NEW YORK, Nov. 19, 2015 /PRNewswire/ -- INTRODUCTION
Cancer is known to be one of the leading causes of death worldwide. The field of oncology is vast and comprises several indications, including some rare / orphan forms. Although oncology continues to be one of the most active areas in terms of drug development, there is still a significant unmet need. The focus of drug developers is gradually moving towards immunotherapeutics, which make use of the body's own immune system or its components to fight cancer. It is a relatively new concept, with the only success being targeted antibody based therapeutics (including monoclonal and conjugated antibodies). Interest has surged in other classes of immunotherapeutics; these include Immune Checkpoint Inhibitors, therapeutic cancer vaccines and other whole cell based therapies.
Immune checkpoints are molecules that regulate (stimulate or inactivate) the immune cells. Yervoy (an anti CTLA-4 drug), the foremost drug to be launched in this domain, is currently being mirrored by various other drugs such as Opdivo, Keytruda (both anti PD-1 drugs) and many under clinical development. The market, with an opportunistic development pipeline, caters to the participation of various market players (big and small) over a common platform.With an ongoing rush to emerge as leaders in the evolving market, various stakeholders have collaborated to establish their foothold in a relatively short time period.
In addition to the marketed drugs (Yervoy, Opdivo and Keytruda), we expect a number of drugs currently in advanced stages of development (Tremelimumab, Elotuzumab, RG7446 and Avelumab)to achieve blockbuster status in the near future. The anticipated success of Immune Checkpoint Inhibitors shall prove to be a harbinger for emerging players and a strong impetus to the development pace of the other pharmaceutical giants.
SCOPE OF THE REPORT
The "Immune Checkpoint Inhibitors Market (2nd edition), 2015-2025" report provides a comprehensive analysis of the current market landscape and the future outlook of the growing pipeline of Immune Checkpoint Inhibitors. The immuno-oncology market encompasses a myriad of immune checkpoint targeting drugs which can be potentially exploited for a broad range of cancer indications. Specifically, CTLA-4 inhibitors were the pioneers in this segment. Yervoy, the flagship molecule from BMS, was the only immunotherapeutic commercially available until other classes recently stepped in. The recent approval of anti PD-1 drugs and emergence of anti PD-L1 drugs has provided a significant boost to the market.
In addition, there are several novel checkpoint inhibitors (e.g. IDO, LAG-3, CD70, OX40, CD40, GITR, TIM-3, CD137/4-1BB, KIR, TDO, VISTA, CS1, NKG2A, GARP, ICOS) which have recently gained ground and are expected to retain attention in the future.
One of the key objectives of the study is to review the prospects laid by the robust, opportunistic and broad pipelines of the pharmaceutical firms. With three marketed drugs (Yervoy, Keytruda and Opdivo), the market is treading its way towards fulfilling the huge untapped promise. Amongst other elements, the report elaborates upon the following key areas:
The current state of the market with respect to key players, developmental stage of pipeline products (both clinical / pre-clinical) and indications targeted
Recent partnerships which have taken place over the last five years including product co-development, licensing and clinical trial collaborations
Combinationtherapies where Immune Checkpoint Inhibitors are being evaluated in combination with other anti-cancer agents/therapies
Various investments and grants received by the companies focused in this area
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 base year for the report is 2015. The report provides the market forecast for the period 2015-2025, respectively. The research, analysis and insights presented in this report include potential sales of several Immune Checkpoint Inhibitors; this analysis is backed by a deep understanding of key drivers behind the growth.
Owing to niche nature of the market, with most products in the pipeline, 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. 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 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
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 secondary and primary sources of information.
Chapter 2 presents an executive summary of the report. It offers a high level view on where the Immune Checkpoint Inhibitors market is headed in the mid-long term.
Chapter 3 provides a general introduction to Immune Checkpoint Inhibitors. In this section, we have briefly discussed the conventional therapies being used for oncology treatment, the advent of cancer immunotherapy and, specifically, the emergence of Immune Checkpoint Inhibitors.
Chapter 4 provides a comprehensive landscape of the Immune Checkpoint Inhibitors market. This chapter includes information on more than 100 inhibitors which are currently in different stages of development (both clinical and pre-clinical / discovery). The detailed analysis of this development pipeline includes information on types of molecules, most commonly targeted indications, current phases of development and the likely launch timelines.
Chapter 5 focuses on CTLA-4 inhibitors and presents the current scenario and the future outlook for this specific class of molecules. The chapter includes detailed drug profiles of the marketed and drugs under development. We have presented information on several parameters such as history of development, clinical trial results, manufacturing, cost and reimbursement. It includes the likely sales forecast of the drugs currently in advanced stage of development.
Chapter 6 focuses on PD-1 and PD-L1 inhibitors and presents the current scenario and the future outlook for this specific class of inhibitors. As with the CTLA-4 inhibitors, this chapter provides a holistic view on the various drugs belonging to this class and their future sales potential.
Chapter 7 focuses on novel inhibitors. Examples of these inhibitors include IDO, LAG-3, CD70, OX40, CD40, GITR, TIM-3, CD137/4-1BB, KIR, TDO, VISTA, CS1, NKG2A, GARP and ICOS. As in the earlier two chapters, we have provided detailed drug profiles and the future outlook for these new set of inhibitors.
Chapter 8 provides details on all the active/planned clinical studies evaluating Phase II/III/marketed Immune Checkpoint Inhibitors as combination therapies. The chapter focuses on the most common combinations, provides adetailed analysis of all the listed clinical studies and highlights the evolving preference of pharma companies in terms of differing combination classes.
Chapter 9 offers a comprehensive competitive landscape of various therapies being used for the treatment of certain oncological indications; these indications have been the prime focus of companies developing Immune Checkpoint Inhibitors.
Chapter 10 includes an elaborate discussion on the various collaborations and partnerships which have been forged amongst the players in the market over the last several years.
Chapter 11 presents details on the various investments and grants received by the companies focused in the area of Immune Checkpoint Inhibitors. The analysis highlights the growing interest from the VC community and other strategic investors.
Chapter 12 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 13 is a collection of transcripts of interviews conducted during the course of this study.
Chapter 14 summarises the overall report. In this chapter, we have provided a recap of the key takeaways and our independent opinion based on the research and analysis described in previous chapters.
Chapter 15 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.
Chapter 16 provides the list of companies mentioned in the report.
1.The industry is characterized by the presence of three marketed drugs and 34 drugs in clinical development for oncological indications. The marketed and clinical pipeline includes two CTLA-4, nine PD-1 / PD-L1 and 26 novel Immune Checkpoint Inhibitors.The dynamic pipeline also includes several molecules in preclinical/ discovery stage; in our research, we identified about 70 such molecules.
2. BMS, with ten Immune Checkpoint Inhibitors (marketed / under development), is the leading player. Other pharmaceutical giants include AstraZeneca, Merck & Co, Pfizer, Merck KGaA, Roche, GSK, Novartis and Amgen.
3. Many start-ups, small companies and university spin-offs have also emerged in the past two years. Examples (in alphabetical order) include Agenus, Alligator Bioscience, Ambrx, AnaptysBio, arGEN-X, Bioceros, BioNovion, Cellerant Therapeutics, Checkpoint Therapeutics, Compugen, CureTech, Enumeral, Five Prime Therapeutics, Genmab, GITR, ImmuNext, IOmet Pharma, iTeos Therapeutics, Jounce Therapeutics, KAHR Medical, Multimeric Biotherapeutics, Nativis, Orega Biotech, Pelican Therapeutics, Pieris Pharmaceuticals, Prima BioMed, Redx Pharma, Sorrento Therapeutics,Tesaro, TG Therapeutics, Theravectys and ToleroTech.
4. Amongst the novel Immune Checkpoint Inhibitors, IDO inhibitors have gained maximum attention; this is followed by molecules targeting LAG-3, CD-70, OX-40 and CD-40. Although Elotuzumab is the only drug in late stage development, novel checkpoints have paved the way for smaller biotechnology firms to enter the immuno-oncology market.
5. Collaborations have helped the market reach its current growth trajectory.Specifically, clinical trial collaborations to evaluate Immune Checkpoint Inhibitors as combination therapies are very common; the period Jan 2014-May 2015 saw over 40 such collaborations for a number of molecules.
6. We expect Immune Checkpoint Inhibitors to be a multi-billion dollar market over the coming decade; during the period 2015 - 2025, our forecast suggests that the market will witness an annualized growth rate of 27.7%.
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