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市場調査レポート

乳癌治療用モノクローナル抗体市場:新規HER2標的薬の取り込みで、強固な成長を促進

Monoclonal Antibodies Market in Breast Cancer to 2019 - Strong Uptake of Novel HER-2 Targeted Therapies to Drive Robust Growth

発行 GBI Research 商品コード 290191
出版日 ページ情報 英文 112 Pages
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乳癌治療用モノクローナル抗体市場:新規HER2標的薬の取り込みで、強固な成長を促進 Monoclonal Antibodies Market in Breast Cancer to 2019 - Strong Uptake of Novel HER-2 Targeted Therapies to Drive Robust Growth
出版日: 2013年10月31日 ページ情報: 英文 112 Pages
概要

当レポートでは、世界の乳癌治療用モノクローナル抗体市場について調査分析し、乳癌の治療法、モノクローナル抗体による乳癌治療アルゴリズム、主な上市製品、開発パイプライン分析、地域別の市場予測、最近の業界取引に関する情報などを提供して、概略以下の構成でお届けいたします。

第1章 目次

第2章 乳癌治療用モノクローナル抗体市場:イントロダクション

  • 症状
  • 病因
  • 疫学
  • 病態生理学
  • 診断
  • 予後と病期分類
  • 治療法の選択肢

第3章 上市製品

  • ハーセプチン(Trastuzumab)- Hoffmann La Roche
  • アバスチン(Bevacizumab)- Hoffmann La Roche
  • Kadcyla(Trastuzumab Emtansine)- Hoffmann La Roche
  • Perjeta(Pertuzumab)- Hoffmann La Roche
  • Xgeva(denosumab)- Amgen
  • 上市製品のヒートマップ
  • 結論

第4章 乳癌治療用モノクローナル抗体のパイプライン

  • パイプライン全体
  • 作用機序
  • 臨床試験
  • 有望なパイプライン薬
    • CDX-011(glembatumumab vedotin)- Celldex Therapeutics
    • Metmab(onartuzumab)- Hoffman La Roche
    • Hu3S193 - Recepta Biopharma
    • MM-121 - Merrimack Pharmaceuticals
    • IMC-18F1(Icrucumab)- Eli Lilly
    • Rexomun(Ertumaxomab)- Fresenius Biotech
    • Medi-573(Dusigitumab)- Medimmune
    • MK-0646(Dalotuzumab)- Merck and Co
    • LY3012217(Cixutumumab)- Eli Lilly
  • 結論

第5章 市場予測

  • 世界市場
    • 治療利用パターン
    • 市場規模
  • 米国
    • 治療利用パターン
    • 市場規模
  • カナダ
    • 治療利用パターン
    • 市場規模
  • 欧州
    • 治療利用パターン
    • 年間治療費(ACT)
    • 市場規模
  • 日本
    • 治療利用パターン
    • 市場規模
  • 促進要因と障壁
    • 促進要因
    • 障壁

第6章 取引と戦略的統合

  • R&Dライセンス契約
  • 共同開発契約

第7章 付録

図表

目次
Product Code: GBIHC309MR

GBI Research has released the pharmaceutical report "Monoclonal Antibodies Market in Breast Cancer to 2019 - Strong Uptake of Novel HER-2 Targeted Therapies to Drive Robust Growth". The current market for breast cancer consists of five monoclonal Antibodies (mAbs), three of which are targeted at the Human Epidermal growth factor Receptor 2 (HER-2) protein. Four are aimed at improving overall survival in the metastatic setting, and two of these have also received further approvals in the early setting in order to improve long-term remission rates.

The market is currently led by the HER-2 inhibitor Herceptin, which achieved global sales amounting to $6.2 billion in 2012. Over the forecast period from 2012 to 2019, the two novel HER-2 inhibitors, Kadcyla and Perjeta, are expected to achieve strong market penetration due to their appreciable incremental efficacy benefits. Additionally, the market conditions are currently favorable towards mAbs, with a low rate of price depreciation following patent expiry and a high rate of inflation for specialty pharmaceuticals in the US. As a result of this, and despite the empty Phase III pipeline, GBI Research believes that the global market across the leading eight countries have the potential to grow to a value of $10.6 billion by 2019.

Scope

  • An introduction to the treatments available for breast cancer, treatment algorithms and the contexts in which mAbs are clinically relevant to this type of cancer.
  • In-depth analysis of the five mAbs approved for breast cancer, with analysis of their safety, efficacy, treatment patterns and strengths and weaknesses. This includes a heat map comparing the drugs in terms of clinical trial results.
  • A comprehensive review of the pipeline for breast cancer therapies, including individual analysis of a number of late-stage pipeline drugs that are likely to enter the market during the forecast period. The pipeline for mAbs is analyzed on the basis of phase distribution, program type and molecular target, as is the entire pipeline for all molecule types.
  • Detailed analysis of pipeline drug clinical trials by trial size, trial duration and program failure rate for each molecule type and mechanism of action. Additionally, a detailed analysis of clinical trial endpoints is provided, detailing their importance in this disease area and their commercial relevance to currently marketed products.
  • Multi-scenario forecast data for the market is provided to 2019, which takes into account how it will be affected by the introduction of new drugs, the expiry of key patents on current drugs and the changes in disease epidemiology across the key developed markets including the US, Japan, Germany, the UK, France, Italy and Spain.
  • Discussion of the drivers and barriers for market growth
  • Complete analysis of licensing and co-development deals in this market, by year, value, molecule type, Phase and mechanism of action. Additionally, the international network of licensing deals in breast cancer is mapped out by geography.

Reasons to buy

  • Understand the different indications for breast cancer, from early-stage to the metastatic disease
  • Grasp the vast scope of the pipeline, including which molecule types and mechanisms of action are prominent, and the context of mAbs in the pipeline
  • Pinpoint the trends in clinical trial duration and size amongst clinical Phases and molecule types, and use the clinical trial failure rate analysis to assess the risk profiles of current and/or future developmental programs for breast cancer therapeutics. Determine the risk associated with the development of mAbs compared to other molecule types.
  • Observe the shift in clinical trial endpoints by clinical Phase, and use this data to potentially influence any future developmental programs. Understand the importance of selecting the correct endpoints in the study of drugs for this disease.
  • Assess the potential clinical and commercial impact of recently-approved molecules on the breast cancer market and determine the potential revenues associated with the launch of a novel product, in addition to the level of competitiveness in the market.

Abstract:

Monoclonal Antibodies Market for Breast Cancer to More than Double by 2019, but Unmet Need Still to be Fulfilled, says GBI Research

The market value for monoclonal antibodies (mAbs) in breast cancer treatment will experience a massive increase from $4.8 billion in 2012 to $10.9 billion in 2019, demonstrating a Compound Annual Growth Rate (CAGR) of 12.2%, according to a new report from business intelligence provider GBI Research.

The company's latest report* states that this double-digit increase will be driven mainly by the uptake of two recent approvals, Perjeta and Kadcyla, along with the rapid year-on-year growth in specialty pharmaceuticals in the US, which boasts the largest regional market for breast cancer treatment.

Roche is currently the dominant player within this market, with a franchise of drugs (including the blockbuster Herceptin) that target the Human Epidermal growth factor Receptor-2 (HER-2), which is overexpressed in 20-25% of breast cancer patients.

However, as there are currently no effective mAbs for patients who do not overexpress this protein, a strong unmet need remains in this area, particularly in patients with the metastatic form of the disease.

Dominic Trewartha, Analyst for GBI Research, says: "For the majority of patients diagnosed in the early stages of breast cancer, survival rates are high, ranging from 80% to almost 100%. However, stage IV breast cancer is incurable, as with all other forms of metastatic cancer, so the primary treatment goal is limited to effective tumor remission over an extended period of time.

"While chemotherapy, surgery and radiation therapy are able to improve outcomes to an extent, mAb products that are currently available in the market are far more effective and safe than chemotherapy in this regard, affording a superior standard of care in suitable patients. The development of these products to provide greater survival benefits to patients diagnosed with metastatic breast cancer is therefore an obvious goal."

According to GBI Research, a realistic next step in terms of manufacturing novel mAb products would be to build on the benefit provided by the current range of marketed products and improve survival times further, with fewer side-effects.

"As 75% of the patient population is currently unable to benefit from mAb therapies, a new market entrant that is not specifically indicated for HER-2 positive cancers would face little competition. This therefore presents a very strong commercial opportunity for drug developers within this particular market segment," the analyst concludes.

Monoclonal Antibodies Market in Breast Cancer to 2019 - Strong Uptake of Novel HER-2 Targeted Therapies to Drive Robust Growth

This report provides an introduction to the treatments available for breast cancer, treatment algorithms and the contexts in which monoclonal antibodies (mAbs) are clinically relevant to this type of cancer. It provides analysis of the five mAbs approved for breast cancer, including their safety, efficacy, treatment patterns and strengths and weaknesses, along with a comprehensive review of the pipeline for breast cancer therapies.

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GBI Research's team of industry experts.

Table of Contents

1. Table of Contents

  • 1.1. List of Tables
  • 1.2. List of Figures

2. Monoclonal Antibodies Market in Breast Cancer to 2019 - Introduction

  • 2.1. Symptoms
  • 2.2. Etiology
  • 2.3. Epidemiology
  • 2.4. Pathophysiology
  • 2.5. Diagnosis
  • 2.6. Prognosis and Disease Staging
    • 2.6.1. Classification
  • 2.7. Treatment Options
    • 2.7.1. Surgery and Radiation Therapy
    • 2.7.2. Chemotherapy
    • 2.7.3. Hormonal Therapies
    • 2.7.4. Targeted Therapies
    • 2.7.5. Resistance to Pharmacological Therapies
    • 2.7.6. Treatment Guidelines
    • 2.7.7. Measuring the Effectiveness of Treatment

3. Marketed Products

  • 3.1. Herceptin (Trastuzumab) - Hoffmann La Roche
  • 3.2. Avastin (Bevacizumab) - Hoffmann La Roche
  • 3.3. Kadcyla (Trastuzumab Emtansine) - Hoffmann La Roche
  • 3.4. Perjeta (Pertuzumab) - Hoffmann La Roche
  • 3.5. Xgeva (denosumab) - Amgen
  • 3.6. Heat Map for Marketed Products
  • 3.7. Conclusion

4. Pipeline for Breast Cancer Monoclonal Antibody Therapeutics

  • 4.1. Overall Pipeline
  • 4.2. Mechanisms of Action
  • 4.3. Clinical Trials
    • 4.3.1. Attrition Rate
    • 4.3.2. Clinical Trial Size
    • 4.3.3. Duration
    • 4.3.4. Clinical Trial End-points
  • 4.4. Promising Drug Candidates in the Pipeline
    • 4.4.1. CDX-011 (glembatumumab vedotin) - Celldex Therapeutics
    • 4.4.2. Metmab (onartuzumab) - Hoffman La Roche
    • 4.4.3. Hu3S193 - Recepta Biopharma
    • 4.4.4. MM-121 - Merrimack Pharmaceuticals
    • 4.4.5. IMC-18F1 (Icrucumab) - Eli Lilly
    • 4.4.6. Rexomun (Ertumaxomab) - Fresenius Biotech
    • 4.4.7. Medi-573 (Dusigitumab) - Medimmune
    • 4.4.8. MK-0646 (Dalotuzumab) - Merck and Co
    • 4.4.9. LY3012217 (Cixutumumab) - Eli Lilly
  • 4.5. Conclusion

5. Market Forecast to 2019

  • 5.1. Global
    • 5.1.1. Treatment Usage Patterns
    • 5.1.2. Market Size
  • 5.2. US
    • 5.2.1. Treatment Usage Patterns
    • 5.2.2. Market Size
  • 5.3. Canada
    • 5.3.1. Treatment Usage Patterns
    • 5.3.2. Market Size
  • 5.4. Europe
    • 5.4.1. Treatment Usage Patterns
    • 5.4.2. Annual Cost of Therapy
    • 5.4.3. Market Size
  • 5.5. Japan
    • 5.5.1. Treatment Usage Patterns
    • 5.5.2. Market Size
  • 5.6. Drivers and Barriers
    • 5.6.1. Drivers
    • 5.6.2. Barriers

6. Deals and Strategic Consolidations

  • 6.1. R&D Licensing Agreements
    • 6.1.1. Key Licensing Deals
  • 6.2. Co-development Agreements
    • 6.2.1. Key Deals

7. Appendix

  • 7.1. References
  • 7.2. References for Heat Map
  • 7.3. All Pipeline Products, by Phase
    • 7.3.1. Discovery
    • 7.3.2. Preclinical
    • 7.3.3. IND/CTA Filed and Phase I
    • 7.3.4. Phase II
    • 7.3.5. Phase III and Pre-Registration
  • 7.4. Market Definitions
  • 7.5. Abbreviations
  • 7.6. Tabular Forecast Data
    • 7.6.1. Global
    • 7.6.2. US
    • 7.6.3. Canada
    • 7.6.4. UK
    • 7.6.5. France
    • 7.6.6. Germany
    • 7.6.7. Italy
    • 7.6.8. Spain
    • 7.6.9. Japan
  • 7.7. Research Methodology
    • 7.7.1. Coverage
    • 7.7.2. Secondary Research
  • 7.8. Therapeutic Landscape
  • 7.9. Epidemiology-Based Forecasting
  • 7.10. Market Size by Geography
  • 7.11. Geographical Landscape
  • 7.12. Pipeline Analysis
  • 7.13. Competitive Landscape
    • 7.13.1. Expert Panel Validation
  • 7.14. Contact Us
  • 7.15. Disclaimer

List of Tables

  • Table 1: Market for mAbs in Breast Cancer, Global, TNM Staging, 2010-2013
  • Table 2: Market for mAbs in Breast Cancer, US, Disease Stage at Diagnosis and Five-year Relative Survival (%), 2013
  • Table 3: Market for mAbs in Breast Cancer, References for Heat Map (Figure 6)
  • Table 4: Breast Cancer Therapeutics, Global, All Pipeline Products (Discovery), 2013
  • Table 5: Breast Cancer Therapeutics, Global, All Pipeline Products (Preclinical), 2013
  • Table 6: Breast Cancer Therapeutics, Global, All Pipeline Products (Phase I and IND/CTA filed), 2013
  • Table 7: Breast Cancer Therapeutics, Global, All Pipeline Products (Phase II), 2013
  • Table 8: Breast Cancer Therapeutics, Global, All Pipeline Products (Phase III and Pre-Registration), 2013
  • Table 9: Market for mAbs in Breast Cancer, Global, Forecast Data, 2012-2019
  • Table 10: Market for mAbs in Breast Cancer, US, Forecast Data, 2012-2019
  • Table 11: Market for mAbs in Breast Cancer, Canada, Forecast Data, 2012-2019
  • Table 12: Market for mAbs in Breast Cancer, UK, Forecast Data, 2012-2019
  • Table 13: Market for mAbs in Breast Cancer, France, Forecast Data, 2012-2019
  • Table 14: Market for mAbs in Breast Cancer, Germany, Forecast Data, 2012-2019
  • Table 15: Market for mAbs in Breast Cancer, Italy, Forecast Data, 2012-2019
  • Table 16: Market for mAbs in Breast Cancer, Spain, Forecast Data, 2012-2019
  • Table 17: Market for mAbs in Breast Cancer, Japan, Forecast Data, 2012-2019

List of Figures

  • Figure 1 Market for mAbs in Breast Cancer, Global, Treatment Algorithm for Cancer Diagnosed at Stages I to III
  • Figure 2: Market for mAbs in Breast Cancer, Global, Treatment Algorithm for Cancer Diagnosed at Stage IV
  • Figure 3: Market for mAbs in Breast Cancer, Global, Sales of Herceptin ($bn), 1999-2012
  • Figure 4: Market for mAbs in Breast Cancer, Global, Sales of Avastin ($bn), 2004-2012
  • Figure 5: Market for mAbs in Breast Cancer, Global, Aggregate Sales of Xgeva and Prolia ($m), 2010-2012
  • Figure 6: Market for mAbs in Breast Cancer, Global, Heat Map (Marketed Products)
  • Figure 7: Market for mAbs in Breast Cancer, Global, Pipeline by Stage of Development, 2013
  • Figure 8: Market for mAbs in Breast Cancer, Global, mAbs by Mechanism of Action, 2013
  • Figure 9: Market for mAbs in Breast Cancer, Global, mAbs by Mechanism of Action (Growth Factor Inhibitors), 2013
  • Figure 10: Market for mAbs in Breast Cancer, Global, mAbs by Molecular Target (Targeted Cytotoxic), 2013
  • Figure 11: Market for mAbs in Breast Cancer, Global, Pipeline by Stage of Development, 2013
  • Figure 12: Market for mAbs in Breast Cancer, Global, Pipeline by Stage of Development, 2013
  • Figure 13: Market for mAbs in Breast Cancer, Global, Clinical Trial Size, 2013
  • Figure 14: Market for mAbs in Breast Cancer, Global, Clinical Trial Duration, 2006-2013
  • Figure 15: Market for mAbs in Breast Cancer, Global, Clinical Trial Durations, 2006-2013
  • Figure 16: Market for mAbs in Breast Cancer, Global, Clinical Trial Endpoints for Phases II and III, 2006-2012
  • Figure 17: Market for mAbs in Breast Cancer, Global, Clinical Trial Endpoints for Phases II and III per Product, 2006-2012
  • Figure 18: Market for mAbs in Breast Cancer, Global, Treatment Usage Patterns, 2012-2019
  • Figure 19: Market for mAbs in Breast Cancer, Global, Market Size ($bn), 2012-2019
  • Figure 20: Market for mAbs in Breast Cancer, US, Treatment Patterns, 2012-2019
  • Figure 21: Market for mAbs in Breast Cancer, US, Market Size ($bn), 2012-2019
  • Figure 22: Market for mAbs in Breast Cancer, Canada, Treatment Usage Patterns, 2012-2019
  • Figure 23: Market for mAbs in Breast Cancer, Canada, Market Size ($m), 2012-2019
  • Figure 24: Market for mAbs in Breast Cancer, Top Five European Markets, Treatment Usage Patterns, 2012-2019
  • Figure 25: Market for mAbs in Breast Cancer, Top Five European Markets, Annual Cost of Therapy ($), 2012-2019
  • Figure 26: Market for mAbs in Breast Cancer, Top Five European Markets, Market Size ($m), 2012-2019
  • Figure 27: Market for mAbs in Breast Cancer, Japan, Treatment Usage Patterns, 2012-2019
  • Figure 28: Market for mAbs in Breast Cancer, Japan, Market Size ($m), 2012-2019
  • Figure 29: Market for mAbs in Breast Cancer, Global, Licensing Deals (All Molecule Types), 2006-2012 (A)
  • Figure 30: Market for mAbs in Breast Cancer, Global, Licensing Deals (All Molecule Types), 2006-2012 (B)
  • Figure 31: Market for mAbs in Breast Cancer, Global, Licensing Deals (All Molecule Types), 2006-2012 (C)
  • Figure 32: Market for mAbs in Breast Cancer, Global, Co-development Deals (All Molecule Types) by Partner Country, 2006-2012
  • Figure 33: Market for mAbs in Breast Cancer, Global, Co-development Deals by Molecule Type, 2006-2012
  • Figure 34: GBI Research Market Forecasting Model
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