1 Executive Summary: Theranostics 2007-2012
2 An Introduction to Theranostics
2.1 The World Pharmaceutical Market Continues to Grow, But Faces Mounting Challenges
2.2 The Continuing Success of the Pharmaceutical Industry is Dependent Upon Important Drivers and Restraints
2.3 The Pharmaceutical Sector Is Gradually Changing Its Strategic Focus to Overcome Challenges in the Market
2.3.1 Reducing Efficiencies in R&D Result in Concerns Over Thinning Pipelines
2.4 Theranostics is Essentially a Fusion of Drug Therapy and Diagnostics
2.4.1 Recent Advances in Biomedical Sciences Have Made Theranostics Possible
2.4.2 Genentech’s Herceptin is a Prominent Example of the Theranostics Approach
2.4.3 Diagnostics is Now Increasingly Reliant on Genetic and Protein-Based Markers
2.4.4 Recent FDA Publication Places Increasing Importance on Theranostics
2.5 The Human Genome Project Has Provided Important Scope for Pharmaceutical Development – Genomics and Proteomics
2.5.1 Pharmacogenomics is Increasingly Relevant to Pharmaceutical Development
2.5.2 Proteomics Constitutes the "Next Step" After Genomics
2.6 Advanced Diagnostics and Personalised Medicine
2.6.1 The Dawn of Pharmacogenomic Medicine
2.6.2 Personalised Medicine Will Rely Heavily Upon Theranostics
2.7 The Market for Theranostic Products is Creating Opportunities for Pharmaceutical and Diagnostic Companies
2.8 While Medical Stakeholders Will Benefit from Theranostics, Concerns Over Privacy Likely to Impede Progress
3 Key Players in the Theranostics Field
3.1 Genentech’s Herceptin and Novartis’ Gleevec are Probably the Best Known Examples of a Theranostic Approach in Use
3.2 PharmaNetics’ Thrombolytic Assessment System – Pioneers in the Field
3.3 Genentech and DakoCytomation: Herceptin and HercepTest
3.4 ImClone Systems and DakoCytomation: Erbitux and EGFR pharmDx Test
3.5 Abbott Laboratories’ PathVysion HER-2 DNA Probe Kit
3.6 Bayer’s ADVIA Centaur Immunoassay System – An Early Entrant to the Theranostics Market
3.7 Novartis and Ventana Medical Systems: Gleevec and VentanaDx c-Kit
3.8 Roche’s Diagnostics Division: The AmpliChip CYP450 Array
3.9 Innogenetics
3.10 A&G Pharmaceutical a Leading Participant in the Monoclonal Theranostics Field
3.11 HBV Theranostica
3.12 Visible Genetics’ Pharmacogenomic HIV Drug Resistance Test
3.13 NGI An Industry Leader in Blood Plasma Nucleic Acid Testing
3.14 Investigen’s SmartDNA a New Diagnostic Tool
3.15 Lpath Therapeutics Merges With Public Company
3.16 Itsi-Biosciences
3.17 Amorfix Life Sciences and Biogen Idec Collaborate on Research for ALS disease
3.18 Clinical Data’s DNA-based Diagnostic and Therapeutic Products
3.18.1 Vilazodone
3.18.2 PGxTest:WARFARIN
3.19 Axis-Shield
3.20 Conclusions
4 Forecast of the Market for Theranostics, 2007-2012
4.1 Molecular Diagnostics Will Contribute an Increasing Proportion of Revenues Within The World In Vitro Diagnostics Market
4.2 Theranostics Will Exhibit Rapid Market Growth from 2007-2012
4.3 Drug Toxicity Testing, Oncology and Infection Segments Will Contribute the Highest Revenues to the World Theranostics Market from 2006-2012
4.4 Personalised Medicine Will Become More Prominent in Healthcare With Theranostics Benefiting as a Result
4.4.1 The Completion of the Human Genome Project Has Been a Major Driver of Molecular Diagnostics
4.5 Industry Has Been Relatively Slow to Adopt Theranostics - But That Situation Is Changing
4.5.1 Will The Success of Theranostics Lead To a Shift in Spending From Drugs to Diagnostics?
4.6 Theranostics Will Take Off In a Few Important Therapy Areas First
4.6.1 Cancer Diagnostic Technologies Constitute a Particularly Important Application
4.7 The Improvement in Clinical Performance from Theranostics Will Make It Easier To Justify The Costs to Payers
4.7.1 A Theranostic Combination Can Provide an Important Competitive Advantage During This Emergent Period
4.8 Personalised Medicine Supported By Theranostics Could Supersede the Existing Blockbuster Model, With Sustainable Revenue Flows Continuing
4.9 The Market for Theranostic Products Is Creating Significant Opportunities for Many Companies in the Pharmaceutical, Diagnostics and Biotechnological Sectors
4.9.1 Rising Insurance Coverage Will Benefit the Market
4.10 The FDA and Other Agencies Have Expressed Significant Interest in Theranostics
4.11 Inter-Industry Will Continue to Drive the Theranostics Market
4.12 Biomarker Technology is Still Emerging – But The Technological and Commercial Potential Remains Very Significant
4.12.1 While The Prospects for Clinical Studies Are Good, Concerns Over Privacy May Impede Progress
4.13 Several Key Factors Are Required for Success in the Theranostics Market
5 Discussion of Issues Affecting Theranostic Applications
5.1 A SWOT Analysis for Theranostics
5.2 Theranostic Solutions Will Continue To Expand Their Presence in the Pharmaceutical Industry
5.3 Theranostic Applications Face No Significant Restraints to Their Continuing Adoption Within the Pharmaceutical Sector
5.4 Theranostics will Benefit from FDA’s Guidance on Pharmacogenomic Data Submission
5.4.1 Distinguishing Patients at a Greater Risk is Vital
5.4.2 In Future Parallel Use of Markers and Drugs Will Become Prevalent
5.5 The EDMA Cites Theranostics as a Medium-to-Long-Term Driver for Healthcare
5.6 Personalised Medicine is a Strong Driver of the Theranostics Sector
5.6.1 While Personalised Medicine Is Still A Goal for the Future, The Technology Is Already Emergent
5.7 Identifying Suitable Biomarkers Remains a Significant Challenge
5.8 Theranostics Bill Introduced in the US Senate During 2006
5.9 Funding for Theranostics R&D Efforts May Be Limited by Low Reimbursement Rates
5.10 Cancer Diagnostics is an Important Growth Area With Relevance to Theranostics
5.11 Collaboration Among Stakeholders is Essential
5.12 Nucleic Acid Testing Technologies Will Be Decisive in the Development of the Theranostics Market
5.13 The Outlook for Theranostics
6 Current and Future Developments in Theranostics – The Views of Experts in the Field
6.1 How Influential Will Theranostics Be In Coming Years?
6.2 Are Pharmaceutical and Diagnostic Companies Ready for Closer Links?
6.3 Will Theranostics Contribute Significantly to Clinical Trials?
6.4 In What Areas Will Theranostics Be Most Prominent?
7 Conclusions
7.1 Theranostics is Essentially a Fusion of Drug Therapy and Diagnostics
7.2 Theranostics Will Exhibit Rapid Market Growth from 2007-2012
7.3 Drug Toxicity Testing, Oncology and Infection Segments Will Contribute the Highest Revenues to the World Theranostics Market from 2006-2012
7.4 Theranostics Constitute A Significant Market Opportunity for The Healthcare Industry
List of Tables
Table 2.1 Revenue Generation ($bn) by the World Pharmaceutical Industry, 1999-2005
Table 4.1 The World Market for In Vitro Diagnostics ($bn) Showing Revenues for Molecular and Theranostic Applications, 2006-2012
Table 4.2 Share (%) of the World In Vitro Diagnostics Market Held by Molecular Diagnostics, 2006 & 2012
Table 4.3 Share (%) of the World Molecular Diagnostics Market Held by Theranostics, 2006 & 2012
Table 4.4 Revenues ($m) and Growth (%) for Components of the World Theranostics Market, 2006-2012
Table 4.5 Market Shares and CAGRs for Applications Within the Theranostics Sector, 2006-2012
Table 5.1 A SWOT Chart for Theranostic Applications, 2007-2012
List of Figures
Figure 2.1 The Increasing Average Cost ($m) of NCE Development, 1976-2005
Figure 4.1 The World Market for In Vitro Diagnostics ($bn) Showing Revenues for Molecular and Theranostic Applications, 2006-2012
Figure 4.2 Share (%) of the World In Vitro Diagnostics Market Held by Molecular Diagnostics, 2006
Figure 4.3 Share (%) of the World In Vitro Diagnostics Market Held by Molecular Diagnostics, 2012
Figure 4.4 World Revenues ($m) for Theranostic Applications, 2006-2012
Figure 4.5 Share (%) of the World Molecular Diagnostics Market Held by Theranostics, 2006
Figure 4.6 Share (%) of the World Molecular Diagnostics Market Held by Theranostics, 2012
Figure 4.7 Revenues ($bn) from Theranostics Compared With Those of the World In Vitro Diagnostics Market, 2006-2012
Figure 4.8 Revenues ($bn) from Theranostics Compared With Those of the World Molecular Diagnostics Market, 2006-2012
Figure 4.9 Share (%) of the World In Vitro Diagnostics Market Held by Theranostics, 2006-2012
Figure 4.10 Share (%) of the World Molecular Diagnostics Market Held by Theranostics, 2006-2012
Figure 4.11 Revenues ($m) for Components of the World Theranostics Market, 2006-2012
Figure 4.12 Components of the World Theranostics Market - Lower Revenues ($m) In Detail, 2006-2012
Figure 4.13 CAGR Values (%) for Market Segments Within the Theranostics Sector, 2006-2012
Figure 4.14 Percentage Share (%) of The World Theranostics Market Held By Component Market Segments, 2006
Figure 4.15 Percentage Share (%) of The World Theranostics Market Held By Component Market Segments, 2012
Figure 4.16 Theranostics: Revenues ($m) for Cardiovascular Applications, 2006-2012
Figure 4.17 Theranostics: Revenues ($m) for Oncological Applications, 2006-2012
Figure 4.18 Theranostics: Revenues ($m) for Infection-Based Applications, 2006-2012
Figure 4.19 Theranostics: Revenues ($m) for CNS Applications, 2006-2012
Figure 4.20 Theranostics: Revenues ($m) for Metabolic Applications, 2006-2012
Figure 4.21 Theranostics: Revenues ($m) for Other Applications, 2006-2012
Figure 4.22 Theranostics: Revenues ($m) for Toxicological Applications in Clinical Studies, 2006-2012