Research Case : Personalized Cancer Therapy - The era of biomarker identification and companion diagnostic co-development

• Publication date: March 2011

About This Report The treatment of cancer has seen a dramatic shift with the addition of molecular targeted therapies. The mixed and unpredictable responses to these targeted therapies are driving the pharmaceutical market to search for disease and patient characteristics which confer the best response rates. Identification of biomarkers and companion diagnostics will pave the way for personalized cancer therapy. W...

About This Report
The treatment of cancer has seen a dramatic shift with the addition of molecular targeted therapies. The mixed and unpredictable responses to these targeted therapies are driving the pharmaceutical market to search for disease and patient characteristics which confer the best response rates. Identification of biomarkers and companion diagnostics will pave the way for personalized cancer therapy.



What's In This Report of this research

• In-depth analysis of companion diagnostic development – when to start development, internal or partnership development, with case study examples
• In-depth analysis of personalized cancer therapy commercial potential – with patient population analysis and case studies
• In-depth analysis of US, EU, and Japanese current and developing regulatory processes for personalized cancer therapy
• Sales projections for two key personalized therapies in late stage development - 2010 to 2019 across the seven major industry s

Research and analysis Key Market Facts

Pharmaceutical industry players face a number of important decisions regarding personalized therapy development. Selecting the correct time to begin companion diagnostic development will help improve the chances of approval and drive new drug uptake. Developers must also assess their position in the industry before choosing internal or external development.

Drug developers are cautious of personalized therapies due to the small patient populations and associated commercial potential. However, Herceptin has been able to dominate a well defined sector of the breast cancer industry and companion diagnostics have recovered the commercial potential of Erbitux and Vectibix.

Regulators have now realized that the regulatory framework must be altered to incorporate both drugs and companion diagnostics. The US, EU and Japanese authorities are all starting to change their guidelines to encourage personalized therapy development. However, there are still hurdles to overcome before co-development becomes common practice.

Key

Why Should You Buy This Report? this research
• Identify key decisions when developing a drug and companion diagnostic, including internal or external development and when to start development
• Identify the commercial benefits of personalized cancer therapy by assessing drugs currently in development or approved
• Assess the changes in regulatory processes in the seven major industry s as the paradigm of personalized cancer medicine grows

Biological Therapy Industry in Japan

TABLE OF CONTENTS
Overview 1
Catalyst 1
Summary 1
About Datamonitor Healthcare 2
About the oncology pharmaceutical analysis team 2

Summary 3
Strategic scoping and focus 3
Datamonitor key findings 3
Related reports 4
Case Study in Personalized Cancer Therapy 6

Introduction 6
Biomarkers 7
Drug and companion diagnostic development 12
Commercial potential 18
Regulators 22
Key pipeline personalized cancer therapies 28
Bibliography 35

Introduction 35
Biomarkers 36
Drug and companion diagnostic development 36
Commercial potential 39
Regulators 41
Key pipeline personalized cancer therapies 42
Appendix A 44
Forecasting hypothesis s 44
Appendix B 45
Report methodology 45
About Datamonitor 45