- Marco Lolicato‡,
- Marco Nardini§,
- Sabrina Gazzarrini‡,
- Stefan Möller¶,
- Daniela Bertinetti¶,
- Friedrich W. Herberg¶,
- Martino Bolognesi§,
- Holger Martin‡,
- Marina Fasolini‖,
- Jay A. Bertrand‖,
- Cristina Arrigoni‡,
- Gerhard Thiel** and
- Anna Moroni‡,1
- From the ‡Department of Biology and Consiglio Nazionale delle Ricerche-Istituto di Biofisica and
- the §Department of Biomolecular Sciences and Biotechnology, University of Milan, Via Celoria 26, 20133 Milan, Italy,
- the ¶Department of Biochemistry, University of Kassel, Heinrich Plett Strasse 40, 34132 Kassel, Germany,
- ‖Nerviano Medical Sciences Srl, Oncology, Viale Pasteur 10, 20014 Nerviano (MI), Italy, and
- the **Institute of Botany, Technische Universität Darmstadt, Schnittspahnstrasse 3, 64287 Darmstadt, Germany
- ↵1 To whom correspondence should be addressed: Dept. of Biology, CNR-IBF, Via Celoria 26, 20133 Milan, Italy. Tel.: 02-5031-4826; Fax: 02-5031-4815; E-mail: anna.moroni{at}unimi.it.
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Table of Contents1. Executive Summary
1.1 Overview of Findings
1.2 Scope and Format of the Report
1.3 Research and Analysis Methods
2. Introduction: Cancer, its Physiology, Burden and Treatment2.1 Targeted Cancer Therapies2.2 The Physiology of Cancer2.2.1 Uncontrolled Growth2.2.2 Dedifferentiation2.2.3 Invasiveness and Metastasis2.2.4 Causes of Cancer2.3 Incidence and Mortality for Cancer2.3.1 Incidence2.3.2 Mortality2.3.3 Survival2.3.3.1 The Developed World2.3.3.2 The Developing World2.4 Treating Tumours2.4.1 Chemotherapy2.4.2 Traditional Antineoplastics2.4.3 Novel Antineoplastics2.4.3.1 Kinase Receptor Antagonists2.4.3.2 Other Novel Antineoplastics2.4.4 Hormone Therapies2.4.5 Active Immunotherapy2.4.6 Passive Immunotherapy: Monoclonal Antibodies2.5 Small-Molecule Targeted Cancer Therapies2.5.1 Signal Transduction Inhibitors2.5.2 Gene Expression and Other Cellular Function Regulators2.5.3 Small-Molecule Apoptotic Inducing Drugs2.5.4 Angiogenesis Blockers2.6 Targeted Cancer Therapies: Small-Molecule Drugs
3. The Small-Molecule Cancer Therapies Market, 2011-2021
3.1 The World Small-Molecule Cancer Therapies Market in 2010
3.2 Growing Market for Small-Molecule Cancer Therapies
3.2.1 Sales Forecast for Small-Molecule Cancer Therapies, 2011-2015
3.2.2 Sales Forecast for Small-Molecule Cancer Therapies, 2016-2021
3.3 Leading Products in Small-Molecule Cancer Therapies Market
4. Small-Molecule Cancer Therapies: Leading National Markets, 2011-20214.1 The US Small-Molecule Cancer Therapies Market, 2011-20214.2 The Japanese Small-Molecule Cancer Therapies Market, 2011-20214.3 The Leading European Small-Molecule Cancer Therapies Markets, 2011-20214.4 Emerging-Economy Small-Molecule Cancer Therapies Markets4.5 The Chinese Small-Molecule Cancer Therapies Market, 2011-20214.6 The Indian Small-Molecule Cancer Therapies Market, 2011-20214.7 Summary of Market Forecasts
5. Leading Small-Molecule Anti-Cancer Products, 2011-2021
5.1 Glivec/Gleevec (Novartis)
5.1.1 Glivec/Gleevec Sales 2010
5.1.2 Glivec/Gleevec Sales Forecast, 2011-2015
5.1.3 Glivec/Gleevec Sales Forecast, 2016-2021
5.1.4 Tasigna Set to Replace Glivec/Gleevec
5.2 Revlimid (Celgene)
5.2.1 Revlimid Sales 2010
5.2.2 Secondary Malignancies
5.2.3 Revlimid Sales Forecast, 2011-2015
5.2.4 Revlimid Sales Forecast, 2016-2021
5.3 Alimta (Eli Lilly)
5.3.1 Alimta Sales 2010
5.3.2 Patent Disputes
5.3.3 Alimta Sales Forecast, 2011-2015
5.3.4 Alimta Sales Forecast, 2016-2021
5.4 Taxotere (Sanofi)
5.4.1 Taxotere Sales 2010
5.4.2 Patent Expiry
5.4.3 Taxotere Sales Forecast, 2011-2015
5.4.4 Taxotere Sales Forecast, 2016-2021
5.5 Velcade (Takeda/J&J)
5.5.1 Velcade Sales 2010
5.5.2 Recent Developments
5.5.3 Velcade Sales Forecast, 2011-2015
5.5.4 Velcade Sales Forecast, 2016-2021
5.6 Arimidex (AstraZeneca)
5.6.1 Arimidex Sales 2010
5.6.2 Patent Expiry
5.6.3 Arimidex Sales Forecast, 2011-2015
5.6.4 Arimidex Sales Forecast, 2016-2021
5.7 Tarceva (Roche)
5.7.1 Tarceva Sales 2010
5.7.2 Patent Expiry
5.7.3 Tarceva Sales Forecast, 2011-2015
5.7.4 Tarceva Sales Forecast, 2016-2021
5.8 Sutent (Pfizer)
5.8.1 Sutent Sales 2010
5.8.2 Generic Launch Expected for Sutent
5.8.3 Sutent Sales Forecast, 2011-2015
5.8.4 Sutent Sales Forecast, 2016-2021
5.8.5 Additional Indication Approval.
5.8.6 Late-Stage Clinical Trials for Additional Uses and Dosage Forms for Sutent
5.9 Nexavar (Bayer/Onyx)
5.9.1 Nexavar Sales 2010
5.9.2 Patent Expiry
5.9.3 Nexavar Sales Forecast, 2011-2015
5.9.4 Nexavar Sales Forecast, 2016-2021
5.10 Sprycel (Bristol-Myers Squibb)
5.10.1 Sprycel Sales 2010
5.10.2 Patent Expiry
5.10.3 Sprycel Sales Forecast, 2011-2015
5.10.4 Sprycel Sales Forecast, 2016-2021
6. R&D Pipeline for Small-Molecule Cancer Products6.1 An Overview6.2 Small-Molecule Lung Cancer Pipeline 20116.2.1 BIBW 2992 (Boehringer Ingelheim)6.2.2 Crizotinib (Pfizer)6.3 Small-Molecule Breast Cancer Pipeline 20116.3.1 Line Extensions6.3.2 Halaven (Eisai)6.4 Small-Molecule Colorectal Cancer Pipeline 20116.4.1 BAY 73-4506 (Bayer)6.4.2 KRX 0401 (Keryx/Aeterna Zentaris)6.5 Small-Molecule Stomach Cancer Pipeline 20116.5.1 Line Extensions6.5.2 Telatinib (ACT Biotech)6.6 Small-Molecule Prostate Cancer Pipeline 20116.6.1 MDV 3100 (Astellas/Medivation)6.6.2 CB7630 (Centocor Ortho Biotech)6.7. Small-Molecule Multiple Myeloma Pipeline, 20116.7.1 Proteasome Inhibitors: the Next Generation6.7.1.1 CEP 18770 (Cephalon)6.7.1.2 Marizomib (Nereus)6.7.1.3 MLN 9708 (Takeda)6.7.1.4 CEP 28331 (Cephalon)6.7.2 Immunomodulators: the Past or the Future for Myeloma Treatment?6.7.2.1 Afinitor (Novartis)6.7.2.2 E-Selectin Antagonists (GlycoMimetics)6.7.3 Histone Deacetylase Inhibitors: An Important New Sector6.7.3.1 Istodax (Celgene Corporation)6.7.3.2 Zolinza (Merck & Co.)6.7.3.3 AR 42 (Arno)6.7.3.4 Givinostat (Italfarmaco)6.7.3.5 HDAC6 Inhibitors (Acetylon)6.7.4 Kinase Inhibitors/Signal Transduction Blockers: The Largest Pipeline Sector6.7.4.1 Votrient (GlaxoSmithKline)6.7.4.2 Lenocta (VioQuest)6.7.4.3 Ruxolitnib (Novartis)6.7.4.4 Lestaurtnib (Cephalon)6.7.4.5 Masitnib (AB Science)6.7.4.6 AT 9283 (Astex Therapeutics)6.7.4.7 Dovitnib (Novartis)6.7.4.8 P276 (Piramal Life Sciences)6.7.4.9 PD332991 (Pfizer)6.7.4.10 ENMD 2076 (EntreMed)6.7.4.11 AT 7519 (Astex Therapeutics)6.7.4.12 MLN 8237 (Takeda)6.7.4.13 Estybon (Onconova)6.7.4.14 CX 4945 (Cylene)6.7.4.15 GDC 0941 (Roche)6.7.4.16 INK 128 (Intellikine)6.7.4.17 SF 1126 (Semafore)6.7.4.18 SNS 032 (Sunesis/Bristol-Myers Squibb)6.7.4.19 Sprycel (Otsuka/Bristol-Myers Squibb)6.7.4.20 TG 02 (Tragara/S*BIO)6.7.4.21 R763 (Rigel)6.7.5 Heat Shock Protein Modulators6.7.5.1 AUY 922 (Novartis)6.7.5.2 KW 2478 (Kyowa Hakko Kirin)6.7.5.3 NVP BEP800 (Novartis)6.7.6 Apoptosis Inducers: Four Products at Phase II6.7.6.1 GCS 100 (Prospect Therapeutics)6.7.6.2 Amplimexon (AmpliMed )6.7.6.3 Trisenox (Nippon Shinyaku)6.7.6.4 Noscapine (Cougar Biotechnology)6.7.6.5 BMS 833923 (Bristol-Myers Squibb)6.7.6.6 SNS 01-T (Senesco)6.7.7 Other Small-Molecule Myeloma Products6.7.7.1 Products in Phase II6.7.7.2 Amnolake (CytRx)6.7.7.3 Coprexa TM (Attenuon)6.7.7.4 Brostallacin (Cell Therapeutics)6.7.7.5 CYT 997 (YM BioSciences)6.7.7.6 ARRY 520 (Array BioPharma)6.7.7.7 Zinapar (Ziopharm)6.7.7.8 Products in Phase I6.7.7.9 Quadramet (EUSA Pharma)6.7.7.10 LC1 (Leuchemix)6.7.7.11 MLN 4924 (Takeda)6.7.7.12 OPB 31121 (Otsuka)6.7.7.13 Zalypsis (PharmaMar)6.7.7.14 Products in Preclinical Studies6.7.7.15 INNO 206 (CytRx)6.7.7.16 Ostabolin-C (Zelos)6.7.7.17 IRE1-alfa inhibitor (Mannkind)6.7.7.18 HIF Signalling Inhibitors (Elara)6.7.7.19 PS 031291 (Ligand) 6.7.7.20 SST 0001 (Sigma-Tau) 6.7.7.21 CGEN 928 (Compugen)6.7.7.22 USP7 Inhibitors (Progenra)6.8 Small-Molecule Epigenetic Therapy Pipeline, 20116.8.1 HDAC Inhibitors6.8.1.1 PXD-101 (Belinostat, TopoTarget/Spectrum Pharmaceuticals)6.8.1.2 LBH589 (Panobinostat, Novartis)6.8.1.3 Entinostat (Syndax Pharmaceuticals)6.8.1.4 4SC-201 (Resminostat, 4SC)6.8.1.5 MGCD-0103 (Mocetinostat, MethylGene)6.8.1.6 SB939 (S*BIO)6.8.1.7 ACY-1215 (Acetylon Pharmaceuticals)6.8.1.8 Valproic Acid6.8.2 DNMT Inhibitors6.8.2.1 SGI-110 (Astex Pharmaceuticals)6.8.2.2 CP-4200 (Clavis Pharma)
7. Qualitative Analysis of the Small-Molecule Cancer Therapies Market, 2011-2021
7.1 SWOT Chart for Small-Molecule Cancer Therapies Market 2011-2021
7.2 Strengths
7.2.1 Cancer Treatment has Proven Commercial Potential
7.2.2 High Profile Nature of Cancer
7.2.3 Off-Label Prescriptions are Common
7.2.4 Strong Drug Development Incentives
7.3 Weaknesses
7.3.1 Tumours and Multidrug Resistance (MDR)
7.3.2 Pricing-Out the Developing World?
7.4 Opportunities
7.4.1 Cancer is a Key Business Area for the Pharmaceutical Industry
7.4.2 Rising Incidence of Cancer
7.4.1.1 Aging Populations
7.4.1.2 Smoking
7.4.1.3 Obesity
7.4.1.4 The Developing World
7.4.3 Greater Understanding of Cancer Biology Gives Opportunities in the Cancer Treatment Industry
7.4.4 Advanced Diagnostics with Pharmacogenomics: Impact on Cancer Therapies
7.4.5 Live Licensing and In-Life Testing
7.4.6 Convenience of Targeted Drugs versus Chemotherapy
7.5 Threats
7.5.1 Healthcare Spending Restraints Threaten Cancer Drug Revenues
7.5.2 The Cost-Effectiveness Debate
7.5.3 Governments are a Leading Payer for Drugs
7.5.4 Efficacy, Toxicity and Alternative Treatments
7.6 Biosimilars and Generics: Opportunity or Threat?
7.7 Personalised Medicine and Cancer
7.7.1 Biomarkers and Diagnostics
7.7.2 Small-Molecule (Metabolic) Biomarkers
7.7.3 Cancer Heterogeneity
7.7.4 Pharmacogenomics
7.7.5 Genome Screening
7.7.6 Theranostics
8. Research Interviews8.1 Dr Martin Bonde , CEO, EpiTherapeutics8.1.1 Potential for Histone Methyltransferase Inhibitors8.1.2 Future of Epigenetics Research8.1.3 Histone Methyltransferase Inhibitors on Market within Decade?8.1.4 Challenges in Developing Epigenetic Therapies8.1.5 Benefits of University Spin-Outs8.2 Dr Joanna Horobin , President and CEO, Syndax Pharmaceuticals8.2.1 On Challenges Facing Cancer Therapies8.2.2 On Selective Targeting of Therapies8.2.3 On Drug Resistance and Targeted Therapies8.2.4 On Drug Resistance and Market Opportunity8.2.5 On Entinostat, Lung and Breast Cancer Therapies
9. Conclusions
9.1 Small-Molecule Cancer Therapies Market Offers Promise
9.2 Leading Products in Small-Molecule Cancer Therapies Market, 2010
9.3 The US Will Remain the World’s Largest Small-Molecule Cancer Therapies Market
9.4 India and China Will be the Fastest-Growing National Markets
9.5 R&D Pipelines for Many Cancer Types Are Strong
9.6 Concluding Remarks
List of TablesTable 2.1 Leading Causes of Death Worldwide, 2008 & 2015
Table 2.2 Most Common Cancers by Incidence, 2008
Table 2.3 Most Common Cancers by Mortality, 2008 & 2015
Table 2.4 Five-Year Survival Rates of Nine Cancers in the UK, 2009
Table 2.5 Categories of Anti-Cancer Drug, 2011
Table 2.6 Common Side Effects of Traditional Antineoplastic Chemotherapy
Table 2.7 Subcategories of TANs, 2011
Table 3.1 Small-Molecule Cancer Therapies Market: World Sales Forecast, 2010-2015
Table 3.2 Small-Molecule Cancer Therapies Market: World Sales Forecast, 2016-2021
Table 3.3 Small-Molecule Cancer Market: Top Ten Products – Sales and Market Shares, 2010, 2015 & 2021
Table 4.1 Leading Small-Molecule Cancer Therapies: National Market Forecasts, 2010-2021
Table 5.1 Glivec/Gleevec Sales for US and RoW, 2009 & 2010
Table 5.2 Glivec/Gleevec Sales Forecast, 2010-2015
Table 5.3 Glivec/Gleevec Sales Forecast, 2016-2021
Table 5.4 Glivec/Gleevec: Sales Drivers and Restraints, 2011-2021
Table 5.5 Revlimid Sales Forecast, 2010-2015
Table 5.6 Revlimid Sales Forecast, 2016-2021
Table 5.7 Revlimid: Sales Drivers and Restraints, 2011-2021
Table 5.8 Alimta Sales for US and RoW, 2009 & 2010
Table 5.9 Alimta Sales Forecast, 2010-2015
Table 5.10 Alimta Sales Forecast, 2016-2021
Table 5.11 Alimta: Sales Drivers and Restraints, 2011-2021
Table 5.12 Taxotere: Approved Indications, 2010
Table 5.13 Taxotere Sales by Region, 2009 & 2010
Table 5.14 Taxotere Sales Forecast, 2010-2015
Table 5.15 Taxotere Sales Forecast, 2016-2021
Table 5.16 Taxotere: Sales Drivers and Restraints, 2011-2021
Table 5.17 Velcade Sales by Company, 2010
Table 5.18 Velcade Sales Forecast, 2010-2015
Table 5.19 Velcade Sales Forecast, 2016-2021
Table 5.20 Velcade: Sales Drivers and Restraints, 2011-2021
Table 5.21 Arimidex Sales for US and RoW, 2009 & 2010
Table 5.22 Arimidex Sales by Region, Q1-Q3 2010
Table 5.23 Arimidex Sales Forecast, 2010-2015
Table 5.24 Arimidex Sales Forecast, 2016-2021
Table 5.25 Arimidex: Sales Drivers and Restraints, 2011-2021
Table 5.26 Tarceva Sales Forecast, 2010-2015
Table 5.27 Tarceva Sales Forecast, 2016-2021
Table 5.28 Tarceva: Sales Drivers and Restraints, 2011-2021
Table 5.29 Sutent Sales Forecast, 2010-2015
Table 5.30 Sutent Sales Forecast, 2016-2021
Table 5.31 Sutent: Sales Drivers and Restraints, 2011-2021
Table 5.32 Nexavar Sales Forecast, 2010-2015
Table 5.33 Nexavar Sales Forecast, 2016-2021
Table 5.34 Nexavar Sales Drivers and Restraints, 2011-2021
Table 5.35 Sprycel Sales for US and RoW, 2009 & 2010
Table 5.36 Sprycel Sales Forecast, 2010-2015
Table 5.37 Sprycel Sales Forecast, 2016-2021
Table 5.38 Sprycel: Sales Drivers and Restraints, 2011-2021
Table 6.1 Number of Cancer Drug Pipeline Candidates by Indication, 2009 & 2011
Table 6.2 Abbreviations Used in Chapter 6
Table 6.3 Selected Small-Molecule Lung Cancer Pipeline Candidates in Phase III, 2010
Table 6.4 Selected Small-Molecule Lung Cancer Pipeline Candidates in Phase II, 2010
Table 6.5 Selected Small-Molecule Breast Cancer Pipeline in Phase II & III, 2010
Table 6.6 Selected Small-Molecule Colorectal Cancer Pipeline Candidates in Phase II & III, 2010
Table 6.7 Selected Small-Molecule Stomach Cancer Pipeline Candidates in Phase II & III, 2010
Table 6.8 Selected Small-Molecule Prostate Cancer Pipeline Candidates in Phase II & III, 2010
Table 6.9 Small-Molecule Pipeline Products for Multiple Myeloma, 2011
Table 6.10 Small-Molecule Multiple Myeloma Pipeline: Proteasome Inhibitors, 2011
Table 6.11 Small-Molecule Multiple Myeloma Pipeline: Immunomodulators, 2011
Table 6.12 Small-Molecule Multiple Myeloma Pipeline: Histone Deacetylase Inhibitors, 2011
Table 6.13 Small-Molecule Multiple Myeloma Pipeline: Kinase Inhibitor/Signal Transduction Blockers, 2011
Table 6.14 Small-Molecule Multiple Myeloma Pipeline: Heat Shock Protein Modulators, 2011
Table 6.15 Small-Molecule Multiple Myeloma Pipeline: Apoptosis Inducers, 2011
Table 6.16 Other Small-Molecule Myeloma Products: Phase II Pipeline, 2011
Table 6.17 Other Small-Molecule Myeloma Products: Phase I Pipeline, 2011
Table 6.18 Other Small-Molecule Myeloma Products: Preclinical Pipeline, 2011
Table 6.19 Selected Small-Molecule HDAC Inhibitor Pipeline Candidates, 2011
Table 6.20 Ongoing Clinical Trials for PXD-101 (Belinostat), 2011
Table 7.1 SWOT Analysis of World Small-Molecule Cancer Drugs Market: Strengths and Weaknesses, 2011-2021
Table 7.2 SWOT Analysis of World Small-Molecule Cancer Drugs Market: Opportunities and Threats, 2011-2021
Table 9.1 Small-Molecule Cancer Drug Market: Top Ten Products – Sales and Market Shares, 2010
Table 9.2 Small-Molecule Cancer Drugs Market by Country, 2010, 2015, 2018 & 2021
List of FiguresFigure 2.1 Leading Causes of Death Worldwide, 2008 & 2015
Figure 2.2 Most Common Cancers by Incidence, 2008
Figure 2.3 Most Common Cancers by Mortality, 2008
Figure 2.4 Most Common Cancers by Mortality, 2015
Figure 2.5 Five-Year Survival Rates of Nine Cancers in the UK, 2009
Figure 3.1 Small-Molecule Cancer Therapies Market: World Sales Forecast, 2010-2015
Figure 3.2 Small-Molecule Cancer Therapies Market: World Sales Forecast, 2016-2021
Figure 3.3 Small-Molecule Cancer Therapies: Sales for Leading Products, 2010
Figure 3.4 Small-Molecule Cancer Therapies: Sales for Leading Products, 2015
Figure 3.5 Small-Molecule Cancer Therapies: Sales for Leading Products, 2018
Figure 3.6 Small-Molecule Cancer Therapies: Sales for Leading Products, 2021
Figure 4.1 Leading National Small-Molecule Cancer Therapies: Market Forecasts, 2010-2021
Figure 4.2 National Small-Molecule Cancer Therapies: Market Forecasts, Lower Range, 2010-2021
Figure 4.3 Small-Molecule Cancer Therapies: Sales in Leading National Markets, 2010
Figure 4.4 Small-Molecule Cancer Therapies: Sales in Leading National Markets, 2015
Figure 4.5 Small-Molecule Cancer Therapies: Sales in Leading National Markets, 2018
Figure 4.6 Small-Molecule Cancer Therapies: Sales in Leading National Markets, 2021
Figure 5.1 Glivec/Gleevec Sales for US and RoW, 2010
Figure 5.2 Glivec/Gleevec Sales Forecast, 2010-2021
Figure 5.3 Revlimid Sales Forecast, 2010-2021
Figure 5.4 Alimta Sales for US and RoW, 2010
Figure 5.5 Alimta Sales Forecast, 2010-2021
Figure 5.6 Taxotere Sales by Region, 2010
Figure 5.7 Taxotere Sales Forecast, 2010-2021
Figure 5.8 Velcade Sales by Company, 2010
Figure 5.9 Velcade Sales Forecast, 2010-2021
Figure 5.10 Arimidex Sales by Region, Q1-Q3 2010
Figure 5.11 Arimidex Sales by Region, 2010
Figure 5.12 Arimidex Sales Forecast, 2010-2021
Figure 5.13 Tarceva Sales Forecast, 2010-2021
Figure 5.14 Sutent Sales Forecast, 2010-2021
Figure 5.15 Nexavar Sales Forecast, 2010-2021
Figure 5.16 Sprycel Sales for US and RoW, 2010
Figure 5.17 Sprycel Sales Forecast, 2010-2021
Figure 6.1 Number of Cancer Drug Pipeline Candidates by Indication, 2009 & 2011
Figure 9.1 Small-Molecule Cancer Therapies Market: World Sales Forecast, 2010, 2012, 2015, 2018 & 2021
Companies Listed4SC
AB Science
Abbott Laboratories
Abgenix
Abraxis BioScience
Acceleron
Ascenta Therapeutics
Acetylon
Actavis
ACT Biotech
Active Biotech
Adeona
AERES Biomedical
Aeterna Zentaris
Agennix
Alexion
Alza
Allos Therapeutics
American Society of Clinical Oncology (ASCO)
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