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
