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JAK Inhibitors, Potential Market Opportunity & Clinical Pipeline Insights 2019

  • OI-95
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  • Published date: Apr, 2019
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  • Life Sciences & Healthcare
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  • 0 Pages

Janus kinase (JAK) inhibitors will block the Janus kinase activator enzymes and interrupt signaling pathway. It targets the process that leads to the production of the damaged DNA, which is playing the major role in the production of cancerous cells. Several signal transduction pathways have to be done by JAK activity for inducing normal signaling. The abnormal variation in JAKs activity can lead to a diseased condition. For example, overactivation of JAK can lead to tumorigenesis while the loss of JAK can lead to severe combined immunodeficiency. Janus Kinases family comprises of JAK 1, JAK 2, JAK 3 and also a group of cytoplasmic non-receptor Tyrosine kinases (NRTKs). Different JAK tyrosine kinases are the key elements to mediate signaling processes such as an expression of genes, which are involved in the process of proliferation, apoptosis, migration, and differentiation. They play an important role in immune defense action as many signaling events involved in innate and adaptive immunity is mediated by JAKs. Thus mutation in JAKs is leading to immunodeficiency disorders.


Market Overview


Janus kinase inhibitors have come out as one of the latest potential candidate and growth frontier by many of the scientific researchers involved in the research and development of targeted therapies and cancer drugs. The available JAK inhibitors are most highly focusing on the treatment of rare hematological malignancies including myelofibrosis, primary thrombocythemia, and Polycythemia Vera. Moreover, the continuous efforts of the researchers led to the detection of the JAK role in a wide range of solid tumors like lung cancer, prostate cancer, pancreatic cancer, breast cancer, ovarian cancer, colorectal cancer, gastrointestinal cancers, etc.


Currently, there exists only one Janus kinase inhibitors drug, which is commercially available in the market by the approval of Ruxolitinib. Although this drug is approved to treat rare hematological malignancies, but the occurrence rate of these cancers was shown to be increasing in the past years. Further, the lack of effective treatment for these cancers and greater survival rates of the patients after treatment with Ruxolitinib has aided the commercial success of Ruxolitinib. And 27 drugs are found to be in various clinical development phases. Most of the drugs are in Preclinical phase (13 Drugs) followed by the Phase-II (4 Drugs) clinical trials. It is found to have 6 drugs in Phase III clinical trials of JAK inhibitors. For example, baricitinib, an Eli Lilly & Company’s drug candidate is in Phase III for the treatment of rheumatoid arthritis. Incyte Corporation has reached Phase II clinical trial of Itacitinib JAK inhibitor to treat non-small cell lung cancer, primary myelofibrosis, post-polycythemia vera myelofibrosis and refractory Hodgkin lymphoma. Concert Pharmaceuticals is developing CTP-543, a Phase I drug candidate for alopecia areata. CTP-543 is an inhibitor of JAK1 and JAK2 involved in autoimmune disease. Aclaris Therapeutics, Inc. is developing ATI-50001, a pre-clinical drug candidate for the treatment of alopecia universalis and alopecia totalis. The Promising Candidates in the Clinical Pipeline includes Momelotinib, Lestaurtinib, Pacritinib, Tofacitinib, Ruxolitinib, Baricitinib.


More than 5 JAK inhibitors are expected to enter into the cancer therapeutic market in the next decade. Furthermore, the huge commercial success of the Ruxolitinib JAK inhibitor for myeloproliferative disorders further accelerated the development of more JAK inhibitors in the market. The development of JAK inhibitors has been so impressive and fastest in the past five years and thus expecting a great economic success of this class of drugs in the nearby future. Advances in research and technology will add to the development of JAK inhibitors. The development of more JAK inhibitors will not only provides benefits to the cancer therapeutic market but will also add a better life from cancers to the patients.


Key Developments



  • In March 2019, Celgene announced that the US Food and Drug Administration (FDA) has accepted its new drug application (NDA) for fedratinib (JAK2 inhibitor) for Myelofibrosis and granted a Priority Review.

  • In Feb 2019, AbbVie has announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review of its New Drug Application (NDA) for upadacitinib (JAK1-selective inhibitor) for the treatment of adult patients having moderate to severe rheumatoid arthritis.


Segmentation


This Pipeline research report segments the JAK inhibitors pipeline on the basis of therapies employed (combination therapy, and monotherapy + combination therapy), therapeutic modality (small molecules, and unknown), RoA (oral and unknown), drugs under development (discovery, pre-clinical, phase I, phase I/II, phase II, and phase III), and recruitment status (recruiting, active not recruiting, enrolling by invitation, and undisclosed).


In the pipeline, investigated single molecule is being used as both in monotherapy and combination therapy. Based on RoA, nearly 67% of the total therapeutics is being developed for oral administration where the drug is administered through a mouth cavity.


Some of the key players involved in the research and development of JAK inhibitor drugs include Galapagos NV, AbbVie Inc., Eli Lilly and Company, Gilead Sciences, Inc., Astellas Pharma Inc., CTI BioPharma Corp., Portola Pharmaceuticals, Inc., Japan Tobacco International, Incyte Corporation, Pfizer, Inc., and Asana BioSciences, LLC.

Report Description: The report covers in-depth analysis of JAK Inhibitors-Pipeline Insights, 2019. The report assesses the JAK Inhibitors pipeline by stage of development (early development, pre-clinical, clinical and in approval), by application (lung cancer, prostate cancer, pancreatic cancer, breast cancer, and others). In addition, the report includes key insights on other development activities, including (but not limited to) – licensing (In and Out), collaborations, acquisitions, reimbursement, patent, and regulatory designations.


The report includes in-depth company profiles of key players in the JAK Inhibitors Pipeline. The company profile includes key information on the overview, financial highlights, product portfolio, business strategies, and key recent developments.


The report highlights information on emerging companies with potentially disruptive technologies and new market entrants.


Scope:



  • Provides detailed analysis of the product pipeline structure along with forecast of the various segments and sub-segments of the JAK InhibitorsPipeline.

  • Provides a comparative analysis of key marketed products and pipeline JAK Inhibitors

  • Provides key information on players involved in the JAK Inhibitors Pipeline.

  • Provides a complete overview of market segments and the regional outlook of JAK Inhibitors Pipeline.

  • Provides in-depth coverage of key news related toJAK Inhibitors Pipeline, including major mergers and acquisitions and product development updates such as clinical trial progression updates and regulatory updates

Our research works on a holistic 360° approach to deliver high quality, validated and reliable information in our market reports. The Market estimation and forecasting involve the following steps:




  • Data Collation (Primary & Secondary)




  • In-house Estimation (Based on proprietary databases and Models)




  • Market Triangulation




  • Forecasting




  • Market-related information is assembled from both primary and secondary sources. 






  • Primary sources involved participants from all global stakeholders such as experts from several related industries and suppliers that have been interviewed to obtain and verify critical information as well as to assess prospects of the market. The participants included are CXOs, VPs, and managers. Plus, our in-house industry experts having decades of industry experience contribute their consulting and advisory services. 





  • Secondary sources include public sources such as regulatory frameworks, government IT spending, government demographic indicators, industry association statistics, and company publications annual reports press releases along with paid sources such as Factiva, OneSource, Bloomberg among others. 





  • Top-down and bottom-up approaches: The overall market size was used in the top-down approach to estimate the sizes of other individual submarkets (mentioned in the market segmentation by product, type of manufacturing, and disease) through percentage splits from secondary and primary research. The bottom-up approach was also implemented (wherever applicable) for data extracted from secondary research to validate the market segment revenues obtained. 




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