forecast for PCR devices from 2020-2030 |
3.4. | Technology: DNA sequencing |
3.4.1. | What's DNA sequencing |
3.4.2. | DNA sequencing |
3.4.3. | Applications of DNA sequencing in research and clinical use |
3.4.4. | DNA sequencing provides insight |
3.4.5. | DNA sequencing technology: first generation |
3.4.6. | Capillary Electrophoresis DNA sequencers |
3.4.7. | Next generation sequencing (NGS) |
3.4.8. | Second generation sequencing workflows (Illumina) |
3.4.9. | Key players for second generation sequencing |
3.4.10. | 3rd generation sequencing |
3.4.11. | Key players for third generation sequencing |
3.4.12. | DNA sequencers by Thermo Fisher Scientific |
3.4.13. | DNA sequencers by Oxford nanopore |
3.4.14. | DNA sequencing supply-chain |
3.4.15. | Business model: research, clinical genetic tests, direct-to-consumer |
3.4.16. | Cost for DNA sequencing test |
3.4.17. | Cost to sequence whole human genome |
3.4.18. | Future trends and opportunities |
3.4.19. | Revenue of DNA sequencers from 2010 to 2018 |
3.4.20. | Market share for DNA sequencers in 2019 |
3.4.21. | Market forecast for DNA sequencers from 2020-2030 |
3.5. | Lab-on-a-chip to support molecular diagnostics technologies |
3.5.1. | What is Lab-on-a-chip (LOC)? |
3.5.2. | Ideal LOC devices for POC |
3.5.3. | Lab-on-a-chip applications |
3.5.4. | Example: the simple chip for low-cost, quantitative, and portable nucleic acid testing |
3.5.5. | Lab-on-a-chip for digital polymerase chain reaction (dPCR) |
3.5.6. | Lab-on-a-chip for DNA sequencing |
3.5.7. | Sample preparation |
3.5.8. | Biocompatible photoresists |
3.5.9. | Bio-patterning |
3.5.10. | Photolithography bio-patterning |
3.5.11. | Microstamping bio-patterning |
3.5.12. | Microfluidic patterning |
3.5.13. | Self-assembly bio-patterning |
3.5.14. | Active flow control and digital microfluidics |
3.5.15. | Droplet microfluidics (digital microfluidics) |
4. | MOLECULAR DIAGNOSTICS AT POINT-OF-CARE |
4.1. | Miniaturised devices enable molecular diagnostics at point-of-care |
4.2. | Molecular diagnostics is moving to point-of-care |
4.3. | Varying importance of molecular diagnostics and point-of-care |
4.4. | Market drivers for pushing MDx to the point-of-care |
4.5. | Barriers to success for POC MDx |
4.6. | The impact of POC MDx on the diagnostics market |
4.7. | What it takes to win in point-of-care molecular diagnostics |
4.8. | Examples of POC MDx devices |
4.9. | POC MDx available and in pipeline |
4.10. | Costing of cartridges for POC MDx devices |
4.11. | Examples of disposable cartridge technologies I |
4.12. | Examples of disposable cartridge technologies II |
4.13. | Direction for point-of-care molecular diagnostics |
4.14. | Key trends: multiplexing |
4.15. | Key trends: connectivity and data management |
5. | MARKETS FOR MOLECULAR DIAGNOSTICS |
5.1.1. | Key applications for molecular diagnostics |
5.1.2. | New markets for molecular diagnostics |
5.1.3. | MDx applications are divided into two categories |
5.1.4. | Key players for Human Genetic Tests |
5.1.5. | Numbers of products with FDA approval for Human Genetic Tests for each key players |
5.1.6. | Key players for Microbial Tests |
5.1.7. | Numbers of products with FDA approval for Microbial Tests for each key players |
5.2. | Infectious diseases diagnosis |
5.2.1. | What are infectious diseases |
5.2.2. | Why does it matter |
5.2.3. | Infectious diseases today |
5.2.4. | Infectious diseases will lead to pandemic disease |
5.2.5. | Major infectious threats in 21st Century |
5.2.6. | Main techniques to diagnose infectious diseases |
5.2.7. | Microscopy and culture growth methods |
5.2.8. | Immunoassays |
5.2.9. | Enzyme-linked immunosorbent assay (ELISA) |
5.2.10. | Key players in the lateral flow assay market |
5.2.11. | Molecular diagnostics: Polymerase Chain Reaction (PCR) for infectious disease |
5.2.12. | Point-of-care molecular diagnostic (POC MDx) will take over the infectious disease market from lateral flow assays (LFA) |
5.2.13. | Comparison of MDx and immunoassays for infectious diseases |
5.2.14. | Players in molecular diagnostics for infectious disease detection |
5.2.15. | Devices: Atlas io system |
5.2.16. | Devices: Cobas Liat |
5.2.17. | Devices: Alere i |
5.2.18. | Devices: Alere q Analyzer |
5.2.19. | Devices: Spartan Cube |
5.2.20. | Devices: FilmArray 2.0 |
5.2.21. | Devices: PanNAT system |
5.2.22. | Devices: GeneXpert Omni |
5.2.23. | Devices: Spartan Cube |
5.2.24. | Devices: Q-POC |
5.2.25. | Additional molecular diagnostic systems |
5.2.26. | Market forecast for molecular diagnostics for infectious diseases |
5.3. | Direct-to-consumer (DTC) |
5.3.1. | 23andMe starts DTC business model |
5.3.2. | Customer motivations for DTC |
5.3.3. | Considerations when customers purchase DTC |
5.3.4. | Why DTC diagnostics might not be correct and genetic counsellors are needed |
5.3.5. | Market forecast for molecular diagnostics for direct-to-consumer |
5.4. | Liquid Biopsy |
5.4.1. | Global cancer |
5.4.2. | Liquid biopsy for cancer: Written in blood |
5.4.3. | Circulating tumor DNA (ctDNA) |
5.4.4. | Circulating tumour cells (CTCs) |
5.4.5. | Liquid biopsy for cancer: Challenges |
5.4.6. | Project to study the landscape of genomic cancer signal in the blood |
5.4.7. | Liquid biopsy for lung cancer (OncoCyte) |
5.4.8. | Early cancer detection by DNA sequencing (GRAIL) |
5.4.9. | Debate on ctDNA: evolutional or fantasy |
5.4.10. | Market forecast for molecular diagnostics for cancer diagnostics and liquid biopsy |
5.5. | Companion Diagnostic |
5.5.1. | The future: companion diagnostic (CDx) |
5.5.2. | Some FDA approved CDx products in 2019 |
5.5.3. | Number of FDA approved CDx products (by Oct. 2019) |
5.5.4. | Market forecast for molecular diagnostics for companion diagnostics |
6. | MARKET FORECASTS 2020-2030 |
6.1. | Market forecast for MDx technologies from 2020-2030 |
6.2. | Revenue of DNA microarrays from 2010 to 2018 |
6.3. | Market share of DNA microarrays in 2019 |
6.4. | Market forecast for microarrays devices from 2020-2030 |
6.5. | Revenue of PCR devices from 2010 to 2018 |
6.6. | Market share for PCR equipment in 2019 |
6.7. | Market forecast for PCR devices from 2020-2030 |
6.8. | Revenue of DNA sequencers from 2010 to 2018 |
6.9. | Market share for DNA sequencers in 2019 |
6.10. | Market forecast for DNA sequencers from 2020-2030 |
6.11. | Market forecast for MDx market segments from 2020-2030 |
6.12. | Market forecast for molecular diagnostics for infectious diseases |
6.13. | Market forecast for molecular diagnostics for direct-to-consumer |
6.14. | Market forecast for molecular diagnostics for cancer diagnostics and liquid biopsy |
6.15. | Market forecast for molecular diagnostics for companion diagnostics |
7. | COMPANY PROFILES |
Slides | 311 |
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Forecasts to | 2030 |