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Ovarian Cancer Therapeutics in Asia-Pacific Markets to 2020

Ovarian Cancer Therapeutics in Asia-Pacific Markets to 2020


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Executive Summary

Ovarian Cancer Therapeutics in Asia-Pacific Markets to 2020-Off-patent Chemo-regimens to Retain Dominance Despite New Launches

GBI Research, a leading business intelligence provider, has released its latest research report, "Ovarian Cancer Therapeutics in Asia-Pacific Markets to 2020-Off-patent Chemo-regimens to Retain Dominance Despite New Launches". The report provides estimates of the market size for 2013, along with forecasts until 2020 for the Asia-Pacific markets of India, China, Australia and Japan. It also covers disease epidemiology, treatment algorithms, treatment patterns, in-depth analysis of clinical trials including failure rates and pipeline analysis, and analysis of deals relevant to Ovarian Cancer (OC).

Platinum-based chemotherapy, predominantly the chemotherapy regimen paclitaxel and carboplatin, is the standard of care for the treatment of platinum-sensitive OC (both first-line and recurrent). The initial treatment is quite effective, with the majority of patients entering remission. However, almost all relapse, and after successive periods of remission and relapse either die or progress to platinum-resistant disease, for which the prognosis is poor. There is a clear gap in the market for maintenance therapies, as well as for more effective treatment options in platinum-resistant or refractory patients.

Although the current developmental pipeline is quite crowded, efficacy with these late-stage drugs has been poor, at best demonstrating minimal improvements in progression-free survival, but not overall survival. The promising investigational drug candidates olaparib and trebananib are expected to gain approval during the forecast period. However, even on approval they are not expected to have a high market penetration, owing to their minimal therapeutic efficacy and anticipated premium prices. As a result, the OC market in APAC is expected not be driven by new drug approvals, but primarily by inflation, and the increase in the prevalence of OC. Market revenue is forecast to rise at a limited CAGR of 5.1% to USD 417.6m in 2020.

Despite the poor clinical performance of current late-stage pipeline drugs, there is evidence of continued interest in the OC market, with a high number of drug candidates in the initial developmental pipeline, particularly at the Preclinical phase. There is a wide range of novel molecular targets distributed among these drug candidates, including growth factors, serine/threonine protein kinases and tumor associated antigens. This suggests a continued interest in introducing more targeted therapies into the treatment of OC, the use of which in this indication lags significantly behind that in others in oncology.

Scope

The report analyzes treatment usage patterns, drug types available and pipeline and market forecasts for OC. It covers and includes

A brief introduction to OC, including the disease's pathogenesis, risk factors and diagnosis

In-depth analysis of the drug combinations used in the treatment of OC, including analyses of their safety, efficacy, and place in the disease treatment algorithm, as well as a heat map comparing the drug combinations in terms of safety and efficacy

A comprehensive review of the pipeline for OC therapies, including individual analysis of a number of late-stage pipeline drugs that have the potential to enter the market in the forecast period; the pipeline is analyzed on the basis of phase distribution, molecule type and molecular target, and route of administration

Additional in-depth analysis of pipeline drug clinical trials by phase, molecule type, trial size, and trial duration, and program failure rate analyses for each molecule type and mechanism of action

Multi-scenario forecast market data to 2020, taking into account how it will be affected by the introduction of new drugs, the expiry of key patents on current drugs, and the changes in disease epidemiology across the APAC markets

Discussion of the drivers and barriers for market growth

In-depth analysis of licensing and co-development deals involving drugs indicated in OC, including an outline of the key deals

Reasons To Buy

The report will assist business development and enable marketing executives to strategize their product launches, by allowing them to

Understand the efficacy and safety of the current monotherapies and drug combinations used in the treatment of OC, with in-depth analysis of the disease treatment algorithm

Understand the key signaling pathways and molecular targets currently under investigation in OC drug development

Understand the vast scope of the pipeline, including which molecule types and mechanisms of action are prominent

Observe the trends in clinical trial duration and size among clinical phases and molecule types, and use the clinical trial failure rate analysis to assess the risk profiles of current and/or future developmental programs for OC therapeutics

Assess the potential clinical and commercial impact of current late-stage pipeline molecules in the OC therapeutics market

1 Table of Contents

1 Table of Contents 5

1.1 List of Tables 7

1.2 List of Figures 7

2 Introduction 9

2.1 Disease Pathophysiology 9

2.1.1 Ovarian Cancer-A Group of Distinct Diseases 9

2.1.2 Ovarian Cancer is Highly Heterogenic with Multiple Mutations and Affected Signaling Pathways 10

2.2 Symptoms and Diagnosis 12

2.3 Risk Factors 14

2.3.1 Age 14

2.3.2 Inherited Genetic Mutations 14

2.3.3 Greater Number of Lifetime Ovulations 14

2.3.4 Weight 14

2.3.5 Previous Medical Conditions 14

2.4 Treatment Algorithm 14

2.4.1 Surgery 14

2.4.2 First-Line Chemotherapy 15

2.4.3 Maintenance Therapy 18

2.5 Recurrent Disease 20

3 Marketed Products 38

3.1 Carboplatin 38

3.2 Paclitaxel 39

3.3 Gemcitabine 40

3.4 Topotecan 41

3.5 Pegylated Liposomal Doxorubicin 41

3.6 Yondelis 42

3.7 Avastin 42

4 Product Pipeline 44

4.1 Overview of Pipeline by Phase and Route of Administration 44

4.2 Overview of Pipeline by Molecule Type, Mechanism of Action and Molecular Target 46

4.2.1 Molecular Targets in the Developmental Pipeline 48

4.3 Clinical Trials 51

4.3.1 Clinical Trial Duration 52

4.3.2 Clinical Trial Size 54

4.3.3 Failure Rate 55

4.3.4 Discussion 57

4.4 Late-Stage Drugs in Developmental Pipeline 57

4.4.1 Niraparib 57

4.4.2 Olaparib 58

4.4.3 Vargatef 60

4.4.4 Trebananib 61

4.4.5 Farletuzumab 65

4.4.6 Karenitecin 66

4.5 Discussion 73

5 Market Forecasts 74

5.1 Asia-Pacific 74

5.1.1 Overview 74

5.1.2 Treatment Use Patterns and Revenues in Asia-Pacific Markets 74

5.2 India 76

5.2.1 Treatment Use Patterns 76

5.2.2 Annual Cost of Therapy 76

5.2.3 Market Forecast 77

5.3 China 78

5.3.1 Treatment Use Patterns 78

5.3.2 Annual Cost of Therapy 78

5.3.3 Market Forecast 79

5.4 Japan 80

5.4.1 Treatment Use Patterns 80

5.4.2 Annual Cost of Therapy 80

5.4.3 Market Forecast 81

5.5 Australia 82

5.5.1 Treatment Use Patterns 82

5.5.2 Annual Cost of Therapy 83

5.5.3 Market Forecast 84

5.6 Drivers and Barriers 85

5.6.1 Drivers 85

5.6.2 Barriers 86

6 Deals 87

6.1 Licensing Deals 87

6.1.1 Clovis Oncology Enters into Licensing Agreement with Pfizer for PF-01367338 89

6.1.2 PharmaMar Enters into Licensing Agreement with Janssen for Yondelis 89

6.1.3 Hana Enters into Licensing Agreement with Tekmira 90

6.1.4 AstraZeneca Enters into Licensing Agreement with Merck for MK-1775 90

6.1.5 Tesaro Enters into Licensing Agreement with Merck Sharp & Dohme for Cancer Drug 90

6.1.6 Oasmia Enters into Licensing Agreement with Medison for Paclical 91

6.1.7 Orion Enters into Agreement with Oasmia 91

6.1.8 Ohio University Enters into Licensing Agreement with Phosplatin 91

6.1.9 Genta Enters into Licensing Agreement with Daiichi Sankyo 91

6.1.10 Celldex Enters into Licensing Agreement with the Ludwig Institute for Cancer Research 92

6.1.11 NanoCarrier Enters into Licensing Agreement with Kowa for NC-6300 92

6.2 Co-development Deals 92

6.2.1 Bristol-Myers Squibb Enters into Co-development Agreement with Ono Pharma 94

6.2.2 Merck Enters into Co-development Agreement with Endocyte for Cancer Drug 94

6.2.3 Pfizer Enters into Research Agreement with BC Cancer Agency and Vancouver Prostate Centre 94

6.2.4 Almac Discovery Enters into an Agreement with Queen's University Belfast for Drug Discovery 95

7 Appendix 96

7.1 All Pipeline Drugs by Phase 96

7.1.1 Discovery 96

7.1.2 Preclinical 97

7.1.3 IND/CTA-Filed 102

7.1.4 Phase I 103

7.1.5 Phase II 106

7.1.6 Phase III 111

7.1.7 Pre-Registration 111

7.2 Market Forecasts to 2020 112

7.2.1 Asia-Pacific 112

7.2.2 India 112

7.2.3 China 113

7.2.4 Japan 113

7.2.5 Australia 114

7.3 Abbreviations 115

7.4 Bibliography 117

7.5 Research Methodology 122

7.5.1 Coverage 122

7.5.2 Secondary Research 123

7.5.3 Primary Research 123

7.5.4 Therapeutic Landscape 124

7.5.5 Geographical Landscape 126

7.5.6 Pipeline Analysis 126

7.6 Expert Panel Validation 126

7.7 Contact Us 126

7.8 Disclaimer 126

1.1 List of Tables

Table 1: Ovarian Cancer Therapeutics, Histological Subtypes and Associated Genetic Mutations 10

Table 2: Ovarian Cancer Therapeutics, Affected Signaling Pathways in Ovarian Cancer, Associated Mutations and Effects on Cancer Development 12

Table 3: Ovarian Cancer Therapeutics, Ovarian Cancer Disease Staging 13

Table 4: Ovarian Cancer Therapeutics, Eastern Cooperative Oncology Group Performance Status Scores and Description 15

Table 5: Ovarian Cancer Therapeutics, Common Endpoints in Ovarian Cancer and Details of Criteria 16

Table 6: Ovarian Cancer Therapeutics, Rates of Sensory and Motor Neuropathy with Pegylated Liposomal Doxorubicin and Paclitaxel in Combination with Carboplatin (%), 2010 23

Table 7: Ovarian Cancer Therapeutics, Yondelis Phase III Clinical Trial, Patient Stratification by Platinum-Free Interval, 2010 27

Table 8: Ovarian Cancer Therapeutics, Poly ADP Ribose Polymerase Inhibitors Under Development, 2014 48

Table 9: Ovarian Cancer Therapeutics, Epidermal Growth Factor Receptor Inhibitors Under Development, 2014 49

Table 10: Ovarian Cancer Therapeutics, Mucin Inhibitors Under Development, 2014 50

Table 11: Ovarian Cancer Therapeutics, Aurora Kinase Inhibitors Under Development, 2014 51

Table 12: Ovarian Cancer Therapeutics, Average Clinical Trial Duration across Each Phase for Ovarian Cancer, across Oncology and Entire Industry (months), 2014 52

Table 13: Ovarian Cancer Therapeutics, Global, Patient Demographics of a Phase III Clinical Trial of Trebananib (%), 2011 63

Table 14: Ovarian Cancer Therapeutics, Global, Developmental Pipeline, Discovery Phase, 2014 96

Table 15: Ovarian Cancer Therapeutics, Global, Developmental Pipeline, Preclinical Phase, 2014T 97

Table 16: Ovarian Cancer Therapeutics, Global, Developmental Pipeline, IND/CTA-Filed, 2014 102

Table 17: Ovarian Cancer Therapeutics, Global, Developmental Pipeline, Phase I, 2014 103

Table 18: Ovarian Cancer Therapeutics, Global, Developmental Pipeline, Phase II, 2014 106

Table 19: Ovarian Cancer Therapeutics, Global, Developmental Pipeline, Phase III, 2014 111

Table 20: Ovarian Cancer Therapeutics, Global, Developmental Pipeline, Pre-Registration, 2014 111

Table 21: Ovarian Cancer Therapeutics, Asia-Pacific, Market Forecast, 2013-2020 112

Table 22: Ovarian Cancer Therapeutics, India, Market Forecast, 2013-2020 112

Table 23: Ovarian Cancer Therapeutics, China, Market Forecast, 2013-2020 113

Table 24: Ovarian Cancer Therapeutics, Japan, Market Forecast, 2013-2020 113

Table 25: Ovarian Cancer Therapeutics, Australia, Market Forecast, 2013-2020 114

Table 26: Abbreviations 115

1.2 List of Figures

Figure 1: Ovarian Cancer Therapeutics, Efficacy Results for Key Parameters-Marketed Products, First-Line and Maintenance Therapies 30

Figure 2: Ovarian Cancer Therapeutics, Safety Results for Key Parameters-Marketed Products, First-Line and Maintenance Therapies 31

Figure 3: Ovarian Cancer Therapeutics, Efficacy Results for Key Parameters-Marketed Products, Recurrent Disease: All Patients 32

Figure 4: Ovarian Cancer Therapeutics, Safety Results for Key Parameters-Marketed Products, Recurrent Disease: All Patients 33

Figure 5: Ovarian Cancer Therapeutics, Efficacy Results for Key Parameters-Marketed Products, Recurrent Disease: Platinum-Sensitive 34

Figure 6: Ovarian Cancer Therapeutics, Safety Results for Key Parameters-Marketed Products, Recurrent Disease: Platinum-Sensitive 35

Figure 7: Ovarian Cancer Therapeutics, Efficacy Results for Key Parameters-Marketed Products, Recurrent Disease: Platinum-Resistant 36

Figure 8: Ovarian Cancer Therapeutics, Safety Results for Key Parameters-Marketed Products, Recurrent Disease: Platinum-Resistant 37

Figure 9: Ovarian Cancer Therapeutics, Global, Pipeline Distribution by Stage, Program Type and Route of Administration, 2014 45

Figure 10: Ovarian Cancer Therapeutics: Global, Pipeline by Molecule Type and Mechanism of Action, 2014 47

Figure 11: Ovarian Cancer Therapeutics, Global, Molecular Targets of the Developmental Pipeline, 2014 51

Figure 12: Ovarian Cancer Therapeutics, Global, Clinical Trial Duration (months), 2006-2014 53

Figure 13: Ovarian Cancer Therapeutics, Global, Clinical Trial Size (participants), 2006-2014 55

Figure 14: Ovarian Cancer Therapeutics, Global, Clinical Trial Failure Rate and Reasons for Failure (%), 2006-2014 56

Figure 15: Ovarian Cancer Therapeutics, Efficacy Results for Key Parameters-Pipeline (blue) and Marketed Products Comparison. Recurrent Disease: All Patients 67

Figure 16: Ovarian Cancer Therapeutics, Safety Results for Key Parameters-Pipeline (blue) and Marketed Products Comparison. Recurrent Disease: All Patients 68

Figure 17: Ovarian Cancer Therapeutics, Efficacy Results for Key Parameters-Pipeline (blue) and Marketed Products Comparison. Recurrent Disease: Platinum-Sensitive 69

Figure 18: Ovarian Cancer Therapeutics, Safety Results for Key Parameters-Pipeline (blue) and Marketed Products Comparison. Recurrent Disease: Platinum-Sensitive 70

Figure 19: Ovarian Cancer Therapeutics, Efficacy Results for Key Parameters-Pipeline (blue) and Marketed Products Comparison. Recurrent Disease: Platinum-Resistant 71

Figure 20: Ovarian Cancer Therapeutics, Efficacy Results for Key Parameters-Pipeline (blue) and Marketed Products Comparison. Recurrent Disease: Platinum-Resistant 72

Figure 21: Ovarian Cancer Therapeutics, Global, Treatment Use Patterns and Market Size, 2013-2020 75

Figure 22: Ovarian Cancer Therapeutics, India, Treatment Use Patterns ('000), 2013-2020 76

Figure 23: Ovarian Cancer Therapeutics, India, Annual Cost of Therapy (USD ), 2013-2020 77

Figure 24: Ovarian Cancer Therapeutics: India, Market Size (USD m), 2013-2020 77

Figure 25: Ovarian Cancer Therapeutics, China, Treatment Use Patterns ('000), 2013-2020 78

Figure 26: Ovarian Cancer Therapeutics, China, Annual Cost of Therapy (USD ), 2013-2020 79

Figure 27: Ovarian Cancer Therapeutics: China, Market Size (USD m), 2013-2020 79

Figure 28: Ovarian Cancer Therapeutics, Japan, Treatment Use Patterns ('000), 2013-2020 80

Figure 29: Ovarian Cancer Therapeutics, Japan, Annual Cost of Therapy (USD ), 2013-2020 81

Figure 30: Ovarian Cancer Therapeutics: Japan, Market Size (USD m), 2013-2020 82

Figure 31: Ovarian Cancer Therapeutics, Australia, Treatment Use Patterns ('000), 2013-2020 83

Figure 32: Ovarian Cancer Therapeutics, Australia, Annual Cost of Therapy (USD ), 2013-2020 84

Figure 33: Ovarian Cancer Therapeutics: Australia, Market Size (USD m), 2013-2020 84

Figure 34: Ovarian Cancer Therapeutics, Global, Licensing Deals by Location, Year and Value, 2006-2014 88

Figure 35: Ovarian Cancer Therapeutics, Global, Licensing Deals by Phase, Molecule Type and Mechanism of Action, 2006-2014 89

Figure 36: Ovarian Cancer Therapeutics, Global, Co-development Deals by Location, Year and Value, 2006-2014 93

Figure 37: GBI Research Market Forecasting Model 125

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