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Non-Tyrosine Kinase Inhibitors in Oncology, 2015-2025

  • April 2015
  • -
  • Roots Analysis Private Ltd.
  • -
  • 316 pages

INTRODUCTION

Over decades, the oncology market has been led by surgery, chemotherapy and radiotherapy. The non-specificity of chemotherapy/radiotherapy and limitations of surgery has expanded the focus of many pharmaceutical companies to improve these treatments as well as discover novel cancer therapies with minimum toxic effects.

Targeted cancer therapy is an upcoming area gaining strong foothold in the industry and has already become the focus of a number of pharmaceutical companies. Different types of drugs/antibodies and mechanism of actions have been adopted to specifically target the cancer cells. Small molecule protein kinase inhibitors are a type of targeted therapy that involves small molecule drugs administered in the cancer patient for specifically targeting certain proteins, called kinases, involved in the growth of cancer cells. The approach can be broadly subdivided into two drug classes: tyrosine kinase inhibitors and non-tyrosine kinase inhibitors. The market currently is led by the former; however, several drugs are being developed to target non-tyrosine kinases such as mTOR, CDK, MEK and RAF.

In fact, non-tyrosine kinase inhibitors have gradually gained attention in the last few years. Amongst the marketed drugs, Nexavar and Afinitor have already achieved blockbuster status. With several new drugs under development, companies are also evaluating combination therapies of marketed drugs for the approved or additional oncological indications.

Apart from the bigger pharmaceutical companies such as Roche/Genentech, Eli Lilly, Novartis, Pfizer, AstraZeneca, several smaller/ start-up companies have shown their participation in this area. As the industry gains momentum, many companies have already benefitted by adopting the strategy of discovering the compounds and then out-licensing to bigger companies.

SCOPE OF THE REPORT

The “Non-Tyrosine Kinase Inhibitors in Oncology, 2015-2025” report provides a comprehensive analysis of the current market landscape and the future outlook of kinase inhibitors not specifically targeting tyrosine kinases. These include kinase inhibitors with activity against serine/threonine kinases, dual specificity kinases or both tyrosine and serine/threonine kinases being developed for oncological indications. Targeted therapy, specifically small molecule protein kinase inhibitors, has emerged as the new generation of cancer treatment that specifically targets only cancer cells. Although the market of protein kinase inhibitors is dominated by tyrosine kinase inhibitors, non-tyrosine kinase inhibitors (serine/threonine kinase inhibitors, dual specificity kinase inhibitors and drugs that inhibit both tyrosine and serine/threonine kinases) have gained a significant momentum in the last few years. There are total seven marketed non-tyrosine kinase inhibitors approved so far. Nexavar, the first drug of this type, received approval in 2005. Subsequently, Torisel (2007), Afinitor (2009), Zelboraf (2011), Tafinlar (2013), Mekinist (2013) and Ibrance (2015) were approved. The pipeline is rich and holds a significant potential for future.

Most of the non-tyrosine kinase inhibitors identified during our research target mTOR, CDK, RAF and MEK kinases. In addition, there are several novel non-tyrosine kinase inhibitors under development that target other serine/threonine and dual specificity kinases (e.g. PLK1, ERK, PIM, Chk kinases).

The report covers various aspects such as key players, marketed non-tyrosine kinase inhibitors, products in clinical / pre-clinical research, associated patents, likely future developments and upcoming opportunities for a variety of stakeholders.With the seven marketed drugs and several in late stage of development, the market is expected to grow at a healthy rate in the coming few years. The report elaborates and provides detailed sales forecasts of many promising drugs for the period 2015 – 2025. Owing to the relatively niche nature of the market, we have provided three market forecast scenarios to add robustness to our model. The conservative, base and optimistic scenarios represent three different tracks of industry evolution.

RESEARCH METHODOLOGY

Most of the data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include
§ Annual reports
§ Investor presentations
§ SEC filings
§ Industry databases
§ News releases from company websites
§ Government policy documents
§ Other analysts’ opinion reports

While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

CHAPTER OUTLINES

Chapter 2 presents an executive summary of the report. It offers a high level view on where the non-tyrosine kinase inhibitors market is headed in the mid-long term.

Chapter 3 provides a general introduction to cancer therapies. In this section, we have briefly discussed the conventional therapies being used for oncology treatment, the need and types of targeted therapy. The chapter then introduces protein kinase inhibitors, their classification and the list of all validated target kinases.

Chapter 4 provides a comprehensive landscape of the non-tyrosine kinase inhibitors market. This chapter briefly discusses the distribution of approved protein kinase inhibitors between both tyrosine and non-tyrosine kinase inhibitors. It also includes information on 140 non-tyrosine kinase inhibitors which are currently in different stages of development (both clinical and pre-clinical / discovery). The detailed analysis of this development pipeline highlights types of molecules, most commonly targeted sites, current phases of development and key players in this area.

Chapter 5 focuses on mTOR inhibitors and presents the current scenario and the future outlook of this specific class of inhibitors. The chapter includes detailed profiles of the marketed drugs and those in the later stages of development. We have presented information on several parameters such as history of development, clinical trial results, manufacturing, cost and reimbursement. It also includes the likely sales forecast of these drugs over the next ten years.

Chapter 6 focuses on CDK inhibitors and presents the current scenario and the future outlook of this specific class of inhibitors.As with the mTOR inhibitors, this chapter provides a holistic view on the various drugs and their future sales potential.

Chapter 7 focuses on RAF/MEK inhibitors and presents the current scenario and the future outlook of this specific class of inhibitors.As with the mTOR and CDK inhibitors, this chapter also provides detailed information on several parameters for various drugs and their future sales potential.

Chapter 8 focuses on novel non-tyrosine kinase inhibitors. As in the earlier three chapters, we have provided detailed drug profiles and analysis on the most common novel class of inhibitors.

Chapter 9 provides detailed company profiles of the leading players in the market. Each company profile includes information such as financial performance, geographical presence, marketed / pipeline drugs and recent collaborations and developments.

Chapter 10 is a collection of transcripts of interviews conducted during the course of this study.

Chapter 11 summarizes the overall report. In this chapter, we provide a recap of the key takeaways and our independent opinion based on the research and analysis described in previous chapters.

Chapter 12 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 13 provides the list of companies mentioned in the report.
EXAMPLE HIGHLIGHTS

1. Approximately 140 non-tyrosine kinase inhibitors are in different stages of development. In addition to the seven marketed drugs, nine are expected to be commercialized by 2017/2018. 70% of the pipeline drugs are in early stages of development. Most of the drugs being developed are serine/threonine kinase inhibitors.
2. In addition to the common drug classes (mTOR / CDK / RAF/ MEK inhibitors), many novel non tyrosine kinase inhibitors are also being developed. Overall, 35% of the pipeline drugs are based on these novel inhibitors; examples include AKT/ERK/PIM/PLK/Chk/Aurora kinase inhibitors.
3. Combination therapies are expected to act as the main driver of the market. Several drugs (both marketed and pipeline) are being evaluated as combination therapies. In fact, earlier this year, Ibrancereceived initial approval as a combination therapy. Another drug, cobimetinib, has been filed for initial NDA as combination therapy.
4. Currently, mTOR inhibitors (53%) and RAF/MEK inhibitors (46%) are the main contributors to the market.With the launch of additional drugs, CDK inhibitors are likely to gain significant ground; by 2025, we forecast CDK inhibitors to capture 33% of the market.
5. Apart from the well-established names, several small and new companies have gained foothold in the market. These include Onconova Therapeutics, Eternity Biosciences, Nerviano Medical Sciences, Cyclacel Pharmaceuticals, G1 Therapeutics, Tragara Pharmaceuticals, SignalRx, Jasco Pharmaceuticals, Tolero Pharma, Hanmi Pharma, CASI Pharma, Tekmira, Ability Pharma, Piqur, Verastem, Flexus, Erimos Pharma, Agennix, Taiho Pharma, OncoTherapy Science, ArQule, Advenchen Laboratories, Bionovo, Inflection Biosciences, Xcovery, Selvita Syros Pharma, Enzo Life Sciences Asana Biosciences, Allomek Therapeutics, ÆternaZentaris and Aptose Biosciences.
6. In addition to Nexavar and Afinitor, there are other drugs with the potential to achieve a blockbuster status; combined with a favourable regulatory regime, the overall opportunity could be significantly higher.

Table Of Contents

Non-Tyrosine Kinase Inhibitors in Oncology, 2015-2025
Table of Contents

1. PREFACE
1.1. Scope of the Report
1.2. Research Methodology
1.3. Chapter Outlines

2. EXECUTIVE SUMMARY

3. CANCER THERAPEUTICS AND TARGETED CANCER THERAPY
3.1. Chapter Overview
3.2. Cancer Therapy: History of Development
3.3. Targeted Therapy: Emerging Cancer Treatment
3.4. Classification of Targeted Cancer Therapy
3.4.1. By Mechanism of Action
3.4.2. By Product Class
3.5. Small Molecule Protein Kinase Inhibitors: Overview
3.5.1. Introduction to Protein Kinases
3.5.2. Chemical Activity of Protein Kinases
3.6. Small Molecule Protein Kinase Inhibitors: Classification by Type of Target Kinases
3.6.1. Tyrosine Kinase Inhibitors
3.6.2. Non-Tyrosine Kinase Inhibitors

4. NON-TYROSINE KINASE INHIBITORS: CURRENT MARKET LANDSCAPE
4.1. Chapter Overview
4.2. Protein Kinase Inhibitors in Oncology: Market Overview
4.3. Our Focus of Study: Non-Tyrosine Kinase Inhibitors in Oncology
4.3.1. Seven Approved Non-Tyrosine Kinase Inhibitors in Market
4.3.2. Clinical and Preclinical Pipeline Drugs
4.3.3. Non-Tyrosine Kinase Inhibitors: Distribution by Highest Phase of Development
4.3.4. Non-Tyrosine Kinase Inhibitors: Distribution by Type
4.3.5. Non-Tyrosine Kinase Inhibitors: Distribution by Target Sites
4.3.6. Non-Tyrosine Kinase Inhibitors: Distribution by Key Players
4.4. Future Outlook: Sales Forecast, 2015 - 2025
4.4.1. Scope and Forecast Methodology
4.4.2. Overall Market Size and Forecast

5. mTOR INHIBITORS: KEY MOLECULES AND FUTURE OUTLOOK
5.1. mTOR Inhibitors: Mechanism of Action
5.2. mTOR Inhibitors: Market Overview
5.3. mTOR Inhibitors: Pipeline Analysis
5.3.1. mTOR Inhibitors: Distribution by Highest Phase of Development
5.3.2. mTOR Inhibitors: Key Players

5.4. Torisel / Temsirolimus (Wyeth/Pfizer)
5.4.1. Introduction
5.4.2. History of Development
5.4.3. Orphan Drug Designation
5.4.4. Dosage Form, Dosing Regime, Pricing
5.4.5. Manufacturing
5.4.6. Patent Expiry
5.4.7. Reimbursement
5.4.8. Historical Sales
5.4.9. Current Development Status
5.4.10. Target Population
5.4.11. Torisel /Temsirolimus Sales Forecast, 2015 - 2025

5.5. Afinitor / Votubia /Everolimus (Novartis)
5.5.1. Introduction
5.5.2. History of Development
5.5.3. Orphan Drug Designation
5.5.4. Dosage Form, Dosing Regime, Pricing
5.5.5. Manufacturing
5.5.6. Reimbursement
5.5.7. Historical Sales
5.5.8. Current Development Status
5.5.9. Target Population
5.5.10. Afinitor / Votubia / Everolimus Sales Forecast, 2015- 2025
5.6. mTOR Inhibitors: Roots Analysis' Perspective

6. CDK INHIBITORS: KEY MOLECULES AND FUTURE OUTLOOK
6.1. CDK Inhibitors: Mechanism of Action
6.2. CDK Inhibitors: Market Overview
6.3. CDK Inhibitors: Pipeline Analysis
6.3.1. CDK Inhibitors: Distribution by Highest Phase of Development
6.3.2. CDK Inhibitors: Key Players

6.4. Ibrance / Palbociclib (Pfizer)
6.4.1. Introduction
6.4.2. Collaboration with Onyx (Amgen)
6.4.3. History of Development
6.4.4. Dosage Form, Dosage Regime, Pricing
6.4.5. Key Clinical Trial Results
6.4.6. Current Development Status
6.4.7. Target Population
6.4.8. Ibrance/Palbociclib Sales Forecast, 2015 - 2025

6.5. Abemaciclib / LY2835219 (Eli Lilly)
6.5.1. Introduction
6.5.2. Key Clinical Trial Results
6.5.2.1. Phase II Study Results
6.5.2.2. Phase I Study Results
6.5.3. Current Development Status
6.5.4. Target Population
6.5.5. Abemaciclib/LY2835219 Sales Forecast, 2017 - 2025

6.6. Ribociclib / LEE011 (Novartis)
6.6.1. Introduction
6.6.2. Collaboration with Astex
6.6.3. Current Development Status
6.6.4. Key Clinical Trial Results
6.6.5. Target Population
6.6.6. Protecting the Breast Cancer Franchise
6.6.7. Ribociclib/ LEE011 Sales Forecast, 2017 - 2025
6.7. CDK Inhibitors: RootsAnalysis' Perspective

7. RAF / MEK INHIBITORS: KEY MOLECULES AND FUTURE OUTLOOK
7.1. RAF / MEK Inhibitors: Mechanism of Action
7.2. RAF / MEK Inhibitors: Market Overview
7.3. RAF /MEK Inhibitors: Pipeline Analysis
7.3.1. MAPK/ERK Signaling Pathway Inhibitors: Distribution by Target Kinases (RAF or MEK)
7.3.2. RAF Inhibitors: Distribution by Highest Phase of Development
7.3.3. MEK Inhibitors: Distribution by Highest Phase of Development
7.3.4. RAF/MEK Inhibitors: Key Players

7.4. Nexavar / Sorafenib (Bayer and Onyx)
7.4.1. Introduction
7.4.2. Bayer and Onyx Collaboration
7.4.3. History of Development
7.4.4. Patent Expiry and Litigations
7.4.5. Orphan Drug Designation
7.4.6. Dosage Form, Dosing Regime and Pricing
7.4.7. Historical Sales
7.4.8. Reimbursement
7.4.9. Manufacturing
7.4.10. Current Development Status
7.4.11. Target Population
7.4.12. Nexavar/Sorafenib Sales Forecast, 2015 - 2025

7.5. Zelboraf / Vemurafenib (Daiichi-Sankyo and Roche)
7.5.1. Introduction
7.5.2. History of Development
7.5.3. Orphan Drug Designation
7.5.4. Dosage Form, Dosage Regime and Pricing
7.5.5. Reimbursement
7.5.6. Manufacturing
7.5.7. Historical Sales
7.5.8. Current Development Status
7.5.9. Target Population
7.5.10. Zelboraf /Vemurafenib Sales Forecast, 2015 - 2025

7.6. Tafinlar / Dabrafenib (GSK/Novartis)
7.6.1. GSK and Novartis Collaboration
7.6.2. History of Development
7.6.3. Orphan Drug Designations
7.6.4. Manufacturing
7.6.5. Dosage Form, Dosing Regime, Pricing
7.6.6. Reimbursement
7.6.7. Historical Sales
7.6.8. Current Development Status
7.6.9. Target Population
7.6.10. Tafinlar/Dabrafenib Sales Forecast, 2015 - 2025

7.7. Encorafenib / LGX818 (Array BioPharma)
7.7.1. Introduction
7.7.2. Agreement with Novartis
7.7.3. Key Clinical Trial Results
7.7.4. Current Status of Development
7.7.5. Target Population
7.7.6. Encorafenib// LGX818 Sales Forecast, 2018- 2025

7.8. Mekinist / Trametinib (GSK/Novartis)
7.8.1. Introduction
7.8.2. GSK and Novartis Collaboration
7.8.3. History of Development
7.8.4. Orphan Drug Designation
7.8.5. Manufacturing
7.8.6. Dosage Form, Dosing Regime and Pricing
7.8.7. Reimbursement
7.8.8. Historical Sales
7.8.9. Current Development Status
7.8.10. Target Population
7.8.11. Mekinist/ Trametinib Sales Forecast, 2015 - 2025

7.9. Binimetinib / MEK162/ARRY-162 (Array BioPharma)
7.9.1. Introduction
7.9.2. Array and Novartis Collaboration
7.9.3. Key Clinical Trial Results
7.9.3.1. Phase II Results
7.9.4. Current Development Status
7.9.4.1. Phase III Study Data
7.9.5. Target Population
7.9.6. Binimetinib / MEK162/ARRY-162 Sales Forecast, 2017 - 2025

7.10. Cobimetinib / GDC-0973 / XL518 (Roche/Genentech)
7.10.1. Introduction
7.10.2. Collaboration with Exelixis
7.10.3. History of Development
7.10.4. Key Clinical Trial Data
7.10.5. Current Development Status
7.10.6. Target Population
7.10.7. Cobimetinib / GDC-0973 / XL518 Sales Forecast, 2016 - 2025

7.11. Selumetinib / ARRY-886/ AZD6244 (AstraZeneca)
7.11.1. Agreement with Array BioPharma
7.11.2. AstraZeneca's Key to Expand Their Presence in NSCLC Market
7.11.3. Current Development Status
7.11.4. Key Clinical Trial Results
7.11.5. Target Population
7.11.6. Selumetinib / ARRY-886/ AZD6244 Sales Forecast, 2016 - 2025
7.12. RAF/MEK Inhibitors: Roots Analysis' Perspective
8. NOVEL NON-TYROSINE KINASE INHIBITORS: KEY MOLECULES AND FUTURE OUTLOOK
8.1. Chapter Overview
8.2. Novel Non-Tyrosine Kinase Inhibitors: Pipeline Analysis
8.2.1. Novel Non-Tyrosine Kinase Inhibitors: Distribution by Target Kinases
8.2.2. Novel Non-Tyrosine Kinase Inhibitors: Distribution by Highest Phase of Development

8.3. Midostaurin / PKC412 / CGP 41251 / CGP 41231 (Novartis)
8.3.1. Introduction
8.3.2. History of Development
8.3.3. Key Clinical Study Data
8.3.4. Current Status of Development
8.3.5. Target Population
8.3.6. Midostaurin / PKC412 / CGP 41251 / CGP 41231 Sales Forecast, 2016 - 2025

8.4. Estybon / Rigosertib (Onconova Therapeutics)
8.4.1. Introduction
8.4.2. Agreement with Baxter
8.4.3. Key Clinical Trial Results
8.4.4. Current Status of Development
8.4.5. Target Population
8.4.6. Estybon / Rigosertib Sales Forecast, 2017 - 2025

8.5. Volasertib / BI 6727 (Boehringer Ingelheim)
8.5.1. Introduction
8.5.2. History of Development
8.5.3. Key Clinical Trial Results
8.5.4. Current Status of Development
8.5.5. Target Population
8.5.6. Volasertib / BI 6727 Sales Forecast, 2016 - 2025
8.6. Novel Non-Tyrosine Kinase Inhibitors: RootsAnalysis' Perspective

9. COMPANY PROFILES
9.1. Roche
9.1.1. Company Overview
9.1.2. Financial Performance
9.1.3. Non-Tyrosine Kinase Inhibitors Pipeline
9.1.4. Collaborations

9.2. Eli Lilly
9.2.1. Company Overview
9.2.2. Financial Performance
9.2.3. Non-Tyrosine Kinase Inhibitor Pipeline
9.2.4. Collaborations

9.3. Novartis
9.3.1. Company Overview
9.3.2. Financial Performance
9.3.3. Non-Tyrosine Kinase Inhibitors Pipeline
9.3.4. Collaborations

9.4. Array BioPharma
9.4.1. Company Overview
9.4.2. Financial Performance
9.4.3. Non-Tyrosine Kinase Inhibitors Pipeline
9.4.4. Collaborations

9.5. Nerviano Medical Sciences
9.5.1. Company Overview
9.5.2. Non-Tyrosine Kinase Inhibitors Pipeline
9.5.3. Collaborations

9.6. Cyclacel Pharmaceuticals
9.6.1. Company Overview
9.6.2. Financial Overview
9.6.3. Non-Tyrosine Kinase Inhibitors Pipeline

9.7. Daiichi Sankyo
9.7.1. Company Overview
9.7.2. Financial Performance
9.7.3. Non-Tyrosine Kinase Inhibitors Pipeline

9.8. Onconova Therapeutics
9.8.1. Company Overview
9.8.2. Financial Performance
9.8.3. Non-Tyrosine Kinase Inhibitors Pipeline
9.8.4. Collaborations

9.9. AstraZeneca
9.9.1. Company Overview
9.9.2. Financial Performance
9.9.3. Non-Tyrosine Kinase Inhibitors Pipeline
9.9.4. Collaborations

9.10. GlaxoSmithKline (GSK)
9.10.1. Company Overview
9.10.2. Financial Performance
9.10.3. Non-Tyrosine Kinase Inhibitors Pipeline
9.10.4. Collaborations

9.11. Pfizer
9.11.1. Company Overview
9.11.2. Financial Performance
9.11.3. Non-Tyrosine Kinase Inhibitors Pipeline
9.11.4. Collaborations

9.12. Merck KGaA
9.12.1. Company Overview
9.12.2. Financial Performance
9.12.3. Non-Tyrosine Kinase Inhibitors Pipeline
9.12.4. Collaborations

9.13. Astex Pharmaceuticals
9.13.1. Company Overview
9.13.2. Financial Performance
9.13.3. Non-Tyrosine Kinase Inhibitors Pipeline

9.14. Carna Biosciences
9.14.1. Company Overview
9.14.2. Financial Overview
9.14.3. Non-Tyrosine Kinase Inhibitors Pipeline
9.14.4. Collaborations

9.15. Celgene Corporation
9.15.1. Company Overview
9.15.2. Financial Performance
9.15.3. Non-Tyrosine Kinase Inhibitors Pipeline

9.16. Eternity Bioscience
9.16.1. Company Overview
9.16.2. Non-Tyrosine Kinase Inhibitors Pipeline

9.17. Jasco Pharmaceuticals
9.17.1. Company Overview
9.17.2. Non-Tyrosine Kinase Inhibitors Pipeline
9.17.3. Collaborations

10. INTERVIEW TRANSCRIPTS
10.1 Interview 1: Joseph R. Garlich, Chief Scientific Officer, SignalRx Pharmaceuticals
10.2 Interview 2: Gregory J. Mossinghoff, Chief Business Officer, G1 Therapeutics
10.3 Interview 3: Christopher C. LeMasters, Chief Business Officer, Tragara Pharmaceuticals

11. CONCLUSION
11.1. A New Generation of Cancer Treatment with Broad Therapeutic Window
11.2. mTOR, CDK, RAF, MEK Kinases are the Most Common Non-Tyrosine Kinases Being Targeted
11.3. Combination Therapies Likely To Be The Key To Future Success
11.4. Overall Opportunity is Big; We Project a 9% Growth in Our ‘Base' Scenario
11.5. Concluding Remarks

12. APPENDIX 1: Tabulated Data

13. APPENDIX 2: List of Companies and Organizations

List of Figures

Figure 3.1 Types of Cancer Therapies
Figure 3.2 Targeted Cancer Therapy: Classification by Product Class
Figure 4.1 Approved Protein Kinase Inhibitors, 2001-2015
Figure 4.2 Marketed Protein Kinase Inhibitors: Distribution by Type of Target Kinases
Figure 4.3 Non-Tyrosine Kinase Inhibitors: Distribution by Highest Phase of Development
Figure 4.4 Non-Tyrosine Kinase Inhibitors: Distribution by Type
Figure 4.5 Non-Tyrosine Kinase Inhibitors: Distribution by Target Sites
Figure 4.6 Non-Tyrosine Kinase Inhibitors: Distribution by Key Players
Figure 4.7 Non-Tyrosine Kinase Inhibitors: Overall Sales Forecast, 2015 - 2025: Base Scenario (USD Million)
Figure 4.8 Non-Tyrosine Kinase Inhibitors Market, Share of Specific Drug Classes: Base Scenario 2015, 2020 and 2025
Figure 5.1 mTOR Inhibitors: Distribution by Highest Phase of Development
Figure 5.2 Torisel /Temsirolimus Sales Forecast, 2015-2025: Base Scenario
(USD Million)
Figure 5.3 Afinitor / Votubia/Everolimus Sales, 2009-2014 (USD Million)
Figure 5.4 Afinitor / Votubia / Everolimus Sales Forecast, 2015-2025: Base Scenario (USD Million)
Figure 5.5 mTOR Inhibitors: Drivers and Restraints
Figure 5.6 Overall mTOR Inhibitors Market, 2015-2025: Base Scenario (USD Million)
Figure 6.1 CDK Inhibitors: Distribution by Highest Phase of Development
Figure 6.2 Ibrance/Palbociclib Sales Forecast, 2015-2025: Base Scenario (USD Million)
Figure 6.3 Abemaciclib / LY2835219 Sales Forecast, 2017-2025: Base Scenario
(USD Million)
Figure 6.4 Ribociclib/LEE011 Sales Forecast, 2017-2025: Base Scenario (USD Million)
Figure 6.5 CDK Inhibitors: Drivers and Restraints
Figure 6.6 Overall CDK Inhibitors Market, 2015-2025: Base Scenario (USD Million)
Figure 7.1 MAPK/ERK Signaling Pathway Inhibitors: Distribution by Target Kinases (RAF or MEK)
Figure 7.2 RAF Inhibitors: Distribution by Highest Phase of Development
Figure 7.3 MEK Inhibitors: Distribution by Highest Phase of Development
Figure 7.4 RAF/MEK Inhibitors: Key Players
Figure 7.5 Nexavar Worldwide Sales, 2006-2013: By Bayer (EUR Million)
Figure 7.6 Nexavar/Sorafenib Sales Forecast, 2015-2025: Base Scenario (USD Million)
Figure 7.7 Zelboraf/Vemurafenib Sales, 2011-2014 (CHF Million)
Figure 7.8 Zelboraf/Vemurafenib Sales Forecast, 2015-2025: Base Scenario
(USD Million)
Figure 7.9 Tafinlar/Dabrafenib Sales, 2014 (EUR Million): Distribution by Region
Figure 7.10 Tafinlar/Dabrafenib Sales Forecast, 2015-2025: Base Scenario (USD Million)
Figure 7.11 Encorafenib/LGX818 Sales Forecast, 2018-2025: Base Scenario
(USD Million)
Figure 7.12 Mekinist/Trametinib Sales Forecast, 2015-2025: Base Scenario (USD Million)
Figure 7.13 Binimetinib/ MEK162/ARRY-162 Sales Forecast, 2017-2025: Base Scenario (USD Million)
Figure 7.14 Cobimetinib / GDC-0973 / XL518 Sales Forecast, 2016-2025: Base Scenario (USD Million)
Figure 7.15 Selumetinib / ARRY-886/ AZD6244 Sales Forecast, 2017-2025: Base Scenario (USD Million)
Figure 7.16 RAF/MEK Inhibitors: Drivers and Restraints
Figure 7.17 Overall RAF/MEK Inhibitors Market, 2015-2025: Base Scenario
(USD Million)
Figure 8.1 Novel Non-Tyrosine Kinase Inhibitors: Distribution by Target Kinases
Figure 8.2 Novel Non-Tyrosine Kinase Inhibitors: Distribution by Highest Phase of Development
Figure 8.3 Midostaurin / PKC412 / CGP 41251 / CGP 41231 Sales Forecast, 2016-2025: Base Scenario (USD Million)
Figure 8.4 Estybon/Rigosertib Sales Forecast, 2017-2025: Base Scenario (USD Million)
Figure 8.5 Volasertib / BI 6727 Sales Forecast, 2016-2025: Base Scenario (USD Million)
Figure 8.6 Novel Non-Tyrosine Kinase Inhibitors: Drivers and Restraints
Figure 8.7 Overall Novel Non-Tyrosine Kinase Inhibitors Market, 2016-2025: Base Scenario (USD Million)
Figure 9.1 Roche Revenues, 2009-2014 (CHF Billion)
Figure 9.2 Roche Revenues: Distribution by Business Segments, 2011- 2014
(CHF Billion)
Figure 9.3 Roche Pharmaceutical Revenues: Distribution by Therapeutic Areas, 2014 (CHF Billion)
Figure 9.4 Eli Lilly Revenues, 2009- 2014 (USD Million, %)
Figure 9.5 Eli Lilly Revenues: Distribution by Business Segments, 2013-2014
(USD Million, %)
Figure 9.6 Eli Lilly Human Pharmaceutical Segment Revenues: Distribution by Operating Segments, 2013- 2014 (USD Million, %)
Figure 9.7 Novartis Revenues, 2009-2013 (USD Billion, %)
Figure 9.8 Novartis Revenues: Distribution by Business Segments, 2014 (USD Billion)
Figure 9.9 Array BioPharma Revenues, FY 2010-2014 (USD Million)
Figure 9.10 Cyclacel Pharmaceuticals Revenues, 2011-2014 (USD Million)
Figure 9.11 Daiichi Sankyo Revenues, 2009 - Q3 2014 (JPY Million,%)
Figure 9.12 Onconova Therapeutics Revenues, FY 2011-FY 2014(USD Million)
Figure 9.13 AstraZeneca Revenues, FY 2009-2014(USD Million)
Figure 9.14AstraZeneca Revenues: Distribution by Therapeutic Areas, 2013-2014
(USD Billion)
Figure 9.15 GSK Annual Revenues, 2009-2014 (GBP Billion, %)
Figure 9.16 GSK Pharmaceutical Revenues: Distribution by Business Domains 2014, (GBP Billion)
Figure 9.17 Pfizer Revenues, 2011-2014 (USD Million)
Figure 9.18 Pfizer Revenues: Distribution by Business Segments, 2014 (USD Million)
Figure 9.19 Pfizer Revenues: Distribution by Therapeutic Areas, 2013-2014, (USD ‘000)
Figure 9.20 Merck Group Revenues, 2009- 2014 (EUR Million, %)
Figure 9.21 Merck Revenues: Distribution by Business Divisions, 2013- 2014
(EUR Million)
Figure 9.22 Astex Pharmaceuticals Revenues, 2008-2012 (USD Million)
Figure 9.23 Carna Biosciences Revenues, 2010-2014 (JPY Million)
Figure 9.24 Celgene Annual Revenues, 2009-2014 (USD Million)
Figure 11.1 Non-Tyrosine Kinase Inhibitors Market (USD Million), 2015, 2020 and 2025

List of Tables

Table 3.1 Receptor Tyrosine Kinases: Subfamilies and Members
Table 3.2 Non-Receptor Tyrosine Kinases: Subfamilies and Members
Table 3.3 Serine/Threonine Kinases: Subfamilies and Members
Table 3.4 Dual Specificity Kinases: Subfamilies and Members
Table 4.1 Protein Kinase Inhibitors in Oncology: Marketed Drugs
Table 4.2 Non-Tyrosine Kinase Inhibitors: Clinical and Preclinical Pipeline, 2015
Table 4.3 Non-Tyrosine Kinase Inhibitors: Current Development Phase and Expected Launch Year of Drugs
Table 5.1 Pipeline of mTOR Inhibitors, 2015
Table 5.2 Torisel/Temsirolimus: Orphan Drug Designations by FDA
Table 5.3 Torisel/Temsirolimus: Orphan Drug Designations by EMA
Table 5.4 Torisel/Temsirolimus: Current Status of Development
Table 5.5 Afinitor/Votubia /Everolimus: Orphan Drug Designations by FDA
Table 5.6 Afinitor/Votubia /Everolimus: Orphan Drug Designations by EMA
Table 5.7 Afinitor / Votubia / Everolimus: Current Status of Development
Table 6.1 Pipeline of CDK Inhibitors, 2015
Table 6.2 Ibrance/Palbociclib: Ongoing / Planned Clinical Trials
Table 6.3 Abemaciclib/LY2835219: Ongoing / Planned Clinical Trials
Table 6.4 Ribociclib/LEE011: Ongoing / Planned Clinical Trials
Table 7.1 Pipeline of RAF Inhibitors, 2015
Table 7.2 Pipeline of MEK Inhibitors, 2015
Table 7.3 Nexavar/Sorafenib: Orphan Drug Designations by FDA
Table 7.4 Nexavar/Sorafenib: Orphan Drug Designations by EMA
Table 7.5 Nexavar/Sorafenib: Current Status of Development
Table 7.6 Zelboraf/Vemurafenib: Orphan Drug Designations by FDA
Table 7.7 Zelboraf/Vemurafenib: Current Status of Development
Table 7.8 Tafinlar/Dabrafenib: Orphan Drug Designations by FDA
Table 7.9 Tafinlar/Dabrafenib: Current Status of Development
Table 7.10 Encorafenib/LGX818: Ongoing/Planned Clinical Trials
Table 7.11 Mekinist/Trametinib: Orphan Drug Designations by FDA
Table 7.12 Mekinist/Trametinib: Current Status of Development
Table 7.13 Binimetinib/ MEK162/ARRY-162: Ongoing / Planned Clinical Trials
Table 7.14 Cobimetinib/ GDC-0973 / XL518: Ongoing / Planned Clinical Trials
Table 7.15 Selumetinib/ ARRY-886/ AZD6244: Ongoing / Planned Clinical Trials
Table 8.1 Pipeline of Other NovelNon-Tyrosine Kinase Inhibitors, 2015
Table 8.2 Midostaurin/ PKC412 / CGP 41251 / CGP 41231: Ongoing / Planned Clinical Trials
Table 8.3 Estybon/Rigosertib: Ongoing Clinical Trials
Table 8.4 Volasertib/ BI 6727: Ongoing / Planned Clinical Trials
Table 9.1 Roche Non-Tyrosine Kinase Inhibitors Pipeline, 2015
Table 9.2 Eli Lilly Non-Tyrosine Kinase Inhibitors Pipeline, 2015
Table 9.3 Novartis Non-Tyrosine Kinase Inhibitors Pipeline, 2015
Table 9.4 Array BioPharma Non-Tyrosine Kinase Inhibitors Pipeline, 2015
Table 9.5 Nerviano Medical Sciences Non-Tyrosine Kinase Inhibitors Pipeline, 2015
Table 9.6 CyclacelPharmaceuticals Non-Tyrosine Kinase Inhibitors Pipeline, 2015
Table 9.7 Daiichi Sankyo Non-Tyrosine Kinase Inhibitors Pipeline,2015
Table 9.8 Onconova Therapeutics Non-Tyrosine Kinase Inhibitors Pipeline, 2015
Table 9.9 AstraZeneca Non-Tyrosine Kinase Inhibitors Pipeline, 2015
Table 9.10 GSK Non-Tyrosine Kinase inhibitors Pipeline, 2015
Table 9.11 Pfizer Non-Tyrosine Kinase Inhibitor Pipeline, 2015
Table 9.12 Merck KGaANon-Tyrosine Kinase Inhibitor Pipeline, 2015
Table 9.13 AstexPharmaceuticals Non-Tyrosine Kinase Inhibitors Pipeline, 2015
Table 9.14 Carna Biosciences Non-Tyrosine Kinase Inhibitors Pipeline, 2015
Table 9.15 Celgene Non-Tyrosine Kinase Inhibitors Pipeline,2015
Table 9.16 Eternity Bioscience Non-Tyrosine Kinase Inhibitors Pipeline, 2015
Table 9.17 Jasco Pharmaceuticals Non-Tyrosine Kinase Inhibitors Pipeline, 2015
Table 12.1 Marketed Protein Kinase Inhibitors: Distribution by Type of Target Kinases
Table 12.2 Non-Tyrosine Kinase Inhibitors: Distribution by Highest Phase of Development
Table 12.3 Non-Tyrosine Kinase Inhibitors: Distribution by Type
Table 12.4 Non-Tyrosine Kinase Inhibitors: Distribution by Target Sites
Table 12.5 Non-Tyrosine Kinase Inhibitors: Distribution by Key Players
Table 12.6 Non-Tyrosine Kinase Inhibitors: Overall Sales Forecast 2015 - 2025: Base Scenario (USD Million)
Table 12.7 Non-Tyrosine Kinase Inhibitors Market, Share of Specific Drug Classes: Base Scenario 2015, 2020 and 2025
Table 12.8 mTOR Inhibitors: Distribution by Highest Phase of Development
Table 12.9 ToriselSales Forecast, 2015-2025: Base Scenario (USD Million)
Table 12.10 ToriselSales Forecast, 2015-2025: Conservative Scenario (USD Million)
Table 12.11 ToriselSales Forecast, 2015-2025: Optimistic Scenario (USD Million)
Table 12.12 Afinitor / Votubia/Everolimus Sales, 2009-2014 (USD Million)
Table 12.13 Afinitor Sales Forecast, 2015-2025: Base Scenario (USD Million)
Table 12.14 Afinitor Sales Forecast, 2015-2025: Conservative Scenario (USD Million)
Table 12.15 Afinitor Sales Forecast, 2015-2025: Optimistic Scenario (USD Million)
Table 12.16 Overall mTOR Inhibitors Market, 2015-2025: Base Scenario (USD Million)
Table 12.17 Overall mTOR Inhibitors Market, 2015-2025: Conservative Scenario (USD Million)
Table 12.18 Overall mTOR Inhibitors Market, 2015-2025: Optimistic Scenario (USD Million)
Table 12.19 CDK Inhibitors: Distribution by Highest Phase of Development
Table 12.20 Ibrance Sales Forecast, 2015-2025: Base Scenario (USD Million)
Table 12.21 Ibrance Sales Forecast, 2015-2025: Conservative Scenario (USD Million)
Table 12.22 Ibrance Sales Forecast, 2015-2025: Optimistic Scenario (USD Million)
Table 12.23 Abemaciclib Sales Forecast, 2017-2025: Base Scenario (USD Million)
Table 12.24 Abemaciclib Sales Forecast, 2017-2025: ConservativeBase Scenario
(USD Million)
Table 12.25 Abemaciclib Sales Forecast, 2017-2025: Optimistic Scenario (USD Million)
Table 12.26 Ribociclib/LEE011 Sales Forecast, 2017-2025: Base Scenario (USD Million)
Table 12.27 Ribociclib/LEE011 Sales Forecast, 2017-2025: Conservative Scenario
(USD Million)
Table 12.28 Ribociclib/LEE011 Sales Forecast, 2017-2025: Optimistic Scenario (USD Million)
Table 12.29 Overall CDK Inhibitors Market, 2015-2025: Base Scenario (USD Million)
Table 12.30 Overall CDK Inhibitors Market, 2015-2025: Conservative Scenario (USD Million)
Table 12.31 Overall CDK Inhibitors Market, 2015-2025: Optimistic Scenario (USD Million)
Table 12.32 MAPK/ERK Signaling Pathway Inhibitors: Distribution by Target Kinases (RAF or MEK)
Table 12.33 RAF Inhibitors: Distribution by Highest Phase of Development
Table 12.34 MEK Inhibitors: Distribution by Highest Phase of Development
Table 12.35 RAF/MEK Inhibitors: Key Players
Table 12.36 Nexavar Worldwide Sales, 2006-2013: By Bayer (EUR Million)
Table 12.37 Nexavar/Sorafenib Sales Forecast, 2015-2025: Base Conservative Scenario (USD Million)
Table 12.38 Nexavar/Sorafenib Sales Forecast, 2015-2025: Conservative Scenario (USD Million)
Table 12.39 Nexavar/Sorafenib Sales Forecast, 2015-2025: Optimistic Scenario (USD Million)
Table 12.40 Zelboraf/Vemurafenib Sales, 2011-2014 (CHF Million)
Table 12.41 Zelboraf/Vemurafenib Sales Forecast, 2015-2025: Base Scenario
(USD Million)
Table 12.42 Zelboraf/Vemurafenib Sales Forecast, 2015-2025: Conservative Scenario (USD Million)
Table 12.43 Zelboraf/Vemurafenib Sales Forecast, 2015-2025: Optimistic Scenario (USD Million)
Table 12.44 Tafinlar/ Dabrafenib Sales, 2014 (EUR Million): Distribution by Region
Table 12.45 Tafinlar/Dabrafenib Sales Forecast, 2015-2025: Base Scenario (USD Million)
Table 12.46 Tafinlar/Dabrafenib Sales Forecast, 2015-2025: Conservative Scenario (USD Million)
Table 12.47 Tafinlar/Dabrafenib Sales Forecast, 2015-2025: Optimistic Scenario (USD Million)
Table 12.48 Encorafenib/ LGX818 Sales Forecast, 2018-2025: Base Scenario (USD Million)
Table 12.49 Encorafenib/ LGX818 Sales Forecast, 2018-2025: Conservative Scenario (USD Million)
Table 12.50 Encorafenib/ LGX818 Sales Forecast, 2018-2025: Optimistic Scenario (USD Million)
Table 12.51 Mekinist/Trametinib Sales Forecast, 2015-2025: Base Scenario (USD Million)
Table 12.52 Mekinist/Trametinib Sales Forecast, 2015-2025: Conservative Scenario (USD Million)
Table 12.53 Mekinist/Trametinib Sales Forecast, 2015-2025: Optimistic Scenario (USD Million)
Table 12.54 Binimetinib/ MEK162/ARRY-162 Sales Forecast, 2017-2025: Base Scenario (USD Million)
Table 12.55 Binimetinib/ MEK162/ARRY-162 Sales Forecast, 2017-2025: Conservative Scenario (USD Million)
Table 12.56 Binimetinib/ MEK162/ARRY-162 Sales Forecast, 2017-2025: Optimistic Scenario (USD Million)
Table 12.57 Cobimetinib / GDC-0973 / XL518 Sales Forecast, 2016-2025: Base Scenario (USD Million)
Table 12.58 Cobimetinib / GDC-0973 / XL518 Sales Forecast, 2016-2025: Conservative Scenario (USD Million)
Table 12.59 Cobimetinib / GDC-0973 / XL518 Sales Forecast, 2016-2025: Optimistic Scenario (USD Million)
Table 12.60 Selumetinib / ARRY-886/ AZD6244 Sales Forecast, 2017-2025: Base Scenario (USD Million)
Table 12.61 Selumetinib / ARRY-886/ AZD6244 Sales Forecast, 2017-2025: Conservative Scenario (USD Million)
Table 12.62 Selumetinib / ARRY-886/ AZD6244 Sales Forecast, 2017-2025: Optimistic Scenario (USD Million)
Table 12.63 Overall RAF/MEK Inhibitors Market, 2015-2025: Base Scenario (USD Million)
Table 12.64 Overall RAF/MEK Inhibitors Market, 2015-2025: Conservative Scenario (USD Million)
Table 12.65 Overall RAF/MEK Inhibitors Market, 2015-2025: Optimistic Scenario (USD Million)
Table 12.66 Novel Non-Tyrosine Kinase Inhibitors: Distribution by Target Kinases
Table 12.67 Novel Non-Tyrosine Kinase Inhibitors: Distribution by Highest Phase of Development
Table 12.68 Midostaurin / PKC412 / CGP 41251 / CGP 41231 Sales Forecast, 2016-2025: Base Scenario (USD Million)
Table 12.69 Midostaurin / PKC412 / CGP 41251 / CGP 41231 Sales Forecast, 2016-2025: Conservative Scenario (USD Million)
Table 12.70 Midostaurin / PKC412 / CGP 41251 / CGP 41231 Sales Forecast, 2016-2025: Optimistic Scenario (USD Million)
Table 12.71 Estybon/Rigosertib Sales Forecast, 2017-2025: Base Scenario (USD Million)
Table 12.72 Estybon/Rigosertib Sales Forecast, 2017-2025: Conservative Scenario (USD Million)
Table 12.73 Estybon/Rigosertib Sales Forecast, 2017-2025: Optimistic Scenario(USD Million)
Table 12.74 Volasertib / BI 6727 Sales Forecast, 2016-2025: Base Scenario (USD Million)
Table 12.75 Volasertib / BI 6727 Sales Forecast, 2016-2025: Conservative Scenario (USD Million)
Table 12.76 Volasertib / BI 6727 Sales Forecast, 2016-2025: Optimistic Scenario (USD Million)
Table 12.77 Overall Novels Non Tyrosine Kinase Inhibitors Market, 2016-2025: Base Scenario (USD Million)
Table 12.78 Overall Novels Non Tyrosine Kinase Inhibitors Market, 2016-2025: Conservative Scenario (USD Million)
Table 12.79 Overall Novels Non Tyrosine Kinase Inhibitors Market, 2016-2025: Optimistic Scenario (USD Million)
Table 12.80 Roche Revenues, 2009-2014 (CHF Billion)
Table 12.81 Roche Revenues: Distribution by Business Segments, 2011- 2014 (CHFBillion)
Table 12.82 Roche Pharmaceutical Revenues: Distribution by Therapeutic Areas, 2014 (CHF Billion)
Table 12.83 Eli Lilly Revenues, 2009- 2014 (USD Million, %)
Table 12.84 Eli Lilly Revenues: Distribution by Business Segments, 2013-2014 (USD Million, %)
Table 12.85 Eli Lilly Human Pharmaceutical Segment Revenues: Distribution by Operating Segments, 2013- 2014 (USD Million, %)
Table 12.86 Novartis Revenues, 2009-2013 (USD Billion, %)
Table 12.87 Novartis Revenues: Distribution by Business Segments, 2014 (USD Billion)
Table 12.88 Array BioPharma Revenues, FY 2010-2014 (USD Million)
Table 12.89 Cyclacel Pharmaceuticals Revenues, 2011-2014(USD Million)
Table 12.90 Daiichi Sankyo Revenues, 2009 - Q3 2014 (JPY Million,%)
Table 12.91 Onconova Therapeutics Revenues, FY 2011-FY 2014 (USD Million)
Table 12.92 AstraZenecaRevenues, FY 2009-2014(USD Million)
Table 12.93 AstraZeneca Revenues: Distribution by Therapeutic Areas, 2013-2014 (USD Billion)
Table 12.94 GSK Annual Revenues, 2009-2014 (GBP Billion, %)
Table 12.95 GSK Pharmaceutical Revenues: Distribution by Business Domains 2014, (GBP Billion)
Table 12.96 Pfizer Revenues, 2011-2014 (USD Million)
Table 12.97 Pfizer Revenues: Distribution by Business Segments, 2014 (USD Million)
Table 12.98 Pfizer Revenues: Distribution by Therapeutic Areas, 2013-2014, (USD ‘000)
Table 12.99 Merck Group Revenues, 2009- 2014 (EUR Million, %)
Table 12.100 Merck Revenues: Distribution by Business Divisions, 2014(EUR Million)
Table 12.101 Astex Pharmaceuticals Revenues, 2008-2012 (USD Million)
Table 12.102 Carna Biosciences Revenues, 2010-2014 (JPY Million)
Table 12.103 Celgene Annual Revenues, 2009-2014 (USD Million)

Companies Mentioned

1. Ability Pharma
2. Accord Healthcare
3. Advenchen Laboratories
4. ÆternaZentaris
5. Agennix
6. Allomek Therapeutics
7. Altana
8. Ambit
9. Amgen
10. Aptose Biosciences (formerly named Lorus Therapeutics)
11. Ariad Pharmaceuticals
12. ArQule
13. Array BioPharma
14. Asana Biosciences
15. ASLAN Pharmaceutical
16. Astex Pharmaceuticals
17. AstraZeneca
18. Barclays
19. Baxter International
20. Bayer
21. BeiGene
22. Biocon
23. Biogen
24. Bionovo
25. Boehringer Ingelheim
26. Bristol Myers Squibb
27. Carna Biosciences
28. CASI Pharmaceuticals
29. Celgene
30. ChemDiv.
31. Chugai
32. Chugai Pharmaceuticals
33. Cipla
34. Crown Biosciences
35. Cyclacel Pharmaceuticals
36. Daiichi Sankyo
37. Deciphera Pharmaceuticals
38. Eli Lilly
39. EMD Serono
40. Enzo Life Sciences
41. Erimos Pharma
42. Eternity Bioscience
43. Exelixis
44. Flexus
45. G1 Therapeutics
46. Genentech
47. Genzyme
48. GSK
49. GVK Biosciences
50. Hangzhou Tigermed Consulting
51. Hanmi Pharmaceutical
52. Ignyta
53. Incyte
54. Inflection Biosciences
55. JandJ
56. Janssen
57. Jasco Pharmaceuticals
58. Jiangsu Heingrui Medicine
59. Loxo Oncology
60. McLaren
61. Medinol
62. MedPacto
63. Merck
64. Millennium Pharmaceuticals
65. Natco Pharma
66. NerPharMa DS
67. Nerviano Medical Sciences
68. Novartis
69. Onconova Therape

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