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Breast Cancer Drug Discoveries: What the Future Holds


Description: Unique market share sales forecasts by product to 2014

The breast cancer (BC) market is a steadily growing market due to effective treatments which have decreased mortality and resulted in a longer duration of therapy. The five-year survival rates for women with BC have increased from under 70% 50 years ago to around 90% now. In 2007, we estimate that sales grew by 22% compared to 2006, generating revenue of over US$11.3 billion. Branded therapies were responsible for 92% of this total (US$10.5 billion).

In 2007, approximately 47% of BC sales were derived from the US, with 41% in Europe and 12% in Japan. Over the next six years we forecast that novel therapies including targeted monoclonal antibodies and small-molecule inhibitors, will increasingly be used in combination with chemotherapy and hormonal therapy.

The corporate landscape
Already the dominant force, throughout the next six to seven years Roche will continue to go from strength to strength, increasing its market share as its existing and future targeted therapies penetrate the BC market successfully. We believe the combination of Herceptin and pertuzumab has the potential to become the new standard of care in HER2-positive metastatic BC. Many of the existing players will be hit by generic competition over the coming 5 years, AstraZeneca, Novartis and sanofiaventis being notable.

Understand the prospects for this US$11.3 billion sector.

All change in the BC market. The growing success of biologicals will be aided by generic competition to many first-line therapies. But pricing policy will be critical in keeping health payers onside.

Globally, BC is the second most common cancer after lung cancer and the most common cancer for women. It exceeds lung cancer as the most common cause of death from cancer in women. The BC market was estimated to be worth around US$11.3 billion in 2007, with a growth rate of 22% year-on-year.

MARKET DRIVERS
Improved diagnosis: Improvements in screening have helped lead to a reduction in mortality rates. New imaging modalities and pathology techniques (response to therapy) are being applied to improve diagnosis and determine the most appropriate treatment option. Whilst tests are readily available, their application varies considerably in Europe and the US. For example, only around 20% of patients obtain a HER2 test in the UK versus over 80% in Germany and the US.

Optimisation of current therapies: Surgery/radiation/chemotherapy and hormonal therapy. Long-term clinical trials evaluating the use of mono-and combination therapies are beginning to establish optimal treatment regimes for early to advanced BC.

Market extension: Availability of chemotherapeutic/hormonal agents to the racial and ethnic minorities.

DRUG GROWTH DRIVERS
Curative treatment: There is a lack of curative agents and in the advanced stages of the disease a high proportion, around 30%, of patients face recurrence.

Drug resistance: There remains a significant need to improve current therapies where drug resistance develops against cytotoxic and hormonal therapies; for example, between 25-35% of patients develop resistance to Nolvadex (tamoxifen). Several companies are evaluating drugs that may be used in combination with current therapies to avoid the development of drug resistance.

Efficacy and tolerability: One of the major issues with current therapies, particularly cytotoxic agents, is the issue of toxicity which limits their long-term use and affects patients’ quality of life. The launch of new products with improved specificity and tolerability would significantly drive drug sales growth. Several companies are developing drugs which target specific cancer sub-types and that are highly specific.

Improvements in identifying patients: Biomarkers may help to identify which patients are most likely to respond to treatment through the identification of specific biomarkers and development of molecular diagnostic tests.

By 2014, targeted cancer treatments will command 49% of the market by value.


Contents: EXECUTIVE SUMMARY

THE FACTS
What is BC and How Does it Affect Patients?
Risk Factors
Diagnosis
Stages of the Disease

PATIENT STATISTICS
The US
Europe
Japan

PATIENT MODEL
The prevalence of people living with BC will increase by 26.6 per cent by 2014

DRUG GROWTH DRIVERS

DRUG GROWTH RISKS/DAMPENERS

THE BREAST CANCER MARKET

BC THERAPY SALES SPLIT
GLOBAL BC SALES SPLIT
US Market
European Market
Japanese Market

THE PLAYERS
Players and Products in 2007
Players and Products in 2014

CURRENT TREATMENTS
SURGERY
RADIATION
HORMONAL THERAPY
Leading Brands
Current Products’ Patent Exposure

CHEMOTHERAPY
Leading Brands
Current Products' Patent Exposure

MOLECULAR TARGETED THERAPY
Leading Brands
Curent Products' Patent Exposure

ANALYSIS OF LEADING BRANDS

HORMONAL THERAPY
Anti-oestrogen Drugs
Evista
Faslodex
Nolvadex
Aromatase Inhibitors
Arimidex
Aromasin
Femara

LHRH Agonists
Zoladex

CHEMOTHERAPY
Taxanes
Abraxane
Taxol
Taxotere
Antimetabolites
Gemzar
Xeloda
Epothilone analogues
Ixempra

MOLECULAR TARGETED THERAPY
Avastin
Herceptin
Tykerb
Sales Forecast of Curent BC Drugs

RESEARCH & DEVELOPMENT OF BC DRUGS
ANALYSIS OF PHASE III DRUGS
MOLECULAR TARGETED THERAPY
Angiogenesis Inhibitors
Armala
IMC-1121B
Sutent
HER2/neu Dimerisation Inhibitor
Pertuzumab

HORMONAL THERAPY
Arzoxifene

GLOBAL SALES FORECASTS OF PHASE III BC DRUGS 2007A - 2014E
Model Assumptions

ANALYSIS OF PHASE II DRUGS

MOLECULAR TARGETED THERAPY
PARP Inhibitors
AZD2281
BSI-201
Therapeutic Vaccines
AE37
MVA-BN-HER2
NeuVax
Angiogenesis Inhibitor
Axitinib
IGF-1r Inhibitors
AVE1642
IMC-A12
Heat Shock Protein Inhibitors
Tanespimycin
Anti-phospholipid Therapy
Bavituximab

CHEMOTHERAPY
Sagopilone

HORMONAL THERAPY
ZK-PRA
COMPETITOR RATIO ANALYSIS
Competitor Ratio Analysis Criteria

COMPETITOR RATIO ANALYSIS – PRODUCTS

COMPETITOR RATIO ANALYSIS - COMPANIES
Winners & Losers
Winners
Losers

DISCONTINUATION OF DRUGS

APPENDIX 1: Diagnostic Assays
HER2 diagnostics3
“Virtual Cancer Patient” technology - Optimata
BRCA tests
BC Detection
Future Advances In Diagnostics

APPENDIX 2: PATIENT MODEL
APPENDIX 3: GLOBAL BC DRUG SALES
APPENDIX 4: Phase transition probability

GLOSSARY
BIBLIOGRAPHY

WEBSITE REFERENCES
acronyms

Index of Tables
TMN Classification in BC
US BC Statistics
European (Top 5 Countries) BC Statistics
Japanese BC Statistics
Summary of Patient Population Forecasts in the Top 7 Countries (2007-2014E)
Current Major Hormonal Therapies
Comparison of Leading Hormonal Therapies
Patent Exposure of Leading Brands
Chemotherapy Combinations Currently Prescribed in Early-Stage BC
Patent Exposure of Leading Brands
Proposed Filings of New Indications for Avastin
Global Sales of Leading BC Drugs 2007A-2014E (US$ millions)
Products in Clinical Development for the Treatment of BC
New Drugs in Phase III Development to Treat BC
Sales Forecasts of Phase III Developmental BC Drugs (US$ million)
New Drugs in Phase II Development to Treat BC
Key BC Drugs on the Market by 2014
Company Competitor Ratio Analysis Scores
Summary of Key Companies and Drugs in the BC Market by 2014
BC Drugs Discontinued During Development
Summary of US BC Patient Population Forecasts
Summary of European (Top 5) BC Patient Population Forecasts
Summary of Japanese BC Patient Population Forecasts
Global BC Drugs Sales 2007A-2014E8
Probability of Launch

Index of Charts
Schematic of the Breast
BC Market Opportunities
Impact of Biomarker Identification on BC Patients
Impact of Biomarker Identification on Dose Selection Studies in BC Patients
Global BC Market by Therapy Class (2007A)
Global BC Market by Therapy Class (2014E)
Global Sales Split By Region (2007)
BC US Drugs Sales Split (2007)
Market Share of BC Players by Sales (2007A)
Global Market Share of BC Players by Sales (Dec 2014E)
Schematic of Treatment Options in BC
Hormones Affecting BC
Mode of Action of Anti-oestrogens
Evista - Invasive BC Incidence - STAR Trial
Evista - Invasive BC Placebo Trials
Evista BC Sales (2007E-2014E)
EFECT Trial Design - Fasoldex vs Aromasin
Faslodex Sales (2005A-2014E)
Nolvadex Sales (2005A-2014E)
Mode of Action of Aromatase Inhibitors
Clinical Trial Data Drives Growth of BC Products
Arimidex Sales (2005A-2014E)
Pfizer’s Broad Oncology Pipeline
Aromasin Sales (2005A-2014E)
Market Potential for Femara in Extended Adjuvant Setting
Femara Sales (2005A-2014E)
Zoladex Sales (2005A-2014E)
Clinical Efficacy of Abraxane in BC
Abraxane BC Sales (2005A-2014E)
Taxol BC sales (2005A-2014E)
Taxotere Growth
Taxotere BC Sales (2005A-2014E)
a) Time-to-disease progression and b) overall response rate of metastatic BC to Gemzar treatment
Gemzar BC Sales (2005A-2014E)
Xeloda BC Sales (2005A-2014E)
Ixabepilone: Preclinical Synergy With Targeted Therapies
Ixempra BC Sales (2007A-2014E)
Avastin Clinical Trials
Avastin BC Sales (2007A-2014E)
Mechanism of Action of Herceptin
A) Herceptin Positive and Negative BC Patient Split and B) Marketing Opportunities for Herceptin in Chemotherapy Patients
Herceptin BC Sales (2005A-2014E)
GSK to Target a Broad BC Population With Tykerb
BC Treatment Opportunities
Tykerb Sales (2007A-2014E)
Armala BC Sales (2012E-2014E)
IMC-1121B BC Sales (2013E-2014E)
First-line Phase III BC Trial
Second/third-line Phase III BC Trial
Pfizer's BC Clinical Development Programme
Sutent BC Sales (2012E-2014E)
Pertuzumab BC Sales (2012E-2014E)
Arzoxifene BC Sales (2010E-2014E)
The Role of Hsp90 in Chaperoning Client Proteins
Company Competitor Ratio Analysis Scores


Summary: THE FACTS
- Risk factors, how the disease affects patients, diagnosis and stages of the disease

PATIENT STATISTICS
- Prevalence in the US, Europe and Japan
- Diagnosis and treatment rates

THE MARKET
- BC market split by US, Europe and Japan
- Drug growth drivers/dampeners
- The companies – market share 2007 and 2014

CURRENT TREATMENTS
- Interventions by type
- Unique five point competitive assessment of current therapies and companies involved
- Sales forecasts by product 2007-2014

R&D: DRUGS IN PHASE II/III
- Focus on new classes of drugs and the companies involved
- Unique competitive assessment of current therapies and companies involved

COMPETITOR ANALYSIS – PRODUCTS & COMPANIES
- Winners and losers in the future

EXTENSIVE APPENDICES
- Statistics on key areas such as patient population, launch probability




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