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An Evaluation of Products and Technologies for Molecular Diagnostics within Oncology


Description: This latest Multi Client Publication provides:

- An overview of current industry-landscape for molecular diagnostics within the oncology area

- Analysis of the key European markets including forecasts for growth, drivers and restraints in the marketplace

- Reimbursement and legislation environment, the most relevant national guidelines relating to genetic testing

- Understanding of market opportunities for molecular diagnostics within the oncology market as an area of growth, research and future developments

- Data in Excel Spreadsheet


The primary objective of this report, compiled from an analysis of primary and secondary research data, is to
provide an overview of the molecular diagnostics market for selected oncology markers in the country markets
listed below.

- France
- Germany
- Italy
- United Kingdom
- USA

The following key issues have been addressed:
- Provide a reflective picture of the type and number of relevant testing institutions
- Which and how many parameters are tested (market size). Top 3 solid markers, top 3 lymphoid markers
and emerging markers identified.
- Which assays are used (home brew or commercial)
- Current market growth per parameter
- Expected market growth rates per parameter in the next 5 years
- Which technologies are used (PCR, RT-PCR, FISH, sequencing, microarrays, others) and what is the anticipated shift in use of these.

- Devices used
- The regulatory issues per country (legislation, reimbursement etc.)
- Future trends & emerging technologies


Contents: Introduction

Part 1 – France
1 Current Situation
1.1 Respondent Population France
1.2 Nucleic Acid Based Testing
1.3 Genetic Testing - Routine or Research
1.4 HPV Testing
1.5 Oncology Markers
1.5.1 Solid Tumor Marker
1.5.2 Lymphoid Tumour Marker
1.6 Nucleic Acid Sample Preparation
1.7 Trends in NA-Based Oncology Diagnostics
1.7.1 Emerging Markers
1.7.2 CE approval
1.8 NAT - application and technical appraisal
1.9 Politics and Reimbursement
1.9.1 Drivers of NAT
1.9.2 Restraints on NAT
1.10 Summary and Conclusions

Part 2 – Germany
2 Current Situation
2.1 Respondent Population Germany
2.2 Nucleic Acid Based Testing
2.3 Genetic Testing - Routine or Research
2.4 HPV Testing
2.5 Oncology Markers
2.5.1 Solid Tumor Marker
2.5.2 Lymphoid Tumor Marker
2.6 Nucleic Acid Sample Preparation
2.7 Trends in Genetics Based Oncology Diagnostics
2.7.1 Emerging Markers
2.7.2 CE certification
2.8 NAT - application and technical appraisal
2.9 Politics and Reimbursement
2.9.1 Drivers of NAT
2.9.2 Restraints on NAT
2.10 Summary and Conclusions

Part 3 – Italy
3 Current Situation
3.1 Respondent Population – Italy
3.2 Nucleic Acid Based Testing
3.2.1 Types of testing performed
3.3 Genetic Testing - Routine or Research
3.4 HPV Testing
3.5 Oncology Markers
3.5.1 Solid Tumor Marker
3.5.2 Lymphoid Tumor Marker
3.6 Nucleic Acid Sample Preparation
3.7 Trends in NA-Based Oncology Diagnostics
3.7.1 Emerging Markers
3.7.2 CE or FDA approval
3.8 NAT - application and technical appraisal
3.9 Politics and Reimbursement
3.9.1 Drivers of NAT
3.9.2 Restraints on NAT
3.10 Summary and Conclusions

Part 4 – United Kingdom
4 Current Situation
4.1 Respondent Population UK
4.2 Nucleic Acid Based Testing
4.3 Genetic Testing - Routine or Research
4.4 HPV Testing
4.5 Oncology Markers
4.5.1 Solid Tumor Marker
4.5.2 Lymphoid Tumor Marker
4.6 Nucleic Acid Sample Preparation
4.7 Trends in NA-Based Oncology Diagnostics
4.7.2 Emerging Markers
4.7.3 CE certification
4.8 NAT - application and technical appraisal
4.9 Politics and Reimbursement
4.9.1 Drivers of NAT
4.9.2 Restraints on NAT
4.10 Summary and Conclusions

Part 5 – USA
5 Current Situation
5.1 Respondent Population US
5.2 Nucleic Acid Based Testing
5.2.1 Types of testing performed
5.3 Genetic Testing - Routine or Research
5.4 HPV Testing
5.5 Oncology Markers
5.5.1 Solid Tumor Marker
5.5.2 Lymphoid Tumor Marker
5.6 Nucleic Acid Sample Preparation
5.7 Trends in NA-Based Oncology Diagnostics
5.7.1 Emerging Marker
5.7.2 Test Certification
5.8 NAT - application and technical appraisal
5.9 Politics and Reimbursement
5.9.1 Drivers of NAT
5.9.2 Restraints on NAT
5.10 Summary and Conclusions


Methodology Interview numbers were selected to ensure an accurate representation of the country laboratory structures, which vary widely and are described within the report. The study focuses on institutions that have a specialization in Oncology and Molecular Diagnostics. There is no differentiation between public and private laboratories; however, where differences, relevant for the analysis were found to be obvious, these are highlighted. Target respondents were Heads of Departments or senior personnel able to provide sufficient qualitative answers based upon their experience within the clinical diagnostic laboratory setting. The information gathering was carried out blind. To support the primary data the author utilised a combination of internal and external secondary data to provide further input to the overall analysis. To allow an interpretation for the whole market segment, the findings from primary research were projected onto the base population (laboratories performing nucleic acid based testing in oncology) which was determined by the first level of primary research in the form of snapshot interviews. Interviews were conducted with respondents within at least 16 laboratories per country.


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