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Renal Cell Carcimona Drug Discoveries - what the future holds
This is a very exciting time in the treatment of renal cell carcinoma (RCC)...
With the advent of the new targeted therapies there has been a complete shift in paradigm. Treatment options for patients with advanced disease have improved dramatically; until recently there was limited choice and therapies were poorly tolerated, with relatively low response rates. Patients now face multiple options with improved safety and efficacy, and there are plenty of further therapies in the pipeline. The overall prognosis has changed for these patients and survival is now much longer.
While the RCC market has traditionally constituted a relatively small segment of the oncology market, it has more recently attracted considerable R&D investment from big pharma, biotechnology companies and specialty pharma. Older immunotherapy regimens have now been replaced as the standard of care by the newer targeted therapies launched in recent years, namely Pfizer's Sutent (sunitinib), Bayer/Onyx' Nexavar (sorafenib), Roche's Avastin (bevacizumab) and Pfizer's Torisel (temsirolimus). Since the launch of these agents in 2005/2006, the RCC market has become a rapidly-growing segment, with almost US$2.2 billion spent on branded drugs in 2008.
Significant opportunities still exist for products to expand within this marketplace. A large percentage of patients are not currently treated with drug therapies and are not cured by surgery alone; patients with localised and locally-advanced disease represent a significant patient population that may be suitable for adjuvant therapy with targeted therapies. Established agents such as Sutent, Nexavar and Avastin are being investigated in the adjuvant setting, along with new therapies including Wilex' Rencarex (girentuximab), currently in Phase III trials. In addition, many patients do not respond to current therapies, and more effective product introductions and greater use of combination therapies will address this clinical need for patients with metastatic RCC.
This report forecasts that sales of RCC treatments will increase substantially to almost US$6.5 billion in 2015, with a compound annual growth rate of 16.8%
The number of patients by value in the US, Europe (top five countries) and Japan will increase by 35.7% by 2015 (from around 613,000 in 2008 to approximately 832,000 in 2015). We estimate that approximately 18% of the RCC patient population currently receives drug therapy. By 2015, we expect a higher percentage of patients to receive treatment, reflecting an increase in the number of treatment options, improvements in drug efficacy and the use of drug therapy earlier in the course of the disease.
Why this sector is important: positive drivers
Better US diagnosis rates: Over 30% of RCC cases in the US are diagnosed at Stages III or IV, an area of high unmet clinical need.
The need for improved efficacy: Around 50% of early-stage patients are not cured by surgery and around 80% of patients with advanced disease fail to respond to approved therapies.
Alternative drug administration: Current immunotherapy requires frequent administration, intramuscularly or intravenously, and the advent of longer-acting oral products will be welcomed by clinicians and patients alike.
More therapy choice: New treatments will gain broader indications in the treatment of RCC eg in the adjuvant or neoadjuvant setting at earlier stages of disease due to their proven track record of safety and efficacy.
Improved funding: Increased accessibility to cancer drugs via Medicare reform, Medicaid coverage and the European and Japanese regulatory health authorities.
The shape of the RCC sector in 2008...
In 2008, the RCC market was driven by sales of new targeted agents, namely Pfizer's Sutent (sunitinib) and Bayer/Onyx' Nexavar (sorafenib) as the clear leaders, followed by Roche's Avastin (bevacizumab) and Pfizer's Torisel (temsirolimus). Together these therapies secured sales of almost US$1.8 billion. Just five major players competed for a share of the RCC market. The introduction of targeted therapies in 2005/2006 has seen Pfizer and Bayer/Onyx come from nowhere to now dominate with a combined 67% market share.
...and in 2015
The total RCC sales for branded products will increase substantially from almost US$2.2 billion in 2008, to almost US$6.5 billion in 2015, with a compound annual growth rate of 16.8%. Sales will be driven by the new targeted therapies which will account for sales of around US$6.1 billion in 2015, with Pfizer's Sutent, Bayer/Onyx' Nexavar, Roche's Avastin and GlaxoSmithKline's Armala/Votrient responsible for approximately US$4.5 billion of this. There are four current Phase III products which have the potential to reach the market by 2015, including Wilex' Rencarex.
EXECUTIVE SUMMARY
WHAT IS RENAL CELL CARCINOMA?
Stages of the Disease
Risk Factors
PATIENT STATISTICS
Incidence and Mortality
Survival and Stage at Diagnosis
PATIENT MODEL
DRUG GROWTH DRIVERS
DRUG GROWTH RISKS/DAMPENERS
CURRENT TREATMENTS
Leading Brands
Current Products' Patent Exposure
THE CURRENT RENAL CELL CARCINOMA MARKET
PLAYERS AND PRODUCTS IN 2008
Geographic Areas
RESEARCH & DEVELOPMENT OF RCC DRUGS
WHAT THE FUTURE HOLDS
GLOBAL SALES FORECASTS TO 2015
Model Assumptions
PLAYERS AND PRODUCTS IN 2015
COMPETITOR RATIO ANALYSIS
Competitor Ratio Analysis Criteria
COMPETITOR RATIO ANALYSIS - PRODUCTS
COMPETITOR RATIO ANALYSIS - COMPANIES
Winners and Losers
Winners
Losers
Analysis of Leading Brands
Targeted Therapies
Armala/Votrient
Avastin
Afinitor
Nexavar
Oncophage
Sutent
Torisel
Immunotherapies
Intron A
Roferon-A
Pegasys
PEG-Intron
Proleukin
Analysis Of Products Under Development
Phase III Projects
Anyara
Axitinib
Rencarex
Tivozanib
Phase II Projects
Archexin
AS1411
Foretinib
IMA901
Interleukin-21
Perifosine
Regorafenib
Talactoferrin alpha
Phase I/II Projects
AGS-003
ImmuFact
DISCONTINUATION OF DRUGS
APPENDIX 1
Appendix 2
Appendix 3
Phase Transition Probability
RCC GLOSSARY
Index of Tables
RCC Stages
RCC Stage at Diagnosis, US
Five-year Relative Survival Rates by Stage at Diagnosis, 1996-2004
RCC US Population Model, 2008-2015
RCC European Population Model, 2008-2015
RCC Japanese Population Model, 2008-2015
RCC Population Models, Top Seven Countries, 2008-2015
Worldwide RCC Population Model, 2008-2015
Summary of Standard Treatment Options for RCC
Comparison of Leading RCC Agents
Comparison of Recently-Launched RCC Agents
Patent Exposure of Leading Brands
Drugs in Development to Treat RCC
Timeline of Selected RCC Development Projects
Sales Forecasts of Current and Future Leading RCC Drugs (US$ millions)
Key RCC Drugs Analysed
Summary of Key Companies in the RCC Market by 2015
Axitinib Treatment-Related Adverse Events
Drugs Discontinued from Clinical Development in RCC
Fuhrman Grading System for Renal Cell Carcinoma
TNM Staging of Renal Cell Carcinoma
AJCC Stage Groupings
Probability of Launch
Index of Charts
Schematic of Kidney
RCC Incidence by Age at Diagnosis, UK
Worldwide Incidence of the Major Cancers, 2008
International Variation in RCC Incidence Rates, 2002
RCC Incidence Rates for Selected Countries, 2002
US Kidney Cancer Incidence Rates by Age, 1992-2006
US Age-Adjusted Kidney Cancer Incidence Rates by Race/Ethnicity, 1992-2006
US Kidney Cancer Mortality Rates by Age, 1992-2006
Projected % Change in Age-Standardised RCC Mortality in the US, Europe and Japan, 2002-2015
RCC Mortality Rates for Selected Countries, 2002
RCC Incidence, Top Seven Countries, 2008-2015
RCC Mortality, Top Seven Countries, 2008-2015
Market Share (Branded Sales) of Top Five Cancers, 2008
Therapy Sales Split for Major Branded RCC Products, 2008
Market Share for Major Branded RCC Products, 2008
Market Share for Major RCC Players, 2008
Sales Forecasts of RCC Therapies Launched in 2008 (US$ millions)
Sales Forecasts of RCC Therapies Launched from 2009 (US$ millions)
Therapy Sales Split for Major Branded RCC Products, 2015
Market Share for Major Branded RCC Products, 2015
Market Share for Major RCC Players, 2015
Competitor Ratio Analysis Scores by Product
Major RCC Products, 2008
Analysis of RCC Products based on Drug Class, 2015
Table of Contents
©Espicom Business Intelligence vi February 2010
Section Name Renal Cell Carcinoma Drug Discoveries
Analysis of RCC Products based on Delivery, 2015
Competitor Ratio Analysis of RCC Products Based on Company, 2015
Votrient/Armala RCC Sales (2009E-2015E)
Avastin Mode of Action
Avastin RCC Sales (2008E-2015E)
Afinitor Mode of Action
Afinitor RCC Sales (2009E-2015E)
Nexavar's Dual Mode of Action
Nexavar RCC Sales (2008E-2015E)
Oncophage RCC Sales (2009E-2015E)
Sutent Mode of Action
Sutent RCC Sales (2008E-2015E)
Torisel's Mode of Action
Torisel RCC Sales (2008E-2015E)
Intron A RCC Sales (2008E-2015E)
Roferon-A RCC Sales (2008E-2015E)
Pegasys RCC Sales (2008E-2015E)
PEG-Intron RCC Sales (2008E-2015E)
Proleukin Mode of Action
Proleukin RCC Sales (2008E-2015E)
Anyara's Mode of Action
Anyara RCC Sales (2013E-2015E)
Axitinib RCC Sales (2012E-2015E)
Rencarex' Mode of Action
Tivozanib RCC Sales (2013E-2015E)
Signalling Pathways Affected by Archexin
AS1411 Proposed Mechanism of Action
Mode of Action of IMA901
IL-21 Initiating Antibody-mediated Tumour Lysis
Perifosine's Mechanism of Action
Talactoferrin's Mechanism of Action in Cancer.
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