PharmaFocus: Supportive Care in Oncology

PharmaFocus: Supportive Care in Oncology


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Executive Summary

PharmaFocus: Supportive Care in Oncology

Summary

Supportive care in oncology is a broad term that is composed of indications that are either a symptom of a patient's cancer or a side effect of cancer treatment. This report focuses on six prominent cancer supportive care indications: chemotherapy-induced nausea and vomiting (CINV), cancer cachexia, oral mucositis, bone metastases, chemotherapy-induced neutropenia (CIN), and chemotherapy-induced anemia (CIA).

There is a consensus among KOLs across the 7MM that supportive oncology had not been given much priority by physicians and institutions in the past. However, there is also a consensus that this situation has been improving in recent years, with increasing recognition of the importance of supportive care.

A growing library of evidence indicates that supportive care: increases likelihood of completing treatment, without the need for dose reductions or treatment pauses; can reduce costs for healthcare institutions; and can improve quality of life for patients-all of which will become increasingly important as patients continue to live longer and cancer progresses to become more like a chronic disease. Despite the trends in oncology towards targeted therapies, KOLs agree that chemotherapy will remain the backbone of cancer treatment for the next five to 10 years. Thus, as the incidence of cancer rises over the next 10 years, so will the cases of chemotherapy-related conditions, in addition to a rise in general oncology-related conditions.

Scope

Highlight KOL views on the past, present, and future trends in supportive care in oncology in their countries

Provide cancer and cancer supportive care epidemiological insight

Provide an overview of the market landscape and available therapies

Provide an overview of all late-stage (Phase II and III) candidates and evaluate the prominent pipeline agents that are closest to market entry

Identify the unmet needs and opportunities in each indication

Highlight R&D strategies used by developers in this field, alongside clinical trial design considerations and challenges

Provide detailed key opinion leader insight throughout each indication and aspect of this report.

Reasons to buy

The report will enable you to-

Develop business strategies by understanding the trends shaping and driving the global supportive care in oncology market

Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global supportive care market in the future.

Formulate effective sales and marketing strategies by understanding the competitive landscape

Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.



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1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Executive Summary

2.1 Traditionally Overlooked Field, but Recognition of Supportive Oncology is Growing Across the 7MM, and will Continue to do so in the Next Five to Ten Years.

2.2 Marketed Landscape Varies Significantly-Blockbuster Drugs in CIN, CIA, and Bone Metastases, but Nothing Available for Cancer Cachexia

2.3 CIN and Oral Mucositis Possess the Largest Late Stage (Phase II and III) Pipelines

2.4 Unmet Needs Remain in Each Indication, Primarily in Cancer Cachexia and Oral Mucositis, Given the Lack of Effective Therapies

2.5 R&D and Clinical Trial Design in Supportive Oncology Presents Unique Challenges

2.6 What Do Physicians Think?

3 Introduction

3.1 Objectives

3.2 Related Reports

4 Supportive Care in Oncology Global Landscape: KOL Views

4.1 Overview

4.2 US Supportive Care Landscape

4.2.1 Current Status of Supportive Care in Oncology

4.2.2 Physician and Patient Attitudes Towards Supportive Care in Oncology

4.2.3 Future Trends

4.3 UK Supportive Care Landscape

4.3.1 Current Status of Supportive Oncology and Physician/Patient Attitudes towards Supportive Oncology

4.3.2 Future Trends

4.4 Germany Supportive Care Landscape

4.4.1 Current Status of Supportive Oncology and Physician/Patient Attitudes towards Supportive Oncology

4.4.2 Future Trends

4.5 Spain Supportive Care Landscape

4.6 Japan Supportive Care Landscape

4.6.1 Who Provides Supportive Care in Japan

4.6.2 Current State of Supportive Oncology in Japan

4.6.3 Future Trends

4.7 Guidelines Followed by KOLs

4.7.1 Chemotherapy Induced Nausea and Vomiting

4.7.2 Chemotherapy-Induced Neutropenia

5 Epidemiology

5.1 Cancer Background, Global and Historic Trends

5.2 Methodology and Sources

5.2.1 Assumptions and Methods

5.3 Epidemiology for Supportive Care in Oncology (2016-2026)

5.3.1 Diagnosed Incident Cases of All Cancer

5.3.2 Diagnosed Incident Cases of All Cancer Receiving Chemotherapy Treatment

5.3.3 Diagnosed Incident Cases of Chemotherapy-Induced Conditions

5.3.4 Diagnosed Incident Cases of Prostate Cancer

5.3.5 Diagnosed Incident Cases of Prostate Cancer That Develop Bone Metastasis

5.3.6 Diagnosed Incident Cases of Breast Cancer

5.3.7 Diagnosed Incident Cases of Breast Cancer That Develop Bone Metastasis

5.3.8 Diagnosed Incident Cases of Lung Cancer

5.3.9 Diagnosed Incident Cases of Lung Cancer that Develop Bone Metastasis

5.3.10 Five-Year Diagnosed Prevalent Cases of All Cancer

5.4 Discussion, Limitations and Strengths of Analysis

6 Marketed Products

6.1 Chemotherapy-Induced Nausea and Vomiting

6.1.1 Emend and Emend for Injection

6.1.2 Varubi and Varubi IV

6.1.3 Aloxi

6.1.4 Sustol

6.1.5 Akynzeo

6.1.6 Syndros and Marinol

6.1.7 Olanzapine-Off-Label Use

6.2 Cancer Cachexia

6.3 Oral Mucositis

6.3.1 Kepivance

6.3.2 Mucosta (Off-Label) and Gels for Oral Mucositis

6.4 Bone Metastases

6.4.1 Xgeva

6.4.2 Xofigo

6.4.3 Zometa and Aredia

6.5 Chemotherapy-Induced Neutropenia

6.5.1 Neupogen

6.5.2 Filgrastim Biosimilars

6.5.3 Granix and Granocyte

6.5.4 Neulasta

6.5.5 Lonquex and Leukine

6.6 Chemotherapy Induced Anemia

6.6.1 Procrit/Eprex/Epogen

6.6.2 Epoetin Alfa Biosimilars, NeoRecormon, and Eporatio / Biopoin

6.6.3 Aranesp

7 Pipeline Assessment

7.1 Chemotherapy-Induced Nausea and Vomiting

7.1.1 CINV Phase II and III Pipeline

7.1.2 APD403 (Amisulpride)-Acacia Pharma

7.1.3 Cinvanti (Aprepitant/HTX-019)-Heron Therapeutics

7.2 Cancer Cachexia

7.2.1 Cancer Cachexia Phase II and III Pipeline Overview

7.2.2 Adlumiz (Anamorelin)-Helsinn 10

7.2.3 Xilonix (MABp1)-XBiotech

7.3 Oral Mucositis

7.3.1 Oral Mucositis Phase II and III Pipeline Overview

7.3.2 SGX942 (Dusquetide)-Soligenix Inc.

7.3.3 Validive (Clonidine Lauriad)-Onxeo/Monopar Therapeutics

7.4 Bone Metastases

7.4.1 Bone Metastases Phase II and III Pipeline Overview

7.4.2 Tanezumab-Pfizer and Eli Lilly

7.5 Chemotherapy-Induced Neutropenia

7.5.1 CIN Phase II and III Pipeline Overview

7.5.2 Rolontis (eflapegrastim/SPI-2012)-Spectrum Pharmaceuticals and Hanmi Pharmaceuticals

7.5.3 Plinabulin (NPI-2358)-BeyondSpring Pharmaceuticals

7.6 Chemotherapy-Induced Anemia

7.6.1 CIA Phase II and III Pipeline Overview

7.6.2 SPP-003 (5-Aminolevulinic Acid Hydrochloride and Sodium Ferrous Citrate)-SBI Pharmaceuticals

8 Unmet Needs and Opportunities

8.1 Chemotherapy-Induced Nausea and Vomiting

8.1.1 Therapies with More Effective Control of Nausea

8.1.2 Novel Mechanisms of Action and Differentiation from Currently Available Therapies

8.1.3 CINV Treatment/Regimens for Oral Anti-Cancer Drugs

8.1.4 Education of Stakeholders on Available Treatment Options and Proper Utilization

8.1.5 Other Unmet Needs

8.2 Cancer Cachexia

8.2.1 Huge Unmet Need for Treatments

8.2.2 Need for Improved Diagnosis and Identification of Cachexia in Obese Patients

8.2.3 Lack of Research, and Cachexia Not Given Priority in Cancer Care

8.3 Oral Mucositis

8.3.1 Need for Effective Treatments

8.3.2 Improved Forms of Administration

8.4 Bone Metastases

8.4.1 New Targets and Novel Mechanisms of Action

8.4.2 Improvements in Quality of Life and in Pain

8.4.3 Therapies with Oral Administration

8.4.4 Further Investigation of Corticosteroids for Painful Bone Metastases

8.5 Chemotherapy-Induced Neutropenia

8.5.1 New Treatments to Update Regimens from the Decades-Old Therapies Currently Available

8.5.2 New Forms of Administration, Fewer Side Effects, and Biomarkers

8.6 Chemotherapy-Induced Anemia

8.6.1 Therapies with a Better Side Effect Profile and Faster Demonstration of Effectiveness than ESAs

8.6.2 Further Investigation of IV Iron in CIA, and Subsequent Update to Treatment Guidelines

9 R&D Strategies and Clinical Trial Design

9.1 Overview of Clinical Development in Supportive Oncology

9.2 Chemotherapy-Induced Nausea and Vomiting

9.2.1 R&D Strategies

9.2.2 Clinical Trial Design Considerations

9.3 Cancer Cachexia

9.3.1 R&D Strategies

9.3.2 Clinical Trial Design Considerations

9.4 Oral Mucositis

9.4.1 R&D Strategies

9.4.2 Clinical Trial Considerations

9.5 Bone Metastasis

9.5.1 R&D Strategies and Clinical Trial Considerations

9.6 Chemotherapy-Induced Neutropenia

9.6.1 R&D Strategies

9.6.2 Clinical Trial Design Considerations

9.7 Chemotherapy-Induced Anemia

9.7.1 R&D Strategies and Clinical Trial Design Considerations

10 Appendix

10.1 Bibliography

10.2 Abbreviations

10.3 Primary Research-KOLs Interviewed for This Report

10.4 About the Authors

10.4.1 Analyst

10.4.2 Therapy Area Director

10.4.3 Epidemiologists

10.4.4 Reviewers

10.4.5 Global Director of Therapy Analysis and Epidemiology

10.4.6 Global Head and EVP of Healthcare Operations and Strategy

10.5 About GlobalData

10.6 Contact Us

10.7 Disclaimer

1.2 List of Figures

Figure 1: 7MM, Age-Standardized Diagnosed Incidence of All Cancer, Men, Ages ?18 Years, 2016-

Figure 2: 7MM, Age-Standardized Diagnosed Incidence of All Cancer, Women, Ages ?18 Years, 2016-2026

Figure 3: 7MM, Sources Used to Forecast Diagnosed Incident Cases of All Cancer

Figure 4: 7MM, Sources Used to Forecast Five-Year Diagnosed Prevalent Cases of All Cancer

Figure 5: 7MM, Sources Used to Forecast Diagnosed Incident Cases of Prostate Cancer

Figure 6: 7MM, Sources Used to Forecast Diagnosed Incident Cases of Breast Cancer

Figure 7: 7MM, Sources Used to Forecast Diagnosed Incident Cases of Lung Cancer

Figure 8: 7MM, Sources Used to Forecast Chemotherapy-Induced Conditions

Figure 9: 7MM, Sources Used to Forecast Bone Metastasis in Prostate, Breast, and Lung Cancer

Figure 10: 7MM, Diagnosed Incident Cases of All Cancer Receiving Chemotherapy Treatment, Men and Women, Ages ?18 Years

Figure 11: 7MM, Diagnosed Incident Cases of All Cancer With Chemotherapy-Induced Conditions, Men and Women, Ages ?18 Years

Figure 12: 7MM, Diagnosed Incident Cases of Prostate Cancer, Men, Ages ?35 Years

Figure 13: 7MM, Diagnosed Incident Cases of Prostate Cancer That Have Developed or Will Develop Bone Metastasis, Men, Ages ?35 Years

Figure 14: 7MM, Diagnosed Incident Cases of Breast Cancer, Women, Ages ?20 Years

Figure 15: 7MM, Diagnosed Incident Cases of Breast Cancer That Have Developed or Will Develop Bone Metastasis, Women, Ages ?20 Years

Figure 16: 7MM, Diagnosed Incident Cases of Lung Cancer, Men and Women, Ages ?20 Years

Figure 17: 7MM, Diagnosed Incident Cases of Lung Cancer That Have Developed or Will Develop Bone Metastasis, Men and Women, Ages ?20 Years

Figure 18: 7MM, Five-Year Diagnosed Prevalent Cases of All Cancer, Men and Women, All Ages

Figure 19: Unmet Needs and Opportunities in CINV, 2017

Figure 20: Unmet Needs and Opportunities in Cancer Cachexia, 2017

Figure 21: Unmet Needs and Opportunities in Oral Mucositis 2017

Figure 22: Unmet Needs and Opportunities in Bone Metastases, 2017

Figure 23: Unmet Needs and Opportunities in CIN, 2017

Figure 24: Unmet Needs and Opportunities in CIA 2017

1.1 List of Tables

Table 1: 7MM, Diagnosed Incident Cases of All Cancer, Men and Women, Ages ?20 Years

Table 2: CINV Marketed Products Overview

Table 3: Types of CINV

Table 4: Product Profile-Emend

Table 5: Product Profile-Emend for Injection / IVemend

Table 6: Product Profile-Varubi and Varubi IV

Table 7: Product Profile-Aloxi

Table 8: Product Profile-Sustol

Table 9: Product Profile-Akynzeo

Table 10: Product Profile-Kepivance

Table 11: Bone Metastases Marketed Products Overview

Table 12: Product Profile-Xgeva

Table 13: Product Profile-Xofigo

Table 14: Product Profile-Zometa

Table 15: Product Profile-Aredia

Table 16: CIN Marketed Products Overview

Table 17: Product Profile-Neupogen

Table 18: Filgrastim Biosimilars

Table 19: Product Profile-Granix

Table 20: Product Profile-Granocyte

Table 21: Product Profile-Neulasta

Table 22: Product Profile-Lonquex

Table 23: Product Profile-Leukine

Table 24: CIA Marketed Products Overview

Table 25: National Cancer Institute Anemia Scale

Table 26: Product Profile-Procrit/Eprex/Epogen

Table 27: Epoetin Alfa Biosimilars

Table 28: Product Profile-NeoRecormon

Table 29: Product Profile-Eporatio/Biopoin

Table 30: Product Profile-Aranesp

Table 31: CINV Phase II and III Pipeline

Table 32: APD403 (Amisulpride)-Acacia Pharma, SWOT Analysis, 2017

Table 33: Cinvanti (Aprepitant/HTX-019)-Heron Therapeutics, SWOT Analysis, 2017

Table 34: Cancer Cachexia Phase II and III Pipeline

Table 35: Adlumiz (Anamorelin)-Helsinn, SWOT Analysis, 2017

Table 36: Xilonix (MABp1)-XBiotech, SWOT Analysis, 2017

Table 37: Oral Mucositis Phase II and III Pipeline

Table 38: Phase III Clinical Development Programs for SGX942 (Dusquetide) in Oral Mucositis

Table 39: SGX942 (Dusquetide)-Soligenix, SWOT Analysis, 2017

Table 40: Validive (Clonidine Lauriad)-Onxeo / Monopar Therapeutics, SWOT Analysis, 2017

Table 41: Bone Metastases Phase II and III Pipeline

Table 42: Phase III Clinical Development Programs for Tanezumab-Pfizer and Eli Lilly in Bone Metastases

Table 43: Tanezumab-Pfizer and Eli Lilly, SWOT Analysis, 2017

Table 44: CIN Phase II and III Pipeline

Table 45: Phase III Clinical Development Program for Rolontis (Eflapegrastim/SPI-2012-Spectrum Pharmaceuticals and Hanmi Pharmaceuticals) in CIN

Table 46: Rolontis (Eflapegrastim/SPI-2012)-Spectrum Pharmaceuticals and Hanmi Pharmaceuticals, SWOT Analysis, 2017

Table 47: Phase II/III Clinical Development Programs for Plinabulin (NPI-2358)-BeyondSpring Pharmaceuticals in CIN

Table 48: Plinabulin (NPI-2358)-BeyondSpring Pharmaceuticals, SWOT Analysis, 2017

Table 49: CIA Phase II and III Pipeline

Table 50: SPP-003 (5-Aminolevulinic Acid Hydrochloride and Sodium Ferrous Citrate)-SBI Pharmaceuticals, SWOT Analysis, 2017

Table 51: Oral Mucositis Pipeline Agents: Methods of Administration

Table 52: Definitions of the Most Common CINV Trial Endpoints

Table 53: Oral Mucositis Late-Stage Pipeline Agents: FDA Fast Track Designations

Table 54: Primary Endpoints Used in Trials for Oral Mucositis Pipeline Agents

Table 55: Examples of Primary and Secondary Endpoints that Can Be Studied in CIN Trials

Table 56: Common Outcomes of Interest in Anemia Clinical Trials

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