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- Breast Cancer Therapeutics - Global Strategic Business Report
Summary
This report analyzes the worldwide markets for Breast Cancer Therapeutics in US$ Million. The major product segments analyzed are Hormonal Therapy, Chemotherapy, and Innovative Therapy. The report provides separate comprehensive analytics for the USA, Europe and Rest of World. Annual forecasts are provided for the period of 2000 through 2010. The report profiles 102 companies including many key and niche players worldwide such as Abraxis Bioscience Inc., Aeterna Zentaris Inc., Agendia BV, Aphton Corp., Array BioPharma Inc., AstraZeneca Plc, Bristol Myers Squibb, Dendreon Corporation, Eli Lilly and Company, Genentech Inc., Genta Inc., Novartis AG, Pfizer Inc., Roche Group, Sanofi-Aventis, Schering AG, Therion Biologics Corporation, and ViRexx Medical Corp. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.
BREAST CANCER THERAPEUTICS MCP-1553
A GLOBAL STRATEGIC BUSINESS REPORT
CONTENTS
I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability And Reporting Limitations I-1
Disclaimers I-2
Data Interpretation & Reporting Level I-2
Quantitative Techniques & Analytics I-3
Product Definitions And Scope Of Study I-3
II. EXECUTIVE SUMMARY
1. Market Dynamics II-1
Outlook & Trends II-1
Targeted Therapies Bridge Therapeutic Gap II-1
Significant Unmet Medical Need Drives Growth II-1
Herceptin Makes Headway as a Breakthrough Breast Cancer
Therapeutic II-2
Aromatase Inhibitors Dethrone Tamoxifen's Gold-Standard Status II-2
Biotechnology Makes its Presence Felts II-3
Toxicity of Chemotherapeutic Agents In the Spotlight II-3
Pipeline Diversity Ranging from Novel Cytotoxics to
Metronomic Therapy II-4
Advances in Screening, Testing and Diagnosis Exert Positive
Impact II-4
Fundamental Trends Fuel Demand for Quality Healthcare II-5
Pharmaceutical Industry Faces Aggressive Pricing Regulations II-5
An Overview of the Pharmaceutical and Oncology Markets II-5
Pharmaceutical Industry: A Review II-5
A Note on the Pharma Industry II-5
2005 in a Nutshell II-6
Market Issues II-6
Cost Control: A Major Hurdle II-6
Price Controls: Companies under Pressure II-6
United States II-7
Europe II-7
Japan II-7
Cross-Border Selling: Widespread Phenomena II-7
The Process of Approval II-7
Competitive Landscape II-8
A Brief Study of the Oncology Sector II-8
Competition in the Cancer Therapeutics Market II-8
Table 1: Share of Leading Players in the Global Cancer
Therapeutics Market: 2000 & 2005 (includes corresponding
Graph/Chart) II-9
Market Landscape in Breast Cancer Therapeutics II-10
Global Breast Cancer Therapeutics Market II-10
Pharma Powerhouses Dominate Breast Cancer Therapeutics II-10
Table 2: Global Sales of Leading Breast Cancer Drugs:
2003-2005 (US$ Million) (includes corresponding
Graph/Chart) II-10
Table 3: Global Market Share of Companies Offering Breast
Cancer Therapeutics: 2004 (includes corresponding Graph/
Chart) II-11
Why do the Top Three have a Lion's Share? II-11
Table 4: Percent Share of Global Breast Cancer Therapies by
Type - Chemotherapy, Hormonals and Innovatives: 2006E
(includes corresponding Graph/Chart) II-11
Table 5: Share of Various Treatment Regimens in the Breast
Cancer Market: 2001 (includes corresponding Graph/Chart) II-12
Hormonal Therapy Segment II-12
Global Hormonal Therapeutics II-12
Table 6: Global Share of Hormonal Therapeutics in Breast
Cancer: 2002 & 2005 (includes corresponding Graph/Chart) II-12
Table 7: Global Aromatase Inhibitor Sales in Adjuvant and
Metastatic Settings (US$ Million): 2003 II-13
Arimidex II-13
Table 8: Global Sales of Aromatase Inhibitor - Arimidex:
1998-2005 (US$ Million) (includes corresponding Graph/
Chart) II-13
Femara II-13
Table 9: Global Sales of Aromatase Inhibitor - Femara: 1998
-2006 (US$ Million) (includes corresponding Graph/Chart) II-14
Aromasin II-14
Table 10: Global Sales of Aromatase Inhibitor - Aromasin:
2001-2006 (US$ Million) (includes corresponding Graph/
Chart) II-14
Nolvadex II-14
Table 11: Global Sales of Tamoxifen (Nolvadex): 1997-2005
(US$ Million) (includes corresponding Graph/Chart) II-14
Faslodex II-15
Table 12: Global Sales of Faslodex: 2002-2005 (US$ Million)
(includes corresponding Graph/Chart) II-15
Zoladex II-15
Table 13: Global Sales of Zoladex: 2000-2005 (US$ Million)
(includes corresponding Graph/Chart) II-15
Chemotherapy Segment II-15
Table 14: Estimated Share of Various Chemotherapeutics in
Breast Cancer: 2002 (includes corresponding Graph/Chart) II-15
Table 15: Global Sales of Anthracyclines - Epirubicin,
Doxorubicin, Idarubicin, Daunorubicin: 2002 (US$ Million)
(includes corresponding Graph/Chart) II-16
Targeted Therapy Segment II-16
Table 16: Global Sales of Herceptin: 1999-2006 (US$
Million) (includes corresponding Graph/Chart) II-16
Competitive Factors II-16
2. Product Overview II-17
History in a Nutshell II-17
Anatomy of the Breast II-17
What is Breast Cancer? II-17
Origin II-18
Symptoms II-18
Stages II-18
Spread II-18
Pathology II-19
Ductal Cancer II-19
In Situ II-19
Invasive II-19
Lobular Cancer II-19
In-Situ II-19
Invasive II-19
Others II-19
Inflammatory Cancer II-19
Paget's Disease II-19
Prognosis II-20
Factors for Good Prognosis II-20
Factors for Poor Prognosis II-20
Statistics on Breast Cancer Incidence Worldwide II-20
Terminology II-20
Incidence Statistics: What the Numbers Mean? II-20
Table 17: New Breast Cancer Cases Worldwide by
Region/Country - Western World (US, Canada, Japan, European
Union), Developing Nations and Others: 2005 (includes
corresponding Graph/Chart) II-21
Table 18: Estimated Number of New Breast Cancer Cases/Deaths
Worldwide: 2000 (includes corresponding Graph/Chart) II-21
Table 19: Age-Adjusted Death Rates in Female Breast Cancer
Worldwide - by Select Countries: 2002 (Per 100,000
Population) (includes corresponding Graph/Chart) II-22
Prevalence Patterns II-22
Incidence Rates: Rising Worldwide II-22
Occurrence of Male Breast Cancer II-23
Survival: A Critical Factor II-23
Table 20: Five-Year Survival Rate by Cancer Stages
(includes corresponding Graph/Chart) II-23
Table 21: Five-Year Survival Rate for Local, Regional and
Metastasized Cancer II-23
Risk Factors II-24
Geographical Variances II-24
Age II-24
Table 22: Age and Breast Cancer Incidence II-24
Table 23: Global Population of Women Aged 65 years and
Above by Region - North America, Japan, Europe, Asia, Latin
America and Rest of World: 2005E (includes corresponding
Graph/Chart) II-25
Table 24: Global Population of Women Aged 65 years and
Above by Select Countries - US, Canada, Japan, France,
Germany, UK, Italy, Spain, Russia, China, India,
Argentina, Brazil, Mexico and South Africa (In Thousands)
(includes corresponding Graph/Chart) II-25
Reproductive Factors II-25
Age at First Full-Term Pregnancy II-26
Genetic Predisposition II-26
Breast Condition II-26
Radiation II-26
Fat Intake II-26
Weight or Obesity II-26
Alcohol Consumption II-27
Intake of Hormones II-27
Hormone Replacement Therapy II-27
Screening and Diagnosis II-27
Mammography Screening II-27
The Technique II-27
Types II-27
Screening Mammography II-27
Diagnostic Mammography II-28
Digital Mammography II-28
Full-Field Digital Mammography II-28
Trends in Mammography II-28
Digital Systems Drive Market Growth II-28
Diagnostic Investigations II-29
Breast Self-Examination II-29
Clinical Breast Examination II-29
Biopsy II-29
Needle Biopsy II-29
Sentinel Lymph Node Biopsy II-29
Steriotactic Needle Biopsy II-29
Other Diagnostic Techniques II-29
DOBI Medical's Dynamic Optical Breast Imaging (DOBI) II-29
Hologic's 3-D Tomosynthesis II-30
Patient Awareness & Education II-30
3. A Study Of Therapeutic Strategies II-31
Therapy Types II-31
A Complex Disease with Multiple Treatment Options II-31
Flowchart of Treatment Options for Metastatic and Non-
Metastatic Breast Cancer II-31
Breast Cancer Treatments (All Types) for Various Stages II-33
Factors that Determine Therapeutic Conduct II-33
A Study of Various Therapy Types II-34
Definitions and Scope II-34
Hormonal Therapy II-34
What is Endocrine/Hormonal Therapy? II-34
The Biochemical Process of Sex hormones II-35
What are the Drug Categories? II-35
Categories of Hormonal Agents II-35
Hormonal Therapies and their Indications II-36
An Analysis of Hormonal Drug Classes II-36
SERM II-36
Mechanism of Action II-36
Products in the Drug Class II-36
Nolvadex (Tamoxifen) II-37
Evista (Raloxifene) II-37
Fareston (Toremifene) II-37
Arzoxifene II-37
SERD II-37
Mechanism of Action II-37
Products in the Drug Class II-38
Faslodex (Fulvestrant) II-38
Differences in ERDs and SERMs II-38
Aromatase Inhibitors II-38
History II-38
Mechanism of Action II-39
Products in the Drug Class II-39
Arimidex (Anastrozole) II-39
Femara (Letrozole) II-39
Aromasin (Exemestane) II-40
Differences Among the Trio II-40
Costs II-40
Table 25: Comparative Cost of Tamoxifen and Aromatase
Inhibitors in the US and Europe (includes corresponding
Graph/Chart) II-40
LHRH Analogs II-41
The Pituitary-Gonadal System II-41
What are LHRH Analogs? II-41
LHRH Agonists vs. Antagonists II-41
Products in the Drug Class II-41
Lupron (Leuprolide) II-41
Zoladex (Goserelin Acetate) II-42
Progestogens II-42
Ovarian Shutdown and Removal II-42
Target Audience II-43
Where is it Used? II-43
Choosing the Right Therapeutic Strategy II-43
Side Effects II-44
Duration of Therapy II-44
Therapy Types II-45
Adjuvant Hormonal Therapy II-45
Neoadjuvant Hormonal Therapy II-45
Metastatic Hormonal Therapy II-45
Benefits II-45
Advances II-45
Comparative Study of Hormonal Therapies II-46
Aromatase Inhibitors vis-à-vis SERMs II-46
SERMs, Aromatase Inhibitors, and SERDs II-46
Pivotal Clinical Trials II-47
ATAC Trial: Arimidex, Tamoxifen Alone or in Combination II-47
Replacing Tamoxifen with Anastrozole II-47
Hormone Receptor Status and Endocrine Therapy II-47
Extended Adjuvant Endocrine Therapy II-48
Neoadjuvant Endocrine Therapy II-48
Austrian Breast and Colorectal Cancer Study Group [ABSCG
]-8/Arimidex-Nolvadex [ARNO]-95 trials II-48
Italian Tamoxifen-Arimidex (ITA) trial II-49
STAR: Study of Tamoxifen and Raloxifene II-49
IBIS: International Breast Cancer Intervention Studies II-49
IBIS I II-49
IBIS II II-49
IES: Intergroup Exemestane Study II-50
MA 17 Study II-50
BIG 1-98 II-50
Chemotherapy II-51
What is Chemotherapy? II-51
Efficacy II-51
Areas of Use II-51
Adjuvant Setting II-52
Neoadjuvant Setting II-52
Metastatic Setting II-52
Classes of Cytotoxic Agents II-52
Cell Cycle and Effects of Cytotoxics on Various Phases II-53
Cytotoxic Drug Classes and Mode of Action II-53
Anthracyclines II-53
Description II-53
Mode of Action II-53
Products in the Drug Class II-54
Doxorubicin and Epirubicin II-54
Side Effects II-54
Mitotic Inhibitors II-54
Description and Mechanism of Action II-54
Current Research Activity II-55
Taxanes & Vinca Alkaloids II-55
Mechanism of Action - Taxanes II-55
Products in the Drug Class II-55
Abraxane (albumin-bound paclitaxel) II-55
A Breakthrough Formulation II-55
The Product and the Technology II-56
Abraxane Eliminates Solvent Related Toxicity II-56
How does nab T Technology Work? II-56
Clinical Trial Data II-56
Current Approval II-57
Taxotere (Docetaxel) II-57
Taxol(Paclitaxel) II-57
Vinorelbine II-57
Antimetabolites II-58
Description II-58
Mechanism of Action II-58
Types II-58
Purine Analogues II-58
Folic Acid Analogues II-58
Products in the Drug Class II-58
Xeloda (Capecitabine) II-58
Xeloda and Taxotere Combination Therapy II-58
Xeloda Monotherapy II-59
Gemzar (Gemcitabine) II-59
New Developments II-59
Alkylating Agents II-59
Description II-59
Mechanism of Action II-59
Classes of Alkylating Agents II-60
Nitrosoureas II-60
Topoisomerase II Inhibitors II-61
Other Chemotherapy Drugs II-61
A Compilation of Various Chemotherapeutic Agents II-61
Common Chemotherapy Regimens II-64
Established and Emerging Regimens II-64
CMF II-64
TAC & FAC II-64
CA Followed by Trastuzumab + Paclitaxel II-64
High-Dose Chemo with Peripheral-Blood Stem-Cell or Bone
Marrow Transplantation II-64
Side Effects Associated with Cytotoxic Agents II-64
Overcoming Cytotoxic Resistance II-65
Immunotherapy II-65
The Concept of Immunotherapy II-65
Cancer Vaccines II-65
Breast Cancer Vaccine Pipeline II-66
Monoclonal Antibodies II-66
Types of Monoclonal Antibodies II-66
Mechanism of Action II-66
Herceptin - A Potential Blockbuster II-66
About HER2+Breast Cancer II-66
Incidence of HER2+ Cases II-67
What is Herceptin? II-67
Herceptin its Indications II-67
Potential for Herceptin II-67
Where is it Indicated? II-67
Current Areas of Indication II-67
Use in Metastatic and Non-Metastatic Stages II-68
For Metastatic Indication II-68
For Non-Metastatic Disease II-68
Mechanism of Action II-68
Toxicity Profile II-68
Therapy Determination Tests II-69
IHC II-69
FISH II-69
Global Availability II-69
Global and Regional Marketers II-69
Studies Evaluating Efficacy of Herceptin II-69
HERA Study II-69
M77001 Study Group Trial II-70
B-31 and N9831Clinical Trials II-70
Novel Therapy II-70
What are Novel Therapeutics? II-70
Drugs Targeting Receptors/Pathways Active in Breast Cancer II-71
Avastin - In the Wings II-71
Product Description II-71
Avastin and its Indications II-71
Avastin Breast Cancer Trials II-72
Market Issues II-72
Disappointments Galore in the Anti-Angiogenesis Area II-72
Growth Factor Inhibitors II-73
ErbB-2 Inhibitors II-73
EGFR Inhibitors II-73
Angiogenesis Inhibitors II-73
The Process II-73
Drugs under Development II-73
Lapatinib (previously GW572016) II-73
Iressa (Gefitinib) II-73
MEK Inhibitors/Farnesyl Transferase II-74
Targeting Apoptosis II-74
Antisense Technology II-74
Targeting mTOR Pathway II-75
Radiation Therapy II-75
Definition II-75
Types of Radiotherapy II-75
Whole-Breast External Beam Radiation Therapy II-75
Accelerated Partial Breast Irradiation Therapy II-75
Side Effects II-76
Notable Products II-76
Cytokinetics' MammoSite Radiation Therapy System II-76
Surgery II-77
Conventional Treatment Method II-77
Types of Surgical Procedures II-77
Lumpectomy II-77
Mastectomy II-77
Table 26: Five-Year Survival Rate Based on Type of Surgery
(includes corresponding Graph/Chart) II-78
Breast Reconstruction II-78
Palliation and Support II-78
4. Research and Development II-79
Product Development Timeline and Clinical Stages II-79
Pipeline Drugs (Phases I, II and III) and their Clinical Status II-80
Tests Available or under Development II-83
BioLabs' Mammastatin Serum Assay (MSA) II-83
Agendia's MammaPrint Test II-83
Matritech's Nuclear Matrix Protein (NMP66) II-83
Power3 Medical Products' NAF Test II-83
Genomics Health's Oncotype DX II-83
Use of DNA Microarray with a Chemotherapeutic Agent II-84
Novel Therapeutic Technologies II-84
Gene Expression Profiling II-84
Genetic Testing II-84
Biomarkers II-84
Types and Significance II-84
Blood and Body Fluids as Biomarkers II-85
Hybrid Assays II-85
CTC Detection II-85
Prediction of Therapeutic Response and Prognosis II-85
Proteomics II-86
5. Focus on Select Players II-87
Abraxis Bioscience Inc, US II-87
Aeterna Zentaris Inc, Canada II-87
Agendia BV, The Netherlands II-87
Aphton Corp, US II-88
Array BioPharma Inc, US II-88
AstraZeneca Plc, UK II-88
Bristol Myers Squibb, US II-88
Dendreon Corporation, US II-88
Eli Lilly and Company, US II-89
Genentech Inc, US II-89
Genta Inc, US II-89
Novartis AG, Switzerland II-89
Pfizer Inc, US II-90
Roche Group, Switzerland II-90
Sanofi-Aventis, France II-90
Schering AG, Germany II-90
Therion Biologics Corporation, US II-91
ViRexx Medical Corp, Canada II-91
6. Product Launches & Approvals II-92
EC Approves Herceptin for Early Stage Adjuvant Treatment II-92
Novartis and Chugai Pharmaceuticals Introduce Femara in Japan II-92
Abraxane Receives Canadian Approval for Metastatic Breast Cancer II-92
Roche Files Marketing Authorization Application for Early-
Stage Herceptin Therapy II-92
Genentech and Roche Submit Avastin sBLA for Metastatic Breast
Cancer II-92
Abraxane Receives Approval in the US for Metastatic Breast
Cancer II-93
Femara Approved in the US for Early Adjuvant Setting II-93
Aromasin Approved for Adjuvant Use in Early Breast Cancer II-93
Femara Approved in UK for Early-Stage Breast Cancer II-94
Schering Commences Three Phase 2 Clinical Trials with ZK-EPO II-94
7. Recent Industry Activity II-95
AstraZeneca and Schering Collaborate for SERD Breast Cancer Drug II-95
Bayer to Acquire Schering AG II-95
AstraZeneca in Co-Promotion Agreement with Abraxis II-95
American Pharmaceutical Partners and American BioScience
Merge to Form Abraxis BioScience II-95
AstraZeneca Acquires KuDOS Pharmaceuticals II-96
BioMérieux and ExonHit Therapeutics in Research Collaboration II-96
Biomedical Diagnostics Signs Up with Harlan Bioproducts for
Science II-96
bioMerieux to Use Affymetrix' GeneChip Technology in Breast
Cancer Diagnostics II-96
YM BioSciences Signs a Collaborative Agreement with Sanofi-
Aventis II-96
Genesis BioVentures and Corgenix to Merge II-97
Celera Diagnostics Forms Research Collaboration with Merck II-97
8. Global Market Perspective II-98
Table 27: Global Recent Past, Current & Future Analysis for
Breast Cancer Therapeutics by Geographic Region - US, Europe
and Rest of World Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2000 through 2010
(includes corresponding Graph/Chart) II-98
Table 28: Global 10-Year Perspective for Breast Cancer
Therapeutics by Geographic Region - US, Europe and Rest of
World Markets for 2000, 2006, and 2010 (includes
corresponding Graph/Chart) II-98
Table 29: Global Recent Past, Current & Future Analysis for
Breast Cancer Hormonal Therapy by Geographic Region - US,
Europe and Rest of World Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2000 through
2010 (includes corresponding Graph/Chart) II-99
Table 30: Global 10-Year Perspective for Breast Cancer
Hormonal Therapy by Geographic Region - US, Europe and Rest
of World Markets for 2000, 2006, and 2010 (includes
corresponding Graph/Chart) II-99
Table 31: Global Recent Past, Current & Future Analysis for
Breast Cancer Chemotherapy by Geographic Region - US, Europe
and Rest of World Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2000 through 2010
(includes corresponding Graph/Chart) II-100
Table 32: Global 10-Year Perspective for Breast Cancer
Chemotherapy by Geographic Region - US, Europe and Rest of
World Markets for 2000, 2006, and 2010 (includes corresponding
Graph/Chart) II-100
Table 33: Global Recent Past, Current & Future Analysis for
Breast Cancer Innovative Therapy by Geographic Region - US and
Rest of World Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2000 through 2010 (includes
corresponding Graph/Chart) II-101
Table 34: Global 10-Year Perspective for Breast Cancer
Innovative Therapy by Geographic Region - US and Rest of
World Markets for 2000, 2006 and 2010 II-101
III. MARKET
1. United States III-1
A.Market Analysis III-1
Outlook and Trends III-1
Aromatase Inhibitors on an Upward Trajectory III-1
Table 35: Market Share of SERMs and Aromatase Inhibitors
in the US: 2005 (includes corresponding Graph/Chart) III-1
Table 36: Market Share of Aromatase Inhibitors in the US:
2005 (includes corresponding Graph/Chart) III-2
Immense Potential Exists for Innovatives/Targeted Therapy III-2
Table 37: US Sales of Herceptin: 1998- 2005 (US$ Million)
(includes corresponding Graph/Chart) III-2
New Chemotherapeutic Agents Feature Reduced Toxicity III-2
Patent Expiries Encourage Interest in Biotech Products III-3
Growth Backed by New Product Approvals and Expanded
Indications III-3
Adjuvant Settings Emerge as a Promising Area III-3
Patient Population III-3
Innovative Therapy III-3
Herceptin III-3
Avastin III-3
Surgery III-4
US Market Dynamics III-4
TNM Classification III-4
TNM Grouping by Stage, Tumor Size, Nodal Involvement and Risk III-5
Table 38: Percentage of Patients by Stage of Diagnosis in
the US: Share by Stage - 2005 (includes corresponding
Graph/Chart) III-6
Incidence III-6
Statistics III-7
Table 39: Leading Types of Female Cancers in the US - %
of New Cases and Deaths: 2005 (includes corresponding
Graph/Chart) III-7
Table 40: Estimated Number of New Female Breast Cancer
Cases and Deaths in the US: 1997-2006E (includes
corresponding Graph/Chart) III-7
Table 41: Estimated New Female Breast Cancer Cases in Top
20 States in the US: 2000-2005 (includes corresponding
Graph/Chart) III-8
Table 42: Estimated Female Breast Cancer Deaths in Top 20
States in the US: 2000-2005 (includes corresponding
Graph/Chart) III-9
Risk Factors III-9
High, Medium and Low Risk Factors Associated with Breast
Cancer III-10
Risk of Developing Breast Cancer: US Data III-10
Ethnicity III-11
Table 43: Leading Types of Cancers in African American
Females - % of New Cases and Deaths: 2005E (includes
corresponding Graph/Chart) III-11
Table 44: Staged Distribution for Female Breast Cancer in
African American and Whites: 1995-2000 (includes
corresponding Graph/Chart) III-12
Table 45: Female Breast Cancer Incidence and Death Rates
(age-adjusted) by Race and Ethnicity, US: 1998-2002
(includes corresponding Graph/Chart) III-12
Table 46: US-Five Year Relative Survival Rates in
African American and White Females by Stage: 1995-2000
(includes corresponding Graph/Chart) III-13
Table 47: Leading Causes of Disease-Related Deaths Among
US Hispanics: 2000 (includes corresponding Graph/Chart) III-13
Table 48: Leading Types of Cancers in Hispanic Females -
% of New Cases and Deaths: 2003E (includes corresponding
Graph/Chart) III-14
Family History III-14
Hereditary Factors III-14
Hormone Replacement Therapy III-15
Breast Biopsy III-15
Breast Radiation III-15
Menstrual Periods III-15
Diethylstilbestrol III-15
Lifestyle III-15
Breast-Feeding III-15
Physical Activity III-16
Genetic Testing III-16
Other Factors III-16
Survival Rates and its Implications III-16
Relative Survival Rates III-16
Table 49: Five-year Relative Survival Rates Among Female
Breast Cancer Patients Based on the Number of Years
Since Diagnosis (includes corresponding Graph/Chart) III-16
Table 50: Five-year Relative Survival Rates Among Female
Breast Cancer Patients Based on Age at Diagnosis
(includes corresponding Graph/Chart) III-17
Process of Therapy III-17
A Focus on Mammography III-18
Highest Number of Screening Procedures Worldwide III-18
Table 51: Mammography in Women Aged 40 and Above:US
(2000) III-18
Table 52: Estimated Prices of Breast Cancer Testing
Modalities in the US III-18
Regulatory Forces Shape Mammography Fortunes III-19
USPSTF Recommends Mammography for Women Over 40 III-19
Competitive Dynamics of Regulatory, Prescription and
Reimbursement Issues III-19
Pharmaceutical Registration Process in the US III-19
An Overview of Regulatory Scenario in the US III-20
New Regulations Intensify Competitive Conditions III-21
Prescription Conduct: Under Scrutiny III-21
Generic Medicines Preferred to Branded Medicines III-21
A Review of Select Medical Acts III-22
Medicare Prescription Drug, Improvement and Modernization Act III-22
Medicare Prescription Drug Benefit III-22
Medicaid Program III-23
Women's Health and Cancer Rights Act III-23
Women's Health and Wellness Act III-23
Mammography Quality and Standards Act III-23
Reimbursement Issues Concerning Oncology Therapies III-23
Male Breast Cancer III-24
Anatomy III-24
Symptoms III-24
Types of Breast Cancer III-24
Treatment III-24
Incidence III-24
Table 53: Estimated Number of New Male Breast Cancer Cases
and Deaths: 1997-2006E (includes corresponding
Graph/Chart) III-25
Mortality and Survival III-25
ASCO Trials III-25
Major Breast Cancer Trials for Key Products Conducted by ASCO III-25
B.Market Analytics III-27
Table 54: US Recent Past, Current & Future Analysis for
Breast Cancer Therapeutics by Product Segment - Hormonal
Therapy, Chemotherapy and Innovative Therapy Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2000 through 2010 (includes corresponding
Graph/Chart) III-27
Table 55: US 10-Year Perspective for Breast Cancer
Therapeutics by Product Segment- Hormonal Therapy,
Chemotherapy and Innovative Therapy Markets for 2000, 2006,
and 2010 (includes corresponding Graph/Chart) III-27
2. Europe III-28
A.Market Analysis III-28
Incidence III-28
Table 56: Proportion of New Breast Cancer Cases (by Stage)
in Europe At Diagnosis: 2005 (includes corresponding
Graph/Chart) III-28
Mortality and Survival III-28
Table 57: Age-Adjusted Death Rates Per 100,000 Population
Due to Female Breast Cancers in Europe - by Select
Countries: 2002 (includes corresponding Graph/Chart) III-29
Demographics III-29
Table 58: Population of Women Aged 65 years and Above by
Country - Russia, Germany, Italy, France, UK, Spain,
Poland, The Netherlands, Belgium, Hungary, Czech Republic,
Sweden, Austria, Switzerland, Finland, Denmark and Norway:
2005E (In Thousands) (includes corresponding Graph/Chart) III-29
Screening and Diagnosis III-30
Reimbursement of Mammography Procedures III-30
Market Trends III-30
Rapid Uptake of Aromatase Inhibitors III-30
Chemotherapy Targets Hormone Negative Cancers III-30
Innovative/Targeted therapy: Still on the Fringes III-31
Market Structure III-31
Table 59: Market Share of Companies in the European
Hormonals Segment: 2002 (In terms of Sales) (includes
corresponding Graph/Chart) III-31
Table 60: Market Share of Companies in the European
Chemotherapy Segment: 2002 (In terms of Sales) (includes
corresponding Graph/Chart) III-31
Opportunities and Challenges Presented by the Therapeutics
Market III-32
Pharmaceutical Registration Process in Europe III-32
Mutual Recognition Procedure III-32
Centralized Procedure III-32
Reimbursement Scenario III-33
Aggressive Efforts Underway to Control Healthcare Costs III-33
B.Market Analytics III-34
Table 61: European Recent Past, Current & Future Analysis
for Breast Cancer Therapeutics by Geographic Region -France,
Germany, Italy, UK, Spain & Rest of Europe Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2000 through 2010 (includes corresponding
Graph/Chart) III-34
Table 62: European 10-Year Perspective for Breast Cancer
Therapeutics by Geographic Region - France, Germany, Italy,
UK, Spain & Rest of Europe Markets for 2000, 2006, and 2010
(includes corresponding Graph/Chart) III-34
Table 63: European Recent Past, Current & Future Analysis
for Breast Cancer Therapeutics by Product Segment - Hormonal
Therapy and Chemotherapy Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2000
through 2010 (includes corresponding Graph/Chart) III-35
Table 64: European 10-Year Perspective for Breast Cancer
Therapeutics by Product Segment- Hormonal Therapy and
Chemotherapy Markets for 2000, 2006, and 2010 III-35
2a. France III-36
A.Market Analysis III-36
Highlights III-36
Market Structure III-36
Table 65: Market Share of Companies in the French
Chemotherapeutic Segment: 2002 (includes corresponding
Graph/Chart) III-36
Table 66: Market Share of Companies in the French Hormonal
Therapy Segment: 2002 (includes corresponding Graph/Chart) III-36
Regulatory Structure III-37
B.Market Analytics III-38
Table 67: French Recent Past, Current & Future Analysis for
Breast Cancer Therapeutics by Product Segment - Hormonal
Therapy and Chemotherapy Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2000 through
2010 (includes corresponding Graph/Chart) III-38
Table 68: French 10-Year Perspective for Breast Cancer
Therapeutics by Product Segment- Hormonal Therapy and
Chemotherapy Markets for 2000, 2006, and 2010 III-38
2b. Germany III-39
A.Market Analysis III-39
Snapshots III-39
Market Share Data III-39
Table 69: Share of Companies in the German Breast Cancer
Therapeutics Market: 2002 (includes corresponding Graph/
Chart) III-39
Table 70: Market Share of Companies in the German
Chemotherapeutic Segment: 2002 (includes corresponding
Graph/Chart) III-39
Table 71: Market Share of Companies in the German Hormonal
Therapy Segment: 2002 (includes corresponding Graph/Chart) III-40
Regulatory Scenario III-40
B.Market Analytics III-41
Table 72: German Recent Past, Current & Future Analysis for
Breast Cancer Therapeutics by Product Segment - Hormonal
Therapy and Chemotherapy Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2000 through
2010 (includes corresponding Graph/Chart) III-41
Table 73: German 10-Year Perspective for Breast Cancer
Therapeutics by Product Segment- Hormonal Therapy and
Chemotherapy Markets for 2000, 2006, and 2010 III-41
2c. United Kingdom III-42
A.Market Analysis III-42
Highlights III-42
Epidemiological Data III-43
Table 74: Number of Female New Breast Cancer Cases and
Deaths in the UK: 1993-2002 (includes corresponding
Graph/Chart) III-43
Table 75: Most Common Female Cancers in the UK: 2002
(includes corresponding Graph/Chart) III-43
Table 76: Number of New Female Breast Cancer Cases
Diagnosed in the UK: 2000 (includes corresponding
Graph/Chart) III-44
Table 77: Number of Female Breast Cancer Deaths in the UK:
2002 (includes corresponding Graph/Chart) III-44
Issues & Trends III-45
Aromatase Inhibitors: On the Recommendation List III-45
Massive Government Efforts to Enhance Breast Cancer Awareness III-45
Implementation of the National Screening Program III-45
Reimbursement and Regulatory Environment III-45
Competition III-46
Table 78: Market Share of Companies in the UK
Chemotherapeutic Segment: 2002 (includes corresponding
Graph/Chart) III-46
Table 79: Market Share of Companies in the UK Hormonal
Therapy Segment: 2002 (includes corresponding Graph/Chart) III-46
B.Market Analytics III-47
Table 80: UK Recent Past, Current & Future Analysis for
Breast Cancer Therapeutics by Product Segment - Hormonal
Therapy and Chemotherapy Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2000 through
2010 (includes corresponding Graph/Chart) III-47
Table 81: UK 10-Year Perspective for Breast Cancer
Therapeutics by Product Segment- Hormonal Therapy and
Chemotherapy Markets for 2000, 2006, and 2010 III-47
2d. Italy III-48
A.Market Analysis III-48
Market Snippets III-48
Competitive Framework III-48
Table 82: Market Share of Companies in the Italian
Chemotherapeutic Segment: 2002 (includes corresponding
Graph/Chart) III-48
Table 83: Market Share of Companies in the Italian Hormonal
Therapy Segment: 2002 (includes corresponding Graph/Chart) III-48
Regulatory Scenario III-49
B.Market Analytics III-50
Table 84: Italian Recent Past, Current & Future Analysis for
Breast Cancer Therapeutics by Product Segment - Hormonal
Therapy and Chemotherapy Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2000 through
2010 (includes corresponding Graph/Chart) III-50
Table 85: Italian 10-Year Perspective for Breast Cancer
Therapeutics by Product Segment- Hormonal Therapy and
Chemotherapy Markets for 2000, 2006, and 2010 III-50
2e. Spain III-51
A.Market Analysis III-51
Snapshots III-51
Market Participants III-51
Table 86: Share of Companies in the Spanish Breast Cancer
Therapeutics Market: 2002 (includes corresponding Graph/
Chart) III-51
Table 87: Market Share of Companies in the Spanish
Chemotherapeutic Segment: 2002 (includes corresponding
Graph/Chart) III-51
Table 88: Market Share of Companies in the Spanish Hormonal
Therapy Segment: 2002 (includes corresponding Graph/Chart) III-52
Regulatory Scenario III-52
B.Market Analytics III-53
Table 89: Spanish Recent Past, Current & Future Analysis for
Breast Cancer Therapeutics by Product Segment - Hormonal
Therapy and Chemotherapy Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2000 through
2010 (includes corresponding Graph/Chart) III-53
Table 90: Spanish 10-Year Perspective for Breast Cancer
Therapeutics by Product Segment- Hormonal Therapy and
Chemotherapy Markets for 2000, 2006, and 2010 III-53
2f. Rest of Europe III-54
A.Market Analysis III-54
Highlights III-54
B.Market Analytics III-54
Table 91: Rest of Europe Recent Past, Current & Future
Analysis for Breast Cancer Therapeutics by Product Segment -
Hormonal Therapy and Chemotherapy Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2000 through 2010 (includes corresponding Graph/Chart) III-54
Table 92: Rest of Europe 10-Year Perspective for Breast
Cancer Therapeutics by Product Segment- Hormonal Therapy and
Chemotherapy Markets for 2000, 2006, and 2010 III-55
3. Rest of World III-56
A.Market Analysis III-56
Outlook III-56
Focus on Select Regions III-56
Canada III-56
Highlights III-56
Table 93: Breast Cancer Incidence in Canada by Age
Group: 2006E III-57
Table 94: Breast Cancer Mortality in Canada by Age
Group: 2006E (includes corresponding Graph/Chart) III-57
Table 95: Breast Cancer Incidence and Mortality in
Canada by Age Group: 2005 (includes corresponding
Graph/Chart) III-57
Table 96: New Cases of Breast Cancer in Canada, By Age
Group: 2004 (includes corresponding Graph/Chart) III-58
Table 97: Breast Cancer Deaths in Canada by Age Group:
2004 (includes corresponding Graph/Chart) III-58
Japan III-58
Incidence III-58
Regulatory Environment III-58
An Overview III-58
Expedited Approval for Marketed/Approved US and European
Products III-59
Reimbursement and Pricing Issues III-59
Pharmaceutical Registration Process in Japan III-59
Key Player III-60
Chugai Pharmaceutical Co III-60
Asia III-60
Demographics III-60
Table 98: Population of Women Aged 65 years and Above in
Select Asian Countries - China, India, Indonesia,
Thailand, South Korea, Australia and Taiwan:2005E
(includes corresponding Graph/Chart) III-60
Table 99: Population of Women Aged 65 years and Above in
Latin America - Argentina, Brazil, Chile, Colombia,
Mexico, Peru and Venezuela: 2005E (includes corresponding
Graph/Chart) III-61
Table 100: Age-Adjusted Death Rates Per 100,000
Population Due to Female Breast Cancers in anada, Japan,
Asia and Latin American Countries: 2002 (includes
corresponding Graph/Chart) III-61
Australia III-61
China III-62
Highlights III-62
Market Size III-62
Table 101: Chinese Market for Breast Cancer Therapeutics
with Annual Sales Figures in US$ Million for Years 2000
through 2006 (includes corresponding Graph/Chart) III-62
India III-63
Latin America III-63
Ukraine III-63
B.Market Analytics III-64
Table 102: Rest of World Recent Past, Current & Future
Analysis for Breast Cancer Therapeutics with Annual Sales
Figures in US$ Million for Years 2000 through 2010
(includes corresponding Graph/Chart) III-64
IV. COMPETITIVE LANDSCAPE
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