In spite of major advances in early detection and adjuvant therapy, breast cancer, especially advanced-stage disease, remains a major clinical and human problem.  There is an urgent need for new therapies and novel agents that are more effective than those currently available for the treatment of advanced breast cancer and will improve the survival rates and improve quality of life for patients.

There are three principal approaches to the treatment of this disease:  surgery, radiotherapy, and medical intervention (chemotherapy, hormonal).  The current practices and advances in these fields, and their potential impacts on patients and cancer therapeutics markets are discussed in this report, along with a detailed examination of emerging therapeutics, such as advanced pharmaceutical and pharmaceutical delivery approaches, immunotherapy, genetic therapy, and tumor ablation through a variety of energy sources.  This report discusses the companies and technologies working to shape the U.S. breast cancer therapeutics market throughout this decade, and analyzes the U.S. markets for breast cancer chemotherapy, immunotherapy (including immune stimulants and cancer vaccines), angiogenesis drugs, gene therapy, and ablation products, from 2001 to 2011.  In addition, profiles of 20 key players in this market are provided.

TABLE OF CONTENTS

SECTION 1: EXECUTIVE SUMMARY

1.1   Breast Radiotherapy

1.2   Chemotherapy for Breast Cancer

1.3   Angiogenesis Drugs

1.4   Immune Stimulants

1.5   Cancer Vaccines

1.6   Gene Therapy

1.7   Ablation Products

SECTION 2: CLINICAL AND STATISTICAL OVERVIEW

2.1   Breast Anatomy and Disease Processes

2.1.1   Normal Breast Development and Physiology

2.1.2   Benign Disease

2.1.2.1     Fibroadenoma

2.1.2.2     Fibrocystic Disease

2.1.2.3     Atypical Ductal Hyperplasia

2.1.2.4     Other Benign Conditions

2.1.3   Malignant Conditions

2.1.3.1     In Situ Breast Cancer/Ductal Carcinoma In Situ (DCIS)

2.1.3.2     Breast Cancer Description and Behavior

2.1.3.3     Invasive Breast Cancer

2.1.4   Less Common Types of Breast Cancer

2.2   Breast Cancer Statistics and Trends         

2.2.1   Signs and Symptoms

2.2.2   Incidence, Prevalence, Mortality and Survival

2.2.3   Causes and Risk Factors

2.2.4   The Cost of Treating Breast Cancer

2.2.5   Breast Cancer Prevention Efforts

SECTION 3: ESTABLISHED BREAST DISEASE THERAPIES

3.1   Surgery

3.1.1   Types of Breast Surgery

3.1.1.1     Simple (Total) Mastectomy

3.1.1.2     Modified Radical Mastectomy

3.1.1.3     Radical Mastectomy

3.1.1.4     Breast-Conserving Surgery

3.1.1.5     Lymph Node Removal

3.1.1.5.1     Sentinel Node Mapping

3.1.1.6     Adjuvant Therapy

3.1.2   Surgical Approaches to Specific Cancers

3.1.2.1     Noninvasive Carcinoma

3.1.2.1.1     Lobular Carcinoma In Situ

3.1.2.1.2     Ductal Carcinoma In Situ

3.1.2.2     Invasive Carcinoma—Stages I and II

3.1.2.3     Locally Advanced Breast Cancer

3.1.2.4     Axillary Dissection

3.1.2.5     Reconstructive Surgery

3.2   Radiotherapy

3.2.1   External Beam Radiation

3.2.1.1     Intraoperative Radiotherapy

3.2.1.2     Clinical Trials in Breast Cancer Radiotherapy

3.2.1.3     Intensity Modulated Radiation Therapy

3.2.2   Targeted Internal Radiation

3.2.2.1     Brachytherapy

3.2.3   Commercial Activity in Breast Radiotherapy

3.2.3.1     ARTEMIS MEDICAL

3.2.3.2     BIONIX

3.2.3.3     ELEKTA

3.2.3.4     HAYNES RADIATION

3.2.3.5     HUESTIS MEDICAL

3.2.3.6     MDS NORDION

3.2.3.7     MIDCO

3.2.3.8     NOMOS

3.2.3.9     NUCLETRON B.V.

3.2.3.10   PHILIPS MEDICAL SYSTEMS

3.2.3.11   PHOTOELECTRON

3.2.3.12   PROXIMA THERAPEUTICS

3.2.3.13   SIEMENS MEDICAL SOLUTIONS

3.2.3.14   SYNCOR INTERNATIONAL

3.2.3.15   THERMO ELECTRON

3.2.3.16   VARIAN MEDICAL SYSTEMS

3.2.4   Breast Brachytherapy Market Analysis

3.3   Chemotherapeutic Agents

3.3.1   Classifications of Agents

3.3.2   Cytotoxic Chemotherapy

3.3.2.1     Cytotoxic Chemotherapy Regimens

3.3.2.2     Taxanes

3.3.2.2.1     Paclitaxel

3.3.2.2.2     Docetaxel

3.3.2.3     Antitumor Antibiotics

3.3.2.3.1     Epirubicin

3.3.2.4     Antimetabolites

3.3.2.4.1     Capecitabine

3.3.2.4.2     Carboplatin

3.3.2.4.3     Cisplatin

3.3.2.4.4     Etoposide

3.3.2.4.5     5-fluorouracil

3.3.2.4.6     Gemcitabine

3.3.2.4.7     Methotrexate

3.3.3   Hormone Therapy

3.3.3.1     Aromatase Inhibitors

3.3.3.1.1     Aminoglutethimide

3.3.3.1.2     Anastrozole

3.3.3.1.3     Letrozole

3.3.3.1.4     Exemestane

3.3.3.2     Progestational Agents

3.3.3.3     Estrogen Receptor Modulators

3.3.3.3.1     Tamoxifen

3.3.3.4     Pituitary Agents

3.3.3.4.1     New Approaches to Estrogen-Related Breast Cancer

3.3.3.5     Growth Factor-Related Agents

3.3.3.5.1     Trastuzumab

3.3.3.5.2     Development in Growth Factor-Related Agents

3.3.3.6     Hormone Therapy for High-Risk Women

3.3.4   Administration of Chemotherapeutic Agents

3.3.5   High-Dose Chemotherapy and Bone Marrow/Stem Cell Transplantation

3.3.5.1     Side Effects of Increased Chemotherapy Dosages

3.3.5.1.1     Anemia

3.3.5.1.2     Infection

3.3.6   Developments in Breast Cancer Chemotherapeutic Agents

3.3.7   Chemotherapeutic Agents Market Analysis

SECTION 4: EMERGING BREAST CANCER THERAPIES

4.1   Biological Response/Process Modifiers

4.1.1   Angiogenesis Approaches

4.1.1.1     Background

4.1.1.1.1     Basic Fibroblast Growth Factor (bFGF)

4.1.1.1.2     Vascular Permeability Factor/Vascular 
Endothelial Growth Factor (VEGF)

4.1.1.1.3     Other Angiogenic Factors

4.1.1.1.4     Angiogenesis Inhibitors and Thrombospondin

4.1.1.2     Progress in Angiogenesis Therapeutics

4.1.1.2.1     COL-3

4.1.1.2.2     Endostatin

4.1.1.2.3     Farnesyl Transferase Inhibitors

4.1.1.2.4     Marimastat

4.1.1.2.5     Thalidomide

4.1.1.2.6     Combretastatins

4.1.1.2.7     TNP-470

4.1.1.2.8     SU6668

4.1.1.2.9     SU5416

4.1.1.2.10   Angiozyme

4.1.1.2.11   Interferon-a

4.1.1.2.12   Anti-VEGF MAb

4.1.1.2.13   Vasostatin and Interleukin-12

4.1.1.2.14   Other Antiangiogenesis Drugs

4.1.1.2.15   Clinical Trials

4.1.1.3     Commercial Outlook for Angiogenesis Approaches to Breast Cancer

4.1.2   Immunotherapy Approaches

4.1.2.1     Background

4.1.2.1.1     Coley Toxins

4.1.2.1.2     The Issels Treatment

4.1.2.1.3     Other Approaches

4.1.2.1.4     BCG (Bacillus Calmette-Guerin)

4.1.2.2     Immunology and Cancer

4.1.2.2.1     Vaccines

4.1.2.2.2     Immune Hormone Stimulation

4.1.2.3     Progress in the Immunotherapy of Breast Cancer

4.1.2.3.1     Early Efforts in Vaccine Therapy and 
Technology

4.1.2.3.2     Barriers to Immunotherapy Technology

4.1.2.3.3     Summary of Immunotherapy Approaches 
to Breast Cancer

4.1.3   Genetic Approaches

4.1.3.1     Background

4.1.3.2     Direct Gene Therapy

4.1.3.2.1     Physical Transfection

4.1.3.2.2     Chemical Transfection

4.1.3.2.3     Biological Transfection

4.1.3.3     Phenotype Alteration

4.1.3.3.1     Antisense Inhibition of Oncogenes

4.1.3.3.2     Triplex DNA Technology

4.1.3.3.3     Ribozyme Technology

4.1.3.3.4     Monoclonal Antibody Technology

4.1.3.4     Drug-Resistant Genes

4.1.3.4.1     MDR-1 Gene

4.1.3.4.2     Topoisomerase II

4.1.3.5     Suicide Genes

4.1.3.6     Summary of Therapeutic Genetic Approaches

4.2   Tumor Ablation

4.2.1   Photodynamic Therapy

4.2.1.1     Mechanisms of Photodynamic Therapy

4.2.1.1.1     Photosensitizers

4.2.1.2     The Pros and Cons of Photodynamic Therapy

4.2.1.3     Applications of Photodynamic Therapy in Breast Cancer

4.2.1.4     Summary of Commercial Outlook

4.2.2   Energy-Based Ablation

4.2.2.1     Radiofrequency

4.2.2.1.1     RADIOTHERAPEUTICS/BOSTON SCIENTIFIC

4.2.2.1.2     RADIONICS

4.2.2.1.3     RITA MEDICAL SYSTEMS

4.2.2.1.4     ARTEMIS MEDICAL

4.2.2.1.5     SENORX

4.2.2.2     Focused Microwave Thermotherapy

4.2.2.2.1     CELSION

4.2.2.2.2     VIVANT MEDICAL

4.2.3   Focused Ultrasound

4.2.3.1     EDAP/SIEMENS

4.2.3.2     INSIGHTEC-TXSONICS

4.2.4   Other Ablation Approaches

4.2.4.1     Laser Ablation

4.2.4.2     Cryoblation

4.2.4.2.1     SANARUS MEDICAL

4.2.5   Progress in Tumor Ablation

4.3   Emerging Therapies Market Analysis

SECTION 5: COMPANY PROFILES

5.1   ARTEMIS MEDICAL, INC.

5.2   ASTRAZENECA PLC

5.3   BIOMIRA, INC.

5.4   BRISTOL-MYERS SQUIBB COMPANY

5.5   CELSION CORPORATION

5.6   ENDOCARE, INC.

5.7   GENENTECH, INC.

5.8   ISIS PHARMACEUTICALS, INC.

5.9   NOMOS CORPORATION

5.10 NUCLETRON B.V.

5.11 PHARMACIA

5.12 PHOTOELECTRON

5.13 PROXIMA THERAPEUTICS, INC.

5.14 RADIONICS/TYCO HEALTHCARE GROUP LP

5.15 RADIOTHERAPEUTICS/BOSTON SCIENTIFIC CORPORATION

5.16 RITA MEDICAL SYSTEMS, INC.

5.17 SANARUS MEDICAL, INC.

5.18 SIEMENS MEDICAL SOLUTIONS

5.19 SIGNALGENE, INC.

5.20 VARIAN MEDICAL SYSTEMS, INC.   

APPENDIX A:  COMPANY LISTING   

LIST OF EXHIBITS

Exhibit 1-1:    Established and Emerging Breast Cancer Therapeutics, U.S. Market Forecast, 2001-2011E

Exhibit 1-2:    Breast Brachytherapy Disposables, U.S. Market Forecast, 2001-2011E

Exhibit 1-3:    Breast Chemotherapy Pharmaceuticals, U.S. Market Forecast, 2001-2011E

Exhibit 1-4:    Key Angiogenesis Inhibitors in Development with Potential Application 
to Breast Cancer

Exhibit 1-5:    Selected U.S. Companies Participating in In Situ Breast Cancer Ablation

Exhibit 1-6:    Emerging Breast Cancer Therapy Products, U.S. Market Forecast, 2001-2011E

Exhibit 2-1:    Female Breast Structure

Exhibit 2-2:    Benign Breast Disease and Relative Risk for Subsequent Invasive 
Breast Cancer

Exhibit 2-3:    Benign Breast Disease Categories

Exhibit 2-4:    U.S. Incidence of Breast Cancer in Women, by Age Group

Exhibit 2-5:    Major Forms of Breast Cancer

Exhibit 2-6:    Most Common Histologic Diagnoses of U.S. Breast Biopsies Found to be Cancerous

Exhibit 2-7:    Leading Sites of New Cancer Cases and Deaths in Females, 2002 Estimates

Exhibit 2-8:    Estimated Number of Females Alive in the U.S. Diagnosed with 
Selected Cancers in the Last 20 or More Years, by Diagnosis

Exhibit 2-9:    Five-Year U.S. Survival Rate for Breast Cancer, by Stage at Diagnosis

Exhibit 2-10:  Overall Breast Cancer Survival Rate, U.S.

Exhibit 2-11:  Risk Factor Categories for Breast Cancer

Exhibit 2-12:  Medicare Payments in Metastatic Breast Cancer Cases versus Controls

Exhibit 3-1:    American Joint Committee on Cancer’s TNM Staging System

Exhibit 3-2:    U.S. Mastectomy Procedures, by Type, 2002E

Exhibit 3-3:    Simple Mastectomy

Exhibit 3-4:    Modified Radical Mastectomy

Exhibit 3-5:    Radical Mastectomy

Exhibit 3-6:    Breast-Conserving Surgery

Exhibit 3-7:    Comparison of Disease-Free Survival Rates in Breast Cancer Patients Undergoing Mastectomy or Breast-Conserving Surgery and 
Radiotherapy

Exhibit 3-8:    Selected Ongoing Clinical Trials Involving Breast Cancer Radiotherapy

Exhibit 3-9:    Selected FDA-Approved Radiotherapy Products Used in the Breast, by Supplier

Exhibit 3-10:  Breast Brachytherapy Disposables, U.S. Market Forecast, 2001-2011E

Exhibit 3-11:  Commonly Used Breast Cancer Chemotherapeutic Agents

Exhibit 3-12:  Standard Chemotherapeutic Approaches to Breast Cancer

Exhibit 3-13:  Commonly Used Breast Cancer Chemotherapeutic Hormone Agents

Exhibit 3-14:  Key Findings of NSABP Tamoxifen Breast Cancer Trials Published Since 1981

Exhibit 3-15:  Ongoing Clinical Trials Involving Breast Cancer Pharmaceuticals in the Commercial Sector

Exhibit 3-16:  Key Ongoing Clinical Trials Involving Breast Cancer Pharmaceutical Therapy

Exhibit 3-17:  Breast Chemotherapy Pharmaceuticals, U.S. Market Forecast, 2001-2011E

Exhibit 3-18:  U.S. Market Segment Distribution of Breast Cancer Chemotherapeutic Sales, 2002 and 2011E

Exhibit 3-19:  Trends in the U.S. Market for Breast Chemotherapeutics, 2001–2011E

Exhibit 4-1:    Endogenous Angiogenesis Regulators

Exhibit 4-2:    Key Angiogenesis Inhibitors in Development with Potential Application 
to Breast Cancer

Exhibit 4-3:    Clinical Trials of Angiogenesis Inhibitors with Potential Application to Breast Cancer

Exhibit 4-4:    Cytokines and Growth Factors that Influence the Immune System in Cancer Patients

Exhibit 4-5:    Active Clinical Trials Involving Breast Cancer Immunotherapy

Exhibit 4-6:    Physical Gene Transfer Technologies        

Exhibit 4-7:    Chemically Assisted Gene Transfer Technologies

Exhibit 4-8:    Viral Vector Gene Transfer Technologies

Exhibit 4-9:    Gene Therapy Clinical Trials for Breast Cancer

Exhibit 4-10:  History of Approved Uses for Photodynamic Therapy

Exhibit 4-11:  Photosensitizers Used in Cancer Photodynamic Therapy

Exhibit 4-12:  Benefits and Limitations of PDT Therapy

Exhibit 4-13:  Selected Ongoing Clinical Trials Involving Photodynamic Therapy for Cancer

Exhibit 4-14:  Selected U.S. Companies Participating in In Situ Breast Cancer Ablation

Exhibit 4-15:  Conditions Treated with Radiofrequency Ablation

Exhibit 4-16: