Personalized Medicine, Targeted Therapeutics and Companion Diagnostic Market to 2025 - Strategic Analysis of Industry Trends, Technologies, Participants, and Environment

Table of Contents

1.0 Executive Summary
1.1 Objectives of Report  
1.2 Scope of Study
1.3 Data Sources and Methodology
1.4 Key Findings and Observations
1.4.1 Summary
1.4.2 New Therapies and Companion Diagnostics Launched
1.4.3 Public and Private Funding for Personalized Medical Research
1.4.4 Personalized Medicine Market Forecast
1.4.5 Personalized Medicine Oncology Therapeutics & Diagnostics Market
1.4.6 Personalized Medicine Cardiovascular Therapeutics Market
1.4.7 Personalized Medicine Infection Disease Market
1.4.8 Personalized Medicine Geographical Market Share Analysis
1.4.9 Profit Margin Analysis on Major Players
1.4.10 Future of Personalized Medicine

2.0 Introduction to Precision/Personalized Medicine
2.1 Genetics Basis of Personalized Medicine
2.1.1 Why is the Central Dogma of Molecular Biology Important in Personalized Medicine?
2.1.2 Genetic Mutations Explained  
2.1.3 What is the Difference between Genotype and Phenotype?  
2.1.4 Why do we Need to Look at Genetic Diversity with Respect to Personalized Medicine?
2.2  Introduction to Personalized Medicine
2.3 Pharmacogenetics
2.4 How Personalized Medicine Monitoring can Reduce Adverse Drug Reactions
2.5 Pharmacogenetic Study Challenges   
2.6 Pharmacogenomics  
2.7 Applications of Pharmacogenomics  
2.7.1 Pharmacogenomics: Improving the Safety of Medications  
2.7.1.1 Adverse Drug Reactions
2.7.1.2 Pharmacogenomics: Improving the Efficacy of Therapeutics
2.7.2 Vioxx Disaster Could have been Prevented with Personalized Medicine
2.8 Pharmacogenetic Analysis
2.8.1 Single Base Primer Extension  
2.8.2 Primer Based Base Extension  
2.8.3 Hybridization Based SNP Analysis
2.8.4 Ligation Based Approach
2.8.5 New-Generation Sequencing Technologies  
2.8.6 Ultra-High Throughput Sequencing  
2.9 Companion Diagnostics
2.9.1 Introduction 
2.9.2 Companion Diagnostics in Clinical Trials
2.9.3 Companion Diagnostic Deals
2.10 Selected Personalized Medicine Drugs by Biomarker and Indication  
2.11 Selected Personalized Medicine Test/Kit According to Therapeutic and Indication
2.12  Targeted Cancer Therapy
2.13 What Percentage of Cancer Patients Could be Treated by Targeted Therapy?
2.14 Liquid Biopsies  
2.14.1 CANCER-ID Project  
2.14.2 Challenges for Liquid Biopsies
2.15 Tumor Genetic Heterogeneity  
2.15.1 Introduction  
2.15.2 Clonal Evolution – How Phylogenetic Analysis is Aiding Personalized Medicine
2.15.3 Therapeutic Resistance
2.15.4 Tumor Immunogenicity
2.15.5 Tumor Neo-Antigen Production
2.15.6 Sampling Tumor Heterogeneity with Liquid Biopsies  
2.15.7 How Does Tumor Heterogeneity Impact Personalized Medicine?  
2.15.8 Summary
2.16 How Next Generation Functional Diagnostics is Helping Personalized Medicine

3.0 Personalized Medicine Targeted Therapeutics and Associated Companion Diagnostics  
3.1 CYP2C9 and VKORC1 mutations and Warfarin Response
3.2 HLA-B*5701 and Abacavir Response  
3.3 KRAS Mutations
3.3.1 Erbitux  
3.3.2 Vectibix
3.4 Herceptin® and Breast Cancer
3.5 BRACAnalysis®
3.5.1 Comprehensive BRACAnalysis®
3.5.2 BRACAnalysis® Rearrangement Test (BART)
3.5.3 Single Site BRACAnalysis®  
3.5.4 Multisite 3 BRACAnalysis®  
3.6 Oncotype Dx Test
3.7 Therascreen® EGFR RGQ PCR Kit  
3.8 Therascreen KRAS RGQ PCR System  
3.9 Therascreen® IDH1/2 test  
3.10 THxID™ -BRAF Kit
3.11 Cobas® EGFR Mutation Test (Roche)
3.12 Prolaris Prostate Cancer Test  
3.13 ALK and Non-Small Cell Lung Cancer  
3.13.1 ALK-Fusion Testing  
3.13.2 VYSIS ALK Break Apart FISH Probe Kit
3.13.3 VENTANA ALK (D5F3) CDx Assay
3.13.4 ResponseDx: Lung™  
3.13.5 FoundationOne CDx
3.13.6 Oncomine DX Target Test

4.0 Personalized Medicine and Integration into the Healthcare System
4.1 The Personalized Medicine Coalition  
4.2 Personalized Medicine and the Healthcare System  
4.3 Clinical Application of Personalized Medicine  
4.4 Clinical Laboratory Improvement Amendments-Certified Laboratory of Genomic Pathology

5.0 Private and Public Funding and Personalized Medicine Reimbursement
5.1 International Research and Development Personalized Medicine Activity  
5.1.1 Publically Funded Personalized Medicine Research  
5.1.2 Privately Funded Personalized Medicine Research  
5.2 Popular Biological Targets/Pathways in Pharmacogenetic/Pharmacogenomic Research
5.3 Equitable Payer Reimbursement
5.3.1 Molecular Diagnostic Payments in Personalized Medicine  
5.3.1.1 RVU-CPT-ICD Coding System  
5.3.2 Laboratory Service Payments in Personalized Medicine
5.3.3 Revisions to Current Payment System
5.4 Biorepositories and Biobanks  
5.5 Intellectual Property and Personalized Medicine

6.0 European Personalized Medicine Market - Payments and Investment
6.1 Personalized Medicine and The European Market  
6.2 European Investment in Personalized Medicine
6.3 Overview of Reimbursement Policies in Europe
6.4 Gaining Market Penetration in the EU
6.5 Personalized (Stratified) Medicine Regulation and Reimbursement in the UK
6.5.1 Precision Medicine Catapult  
6.6 CE-marked Personalized Medicine/Diagnostic Tests in the UK
6.7 Personalized Medicine Regulation in Germany
6.8 Personalized Medicine Regulation in France  
6.8.1 R&D UNICANCER France
6.9 Personalized Medicine Regulation in Spain  
6.10 The Personalized Medicine Regulation in Italy
6.11 Challenges of Future Personalized Medicine Development in Europe

7.0 Personalized Medicine - Business Model Analysis
7.1 New Business Model Required for Personalized Medicine  
7.2 Business Model Strategies for Diagnostic, Pharmaceutical and Biotechnology Companies
7.3 Business Model Strategies for Providers, Provider Systems and Academic Medical Centres
7.4 Business Model Strategies for Payers
7.5 Business Model Strategies for Governments
7.6 Introduction of Non-Health Companies to the Personalized Medicine Market
7.7 Change to the Big Pharma Business Model  
7.8 Cost-effectiveness and Business Value of Personalized Medicine  
7.9 Comparative Effectiveness Research in Personalized Medicine  
7.10 Reimbursement, Coverage and Payment Policy

8.0 Personalized Medicine Main Industry Players
8.1 23andMe
8.1.1 Key Products  
8.2 Abbott Laboratories  
8.2.1 Abbott Molecular Inc.  
8.3 Admera Health (GENEWIZ)  
8.3.1 Products and Kits
8.3.2 PGxOne
8.3.3 OncoGxOne  
8.3.4 OncoGxOne Plus  
8.3.5 FloraCheck
8.3.6 EGFR & KRAS Clinical Sequencing
8.3.7 LiquidGx
8.3.8 AtheroGxOne
8.3.9 CardioGxOne  
8.4 Agena Biosciences (Sequenom)
8.4.1 MassARRAY System  
8.4.2 Acquisition of Sequenom’s Bioscience Business by Agena Biosciences
8.5 Affymetrix  
8.5.1 Products and Kits
8.6 Agendia
8.7 Alere  
8.8 Amgen Inc.  
8.8.1 Vectibix (panitumumab)
8.8.2 Blinatumomab (Blincyto)
8.8.3 Rilotumumab  
8.9 Astex Pharmaceuticals
8.9.1 Products and Kits
8.10 AstraZeneca  
8.10.1 Iressa  
8.10.2 Tagrisso AZD9291 (Osimertinib)
8.10.3 Lynparza (Olaparib)
8.10.4 Infinzi (Durvalumab)  
8.11 Atossa Genetics
8.11.1 Mammary Aspirate Specimen Cytology Test (MASCT™)
8.11.2 ForeCYTE Breast Health Test (SM)  
8.11.3 ArgusCYTE Breast Health Test(SM)  
8.11.4 FullCYTE Breast Health Test  
8.12 Becton Dickinson
8.12.1 Key Products  
8.13 BioMerieux
8.13.1 Key Products  
8.14 BioRad  
8.15 Bristol-Myers Squibb  
8.15.1 Erbitux (cetuximab)  
8.15.2 OPDIVO (nivolumab)  
8.15.3 Yervoy (ipilimumab)  
8.16 Cancer Genetics
8.16.1 Key Products  
8.17 Celera Corporation (Quest Diagnostics)
8.17.1 ViroSeq ® HIV-1 Genotyping System  
8.17.2 ViroSeq ® HIV-1 Integrase Assay
8.17.3 ViroSeq ® HCV Assay  
8.17.4 ViroSeq ® HBV Assay  
8.17.5 Cystic Fibrosis Genotyping Assay
8.17.6 LDL-S3GGE ® Test
8.17.7 HDL-S10GGE ® Test
8.17.8 KIF6-StatinCheck TM Genotype Test  
8.17.9   LPA-AspirinCheck TM Genotype Test
8.17.10 9p21-EarlyMICheck TM Genotype Test  
8.17.11 AlleleSEQR® HLA PCR/Sequencing Kits
8.17.12 m2000® RealTime PCR System
8.17.13 CEGA -16™ Instrument
8.18 Celldex Therapeutics  
8.19 Cephid
8.20 Claritas Genomics
8.20.1 Products and Kits
8.20.2 ClariFocus Exome for Pediatric Neurology  
8.21 CuraGen
8.22 deCode Genetics (Amgen)  
8.22.1 deCodeT2 Genetic Test
8.22.2 deCODE Breast Cancer™  
8.22.3 deCODE Prostate Cancer™  
8.22.4 deCODE AF™  
8.22.5 deCODE Glaucoma™  
8.22.6 deCODE MI™  
8.22.7 deCODE Complete™  
8.22.8 deCODE Cancer™
8.22.9 deCODE Cardio™
8.22.10 deCODE Services
8.23 EDP Biotech  
8.24 ELDA BioTech  
8.25 Eisai  
8.26 Foundation Medicine  
8.26.1 FoundationOne
8.26.2 FoundationOne Heme
8.26.3 FoundationOne Liquid  
8.27 HalioDx
8.28 Human Longevity Inc (Cypher Genomics)  
8.29 Ikonisys
8.30 Illumina
8.30.1 Illumina HiSeq 2000/1000
8.30.2 Genome Analyzer IIx  
8.30.3 Illumina MiSeq  
8.30.4 Illumina HiScanHQ
8.30.5 Illumina HiScan and iScan Array
8.31  Intergenetics  
8.32 Genelex
8.32.1 You Script™  
8.33 Johnson & Johnson (Janssen)
8.34 LabCorp (Covance)  
8.34.1 Covance and M2Gen Partnership
8.35 Integrated Oncology  
8.35.1 Main Products  
8.36 Merck & Co  
8.36.1 Main Products  
8.37 MDx Health  
8.38 MolecularMD Corporation
8.39 Monogram Biosciences
8.40 Myriad   
8.40.1 Key Products  
8.40.2 COLARIS®/COLARIS AP®  
8.40.3 MELARIS®
8.40.4 PANEXIA®
8.40.5 OnDose®
8.40.6 PREZEON™  
8.40.7 THERAGUIDE® 5FU  
8.40.8 Prolaris®
8.41 Nanostring Technologies
8.42 Nodality
8.42.1 Products and Kits
8.43 Novartis
8.43.1 Novartis Molecular Diagnostics
8.43.2 Novartis Oncology
8.44 Orion Genomics
8.45 Oxford BioTherapeutics
8.46 Pfizer  
8.46.1 Pfizer Merger with Allergan  
8.46.2 Pfizers Oncology Strategy
8.46.3 Pfizer’s Personalized Healthcare Strategy
8.47 Qiagen  
8.47.1 Key Products  
8.47.2 Genotyping Products  
8.47.3 QIAsymphony Platform
8.48 Roche  
8.49 Roche Diagnostics
8.49.1 Roche Acquisition of Ventana Medical Systems  
8.49.2 Roche’s Personalized Medicine Strategy
8.49.3 Avastin (Bevacizumab)
8.49.4 Herceptin (Trastuzumab)
8.49.5 Kadcyla (Trastuzumabum emtansinum)
8.49.6 Perjeta (Pertuzumab)  
8.49.7 MabThera/Rituximab
8.49.8 Tarceva
8.50 Sanofi  
8.50.1 Sanofi’s Personalized Medicine Strategy
8.51 Siemens Healthcare  
8.51.1 Companion Diagnostic Development at the Siemens Clinical Laboratory (SCL)
8.52 Takeda  
8.52.1 Takeda’s to Discover Therapeutic Targets in the Microbiome
8.52.2 Millennium: The Takeda Oncology Company  
8.53 Thermo Fisher Scientific
8.53.1 ThermoFisher’s Personalized Healthcare Strategy  
8.53.2 ThermoFisher’s Involvement in the NCI-MATCH Trial
8.54 Transgenomic  
8.55 Vertex Pharmaceuticals
8.55.1 Orkambi (lumacaftor/ivacaftor)
8.55.2 Kalydeco (ivacaftor)
8.55.3 Symdeko/Symkevi

9.0 Personalized Medicine Market Analysis  
9.1 Companion Diagnostic and Targeted Therapeutic Market   
9.1.1 Global Oncology Therapeutic Market  
9.1.2 Targeted Therapeutics - Oncology  
9.1.3 Top Companies in Oncology Drug Sales to 2025
9.1.4 Top Oncology Drugs to 2025  
9.1.5 Global Oncology Market by Cancer Type
9.1.6 Oncology Targeted Therapeutics Market Analysis to 2025  
9.1.7 Companion Diagnostic Assays - Oncology Market to 2025  
9.2 Cardiovascular Targeted Therapeutics Market to 2025
9.2.1 Cardiovascular Companion Diagnostics Market to 2025
9.3 Infectious Disease Targeted Therapeutics Market to 2025  
9.3.1 Infectious Disease Diagnostic Assay Market to 2025  
9.4 Global Personalized Medicine Market Geographical Analysis to 2025
9.5 Major Player Profit Margin Analysis  
9.6 Select Market Participant Case Study Analysis
9.6.1 Affymetrix  
9.6.2 Astex Pharmaceuticals
9.6.3 Quest Diagnostics
9.6.4 Celldex Therapeutics  
9.6.5 deCode Genetics (Amgen)
9.6.6 Illumina
9.6.7 Genelex
9.6.8 Myriad   
9.6.9 Qiagen  
9.6.10 bioMerieux

10.0 Strengths and Advantages of Personalized Medicine  
10.1 Sequencing of the Human Genome   
10.2 Improving Patient Care and Reducing Side Effects  
10.3 Personalized Medicine will Reduce Healthcare Costs  
10.4 FDA and Global Regulatory Advances  
10.5 Advancing Technologies
10.5.1 Next Generation Sequencing  
10.6 Industry Investing in Pharmacogenomics
10.7 Consumer Genomics and POC Market
10.8 Oncology a Driving Force of Personalized Medicine  

11.0 Restraints of the Personalized Medicine Market
11.1 Lack of Sufficient Regulation  
11.2 Lack of Sufficient Genotypic Linkage Studies to Disease Phenotype  
11.3 Reimbursement Issues

12.0 Personalized Medicine and Regulatory Policies
12.1 Regulation by the Centres for Medicare and Medicaid Services (CMS) and US Food and Drug Administration (FDA)  
12.2 Genetic Information Non-discrimination Act (GINA)  
12.3 FDA Advancements on Genetic Testing Approval
12.4 FDA - New Models to Assess Gene Therapy Safety  
12.5 FDA - Companion Diagnostics  
12.6 FDA - Partnership in Applied Comparative Effectiveness Science (PACES) Initiative
12.7 National Institutes of Health Genetic Testing Registry

13.0 Final Summary and Future Perspectives
13.1 Re-cap of Personalized Medicine  

14.0 Interviews with Key Opinion Leaders  

• Iain D. Miller, PhD, MBA, Founder & CEO, Healthcare Strategies Group
• Stephen Finn, MBBS, PhD, Associate Professor, Cancer Molecular Diagnostic Laboratory, Consultant Histopathologist and Head of Histopathology, St James’s Hospital and Trinity College Dublin, Ireland
• Ronald Przygodzki, MD, Director, Genomic Medicine Implementation at U.S. Dept Veterans Affairs, Washington DC
• Elaine Kenny, PhD, Founder, Elda Biotech, Dublin, Ireland
• Chad Clark, Co-President and Chief Operating Officer, Precision for Medicine
• Tobias Guennel, PhD, Principal, Biomarker and IVD Analytics, Precision for Medicine
• David Parker, PhD, Vice President, Integrated Market Access, Precision for Medicine
• Deborah Phippard, PhD, Vice President, Research, Precision for Medicine
• Judi Smith, MS, Vice President, In Vitro Diagnostics Regulatory and Quality, Precision for Medicine

List of Tables
Table 2.1: Glossary: Common Terms Used in Genetics and Personalized Medicine
Table 2.2: Types of Genetic Markers used as Biomarkers in Personalized Medicine
Table 2.3: Genetic Disease Associated with the Ashkenazi Jew Population
Table 2.4: Disease Types Associated with Specific Populations  
Table 2.5: Personalized Medicine  
Table 2.6: Genetic Mutations that Predispose Individuals to Disease  
Table 2.7: Potential Applications of Pharmacogenetics/genomics in Personalized Medicine
Table 2.8: Main Cytochrome P450 Enzymes Involved in Drug Metabolism
Table 2.9: Rapid & Slow Metabolizer Phenotypes  
Table 2.10: Population Frequency of Cytochrome P450(CYP) 2C19 Metabolizer Types
Table 2.11 Population Frequency of Cytochrome P450 (CYP) Metabolizer Types
Table 2.12 Depression Medications Affected by Genetic Mutations
Table 2.13 Cardiovascular Medications Affected by Genetic Mutations  
Table 2.14: Cancer Medications that may be Affected by Genetic Mutations
Table 2.15: Diabetes Medications Affected by Genetic Mutations  
Table 2.16: Anti-Epileptic Drugs Affected by Genetic Mutations  
Table 2.17: Anti-Retroviral Drugs Affected by Genetic Mutations  
Table 2.18: Anti-Reflux/Ulcer Drugs Affected by Genetic Mutations
Table 2.19: List of Therapeutics According to Cytochrome P450 Subtype Metabolism
Table 2.20: Cytochrome (CYP) P450 Drug-Interactions Inhibitor List
Table 2.21: Cytochrome (CYP) P450 Drug-Interactions Inducer List
Table 2.22: Main Aims of Pharmacogenomics
Table 2.23: How Pharmacogenomics has Influenced the Top Ten Selling Drugs Globally
Table 2.24: Advantages, Disadvantages and Cost of Popular Genotyping Methods
Table 2.25: Top Ten Pharmacogenomics Tests  
Table 2.26: FDA Accepted Pharmacogenomic Biomarkers  
Table 2.27: Benefits of Single Base Primer Extension in Pharmacogenetics
Table 2.28: Future Applications of Ultra-High Throughput Sequencing  
Table 2.29: Comparison of Genotyping Techniques
Table 2.30: Problems associated with Microarray Sequencing  
Table 2.31: Top Ten Genetic Findings by 23andMe
Table 2.32: Selected EMA Approved Drugs that Require Companion Diagnostics
Table 2.33: Selected FDA Approved Drugs that Require Companion Diagnostics   
Table 2.34: FDA Companion Diagnostics Device List: In Vitro and Imaging Tools
Table 2.35: Important Strategies for a Successful Companion Diagnostic Launch
Table 2.36: Selected Personalized Medicine Drugs by Biomarker and Indication  
Table 2.37: Selected Personalized Medicine Test/Kit According to Therapeutic and Indication
Table 2.38: Targeted Cancer Therapeutics by Tumor Type, Target & Detection Method Available
Table 2.39: FDA Approved Targeted Therapies and Approved Indications for Solid Tumors
Table 2.40: List of all Academic and Industry Partners of CANCER-ID Consortium
Table 2.41: Scientific Advisory Board Members of CANCER-ID  
Table 2.42: Details of Tumor Heterogeneity- Intratumor, Interpatient, Inter/intrametastatic
Table 2.43: Polyclonal Genetic Mechanisms of Therapy Resistance by Tumor Type and Study
Table 3.1 Predicted Warfarin Concentrations depending on CYP2C9 and VKORC1 Genotype
Table 3.2 Top Five Most Frequent Cancers in Men and Women, Globally  
Table 3.3 Estimated Age-Standardised Incidence Rate of Breast Cancer per Country, Worldwide
Table 3.4 Types of Diagnostic Tests Available to Determine HER2 Status in Breast Cancer Patients
Table 3.5 Validated HER2 Tests for Cancer
Table 3.6: Advantages and limitations of IHC HER2 testing applied to breast cancer
Table 3.7: In-SituHybridization Determination HER2 Expression: PathVysion® and HER2 FISH pharmDx  
Table 3.8: HER2 CISH Determination
Table 3.9: Validated FISH Kits for HER2 Testing in Breast Cancer
Table 3.10: Validated SISH Kits for HER2 Testing in Breast Cancer
Table 3.11: Validated CISH Kits for HER2 Testing in Breast Cancer
Table 3.12: Advantages and limitations of ISH techniques applied to HER2 testing in breast cancer
Table 3.13: Prevalence of Deleterious Mutations in BRCA1 and BRCA2 Genes  
Table 3.14: Prevalence of Deleterious Mutations in BRCA1 and BRCA2 in Individuals of Ashkenazi Ancestry    
Table 3.15: Risk Factors for Hereditary Breast  and Ovarian Cancer (HBOC)
Table 3.17: BRACAnalysis® Panel of Assays
Table 3.18: The Prolaris Score for Prostate Cancer  
Table 4.1: Objectives of the Personalized Medicine Coalition  
Table 4.2: Current Personalized Medicine Coalition Members  
Table 4.3: Genetic Variants used in the care of melanoma, gastrointestinal stromal tumors, non-small-cell lung cancer, thymic cancer and breast and ovarian cancers.
Table 4.4: Minimum Definition of a clinically Actionable Variant
Table 4.5: Minimum Criteria for Whole Genome Analysis in Clinical Laboratory Improvement Amendments Laboratory of Genomic Pathology, Clinical Whole Genome Analysis
Table 5.1: Public Funding Bodies for Pharmacogenetic/Pharmacogenomic Research
Table 5.2: American Companies Involved in Pharmacogenomics/genetics Drug Development & Diagnostics  
Table 5.3: European Companies Involved in Pharmacogenomics/genetics Drug Development & Diagnostics  
Table 5.4: North American Companies Involved in Pharmacogenomics/genetics Services
Table 5.5: European/Other Companies Involved in Pharmacogenomics/genetics Services
Table 5.6:American Companies Involved in Pharmacogenomics/genetics Tools Kits & Software
Table 5.7: European Companies Involved in Pharmacogenomics/genetics Tools Kits & Software
Table 5.8: North American Companies with Minor interest in Pharmacogenomics/genetics
Table 5.9: European/Other Companies with Minor interest in Pharmacogenomics/genetics
Table 5.10: North American Companies with Minor interest in Pharmacogenomics/genetics
Table 5.11: European/Other Companies with Minor interest in Pharmacogenomics/genetics
Table 5.12: Large US Companies with Investment into Pharmacogenomics/genetics
Table 5.13: Large European Companies with Investment into Pharmacogenomics/genetics
Table 5.14: Large Japanese Companies with Investment into Pharmacogenomics/genetics
Table 5.15: Top Ten Biological Areas of Interest in Pharmacogenetics/genomics
Table 5.16: Top International Pharmacogenetic/Pharmacogenomic Research Institutions
Table 5.17: Top European Pharmacogenetic/Pharmacogenomic Research Institutions  
Table 6.1: Variation of Reimbursement Policies for HER2 & KRAS Testing in Europe
Table 6.2: Pharma Providing Subsidization of Personalized Medicine Tests in Europe
Table 6.3: Challenges Within Personalized Medicine Market in Europe  
Table 6.4: Function of the European network for Health Technology Assessment Organisation
Table 6.5: European network for Health Technology Assessment (EUnetHTA) Partners
Table 6.6: European network for Health Technology Assessment (EUnetHTA) Associates
Table 6.7: Diagnostics Guidance Assessment by the National Institute Health Clinical Excellence
Table 6.8: Current Diagnostics Guidance in Development by the Diagnostics Access Program, UK
Table 6.9: Published Diagnostics Guidance by the Diagnostics Access Program, UK
Table 6.10: Medical Technologies Guidance Assessment by NICE
Table 6.11: Published Medical Technologies Guidance by NICE  
Table 6.12: Published Medical Technologies Guidance in Development NICE  
Table 6.13 Precision Medicine Catapult Tools to Aid Market Entry
Table 6.14 Key Challenges to Personalized Medicine   
Table 6.15:  Strategic Objectives of French Comprehensive Cancer Centers within UNICANCER
Table 6.16: Key Challenges to Personalized Medicine   
Table 6.17: Personalized Medicine - Translation into Medical Applications
Table 7.1: Major Market Trends in Personalized Medicine
Table 7.2:  Collaboration Strategies Required between Industry, Payers & Governments
Table 7.3: Business Model Recommendations: Diagnostic, Pharma& Biotech Companies
Table 7.4: Business Model Recommendations: Providers. Provider Systems & Medical Centres
Table 7.5: Business Model Recommendations for Payers
Table 7.6: Business Model Recommendations for Governments  
Table 7.7: Non-Healthcare Companies with Potential to enter the Personalized Medicine Market
Table 7.8: Hurdles of Personalised Medicine with Respect to Cost-Effectiveness
Table 8.1: 23andMe Disease Risk Genetic Test Panel  
Table 8.2: 23andMe Carrier Status Genetic Test Panel  
Table 8.3: 23andMe Drug Response Genetic Marker Test Panel  
Table 8.4: 23andMe Genetic Traits Test Panel  
Table 8.5: Admera Health Commercial Drug List that are Covered by the PGxOne Assay
Table 8.6: Admera Health PGxOne Gene & Variant List, Therapeutic Area & Endorsing Agency
Table 8.7: Patent Listing of Affymetrix Array technology
Table 8.8: Patent Listing of Affymetrix Genotyping Technology  
Table 8.9: Patent Listing of Affymetrix Expression and Profiling Technology  
Table 8.10: Product Overview of Affymetrix
Table 8.11: Microarray Products by Affymetrix  
Table 8.12: Affymetrix Research Services Laboratory (ARSL) Premier Services  
Table 8.13: Genetic Applications of Axiom® Technology by Affymetrix  
Table 8.14: Amgen’s Oncology Phase III Product Pipeline
Table 8.15: Selected Programs in Pivotal Trial (Phase III) or Development, Amgen
Table 8.16 Advantages of Astex Pharmaceuticals Pyramid™ Fragment-Drug-Discovery System  
Table 8.17: Astex Pharmaceuticals Pipeline Portfolio  
Table 8.18: Astex Pharmaceuticals Pipeline Portfolio Funded Completely by Partner Companies
Table 8.19: Range of Small Molecule Therapeutics Available from Astex Pharmaceuticals
Table 8.20: Biomarkers by Cancer Type Offered by bioMerieux  
Table 8.21: Cancer Genetics Product Portfolio Flow Cytometry Based Assays  
Table 8.22: Cancer Genetics Product Portfolio FISH Based Assays
Table 8.23: Cancer Genetics Product Portfolio Molecular Diagnostics Based Assays
Table 8.24: Cancer Genetics Product Portfolio Complete™ Test Program
Table 8.25: Select One Clinical Trial Services
Table 8.26: Panel of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Mutations Screened for in Celera Cystic Fibrosis Genotyping Assay
Table 8.27: Genetic Tests Available from BHL/Celera
Table 8.28: Panel of BHL Clinical Diagnostic Tests
Table 8.29: Features of the m2000® RealTime PCR System by Celera   
Table 8.30: Potential Business Partnerships of Celldex Therapeutics
Table 8.31: Cephid Product Portfolio in the US  
Table 8.32: Cephid Product Portfolio Internationally
Table 8.33: Claritas Genomics Genetic Test Portfolio, by Gene  
Table 8.34: Genetic Diagnostic Tests Available from deCode Genetics  
Table 8.35: Type 2 Diabetes risk range and distribution according to continental ancestry as Determined by deCodeT2 Genetic Test  
Table 8.36: Genetic Mutations Identified by the deCODE MI™ Test in a European Population
Table 8.37: Genetic Mutations Identified by the deCODE MI™ Test in an East Asian Population
Table 8.38: Disease State Included in the deCODE Complete™ Genetic Screen  
Table 8.39: Panel of Diseases Screened for in the deCODE Cancer™ Test
Table 8.40: Panel of Cardiovascular Diseases in the deCODE Cardio™ Test
Table 8.41: deCODE Genetics Genotyping and Sequencing Service
Table 8.42: deCODE Genetics Data Management, Protection and Storage Service
Table 8.43: deCODE Genetics Sequence Inputation and Data Analysis Service  
Table 8.44: FoundationOne Current Gene List
Table 8.45: FoundationOne Heme Gene List
Table 8.46: Foundation Medicine Company-Sponsored Clinical Trials   
Table 8.47: Illumina Core Technologies  
Table 8.48: Illumina Core Technology Applications
Table 8.49: Illumina Instrument Product Portfolio
Table 8.50: Illumina Assay Product Portfolio
Table 8.51: Illumina HiSeq 2500/1500  Performance Parameters
Table 8.52: Illumina HiSeq 2000/1000 Performance Parameters  
Table 8.53: Genome Analyzer IIx Performance Parameters
Table 8.54: Illumina MiSeq Product Specifications  
Table 8.55: Illumina HiScanHQ Product Specifications  
Table 8.56: Illumina HiScan and iScan Array Product Applications
Table 8.57: Illumina HiScan and iScan Array Kits  
Table 8.58: Clinical Applications of Diagnostic Tests Offered by Intergenetics  
Table 8.59: Genetic Test Panel Available from Genelex for Research Institutions and Clinical Trials
Table 8.60: Panel of Genetic Screens Available from Genelex  
Table 8.61: Drug Sensitivity Screens Available from Genelex
Table 8.62: Integrated Oncology Cancer Test Portfolio  
Table 8.63: Biopharma Merck’s Key Product Range
Table 8.64: Molecular MD Biomarker Assays by Platform and Method Used
Table 8.65: MolecularMD Test Panels by Next Generation Sequencing, Molecular Targeted Therapy Management and Pathway Analysis  
Table 8.66: MolecularMD Companion Diagnostic Development Capabilities
Table 8.67: Monogram Biosciences  HIV Genotypic and Phenotypic Test Portfolio
Table 8.68: Predictive Genetic Tests Available from Myriad  
Table 8.69: Services offered with BRACAnalysis® Testing from Myriad  
Table 8.70: Advantages of BRACAnalysis® Testing
Table 8.71: COLARIS® Test Range by Myriad
Table 8.72: COLARIS AP® Test Range by Myriad  
Table 8.73: MELARIS® Test Range from Myriad  
Table 8.74: Personalized Medicine Tests from Myriad
Table 8.75: OnDose® Testing Procedure from Myriad  
Table 8.76: Nanostring Technologies nCounter Workflow Platform Product Portfolio
Table 8.77: Pre-Clinical, Clinical and Commercial Applications of SCNP by Nodality
Table 8.78: Novartis Oncology Key Personalized Medicine Drug Targets  
Table 8.79: Orion Genomics Collaboration and Commercial Agreements  
Table 8.80: Oxford BioTherapeutics Main Technologies in Cancer Targeting
Table 8.81: Oxford BioTherapeutics Product Pipeline Portfolio by Development Stage
Table 8.82: Pfizer Key Branded Products   
Table 8.83: Pfizer Oncology Targets and Technologies  
Table 8.84: Pfizer Early Stage Pipeline Oncology Portfolio
Table 8.85: Qiagen Timeline of Events – Oncology and Precision Medicine
Table 8.86 Range of Product Groups from Qiagen
Table 8.87: Qiagen Genotyping Products for Sample Collection, stabilization and Storage
Table 8.88: Qiagen Genotyping Products for Genomic DNA Isolation and Purification
Table 8.89: Qiagen Genotyping Products for PCR Based Genotyping Analysis  
Table 8.90: Qiagen Products for Genotyping Analysis
Table 8.91: Qiagen Genotyping Products for PCR Detection
Table 8.92: Qiagen Assays for Genetic Analysis  
Table 8.93: Qiagen Pyrosequencing-Based Genetic Analysis Products  
Table 8.94: Specifications and Features of Qiagen’s QIAsymphony and QIAsymphony RGQ
Table 8.95: Roches Personalized Medicine Products by Patient Stage   
Table 8.96: ThermoFisher Scientific Clinical Assays and Technologies for Personalized Healthcare
Table 8.97: Transgenomic Technology Platforms  
Table 8.98: Transgenomic Partnerships and Collaborations
Table 9.1: Global Market for Oncology Drugs by Geography/Country, Through 2025   
Table 9.2: Top Ten Companies in Oncology Sales Forecast 2017 – 2025
Table 9.3: Top Oncology Drugs, Through 2025  
Table 9.4:  Submarkets within the Personalized Medicine Technology Market  
Table 9.5: Global Market for Liquid Biopsy by Region (North America, Europe, RoW)
Table 9.6: Operating Profit Margin Analysis for Selected Players in the PM Industry
Table 9.7: Personalized Medicine Industry Segments and Companies Analysed
Table 9.8: Acquisition Profile of Affymetrix
Table 9.9: Genetic Applications of Axiom® Technology by Affymetrix  
Table 9.10: Diversified Business Units of Affymetrix
Table 9.11: Affymetrix AgBio Microarray Portfolio  
Table 9.12: Genelex Individual Gene Panel
Table 9.13: Myriad - Core Business Decisions and Impact on Industry   
Table 9.14: Current Test Portfolio of Myriad
Table 9.15: BioMerieux Immunodiagnostic Product Portfolio
Table 9.16: BioMerieux Microbiology Product Portfolio  
Table 9.17: BioMerieux Molecular Diagnostic Product Portfolio  
Table 10.1: Strengths and Advantages of Genotyping Techniques
Table 10.2: Strengths, Drivers and Advantages of Personalized Medicine Market
Table 11.1: Restraints of Personalized Medicine Market  
Table 12.1: Summary of Clinical Laboratory Improvement Amendments (CLIA)             
Table 12.2: Clinical Laboratory Improvement Amendments (CLIA) Testing Categories
Table 12.3: Test Features required prior to FDA Approval and Clearance
Table 12.4: Impact of Genetic Information Non-discrimination Act (GINA) on HealthcaCompanies & Health Plans  
Table 12.5: Impact of Genetic Information Non-discrimination Act (GINA) on US Employeremployment agencies, labor organizations and training programs  
Table 12.6: FDA Commitment to the Personalized Medicine Industry  
Table 12.7: Objectives of the ‘Advancing Regulatory Science at FDA: A Strategic Plan’
Table 12.8: FDA Policy & Guidance Recommendations  
Table 12.9: Implementation Strategy of the FDA to Advance Regulatory Science - Developbetter Models of Human Adverse response  
Table 12.10: Implementation Strategy of the FDA to Advance Regulatory Science - Identiand evaluate biomarkers and endpoints that can be used in non-clinical clinical evaluations
Table 12.11: Implementation Strategy of the FDA to Advance Regulatory Science - Use andevelop computational methods and in silico modelling
Table 12.12: National Institutes of Health Genetic Testing Registry Test Information
Table 13.1 Select Targeted Therapeutic  and Companion Diagnostic FDA Drug Approval

List of Figures
Figure 2.1: DNA, Histones and Chromosomes  
Figure 2.2: DNA is Composed of Four Nucleotide Bases  
Figure 2.3: The Central Dogma of Molecular Biology – How DNA Encodes Protein
Figure 2.4: How Research, Technology, Regulation, Clinical Implementation anLegislation Integrates into Personalized Medicine  
Figure 2.5: Identification of Good and Non-Responders in a Patient Population  
Figure 2.6: Pharmacodynamic and Pharmacokinetic Examples of Drug Targets and Drumetabolism in Pharmacogenomics  
Figure 2.7: Flow Diagram of Pharmacogenetic Analysis  
Figure 2.8: Primer Based Base Extension in Pharmacogenetics  
Figure 2.9: Genetic Mutation Detection by Hybridization  
Figure 2.10: Ligation based SNP Detection  
Figure 2.11: New-Generation Sequencing: Pyrosequencing
Figure 2.12: Selected Diagnostics by Drug, Cancer Type and Technology
Figure 2.13: Percentage of Cancer Patients with Genetic Mutations that could be Treated by Targeted Therapy
Figure 2.14: Detection of Cell Free cfDNA in Cancer Patients – Timeline of Events
Figure 2.15: Cell Free Nucleic Acids Present in Blood from Cancer Patients
Figure 2.16: Detection of cfDNA and its Alterations in Different Forms of Cancer
Figure 2.17: CANCER-ID Consortium Global Location of Collaborators  
Figure 2.18: CANCER-ID Consortium Work Package Outline
Figure 2.19: Use of Tumor Educated Blood Platelet mRNA Expression Levels in Liquid Biopsies
Figure 2.20: Types of Tumor Heterogeneity- Intratumor, Interpatient, Inter/intrametastatic
Figure 2.21: Tumor Clonal Evolution as Depicted in a Phylogenetic Tree  
Figure 2.22: Mechanisms of Resistance to Targeted Therapies (Vemurafenib, Crizotinib, EGFR MAbs, EGFR TKIs, Imatinib)  
Figure 2.23: Next Generation Functional Diagnostics in Cancer  
Figure 3.1: Warfarin Metabolism and Response  
Figure 3.2: Percentage Frequency of CYP2C9 and VKORC1 mutations in Caucasian, African-American and Asian Populations
Figure 3.3: Anti-EGFR Therapy and KRAS Mutations
Figure 3.4: KRAS and BRAF Genetic Tests Available from Asuragen
Figure 3.5: Global Incidence and Mortality of Cancer in Women
Figure 3.6: Cancer Deaths in Women, Globally according to Cancer Type
Figure 3.7: Estimated Age-Standardised Incidence Rate per 100,000 of Breast Cancer Globally
Figure 3.8: HER2 Testing Algorithm for Breast Cancer  
Figure 3.9: HER2 Cellular Signalling
Figure 3.10: Herceptin – Mechanism of Action
Figure 3.11: BRCA Mutation Increases the Risk of Breast and Ovarian Cancer   
Figure 3.12: Proactive Cancer Management and Preventative Measures Reduces the Risks of Developing BRCA-associated Breast and Ovarian Cancer  
Figure 3.13: ALK Cellular and Nuclear Signalling Pathway  
Figure 3.14: ALK-Positive Cancers by Fusion Protein, ALK expression & Point Mutations
Figure 4.1: Integration of Multiple components for a Personalized Medicine Healthcare System
Figure 4.2: Workflow Diagram illustrating Clinical Laboratory Improvement Amendments Certified Laboratory of Genomic Pathology
Figure 4.3: Hypothetical Flow Diagram of a Patient & the Genomic Pathology Clinical Laboratory
Figure 5.1: Personalized Medicine Scheme Interaction with Industry, Regulatory Bodies and Funding Agencies  
Figure 5.2: Number of Publically Funded Pharmacogenetic and Pharmacogenomic Research Teams Internationally
Figure 5.3: Collaborative Institutions of Pharmacogenetics
Figure 6.1: Adverse Drug Reactions are the Fourth Leading Cause of Death  
Figure 6.2: Efficacy Rate of Major Disease Types with Standard Treatment
Figure 6.3: The In Vitro Diagnostic Market in Europe   
Figure 6.4: Organization of the European network for Health Technology Assessment (EUnetHTA)
Figure 6.5: Key Differences in Reimbursement Policy Approaches for Oncology Diagnostics and Therapeutics in Europe and the US
Figure 6.6: Flow Diagram of the German Healthcare System and Key Agencies  
Figure 6.7: German Reimbursement Arrangement, Process and Implications  
Figure 6.8: Key Information about UNICANCER France  
Figure 6.9: Strategic Flow Diagram of UNICANCER France and its Operations  
Figure 7.1: Annual Healthcare Expenditure for Major Industrial Nations  
Figure 7.2: Estimated Life Expectancy from Birth for Major Industrialized Countries
Figure 8.1: Flow Diagram of Celera CEGA -16™ Instrument for Cystic Fibrosis Gene Analysis
Figure 8.2:  Celldex Therapeutics Product Pipeline
Figure 8.3: Percentage of Individual Populations who have an Increased Risk of Developing Type 2 Diabetes as Determined Using the deCodeT2 Genetic Test
Figure 8.4: FoundationOne and FoundationOne Heme Platforms
Figure 8.5: Tumor Microenvironment Showing Infiltrating Immune Cells
Figure 8.6: HalioDx ImmunoScore System
Figure 8.7: Human Longevity Inc (Cypher Genomics) Mantis Technology Platform
Figure 8.8: Illumina New Generation Sequencing Technology Workflow Station
Figure 8.9: Monogram Biosciences HIV Assay Porfolio Timeline  
Figure 8.10: Single Cell Network Profiling (SCNP) Technology by Nodality
Figure 8.11: Developed Functional Assays that Nodality has explored using SCNP Technology
Figure 8.12: Sanofi Late Stage Product Pipeline  
Figure 8.13: Sanofi Pipeline Products in Stage I  
Figure 8.14: Sanofi Pipeline Products in Stage II  
Figure 8.15: Takeda Pipeline Portfolio
Figure 8.16: Millenium Takeda Oncology Development Pipeline  
Figure 8.17: Vertex Pharmaceuticals Cystic Fibrosis, Oncology, Pain & Influenza Pipeline Products
Figure 9.1: Personalized Targeted Therapeutic Sales Revenue by Select Companies, All Indications           
Figure 9.2: Personalized Targeted Therapeutic Market, All Indications, 2019-2025
Figure 9.3: Companion Diagnostic and Targeted Therapeutic Personalized Medicine Market Growth 2019-2025
Figure 9.4: Personalized Companion Diagnostic Market 2019-2025
Figure 9.5: Combined Targeted Therapeutic and Companion Diagnostic Market, 20192025
Figure 9.6: Global Market for Oncology Drugs by Geography/Country, Through 2025
Figure 9.7: Global Oncology Companies Revenue, Through 2025
Figure 9.8: Top Oncology Drugs, Through 2025  
Figure 9.9: Global Oncology Market by Cancer Type 2019-2025      
Figure 9.10: Global Personalized Medicine Oncology Therapeutics Forecast 2019-2025
Figure 9.11: HER-2 Positive Breast Cancer Therapeutic Market Forecast to 2025  
Figure 9.12: Personalized Medicine Oncology Therapeutic Market Forecast 2019-2025
Figure 9.13: Personalized Medicine Branded Oncology Therapeutics Market Share 2019
Figure 9.14: Personalized Medicine Branded Oncology Therapeutics Market Share 2025
Figure 9.15: Top Pharma Companies Revenue from Targeted Therapeutics in Oncology
Figure 9.16: Global Cancer Companion Diagnostics Market 2019-2025  
Figure 9.17: Most Popular Proteomic and Genomic Technologies Performed by End-Users
Figure 9.18: Oncogenic Biomarker Share of Total Personalized Medicine Biomarker Space
Figure 9.19: Oncogenic Biomarker Market Distribution by Cancer Type  
Figure 9.20: Personalized Medicine Branded Cardiovascular Therapeutic Market 2019-2025
Figure 9.21: Personalized Medicine Branded Cardiovascular Therapeutics Market Forecast 2019-2025  
Figure 9.22: Cardiovascular Companion Diagnostics Market Forecast 2019-2025  
Figure 9.23: Personalized Medicine Branded Infectious Disease Therapeutics Market 20192025
Figure 9.24: Select Personalized Medicine Infectious Disease Therapeutics Sales Revenue Forecast 2019-2025  
Figure 9.25: HIV and Hepatitis Diagnostic Assay Market Growth 2019 to 2025  
Figure 9.26: Market Share by Geographic Region ($ Billions) 2019-2025  
Figure 9.27: Percentage Geographical Breakdown of Total Personalized Medicine Market 2019 and 2025
Figure 9.28: Average Operating Profit Margin Analysis for Selected Players in the Personalized Medicine Industry  
Figure 9.29: Affymetrix Revenue by Business Segment (Percentage)
Figure 9.30: Affymetrix Revenue From Affymetrix Core and eBioscience (Percentage)
Figure 9.31: Astex Pharmaceuticals Priority Pipeline Products
Figure 9.32: Quest Diagnostics Revenue ($ Billions)  
Figure 9.33: Quest Diagnostics Routine Clinical Test Revenue 2017-2019
Figure 9.34: Quest Diagnostics Gene-Based and Esoteric Test Revenue 2017-2019
Figure 9.35: Quest Diagnostics Anatomic Pathology Test Revenue 2017-2019
Figure 9.36: Illumina Revenue Generated ($ Billions)  
Figure 9.37: Illumina Sequencing Consumables Income Generated ($ Billions)
Figure 9.37: Illumina Microarray Consumables Income Generated ($ Billions)
Figure 9.38: Myriad Revenue Generated   
Figure 9.39: Operating Income Generated by Myriad  
Figure 9.40: Myriad Revenue Generated by Molecular Diagnostic Testing and Pharmaceutical and Clinical (Companion Diagnostic) Services  
Figure 9.41: Myriad Hereditary Cancer Test Revenue
Figure 9.42: Myriad EndoPredict, Polaris, Vectra, Prenatal and GeneSight Revenue
Figure 9.43: Customer Profile of Qiagen – Percentage of Net Sales  
Figure 9.44: Qiagen Global Net Sales  
Figure 9.45: Qiagen Operating Income   
Figure 9.46: Qiagen Global Net Income/Loss  
Figure 10.1: The Future of Personalized Medicine
Figure 10.2: Percentage Oncology (Lung, Colorectal, Breast, Prostate) Patients Undergoing Next Generation Sequencing Testing in the US   
Figure 10.3:  Pipeline and On-market Oncology (Lung, Breast, Colorectal, Prostate)Therapeutics Directed Against Specific Mutations  
Figure 13.1: Personalized Medicine Percentage of FDA Approvals 2014-2019

Samples

• Abbott Laboratories
• Abbott Molecular Inc.
• Admera Health (GENEWIZ)
• Affymetrix
• Agendia
• Alere
• Amgen
• Astex Pharmaceuticals
• AstraZeneca
• Atossa Genetics
• Becton Dickenson
• bioMerieux
• BristolMyersSquibb
• Cancer Genetics
• Celera (Quest Diagnostics)    
• Celldex Therapeutics        
• Claritas Genomics
• CuraGen
• Danaher (Leica Biosystems)
• deCode Genetics (Amgen)
• Foundation Medicine    
• EDP Biotech
• Eli Lilly
• ELDA BioTech
• Eisai
• Genelex
• GlaxoSmithKline
• Human Longevity Inc (Cypher Genomics)
• HalioDx
• Ikonisys
• Illumina
• InterGenetics
• Johnson & Johnson
• LabCorp
• Life Technologies
• Merck
• MDxHealth
• MolecularMD Corporation
• Monogram Biosciences
• Myriad
• Nodality
• Novartis MDx
• Orion Genomics
• Oxford BioTherapeutics
• NanoString Technologies
• Pfizer
• Qiagen
• Roche Molecular Diagnostics
• Sanofi
• SensiGen
• Siemens Healthcare Diagnostics
• Takeda
• Thermo Fisher Scientific
• Transgenomic
• Ventana (Roche)
• Vermillion (Ciphergen)
• Vertex Pharmaceutical

Methodology

Based on Locations in Europe and Asia, the analyst team are all PhD-level experts and industry-experienced professionals. They pool resources, contacts, business acumen, and technical experience to provide cutting edge insights for all of the reports. The senior analysts have at least ten years’ experience in major strategic corporations such as BCC research and TriMarkPublications. The methodologies are clearly defined from the outset. Initially, a number of clear objectives are set, e.g., to identify the market size, segmentation, key players, SWOT analysis, influential technologies, and business and economic environments:

• By Company
• By Geography (US, UK, EU, Asia)
• By Segment
• By Sub-market

Key Strengths, Weaknesses and Threats InfluencingLeading Player Position within the Market

• Technologies Driving the Market
• Top Fastest Growing Market Segments and Emerging Opportunities
• Top Pharmaceutical Companies within the IPM by Market Share and Revenue
• Comprehensive Product Portfolios, R&D Activity, and Pipeline Therapeutics
• M&A Activity and Future Strategies of Top Personalized Medicine Pharmacos

Following this, the analyst determines key financial data & business strategy information to give clients the most accurate information required to identify areas of profitable growth and what technical advantages are required in a competitive landscape such as company financials, sales & revenue figures.

Market analysis is initiated using primary research tools such as speaking directly with end-users, identifying their needs, and any un-met needs in the market place. This exploratory research identifies any specific requirements in the market and is tailored specifically to niche markets such as gene therapy, regenerative medicine, personalized medicine, targeted therapeutics and companion diagnostics, drug delivery systems, cosmetic surgery and services, cancer biomarkers and immunotherapy. At KellyScientific, we have a wide range of contacts within these niche areas that provide us with cutting edge insights into a marketplace that is beyond the reach of many. We also travel to international conferences quarterly to source new data and trends from global experts.
 
Secondary research performed by Kelly Scientific is meticulously scrutinized and analysed prior to integration into a final report. We only use validated and confirmed sources of information from company-specific corporate websites, government websites and documents, annual reports, press releases, international peer-reviewed scientific and medical journals, and research reports. Together both primary and secondary research and also unique insights from the chief analysts and editor alike provide the client with a report that exceeds its competitors.