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Non-Tyrosine Kinase Inhibitors in Oncology, 2015-2025

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

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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.

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