Cancer Stem Cell Therapies Market, 2017-2030

LONDON, June 26, 2018 /PRNewswire/ -- INTRODUCTION
Cancer stem cells (CSCs) are known to be rare, immortal cells within a tumor that can both self-renew and differentiate into several cell types that form the tumor mass. Over time, the development of CSCs has been shown to be associated with several signaling pathways, which regulate the survival and proliferation of these cells. Presently, a number of initiatives are underway to explore specific targets that can be used to selectively eliminate cancer stem cells and, thereby, confer therapeutic benefits to patients suffering from various forms of cancers.

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The presence of CSCs has been established in various cancers, including oesophageal cancer, gastric cancer, intestinal cancer, colon cancer, hepatic cancer and pancreatic cancer. However, it is postulated that these self-renewing CSCs represent only a small fraction of the cell population (approximately 1%) within the bulk tumor mass. The frequent failure in trying to treat advanced cancers using the current standard of care therapies has been attributed to the presence of CSCs as these cells actively resist all methods of treatment, including chemotherapy and radiotherapy.

The objective of the ongoing R&D is to develop novel CSC directed treatments that can combat complications, such as off target toxicities and disease relapse, associated with the current standard of care treatments. In fact, between January 2008 and December 2016, the number of publications in this domain grew at an annualized rate of 10.4%; overall, there are over 9000 publications available on PubMed, indicating the extensive research activity unfolding in this domain

SCOPE OF THE REPORT
The 'Cancer Stem Cell Therapies Market, 2017-2030' report examines the current landscape and the future outlook of the growing pipeline of products targeting CSCs. We identified over 150 molecules that are currently being investigated as therapeutic interventions for the elimination of CSCs. Over the past few years, this burgeoning field of research has captured the interest of several players in the pharmaceutical industry.

Amongst other elements, the report features:
• An elaborate discussion on the origin, properties and methods for identification of CSCs. It covers the key therapeutic strategies that are being investigated for eliminating CSCs; these include targeting signaling pathways, targeting cancer stemness factors and related surface markers, inhibiting ATP-binding cassette transporters, targeting the tumor microenvironment, and the induction of apoptosis in CSCs.
• A review of the overall landscape of the CSC therapy market with respect to the phase of development, key therapeutic targets, oncological indications, mode of administration, type of molecule (small molecule, monoclonal antibody, peptides, bispecific antibody, gene therapy, fusion proteins and other biologics), geographical distribution of R&D efforts and the key players in this domain.
• A detailed publication analysis on more than 340 articles that have been published between September 2016 and October 2017, highlighting the key focus areas of the ongoing research activity in this field.
• Comprehensive profiles of phase III and marketed drugs featuring a brief company overview and financial details, product description, mechanism of action, current status of development, active clinical trials, key clinical trial results, manufacturing information, dosage and sales information, collaborations established related to the product, and a comprehensive future outlook of the developer. Additionally, the report also includes profiles of drugs that are in phase II of clinical development.
• Insightful representations of the distribution of CSC targeting molecules across various parameters, such as target molecular pathway, therapeutic area, type of molecule and highest phase of development. The report features a bull's eye analysis to specifically highlight the most popular targets from a clinical standpoint. In addition, we have provided a comprehensive overview (in the form of a 2 X 2 matrix) of the competitive landscape of developers, highlighting each developer's product portfolio, company size and location of headquarters.
• An analysis depicting the prevalent and emerging trends related to CSC therapies as observed on the social media platform, Twitter. In addition to the yearly trend, the analysis highlights the most talked about therapeutic targets for CSC therapies and the popular cancer indications.

One of the key objectives of the report was to estimate the future size of the CSC therapy market, specifically in the US and EU. We adopted a bottom-up approach to evaluate the likely success and growth of marketed drugs and those that are in phase II and phase III of clinical development, over the next 10-15 years.

The insights generated on the future opportunity are segmented on the basis of key indications, important target strategies and key products. In order to account for the uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios for the period 2017-2030, namely the conservative, base and optimistic scenarios, which represent three different tracks of the industry's evolution.

The research, analysis and insights presented in this report are backed by a deep understanding of key insights gathered from both secondary and primary research. The report presents details of conversations with (in alphabetical order of company name) Stephen Franklin (CEO, Evgen Pharma), Steven Swanson (Senior Vice President, ImmunoCellular Therapeutics) and Jaffer Ajani (Researcher at MD Anderson Cancer Center).

RESEARCH METHODOLOGY
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
• Industry analysts' views

While the focus has been on forecasting the market till 2030, 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 CSC therapy market is headed in the long term.

Chapter 3 provides a general introduction to the underlying concepts of CSC. In this section, we have briefly discussed the origin, properties, and techniques for identification and isolation of CSCs. The chapter covers details on the fundamentals of the various therapeutic strategies that are being designed against CSCs. These include signaling pathways such as the WNT pathway, Notch pathway, Hedgehog pathway, BMI-1 pathway, important regulatory factors that govern stemness in cancer cells, elements influencing the tumor microenvironment and important surface markers. In addition, the chapter highlights the challenges and future prospects associated with development of CSC therapeutics.

Chapter 4 provides a comprehensive overview of the current landscape of CSC therapeutics market. It includes information on potential drug candidates that are currently in different stages of development (both clinical and preclinical / discovery). It presents a detailed analysis of the pipeline of products in this domain, including information on the current phases of development, most common indications, target strategies, type of molecule, popular routes of administration, geographical distribution of the companies involved in this space. We have also highlighted the key players active in this domain.

Chapter 5 presents important insights from the current pipeline. The chapter features a detailed funnel analysis, highlighting the distribution of candidate drugs based on their target pathways, and highest phase of development. It also highlights the most popular targets within each therapeutic strategy. In addition, it features a competitive landscape of developers, along with information on each developer's product portfolio, company size and the location of headquarters. In addition, this section features a bull's eye analysis of the molecules that are in the clinical stage, highlighting the type of molecule and the highest phase of development.

Chapter 6 provides insights on the popularity of CSC therapies on the social media platform, Twitter. The section highlights the yearly distribution of tweets posted on the platform in the time period 2012-2017, and the most significant events responsible for increase / decrease in the volume of tweets each year. Additionally, the chapter showcases the most talked about therapeutic targets and the important indications, as observed on social media.

Chapter 7 provides a comprehensive publication analysis, highlighting the recent trends in published literature related to CSC therapies. The chapter provides details on novel methods, as well as the attempts that are being made to add value to the ongoing efforts within this domain.

Chapter 8 provides detailed profiles of the molecules that are either marketed, or in phase III of clinical development. Each profile provides information on the mechanism of action, current status of development, dosage form and treatment regimen, information on clinical studies and key clinical trial results of the drug. It also includes an overview of the developer, its financial details and an informed future outlook.

Chapter 9 presents brief profiles of the molecules that are in phase II of clinical development. Each profile provides information on the developer, mechanism of action of the molecule, route of administration, current status of development, clinical studies, key clinical trial results, recent collaborations, and drug-specific designations (if any).

Chapter 10 presents a comprehensive market forecast analysis, highlighting the future potential of the market till the year 2030. It includes future sales projections of CSC therapeutics that are either marketed or are in advanced stages of clinical development (phase II and phase III). The sales potential and growth opportunity were estimated based on the target patient population, likely adoption rates, existing / future competition from other drug classes and the likely price of products. The chapter also presents a detailed market segmentation on the basis of the key indications, important therapeutic strategies and the important players in the market.

Chapter 11 is a summary of the overall report. In this chapter, we have provided a list of key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.

Chapter 12 is a collection of interview transcripts of the discussions held with key stakeholders in this market. In this chapter, we have presented the details of our conversations with (in alphabetical order of company name) Stephen Franklin (CEO, Evgen Pharma), Steven Swanson (Senior Vice President, ImmunoCellular Therapeutics) and Jaffer Ajani (Researcher at MD Anderson Cancer Center).

Chapter 13 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 14 is an appendix, which provides the list of companies and organizations mentioned in the report.

EXAMPLE HIGHLIGHTS
1. Around 150 product candidates are currently under various stages of development for a diverse range of indications. Two molecules, namely Erivedge® (Roche) and Odomzo® (Novartis), are commercially available. Nearly 49% of the pipeline molecules are under clinical development; of these, 4 molecules are being investigated in phase III, 18 molecules in phase II, 18 molecules in phase I/II and 35 molecules in phase I clinical trials. Majority (50%) of the product candidates in the pipeline are still in the preclinical and discovery stages.
2. A significant proportion (49%) of product candidates in the pipeline target various CSC signaling pathways. Specifically, the two commercially available drugs are designed to target the hedgehog pathway. Of the four important pathways (BMI1, Hedgehog, Notch, Wnt), the Wnt pathway (specifically the ?-catenin protein) is presently considered to be the most important target; 25% of the pipeline candidates are being developed to eliminate CSCs by modulating this particular signaling cascade.
3. 71% of the products in the development pipeline are designed to treat solid tumors, including basal cell carcinoma, breast cancer, colon cancer, ovarian cancer and prostate cancer. Nearly 18% of the molecules are being developed for the treatment of hematological malignancies, such as acute myeloid leukemia, acute lymphocytic leukemia, multiple myeloma and myelodysplastic syndrome. The remaining 11% of the pipeline molecules are being developed for treating both types of cancers.
4. The market landscape is characterized by the presence of large-sized (19), mid-sized (19) and small-sized companies (67). Some of the prominent large-sized companies engaged in this domain include (in alphabetical order) AbbVie, AstraZeneca, Bristol Myers Squibb, Dompé Farmaceutici, Janssen, Merck, MorphoSys, Novartis, Pfizer, Roche / Genentech and Sanofi. Similarly, mid-sized companies that are actively contributing to the development of CSC therapies include (in alphabetical order) ASINEX, Boston Biomedical, OncoMed Pharmaceuticals, Redx Pharma and Taiwan Liposome Company. In addition, small companies, such as (in alphabetical order) Agilvax, amcure, BioLineRx, CellCentric, Celon Pharma, Evgen Pharma, Geron, Genus Oncology, HedgePath Pharmaceuticals, ImmunoCellular Therapeutics, Medicenna Therapeutics, Oncoceutics, PellePharm, Peloton Therapeutics, SATHGEN BIOTECH, Verastem and WntResearch are also actively involved in this domain.
5. Several universities / research organizations have also made significant contributions to the development efforts in this market. Examples include (in alphabetical order) the Centre Léon-Bérard, Dana-Farber Cancer Institute, inVentiv Health Clinical, Maastricht University Medical Center, Duke University Medical Center, The Royal Marsden NHS Foundation Trust and University of Pittsburgh.
6. With many candidates in the late stages of development, the market is likely to witness several approvals over the coming decade. We expect the market to grow at an annualized rate of ~33% till 2030. In fact, specific products, being developed for indications with very large target patient populations, are anticipated to achieve blockbuster status (sales over USD 1 billion) and become prime contributors to future revenues.

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