PharmaPoint: Renal Cell Carcinoma – Global Drug Forecast and Market Analysis to 2023

Renal cell carcinoma (RCC) is among the 10 most frequently occurring cancers in Western countries. The RCC market is currently dominated by anti-angiogenic agents and tyrosine kinase inhibitors (TKIs) in particular, but it will experience dramatic changes over the forecast period as patents expire and promising new therapies enter the market. A large share of the RCC market is currently dominated by a few large companies, but they will struggle to retain these shares as they are joined by new entrants. One of these new entrants, Opdivo, is expected to have the largest market share by 2023. The different lines of treatment will offer up different battlegrounds and niches for companies, large and small, to compete for. The battle for the first-line of therapy is expected to be fierce, with three programmed death protein 1 (PD-1)/programmed death ligand 1 (PD-L1)-containing combination therapies backed by large companies lining up to compete. Out of this competition, new standards of care are expected to emerge for the different lines of treatment. There will also be a number of unmet needs still remaining at the end of the forecast period, and with that, the opportunity for pipeline drugs to carve out a niche in the RCC space.

Scope

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

Annualized RCC therapeutics market revenue, average cost of therapy and treatment usage pattern data from 2013 and forecast for ten years to 2023.

Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the RCC therapeutics market.

Pipeline analysis: comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.

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

Key Highlights

The RCC market is marked by the presence of a number of unmet needs. What are the main unmet needs in this market? Will the drugs under development fulfil the unmet needs of RCC market?

The late-stage RCC pipeline has therapies targeting different lines of therapy. Which drugs will have the biggest impact in each RCC setting? Which of these drugs will have the highest peak sales at the highest CAGR, and why?

Current therapies used to treat RCC include tyrosine kinase inhibitors and mTOR inhibitors. What will be the impact of the patent expiry of the current standard of care? How will the advent of new therapies change the drug treatment landscape for RCC? How will new drug combinations change the treatment paradigm of RCC? What are the key drivers and barriers to this change?

Companies mentioned

Acceleron

Argos Therapeutics

AVEO Oncology

Bayer

Bristol-Myers Squibb

Chugai

Eisai

Exelixis

Genentech

Immatics Biotechnologies

Merck & Co

Merck KGaA

Novartis

Ono Pharmaceutical

Pfizer

Rexahn Pharmaceuticals ...

Acceleron

Argos Therapeutics

AVEO Oncology

Bayer

Bristol-Myers Squibb

Chugai

Eisai

Exelixis

Genentech

Immatics Biotechnologies

Merck & Co

Merck KGaA

Novartis

Ono Pharmaceutical

Pfizer

Rexahn Pharmaceuticals

Roche

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 ...

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

3.2Clinical Staging

3.3Symptoms

3.4Prognostic Models

3.5Potential Biomarkers

4Epidemiology

4.1Disease Background

4.2Risk Factors and Comorbidities

4.3Global Trends

4.3.1Incidence

4.3.2Survival Rates for RCC – 8MM

4.4Forecast Methodology

4.4.1Sources Used

4.4.2Sources Not Used

4.4.3Forecast Assumptions and Methods for RCC Diagnosed Incident Cases

4.4.4Forecast Assumptions and Methods for RCC Five-Year Diagnosed Prevalent Cases

4.4.5Forecast Assumptions and Methods for RCC by Clinical Stage at Diagnosis

4.5Epidemiological Forecast of RCC (2013–2023)

4.5.1Diagnosed Incident Cases of RCC

4.5.2Age-Specific Diagnosed Incident Cases of RCC

4.5.3Sex-Specific Diagnosed Incident Cases of RCC

4.5.4Age-Standardized Diagnosed Incidence of RCC

4.5.5Diagnosed Incident Cases of RCC by Clinical Stage at Diagnosis

4.5.6Five-Year Diagnosed Prevalent Cases of RCC

4.6Discussion

4.6.1Epidemiological Forecast Insight

4.6.2Limitations of the Analysis

4.6.3Strengths of the Analysis

5Disease Management

5.1Diagnosis and Treatment Overview

5.1.1Screening and Diagnosis

5.1.2Surgical Management of RCC

5.1.3Treatment Guidelines and Leading Prescribed Drugs

5.1.4Clinical Practice

5.2US

5.2.1Diagnosis and Surgical Management

5.2.2Clinical Practice (Drug Treatment)

5.3France

5.3.1Diagnosis and Surgical Management

5.3.2Clinical Practice (Drug Treatment)

5.4Germany

5.4.1Diagnosis and Surgical Management

5.4.2Clinical Practice (Drug Treatment)

5.5Italy

5.5.1Diagnosis and Surgical Management

5.5.2Clinical Practice (Drug Treatment)

5.6Spain

5.6.1Diagnosis and Surgical Management

5.6.2Clinical Practice (Drug Treatment)

5.7UK

5.7.1Diagnosis and Surgical Management

5.7.2Clinical Practice (Drug Treatment)

5.8Japan

5.8.1Diagnosis and Surgical Management

5.8.2Clinical Practice (Drug Treatment)

5.9China

5.9.1Diagnosis and Surgical Management

5.9.2Clinical Practice (Drug Treatment)

6Competitive Assessment

6.1Overview

6.2Product Profiles – Major Brands

6.2.1Sutent (sunitinib)

6.2.2Nexavar (sorafenib)

6.2.3Votrient (pazopanib)

6.2.4Avastin (bevacizumab)

6.2.5Torisel (temsirolimus)

6.2.6Inlyta (axitinib)

6.2.7Afinitor (everolimus)

6.2.8Interferon-alfa

6.2.9Interleukin-2

6.2.10Tarceva (erlotinib)

7Unmet Needs and Opportunities

7.1Overview

7.2Challenge the Resistance to Metastatic RCC Treatments With New Targeted Agents Improving the Survival of Metastatic RCC Patients

7.2.1Unmet Need

7.2.2Gap Analysis

7.2.3Opportunity

7.3Drugs With Improved Tolerability Profiles

7.3.1Unmet Need

7.3.2Gap Analysis

7.3.3Opportunity

7.4More Efficacious Therapies for the Treatment of Unfavorable Risk Metastatic RCC

7.4.1Unmet Need

7.4.2Gap Analysis

7.4.3Opportunity

7.5Targeted Therapies for Non-Clear Cell RCC

7.5.1Unmet Need

7.5.2Gap Analysis

7.5.3Opportunity

7.6Novel Adjuvant Therapies for Non-Metastatic RCC

7.6.1Unmet need

7.6.2Gap Analysis

7.6.3Opportunity

7.7Biomarkers

7.7.1Overview

7.7.2Gap Analysis

7.7.3Opportunity

8Pipeline Assessment

8.1Overview

8.2Promising Drugs in Clinical Development

8.2.1Opdivo (nivolumab) and Yervoy (ipilimumab)

8.2.2Atezolizumab

8.2.3Cometriq (cabozantinib)

8.2.4IMA901

8.2.5AGS-003 (rocapuldencel-t)

8.2.6Tivozanib

8.2.7Lenvima (lenvatinib)

8.2.8Avelumab

9Promising Approaches in Early-Stage Development

9.1Keytruda (pembrolizumab)

9.1.1Overview

9.2Dalantercept (ACE-041)

9.2.1Overview

9.3Archexin (RX-021)

9.3.1Overview

9.4Other Drugs in Development

10Current and Future Players

10.1Overview

10.2Trends in Corporate Strategy

10.3Company Profiles

10.3.1Pfizer

10.3.2Novartis

10.3.3Bayer

10.3.4Roche

10.3.5Bristol-Myers Squibb

10.3.6Merck & Co.

10.3.7Exelixis

10.3.8Eisai

10.3.9AVEO Oncology

10.3.10Argos Therapeutics

11Market Outlook

11.1Global Markets

11.1.1Forecast

11.1.2Drivers and Barriers – Global Issues

11.2US

11.2.1Forecast

11.2.2Key Events

11.2.3Drivers and Barriers

11.35EU

11.3.1Forecast

11.3.2Key Events

11.3.3Drivers and Barriers

11.4Japan

11.4.1Forecast

11.4.2Key Events

11.4.3Drivers and Barriers

11.5China

11.5.1Forecast

11.5.2Key Events

11.5.3Drivers and Barriers

12Appendix

12.1Bibliography

12.2Abbreviations

12.3Methodology

12.4Forecasting Methodology

12.4.1Diagnosed RCC Patients

12.4.2Percent Drug-Treated Patients

12.4.3Drugs Included in Each Therapeutic Class

12.4.4Launch and Patent Expiration Dates

12.4.5General Pricing Assumptions

12.4.6Average Body Weight and Surface Area Across the 8MM

12.4.7General Forecast Assumptions

12.4.8Individual Drug Assumptions

12.4.9Generic Erosion

12.4.10Pricing of Pipeline Agents

12.5Primary Research – KOLs Interviewed for This Report

12.6Primary Research – High-Prescribers Surveyed for this Report

12.7About the Authors

12.7.1Author

12.7.2Epidemiologist

12.7.3Therapy Director

12.7.4Global Director of Therapy Analysis and Epidemiology

12.7.5Global Head of Healthcare

12.8About GlobalData

12.9Disclaimer

List of Tables

Table 1: Classifications of RCC

Table 2: TNM and Staging Classification System for RCC

Table 3: Symptoms of RCC

Table 4: Risk Factors and Comorbidities ...

Table 1: Classifications of RCC

Table 2: TNM and Staging Classification System for RCC

Table 3: Symptoms of RCC

Table 4: Risk Factors and Comorbidities for RCC

Table 5: Trends in the Age-Adjusted Incidence of Kidney Cancers in the US, Ages =20 Years, 1993–2007

Table 6: Trends in the Age-Adjusted Incidence of Kidney Cancers in the 5EU, Ages =20 Years, 1993–2007

Table 7: Trends in the Age-Adjusted Incidence of Kidney Cancers in Japan, Ages =20 Years, 1993–2007

Table 8: Trends in the Age-Adjusted Incidence of Kidney Cancers in Urban China, Ages =20 Years, 1993–2007

Table 9: Trends in the Five-Year Relative Survival (%) of Kidney Cancers in the 8MM, Both Sexes, 1993–2007

Table 10: 8MM, Sources of Epidemiological Data Used for the Forecast for RCC Diagnosed Incident Cases

Table 11: 8MM, Sources of Epidemiological Data Used for the Forecast for RCC Diagnosed Five-Year Prevalent Cases

Table 12: 8MM, Sources of Epidemiological Data Used for the Segmentation of RCC Incident Cases by Clinical Stage at Diagnosis

Table 13: 8MM, Diagnosed Incident Cases of RCC, Both Sexes, Ages =20 Years, N, 2013–2023

Table 14: 8MM, Age-Specific Diagnosed Incident Cases of RCC, Both Sexes, N (Row %), 2013

Table 15: 8MM, Sex-Specific Diagnosed Incident Cases of RCC, Ages =20 Years, N (Row %), 2013

Table 16: 8MM, Five-Year Diagnosed Prevalent Cases of RCC, Both Sexes, Ages =20 Years, N, 2013–2023

Table 17: Treatment Guidelines for RCC

Table 18: Most Prescribed Drugs for RCC by Class in the 8MM

Table 19: Country Profile – US

Table 20: Country Profile – France

Table 21: Country Profile – Germany

Table 22: Country Profile – Italy

Table 23: Country Profile – Spain

Table 24: Country Profile – UK

Table 25: Country Profile – Japan

Table 26: Country Profile – China

Table 27: Leading Treatments for RCC, 2015

Table 28: Product Profile – Sutent (sunitinib)

Table 29: Results of the Trial Comparing Sutent Versus IFN-alfa

Table 30: Summary of AEs from the Trial of Sutent Versus IFN-alfa

Table 31: Sutent SWOT Analysis, 2014

Table 32: Global Sales Forecasts ($m) for Sutent 2013–2023

Table 33: Product Profile – Nexavar (sorafenib)

Table 34: Results of the Trial Comparing Nexavar Versus Placebo

Table 35: Summary of AEs from the Trial of Nexavar versus Placebo

Table 36: Nexavar SWOT Analysis, 2014

Table 37: Global Sales Forecast ($m) for Nexavar, 2013-2023

Table 38: Product Profile – Votrient (pazopanib)

Table 39: Results of the Trial Comparing Votrient Versus Placebo

Table 40: Summary of the Results of the Trials Comparing Votrient Versus Sutent

Table 41: Summary of AEs from the Trial of Votrient Versus Sutent

Table 42: Votrient SWOT Analysis, 2014

Table 43: Global Sales Forecast ($m) for Votrient, 2013-2023

Table 44: Product Profile – Avastin (bevacizumab)

Table 45: Results of the Trial Comparing Avastin + IFN-alfa Versus IFN-alfa + Placebo

Table 46: Summary of AEs from the Trial of Avastin + IFN-alfa Versus IFN-alfa + placebo

Table 47: Avastin SWOT Analysis, 2014

Table 48: Global Sales Forecasts ($m) for Avastin, 2013-2023

Table 49: Product Profile – Torisel (temsirolimus)

Table 50: Results of the Trial Comparing Torisel Versus IFN-alfa Versus Torisel + IFN-alfa

Table 51: Summary of AEs from the Trial Comparing Torisel Versus IFN-alfa Versus Torisel + IFN-alfa

Table 52: Torisel SWOT Analysis, 2014

Table 53: Global Sales Forecasts ($m) for Torisel, 2013-2023

Table 54: Product Profile – Inlyta (axitinib)

Table 55: Results of the Trial Comparing Inlyta Versus Nexavar

Table 56: Summary of AEs from the Trial Comparing Inlyta Versus Nexavar

Table 57: Inlyta SWOT Analysis, 2014

Table 58: Global Sales Forecasts ($m) for Inlyta, 2013-2023

Table 59: Product Profile – Afinitor (everolimus)

Table 60: Results of the Record-1 Trial Comparing Afinitor Versus Placebo

Table 61: Summary of AEs from the Trial Comparing Afinitor Versus Placebo

Table 62: Afinitor SWOT Analysis

Table 63: Global Sales Forecasts ($m) for Afinitor, 2013-2023

Table 64: Results of the Trial Comparing IFN-alfa Versus IFN-alfa + vinblastine

Table 65: Summary of AEs from the Trial of IFN-alfa

Table 66: Results of the Trial Comparing High-Dose IL-2 Versus IL-2 + IFN-alfa

Table 67: Summary of AEs from the High-Dose IL-2 Versus IL-2 + IFN-alfa Trial

Table 68: Selected placebo-controlled, randomized adjuvant RCC trials

Table 69: Comparison of Therapeutic Classes in Development for RCC, 2016

Table 70: Product Profile – Opdivo (nivolumab)

Table 71: Product Profile – Yervoy (imilimumab)

Table 72: Efficacy of Opdivo in the CheckMate 025 Trial

Table 73: Efficacy of Opdivo + Yervoy, Opdivo + Stutent, and Opdivo + Votrient

Table 74: Safety of Opdivo and Afinitor from the CheckMate 025 Trial

Table 75: Safety Profile of Opdivo + Yervoy, Opdivo + Sutent, and Opdivo + Votrient

Table 76: Opdivo (monotherapy or combination with Yervoy) SWOT Analysis, 2016

Table 77: Global Sales Forecasts ($M) for Opdivo, 2013–2023

Table 78: Product Profile – Atezolizumab

Table 79: Efficacy of Atezolizumab

Table 80: Efficacy of Atezolizumab + Avastin combination therapy

Table 81: Safety of Atezolizumab in Phase Ib Study

Table 82: Atezolizumab SWOT Analysis, 2016

Table 83: Global Sales Forecasts ($M) for Atezolizumab, 2013–2023

Table 84: Product Profile – Cometriq (cabozantinib)

Table 85: Efficacy of Cometriq in the Phase III METEOR Trial

Table 86: Safety of Cometriq

Table 87: Cometriq SWOT Analysis, 2016

Table 88: Global Sales Forecasts ($M) for Cometriq, 2013–2023

Table 89: Product Profile – IMA901

Table 90: Efficacy of IMA901 in the Phase III IMPRINT Trial

Table 91: Product Profile – AGS-003

Table 92: AGS-003 SWOT Analysis, 2016

Table 93: Global Sales Forecasts ($M) for AGS-003, 2013–2023

Table 94: Product Profile – Tivozanib

Table 95: Efficacy of Tivozanib

Table 96: Safety of Tivozanib

Table 97: Safety profile of Tivozanib over time

Table 98: Tivozanib SWOT Analysis, 2016

Table 99: Global Sales Forecasts ($M) for Tivozanib, 2013–2023

Table 100: Product Profile – Lenvima (lenvatinib)

Table 101: Efficacy of Lenvima

Table 102: Lenvima SWOT Analysis, 2016

Table 103: Global Sales Forecasts ($M) for Lenvima, 2013–2023

Table 104: Product Profile – Avelumab

Table 105: Avelumab (in combination with Inlyta) SWOT Analysis, 2016

Table 106: Global Sales Forecasts ($M) for Avelumab, 2013–2023

Table 107: Drug Candidates in Early Development, 2016

Table 108: Key Companies in the RCC Market in the 8MM, 2013–2023

Table 109: Pfizer’s RCC Portfolio Assessment, 2016

Table 110: Novartis’ RCC Portfolio Assessment, 2016

Table 111: Bayer’s RCC Portfolio Assessment, 2016

Table 112: Roche’s RCC Portfolio Assessment, 2016

Table 113: BMS’ RCC Portfolio Assessment, 2016

Table 114: Merck & Co.’s RCC Portfolio Assessment, 2016

Table 115: Exelixis’ RCC Portfolio Assessment, 2016

Table 116: Eisai RCC Portfolio Assessment, 2016

Table 117: AVEO Oncology’s RCC Portfolio Assessment, 2016

Table 118: Argos Therapeutics’ RCC Portfolio Assessment, 2016

Table 119: Sales Forecasts ($m) for Renal Cell Carcinoma in the Global Markets, 2013-2023

Table 120: RCC Market Drivers and Barriers, 2013–2023

Table 121: Sales Forecasts ($m) for Renal Cell Carcinoma in the United States, 2013–2023

Table 122: Key Events Impacting Sales for RCC in the US, 2016

Table 123: US RCC Market Drivers and Barriers, 2016

Table 124: Sales Forecasts ($m) for Renal Cell Carcinoma in 5EU, 2013–2023

Table 125: Key Events Impacting Sales for RCC in 5EU, 2016

Table 126: 5EU RCC Market Drivers and Barriers, 2016

Table 127: Sales Forecasts ($m) for Renal Cell Carcinoma in Japan, 2013–2023

Table 128: Key Events Impacting Sales for RCC in Japan, 2016

Table 129: Japan RCC Market – Drivers and Barriers, 2016

Table 130: Sales Forecasts ($m) for Renal Cell Carcinoma in China, 2013–2023

Table 131: Key Events Impacting Sales for RCC in China, 2016

Table 132: China RCC Market – Drivers and Barriers, 2016

Table 133: RCC Incidence, 2013–2023

Table 134: RCC, Key Launch Dates

Table 135: RCC, Key Patent Expiries

Table 136: Average Body Weight and Surface Area Across the 8MM

Table 137: Average Cost of Therapy of Sutent

Table 138: Average Cost of Therapy of Votrient

Table 139: Average Cost of Therapy of Nexavar

Table 140: Average Cost of Therapy of Avastin

Table 141: Average Cost of Therapy of Inlyta

Table 142: Average Cost of Therapy of Torisel

Table 143: Average Cost of Therapy of Afinitor

Table 144: Average Cost of Therapy of Opdivo

Table 145: Average Cost of Therapy of Yervoy + Opdivo

Table 146: Average Cost of Therapy of Atezolizumab

Table 147: Average Cost of Therapy of Avelumab

Table 148: Average Cost of Therapy of Cometriq

Table 149: Average Cost of Therapy of Lenvima

Table 150: Average Cost of Therapy of tivozanib

Table 151: Average Cost of Therapy of AGS-003

Table 152: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

Figure 1: 8MM, Diagnosed Incident Cases of RCC, Both Sexes, Ages =20 Years, N, 2013–2023

Figure 2: 8MM, Age-Specific Diagnosed Incident Cases of RCC ...

Figure 1: 8MM, Diagnosed Incident Cases of RCC, Both Sexes, Ages =20 Years, N, 2013–2023

Figure 2: 8MM, Age-Specific Diagnosed Incident Cases of RCC, Both Sexes, N, 2013

Figure 3: 8MM, Sex-Specific Diagnosed Incident Cases of RCC, Ages =20 Years, N, 2013

Figure 4: 8MM, Age-Standardized Diagnosed Incidence of RCC (Cases per 100,000 Population), Ages =20 Years, by Sex, 2013

Figure 5: 8MM, Diagnosed Incident Cases of RCC by Clinical Stage at Diagnosis, Ages =20 Years, N, 2013

Figure 6: 8MM, Five-Year Diagnosed Prevalent Cases of RCC, Both Sexes, Ages =20 Years, N, 2013–2023

Figure 7: Treatment Algorithm for RCC

Figure 8: RCC – Phase III Pipeline, 2013–2023

Figure 9: Competitive Assessment of Late-Stage Pipeline Agents in RCC, 2013–2023

Figure 10: Opdivo’s Development in RCC

Figure 11: Clinical and Commercial Positioning of Opdivo

Figure 12: Atezolizumab’s Development in RCC

Figure 13: Clinical and Commercial Positioning of Atezolizumab

Figure 14: Cometriq’s Development in RCC

Figure 15: Clinical and Commercial Positioning of Cometriq

Figure 16: AGS-003’s Development in RCC

Figure 17: Clinical and Commercial Positioning of AGS-003

Figure 18: Tivozanib’s Development in RCC

Figure 19: Clinical and Commercial Positioning of Tivozanib

Figure 20: Lenvima’s Development in RCC

Figure 21: Clinical and Commercial Positioning of Lenvima

Figure 22: Avelumab’s Development in RCC

Figure 23: Clinical and Commercial Positioning of Avelumab

Figure 24: Global Sales of Branded Products for aRCC by Company, 2013–2023

Figure 25: Company Portfolio Gap Analysis in RCC, 2013–2023

Figure 26: Pfizer SWOT Analysis in RCC, 2014

Figure 27: Novartis SWOT Analysis in RCC, 2014

Figure 28: Bayer SWOT Analysis in RCC, 2014

Figure 29: Roche SWOT Analysis in RCC, 2014

Figure 30: Bristol-Myers Squibb SWOT Analysis in RCC, 2014

Figure 31: Merck & Co SWOT Analysis in RCC, 2014

Figure 32: Exelexis SWOT Analysis in RCC, 2014

Figure 33: Eisai SWOT Analysis in RCC, 2014

Figure 34: AVEO Oncology SWOT Analysis in RCC, 2014

Figure 35: Argos Therapeutics SWOT Analysis in RCC, 2014

Figure 36: Global Sales for aRCC by Region, 2013–2023

Figure 37: Global sales for aRCC by Class, 2013–2023

Figure 38: Global Sales for aRCC by Brand, 2013–2023

Figure 39: Sales for aRCC in the US by Class, 2013–2023

Figure 40: Sales for aRCC in the US by Brand, 2013–2023

Figure 41: Sales for aRCC in the 5EU by Class, 2013–2023

Figure 42: Sales for aRCC in 5EU by Brand, 2013–2023

Figure 43: Sales for aRCC in the Japan by Class, 2013–2023

Figure 44: Sales for aRCC in Japan by Brand, 2013–2023

Figure 45: Sales for aRCC in the China by Class, 2013–2023

Figure 46: Sales for aRCC in China by Brand, 2013–2023

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