Theranostics Report 2007-2012

Table of Contents

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