Melanoma – Australia Drug Forecast and Market Analysis to 2023

Pages: 262 Published: April 01, 2015 Report Code: GDHC339CFR

Melanoma is the deadliest and most aggressive form of skin cancer. The major treatments for melanoma are categorized into immunotherapies and BRAF mutation-targeted therapies. GlobalData estimates the 2013 sales for melanoma at approximately $1.34 billion across the 8MM covered in this report. The market will increase by four-fold over the forecast period, reaching $5.64 billion in 2023 at a CAGR of 15.5%. This growth will be driven by an increase in melanoma incident cases as well as the approval and uptake of premium-priced products, such as PD-1-targeting mAbs and BRAF/MEK inhibitor combinations. GlobalData expects, by the end of the forecast period, the checkpoint immunotherapy drug class to dominate the melanoma market (including both BRAF wild-type and mutation-positive patient segments) with an overall 67% share of the melanoma market. GlobalData expects growth of this market to be driven by increasing disease incident cases as the population ages, the launch of expensive new therapies including anti-PD-1 immunotherapies and BMS’ Yervoy/Opdivo combination, and the label expansion of metastatic drugs into the adjuvant setting. However, market growth in Australia is expected to be restricted by the PBS’s reimbursement watchdog, PBAC. At present, Zelboraf and Mekinist have not been given approval from PBAC in Australia, although patients can access Mekinist through a patient access program. In addition, since the reimbursement approval of Tafinlar, Yervoy is only reimbursed when given after BRAF/MEK inhibitor treatment. *This is an on-demand report and will be delivered within 24 hrs. (excluding weekends) of the purchase.

Scope

Overview of Melanoma including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.

Detailed information on the key drugs in Australia including product Melanomacription, safety and efficacy profiles as well as a SWOT analysis.

Sales forecast for the top drugs in Australia from 2013-2023.

Analysis of the impact of key events as well the drivers and restraints affecting Australia Melanoma market.

Reasons to Buy

Understand and capitalize by identifying products that are most likely to ensure a robust return

Stay ahead of the competition by understanding the changing competitive landscape for Melanoma.

Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential

Make more informed business decisions from insightful and in-depth analysis of drug performance

Obtain sales forecast for drugs from 2013-2023 in Australia.

Table of Contents

1Table of Contents

1.1List of Tables

1.2List of Figures

2Introduction

2.1Catalyst

2.2Related Reports

2.3Upcoming Related Reports

3Disease Overview

3.1Etiology and Pathophysiology

3.1.1Etiology

3.1.2Pathophysiology

3.1.3Melanoma Biomarkers

3.2Clinical Staging

3.3Symptoms

3.4Prognosis

3.5Quality of Life

4Disease Management

4.1Diagnosis Overview

4.2Treatment Overview

4.2.1Localized Melanoma: Stage 0 to Stage IIC

4.2.2Regional Melanoma: Stage IIIA to Stage IIIC

4.2.3Unresectable and Metastatic Melanoma: Stage III and Stage IV

4.3Australia

4.3.1Screening and Diagnosis

4.3.2Clinical Practices

5Competitive Assessment

5.1Overview

5.2Interferon-based Adjuvant Therapies

5.2.1Roferon-A (Interferon Alfa-2a)

5.2.2Intron A (Interferon Alfa-2b)

5.2.3Sylatron (Peginterferon Alfa-2b)

5.3Immune Checkpoint Inhibitors

5.3.1Yervoy (Ipilimumab)

5.3.2Opdivo (Nivolumab)

5.3.3Keytruda (Pembrolizumab)

5.4BRAF Mutation-targeted Therapies

5.4.1Zelboraf (Vemurafenib)

5.4.2Tafinlar (Dabrafenib)

5.4.3Mekinist (Trametinib)

5.5Other Therapeutic Classes

6Unmet Need and Opportunity Analysis

6.1Overview

6.2Therapeutic Options for BRAF Wild-Type Patients

6.2.1Unmet Need

6.2.2Gap Analysis

6.2.3Opportunity

6.3Therapies for Non-responders to PD-1 Immunotherapy

6.3.1Unmet Need

6.3.2Gap Analysis

6.3.3Opportunity

6.4Adjuvant Therapies for High-Risk Resectable Melanoma

6.4.1Unmet Need

6.4.2Gap Analysis

6.4.3Opportunity

6.5Effective Treatment for Brain Metastases

6.5.1Unmet Need

6.5.2Gap Analysis

6.5.3Opportunity

6.6Predictive Markers for Therapeutic Response to Immunotherapies

6.6.1Unmet Need

6.6.2Gap Analysis

6.6.3Opportunity

7Pipeline Assessment

7.1Overview

7.2Promising Drugs in Clinical Development

7.3RAF/RAS/MEK Pathway-Targeting Therapies

7.3.1Cobimetinib (GDC-0973)

7.3.2Encorafenib (LGX818)

7.3.3Binimetinib (MEK162)

7.4Immune-Related Therapies

7.4.1Talimogene Laherparepvec

7.4.2Eltrapuldencel-T (NSB20)

7.4.3Seviprotimut-L (POL-103A)

7.4.4PV-10

7.5Promising Drugs in Early-Stage Development

7.5.1PI3K/Akt/mTOR Pathway-Targeting Therapies

7.5.2Cell Cycle Checkpoint Inhibitors

7.5.3Next-Generation BRAF Inhibitors

7.5.4Immunotherapies

7.5.5Antibody-Drug Conjugates

7.6Other Drugs in Development

8Market Outlook

8.1Australia

8.1.1Forecast

8.1.2Key Events

8.1.3Drivers and Barriers — Australia

9Appendix

9.1Bibliography

9.2Abbreviations

9.3Methodology

9.4Forecasting Methodology

9.4.1Diagnosed Melanoma Patients

9.4.2Percent Drug-Treated Patients

9.4.3Drugs Included in Each Therapeutic Class

9.4.4Launch and Patent Expiry Dates

9.4.5General Pricing Assumptions

9.4.6Average Body Weight and Surface Area Across the 8MM

9.4.7Individual Drug Assumptions

9.4.8Generic Erosion

9.4.9Pricing of Pipeline Agents

9.5Primary Research – KOLs Interviewed for this Report

9.6Primary Research – Prescriber Survey

9.7About the Authors

9.7.1Analyst

9.7.2Therapy Area Director

9.7.3Epidemiologist

9.7.4Global Head of Healthcare

9.8About GlobalData

9.9Disclaimer

List of Tables

Table 1: Stage Definitions for Melanoma

Table 2: The ABCED Rule of Melanoma Detection

Table 3: Prognosis of Melanoma

Table 4: Clinical Guidelines for Melanoma

Table 5: Most Prescribed Drugs for Melanoma by Class in the Global Markets, 2013

Table 6: Country Profile — Australia

Table 7: Leading Treatments for Melanoma, 2013

Table 8: Product Profile — Roferon-A

Table 9: Safety of Roferon-A

Table 10: Roferon-A SWOT Analysis, 2015

Table 11: Global Sales Forecast ($m) for Roferon-A, 2013–2023

Table 12: Product Profile — Intron A

Table 13: Efficacy of Intron A (E1684)

Table 14: Safety of Intron A (E1684, E1690, and E1694)

Table 15: Intron A SWOT Analysis, 2015

Table 16: Global Sales Forecast ($m) for Intron A, 2013–2023

Table 17: Product Profile — Sylatron

Table 18: Efficacy of Sylatron (EORTC 18991, NCT00006249)

Table 19: Head-to-Head Comparison Between Sylatron and Low-Dose Interferon

Table 20: Safety of Sylatron

Table 21: Sylatron SWOT Analysis, 2015

Table 22: Global Sales Forecast ($m) for Sylatron, 2013–2023

Table 23: Product Profile — Yervoy

Table 24: Efficacy of Yervoy

Table 25: Comparison of Higher Dose Yervoy and Dacarbazine (NCT00324155)

Table 26: Network Meta-analysis of Yervoy

Table 27: Safety of Yervoy at 3mg/kg (NCT00094653)

Table 28: Safety Data from Yervoy Dose-Escalation Study (NCT00289640)

Table 29: Yervoy SWOT Analysis, 2015

Table 30: Global Sales Forecast ($m) for Yervoy, 2013–2023

Table 31: Product Profile — Opdivo

Table 32: Efficacy of Opdivo

Table 33: Efficacy of Opdivo in BRAF Wild-Type Advanced Melanoma (NCT01721772)

Table 34: Safety Data from Opdivo Dose-Escalation Study (NCT00730639)

Table 35: Safety Data from the CheckMate-037 Trial (NCT01721746)

Table 36: Opdivo SWOT Analysis, 2015

Table 37: Global Sales Forecast ($m) for Opdivo, 2013–2023

Table 38: Product Profile – Keytruda

Table 39: Efficacy of Keytruda from KEYNOTE-001 (NCT01295827)

Table 40: Efficacy of Keytruda from KEYNOTE-002 (NCT01704287)

Table 41: Safety of Keytruda

Table 42: Keytruda SWOT Analysis, 2015

Table 43: Global Sales Forecasts ($m) for Keytruda, 2013–2023

Table 44: Product Profile — Zelboraf

Table 45: Efficacy of Zelboraf

Table 46: Safety of Zelboraf

Table 47: Zelboraf SWOT Analysis, 2015

Table 48: Global Sales Forecasts ($m) for Zelboraf, 2013–2023

Table 49: Product Profile — Tafinlar

Table 50: Efficacy of Tafinlar

Table 51: Safety of Tafinlar

Table 52: Tafinlar SWOT Analysis, 2015

Table 53: Global Sales Forecast ($m) for Tafinlar, 2013–2023

Table 54: Product Profile — Mekinist

Table 55: Efficacy of Mekinist

Table 56: Efficacy Results of the COMBI-d Trial (NCT01584648)

Table 57: Efficacy Results of the COMBI-v Trial (NCT01072175)

Table 58: Safety of Mekinist

Table 59: Safety Results of the COMBI-d trial (NCT01584648)

Table 60: Safety Results of the COMBI-v trial (NCT01584648)

Table 61: Mekinist SWOT Analysis, 2015

Table 62: Global Sales Forecasts ($m) for Mekinist, 2013–2023

Table 63: Summary of Minor Therapeutic Classes, 2013

Table 64: Unmet Needs and Opportunities in Melanoma

Table 65: Product Profile — Cobimetinib

Table 66: Efficacy of the Zelboraf/Cobimetinib Combination

Table 67: Safety of the Zelboraf/Cobimetinib Combination

Table 68: Cobimetinib SWOT Analysis, 2015

Table 69: Global Sales Forecast ($m) for Cobimetinib, 2013–2023

Table 70: Product Profile — Encorafenib

Table 71: Efficacy of Encorafenib

Table 72: Encorafenib SWOT Analysis, 2015

Table 73: Global Sales Forecasts ($m) for Encorafenib, 2013–2023

Table 74: Product Profile — Binimetinib

Table 75: Efficacy of Binimetinib (NCT01320085)

Table 76: Safety of Binimetinib (NCT01320085)

Table 77: Binimetinib SWOT Analysis, 2015

Table 78: Global Sales Forecasts ($m) for Binimetinib, 2013–2023

Table 79: Product Profile — Talimogene Laherparepvec

Table 80: Efficacy of Talimogene Laherparepvec

Table 81: Safety of Talimogene Laherparepvec

Table 82: Talimogene Laherparepvec SWOT Analysis, 2015

Table 83: Global Sales Forecast ($m) for Talimogene Laherparepvec, 2013–2023

Table 84: Product Profile – Eltrapuldencel-T

Table 85: Efficacy of Eltrapuldencel-T

Table 86: Eltrapuldencel-T SWOT Analysis, 2015

Table 87: Global Sales Forecast ($m) for Eltrapuldencel-T, 2013–2023

Table 88: Product Profile — Seviprotimut-L

Table 89: Efficacy of Seviprotimut-L

Table 90: Seviprotimut-L SWOT Analysis, 2015

Table 91: Global Sales Forecast ($m) for Seviprotimut-L, 2013–2023

Table 92: Product Profile — PV-10

Table 93: Efficacy of PV-10

Table 94: Safety of PV-10

Table 95: PV-10 SWOT Analysis, 2015

Table 96: Global Sales Forecast ($m) for PV-10, 2013–2023

Table 97: Clinical Settings of Early-Stage Drugs Targeting the PI3K/Akt/mTOR Pathway

Table 98: Clinical Settings of Early-Stage Drugs Targeting Cell Cycle Checkpoints

Table 99: Clinical Settings of Early-Stage Next-Generation BRAF Inhibitors

Table 100: Clinical Settings of Early-Stage Immunotherapies

Table 101: Clinical Settings of Early-Stage Antibody-drug Conjugates

Table 102: Drugs in Development, 2015

Table 103: Sales Forecast ($m) for Melanoma in Australia, 2013–2023

Table 104: Key Events Impacting Sales for Melanoma in Australia, 2013–2023

Table 105: Melanoma Market in Australia – Drivers and Barriers, 2015

Table 106: Key Launch Dates

Table 107: Key Patent Expiries

Table 108 Average Body Weight and Surface Area Across the 8MM

Table 109: High-Prescribing Physicians Surveyed by Country

List of Figures

Figure 1: Treatment Flowchart for Localized Melanoma

Figure 2: Treatment Flowchart for Regional Melanoma

Figure 3: Treatment Flowchart for Recurrent Melanoma

Figure 4: Treatment Flowchart for Metastatic Melanoma

Figure 5: Yervoy’s Development in Melanoma

Figure 6: Opdivo’s Development in Melanoma

Figure 7: Keytruda’s Development in Melanoma

Figure 8: Zelboraf’s Development in Melanoma

Figure 9: Mekinist’s Development in Melanoma

Figure 10: Melanoma — Phase III Pipeline, 2015

Figure 11: Competitive Assessment of Late-Stage Pipeline Agents in Melanoma, 2013–2023

Figure 12: Cobimetinib’s Development in Melanoma

Figure 13: Clinical and Commercial Positioning of Cobimetinib

Figure 14: Encorafenib’s Development in Melanoma

Figure 15: Clinical and Commercial Positioning of Encorafenib

Figure 16: Binimetinib’s Development in Melanoma

Figure 17: Clinical and Commercial Positioning of Binimetinib

Figure 18: Talimogene Laherparepvec’s Development in Melanoma

Figure 19: Clinical and Commercial Positioning of Talimogene Laherparepvec

Figure 20: Eltrapuldencel-T’s Development in Melanoma

Figure 21: Clinical and Commercial Positioning of Eltrapuldencel-T

Figure 22: Seviprotimut-L’s Development in Melanoma

Figure 23: Clinical and Commercial Positioning of Seviprotimut-L

Figure 24: PV-10’s Development in Melanoma

Figure 25: Clinical and Commercial Positioning of PV-10

Figure 26: Sales for Melanoma in Australia by Drug Class, 2013–2023

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