Melanoma – Global Drug Forecast and Market Analysis to 2029

Melanoma of the skin is a serious and aggressive form of cancer originating from melanocytes, the pigment cells in skin, and can develop anywhere on the body. Although melanoma has high survivability, it remains a significant health risk around the world. Where possible, melanoma is treated with surgery, with stage III patients likely to receive adjuvant therapy with either PD-1 inhibitors; BMS’ Opdivo or Merck & Co’s Keytruda or, if BRAF V600-positive, Novartis’ BRAF/MEK inhibitor combination Tafinlar + Mekinist. Metastatic melanoma is treated with systemic therapy with either PD-1 monotherapy (Opdivo or Keytruda) or BMS’ combination therapy of Opdivo + CTLA-4 inhibitor Yervoy. BRAF V600-positive patients also have the option of receiving targeted therapy.

The global market is expected to grow from $5.6B in 2019 to $7.46B in 2029 at a CAGR of 2.9%. The introduction of 12 new pipeline agents as well as label expansions of currently approved agents are key drivers of this market growth. However, multiple patent expiries of market-leading brands, occurring across the 8MM, will prohibit growth.

KEY QUESTIONS ANSWERED

– 12 late-stage pipeline agents are expected to enter the melanoma market from 2021 onwards. What impact will these agents have on the market? Which of these drugs will have the highest peak sales, and why?

– What are the current unmet needs melanoma, which pipeline agents are positioned to counter these unmet needs? What are the opportunities for R&D?

– What is the market outlook in the 8MM from 2019-2029? Considering major patent expiries, launch of new premium priced agents and expected label expansions.

– What are the main corporate trends? Who are the current and future players?

Scope

Overview of melanoma including epidemiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.

Topline melanoma market revenue, annual cost of therapy, and major pipeline product sales in the forecast period.

Key topics covered include current treatment and pipeline therapies, unmet needs and opportunities, and the drivers and barriers affecting melanoma therapeutics sales in the 8MM.

Pipeline analysis: Comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs (Phase II – III).

Analysis of the current and future market competition in the global melanoma therapeutics market. Insightful review of the key industry drivers and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Key Highlights

The main drivers of growth include the anticipated approval and launch of 12 pipeline therapies, in addition to label expansions of currently marketed therapies across the 8MM during the forecast period.

The main barriers to growth in the 8MM are key patent expiries of immune checkpoint inhibitors and targeted BRAF/MEK inhibitors

Among the late-stage pipeline products and marketed agents, immune checkpoint inhibitors are expected to generate the greatest revenues over the forecast period.

The most important unmet needs in the melanoma market include: wider therapeutic options for patients who progress on immune checkpoint inhibitors, effective treatment for patients with brain metastases, biomarkers to guide treatment decisions, and wider options for patients with acquired resistance to targeted therapy.

Reasons to buy

The report will enable you to:

Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current pipeline products and technologies to identify companies with the most robust pipelines.

Develop business strategies by understanding the trends shaping and driving the global melanoma therapeutics market.

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

Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.

Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.

Track drug sales in the global melanoma therapeutics market from 2019-2029.

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

Companies mentioned

Amgen

Bayer

Bristol Myers Squibb

Checkmate Pharmaceuticals

Chipscreen Biosciences

Clinigen

Eisai

Genentech/Roche

HUYA Biosciences

Idera Pharmaceuticals

Iovance Biotherapeutics

Merck & Co.

Nektar Therapeutics

Novartis

OncoSec Medical

Pfizer/Array BioPharma

Philogen S.p.A

Polynoma LLC

Ultimovacs ASA

Table of Contents

| Contents

| List of Tables

| List of Figures

| About GlobalData

1 Melanoma: Executive Summary

1.1 The Melanoma Market Will Expand to $7.4B in 2029

1.2 BMS Expected to Maintain its Market-Leading Position

1.3 The Lack of Options for Patients Who Progress on Immune Checkpoint Inhibitors Remains a Major Unmet Need

1.4 Novel Immunotherapies Expected to Launch in Adjuvant and Advanced Settings

1.5 What Do Physicians Think?

2 Introduction

2.1 Catalyst

2.2 Related Reports

2.3 Upcoming Reports

3 Disease Overview

3.1 Etiology and Pathophysiology

3.1.1 Etiology

3.1.2 Pathophysiology

3.2 Classification or Staging Systems

4 Epidemiology

4.1 Disease Background

4.2 Risk Factors and Comorbidities

4.3 Global and Historical Trends

4.4 Forecast Methodology

4.4.1 Sources

4.4.2 Forecast Assumptions and Methods

4.4.3 Diagnosed Incident Cases of Melanoma

4.4.4 Diagnosed Incident Cases of Melanoma by Stage at Diagnosis

4.4.5 Mutations Among Diagnosed Incident Cases of Melanoma

4.4.6 Five-Year Diagnosed Prevalent Cases of Melanoma

4.5 Epidemiological Forecast for Melanoma, 2019-2029

4.5.1 Diagnosed Incident Cases of Melanoma

4.5.2 Sex-Specific Diagnosed Incident Cases of Melanoma

4.5.3 Age-Specific Diagnosed Incident Cases of Melanoma

4.5.4 Diagnosed Incident Cases of Melanoma by Stage at Diagnosis

4.5.5 Diagnosed Incident Cases of Melanoma by Mutations

4.5.6 Five-Year Diagnosed Prevalent Cases of Melanoma

4.6 Discussion

4.6.1 Epidemiological Forecast Insight

4.6.2 COVID-19 Impact

4.6.3 Limitations of the Analysis

4.6.4 Strengths of the Analysis

5 Disease Management

5.1 Diagnosis and Treatment Overview

5.1.1 US

5.1.2 EU

5.1.3 Canada

5.1.4 Australia

5.2 KOL Insights on Disease Management

6 Competitive Assessment

6.1 Overview

7 Unmet Needs and Opportunity Assessment

7.1 Overview

7.2 Lack of Options for Patients Who Progress on Immune Checkpoint Inhibitors

7.3 Effective Treatment for Patients with Brain Metastases

7.4 Lack of Biomarkers to Guide Treatment Decisions

7.5 Acquired Resistance to Targeted Therapy

8 R&D Strategies

8.1 Overview

8.1.1 Development of Novel Combinations with Immune Checkpoint Inhibitors

8.1.2 Expansions into Earlier Lines of Therapy

8.1.3 Development of Therapies with Improved Toxicities

8.2 Clinical Trials Design

8.2.1 Addition of Standard of Care Comparator Arms

8.2.2 Preferred Endpoints

8.2.3 Brain Metastases

9 Pipeline Assessment

9.1 Overview

9.2 Promising Drugs in Clinical Development

10 Pipeline Valuation Analysis

10.1 Overview

10.2 Competitive Assessment

11 Current and Future Players

11.1 Overview

11.2 Deal-Making Trends

12 Market Outlook

12.1 Global Markets

12.1.1 Forecast

12.1.2 Drivers and Barriers – Global Issues

12.2 US

12.2.1 Forecast

12.2.2 Key Events

12.2.3 Drivers and Barriers

12.3 5EU

12.3.1 Forecast

12.3.2 Key Events

12.3.3 Drivers and Barriers

12.4 Canada

12.4.1 Forecast

12.4.2 Key Events

12.4.3 Drivers and Barriers

12.5 Australia

12.5.1 Forecast

12.5.2 Key Events

12.5.3 Drivers and Barriers

13 Appendix

13.1 Bibliography

13.2 Abbreviations

13.3 Methodology

13.3.1 Forecasting Methodology

13.4 Primary Research – KOLs Interviewed for This Report

13.4.1 KOLs

13.5 Primary Research – Prescriber Survey

13.6 About the Authors

13.6.1 Analyst

13.6.2 Analyst

13.6.3 Therapy Area Director

13.6.4 Epidemiologist

13.6.5 Epidemiology Reviewers

13.6.6 Global Director of Therapy Analysis and Epidemiology

13.6.7 Global Head and EVP of Healthcare Operations and Strategy

13.7 Contact Us

List of Tables

Table 1: Melanoma Key Metrics in the 8MM

Table 2: Pathologic Stage Definitions for Melanoma

Table 3: Risk Factors and Comorbidities for Melanoma

Table 4: 8MM, Diagnosed Incident Cases of Melanoma by Mutations, Ages ≥18 Years, Both Sexes, N, 2019

Table 5: Treatment Guidelines for Melanoma

Table 6: Top 10 Deals by Value, 2018-2020

Table 7: Melanoma Market – Global Drivers and Barriers, 2019-2029

Table 8: Key Events Impacting Sales for Melanoma in the US, 2019-2029

Table 9: Melanoma Market – Drivers and Barriers in the US, 2019-2029

Table 10: Key Events Impacting Sales for Melanoma in the 5EU, 2019-2029

Table 11: Melanoma Market – Drivers and Barriers in the 5EU, 2019-2029

Table 12: Key Events Impacting Sales for Melanoma in Canada, 2019-2029

Table 13: Melanoma Market – Drivers and Barriers in Canada, 2019-2029

Table 14: Key Events Impacting Sales for Melanoma in Australia, 2019-2029

Table 15: Melanoma Market – Drivers and Barriers in Australia, 2019-2029

Table 16: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

Figure 1: Global Sales Forecast by Country for Melanoma in 2019 and 2029

Figure 2: Analysis of the Company Portfolio Gap in Melanoma During the Forecast Period

Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to be Licensed for the Treatment of Melanoma in the Adjuvant and Neoadjuvant Settings During the Forecast Period

Figure 4: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to be Licensed for the Treatment of Melanoma in the First-Line During the Forecast Period

Figure 5: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to be Licensed for the Treatment of Melanoma in the Second Line During the Forecast Period

Figure 6: Signaling Pathways Commonly Activated in Melanoma

Figure 7: 8MM, Diagnosed Incidence of Melanoma, Men, Ages ≥18 Years, 2009-2029

Figure 8: 8MM, Diagnosed Incidence of Melanoma, Women, Ages ≥18 Years, 2009-2029

Figure 9: 8MM, Sources Used and Not Used to Forecast the Diagnosed Incident Cases of Melanoma

Figure 10: 8MM, Sources Used to Forecast the Diagnosed Incident Cases of Melanoma by Stage at Diagnosis

Figure 11: 8MM, Sources Used to Forecast the Diagnosed Incident Cases of Melanoma by Mutations

Figure 12: 8MM, Sources Used to Forecast the Five-Year Diagnosed Prevalent Cases of Melanoma

Figure 13: 8MM, Diagnosed Incident Cases of Melanoma, Both Sexes, Ages ≥18 Years, N, 2019

Figure 14: 8MM, Diagnosed Incident Cases of Melanoma, by Sex, Ages ≥18 Years, N, 2019

Figure 15: 8MM, Diagnosed Incident Cases of Melanoma by Age, Both Sexes, N, 2019

Figure 16: 8MM, Diagnosed Incident Cases of Melanoma by Stage at Diagnosis, Both Sexes, Ages ≥18 Years, N, 2019

Figure 17: 8MM, Five-Year Diagnosed Prevalent Cases of Melanoma, Ages ≥18 Years, Both Sexes, N, 2019

Figure 18: Overview of the Treatment Algorithm in Melanoma

Figure 19: Unmet Needs and Opportunities in Melanoma

Figure 20: Overview of the Development Pipeline in Melanoma

Figure 21: Key Late-Stage Trials for the Promising Pipeline Agents that GlobalData Expects to Be Licensed for Melanoma in the 8MM During the Forecast Period

Figure 22: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOC, Opdivo – Adjuvant and Neoadjuvant Therapies

Figure 23: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOC, PD-1 Monotherapy – First Line

Figure 24: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOC, Opdivo + Yervoy – Second Line

Figure 25: Analysis of the Company Portfolio Gap in melanoma During the Forecast Period

Figure 26: Global (8MM) Sales Forecast by Country for Melanoma in 2019 and 2029

Figure 27: Sales Forecast by Class for Melanoma in the US in 2019 and 2029

Figure 28: Sales Forecast by Class for Melanoma in the 5EU in 2019 and 2029

Figure 29: Sales Forecast by Class for Melanoma in Canada in 2019 and 2029

Figure 30: Sales Forecast by Class for Melanoma in Australia in 2019 and 2029

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