Cancer Personalized Medicine

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1 GENReports: Market & Tech Analysis Cancer Personalized Medicine > Enal Razvi, Ph.D. Biotechnology Analyst, Managing Director SELECTBIO US

2 Topics Addressed In this GEN Market & Tech Analysis Report we examine the landscape of Cancer Personalized Medicine. Based on the Results of Bottom Up Market Analyses which Pinpoint the Current Status and Trajectory of Cancer Personalized Medicine Quantitative Analysis of Cancer Personalized Medicine and Framing it into the Context of the Broader Personalized Medicine Field Penetrance of Various Biomarker Classes into Research Currently Penetrance of Various Technology Platforms for Biomarker Interrogation Segmentation of the Cancer Personalized Medicine Marketplace vis à viscancerclassesstudied Industry Drivers and Challenges for Adoption

3 Breakout of the Broader Personalized Medicine Marketplace Designing therapeutics based patient populations 11% Developing Technologies and Products/Tools for Personalized Medicine 44% Designing biomarker assays defining patient populations 10% Conducting Clinical Trials using Defined Patient Populations 7% Identifying biomarkers of value for definig patient populations 28% Segmentation of the Field into its Various Constituents

4 Breakout of the Broader Personalized Medicine Space by Disease Class HIV Infection/AIDS 2% Cardiovascular Diseases 9% Drug Toxicity/Adverse Drug Reactions (ADRs) 13% Neurodegenerative Diseases (Parkinson's Disease, Alzheimer's Disease) 7% Other Cancers 28% Breast Cancer 18% Colorectal Cancer 10% Hematological Cancers (leukemia, lymphoma, etc.) 13% Cancer Personalized Medicine Represents ~70% of the Overall Field Currently

5 Penetrance of Various Classes of Biomarkers into the Broader Personalized Medicine Research Space 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% 20.2% 21.1% 4.6% 6.4% 44.0% 51.4% 33.9% MicroRNA Markers/Profiles DNA Methylation Markers/Profiles Histone Methylation Markers/Profiles Histone Acetylation Markers/Profiles Gene Expression (mrna) Profiles Protein Expression Profiles Others Percent of Respondents Classes of Biomarkers on the Abscissa. Arrows Denote the Most Penetrant Biomarker Classes (Gene Expression Profiles, and Protein Expression Profiles).

6 Penetration of Technology Platforms into the Broader Personalized Medicine Space 50.0% 45.0% 40.0% 35.0% 30.0% 25.0% 20.0% 15.0% 10.0% 5.0% 0.0% 41.2% 16.5% 20.6% 32.0% 16.5% 44.3% 46.4% qpcr-based Gene Expression (mrna) Profiling qpcr for microrna Expression Profiling DNA Methylation Analysis via Bisulfite Method for Epigenetic Profiling Microarray-based Gene Expression (mrna) Profiling Microarray-based microrna Expression Profiling Immunoassays for Protein Expression Profiling Proteomic technologies for Protein Expression Profiling (protein arrays, for example) Percent of Respondents Classes of Platforms on the Abscissa. Arrows Denote the Most Penetrant Platforms Classes (qpcr for Gene Expression, and Protein Analyses Platforms) NGS is the New Entrant in this Space and is Expanding Rapidly

7 Segmentation of the Cancer Personalized Medicine Space vis-à-vis Disease Classes Studied Breast Cancer 20% Other type of cancer 25% Prostate Cancer 10% Hematological Cancers (leukemia, lymphoma, etc.) 21% Colorectal Cancer 17% Lung Cancer 7% Breakout of the Field by Cancer Class

8 Industry Drivers of Cancer Personalized Medicine 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 48.2% 47.1% 35.3% 28.2% 25.9% 11.8% 0.0% Clinical trials are faster and more streamlined Regulatory requirement for drug approval Reducing the potential for adverse drug reactions and associated drug withdrawals Doctors (MDs) driving the trend Patients/Patient Advocacy Groups driving the trend Others Percent of Respondents Various Drivers at Play: The Field Resides at a Nexus of Several Disciplines and Therefore there is No One Driver per se

9 Challenges in the Cancer Personalized Medicine Marketplace 70.0% 65.1% 60.0% 50.0% 40.0% 30.0% 20.0% 10.0% 0.0% 44.2% 18.6% 40.7% 9.3% Biomarkers do not exist for characterizing/stratifying patient populations Difficult to associate specific cancer types with molecular markers as yet comprehensively Not required as yet by the FDA Unclear future regulatory considerations Others Percent of Respondents Biggest Challenge in this Space to Overcome: Difficulty in Associating Specific Cancers with Defined Molecular Signature[s] This is Changing and Therefore the Field is Advancing NGS is Offering Unprecedented Illumination of Somatic and Germline Mutations

10 Summary of these Data and Industry Trajectory The quantitative analysis of some elements of the cancer personalized medicine space performed by SELECTBIO presented in this report describes the industry structure and its trajectory The broader personalized medicine field is evolving to include many different stakeholders which are coming together to generate diagnostics, therapeutics, medical devices, and informatics which offers tailored patient care The driver of the overall personalized medicine space is cancer personalized medicine This is at the forefront since cancer is a disease of the genome and the mutations therein are amenable to precise targeting using targeted agents This is where Companion Diagnostics Received its Start But now this is Expanding Beyond Cancer to Other Disease Classes As Personalized Medicine Expands it will Collide with other Disciplines such as Cellular Therapy and Regenerative Medicine as these seek to offer Tailored Patient Care

11 The Arrival of Actionable Personalized Medicine: The Age of Guided Disease Management This Conference brings together all the Stakeholders in Personalized Medicine and seeks to frame the industry perspectives with a cross functional program featuring the major milestones in personalized medicine, regulatory challenges, economic analysis, and presentations from the industry s leaders.