Abstract
The worldwide incidence of colorectal cancer (CRC) is approximately one
million cases per year and, in the US, it is the third most common cancer in
both sexes, accounting for around 8.5 per cent of all cancer deaths.
The rise of targeted therapies
In 2008, the CRC drug market (US, EU and Japan) for major branded therapies
was valued at just over US$8 billion. Whilst chemotherapy is the mainstay of
CRC treatment, driven by sanofi-aventis' Eloxatin (oxaliplatin), Pfizer' s
Camptosar (irinotecan) and Roche' s Xeloda (capecitabine), the use of targeted
therapies such as Roche' s Avastin (bevacizumab), Eli Lilly/Bristol-Myers
Squibb/Merck KGaA' s Erbitux (cetuximab) and Amgen' s Vectibix (panitumumab) are
gaining acceptance in the treatment of advanced disease. We expect this trend
to continue as new combinations are evaluated and therapies are increasingly
used in the adjuvant setting to address the unmet clinical needs within the
market. However, a number of leading CRC agents already face, or will face,
generic competition over the next few years, which will radically change the
dynamics of the market and potentially increase price sensitivity.
Intense research is producing new approaches
There were 64 drugs being evaluated for the treatment of CRC in 2008, out of a
total 750 products in clinical development for the treatment of cancer.
Several companies now have potential CRC drugs in late-stage clinical
development. The majority of projects are in Phase II trials, with several new
treatments becoming available in the near term for both early and advanced CRC.
By 2015, targeted therapies will account for 77% of the colorectal market.
Which products and companies will benefit from this trend and who may lose
out?
Early-stage CRC is generally treated with surgery and radiation, with a high
percentage of patients going on to survive disease-free. Since the disease is
usually asymptomatic at this early stage, screening is necessary to provide
patients with the best chance of a potential cure.
Unfortunately, only around 40% of CRCs are found at this early stage, and, as
a result, there remains considerable unmet clinical need within the CRC
market. For those patients who experience recurrence following surgery, there
is a clear need for effective therapies earlier in the course of the disease.
In addition, with around 76% of patients (Stages II-IV) eligible for
chemotherapy, new formulations that improve patients' quality of life and
increase survival are sorely needed.
The advent of personalised medicine?
To improve patient care and reduce expenditure on ineffective treatments, much
hope is resting on the potential for tailored treatment regimens to fit
patients, ie, the advent of the era of personalised medicine. For example,
both Erbitux and Vectibix have been shown not to work in CRC patients who have
a mutation in the KRAS gene (approximately 40% of patients), resulting in
their approval only for those patients lacking the mutation.
Shape of the industry - 2015
By 2012, we expect products with alternative approaches to the inhibition of
the VEGF pathway to begin challenging Avastin' s dominance. AstraZeneca will
enter the CRC market for the first time with Recentin, which could prove to be
a major competitor given that it requires once-daily oral administration and
has a relatively benign safety profile. In addition, sanofi-aventis'
aflibercept (VEGF Trap) may increase options for patients with metastatic CRC.
By 2015, we predict that Roche will continue to dominate the market,
increasing its market share to 54% as Avastin continues to assert itself as a
front-line therapy in both early and advanced CRC.
Two novel therapies may reach the market for the first time by 2015:
- Vaccinogen has opted for a high-risk/high-reward strategy by
developing what may prove to be the first vaccine for CRC. OncoVAX may become
available from 2014 onwards for Stage II colon cancer patients, where
currently the only approved treatment is surgery.
- Light Sciences Oncology' s Litx Therapy has potential as the first
photodynamic therapy for CRC. With the absence of a cure for advanced disease,
a therapy that can offer some potential without the debilitating side effects
of current chemotherapy is sorely needed.
Growth driver: adjuvant prescribing increases growth
Treatment for early-stage CRC has historically included only surgical
resection, however 5-year overall survival rates decrease from 90 to 67% if
the cancer spreads to nearby lymph nodes and organs. Recent trials suggest
that the use of chemotherapy following surgery (adjuvant) can lead to
significant improvements in survival in early CRC.
This unbeatable executive report provides.....
- A comprehensive review of the market, players and prospects
- Market share and patient population growth to 2015
- An evaluation of the current understanding of colorectal cancer
- A comparison of the corporate and competitive landscape in 2008 and 2015
- Detailed analysis and 5-year sales forecasts for current products by value
- A detailed review of up and coming products with 5-year forecasts from
year of launch
- Unique product assessment and scoring
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
- THE FACTS
- WHAT IS CRC AND HOW DOES IT AFFECT PATIENTS?
- Risk Factors
- Stages of the Disease
- PATIENT STATISTICS
- Incidence, Mortality and Prevalence
- Survival Statistics
- PATIENT MODEL
- The addressable CRC market will increase by 2 per cent by 2015
- DRUG GROWTH DRIVERS
- DRUG GROWTH RISKS/DAMPENERS
- THE CRC MARKET
- GLOBAL CRC SALES SPLIT
- US Market
- European Market
- Japanese Market
- THE PLAYERS
- Players and Products in 2008
- Players and Products in 2015
- CURRENT TREATMENTS
- CHEMOTHERAPY
- Current Products' Patent Exposure
- TARGETED THERAPY
- Targeting the VEGF Pathway
- Targeting the EGF Pathway
- Current Products' Patent Exposure
- ANALYSIS OF LEADING BRANDS
- CHEMOTHERAPY
- Cytotoxic Agents
- Antimetabolites
- TARGETED THERAPY
- GLOBAL SALES FORECASTS OF LEADING BRANDS 2008A - 2015E
- RESEARCH & DEVELOPMENT OF CRC DRUGS
- ANALYSIS OF PHASE III DRUGS
- Targeted Therapy
- Vaccines
- GLOBAL SALES FORECASTS OF PHASE III CRC DRUGS 2008A - 2015E
- ANALYSIS OF PHASE II DRUGS
- Targeted Therapy
- Chemotherapy
- Vaccines
- Other Drugs Of Interest
- COMPETITOR RATIO ANALYSIS
- Competitor Ratio Analysis Criteria
- COMPETITOR RATIO ANALYSIS - PRODUCTS
- COMPETITOR RATIO ANALYSIS - COMPANIES
- WINNERS AND LOSERS
- Winners
- Losers
- DISCONTINUATION OF DRUGS
- APPENDIX 1: PATIENT MODEL
- APPENDIX 2: GLOBAL CRC DRUG SALES
- APPENDIX 3: PHASE TRANSITION PROBABILITY
- GLOSSARY
- BIBLIOGRAPHY
- ACRONYMNS
INDEX OF TABLES
- Classification of CRC
- European Prevalence of CRC
- Japanese Prevalence of CRC
- Survival of CRC Patients Relative to Stage at Diagnosis
- Summary of CRC Patient Population Forecasts in Top Seven Countries
(2008-2015)
- Comparison of Leading CRC Agents
- Patent Exposure of Leading Brands
- Ranking of Specialist Oncologist Sales Forces
- Proposed Filings of New Indications for Avastin
- Global CRC Sales Forecasts of Leading Brands 2008A-2015E (US$ millions)
- Products in Clinical Development for the Treatment of CRC
- New Drugs in Phase III Development to Treat CRC
- Sales Forecasts of Phase III Developmental CRC Drugs (US$ millions)
- New Drugs in Phase II Development to Treat CRC
- Studies in Metastatic CRC with EGFr-Targeting Monoclonal Antibodies in
Irinotecan-Refractory Patients
- Safety Profiles of Leading Anti-EGFr Products and Nimotuzumab
- Key CRC Drugs Analysed
- Summary of Key Companies and Drugs in the CRC Market by 2015
- CRC Drugs Discontinued During Development
- Summary of US CRC Patient Population Forecasts
- Summary of Europe (Top Five) CRC Patient Population Forecasts
- Summary of Japan CRC Patient Population Forecasts
- Global CRC Drugs Sales 2008A-2015E
- Probability of Launch
INDEX OF CHARTS
- Schematic of the Lower Gastrointestinal Tract
- Incidence of CRC in the US and Western Europe
- Incidence of CRC in Men and Women in the US
- US New Cancer Deaths Estimates (2008)*
- CRC Death Rates for Men and Women in the US
- Global CRC Market by Therapy Class (2008A)
- Global CRC Market by Therapy Class (2015E)
- Global CRC Market by Region (2008A)
- CRC US Drugs Sales Split (2008A)
- CRC European Drugs Sales Split (2008A)
- Market Share of Major CRC Players by Sales (2008A)
- Global Market Share of CRC Players by Sales (2015E)
- Agents Targeting the VEGF Pathway
- Overexpression of EGFr Correlates with Increased Metastasis, Decreased
Survival and a Poor Prognosis
- Inhibition of EGFr Prevents Tumour Growth and Dissemination and Induces
Cell Death (apoptosis)
- Camptosar CRC Sales (2008A-2015E)
- Eloxatin CRC Sales (2008A-2015E)
- Xeloda CRC Sales (2008E-2015E)
- Avastin EU Patient Share
- Avastin CRC Sales (2008E-2015E)
- Erbitux CRC Sales (2008A-2015E)
- Schematic of EGFr Inhibition in Tumourgenesis
- Vectibix CRC Sales (2008A-2015E)
- 2008 Survey: Medicines in Development for Cancer
- Aflibercept CRC Sales (2012E-2015E)
- Litx Therapy CRC Sales (2011E-2015E)
- Recentin Mechanism Of Action
- Efficacy and Pharmacokinetic Profile of Recentin (AZD2171) Compared to
Avastin
- Recentin Development Timelines
- Recentin CRC sales (2012E-2015E)
- Sutent CRC Sales (2013E-2015E)
- Study 8701 - Overall Survival In Stage II Colon Cancer Patients
- Colon Cancer Stage at Diagnosis (2008)
- Colon Cancer CRC Stage at Diagnosis (2012)
- OncoVAX CRC Sales (2014E-2015E)
- Arenegyr Structure and Activity
- NGR006 Phase II Trial in CRC
- MolMed Product Pipeline
- TroVax Method of Action
