Pipeline/Commercial Insight: Molecular Targeted Cancer Therapies - More Drugs On The Market, More Targets In The Pipeline : Market Research Report

Pipeline/Commercial Insight: Molecular Targeted Cancer Therapies - More Drugs On The Market, More Targets In The Pipeline

Published by: Datamonitor

Published: Oct. 10, 2006 - 430 Pages

ABOUT DATAMONITOR HEALTHCARE: About the Oncology pharmaceutical analysis team
CHAPTER 1 EXECUTIVE SUMMARY: Scope of analysis; Datamonitor insight into the targeted therapies market
CHAPTER 2 PIPELINE OVERVIEW: Pipeline overview; Pipeline by developmental phase and class of drug; Pipeline by indication; Pipeline by mode of action; Pipeline by company; Key metrics; Datamonitor pipeline assessment summary
CHAPTER 3 PIPELINE DYNAMICS: A diverse range of disease subtypes; Genetic basis of cancer evolution; Existing pharmacotherapy approaches provide limited treatment benefit; The emergence of targeted treatment heralds a revolution in cancer pharmacotherapy; Dynamic cancer market offers significant commercial opportunity; Clinical and strategic threats to the commercialization of cancer drugs
CHAPTER 4 MARKET DEFINITION & PIPELINE CLASSIFICATION: Targeted therapies overview; Market definition; Classification of pipeline products; Pipeline comparator; Current market situation
CHAPTER 5 MARKETED PRODUCTS FORECAST ANALYSIS: Country-specific assumptions and effects; Product assumptions and effects; Forecasts
CHAPTER 6 PIPELINE ANGIOGENESIS INHIBITORS ANALYSIS & FORECASTS: Pipeline overview; AstraZeneca's AZD2171; GlaxoSmithKline's Pazopanib (GW 786034); Novartis/Schering AG's Vatalanib (PTK-787); Sanofi Aventis/Regeneron's VEGF-Trap; Forecasts; Datamonitor drug assessment summary
CHAPTER 7 PIPELINE SINGLE-TARGET SIGNAL TRANSDUCTION INHIBITORS ANALYSIS & FORECASTS: Pipeline overview; Amgen's Vectibix (panitumumab; ABX-EGF); Schering-Plough's Sarasar (Lonafarnib); Abbott Laboratories' Xinlay (atrasentan); Wyeth's Torisel (Temsirolimus; CCI-779); Janssen/Johnson & Johnson's Zarnestra (tipifarnib); YM Bioscience's TheraCIM (Theraloc; Nimotuzumab); Forecasts; Datamonitor drug assessment summary
CHAPTER 8 PIPELINE MULTI-TARGETED INHIBITORS ANALYSIS & FORECASTS: Pipeline overview; GlaxoSmithKline's Tykerb/Tycerb (Lapatinib); ChemGenex Pharmaceuticals' Ceflatonin (CGX-635, Myelostat); Ipsen's Somatuline (Lanreotide); Novartis's Tasigna (Nilotinib, AMN-107); AstraZeneca's Zactima (Vandetanib; ZD6474); Eli Lilly's Enzastaurin (LY317615); Cephalon's Lestaurtinib (CEP-701); Forecasts; Datamonitor drug assessment summary
CHAPTER 9 PIPELINE CELL CYCLE AND APOPTOSIS TARGETED AGENTS ANALYSIS & FORECASTS: Pipeline overview; Genta's Genasense (Oblimersen); Telik's Telcyta (TLK286); Celtic Pharma/Xenova's TransMID (XR-311); Sanofi-Aventis's Alvocidib (Flavopiridol); Novogen's Phenoxodiol; Forecasts; Datamonitor drug assessment summary
CHAPTER 10 PIPELINE EPIGENETIC MODULATORS ANALYSIS & FORECASTS: Pipeline overview; Merck's Zolinza (Vorinostat, SAHA); Gloucester Pharmaceuticals' Romidepsin (FK-228, depsipeptide); Forecasts; Datamonitor drug assessment summary
CHAPTER 11 PIPELINE IMMUNOMODULATORY AND IMMUNOCONJUGATED THERAPEUTICS ANALYSIS & FORECASTS: Pipeline overview; Wilex's Rencarex (WX-G250); Genmab's Ofatumumab (HuMax-CD20); Forecasts; Datamonitor drug assessment summary
CHAPTER 12 COMMERCIAL IMPACT & LIFECYCLE MANAGEMENT: CASE STUDIES: Introduction; Case study one; Case study two
APPENDIX A - MARKET DATA & MAJOR BRAND KEY FACTS: L1X3 (antineoplastic monoclonal antibodies) class market data; L1X9 (all other neoplastics) class market data; Sales data and forecasts; PowerPoint Executive Presentation
APPENDIX B - SALES FORECASTS: US Forecasts; Japan Forecasts; France Forecasts; Germany Forecasts; Italy Forecasts; Spain Forecasts; UK Forecasts; Five Major European Markets (EU5) Forecasts; Seven Major Markets Forecasts
APPENDIX C: List of Tables; List of Figures; Methodology; Abbreviations; Contributing experts; Bibliography; About Datamonitor; Disclaimer
List of Tables: Table 1: Molecular targeted therapies in preregistration, 2006; Table 2: Molecular targeted therapies in Phase III development, 2006; Table 3: Pipeline molecular targeted therapies by development phase and class of drug, 2006; Table 4: Pipeline molecular targeted therapies by indication, 2006; Table 5: Specific target/targets with two candidates in the pipeline, 2006; Table 6: Specific target/targets with three or more candidates in the pipeline, 2006; Table 7: Number of products in the pipeline targeting key molecular drivers of cancer, 2006; Table 8: Companies with two candidates in the molecular targeted therapies pipeline, 2006; Table 9: Companies with three candidates in the molecular targeted therapies pipeline, 2006; Table 10: Companies with four or more candidates in the molecular targeted therapies pipeline, 2006; Table 11: Pfizer's marketed oncology portfolio, 2006; Table 12: Pfizer's molecular targeted cancer therapies portfolio, 2006; Table 13: Novartis' marketed oncology portfolio, 2006; Table 14: Novartis' molecular targeted cancer therapies portfolio, 2006; Table 15: GSK's marketed oncology portfolio, 2006; Table 16: GSK's molecular targeted cancer therapies portfolio, 2006; Table 17: Late-phase pipeline targeted therapies sales forecasts for the seven major markets ($m), 2006-2015; Table 18: Datamonitor drug assessment summary for late-phase pipeline molecular targeted cancer therapies, 2006; Table 19: Common mutations involved in tumor development; Table 20: Forecast incidence of cancer across the seven major markets, 2005-2013; Table 21: Examples of naturally occurring angiogenesis stimulators; Table 22: Recently approved multi-targeted inhibitors, 2006; Table 23: Current targeted therapy marketed products, 2006 (1 of 2); Table 24: Current targeted therapy marketed products, 2006 (1 of 2); Table 25: Targeted therapies sales in the seven major markets, 2005; Table 26: Clinical pipeline for Nexavar, 2006; Table 27: Clinical pipeline for Sprycel, 2006; Table 28: Summary of Phase II Sprycel clinical trial results; Table 29: Clinical pipeline for Sutent, 2006; Table 30: Approved indications for Rituxan in the US and EU, 2006; Table 31: Late-phase pipeline angiogenesis inhibitors, 2006; Table 32: Phase II pipeline angiogenesis inhibitors, 2006; Table 33: Phase I pipeline angiogenesis inhibitors, 2006; Table 34: Ongoing clinical trials involving AZD2171, 2006; Table 35: Ongoing clinical trials involving pazopanib, 2006; Table 36: Ongoing clinical trials involving vatalanib, 2006; Table 37: Ongoing clinical trials involving VEGF-Trap, 2006; Table 38: Forecasting assumptions for late-phase angiogenesis inhibitors, 2006; Table 39: Angiogenesis inhibitors sales forecasts ($m), 2006-2015; Table 40: Research/clinical and commercial attractiveness of pipeline angiogenesis inhibitors, 2006; Table 41: Late-phase pipeline single-target signal transduction inhibitors, 2006; Table 42: Phase II pipeline single-target signal transduction inhibitors, 2006; Table 43: Phase I pipeline single-target signal transduction inhibitors, 2006; Table 44: Ongoing clinical trials involving Vectibix, 2006; Table 45: Ongoing clinical trials involving Sarasar, 2006; Table 46: Ongoing clinical trials involving Xinlay, 2006; Table 47: Historical development of Xinlay, 1994-2005; Table 48: Ongoing Phase II/III trials involving temsirolimus, 2006; Table 49: Ongoing clinical trials involving Zarnestra, 2006; Table 50: Phase I/II trial involving Nexavar, Tarceva, Torisel and Zarnestra, 2006; Table 51: Forecasting assumptions for late-stage pipeline single-target signal transduction inhibitors (1 of 2); Table 52: Forecasting assumptions for late-stage pipeline single-target signal transduction inhibitors (2 of 2); Table 53: Single-target signal transduction inhibitors sales forecasts ($m), 2006-2015; Table 54: Research/clinical and commercial attractiveness of pipeline single-target signal transduction inhibitors (1 of 2); Table 55: Research/clinical and commercial attractiveness of pipeline single-target signal transduction inhibitors (2 of 2); Table 56: Late-phase pipeline multi-targeted inhibitors, 2006; Table 57: Phase II pipeline multi-targeted inhibitors, 2006; Table 58: Phase I pipeline multi-targeted inhibitors, 2006; Table 59: Ongoing breast cancer clinical trials involving Tykerb, 2006; Table 60: Ongoing non-breast cancer clinical trials involving Tykerb, 2006; Table 61: Summary of key Tykerb breast cancer clinical trials, 2006; Table 62: Ongoing clinical trials involving Ceflatonin, 2006; Table 63: Ongoing trials involving Somatuline, 2006; Table 64: Ongoing clinical trials involving Tasigna, 2006; Table 65: Zactima's multiple anticancer targets; Table 66: Ongoing clinical trials involving Zactima; Table 67: Ongoing clinical trials involving enzastaurin, 2006; Table 68: Ongoing clinical trials involving lestaurtinib; Table 69: Forecasting assumptions for late-stage pipeline multi-targeted inhibitors (1 of 2); Table 70: Forecasting assumptions for late-stage pipeline multi-targeted inhibitors (2 of 2); Table 71: Multi-targeted inhibitors sales forecasts ($m), 2006-2015; Table 72: Research/clinical and commercial attractiveness of pipeline multi-targeted inhibitors (1 of 2); Table 73: Research/clinical and commercial attractiveness of pipeline multi-targeted inhibitors (2 of 2); Table 74: Late-phase pipeline cell cycle and apoptosis targeted agents, 2006; Table 75: Phase II pipeline cell cycle and apoptosis targeted agents, 2006; Table 76: Phase I pipeline cell cycle and apoptosis targeted agents, 2006; Table 77: Ongoing clinical trials involving Genasense, 2006; Table 78: Ongoing clinical trials involving Telcyta, 2006; Table 79: NSCLC clinical trial data summary for Telcyta, 2006; Table 80: Key Phase III trials of Telcyta for ovarian cancer, 2006; Table 81: Ongoing clinical trials involving TransMID, 2006; Table 82: Ongoing clinical trials involving alvocidib, 2006; Table 83: Ongoing clinical trials involving phenoxodiol, 2006; Table 84: Forecasting assumptions for late-stage pipeline cell cycle and apoptosis targeted agents (1 of 2); Table 85: Forecasting assumptions for late-stage pipeline cell cycle and apoptosis targeted agents (2 of 2); Table 86: Cell cycle and apoptosis targeted agents sales forecasts ($m), 2006-2015; Table 87: Research/clinical and commercial attractiveness of pipeline cell cycle and apoptosis targeted agents; Table 88: Late-phase pipeline epigenetic modulators, 2006; Table 89: Phase II pipeline epigenetic modulators, 2006; Table 90: Phase I pipeline epigenetic modulators, 2006; Table 91: Ongoing clinical trials involving Zolinza, 2006; Table 92: Ongoing clinical trials involving romidepsin, 2006; Table 93: Zolinza forecasting assumptions; Table 94: Zolinza sales forecasts ($m), 2006-2015; Table 95: Research/clinical and commercial attractiveness of Zolinza; Table 96: Late-phase pipeline immunomodulatory and immunoconjugated therapeutics, 2006; Table 97: Phase II pipeline immunomodulatory and immunoconjugated therapeutics, 2006; Table 98: Phase I pipeline immunomodulatory and immunoconjugated therapeutics, 2006; Table 99: Ongoing clinical trial involving Rencarex, 2006; Table 100: Ongoing clinical trial involving ofatumumab, 2006; Table 101: Forecasting assumptions for late-phase immunomodulatory and immunoconjugated therapeutics; Table 102: Late-phase immunomodulatory and immunoconjugated therapeutics sales forecasts ($m), 2006-2015; Table 103: Research/clinical and commercial attractiveness of the late-phase immunomodulatory and immunoconjugated therapeutics; Table 104: Phase I/II trial involving Nexavar, Tarceva, Torisel and Zarnestra in GBM or gliosarcoma patients, 2006; Table 105: Examples of combinatorial approaches of MAbs with chemotherapy; Table 106: Comparative characteristics of small molecules and MAbs; Table 107: Single agents versus multiple agents in combination; Table 108: Marketed molecular targeted cancer therapies, 2006; Table 109: Rituxan: key facts; Table 110: Herceptin: key facts; Table 111: Campath: key facts; Table 112: Mylotarg: key facts; Table 113: Bexxar: key facts; Table 114: Avastin: key facts; Table 115: Erbitux: key facts; Table 116: Zevalin: key facts; Table 117: Gleevec: key facts; Table 118: Targretin: key facts; Table 119: Iressa: key facts; Table 120: Velcade: key facts; Table 121: Tarceva: key facts; Table 122: Sprycel: key facts; Table 123: Nexavar: key facts; Table 124: Sutent: key facts; Table 125: Ontak: key facts; Table 126: Forecasts for marketed targeted therapies for the US ($m), 2005-2015; Table 127: Forecasts for marketed targeted therapies for Japan ($m), 2005-2015; Table 128: Forecasts for marketed targeted therapies for France ($m), 2005-2015; Table 129: Forecasts for marketed targeted therapies for Germany ($m), 2005-15; Table 130: Forecasts for marketed targeted therapies for Italy ($m), 2005-15; Table 131: Forecasts for marketed targeted therapies for Spain ($m), 2005-15; Table 132: Forecasts for marketed targeted therapies in the UK ($m), 2005-15; Table 133: Forecasts for marketed targeted therapies for the EU5 ($m), 2005-2015; Table 134: Forecasts for marketed targeted therapies for the seven major markets ($m), 2005-2015; Table 135: Datamonitor drug assessment parameters; Table 136: Abbreviations used in Pipeline/Commercial Insight: Molecular Targeted Cancer Therapies (1 of 2); Table 137: Abbreviations used in Pipeline/Commercial Insight: Molecular Targeted Cancer Therapies (2 of 2)
List of Figures: Figure 1: Pipeline molecular targeted therapies by development phase and class of drug, 2006; Figure 2: Pipeline molecular targeted therapies by class of drug, 2006; Figure 3: Pipeline molecular targeted therapies by development phase, 2006; Figure 4: Angiogenesis inhibitors by developmental phase, 2006; Figure 5: Single-target signal transduction inhibitors by developmental phase, 2006; Figure 6: Multi-targeted inhibitors by developmental phase, 2006; Figure 7: Cell cycle and apoptosis targeted agents by developmental phase, 2006; Figure 8: Epigenetic inhibitors by developmental phase, 2006; Figure 9: Immunomodulatory and immunoconjugated therapeutics by developmental phase, 2006; Figure 10: Pipeline molecular targeted therapies by solid tumor indication, 2006; Figure 11: Pipeline molecular targeted therapies by hematological malignancy, 2006; Figure 12: Number of products in the pipeline targeting key molecular drivers of cancer, 2006; Figure 13: Companies with four or more candidates in the molecular targeted therapies pipeline, 2006; Figure 14: Pipeline angiogenesis inhibitors sales forecasts for the seven major markets ($m), 2006-2015; Figure 15: Pipeline single-target signal transduction inhibitors sales forecasts for the seven major markets ($m), 2006-2015; Figure 16: Pipeline multi-targeted inhibitors sales forecasts for the seven major markets ($m), 2006-2015; Figure 17: Pipeline cell cycle and apoptosis targeted agents sales forecasts for the seven major markets ($m), 2006-2015; Figure 18: Pipeline epigenetic modulators sales forecasts for the seven major markets ($m), 2006-2015; Figure 19: Pipeline immunomodulatory and immunoconjugated therapeutics sales forecasts for the seven major markets ($m), 2006-2015; Figure 20: Datamonitor drug assessment summary for pipeline angiogenesis inhibitors, 2006; Figure 21: Datamonitor drug assessment summary for pipeline single-target signal transduction inhibitors, 2006; Figure 22: Datamonitor drug assessment summary for pipeline multi-targeted inhibitors, 2006; Figure 23: Datamonitor drug assessment summary for pipeline cell cycle and apoptosis targeted agents, 2006; Figure 24: Datamonitor drug assessment summary for epigenetic modulators, 2006; Figure 25: Datamonitor drug assessment summary for immunomodulatory and immunoconjugated therapeutics, 2006; Figure 26: Global oncology sales ($m), 2002-09; Figure 27: Oncology pipeline including supportive care, 2006; Figure 28: Forecast incidence of cancer across the seven major markets, 2005-2013; Figure 29: Combined incidence for breast, lung, prostate and colorectal cancer rises with age in seven major markets, 2003; Figure 30: Incidence increases, while the rate of cure and death reduces disease prevalence; Figure 31: Point prevalence for colorectal and lung cancer differs markedly despite similar rates of incidence; Figure 32: Unmet needs in cancer, 2006; Figure 33: The process of tumor angiogenesis; Figure 34: Approaches to inhibition of VEGF signaling; Figure 35: Angiogenesis inhibitors sales forecasts ($m), 2006-2015; Figure 36: Research/clinical and commercial attractiveness of pipeline angiogenesis inhibitors, 2006; Figure 37: Single-target signal transduction inhibitors sales forecasts ($m), 2006-2015; Figure 38: Research/clinical and commercial attractiveness of pipeline single-target signal transduction inhibitors, 2006; Figure 39: Design of Phase III Tykerb plus capecitabine versus capecitabine alone trial; Figure 40: Multi-targeted inhibitors sales forecasts ($m), 2006-2015; Figure 41: Research/clinical and commercial attractiveness of pipeline multi-targeted inhibitors; Figure 42: Telcyta's mechanism of action; Figure 43: TransMID's mode of action; Figure 44: Cell cycle and apoptosis targeted agents sales forecasts ($m), 2006-2015; Figure 45: Research/clinical and commercial attractiveness of pipeline cell cycle and apoptosis targeted agents; Figure 46: Zolinza sales forecasts ($m), 2006-2015; Figure 47: Research/clinical and commercial attractiveness of Zolinza; Figure 48: Rencarex induced ADCC; Figure 49: Rencarex Phase II results: median survival; Figure 50: Late-phase immunomodulatory and immunoconjugated therapeutics sales forecasts ($m), 2006-2015; Figure 51: Research/clinical and commercial attractiveness of the late-phase immunomodulatory and immunoconjugated therapeutics, 2006; Figure 52: Number of marketed MAbs and small molecules, 2006; Figure 53: Number of late-phase MAbs and small molecules, 2006; Figure 54: Number of marketed molecular targeted therapies for solid tumors and hematological malignancies, 2006; Figure 55: Number of late-phase molecular targeted therapies for solid tumors and hematological malignancies, 2006; Figure 56: Number of molecular targeted therapies approved in the 'big four' tumor types, 2006; Figure 57: Number of late-phase molecular targeted therapies in the 'big four' tumor types, 2006; Figure 58: Marketed molecular targeted therapies by indication, 2006; Figure 59: Phase I, II and III molecular targeted therapies by indication, 2006; Figure 60: Approval paths of the marketed molecular targeted therapies; Figure 61: Advantages and disadvantages of developing an MTT in one of the 'Big Four' tumor types; Figure 62: Advantages and disadvantages of developing an MTT in a niche tumor type; Figure 63: Example of Datamonitor drug assessment scorecard; Figure 64: Example of Datamonitor drug assessment graph

Abstract

Introduction

Cancer treatment continues to embrace the inclusion of molecular targeted therapies (MTT) into standard treatment regimens. With an increasing number of candidates gaining approval, and with a dynamic developmental pipeline, further clinical, commercial and strategic challenges are continuing to emerge.

Scope

Seven major pharmaceutical market sales forecasts from 2005 to 2015 for approved molecular targeted therapies and key pipeline candidates
Review of the current targeted therapies market, including profiles, product-specific assumptions and events over the forecasted period
Research and analysis of the targeted therapies pipeline with in-depth clinical and commercial assessment of Phase III candidates, plus expert opinion
Examination of product pipeline by phase, mode of action, indication, drug class and developer, plus two commercial impact case studies

Highlights

In 2005, the MTT market was worth $7.5 billion and the forecast sales of already marketed drugs in this class are expected to grow to $25.2 billion by 2015, at a CAGR of 12.9%. This growth will be driven mainly by Genentech/Roche's Rituxan, Herceptin and Avastin as well as Novartis' Gleevec, all of which have already reached blockbuster status.

274 different pipeline MTTs have been identified. The introduction of current late-phase candidates, including the pre-registered agents Tykerb (lapatinib; GlaxoSmithKline) and Zolinza (vorinostat; Merck), will further increase the market's total value by $3.8 billion, enabling the targeted therapies market to reach $29.1 billion in 2015.

The rise in cost of cancer treatment is unsustainable with growing pharmacoeconomic pressures challenging healthcare payers globally. To counter these hurdles, developers must become more effective at communicating the value of their products. To this end, a comprehensive understanding of the targeted therapies market and pipeline is critical.

Reasons to Purchase

Acquire a detailed appreciation and impartial perspective of the targeted cancer therapies market as a whole
Consider and react to the specific events influencing the future potential of marketed and pipeline targeted therapies
Gain an insight into the emerging clinical, developmental and commercial challenges and opportunities facing key developmental and marketed MTT drugs

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Pipeline/Commercial Insight: Molecular Targeted Cancer Therapies - More Drugs On The Market, More Targets In The Pipeline

Table of Contents

Abstract