Stakeholder Opinions: Hepatocellular Cancer - Market Research Report On Aarkstore Enterprise

Introduction

Introduction

Despite the approval of Nexavar (sorafenib; Onyx pharmaceuticals/Bayer), patient outcomes remain poor. The large patient population and the lack of effective agents are driving R&D interest. The majority of pipeline drugs are molecular targeted therapies (MTTs) and their incorporation into treatment will improve both patient outcomes and commercial potential.

Scope of this research

Hepatocellular cancer overview, including disease definition, epidemiology, discussion of unmet needs, and market potential Discussion of current treatment options for hepatocellular cancer and their limitations Examination of the late-phase hepatocellular cancer pipeline, including drug profiles of late-stage agents Stakeholder opinions based on qualitative interviews with key opinion leaders from the US and Japan Research and analysis highlights

Hepatocellular cancer (HCC) is the fifth and seventh most common cancer in men and women respectively. The majority of patients with HCC are diagnosed with advanced-stage disease and have existing liver damage. The only approved treatment for late-stage disease is Nexavar which is not curative.

Chemotherapy is rarely used in hepatocellular cancer (HCC) as it is associated with low response rates. Regional therapies for early-stage patients have a high exclusion criteria and curative surgery is associated with relapse rates as high as 21.8%. Novel therapies are needed to improve survival rates in both early and late stage disease

There are currently 67 drugs in the pipeline, which is dominated by molecular targeted therapies (71%) and cytotoxic therapies (18%). Competition of late-phase pipeline drugs for first approval in HCC is fierce.

Key reasons to purchase this research

Estimate the number of treatable patients and identify unmet needs for future drug development opportunities Understand the current treatment of the disease, as well as opportunities and threats in the hepatocellular cancer market Analyze the current hepatocellular cancer pipeline and the potential of late-stage drugs

Table of Contents :

Overview 1

Catalyst 1

Summary 1

About Datamonitor healthcare 2

About the Oncology pharmaceutical analysis team 2

About the Epidemiology team 2

Executive Summary 3

Scope of the analysis 3

Datamonitor insight into the hepatocellular cancer market 3

Related reports 4

Upcoming reports 4

Patient Potential 12

Key findings 12

The healthy liver and its function 12

Liver anatomy 12

The function of the liver 13

Liver damage and cirrhosis 13

Hepatocellular cancer 14

Risk factors 15

Hepatitis infection 15

Hepatitis B 15

Hepatitis C 16

Alcohol 17

Aflatoxin exposure 18

Genetic predisposition 18

Diagnosis and screening 19

Complexities of early-stage diagnosis 19

Screening procedures 19

Current diagnosis 20

Staging 20

TNM classification 20

Child-Pugh 20

Cancer of the Liver Italian Program (CLIP) 21

The Barcelona Clinic Liver Classification (BCLC) 21

Treatment options for resectable HCC 22

Liver resection 22

Orthotopic liver transplantation (OLT) 23

Long waiting times due to organ shortage 23

Recurrence 24

Expense 24

Regional therapy; radiofrequency ablation (RFA) 25

Transcatheter arterial chemoembolization (TACE) 26

Percutaneous ethanol injection (PEI) 27

Treatment options for unresectable HCC 28

Chemotherapy: single agents 28

Doxorubicin 30

Cisplatin 31

Gemcitabine 31

Chemotherapy: combination regimens 31

Nexavar (sorafenib; Bayer/Onyx) 32

Nexavar as an adjuvant 36

Unmet need in hepatocellular cancer 37

Increased development of molecular targeted therapies (MTTs) 37

Greater focus on HCC prevention 38

Better designed clinical trials 38

Introduction and background 40

Key points 40

Disease definition and diagnosis criteria 41

Global variation and historical trends in incidence rates 41

Risk factors 46

Environmental risk factors 46

Host risk factors 48

Demographic risk factors 49

Epidemiologic forecasting of hepatocellular cancer 50

Cancer registries: age- and country-specific incidence rates 50

Population denominators 51

Hepatocellular cancer incidence statistical modeling 51

Incidence forecasting 52

Categorization and stratification 53

Age 53

Stage 54

Child-Pugh class 54

Epidemiologic forecast results 55

Estimated incident cases of hepatocellular cancer and future trends 55

Segmentation of incident cases: 2010 58

Segmentation by age group 58

Segmentation by stage 60

Segmentation by Child-Pugh class 61

Discussion 61

US 62

Japan 62

EU 63

Conclusions 63

Key findings 64

Current market overview 64

Target product profile versus current level of attainment 65

Opportunities and threats 66

Opportunities 66

High unmet need in the treatment of hepatocellular cancer 66

Increased interest in defining molecular targets for HCC 67

Growing patient population 67

Threats 67

Effective screening and increasing patient awareness could decrease patient population numbers 67

Pipeline Analysis 69

Key findings 69

Hepatocellular cancer pipeline overview 69

Afinitor (everolimus; Novartis) 75

Drug profile 75

Development overview 76

Product positioning 78

SWOT analysis 80

Tarceva (erlotinib; OSI Pharmaceuticals/Genentech/Roche) 81

Drug profile 81

Development overview 82

Product positioning 85

SWOT analysis 86

ThermoDox (heat activated doxorubicin; Celsion/Yakult Honsha) 87

Drug profile 87

Development overview 88

Product positioning 90

SWOT analysis 90

Brivanib (BMS-582664; Bristol-Myers Squibb) 91

Drug profile 91

Development overview 92

Significance of KRAS mutations for the effectiveness of brivanib 95

Product positioning 96

SWOT analysis 96

Linifanib (ABT-869; Abbott) 97

Drug profile 97

Development overview 98

Product positioning 100

SWOT analysis 101

Aptocine (talaporfin sodium; Light Science Oncology) 102

Drug profile 102

Development overview 103

Product positioning 104

SWOT analysis 105

Bibliography 107

Patient Potential 107

Journal papers 107

Websites 113

Datamonitor reports 115

Other 115

Epidemiology 115

Journal papers 115

Websites 119

Other 120

Datamonitor Reports 121

Market potential 121

Journal papers 121

Websites 121

Other 122

Pipeline analysis 122

Journal papers 122

Websites 124

Appendix 125

Contributing experts 125

Report methodology 125

About Datamonitor 126

About Datamonitor Healthcare 126

About the Oncology analysis team 127

Disclaimer 128

For some-more information, Great fully visit:

http://www.aarkstore.com/reports/Stakeholder-Opinions-Hepatocellular-cancer-88054.html

by: Aarkstore Enterprise

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