NEW YORK, April 19, 2016 /PRNewswire/ -- INTRODUCTION
The human immune system is comprised of a number of different types of specialized molecules and cells that are involved in complex interactions and activities to facilitate an immune response. Immunotherapies exploit the body's innate potential to specifically target a particular molecular antigen and mount an efficient immune response against the cells bearing the diseased signature. Currently, four major types of immunotherapies (classified by product class) targeting the CD19 antigen are under development, namely engineered antibodies, bispecific antibodies (bsAbs), antibody drug conjugates (ADCs) and CAR-T cell therapies. CD19 antigen, an important biomarker has emerged as a promising therapeutic target for a number of disease indications, specifically hematological malignancies (leukemias and lymphomas). The antigen is expressed both on normal cells and malignant B cells as well as follicular dendritic cells. Upon initial discovery, the CD19 antigen was dubbed as the B4 antigen on human B cells.
The pioneer CD19 targeted drug to hit the US and the EU markets was BLINCYTO® (blinatumomab), a bsAb. Different technologies have catered to the development of CD19 targeted therapies. Several researchers and therapy developers are actively involved in developing therapeutics targeting the CD19 antigen for the treatment of B cell malignancies and various autoimmune disorders. With several advantages such as high therapeutic performance and favorable clinical outcomes, the promising pipeline of anti-CD19 drugs is expected to result in a multi-billion dollar market by 2030.
SCOPE OF THE REPORT
The 'CD19 Therapeutics Market, 2016-2030' report provides a comprehensive analysis of the current market landscape and the future outlook of the growing pipeline of anti-CD19 therapeutics. The recent approval of BLINCYTO®, a CD19 targeting bsAb, and emergence of CAR-T therapies has provided a significant boost to this market that has actively evolved in the past few years.
The pipeline comprises of products across four major classes of drugs, namely, engineered antibodies, bsAbs, ADCs and CAR-T therapies. The major focus of these novel molecules is hematological cancers, specifically B cell malignancies, with CAR-T therapies leading the table. Post initial research in CAR-T therapies, many non-industry players have entered into collaborations with industry stakeholders to fund the clinical and commercial development of these products. Some late stage products that have emerged out of such collaborations include KTE-C19, CTL019, JCAR015 and JCAR017.
One of the key objectives of the study is to review and quantify the opportunities laid by the innovative CD19 targeted programs of both small and big pharma firms. Amongst other elements, the report elaborates upon the following key areas:
- The current state of the market with respect to key players, developmental stages of pipeline products (both clinical/preclinical) and target indications
- Partnerships that have taken place in the recent past covering research and development collaborations, manufacturing agreements and license agreements specific to technology platforms, product co-development and co-commercialization
- Competitive landscape and inherent threats to growth in the short and long term
- Development and sales potential based on target consumer segments, likely adoption rate and expected pricing
The study provides an estimate of the short-mid term and long term market forecast for the period 2015 - 2030. The research, analysis and insights presented in this report include potential sales of various marketed and late stage (phase II and phase II/III) anti-CD19 products based on our understanding of the likely future development of individual therapeutics. The opinions and insights, presented in this study, were influenced by discussions that we conducted with experts in this area. These included senior representatives at Kite Pharma, MorphoSys and Theravectys.
Owing to 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. All actual figures have been sourced and analyzed from publicly available information and discussions with industry experts. The figures mentioned in this report are in USD, unless otherwise specified.
Most of the data presented in this report has been gathered via secondary research. For all our projects, we also 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 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 sources of information.
Chapter 2 presents an executive summary of the report. It offers a high level view on where the CD19 therapeutics market is headed in the mid-long term.
Chapter 3 provides a detailed introduction to the CD19 antigen. In this section, we have talked about the structure and role of the human CD19 antigen. Further, we have briefly discussed the conventional therapies being used for different oncological indications and the advent of cancer immunotherapy.
Chapter 4 includes information on over 50 molecules that are either approved or in different stages of development (both clinical and preclinical/discovery). The detailed analysis of this development pipeline includes information on types of molecules, most commonly targeted indications, the phase of development and the developers. In addition, we have also highlighted specific details on the different types of partnerships that have been inked over the last few years; this showcases the growing interest in this field.
Chapter 5 focuses on CAR-T based therapies and highlights prevailing trends pertaining to the ongoing research in this field. It features discussions on targets under investigation, current challenges, toxicity issues and other relevant parameters. To credit the work of the eminent researchers in this space, we have mapped the regional locations of prominent key opinion leaders (KOLs). Similar to earlier chapters, this chapter provides detailed technology and drug profiles for CD19 targeting late stage CAR-T molecules.
Chapter 6 provides detailed information on engineered antibodies, namely Fc and glycoengineered antibodies. It also covers detailed drug profiles for late stage molecules that specifically target the CD19 antigen. Each drug profile includes information such as the clinical stage of development of the molecule, dosage regimen, key clinical trial results and information about the developer. The chapter also includes profiles of technologies being used for the development of these candidate therapies. These profiles provide a brief technology background, pipeline molecules based on the particular technology platform, specific advantages and recent collaborations.
Chapter 7 provides detailed information on bsAbs. Similar to the previous chapter, it provides both drug and technology profiles for CD19 targeting bsAb therapeutics in late stages of clinical development.
Chapter 8 provides detailed information on ADCs. Similar to the previous chapters, it provides both drug and technology profiles for CD19 targeting ADC therapeutics in late stages of clinical development.
Chapter 9 highlights promising therapeutic areas for which CD19 therapeutics are being developed. The chapter also highlights the epidemiological facts and currently available treatment options for each of the discussed indications.
Chapter 10 elaborates on the monetary opportunity presented by anti-CD19 therapeutics. It provides a comprehensive market forecast analysis for molecules in advanced stages of development (approved, phase II/III, phase II and phase I/II) taking into consideration the target patient population, competition, likely adoption rate and price points.
Chapter 11 is an overall summary of the report. In this chapter, we have provided a list of key takeaways and expressed our independent opinion based on the research and analysis described in earlier chapters.
Chapter 12 is a collection of transcripts of interviews conducted during the course of the study.
Chapter 13 is an appendix, containing tabulated data for all figures in the report. It also features a list of companies and organizations involved in this space.
1. CD19 is an important antigen expressed during B cell development; 80 percent of all ALL cases, 88 percent of B cell lymphomas and 100 percent of B cell leukemias express this antigen.
2. During the course of our research, we identified over 50 products in various phases of development. Of these, 70 percent are in the clinical phase of development (with one molecule in phase II/III trial and six molecules in phase II stage).
3. CAR-T therapies (constituting 70 percent of the development pipeline) are the most common, followed by bsAbs (11 percent), ADCs (7 percent) and engineered antibodies (7 percent).
4. The market is highly fragmented with the involvement of several start-ups and many eminent research organizations. Big pharmaceutical players engaged in this space include Amgen, ImmunoGen, MedImmune, Merck and Novartis. Emerging new players/start-ups that are actively investing in this market include Affimed, Bellicum Pharmaceuticals, Juno Therapeutics, Kite Pharma, MorphoSys, Xencor and Zymeworks. The premier research institutes involved in this space include the National Cancer Institute (NCI), MD Anderson Cancer Centre, the University of Pennsylvania, Fred Hutchinson Cancer Research Center (FHCRC) and Memorial Sloan Kettering Cancer Center (MSKCC).
5. Hematological malignancies remain the prime focus of drug developers in this space. However, efforts are also being made to use these therapies in the treatment of other indications including certain autoimmune diseases and solid tumors.
6. Over the coming decade, we expect at least eight anti-CD19 therapies to be made commercially available in addition to marketed drugs. During this period, we believe the market is likely to expand at an annualized growth rate of 41.0 percent; the overall opportunity could be much higher and depends on a number of factors such as favourable market environment, regulatory regimes and therapeutic performance of candidates in the late stages of development.
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