Global Cancer Supportive Care Therapeutics Market to 2022 – Patent Expirations Create Opportunities for Biosimilars in the Chemotherapy Induced Anemia and Neutropenia Markets

The cancer supportive care product market consists of drugs intended to prevent or treat the symptoms of cancer, and reduce the side effects of cancer treatments. Instead of extending a patient’s life expectancy, the emphasis is on improving overall quality of life. The key indications covered in this report are cancer pain, oral mucositis, chemotherapy-induced neutropenia (CIN), chemotherapy-induced anemia (CIA), chemotherapy-induced nausea and vomiting (CINV) and bone metastasis. These indications are not only distressing for patients, but can also lead to treatment cessation, which in turn increases patient mortality. As the number of people being diagnosed with cancer grows and access to effective treatment that allows patients to survive longer increases, demand for safe and effective cancer supportive care drugs will rise.

The majority of indications targeted by cancer supportive care products are the direct result of a patient receiving chemotherapy in an attempt to cure their cancer or relieve symptoms. It is often the case that the most effective chemotherapy regimens result in the most severe symptoms. This increases the need for cancer supportive care products, which can improve patient outcomes by providing greater tolerance to the most effective regimens. Bone metastasis and most forms of cancer pain are not caused by chemotherapy or cancer treatment, and are instead often a symptom of the cancer itself, occurring in a high proportion of cancer patients.

The level of unmet need within the cancer supportive care therapy area varies between indications. CIN and CINV both already have treatment regimens that can significantly decrease the incidence rate. However, the level of unmet need for CIA, cancer pain, oral mucositis and bone metastasis is high, with treatment focusing heavily on alleviating the symptoms instead of treating the underlying cause.

There are 245 products in active development in the cancer supportive care pipeline, but this includes products in development for smaller and less commercially significant indications. There are 169 products in active development for the key indication examined in this report, giving an average of 28 products per indication, the majority of which are at an early stage of development.

Scope

The cancer supportive care market already contains some commercially successful products.

– Which classes of drug dominate the market?

– Which indication is the most commercially successful?

– How will commercially successful drugs perform over the forecast period?

The cancer supportive care pipeline is relatively small, but there is significant diversity in terms of molecule types and targets.

– Which molecular targets appear most frequently in the pipeline?

– What are the commercial prospects for the most promising late-stage pipeline products?

The cancer supportive care market is forecast to grow from $11.7 billion in 2015 to $12.4 billion in 2022, at a compound annual growth rate of 0.9%.

– Which products are forecast to drive growth?

– Will generic and biosimilar competition have a significant impact on the market over the forecast period?

The company landscape is becoming increasingly competitive.

– What are the leading companies in terms of market share?

– Which companies are forecast to experience the greatest growth in market share?

– What are the drivers of growth for key companies in the market?

– How dependent are the key companies on this disease cluster for revenue?

Reasons to buy

This report will allow you to -

- Understand the current clinical and commercial landscape through a comprehensive study of disease pathogenesis, symptoms, diagnosis and prognosis for the key indications covered in the report

- Understand the current treatment landscape, with profiles of key marketed products and a focus on historical and forecast sales patterns, and an overview of each drug’s mechanism of action.

- Identify the key pipeline products, with a particular focus on those due to be brought to market in the near future, as well as sales forecasts for these products.

- Predict growth in market size, with in-depth market forecasting from 2015 to 2022. The forecast will provide an understanding of how epidemiology trends, new drug entries and new drug patents expirations will influence market value.

- Identify the leading companies in the market, in terms of market share and growth. Company analysis illustrates how dependent the key companies in the market are on revenue derived from cancer supportive care products. In addition, analysis determines the primary factors that will drive market growth for the key companies in the market.

- Identify commercial opportunities in the cancer supportive care deals landscape by analyzing trends in licensing and co-development deals.

Table of Contents

1 Table of Contents

1 Table of Contents 5

1.1 List of Tables 7

1.2 List of Figures 7

2 Introduction 10

2.1 Therapy Area Introduction 10

2.2 Epidemiology 10

2.2.1 Cancer Pain 10

2.2.2 Chemotherapy Side Effects 11

2.2.3 Oral Mucositis 11

2.3 Pathophysiology 11

2.3.1 Bone Metastasis 11

2.3.2 Oral mucositis 12

2.3.3 Cancer Pain 12

2.3.4 Chemotherapy-Induced Nausea and Vomiting 12

2.3.5 Chemotherapy-Induced Anemia 13

2.3.6 Chemotherapy-Induced Neutropenia 13

2.4 Etiology 13

2.5 Symptoms 14

2.6 Diagnosis and Grading 14

2.7 Treatment 17

2.7.1 Chemotherapy-Induced Nausea and Vomiting 17

2.7.2 Chemotherapy-Induced Neutropenia 18

2.7.3 Chemotherapy-Induced Anemia 18

2.7.4 Cancer Pain 19

2.7.5 Bone Metastases 19

2.7.6 Oral Mucositis 19

3 Key Marketed Products 21

3.1 Overview 21

3.2 Neulasta (pegfilgrastim) - Amgen 22

3.3 Xgeva (denosumab) - Amgen 23

3.4 Aranesp/Nesp (darbepoetin alfa) - Amgen/Kyowa Hakko Kirin 24

3.5 Xofigo (radium Ra 223 dichloride) - Bayer 26

3.6 Nucynta (tapentadol hydrochloride) - Depomed 27

3.7 Epogen/Procrit (epoetin alfa) - Amgen/Johnson & Johnson 29

3.8 Neupogen (Filgrastim) - Amgen 30

3.9 Aloxi (palonosetron hydrochloride) - Eisai, Helsinn and Otsuka 32

3.10 Conclusion 33

4 Pipeline Landscape Assessment 35

4.1 Overview 35

4.2 Pipeline Development Landscape 35

4.3 Molecular Targets in the Pipeline 38

4.4 Clinical Trials 40

4.4.1 Failure Rate by Stage of Development, Indication, Molecule Type and Molecular Target 41

4.4.2 Clinical Trial Duration by Stage of Development, Indication, Molecule Type and Molecular Target 45

4.4.3 Clinical Trial Size by Stage of Development, Indication, Molecule Type and Molecular Target 49

4.4.4 Aggregate Clinical Program Size by Stage of Development, Indication, Molecule Type and Molecular Target 53

4.4.5 Conclusion 57

4.5 Assessment of Key Pipeline Products 57

4.5.1 Tanezumab - Pfizer and Eli Lilly 57

4.5.2 Rolontis (Eflapegrastim) - Spectrum Pharmaceuticals 59

4.5.3 Conclusion 61

5 Multi-scenario Market Forecast to 2022 62

5.1 Overall Market Size 62

5.2 Generic Penetration 64

5.3 Revenue Forecast by Molecular Target 67

5.3.1 Cytokine Receptors 67

5.3.2 G Protein-Coupled Receptors 68

6 Company Analysis and Positioning 70

6.1 Revenue and Market Share Analysis by Company 72

6.2 Amgen - Can it Retain its Market-Leading Position Despite Patent Expiries for Key Products? 76

6.3 Bayer - Will Revenue from Xofigo Continue to Increase during the Forecast Period? 77

6.4 Heron Therapeutics - Will New Approvals Allow a Small Company to Obtain a Significant Market Share? 78

6.5 Insys Therapeutics - Can Reformulations Be Commercially Successful if Generics are Available? 79

6.6 Kyowa Hakko Kirin - How will the Japanese Cancer Supportive Care Market React to Patent Expiries for Some of the Therapy Area’s Most Successful Drugs? 80

6.7 Daiichi Sankyo - Will Revenue from Injectafer and Ranmark Continue to Increase during the Forecast Period? 81

6.8 Company Landscape 82

6.8.1 Marketed and Pipeline Portfolio Analysis 83

7 Strategic Consolidations 85

7.1 Licensing Deals 85

7.1.1 Deals by Region, Year and Value 85

7.1.2 Deals by Indication, Stage of Development and Value 86

7.1.3 Deals by Molecule Type, Molecular Target and Value 88

7.1.4 Table for Licensing Deals with a Disclosed Value 90

7.2 Co-development Deals 93

7.2.1 Deals by Region, Year and Value 93

7.2.2 Deals by Indication, Stage of Development and Value 94

7.2.3 Deals by Molecule Type, Mechanism of Action and Value 96

7.2.4 Table for Co-development Deals with a Disclosed Value. 98

8 Appendix 99

8.1 Bibliography 99

8.2 All Pipeline Drugs by Phase of Development 103

8.2.1 Discovery 103

8.2.2 Preclinical 105

8.2.3 IND/CTA-filed 114

8.2.4 Phase I 114

8.2.5 Phase II 116

8.2.6 Phase III 119

8.2.7 Pre-registration 121

8.2.8 Unknown 122

8.3 Abbreviations 123

8.4 Disease List 124

8.5 Methodology 124

8.5.1 Coverage 124

8.5.2 Secondary Research 125

8.5.3 Market Size and Revenue Forecasts 125

8.5.4 Pipeline Analysis 125

8.5.5 Competitive Landscape 126

8.6 Contact Us 126

8.7 Disclaimer 126

List of Tables

1.1 List of Tables

Table 1: Cancer Supportive Care Market, Global, Bone Metastasis Grading, 2017 15

Table 2: Cancer Supportive Care Market, Global, Oral Mucositis Grading, 2017 16

Table 3: Cancer Supportive Care Market, Global, Chemotherapy-Induced Neutropenia Grading, 2017 16

Table 4: Cancer Supportive Care Market, Global, Chemotherapy-Induced Anemia Grading, 2017 16

Table 5: Cancer Supportive Care Market, Treatment Guidelines for Chemotherapy-Induced Nausea and Vomiting Treatment 18

Table 6: Cancer Supportive Care Market, Treatment Guidelines for Oral Mucositis 20

Table 7: Cancer Supportive Care Market, Global, Approved Indications for Neulasta, 2017 22

Table 8: Cancer Supportive Care Market, Global, Approved Indications for Xgeva, 2017 23

Table 9: Cancer Supportive Care Market, Global, Approved Indications for Aranesp/Nesp, 2017 25

Table 10: Cancer Supportive Care Market, Global, Approved Indications for Xofigo, 2017 26

Table 11: Cancer Supportive Care Market, Global, Approved Indications for Nucynta, 2017 28

Table 12: Cancer Supportive Care Market, Global, Approved Indications for Epogen / Procrit, 2017 29

Table 13: Cancer Supportive Care Market, Global, Approved Indications for Neupogen, 2017 31

Table 14: Cancer Supportive Care Market, Global, Approved Indications for Aloxi, 2017 32

Table 15 :Cancer Supportive Care Market, Global, Annual Revenue Forecast for Key Products($m), 2015-2022 63

Table 16: Cancer Supportive Care Therapeutics Market, Global, Usage of Generics Across Key Indications, 2017 66

Table 17: Cancer Supportive Care Market, Global, Forecast Revenue by Company, 2015-2022 73

Table 18: Cancer Supportive Care Market, Global, Licensing Deals With a Disclosed Value , 2006-2017 90

Table 19: Cancer Supportive Care Market, Global, Co-development Deals With a Disclosed Value , 2006-2017 98

Table 20: Cancer Supportive Care Market, Global, Pipeline Products, Discovery, 2017 103

Table 21:Cancer Supportive Care Market, Global, Pipeline Products, Preclinical, 2017 105

Table 22: Cancer Supportive Care Market, Global, Pipeline Products, IND/CTA-Filed, 2017 114

Table 23: Cancer Supportive Care Market, Global, Pipeline Products, Phase I, 2017 114

Table 24: Cancer Supportive Care Market, Global, Pipeline Products, Phase II, 2017 116

Table 25: Cancer Supportive Care Market, Global, Pipeline Products, Phase III, 2017 119

Table 26: Cancer Supportive Care Market, Global, Pipeline Products, Pre-registration , 2017 121

Table 27: Cancer Supportive Care Market, Global, Pipeline Products, Unknown Stage of Development, 2017 122

List of Figures

1.2 List of Figures

Figure 1: Cancer Supportive Care Market, Global, Key Marketed Products and Approved Indications, 2017 21

Figure 2: Cancer Supportive Care Market, Global, Annual Revenue for Neulasta ($bn), 2011-2022 23

Figure 3: Cancer Supportive Care Market, Global, Annual Revenue for Xgeva ($bn), 2011-2022 24

Figure 4: Cancer Supportive Care Market, Global, Annual Revenue for Aranesp for Amgen ($bn), 2006-2022 25

Figure 5: Cancer Supportive Care Market, Global, Annual Revenue for Nesp for Kyowa Hakko Kirin ($bn), 2011-2022 26

Figure 6: Cancer Supportive Care Market, Global, Annual Revenue for Xofigo ($bn), 2013-2022 27

Figure 7: Cancer Supportive Care Market, Global, Annual Revenue for Nucynta ($m), 2015-2022 28

Figure 8: Cancer Supportive Care Market, Global, Annual Revenue for Epogen ($bn), 2006-2022 30

Figure 9: Cancer Supportive Care Market, Global, Annual Revenue for Procrit ($bn), 2006-2022 30

Figure 10: Cancer Supportive Care Market, Global, Annual Revenue for Neupogen ($bn), 2011-2022 32

Figure 11: Cancer Supportive Care Market, Global, Annual Revenue for Aloxi ($m), 2011-2022 33

Figure 12: Cancer Supportive Care Market, Global, Overall Pharmaceutical Industry Pipeline by Therapy Area, 2017 35

Figure 13: Cancer Supportive Care Market, Global, Pipeline for Cancer Supportive Care by Stage of Development, Molecule Type and Program Type, 2017 36

Figure 14: Cancer Supportive Care Market, Global, Pipeline for Cancer Supportive Care Indications by Stage of Development, 2017 37

Figure 15: Cancer Supportive Care Market, Global, Pipeline for Cancer Supportive Care Indications by Molecule Type, 2017 38

Figure 16: Cancer Supportive Care Market, Global, Pipeline for Cancer Supportive Care Therapies by Molecular Target, 2017 39

Figure 17: Cancer Supportive Care Market, Global, Pipeline for Key Cancer Supportive Care Indications by Molecular Target, 2017 40

Figure 18: Cancer Supportive Care Market, Global, Clinical Trial Attrition Rates by Stage of Development (%), 2006-2017 41

Figure 19: Cancer Supportive Care Market, Global, Clinical Trial Attrition Rates by Stage of Development and Indication (%), 2006-2017 42

Figure 20: Cancer Supportive Care Market, Global, Clinical Trial Attrition Rates by Stage of Development and Molecule Type (%), 2006-2017 43

Figure 21: Cancer Supportive Care Market, Global, Clinical Trial Attrition Rates by Stage of Development and Molecular Target (%), 2006-2017 44

Figure 22: Cancer Supportive Care Market, Global, Clinical Trial Duration by Stage of Development (months), 2006-2017 45

Figure 23: Cancer Supportive Care Market, Global, Clinical Trial Duration by Stage of Development and Indication (months), 2006-2017 46

Figure 24: Cancer Supportive Care Market, Global, Clinical Trial Duration by Stage of Development and Molecule Type (months), 2006-2017 47

Figure 25: Cancer Supportive Care Market, Global, Clinical Trial Duration by Stage of Development and Molecular Target (months), 2006-2017 48

Figure 26: Cancer Supportive Care Market, Global, Clinical Program Size by Stage of Development (participants), 2006-2017 49

Figure 27: Cancer Supportive Care Market, Global, Clinical Trial Size by Stage of Development and Indication (participants), 2006-2017 50

Figure 28: Cancer Supportive Care Market, Global, Clinical Trial Size by Stage of Development and Molecule Type (participants), 2006-2017 51

Figure 29: Cancer Supportive Care Market, Global, Clinical Trial Size by Stage of Development and Molecular Target (participants), 2006-2017 52

Figure 30: Cancer Supportive Care Market, Global, Clinical Program Size by Stage of Development (participants), 2006-2017 53

Figure 31: Cancer Supportive Care Market, Global, Clinical Program Size by Stage of Development and Indication (participants), 2006-2017 54

Figure 32: Cancer Supportive Care Market, Global, Clinical Program Size by Stage of Development and Molecule Type (participants), 2006-2017 55

Figure 33: Cancer Supportive Care Market, Global, Clinical Program Size by Stage of Development and Molecular Target (participants), 2006-2017 56

Figure 34: Cancer Supportive Care Market, Global, Revenue for Tanezumab (Eli Lilly/Pfizer) ($m), 2018-2022 59

Figure 35: Cancer Supportive Care Market, Global, Revenue for Eflapegrastim ($m), 2018-2022 60

Figure 36: Cancer Supportive Care Market, Global, Market Size ($bn), 2015-2022 63

Figure 37: Cancer Supportive Care Market, Global, Annual Revenue by Premium and Generic Products ($bn), 2015-2022 65

Figure 38: Cancer Supportive Care Market, Global, Annual Revenue Forecast for drugs that’s target Cytokine receptors ($bn), 2015-2022 68

Figure 39: Cancer Supportive Care Market, Global, Annual Revenue Forecast for drugs that’s target GPCRs ($bn), 2015-2022 69

Figure 40: Cancer Supportive Care Market, Global, Company Analysis Matrix, 2015-2022 71

Figure 41: Cancer Supportive Care Market, Global, Cluster by Growth and Market Share, 2015-2022 72

Figure 42: Cancer Supportive Care Market, Global, Forecast Market Share by Company (%), 2015-2022 74

Figure 43: Cancer Supportive Care Market, Global, Companies by Compound Annual Growth Rate (%), Base year-2022 75

Figure 44: Cancer Supportive Care Market, Global, Revenue by Product Type, 2015-2022 76

Figure 45: Cancer Supportive Care Market, Global, Amgen Annual Revenue Forecast ($bn), 2015-2022 77

Figure 46: Cancer Supportive Care Market, Global, Bayer Annual Revenue Forecast ($m/$bn), 2015-2022 78

Figure 47: Cancer Supportive Care Market, Global, Heron Therapeutics Annual Revenue Forecast ($m/$bn), 2015-2022 79

Figure 48: Cancer Supportive Care Market, Global, Insys therapeutics Annual Revenue Forecast ($m), 2015-2022 80

Figure 49: Cancer Supportive Care Market, Global, Kyowa Hakko Kirin, Annual Revenue Forecast ($m/$bn), 2015-2022 81

Figure 50: Cancer supportive Market, Global, Daiichi Sankyo, Annual Revenue Forecast ($bn), 2015-2022 82

Figure 51: Cancer Supportive Care Market, Late-Stage Developers by type, 2017 83

Figure 52: Cancer Supportive care Market, Global, Revenue by Product Type, 2015-2022 83

Figure 53: Cancer Supportive Care Market, Global, Proportion of Total Company Revenue Attributed to Cancer Supportive Care, 2015-2022 84

Figure 54: Cancer Supportive Care Market, Global, Licensing Deals by Region, Year and Value, 2006-2017 86

Figure 55: Cancer Supportive Care Market, Global, Licensing Deals by Indication and Value, 2006-2017 87

Figure 56: Cancer Supportive Care Market, Global, Licensing Deals by Stage of Development and Value, 2006-2017 88

Figure 57: Cancer Supportive Care Market, Global, Licensing Deals by Molecule Type and Target, 2006-2017 89

Figure 58: Cancer Supportive Care Market, Global, Co-development Deals by Region, Year and Value, 2006-2017 94

Figure 59: Cancer Supportive Care Market, Global, Co-development Deals by Indication, 2006-2017 95

Figure 60: Cancer Supportive Care Market, Global, Co-development Deals by Stage of Development and Value, 2006-2017 96

Figure 61: Cancer Supportive Care Market, Global, Co-development Deals by Molecule Type and Target, 2006-2017 97

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