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Published: Oct 10, 2018 Pages: 80
SKU-Code: EKS-22-2017 Region: Global

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Chronic myeloid leukemia (CML) is a clonal myeloproliferative disorder resulting from the neoplastic transformation of the primitive hematopoietic stem cell. It is one of the rarest forms of leukemia in terms of annual incidence and accounts for 10 percent to 15 percent of all incident leukemia cases; however, it is expected to become the most widespread hematologic disorder in the world by 2022. CML is an increasingly attractive market opportunity given the transformational impact of targeted therapies on disease progression and survival; the prevalence of CML is now increasing as patients now have normal lifespans and no longer die shortly after diagnosis, and due to an aging population. The main unmet needs in CML are overcoming TKI resistance and addressing patients with accelerated or blast phase disease. Currently, the existing BCR-ABL inhibitors most commonly used for CML treatment are the first-generation imatinib,as well as the more effective second-generation BCR-ABL inhibitors nilotinib and dasatinib.Ponatinib and bosutinib have recently been approved for market inclusion.

The global CML market is estimated to register 5 percent CAGR between 2017 and 2022. The market is expected to reach $13,840 million in revenue by the end of 2022. Somefactors,including a rise in research and development in the oncology sector, innovations in drug development, new products in the pipeline, and the establishment of novel therapies are resulting in the growth of the market;however, the high cost of treatment and lack of Medicare coverage is one of the biggest factors hampering the growth of the global CML market. The US was observed as the leading geographical region in CML treatment due to factors such as a rising diagnosis rate in patients suffering from cancer, rising awareness in CML patients related to novel drug treatments, and the highest yearly treatment price compared to others regions. Generic imatinib will dominate first-line treatment as Sprycel and Tasigna compete for market share in the second line. The most lucrative CML segment is chronic phase-CML patients currently taking frontline therapy. This segment contains the greatest number of patients, and these patients stay on their treatment longer than patients who have become refractory to or intolerant of prior therapy. Competition for patient share in this segment is fierce, and Novartis and BMS are trying to prove that their second-generation TKIs are superior to Gleevec. ARAID is also aiming to penetrate this segment. Improving CML patients compliance with their prescription regimens is of great commercial interest to companies in this space. Consequently, the major players have instituted programs and tools to encourage patients to adhere to their prescribed frequency of dosing. The CML market has been the most diversified and competitive market that is dominated by numerous players. The main players in this market are Novartis, Bristol-Myers Squibb, Teva., ARIAD Pharmaceuticals, Pfizer, Prism Pharmaceuticals, Incyte, Otsuka Pharmaceutical, and others. Companies planning to enter this market are looking at various targets and indications in order to capture share in the market. Novartis, BMS, and Pfizer have experimented in this area, but most projects have been discontinued after early-phase trials. The rigid criteria for acceptable safety and efficacy profiles of BCR-ABL TKIs make CML a high-risk area for pharmaceutical research and development. Moreover, with the launch of new market entrants Bosulif, Iclusig, and Synribo for patients who are refractory to or intolerant to Gleevec and second-generation TKIs, there is little opportunity for new market entrants. These drugs are targeted towards patients who no longer respond to first or second generation TKIs, and provide options for additional lines of therapy.

Novartis and Roche are the most active assignees in the year 2017. The patents/published applications from Novartis primarily focus on Inhibitors to be used for the treatment of Chronic Myeloid Leukemia wherein the patents/published applications from Roche primarily focus on Novel compounds for the treatment of Chronic Myeloid Leukemia. (Novartis also has the majority of patenting activity in the year 2018.) Many patents are being filed on treatment methods and formulations;therefore, the industry may need the API to conduct research and produce specific formulas.There are patents assigned to Cadila (estimated expiry of 2033) andTeva Pharmaceuticals which claim a highly stable amorphous form of Imatinibmesylate. None of them has demonstrated an EP counterpart. Interestingly, the US patent for Teva expired in the year 2015 and thus, the prospect of freedom to operate in EP for the stable amorphous imatinibmesylate is high.

This report provides strategic insights into the overall CML treatment market, accompanied by the market size and forecast from 2012 to 2022 for major regions, along with approved product sales. The report covers in-depth product profiles of imatinib (Gleevec), nilotinib (Tasigna), dasatinib (Sprycel), bosutinib (Bosulif), ponatinib (Iclusig),and omacetaxine (Synribo) with market sales data for 2014 to 2022. It also provides detailed epidemiology of the CML by major regions (US, the Americas, Europe, and Asia Pacific). Some key players profiled in this report are Novartis, Roche, Teva and Pfizer.

Key Question Answered:

  • Global CML Market by Value; 2008-2022
  • Global CML Market by Drugs; 2017-2022
  • Global Tyrosine Kinase Inhibitors Market by Value; 2008-2022
  • Annual Price Change in Tyrosine Kinase Inhibitors; 2013-2016
  • US CML Market by Value; 2008-2022
  • Gleevec Worldwide Sales; 2012-2022
  • Gleevec Worldwide Sales by Indication; 2014-2022
  • Tasigna Worldwide Sales; 2012-2022
  • Tasigna US Sales; 2012-2022
  • Sprycel Worldwide Sales; 2012-2022
  • Sprycel US Sales; 2012-2022
  • Iclusig Worldwide Sales; 2013-2022
  • Iclusig Sales by Regions; 2013-2022
  • Iclusig Sales by Players; 2013-2022
  • Iclusig Sales by Indications; 2017
  • Bosulif Worldwide Sales; 2012-2022
  • Bosulif US Sales; 2012-2022
  • Global Prevalence of CML; 2014-2022
  • Americas Prevalence of CML; 2014-2022
  • Europe Prevalence of CML; 2014-2022
  • Asia Pacific Prevalence of CML; 2014-2022
  • Overall IP Trends in CML Market
  • Patent landscape of CML Market by Focus Area, Composition, TKIs, Route of Administration, Key Players and Top Inventors.
  • Growth Drivers, Challenges and Trends
  • Detailed Company Profiling of Key Market Players


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