LONDON, Dec. 8, 2016 /PRNewswire/ -- INTRODUCTION
Epigenetics is defined as a heritable change in the gene expression and its activity without alteration in the DNA sequence. The different epigenetic mechanisms through which gene expression can be modulated primarily include histone modification, DNA methylation, alteration of chromatin architecture and involvement of small-interfering or non-coding RNAs. Enzymes such as histone acetyltransferases (HATs), histone methyltransferases (HMTs), histone deacetylases (HDACs) and histone demethylases (DMTs) play significant role in epigenetic regulation. HATs and HDACs are the two major enzyme classes involved in post-translational modification of N-terminal tail of the histone proteins; HATs are responsible for acetylation of N-terminal histone tail whereas HDACs possess an opposite mode of action and act by removing the attached acetyl group.
Currently, HDACs are widely being studied as a promising therapeutic target. HDAC inhibitors can be classified into four main categories based on the structural characteristics of the Zn2+ binding domain. These include hydroxamic acids, cyclic peptides, short-chain fatty acids and benzamides. In addition to the synthetic HDAC inhibitors, the HDAC inhibitory role of various naturally occurring molecules has recently been discovered. These include molecules such as curcumin, depudecin, flavone and taipoxin.
There are five commercialized HDAC inhibitors, majority of which are primarily targeting hematological malignancies. Approval of the first HDAC inhibitor, Zolinza™ (vorinostat), in 2006 for treatment of CTCL gave the market an initial impetus. The momentum was carried on by the other molecules that were marketed in 2009 (Istodax®), 2014 (Beleodaq®, Epidaza®) and 2015 (Farydak®). These drugs are currently being evaluated for several other indications as a single agent or as a combination therapy in lower stages of development.
SCOPE OF THE REPORT
The "HDAC Inhibitors Market, 2016-2026" report was commissioned to examine the current landscape and the future outlook of the growing pipeline of products in this area. HDACs have been studied in cellular processes such as apoptosis, autophagy, metabolism, DNA damage repair, cell cycle control and senescence. Altered expression of HDACs has been observed in different tumors; this makes them a potential target for treatment of cancer and other genetic or epigenetic related disorders. Inhibition of HDACs has shown positive results in disruption of multiple cell signaling pathways and prevention of tumor growth.
The HDAC inhibitors market has steadily evolved over the last few years with many drug candidates designed to address a wide range of oncological and non-oncological disorders. With five commercialized products, the market has gained attention from several industry and non-industry players. Initially, the market was led by big pharma players; however, the success of the marketed products has encouraged several start-ups and mid-sized firms to step into this lucrative space. We identified around 21 start-ups and 14 mid-sized companies that are exploring the opportunities presented by HDAC inhibitors. Currently, the HDAC inhibitors' pipeline comprises of over 90 molecules under development. It is worth highlighting that over the last few years, the focus has shifted from pan-HDAC to class-specific HDAC inhibitors. Additionally, the research activity, with respect to the number of publications, has been highly promising. With an intense research framework, there have been over 9500 papers published in the last 10 years (as captured in PubMed). Further, increasing popularity on social media validates the growing interest in this field. The analysis conducted from 2009 to 2015 demonstrates a Compound Annual Growth Rate (CAGR) of 33% in the tweets registered on Twitter. Similar trends have been observed on Facebook.
As pharmaceutical companies continue to initiate and expand their research programs in this area, one of the key objectives outlined for this report was to understand the future potential of the market. This was done by analyzing:
- The HDAC inhibitor pipeline (marketed, clinical and preclinical drugs) in terms of phase of development, HDAC class specificity and the evolving therapeutic areas / target indications.
- The likely adoption of the HDAC inhibitors by understanding the competition posed by the current treatment regime in the coming few years.
- The emerging trends and the popularity of HDAC inhibitors on social media such as Twitter and Facebook over the last few years.
- The research activity in this field in terms of the focus of the publications / research articles granted across the globe in the last two years.
The study provides a detailed market forecast and opportunity analysis for the time period 2016-2026. The research, analysis and insights presented in this report include potential sales of the approved drugs and the ones in late stages of development (phase III and phase II). To add robustness to our model, we have provided three scenarios for our market forecast; these include the conservative, base and optimistic scenarios. Our opinions and insights, presented in this study were influenced by several discussions we conducted with experts in this area. All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.
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
- Industry analysts' views
While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various 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 2 provides an executive summary of the report. It offers a high level view on where the HDAC inhibitors market is headed in the mid to long term.
Chapter 3 explains the central dogma of molecular biology and fundamentals of epigenetics. It elaborates on the effects of histone modifications such as methylation, acetylation, phosphorylation, ubiquitination and sumoylation on the biological processes such as DNA replication, transcription and repair. Additionally, the chapter highlights the classification of HDACs and HDAC inhibitors and discusses the specific role of HDAC inhibition in regulation of various biological processes. The chapter also provides an overview of the various disease indications across multiple therapeutic areas being targeted by HDAC inhibitors.
Chapter 4 includes information on over 90 molecules that are either approved or are being evaluated in different stages of development (clinical and preclinical/discovery). We have identified the companies that are active in this market and conducted a detailed pipeline analysis highlighting the most commonly targeted indications, target classes of HDAC, phases of development and specific geographical pockets where innovation is mostly concentrated.
Chapter 5 provides comprehensive profiles of the marketed, phase III and phase II drug candidates with a detailed understanding on the drug specification, mechanism of action, clinical development status, key clinical trial results, collaborations and overview of sponsors.
Chapter 6 presents key insights on HDAC inhibitors. It provides a schematic representation highlighting the distribution of HDAC inhibitors by target class, therapeutic area and highest phase of development. The chapter presents the landscape of industrial and non-industrial developers of HDAC inhibitors. Additionally, it presents a detailed comparative analysis on the key clinical trial endpoints for drugs that are marketed or in phase III and phase II of development.
Chapter 7 highlights the sales forecast and the associated monetary opportunity offered by this class of drugs. We have provided detailed insights covering target patient population, likely price points and the adoption rates of marketed, phase III and phase II HDAC inhibitors.
Chapter 8 presents publication analysis of the articles published on HDAC inhibitors in PubMed over the last two years. The chapter covers some important aspects of these publications such as the most studied disease areas, phase of the study and the drug combinations under investigation.
Chapter 9 provides the emerging trends on social media related to HDAC inhibitors. It presents an overview of the popularity of the keywords histone deacetylase inhibitor and HDAC inhibitor on Twitter and Facebook from 2009 to 2015.
Chapter 10 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 11 is a collection of interview transcripts of the discussions that were held with key stakeholders in this market. We have presented the details provided to us by Dr. Simon Kerry (CEO of Karus Therapeutics), Dr. James Christensen (CSO and Senior VP of Mirati Therapeutics) and Dr. Hyung J. Chun (Associate Professor of Medicine, Yale School of Medicine)
Chapter 12 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.
Chapter 13 is an appendix, which provides the list of companies and organizations mentioned in the report.
1. Nearly 90 HDAC inhibitors are currently in clinical / preclinical stages of development; the clinical molecules account for over 30% of the pipeline while over 60% is captured by molecules in the preclinical / discovery stage.
2. With 66% of the pipeline molecules targeting oncological indications, cancer remains one of the most widely studied field for HDAC inhibitors. Within oncology, hematological malignancies such as PTCL and CTCL are popular targets; three HDAC inhibitors (Zolinza™, ISTODAX® and BELEODAQ®) are approved for these indications. Other therapeutic areas such as autoimmune disorders, infectious diseases, inflammatory disorders, neurological disorders, are also gradually gaining traction.
3. Although the market was initially led by the large-size pharma players (such as Celgene, Merck, Novartis), the current market is characterized by the presence of several small / mid-sized pharma players. Notable examples of the small and mid-sized firms include 4SC, Chroma Therapeutics, CrystalGenomics, Curis, Evgen Pharma, FORUM Pharmaceuticals, Karus Therapeutics, Mirati Therapeutics, MEI Pharma, Shenzhen Chipscreen Biosciences, Syndax Pharmaceuticals and TetraLogic Pharmaceuticals.
4. In addition, there are several non-industry institutes and universities that are primarily carrying out preclinical research. Examples of these include Harvard Medical School (BG45), Imperial College London (C1A), Kyoto University (J?, S?), National Taiwan University (Quinazolin-4-one derivatives), Taipei Medical University (MPT0E028), University of Messina (MC-1575, MC-1568).
5. Four of the five approved drugs are pan-HDAC inhibitors targeting HDAC isoforms non-specifically. However, in the past few years, several class selective HDAC inhibitors have entered the clinic; these are associated with a higher efficacy and result in decreased toxicity from the treatment. Of the total HDAC inhibitors identified, 52% of the molecules are class specific; of these, 33% molecules target Class I specific isoforms and the rest target Class II specific isoforms of HDACs. Notable examples of molecules targeting class-specific HDACs include entinostat (phase III), resminostat (phase II), SHP-141 (phase II), mocetinostat (phase II), CHR-3996 (phase I/II) and ricolinostat (phase I/II).
6. The HDAC inhibitors market is expected to grow at a healthy annual rate of 32% over the next decade. With multiple potential target indications, Istodax® is expected to capture the largest market share (close to 21%) in 2026, followed by entinostat, Farydak® and Beleodaq®.
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