標的治療の今後

Abstract

In recent years, the maximization of blockbuster revenues has been compromised by generic price erosion and a decline in new drug approvals. Large pharmaceutical companies are coming under pressure to explore new R&D strategies and implement more cost-effective sourcing methods for innovative new molecules. The biotechnology industry is emerging as a hub of innovation for biomarker and new chemical entity (NCE) identification, and has become a vital component in the preclinical development of new drug technologies. As therapy focus shifts to treating the causal pathway of disease and not merely the symptomology, the majority of emerging targeted therapeutics are large molecule biologics, while monoclonal antibody therapies represents the fastest growing segment within the pharmaceutical industry. The Future of Targeted Therapeutics: Key technologies, new therapy area applications and leading players is a new report published by Business Insights that examines various types of targeted therapy within pharma pipelines, highlighting the molecules of greatest significance to major therapy areas. The key revenue drivers and product focus within targeted technology markets are also assessed. This report also measures the impact of the new model of targeted therapeutic development upon stakeholder demand and health economics. Discover the most promising targeted molecules within each therapeutic area, identify the pipeline potential of leading companies and align your R&D strategies with the latest innovations and development models...

Table of Contents

Executive Summary

• Emergence of targeted therapeutics
• Analysis of stakeholder incentives
• Types of targeted therapeutics
• Role of targeted therapeutics in selected therapy areas

Chapter 1 Emergence of targeted therapeutics

• Summary
• Introduction
• Decline of the blockbuster model
• The "nichebuster" model
• The emergence of targeted therapeutics
• Convergence of biotechnology and pharmaceutical companies
  • Licensing incentives
  • Risk management
• Role of biomarkers and diagnostics
• Academic research and technology transfer

Chapter 2 Analysis of stakeholder incentives

• Summary
• Introduction
• Institutional payors
• Regulators
• Patients and patient advocacy groups
• Physicians
• Pharmaceutical companies

Chapter 3 Types of targeted therapeutics

• Summary
• Introduction
• Innovative small molecules
• Mechanism of action
• Examples
  • Gleevec
  • Lapatinib (Tykerd/Tyverb)
  • SNS-032
  • PLX4032
• Market synopsis
• Protein/Peptide drugs
• Mechanism of action
• Examples
  • AGRO100
  • PRX321
• Market synopsis
• Monoclonal antibodies and antibody-like structures
• Mechanism of action
• Examples
  • Rituximab (Rituxan)
  • Alemtuzumab (Campath)
  • Erbitux/cetuximab
  • Avastin/bevacizumab
  • Herceptin/trastuzumab
  • Ibritumomab tiuxetan (Zevalin)
  • Tositumomab (Bexxar)
• Market synopsis
• Nucleic acid therapies
• Mechanism of action
• Examples
  • Genasense (oblimersen sodium)
  • Nexagon
  • 4-Thio FAC
• Market synopsis
• RNA interference
• Mechanism of action
• Examples
  • CALAA-01
  • siRNA AV-34
  • Bioral SiRNA
• Market synopsis
• Stem cell therapies
• Market synopsis
• Future therapeutic applications
• Regulatory concerns
• Gene therapy
• Drug delivery and nanotechnology in targeted therapeutics
• Mechanism of action
• Examples
  • BioVant
  • ATI-1123 (docetaxel)
  • Rexin-G
  • Abraxane
  • 131I-TM-601
• Market synopsis
• Conclusion

Chapter 4 Role of targeted therapeutics in selected therapy areas

• Summary
• The cancer market
  • Targeting cancer cells for destruction
  • Blocking growth signalling pathways
• Epidemiology
• Current treatments
• Unmet needs and innovation
• Medical Needs
  • High toxicity and side effect profiles
  • Variable efficacy rates
  • The multifactorial nature of disease
  • Targeting brain tumors
• Economic Needs
  • Reimbursement policies
• Targeted therapeutics in cancer
• Antineoplastics
  • Innovative small molecule therapies
  • Monoclonal antibody therapies
  • Proteins and Peptides
  • Application of genetic technology
  • RNAi in cancer
  • Applications of nanotechnology
  • Novel drug delivery approaches
• The Cardiovascular Market
• Epidemiology
• Current market scenario
• Unmet needs and innovation
  • Pill burden and patient compliance
  • Inefficient mechanism of action
  • Drug delivery technology limitations
• Targeted therapeutics in cardiovascular diseases
  • Protein and nucleic acid therapies
  • Targeted small molecule drugs
  • Monoclonal antibody therapies
  • Stem cells
  • Nanotechnology
• The CNS Market
• Epidemiology
• Current treatments
• Unmet needs and innovation
• Crossing the blood-brain barrier
• Improving specificity and affinity
• Accuracy in determining drug bioavailability
• Improved side effect profiles
• Appropriate clinical trial design - defining target patient subsets
• Diagnosis-specific unmet needs
  • Depression
  • Schizophrenia
  • Sleep disorders
  • Alzheimer' s disease and other dementias
  • Epilepsy
  • Parkinson' s disease and movement disorders
  • Pain therapeutics
• Targeted therapeutics in CNS
• Innovative small molecules
• Nucleic acid therapies
• Monoclonal antibodies
• Stem cell and gene therapy
• Novel therapeutic mechanisms of action
  • Synthetic toxins
  • Targeted viral delivery systems
  • Innovative diagnostic devices
• The Infectious Diseases Market
• Epidemiology
• Viral Infections
  • Hepatitis
  • Influenza
  • Herpes simplex virus
  • Bacterial infections
  • Fungal infections
• Current market scenario
• Unmet Needs and Innovations
• Efficacy
• Emerging resistance to existing treatments and lack of innovation
• Immunoglobin (vaccination) drug delivery mechanisms
• Targeted therapeutics in infectious diseases
• Innovative small molecules
• Applications of genetic technology
  • Therapeutic proteins and peptides
  • RNAi in infectious diseases
  • Antibodies
  • Novel targeted drug delivery mechanisms

Chapter 5 Appendix

• Research methodology
• ATC Codes
• Cancer Therapies
• Antineoplastic and immunomodulating agents
  • L1: Cytostatics
  • L2: Cytostatic hormone therapy
  • L3: Immunostimulating agents
• Cardiovascular Therapies
  • B1: Anti-thrombotic agents
  • C1: Cardiac Therapy
  • C2 Antihypertensives
  • C3 Diuretics
  • C7 Beta Blockers
  • C8 Calcium antagonists
  • C9 Agents acting on the renin-angiotensin system
  • C10 Hypolipidaemics/Anti-Atheroma Preparations
• Index

List of Figures

• Figure 1.1: Forecast growth for the top 20 biopharmaceutical companies, 2006-12
• Figure 1.2: Evolution of the biopharmaceutical corporation
• Figure 1.3: Reliance on licensed products vs. forecast revenue growth, top 20 pharmaceutical firms, 2006-12
• Figure 1.4: FDA new drug approvals and Phase 3 failures, 2006-2007
• Figure 2.5: Typical health economic value proposition for innovative or personalized therapies
• Figure 3.6: Mechanism of action of targeted small-molecule inhibitors
• Figure 3.7: Schematic presentation of targeted delivery of therapeutic proteins and peptides to antigen-positive tumor cells or tumor vasculature
• Figure 3.8: Mechanism of action of monoclonal antibodies
• Figure 3.9: Mechanism of post-transcriptional gene silencing by siRNA
• Figure 4.10: Global cancer innovatives market, 2003-2006
• Figure 4.11: Targeted oncology pipeline by indication, 2006

List of Tables

• Table 1.1: Global revenues from blockbuster drugs, top 10 pharma companies, 2006 ($m)
• Table 1.2: Complementary strengths of pharma and biotech companies
• Table 4.3: Estimated annual incidence of cancer diagnoses (‘000s), global, 2002 census
• Table 4.4: Breakdown of the global antineoplastic market by drug class,
• Table 4.5: Leading therapies in the global antineoplastics market, 2005-07
• Table 4.6: Antineoplastic sales forecast, 2006-12
• Table 4.7: Chemotherapeutic siRNA targets in drug development pipelines
• Table 4.8: Key pipeline oncology drugs and technologies utilizing nanotechnology, 2008
• Table 4.9: Estimated prevalence of CVD across the seven major markets, 2006
• Table 4.10: Breakdown of the global CVD market by drug class, 2003-07
• Table 4.11: Estimated prevalence of CNS disorders across the seven major markets, 2006
• Table 4.12: Global sales of CNS products by disease indication, 2005-2007, $m
• Table 4.13: Top 10 CNS brands, sales revenues, global, 2007, $m
• Table 4.14: Medicinal chemical properties of a successful CNS drug
• Table 4.15: Estimated prevalence of infective diseases across seven major markets, 2005
• Table 4.16: The anti-infectives market, global sales revenues, 2003-2007, $m