| Publications by Biophoenix' Principals |
| Theranostics: Commercial Opportunities for Diagnostic and Pharmaceutical Companies | |
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| Publisher: | D&MD Publications Inc |
| Year of publication: | 2001 |
| Type of publication: | Management report |
| Publisher's reference (if any): | 9017 |
| Author(s): | Sreten Bogdanovic and Beata Langlands |
| Approximate page count: | 100 |
| Price when published: | $1,995 (Print or CD-ROM) $2,995 (Both) |
Remarks:
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THERANOSTICS:
COMMERCIAL OPPORTUNITIES FOR DIAGNOSTIC AND PHARMACEUTICAL COMPANIES
An Executive Briefing for
Drug & Market Development Publications Inc
TABLE OF CONTENTS
Page
TABLE OF CONTENTS i
LIST OF TABLES iii
EXECUTIVE SUMMARY ES.1
CHAPTER 1 INTRODUCTION
1.1 Introduction to theranostics 1
1.2 Market drivers 2
1.2.1 The growth of the point-of-care (POC) market 2
1.2.2 The growth of the nucleic acid
testing (NAT) market 4
1.3 Applications of theranostics to drug therapies 4
1.3.1 Established drug therapies 4
1.3.2 New drugs in development 5
1.4 Major therapy areas addressed by POC theranostics 5
1.4.1 Cardiovascular disease and critical care 5
1.4.2 Miscellaneous diseases including cancer 7
1.5 NAT-based theranostics and pharmacogenomics 9
1.5.1 Genetic variability and drug responses 10
1.5.2 New technologies for variability analysis 11
1.6 Major therapy areas addressed by NAT theranostics 12
1.6.1 Viral infectious disease 12
1.6.2 Prediction of drug toxicity 14
1.6.3 Cancer 16
1.6.4 Cardiovascular disease 19
1.6.5 Alzheimer's disease 20
1.6.6 Asthma and miscellaneous other diseases 21
1.7 Related issues outside the scope of this report 24
CHAPTER 2 PROFILES OF COMPANIES DEVELOPING
THERANOSTIC TESTS AND CAPABILITIES
2.1 Affymetrix Inc 25
2.2 Axys Pharmaceuticals Inc 27
2.2.1 PPGx INC (to be acquired by DNA Sciences Inc) 27
2.3 CompuCyte Corporation 30
2.4 CuraGen Corporation 32
2.5 DAKO A/S 35
2.6 diaDexus Llc 36
2.7 Eurona Medical A/B 38
2.8 Gemini Holdings Plc 40
2.9 Genaissance Pharmaceuticals Inc 42
2.10 Gene Logic Inc 45
2.11 Genset SA 48
2.12 Hyseq Inc 51
2.13 Infogene Medizinische Genetik GmbH 52
2.14 Innogenetics N.V. 54
2.15 MassTrace Inc 56
2.16 Millennium Pharmaceuticals Inc 57
2.17 MitoKor 60
2.18 Myriad Genetics Inc 62
2.19 Nova Molecular Diagnostics Inc 64
2.20 Orchid Biocomputer Inc 66
2.21 Ostex International 68
2.22 PharmaNetics Inc 70
2.23 Quest Diagnostics Inc 72
2.24 Variagenics Inc 74
2.25 Virco 77
2.26 Visible Genetics Inc 79
2.27 Xenometrix Inc 82
CHAPTER 3 MARKET CONSIDERATIONS AND FORECASTS
3.1 Overview of the World In Vitro Diagnostics Market 84
3.2 IVD product market 84
3.3 IVD Geographical Market 85
3.4 IVD Supplier Market 86
3.5 IVD Customer Market 88
3.6 The Point-of-Care Market 89
3.7 Biochips and arrays 89
3.8 Current Theranostics Market, by Application 91
3.9 Value of the theranostics market in 2000 and 2006 93
3.10 Major applications of theranostics to 2006 93
3.10.1 Cancer 93
3.10.2 Cardiovascular diseases 94
3.10.3 AIDS and other viral diseases 95
3.10.4 Central nervous system (CNS) conditions 96
3.10.5 Prevention of adverse drug reactions 97
CHAPTER 4 TRENDS AND OPPORTUNITIES
4.1 The advent of a new industrial sector 98
4.2 New market takes shape through alliances 98
4.3 Healthcare expenditure may shift to diagnostics 99
4.4 A challenge to the pharmaceutical industry 100
4.5 New drug targets, new theranostic opportunities 101
4.6 The challenge of adverse drug reactions 102
4.7 The trend towards patient-initiated-prescribing 103
4.8 A new focus for the growing POC market 103
4.9 The challenge of POC nucleic acid-based testing 104
4.10 Theranostic applications of DNA microarrays 105
4.11 NAT-based theranostics and existing drugs 106
4.12 NAT-based theranostics in clinical trials 107
4.13 The future of drug discovery 108
4.14 Sources of new theranostics 109
APPENDIX 1 GLOSSARY OF TECHNICAL TERMS AND ABBREVIATIONS 111
LIST OF TABLES
Page
Table 1.1 Theranostic Products For Cardiovascular Disease
And Critical Care Based On Traditional Technologies 6
Table 1.2 Theranostic Products For Miscellaneous Diseases
Based On Traditional Technologies 8
Table 1.3 Theranostic Products For Infectious Disease
Based On Nucleic Acid Testing Technologies 14
Table 1.4 Theranostic Products For Prediction Of Drug Tox-
icity Based On Nucleic Acid Testing Technologies 16
Table 1.5 Theranostic Products For Cancer Based
On Nucleic Acid Testing Technologies 18
Table 1.6 Theranostic Products For Cardiovascular
Disease Based On Nucleic Acid Testing Technologies 20
Table 1.7 Theranostic Products For Alzheimer Disease
Based On Nucleic Acid Testing Technologies 21
Table 1.8 Theranostic Products For Miscellaneous Diseases
Based On Nucleic Acid Testing Technologies 22
Table 3.1 Worldwide Diagnostics Market By Product Type 84
Table 3.2 World Diagnostics Sales By Region 85
Table 3.3 Leading Diagnostics Companies By Worldwide Sales 86
Table 3.4 Worldwide Diagnostics Production By Region 87
Table 3.5 Sales Of Diagnostic Products By Customer Market 88
Table 3.6 Important Applications Of Theranostics 91
Table 3.7 World Pharmaceutical Market By Region In 2000 92
Table 3.8 Sizes Of Major Pharma Markets In 2000 92
Table 3.9 Prevalence Of Cardiovascular Disease In The USA 94
This briefing provides an overview of the recent developments in the emerging field of theranostics, which is bringing together the diagnostic and pharmaceutical industries. The briefing highlights the therapeutic areas where theranostics has already made its mark, and examines technology developments in this area. It provides a thorough review of theranostic products in development, explains their applications and profiles leading market players. It also examines the in vitro diagnostic market sectors relevant to theranostics and the theranostic market by therapeutic application, and provides revenue forecasts to 2006. In traditional medical practice therapeutic choices follow diagnosis, which may be based on clinical signs alone, or may be made in conjunction with an in vivo or in vitro diagnostic test. However, the effectiveness of the prescribed drug therapy and the likelihood of side effects often cannot be predicted for individual patients. Now a new generation of theranostic tests promises to transform the art of medical diagnosis and treatment into a predictive science. Theranostics (therapy specific diagnostics) are being developed specifically for predicting and assessing drug response in individual patients rather than diagnosing disease. Theranostic tests can be used to select patients for treatments that are particularly likely to benefit them and unlikely to produce side-effects. They can also provide an early and objective indication of treatment efficacy in individual patients, so that (if necessary) the treatment can be altered with a minimum of delay. This Briefing profiles leading companies developing theranostic products, which are predominantly in the areas of cardiovascular disease, cancer, infectious diseases, Alzheimer's disease, and prediction of drug toxicity. Theranostics aims at enhancing the effectiveness of drugs, and as such represents a commercial opportunity for both the pharmaceutical and diagnostic industries. Traditional pharmaceutical companies face intense pressure to maintain revenue growth rates and profitability. Theranostics holds the key to improving the success rate of drug candidates entering clinical trials (currently around 20%) and to marketing approved drugs more effectively. Traditional diagnostic companies are operating in an industry which is currently growing at a rate of only 4% per annum overall, and need to seize new opportunities to ensure their survival. Overall, the advent of theranostics is expected significantly to increase healthcare spending on diagnostics. The advent of theranostics is likely to lead to more pharmaceutical companies setting up diagnostic divisions, or acquiring specialist diagnostic companies. It also presents fresh opportunities for collaboration between diagnostic and pharmaceutical companies in bringing new drugs to market. Spearheading this trend, DAKO and Genentech together created HercepTest and Herceptin (trastuzumab), the first theranostic test approved simultaneously with a new therapeutic drug. In addition to HercepTest (which is an immunohistochemical test), other theranostic tests are in development which use traditional clinical chemistry, immunoassay and cell-based technologies. Theranostic tests based on traditional diagnostic technologies belong largely to the point-of-care category of diagnostic tests. However, most of the theranostic tests currently in development are nucleic acid tests. At present the largest application for nucleic acid testing is in infectious diseases. In viral infections due to Hepatitis B, Hepatitis C or HIV, drug resistance can emerge due to mutations of the virus. Theranostic tests can examine the viral nucleic acid to detect emerging drug resistance and thereby guide therapy choice. Other nucleic acid tests aim to predict a patient's response to therapy or susceptibility to toxic reactions from their genetic make-up. An example of the former is Eurona's lead product in development, the ACE Inhibitor Responder Assay, which is based on genetic variations in the renin-angiotensin-aldosterone system, and which can be used to identify and pre-select patients who would experience a maximal reduction in blood pressure following treatment with ACE inhibitors alone, while an example of the latter is PPGx's recently launched TPMT (thiopurine S-methyltransferase) test, which is enabling doctors to identify patients at risk for potentially fatal adverse reactions to 6-mercaptopurine, an agent used in the treatment of leukemia. Recent studies estimate that adverse drug reactions are the fourth leading cause of death in the US. Future progress in theranostics will draw on developments in pharmacogenomics, which seeks to establish correlations between responses to specific drugs and the genetic profiles of patients. The most common form of genetic profiling relies on the use of DNA sequence variations called single nucleotide polymorphisms (SNPs). Currently patient genetic data is used mainly to make drug development more efficient and cost-effective. SNP genotyping is being used to determine genotypes associated with drug responsiveness, side effects, or optimal dose. Nova Molecular pioneered SNP genotyping of the apolipoprotein E gene to predict Alzheimer's disease patients' responses to cholinomimetic therapies and it is now widely used in clinical trials of new drugs for this indication. Stratifying patients according to variables that may be predictors of safety or efficacy can enhance the statistical power of a clinical trial. DNA microarray technologies are being used increasingly to evaluate patient-to-patient variations in both gene sequence and gene expression. This Briefing summarises key developments in this technology area and profiles leading companies analysing genetic variability, in particular SNP variability, and drug responses. The Briefing contains profiles of the following companies: Affymetrix Inc, Axys Pharmaceuticals and PPGx, CompuCyte Corporation, CuraGen Corporation, DAKO A/S, diaDexus Llc, Eurona Medical A/B, Gemini Holdings Plc, Genaissance Pharmaceuticals Inc, Gene Logic Inc, Genset SA, Hyseq Inc, Infogene Medizinische Genetik GmbH, Innogenetics N.V., MassTrace Inc, Millennium Pharmaceuticals Inc, MitoKor, Myriad Genetics Inc, Nova Molecular Diagnostics Inc, Orchid Biocomputer Inc, Ostex International, PharmaNetics Inc, Quest Diagnostics Inc, Variagenics Inc, Virco, Visible Genetics Inc and Xenometrix Inc. | |
