Abstract
The prostate cancer market is on the verge of considerable change with the
imminent arrival of new targeted therapies that will prolong patient
survival.
Prostate cancer (PCA) is the second leading cause of new cancer cases in men
worldwide and the sixth leading cause of cancer death in men. In the US, over
two million men currently suffer with PCA and it is estimated that there were
192,311 new cases and 29,698 deaths due to the disease in 2008. There have
been dramatic improvements in PCA survival over the last 25 years, mainly due
to a combination of earlier diagnosis and improvements in treatments, although
rates vary between countries.
The PCA market was estimated to be worth US$5.2 billion in 2008; it is one of
the larger segments of the oncology market, alongside breast, non-small cell
lung and colorectal cancers. The market is currently driven by the use of
hormonal therapies, which are prescribed mainly for advanced hormone-dependent
PCA, and include AstraZeneca' s Zoladex (goserelin) and Casodex (bicalutamide),
Abbott/Takeda' s Lupron/Lupron Depot (leuprolide subcutaneous injection or
intramuscular depot) and sanofi-aventis/Astellas Pharma' s Eligard (leuprolide
subcutaneous depot). In addition, sanofi-aventis' Taxotere (docetaxel) has
become the standard treatment for hormone-refractory prostate cancer (HRPCA).
However, the market dynamics will change considerably over the next six years
as patents expire and generic competition intensifies. Research into new
therapies is extremely active and new agents with novel modes of action are
being evaluated in clinical trials, including Dendreon' s Provenge, which is
likely to be the first therapeutic cancer vaccine to market, and Bristol-Myers
Squibb' s fully-human monoclonal antibody, ipilimumab. Other companies are
extending existing products' indications into PCA, with Roche' s angiogenesis
inhibitor, Avastin (bevacizumab), and GlaxoSmithKline' s preventative
treatment, Avodart (dutasteride), as the most notable examples.
Espicom estimates that sales of prostate cancer treatments will increase to over US$7.7 billion by 2015, with a compound annual growth rate of 5.9%
There is currently a huge interest in developing new treatments for PCA, with
96 drugs estimated to be in clinical development. The majority of these are
the new targeted therapies, including small-molecule tyrosine kinase
inhibitors, monoclonal antibodies and therapeutic vaccine candidates. In
addition to the development of novel products, some companies are seeking to
optimise the life-cycle of drugs already approved in other indications such as
Roche' s Avastin (bevacizumab), Pfizer' s Sutent (sunitinib) and Novartis'
Glivec/Gleevec (imatinib).
Hormone-refractory prostate cancer (HRPCA) - a focus of attention
Market opportunities are largest for novel treatment strategies that prolong
survival. Many of the new targeted approaches are focused on the treatment of
hormone-refractory PCA (HRPCA), an area where, up until the recent approval of
Taxotere, there were very few options for patients. Whereas previous research
has focused mainly on the hormone-dependency of PCA, the rationale for new
drugs coming through research is based on the increasing knowledge of the
molecular abnormalities underlying PCA.
The arrival of innovative targeted therapies will not make traditional
hormonal or chemotherapies redundant. Rather, targeted therapies will be used
in combination with traditional therapies and each other. The limits to
combinations will likely be cost, as the novel therapies can be expected to be
comparable to recently-launched novel therapies in other cancers, for example
Avastin at over US$50,000 per annum.
Shape of the industry in 2008...
The PCA market is currently dominated by a handful of pharmaceutical
companies, the most significant of which is AstraZeneca. In 2008, AstraZeneca
had a 41% share of the PCA market through the marketing of the LHRH analogue,
Zoladex, and the anti-androgen, Casodex. AstraZeneca' s leadership position has
been untouchable for many years and is primarily due to the combined androgen
blockade therapeutic approach in PCA and expanded licenses for both advanced
and locally-advanced PCA in some markets.
...and in 2015
With the advent of the new targeted therapies, the PCA market will change
considerably by 2015. In 2008, most drug treatment occurred in the advanced
hormone-responsive PCA market segment. By 2015, we expect the balance to shift
to the HRPCA segment of the PCA market as more effective products are
introduced and combined to address the unmet clinical need for patients in
this sector. In addition, there will be significant opportunities to expand
within the early PCA market. In addition to HRCPA treatments, Dendreon' s novel
therapeutic cancer vaccine, Provenge, should achieve blockbuster sales and
ensure a substantial market share for the company.
About the Author
This report has been researched and written by senior Espicom pharmaceutical
analyst, Sue Viney. For over 10 years she has played a pivotal role in
tracking trends in drug development and corporate performance. In addition to
this report she has produced detailed product analysis in the CNS, Breast/Lung
Cancer and Rheumatoid Arthritis sectors.
Table of Contents
- EXECUTIVE SUMMARY
- WHAT IS PROSTATE CANCER AND HOW DOES IT AFFECT PATIENTS?
- Screening
- Risk Factors
- Stages of the Disease
- PATIENT STATISTICS
- Incidence, Mortality and Survival
- PATIENT MODEL
- DRUG GROWTH DRIVERS
- DRUG GROWTH RISKS/DAMPENERS
- CURRENT TREATMENTS
- Watchful Waiting/Active Monitoring
- Surgery
- Radiotherapy
- Hormone Therapy
- Chemotherapy
- THE CURRENT PROSTATE CANCER MARKET
- PLAYERS AND PRODUCTS IN 2008
- RESEARCH & DEVELOPMENT OF PROSTATE CANCER DRUGS
- WHAT THE FUTURE HOLDS
- GLOBAL SALES FORECASTS TO 2015
- 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
- Winners/Losers
- ANALYSIS OF LEADING BRANDS
- Current Products' Patent Exposure
- LHRH Analogues
- Eligard
- Lupron/Lupron Depot
- Zoladex
- LHRH Antagonist
- Anti-Androgens
- Chemotherapy
- ANALYSIS OF PHASE III DRUGS
- Chemotherapy
- Angiogenesis Inhibitors
- Aflibercept
- Avastin
- Sprycel
- Sutent
- Hormone Therapy
- Abiraterone
- Acapodene
- Avodart
- MDV3100
- Immunotherapy
- Selective Endothelial Receptor Antagonists
- ANALYSIS OF PHASE II DRUGS
- ASA404
- AT-101
- OGX-011
- Onyvax-P
- PROSTVAC
- TASQ
- Panobinostat
- DISCONTINUATION OF DRUGS
- APPENDIX 1
- APPENDIX 2
- PCA Tumour Grading System - Gleason Score
- APPENDIX 3
- Phase Transition Probability
- GLOSSARY
- REFERENCES
- ACRONYMS
INDEX OF CHARTS
- Number of New UK Prostate Cancer Cases and Age-Specific Incidence Rates,
2006
- International Variation in Prostate Cancer Incidence Rates
- US Male Age-Adjusted Prostate Cancer Incidence Rates by Race/Ethnicity
(1992-2006)
- Projected % Change in Age-Standardised Prostate Cancer Mortality in the
US, Europe and Japan, 2002-2015
- Incidence and Mortality Rates of Prostate Cancer in Selected Countries
- Estimated US Cancer Cases, 2009
- Estimated US Cancer Deaths, 2009
- Prostate Cancer Incidence, Top Seven Countries (2008-2015)
- Prostate Cancer Mortality, Top Seven Countries (2008-2015)
- Therapy Sales Split for Major Prostate Cancer Products, 2008
- Market Share for Major Branded Prostate Cancer Drugs, 2008
- Market Share of Major Prostate Cancer Players by Sales, 2008
- US Prostate Cancer Branded Drugs Sales Split, 2008
- Sales Forecasts of Current Leading PCA Drugs (US$ millions)
- Sales Forecasts of Future Leading PCA Drugs (US$ millions)
- Therapy Sales Split for Major Prostate Cancer Products, 2015
- Global Market Share of Prostate Cancer Players by Sales (Dec 2015E)
- Competitor Ratio Analysis Scores by Product
- Current Major Prostate Cancer Products
- Major Prostate Cancer Products, 2015
- Combined Company Competitor Ratio Analysis Scores
- Eligard Prostate Cancer Sales (2008A-2015E)
- Lupron Prostate Cancer Sales (2008E-2015E)
- Zoladex Prostate Cancer Sales (2008E-2015E)
- Firmagon Prostate Cancer Sales (2009E-2015E)
- Casodex Prostate Cancer Sales (2008A-2015E)
- Taxotere Prostate Cancer Sales (2008A-20015E)
- Cabazitaxel Prostate Cancer Sales (2011E-2015E)
- Angiogenesis is the Formation of New Blood Vessels
- Agents Targeting the VEGF Pathway
- Aflibercept Prostate Cancer Sales (2013E-2015E)
- Avastin Prostate Cancer Sales (2012E-2015E)
- Sprycel Prostate Cancer Sales (2014E-2015E)
- Sutent Prostate Cancer Sales (2012E-2015E)
- Mode of Action of Abiraterone
- Abiraterone Prostate Cancer Sales (2013E-2015E)
- Acapodene Prostate Cancer Sales (2011E-1015E)
- Avodart Prostate Cancer Sales (2010E-2015E)
- Schematic of MDX-010' s Mechanism of Action
- Ipilimumab Prostate Cancer Sales (2014E-2015E)
- Schematic of Provenge' s Mechanism of Action
- Provenge Prostate Cancer Sales (2010E-2015E)
- Phase II EPOC Study Results
- ZD4054 Prostate Cancer Sales (2012E-2015E)
- ASA404 Mechanism of Action
- ASA404 Phase II Results
- Ascenta AT-101 Pipeline
- OGX-011 Phase II Measurable Disease Response
- OGX-011 Phase II Conclusions
- TASQ Phase Ib Efficacy in HRPCA
- Panobinostat Mechanism of Action
- TNM Staging System for Prostate Cancer
- Gleason Grading System
INDEX OF TABLES
- Worldwide Prostate Cancer Population Model (2008-2015)
- Prostate Cancer Population Models, Top Seven Countries (2008-2015)
- Drugs in Development to Treat Prostate Cancer
- Timeline of Selected PCA Development Projects
- Sales Forecasts of Current and Future Leading PCA Drugs (US$ millions)
- Key Prostate Cancer Drugs Analysed
- Summary of Key Companies and Drugs in the PCA Market by 2015
- Comparison of Leading PCA Agents
- Patent Exposure of Leading Brands
- Major Phase III Development Candidates for PCA
- Proposed Filings of New Indications for Avastin
- Selected Phase II PCA Development Candidates
- Drugs Discontinued from Clinical Development in PCA
- Probability of Launch
