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  SMALL MOLECULE KINASE INHIBITORS
A Global Strategic Business Report

This report analyzes the Global Market for Small Molecule Kinase Inhibitors in Millions of US$ by the following Product Segments: Gleevec/Glivec, Tarceva, Sutent, Nexavar, Sprycel, Iressa, Tykerb/Tyverb, and Others. Annual forecasts are provided for the period 2006 through 2015. The report profiles 83 companies including many key and niche players worldwide such as Amgen, Inc., Asahi Kasei Pharma Corporation, AstraZeneca plc., Bayer Schering Pharma AG, Bristol-Myers Squibb Company, Celgene Corporation, Exelixis, Inc., F. Hoffmann-La Roche, Ltd., Chugai Pharmaceutical Co, Ltd., Genentech, Inc., GlaxoSmithKline plc., KAI Pharmaceuticals, Inc., Merck & Co., Inc., Mitsubishi Tanabe Pharma Corporation, Novartis International AG, Onyx Pharmaceuticals, Inc., OSI Pharmaceuticals, Inc., Pfizer, Inc., Takeda Pharmaceutical Company Limited, Millennium Pharmaceuticals Inc, S*Bio Pte Ltd., Sanofi-Aventis, Vertex Pharmaceuticals Incorporated, and Wyeth. Market data and analytics are derived from primary and secondary research. Company profiles are mostly extracted from URL research and reported select online sources.

CODE:    MCP-1723  PAGES:    558
PRICE:    $3950  DATE:       July 2009
COMPANIES:  83  MARKET DATA TABLES:   217
Due to the proprietary nature, our previews are offered only to manufacturers, top-tier management consultants, investment banks, and investment research groups.

 TABLE OF CONTENTS  
  SMALL MOLECULE KINASE INHIBITORS (Complete Report) Pages : 558   | $3950
I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS3$100
   Study Reliability and Reporting Limitations.....I-1  
   Disclaimers.....I-2  
   Data Interpretation & Reporting Level.....I-3
Quantitative Techniques & Analytics.....I-3
Product Definitions and Scope of Study.....I-3
  
II. EXECUTIVE SUMMARY72$3000
  1. INDUSTRY OVERVIEW.....II-128 $2850  
   Kinase Inhibitors Industry: A Prelude.....II-1
Understanding Kinase Inhibitors.....II-1
Drug Development Interest in Kinase Inhibitors Soars.....II-1
1$100
   Table 1: Clinical Phase Transition Percentage for Novel Kinase Inhibitor Compounds in Clinical Development - All Drugs Vs Kinase Inhibitors, During the Period (1995-2007) (includes corresponding Graph/Chart).....II-2
Protein Kinases As Potential Drug Targets: Opportunities Abound.....II-2
Kinase Profiling: The Backbone for pKi Drug Development.....II-2
1$300
   Developing Kinase Inhibitors.....II-3
Kinase Inhibitors: Huge Potential Envisaged in the Treatment of Cancer.....II-3
1$100
   Rising Incidences of Cancer & Unmet Treatment Needs: A Prime Driver.....II-4
Table 2: Global New Cases Registered and Total number of Deaths Resulting From Cancer (2007): Breakdown by Male and Female (In Million).....II-4
In the Cancer End-Use Market Growth Fundamentals Get Stronger .....II-4
Interest in Non-Cancer Therapies Gains Traction.....II-4
1$300
   Multi-Targeted Kinase Inhibitors: The Next Frontier.....II-5
Rising Incidences of Resistance Sparks Interest in Combination Drug Therapies.....II-5
1$100
   Single Vs Multi-Target Kinase Inhibitor Drugs.....II-6
Tough Regulatory Riders Threaten to Slow Down Number of Approvals.....II-6
1$100
   Spiraling Cost of Next Generation Cancer Drugs: A Cause for Concern.....II-7 1$100
   Table 3: Average Monthly Costs of Anti-Cancer Drugs (2007): Breakdown of Treatment Costs by Cancer Drug Brands - Rituxan, Erbitux, Revilimid, Avastin - High Dose, Avastin - Low Dose, Nexavar, Sutent, Herceptin, Gleevec, Tarceva, Tykerb, Iressa, Vectibix, Torisel and Targeted Therapies (In US$) for US, EU and Japan.....II-8
Adequate Reimbursements: Critical to Product Success in the Marketplace.....II-8
The Truth Behind Inadequate Reimbursement of New Cancer Drugs.....II-8
1$300
   Manufacturers Find Risk-Sharing, Rebating, & Contracting As Effective
  Antidotes.....II-9
1$100
   Financial-based Contracts.....II-10
Performance-based Contracts.....II-10
Reimbursements Issues in UK.....II-10
On Cards: Reimbursement for Pfizer’s Sutent in UK.....II-10
Reimbursement for GlaxoSmithKline’s Tyverb Hits a Roadblock in UK.....II-10
Reimbursements Issues in the United States.....II-10
Medicare Shifts Oral Anti Cancer Drugs to Higher Drug Formulary Tiers.....II-10
1$100
   Implications for the Patient.....II-11 1$100
   Table 4: Oral Anticancer Drugs Covered in Medicare Part D Plans (2009): Percentage Share Breakdown of Plans, Which Require Prior Authorization, & Plans, Which Have Quantity Limits, by Drug Brand (includes corresponding Graph/Chart).....II-12

Table 5: Oral Anticancer Drugs Covered in Medicare Part D Plans (2009): Breakdown of Cost Sharing Range by Drug Brand.....II-12
1$300
   Table 6: Placement of Select Oral Anticancer Drugs in the Drug Tier System Covered in Medicare Part D Plans for the Year 2009).....II-13
Transition of Oral Anti-Cancer Drugs to Higher Cost Sharing Tiers: Gleevec A Case in
  Point:.....II-13
Table 7: Percentage Breakdown of Beneficiaries Prescribed Gleevec and Covered Under Standalone Prescription Drug Plans (PDPs) by Tier For Years 2006 through 2009 (includes corresponding Graph/Chart).....II-13
1$300
   Table 8: Change in Percentage of Co-insurance Amount for Leading Oral Cancer Therapies Under Standalone Prescription Drug Plans (PDPs) (During 2006 to 2009) – For Gleevec, Tarceva, Sutent, and Tykerb (includes corresponding Graph/Chart).....II-14
Emergence of Newer Side effects: An Area of Concern for Modern pKis.....II-14
Hsp90 Inhibitors: Hope for Cancer Patients Resistant to Kinase Inhibitor
  Drugs.....II-14
1$300
   Noteworthy Issues Related to Major Drugs: An Evaluation of Pros and Cons.....II-15
Tussle Between Tasigna and Sprycel, to Break Into the Gleevec Empire.....II-15
1$100
   Table 9: A Review of the Effectiveness of Sprycel and Tasigna in the Treatment of Chronic Myeloid Leukaemia (CML): Percentage Breakdown of Efficiency Levels by Clinical Endpoints As a Measure of Patient Response (includes corresponding Graph/Chart) .....II-16
Challenges Ahead for Tykerb.....II-16
1$300
   Nexavar Shows Promise in the HCC Market.....II-171$100
   Key Statistical Findings.....II-18
Table 10: Global Tykerb Market (2007&2015): Percentage Breakdown of Revenue by Indication - Breast Cancer (HER2 positive) 1st, Breast Cancer (HER2 positive) 2nd, Breast Cancer (HER2 positive) 3rd, Breast Cancer (HER2 positive) Brain, H&N adjuvant, Gastric (HER2 positive) 2nd line and Adjuvant Breast (HER2 positive) (includes corresponding Graph/Chart).....II-18

Table 11: Tykerb Market (2009 & 2015): Percentage Breakdown of Dollar Sales by Region - US, Europe and Rest of World (includes corresponding Graph/Chart).....II-18
1$300
   Table 12: Global Sales of Iressa in the Treatment of NSCLC (2009E): Percentage Breakdown by First Line NSCLC, Second Line NSCLC and Third Line NSCLC (includes corresponding Graph/Chart).....II-19

Table 13: Global Sales of Nexavar (2009 & 2015P): Percentage Breakdown of Dollar Sales by Indication – Renal Cell Carcinoma, Hepato Cellular Carcinoma, Melanoma, and Non-small Cell Lung Cancer (includes corresponding Graph/Chart).....II-19
1$300
   Table 14: Global Sales of Nexavar (2009 & 2015P): Percentage Breakdown of Dollar Sales by Geographic Region/Country – United States, Europe, and Rest of World (includes corresponding Graph/Chart).....II-20

Table 15: Global Tarceva Market (2009 & 2015): Percentage Breakdown of Patient Penetration (%) in Treatment of First Line NSCLC, First line Maintenance Therapy following Avastin in NSCLC, Second line NSCLC, and Third line NSCLC, in the US and Rest of World Markets (includes corresponding Graph/Chart).....II-20
1$300
   Table 16: Canadian Healthcare Market (2007): Breakdown of Total Payments Made by Private and Public Insurers Towards Take Home Cancer Drugs (THCDs) by Select Drug Brands - Gleevec, Tarceva, Sutent, Nexavar, Sprycel, and Iressa (In US$ million) (includes corresponding Graph/Chart).....II-21

Table 17: Canadian Healthcare Market (2007&2008): Percentage Share Breakdown of Patient Claims Made for Small Molecule Kinase Inhibitors by Select Drug Brands – Gleevec, Tarceva, Sprycel, and Tasigna (includes corresponding Graph/Chart).....II-21
1$300
   Outlook.....II-22
Future Directions: The Shape of Things to Come.....II-22
Spotlight On HER3 Kinase Inhibitors to Overcome Resistance to EGFR & HER2 Kinase
  Inhibitors.....II-22
Ras-Raf-MEK-ERK: A New Kinase Pathway to Achieve Cell Cycle Arrest.....II-22
1$100
   Key Small Molecule pKis Under Different Stages of Clinical Trials.....II-232$200
   Pharmaceutical Industry: Review of the Present Scenario.....II-25
Developing Countries Hold the Key to Future Growth.....II-25
1$100
   Table 18: World Pharmaceutical Industry (2007): BRIC Nations (Brazil, Russia, India and China), & United States Ranked by Percentage Growth (includes corresponding Graph/Chart).....II-26
Consolidation Gets Underway.....II-26
1$300
   Landmark Deals Announced or Completed by Pharma and Biotech Companies Engaged in
  Developing Kinase Inhibitor Drugs, During the Year 2008 & 2009.....II-27
Impact of the Recession: An Unequivocal Review.....II-27
Recession Brings Drug Development Efforts Under Siege.....II-27
1$100
   Biotech Bankruptcies: Casualties On the Rise.....II-28
1$100
  2. KINASE INHIBITOR DRUGS: AN OVERVIEW.....II-2911 $800  
   Small Molecule Kinase Inhibitors: A Definition.....II-29
Imatinib (Gleevec®, Glivec® – Novartis).....II-29
Approvals.....II-29
Approvals Pending.....II-29
Erlotinib (Tarceva® - OSI Pharmaceuticals/ Genentech/ Roche).....II-29
1$100
   Approvals.....II-30
Approvals pending.....II-30
Related Clinical Trials.....II-30
Sunitinib (Sutent® - Pfizer).....II-30
Approvals.....II-30
1$100
   Related Clinical Trials.....II-31
Sorafenib (Nexavar™ - Bayer / Onyx).....II-31
Approvals.....II-31
Related Clinical Trials.....II-31
1$100
   Dasatinib (SPRYCEL® - Bristol-Myers Squibb).....II-32
Approvals.....II-32
Gefitinib (Iressa® - AstraZeneca).....II-32
Iressa®: A Controversial Anti-Cancer Drug.....II-32
1$100
   Approvals.....II-33
Approvals Pending.....II-33
Related Clinical Trials.....II-33
Key Ongoing Clinical Trials on Iressa.....II-33
Lapatinib (Tyverb® / Tykerb® - Glaxo SmithKline).....II-33
1$100
   Approvals.....II-34
Related Clinical Trials.....II-34
Temsirolimus (TORISEL™ - Wyeth).....II-34
Approvals.....II-34
Rapamycin (Rapamune® - Wyeth).....II-34
Approvals.....II-34
Nilotinib (Tasigna® - Novartis).....II-34
1$100
   Approvals.....II-35
Approvals Pending.....II-35
Related Clinical Trials.....II-35
Everolimus (Afinitor® - Novartis).....II-35
Approvals.....II-35
Approvals Pending.....II-35
Related Clinical Trials.....II-35
1$100
   Small Molecule Kinase Inhibitor Drugs In Pipeline.....II-36
Pazopanib (Glaxo SmithKline).....II-36
Approvals Pending.....II-36
Related Clinical Trials.....II-36
Vandetanib (Zactima® - AstraZeneca).....II-36
Related Clinical Trials.....II-36
1$100
   Cediranib (Recentin™ - AstraZeneca).....II-37
Related Clinical Trials.....II-37
Ridaforolimus (Merck/ ARIAD).....II-37
Related Clinical trials.....II-37
1$100
   Bosutinib (Wyeth).....II-38
Related Clinical Trials.....II-38
Alvocidib (Sanofi-Aventis).....II-38
Related Clinical Trials.....II-38
Motesanib (Amgen/ Takeda).....II-38
Related Clinical Trials.....II-38
1$100
   CP-690550 (Pfizer).....II-39
Related Clinical Trials.....II-39
1$100
  3. KINASE INHIBITORS: A RUDIMENTARY OVERVIEW.....II-407 $500  
   Kinase Inhibitors: A Definition.....II-40
Kinase Inhibitors Vs Monoclonal Antibodies (mAbs): A Comparison.....II-40
1$100
   Comparison of Various Pharmacological and Pharmacokinetic Parameters For Small
  Molecules and Monoclonal Antibodies.....II-41
Types of Protein Kinase Inhibitors: A Classification.....II-41
1$100
   Receptor Tyrosine Kinase (RTK) Inhibitors.....II-42
EGFR (Epidermal Growth Factor Receptor) Inhibitors.....II-42
HER2 Inhibitors.....II-42
VEGF (Vascular Endothelial Growth Factor) Inhibitors.....II-42
1$100
   FLT3 (Fms-like tyrosine kinase 3) Inhibitors.....II-43
Non- Receptor Tyrosine Kinase Inhibitors.....II-43
BCR-Abl Kinase Inhibitors.....II-43
Src Kinase Inhibitors.....II-43
1$100
   Janus (JAK) Kinase Inhibitors.....II-44
Serine-Threonine Kinase Inhibitors.....II-44
mTOR (Mammalian Target of Rapamycin) Inhibitors.....II-44
Rho Kinase Inhibitors.....II-44
1$100
   CDK (Cyclin Dependent Kinase) Inhibitors.....II-45
Protein Kinase C (PKC) Inhibitors.....II-45
PI3K (Phosphatidylinositol-3-Kinase) Inhibitors.....II-45
Aurora Kinase Inhibitors.....II-45
1$100
   MAP (Mitogen activated protein) / MEK Inhibitors.....II-46
JNK (C-JUN N-TERMINAL KINASE) INHIBITORS.....II-46
Others.....II-46
1$100
  4. CLINICAL DEVELOPMENTS AND PRODUCT LAUNCHES.....II-478 $600  
   KAI Initiates Third Phase IIa Trial for KAI-1678.....II-47
SuperGen Discovers a New Class of Kinase Inhibitors.....II-47
AVEO Joins Hands with Biogen to Develop and Market ErbB3-Targeted Antibodies.....II-47
1$100
   AVEO Identifies New Indication for AV-951 Triple VEGF Receptor Inhibitor.....II-48
GPC Biotech Demonstrates Role of Kinase Inhibitor in Multiple Myeloma
  Treatment.....II-48
MD Biosciences and PharmaGap Join Hands.....II-48
New JAK Inhibitor Drug from Pfizer Enters Phase III Trial.....II-48
1$100
   Millennium Commences Phase II Trials for MLN8237.....II-49
Astex Therapeutics Develops Structure of Cyclin Dependent Kinase 4.....II-49
Astex Teams up with Cancer Research UK on Clinical Trials of AT9283.....II-49
Astex Presents AT7519, a Cyclin Dependent Kinase Inhibitor.....II-49
1$100
   Cell Biosciences Unveils First Kits for Oncoprotein Analysis.....II-50
Plexxikon Partners with Roche to Develop and Commercialize PLX5568.....II-50
OSI Applies Additional NDA for Tarceva.....II-50
1$100
   KAI and BMS Forms Global Alliance on KAI-9803.....II-51
Kosan Biosciences Commences Phase II Trial for Alvespimycin.....II-51
Plexxikon Announces Commencement of Phase 1 PLX5568 Trial.....II-51
Exelixis Instigates Phase III XL184Trial.....II-51
1$100
   Oncothyreon Commences Phase I PX-866 Clinical Trial.....II-52
Iressa As Efficient as Chemotherapy for Lung Cancer.....II-52
Iressa Proves Useful for Non-smoker Patients.....II-52
GPC Biotech Commence Enrollment in Phase 1 RGB-286638 Trial.....II-52
AVEO Commences Phase I Clinical Trials of AV-951.....II-52
1$100
   Onyx and Bayer Secure FDA and EC Approval for Nexavar®.....II-53
Product Patent Application for Iressa Rejected.....II-53
OSI Pharmaceuticals to Launch Tarceva® in Japan.....II-53
1$100
   New Plk1 Kinase Inhibitor BI 2536 Developed.....II-54
Kinex Files IND Application for KX2-391.....II-54
Wyeth Receives FDA Approval for TORISEL for Advanced Renal Cancer Treatment.....II-54
Nexavar Gets Approval from Swiss Authorities for Treatment of Kidney Cancer
  (Switzerland).....II-54
1$100
  5. RECENT INDUSTRY ACTIVITY.....II-558 $600  
   Merck Agrees to Merge with Schering-Plough.....II-55
Pfizer Agrees to Acquire Wyeth.....II-55
S*BIO, Tragara Signs Exclusive Agreement.....II-55
GPC Biotech to Merge with Agennix.....II-55
1$100
   Sanofi-Aventis to acquire Bipar Sciences.....II-56
Pfizer Takes Over Serenex.....II-56
Roche to Acquire Piramed.....II-56
1$100
   Eli Lilly Acquires SGX Pharmaceuticals.....II-57
Takeda Acquires Millennium.....II-57
Eli Lilly Acquires ImClone Systems.....II-57
1$100
   Antisoma Acquires Xanthus.....II-58
Cellzome and GSK to Jointly Develop Kinase Inhibitors.....II-58
Deciphera Pharmaceuticals Partners with Eli Lilly in Oncology Therapy.....II-58
1$100
   ACT Biotech Agrees to Acquire the Under Clinical Stage Oncology Portfolio of Bayer
  Healthcare.....II-59
Cancer Research UK Enters into Clinical Development Agreement with AstraZeneca.....II-59
Daiichi and ArQule Enter into Product Development Agreement.....II-59
1$100
   Cellzome and GlaxoSmithKline Form Alliance.....II-60
Emiliem Enters into Agreement with NIH.....II-60
Astex and Janssen Pharmaceutica Form Alliance.....II-60
Millipore Launches Tyrosine Kinases Integrated with BioForm Technology.....II-60
1$100
   Aegera Therapeutics Takes over LymphoSign.....II-61
ARIAD and Merck Collaborate on AP23573.....II-61
Invitrogen Form Partnership with Emiliem.....II-61
1$100
   Pfizer Collaborate with Rigel, to Develop R343 as Treatment for Allergic
  Asthma.....II-62
1$100
  6. FOCUS ON SELECT PLAYERS.....II-638 $600  
   Amgen, Inc. (US).....II-63
Asahi Kasei Pharma Corporation (Japan).....II-63
AstraZeneca plc (UK).....II-63
Bayer Schering Pharma AG (Germany).....II-63
1$100
   Bristol-Myers Squibb Company (US).....II-64
Celgene Corporation (US).....II-64
Exelixis, Inc. (US).....II-64
1$100
   F. Hoffmann-La Roche, Ltd. (Switzerland).....II-65
Chugai Pharmaceutical Co, Ltd. (Japan).....II-65
Genentech, Inc. (US).....II-65
GlaxoSmithKline plc (UK).....II-65
1$100
   KAI Pharmaceuticals, Inc (USA).....II-66
Merck & Co., Inc (USA).....II-66
1$100
   Mitsubishi Tanabe Pharma Corporation (Japan).....II-67
Novartis International AG (Switzerland).....II-67
Onyx Pharmaceuticals, Inc. (US).....II-67
OSI Pharmaceuticals, Inc. (US).....II-67
1$100
   Pfizer, Inc. (US).....II-68
Takeda Pharmaceutical Company Limited (Japan).....II-68
Millennium Pharmaceuticals Inc (USA).....II-68
1$100
   S*Bio Pte Ltd (Singapore).....II-69
Sanofi-Aventis (France).....II-69
Vertex Pharmaceuticals Incorporated (US).....II-69
1$100
   Wyeth (US).....II-70
1$100
  7. GLOBAL MARKET PERSPECTIVE.....II-71   
   Table 19: World Recent Past, Current & Future Analysis for Kinase Inhibitors by Product Segment – Gleevec/Glivec, Tarceva, Sutent, Nexavar, Sprycel, Iressa, Tykerb/Tyverb and Others Independently Analyzed with Annual Sales Figures in US$ Million for Years 2006 through 2015 (includes corresponding Graph/Chart).....II-711$300
   Table 20: World 10-Year Perspective for Kinase Inhibitors by Product Segment – Percentage Breakdown of Dollar Sales for Gleevec/Glivec, Tarceva, Sutent, Nexavar, Sprycel, Iressa, Tykerb/Tyverb and Others For Years 2006, 2009 & 2015 (includes corresponding Graph/Chart).....II-721$300
III. COMPETITIVE LANDSCAPE 471$995
  
Total Companies Profiled: 83 (including Divisions/Subsidiaries - 95)

Region/Country                 Players


The United States                55
Canada                            5
Japan                             6
Europe                           26
     France                       1 
     Germany                      9
     The United Kingdom           6
     Rest of Europe              10 
Asia-Pacific (Excluding Japan)    3
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