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市場調查報告書 - 139758

個別化醫療市場:用以挑戰傳統治療法的人類基因學與蛋白質體學的進化

Personalized Medicine Market - Advances in Human Genomics and Proteomics to Challenge Traditional Therapeutics

出版商 GBI Research
出版日期 2010年12月01日 內容資訊 英文 124 Pages
價格
個別化醫療市場:用以挑戰傳統治療法的人類基因學與蛋白質體學的進化 Personalized Medicine Market - Advances in Human Genomics and Proteomics to Challenge Traditional Therapeutics
出版日期: 2010年12月01日 內容資訊: 英文 124 Pages
簡介

本報告書為個別化醫療市場相關的促進因子與障礙、現在藥劑簡介、管道產品簡介與研究動向、相關企業簡介與競爭動向等,概述如下。

第1章 目次

第2章 個別化醫療市場:市場概要

第3章 促進因子與阻礙因子

  • 促進因子
    • 醫療費增加
    • 凌駕傳統創藥方法的優點
    • 患者的適合性
    • 疾病的早期發見
    • 更好的法規基準與驗證順續促進了個別化醫療市場的成長
  • 障礙
    • 支付者償還問題
    • 倫理的問題
    • 醫療情報技術
    • 認知的落差:醫師教育不足與對新技術認知不足
    • 煩人的漫長開發手續阻擋了醫藥品部門的生物標記研究意願

第4章 個別化治療藥與診斷藥

  • 治療藥:藥劑簡介
  • 同伴診斷
    • 個別化醫療所採用的同伴診斷
  • 生物標記
    • 癌症研究中的生物標記
    • 市場規模與預測
    • 不同適應的分類

第5章 管道產品簡介

  • PF-4948568
  • PF-02341066 + Erlotinib
  • PF-299804
  • CEP-701
  • TBR-652
  • Brivanib
  • Ipilimumab
  • BiovaxID (Accentia Biopharmaceuticals, Inc

第6章 個別化醫療之研究動向

第7章 競爭環境

  • 競爭簡介
  • Clarient, Inc
  • Qiagen N.V.
  • Laboratory Corporation of America Holdings
  • bioMerieux S.A
  • Pfizer
  • Eli Lily and Company
  • Novartis
  • F. Hoffman La Roche
  • Bristol-Myers Squibb
  • Merck KGaA
  • Dako Denmark A/S

第8章 結論

第9章 附錄

圖表

目錄

Abstract

GBI Research' s new report “Personalized Medicine Market - Advances in Human Genomics and Proteomics to Challenge Traditional Therapeutics” provides an in-depth analysis on the potential applications of personalized medicine in pharmaceutical drug discovery and clinical services. The report suggests investment decisions in personalized medicine by providing information on valid personalized therapeutics, biomarkers, companion diagnostics, pipeline, the competitive landscape, mergers and acquisitions and market potential. In addition to this, the report also covers market drivers and restraints for the global personalized medicine market.

Companion Diagnostics to Foster the Transformational Trend Towards Personalized Medicine

Companion diagnostics facilitate identification of a patient' s response to drugs depending on an individual’s genetic or proteomic profile. Companion diagnostics thus allow customization of treatment based on a patient' s molecular or genetic make up, minimizing the risk of adverse reactions. Examples of successful therapeutics linked to companion diagnostic tests include Herceptin (trastuzumab), Gleevec (imatinib), Coumadin (warfarin), Camptosar (irinotecan) and Erbitux (cetuximab). Herceptin, for instance, is used to treat breast cancer patients that over-express HER2 protein. This subset of the patient population accounts for nearly 30% of the total breast cancer patients. HercepTest, the first test to be associated with a drug, was launched in 1998. HercepTest detects the over-expression of the HER2 protein, as a result increasing the accuracy and efficacy of treatment. Herceptin generated revenues of $5.2 billion in 2009, a growth of 10% from sales of $4.7 billion in 2007.

More and more companies are becoming increasingly involved in the development of companion diagnostics owing to the cost-effectiveness and accuracy of companion diagnostics in treatment and the drug discovery process as well. Oncology, in particular, is witnessing increased acceptance of companion diagnostics as the conventional trial and error method can prove to be cumbersome in patients with standard care. Companion diagnostics is also referred to as theranostics, holds immense potential, raising the prospect of a new standard of healthcare.

Major Players Are Becoming Increasingly Aligned Around Personalized Medicine - Oncology Continues to be the Prime Focus

Developing a new drug is a costly and time-consuming process. The application of advanced technologies for the development of personalized medicine, be it diagnostics or therapeutics, in the drug discovery process is becoming increasingly evident. The integration of pharmacogenomic data in clinical trials and drug development process helps in selecting patients that are more likely to respond or least likely to suffer any side effects. This considerably reduces the time, size and expense of clinical trials and also helps pharmaceutical companies to overcome the challenges posed by conventional processes which are time consuming and expensive.

Application of personalized medicine in the pharmaceuticals sector has the potential to revolutionize drug discovery process by facilitating treatment decisions and introducing preventive care. Applications of personalized medicine in oncology are becoming increasingly prominent, owing to genetic variations causing tumors and the resulting genetically defined patient subtypes. A number of therapeutics and biomarkers are focused on cancer research to allow better understanding of the disease. Within oncology, the major indications are breast cancer, lung cancer and colorectal cancer. The other major therapeutic areas include infectious diseases, immunology and cardiovascular diseases.

Personalized Medicine Market, Global, Adoption of Personalized Medicine by Top Companies in Drug Discovery, 2010

Source: GBI Research, Company Websites, US FDA (United States’ Food and Drug Administration)

Fundamental Business Models Including Regulatory and Reimbursement Regimes Need to be Revisited

Regulatory approval of innovative diagnostics or companion diagnostics will require a new regulatory process that considers the relevance of individual genetic profiles of patients and clinical outcomes. In the US, the Food and Drug Administration (FDA) and the Center for Medicare and Medicaid Services (CMS) are authorized to regulate and oversee the approval of medical devices, diagnostics and therapeutics and compliance with performance standards. The FDA is very supportive of the advancements in personalized medicine. Approval of certain genetic assays, reviews of pharmacogenomic guidance for the industry and the publication of papers and reviews on various related concepts such as biomarkers and drug-diagnostic co-development are some of the many efforts taken by the FDA in encouraging public education in personalized medicine. However, clear regulatory guidelines on the requirements for the development of companion diagnostics are yet to be formulated.

The success of personalized medicine relies largely on adequate payer coverage and reimbursement. Increasing evidence from pharmacogenomics research suggests that the conventional “one drug fits all” model doesn’t hold true in all cases. Thus, treatment has to be customized based on individual genetic profiles. Reimbursement policies, particularly for companion diagnostic tests, need to be realigned to keep pace with scientific progress and allow for increased adoption by physicians and patients.

Biomarkers Facilitate Quick Turnover of Drugs and Significant Reduction in Drug Discovery and Development Costs

High drug attrition rates, safety and efficacy concerns, and time consuming methods, have encouraged the pharmaceuticals sector to adopt the use of biomarkers in the drug discovery process on a large scale. According to the FDA the biomarkers are 10% more efficient in predicting drug failures and as a result can save approximately $100m and three to four years in each drug discovery process. In addition, drugs that are failing in clinical trials or have been withdrawn from the market due to unresponsiveness of a broader patient population can be rescued and reconsidered for studies in benefiting a subset of population.

Personalized Medicine, Global, Biomarkers Facilitating Quick Turnover of Drugs, 2010

Source: GBI Research, FDA

Personalized Medicine Market - Advances in Human Genomics and Proteomics to Challenge Traditional Therapeutics

Summary

GBI Research, the leading business intelligence provider, has released its latest report, “Personalized Medicine Market - Advances in Human Genomics and Proteomics to Challenge Traditional Therapeutics” that provides key data, information and analysis of the major trends and issues in Personalized Medicine Market. The report provides a comprehensive insight into the role of Human Genomics and Proteomics to challenge traditional therapeutics. The report also provides a detailed analysis of market characterization of personalized medicine market in terms of its market size, segmentation by key geography types and the major market drivers and barriers. The report also talks about the patent landscape for human genomics and proteomics and provides comprehensive analysis.

Scope

The scope of the report includes:
- Detailed overview of Personalized Medicine Market in pharmaceutical industry along with their use, efficiency and limitation.
- Annualized market data from 2007 and forecast forward till 2016 along with segmentation by geography.
- Key market drivers and restraints shaping the Personalized Medicine Market.
- Competitive landscape analysis with competitive profiling of leading companies.
- Analysis of partnership deals from 2006 to 2010
- Analysis of M&A deals from 2005 to 2010 along with segmentation by value geography and companies.

Reasons to buy

The report will enhance your decision making capability. It will allow you to
- Develop better strategies for personalized medicine market research by understanding the market dynamics.
- Develop market-entry and market expansion strategies by identifying the key development area
- Understand the factors shaping the Personalized Medicine Market
- For understanding the role of Human Genomics and Proteomics to challenge traditional therapeutics.
- Identify the key players best positioned to take the advantage of the opportunities in the global market.
- Exploit partnership and acquisition opportunities by identifying the products that could fill the portfolio gaps.

Table of Contents

1 Table of Contents 4
1.1 List of Tables 7
1.2 List of Figures 9
2 Personalized Medicine Market: Market Overview 10
2.1 Introduction 10
2.1.1 Potential Applications of Personalized Medicine 12
2.2 GBI Research Report Guidance 14
3 Personalized Medicine Market: Drivers and Barriers 15
3.1 Drivers 16
3.1.1 Increase in healthcare costs 16
3.1.2 Advantages over conventional drug discovery methods 16
3.1.3 Patient compliance 16
3.1.4 Early detection of disease 17
3.1.5 Better regulatory norms and validation procedures encourage growth of the personalized medicine market 17
3.2 Barriers 17
3.2.1 Payer Reimbursement Issues 17
3.2.2 Ethical Issues 17
3.2.3 Medical Information Technology 18
3.2.4 Awareness Gap - Lack of Physician Education and Awareness about Novel Technologies 18
3.2.5 Cumbersome and Lengthy Development Procedure Discourages Biomarker Research by the Pharmaceutical Sector 18
4 Personalized Medicine Market - Personalized Therapeutics and Diagnostics 19
4.1 Personalized Therapeutics - Drug Profiles 19
4.1.1 Herceptin (trastuzumab) 19
4.1.2 Erbitux (cetuximab) 24
4.1.3 Gleevec (imatinib) 28
4.1.4 Zyprexa (olazapine) 32
4.1.5 Lipitor (atorvastatin) 35
4.1.6 Celebrex (celecoxib) 39
4.1.7 Tarceva (erlotinib) 42
4.1.8 Rituxan (rituximab) 46
4.1.9 Plavix (clopidogrel bisulfate) 49
4.1.10 Risperdal (risperidone) 51
4.1.11 Vectibix (Panitumumab) 54
4.1.12 Coumadin (Warfarin) 56
4.1.13 Iressa (Gefitinib) 57
4.1.14 Sprycel 59
4.1.15 Camptosar 61
4.2 Companion Diagnostics 62
4.2.1 Selected Companion Diagnostics Employed in Personalized Healthcare 64
4.3 Biomarkers 67
4.3.1 Biomarkers in Cancer Research 68
4.3.2 Market Size and Forecasts 69
4.3.3 Segmentation by Indication 70
5 Personalized Medicine Market: Selected Pipeline Product Profiles 80
5.1 PF-4948568 (Pfizer) 80
5.1.1 Overview 80
5.1.2 Mechanism of Action 80
5.1.3 Clinical Study Details 80
5.2 PF-02341066 + Erlotinib (Pfizer) 81
5.2.1 Overview 81
5.2.2 Mechanism of Action 81
5.2.3 Clinical study details 81
5.3 PF-299804 (Pfizer) 82
5.3.1 Overview 82
5.3.2 Mechanism of action 82
5.3.3 Clinical study details 82
5.4 CEP-701 (Cephalon Inc.) 83
5.4.1 Overview 83
5.4.2 Mechanism of action 83
5.4.3 Clinical study details 84
5.5 TBR-652 (Tobira Therapeutics, Inc) 84
5.5.1 Overview 84
5.5.2 Mechanism of action 84
5.5.3 Clinical study details 85
5.6 Brivanib (Bristol-Myers Squibb) 85
5.6.1 Overview 85
5.6.2 Mechanism of action 85
5.6.3 Clinical study details 86
5.7 Ipilimumab (Bristol-Myers Squibb) 86
5.7.1 Overview 86
5.7.2 Mechanism of Action 86
5.7.3 Clinical Study Details 86
5.8 BiovaxID (Accentia Biopharmaceuticals, Inc.) 87
5.8.1 Overview 87
5.8.2 Mechanism of Action 87
5.8.3 Clinical Study Details 87
6 Personalized Medicine Market: Research Trends in Personalized Medicine 88
7 Personalized Medicine Market: Competitive Landscape 89
7.1 Competitive Profiling 89
7.2 Clarient, Inc. 89
7.2.1 Business Description 89
7.2.2 Pipeline 90
7.2.3 Major Products 90
7.2.4 Partnership and Merger and Acquisition (M&A) Deals 91
7.3 Qiagen N.V. 92
7.3.1 Business Description 92
7.3.2 Pipeline 92
7.3.3 Major Products 92
7.3.4 Partnership and M&A Deals 94
7.4 Laboratory Corporation of America Holdings 96
7.4.1 Business Description 96
7.4.2 Pipeline 96
7.4.3 Major Products 96
7.4.4 Partnership and M&A Deals 97
7.5 bioMerieux S.A. 99
7.5.1 Business Description 99
7.5.2 Pipeline 99
7.5.3 Major Products 99
7.5.4 Partnership and M&A Deals 100
7.5.5 Partnership and M&A Deals 102
7.6 Pfizer 102
7.6.1 Business Overview 102
7.6.2 Partnership and M&A Deals 103
7.7 Eli Lily and Company 104
7.7.1 Business Overview 104
7.7.2 Partnership and M&A deals 105
7.8 Novartis 106
7.8.1 Business Overview 106
7.8.2 Partnership and M&A Deals 107
7.9 F. Hoffman La Roche 108
7.9.1 Business Overview 108
7.9.2 Diagnostics 108
7.9.3 Pharmaceuticals 109
7.9.4 Partnership and M&A Deals 110
7.10 Bristol-Myers Squibb 111
7.10.1 Business Overview 111
7.10.2 Partnership and M&A deals 112
7.11 Merck KGaA 113
7.11.1 Business Overview 113
7.11.2 Partnership and M&A deals 114
7.12 Dako Denmark A/S 116
7.12.1 Business Overview 116
7.12.2 Partnership and M&A deals 116
8 Personalized Medicine Market: Conclusion 117
9 Personalized Medicine Market: Appendix 118
9.1 Market Definitions 118
9.2 Abbreviations 118
9.3 Research Methodology 121
9.3.1 Coverage 122
9.3.2 Secondary Research 122
9.3.3 Primary Research 122
9.3.4 Expert Panel Validation 123
9.4 Contact Us 123
9.5 Disclaimer 123
9.6 Sources 123

1.1 List of Tables
Table 1: Herceptin - Snapshot 2010 19
Table 2: Herceptin, Global, Revenues ($m) 2007-2009 23
Table 3: Erbitux - Snapshot 2010 24
Table 4: Erbitux, Global, Revenues ($m) 2007-2009 27
Table 5: Gleevec - Snapshot 2010 28
Table 6: Gleevec, Global, Revenues ($m) 2007-2009 31
Table 7: Zyprexa - Snapshot 2010 32
Table 8: Zyprexa, Global, Revenues ($m) 2007-2009 34
Table 9: Lipitor - Snapshot 2010 35
Table 10: Lipitor, Global, Revenues ($m) 2007-2009 38
Table 11: Celebrex - Snapshot 2010 39
Table 12: Celebrex, Global, Revenues ($m) 2007-2009 41
Table 13: Tarceva - Snapshot 2010 42
Table 14: Tarceva, Global, Revenues ($m) 2007-2009 44
Table 15: Rituxan - Snapshot 2010 46
Table 16: Rituxan, Global, Revenues ($m) 2007-2009 47
Table 17: Rituxan, Global, Revenues 2007-2009 48
Table 18: Plavix - Snapshot 2010 49
Table 19: Plavix, Global, Revenues ($m) 2007-2009 50
Table 20: Risperdal - Snapshot 2010 51
Table 21: Risperdal, Global, Revenues ($m) 2007-2009 53
Table 22: Vectibix - Snapshot 2010 54
Table 23: Coumadin - Snapshot 2010 56
Table 24: Iressa - Snapshot 2010 57
Table 25: Sprycel - Snapshot 2010 59
Table 26: Camptosar - Snapshot 2010 61
Table 27: Personalized Medicine Market, List of Selected Personalized Diagnostics and Therapeutics, 2010* 63
Table 28: Personalized Medicine Market, Biomarkers in Cancer Research, Global, Cancer Biomarkers Market Revenues ($bn), 2007-2016 69
Table 29: Personalized Medicine Market, Global, Biomarkers in Cancer Research, Breast Cancer Biomarkers Market Revenues ($m), 2007-2016 71
Table 30: Personalized Medicine Market, Global, Biomarkers in Cancer Research, Prostate Cancer Biomarkers Market Revenues ($m), 2007-2016 72
Table 31: Personalized Medicine Market, Global, Biomarkers in Cancer Research, Lung Cancer Biomarkers Market Revenues ($m), 2007-2016 73
Table 32: Personalized Medicine Market, Global, Biomarkers in Cancer Research, Colorectal Cancer Biomarkers Market Revenues ($m), 2007-2016 74
Table 33: Personalized Medicine Market, Global, Biomarkers in Cancer Research, Cervical Cancer Biomarkers Market Revenues ($m), 2007-2016 75
Table 34: Personalized Medicine Market, Global, Biomarkers in Cancer Research, Head and Neck Cancer Biomarkers Market Revenues ($m), 2007-2016 76
Table 35: Personalized Medicine Market, Global, Biomarkers in Cancer Research, Pancreatic Cancer Biomarkers Market Revenues ($m), 2007-2016 77
Table 36: Personalized Medicine Market, Global, Biomarkers in Cancer Research, Ovarian Cancer Biomarkers Market Revenues ($m), 2007-2016 78
Table 37: Personalized Medicine Market, Global, Biomarkers in Cancer Research, Stomach Cancer Biomarkers Market Revenues ($m), 2007-2016 79
Table 38: Personalized Medicine Market, Clarient, Pipeline, August 2010 90
Table 39: Personalized Medicine Market, Clarient, Major M&A Deals, 2005-2010 91
Table 40: Personalized Medicine Market, Clarient, Partnership Deals, 2006-2010 91
Table 41: Personalized Medicine Market, QIAGEN, Pipeline, August 2010 92
Table 42: Personalized Medicine Market, QIAGEN, Major M&A Deals, 2005-2010 94
Table 43: Personalized Medicine Market, QIAGEN, Partnership Deals, 2006-2010 95
Table 44: Personalized Medicine Market, Laboratory Corporation of America Holdings, Pipeline, August 2010 96
Table 45: Personalized Medicine Market, Laboratory Corporation of America Holdings, Major M&A Deals, 2005-2010 97
Table 46: Personalized Medicine Market, Laboratory Corporation of America Holdings, Partnership Deals, 2006-2010 98
Table 47: Personalized Medicine Market, bioMerieux, Pipeline, August 2010 99
Table 48: Personalized Medicine Market, bioMerieux, Major M&A Deals, 2005-2010 100
Table 49: Personalized Medicine Market, bioMerieux, Partnership Deals, 2006-2010 101
Table 47: Personalized Medicine Market, Biomoda, Partnership Deals, 2006-2010 102

1.2 List of Figures
Figure 1: Personalized Medicine Market, Potential Applications of Personalized Medicine 12
Figure 2: Personalized Medicine Market, Market Drivers and Restraints, 2010 15
Figure 3: Herceptin, Global, Revenues ($m) 2007-2009 23
Figure 4: Herceptin - SWOT 2010 24
Figure 5: Erbitux, Global, Revenues ($m) 2007-2009 27
Figure 6: Erbitux - SWOT 2010 28
Figure 7: Gleevec, Global, Revenues ($m) 2007-2009 31
Figure 8: Gleevec - SWOT 2010 32
Figure 9: Zyprexa, Global, Revenues ($m) 2007-2009 34
Figure 10: Zyprexa - SWOT 2010 35
Figure 11: Lipitor, Global, Revenues ($m) 2007-2009 38
Figure 12: Lipitor - SWOT 2010 39
Figure 13: Celebrex, Global, Revenues ($m) 2007-2009 41
Figure 14: Celebrex - SWOT 2010 42
Figure 15: Tarceva, Global, Revenues ($m) 2007-2009 44
Figure 16: Tarceva - SWOT 2010 45
Figure 17: Rituxan, Global, Revenues ($m) 2007-2009 47
Figure 18: Rituxan - SWOT 2010 48
Figure 19: Plavix, Global, Revenues ($m) 2007-2009 50
Figure 20: Plavix- SWOT 2010 51
Figure 21: Risperdal, Global, Revenues ($m) 2007-2009 53
Figure 22: Risperdal - SWOT 2010 54
Figure 23: Personalized Medicine Market, Biomarkers in Cancer Research, 2010 68
Figure 24: Personalized Medicine Market, Biomarkers in Cancer Research, Global, Cancer Biomarkers Market Revenues ($bn), 2007-2016 69
Figure 25: Personalized Medicine Market, Global, Biomarkers in Cancer Research, Market Segmentation by Indication, 2009 70
Figure 26: Personalized Medicine Market, Global, Biomarkers in Cancer Research, Breast Cancer Biomarkers Market Revenues ($m), 2007-2016 71
Figure 27: Personalized Medicine Market, Global, Biomarkers in Cancer Research, Prostate Cancer Biomarkers Market Revenues ($m), 2007-2016 72
Figure 28: Personalized Medicine Market, Global, Biomarkers in Cancer Research, Lung Cancer Biomarkers Market Revenues ($m), 2007-2016 73
Figure 29: Personalized Medicine Market, Global, Biomarkers in Cancer Research, Colorectal Cancer Biomarkers Market Revenues ($m), 2007-2016 74
Figure 30: Personalized Medicine Market, Global, Biomarkers in Cancer Research, Cervical Cancer Biomarkers Market Revenues ($m), 2007-2016 75
Figure 31: Personalized Medicine Market, Global, Biomarkers in Cancer Research, Head and Neck Cancer Biomarkers Market Revenues ($m), 2007-2016 76
Figure 32: Personalized Medicine Market, Global, Biomarkers in Cancer Research, Pancreatic Cancer Biomarkers Market Revenues ($m), 2007-2016 77
Figure 33: Personalized Medicine Market, Global, Biomarkers in Cancer Research, Ovarian Cancer Biomarkers Market Revenues ($m), 2007-2016 78
Figure 34: Personalized Medicine Market, Global, Biomarkers in Cancer Research, Stomach Cancer Biomarkers Market Revenues ($m), 2007-2016 79
Figure 35: Research and Innovation Trends in Personalized Medicine 88
Figure 36: Personalized Medicine Market, Global, Geographic Landscape, 2009 89

個別化醫療市場:用以挑戰傳統治療法的人類基因學與蛋白質體學的進化是由出版商GBI Research在2010年12月01日所出版的。這份市場調查報告書包含124 Pages 價格從美金3500起跳。

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