SAN FRANCISCO, May 31, 2022 /PRNewswire/ -- A new market study published by Global Industry Analysts Inc., (GIA) the premier market research company, today released its report titled "Acute Myeloid Leukemia (AML) Therapeutics - Global Market Trajectory & Analytics". The report presents fresh perspectives on opportunities and challenges in a significantly transformed post COVID-19 marketplace.
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Edition: 18; Released: April 2022
Executive Pool: 5362
Companies: 112 - Players covered include AbbVie Inc.; Actinium Pharmaceuticals, Inc.; Agios Pharmaceuticals, Inc.; Amgen Inc.; Astellas Pharma Inc.; Astex Pharmaceuticals, Inc. ; CTI BioPharma Corp.; Cyclacel Pharmaceuticals, Inc.; Daiichi Sankyo Company Limited; F. Hoffmann-La Roche AG; Janssen-Cilag Limited; Jazz Pharmaceuticals plc; MEI Pharma, Inc.; Merus N.V.; Novartis AG; Pfizer Inc.; Takeda Pharmaceutical Company Limited and Others.
Coverage: All major geographies and key segments
Segments: Chemotherapy Type (Cytarabine, Anthracycline Drugs, Tyrosine Kinase Inhibitors, Alkylating Agents, Hormonal Therapy, Anti-Metabolites, Other Chemotherapy Types)
Geographies: World; USA; Canada; Japan; China; Europe; France; Germany; Italy; UK; Spain; Russia; Rest of Europe; Asia-Pacific; Australia; India; South Korea; Rest of Asia-Pacific; Latin America; Middle East; Africa.
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Amid the COVID-19 crisis, the global market for Acute Myeloid Leukemia (AML) Therapeutics estimated at US$587.6 Million in the year 2022, is projected to reach a revised size of US$976.2 Million by 2026, growing at a CAGR of 12.6% over the analysis period. Cytarabine, one of the segments analyzed in the report, is projected to grow at a 15.1% CAGR, while growth in the Anthracycline Drugs segment is readjusted to a revised 13.9%. Leukemias are malignant disorders, the main symptom of which is an abnormally high leucocyte count in the human bone marrow and/or blood. The disease causes a substantial number of deaths worldwide every year. The types of Leukaemia vary by origin, pathogenesis, prognosis, and incidence. The dominant leukemia cells may be mature cells like in chronic lymphocytic leukemia (CLL); acute leukemias with precursor cells of multiple lineages; or both mature and precursor cells like in chronic myeloid leukemia (CML). Leukaemia incidences vary among patients of different sexes, ages and races and these disparities are associated primarily with levels of environmental exposure as also genetic factors. For instance, nearly 10% of patients developing CLL have a history of the ailment in the family. Similarly, ionizing radiation has been identified as a definite cause for ALL in children, and usually happens by way of X-ray pelvimetry done during a pregnancy. Due to previous initiatives taken for combating leukemia, the disease`s epidemiology can change with time, varying from nation to nation. Hence, being aware of leukemia`s upgraded epidemiological data and analyzing the ailment`s temporal trends are vital to learn about its burden and also to assess the overall effectiveness of prevention strategies adopted previously.
The market is set to experience a lucrative growth over the coming years on account of confluence of various factors like rising prevalence of the medical condition and its relapse cases along with increasing focus on development of novel therapies. Increasing cases of acute myeloid leukemia can be credited to several factors like unhealthy lifestyles, genetic mutations, radiation exposure and extended exposure to certain toxic chemicals like benzene. The increasing prevalence along with high mortality rate in the US and other countries is paving way for higher uptake of associated therapies. The market growth is also favored by rising aging population and unmet healthcare needs. Moreover, the market expansion is favored by various benefits of biopharmaceuticals over traditional drugs, an impressive biopharmaceutical pipeline and continuing development of several combination therapies capable of treating challenging medical conditions.
The market is also slated to gain from ongoing advancements in molecular biology and pharmacology for development of novel drugs. Pharmaceutical players operating on the market are making significant investments in research projects to come up with novel options. These R&D endeavors are also attributed to limitations associated with existing therapies available on the market for acute myeloid leukemia. Traditional options for the medical condition are unable to control relapse and linked with various side-effects such as tissue damage, nausea and loss of appetite. These issues are driving companies to focus on advanced approaches such as serine-threonine protein kinases, stem cell transplant and pipeline drugs. The market growth is bound to be facilitated by upcoming therapies such as farnesyltransferase inhibitors, alkylating agents, immunotoxins, FMS-like tyrosine kinase 3 inhibitors, monoclonal antibodies and multi-drug-resistant modulators. These therapies are anticipated to gain acceptance owing to their enhanced survival rates, quality and safety. The market growth is bound to be facilitated by upcoming therapies such as FMS-like tyrosine kinase 3 inhibitors. These therapies are anticipated to gain acceptance owing to their enhanced survival rates, quality and safety.
Various acute myeloid leukemia patients are unable to achieve desirable remission levels with chemotherapy or tend to relapse later. Nearly 25-30% of patients are characterized with primary refractory condition, with majority of them relapsing eventually. On the other hand, there are acute myeloid leukemia patients who are resistant to or refractory to intensive chemotherapy. There are oral inhibitors against mutant versions of IDH1/2 as well as an inhibitor for FLT3 mutations. IDH1 and IDH2 mutations change normal functioning of IDH, deviating them from producing alpha-ketoglutarate to [alpha]-hydroxyglutarate. While ivosidenib is a selective, oral and potent inhibitor that works against IDH1, enasidenib is intended to target IDH2. These drugs have demonstrated their efficacy to result in desirable complete remissions among certain patients. On the other hand, both drugs are associated with a major toxicity issue, differentiation syndrome that is characterized by hypoxia, fever, weight gain, dyspnea, pulmonary infiltrates and hypotension.
FLT3 inhibitors have experienced a decent level of progress in the recent years, with midostaurin being a notable drug option that has secured regulatory approval in the US. The ability of the drug to extend survival rate for patients enabled it to get the regulatory permission. Midostaurin represents a first-generation type-I FLT3 inhibitor that works against FLT3-ITD mutations, but demonstrates relatively low selectivity. Researchers are working on a number of other drugs that display enhanced specificity associated with FLT3 inhibitors. Gilteritinib has gained regulatory approval and is indicated for patients with refractory or relapsed acute myeloid leukemia with FLT3-TKD or FLT3-ITD mutation. During clinical trials, the drug offered enhanced response and survival rates in comparison to chemotherapy. In addition, gilteritinib demonstrated low level of toxicity. Another promising FLT3 inhibitor that is anticipated to receive approval is quizartinib, which demonstrated enhanced overall survival rate for recipients during trials. Gilteritinib has secured regulatory approval from the US FDA that has indicated the drug to treat adults with refractory or relapsed acute myeloid leukemia with FLT3 mutation as per the FDA-approved test. The regulatory agency has also approved phase-III clinical data from ADMIRAL trial and an extended indication for companion diagnostic that was covered with the drug. The LeukoStrat CDx FLT3 Mutation Assay is used for detection of FLT3 mutations among acute myeloid leukemia patients.
The approval is anticipated to help the drug in transforming the therapeutic domain for acute myeloid leukemia. During clinical trials, gilteritinib demonstrated its ability to increase survival rate for patients detected with FLT3 mutation-positive relapsed or refractory acute myeloid leukemia. In addition, the drug demonstrated desirable safety along with enhanced response rate in comparison to chemotherapy. Gilteritinib offers a mutation-targeted, less toxic therapeutic option for people with aggressive refractory or relapsed condition. Representing a kinase inhibitor, gilteritinib presents a promising option for refractory or relapsed acute myeloid leukemia. The drug is an advanced pyrazinecarboxamide derivative, which has displayed enhanced activity, selectivity and potency against FLT3-TKD and FLT3-ITD mutations. In addition, the drug is capable of inhibiting EML4-ALK & AXL, representing an oncogenic receptor tyrosine kinase with perceived role in FLT3-ITD phosphorylation. AXL's activation is considered as a way of secondary resistance toward FLT3 inhibitors. In-vivo models have indicated the role of AXL inhibition in affecting FLT3 phosphorylation as well as allowing differentiation of myeloid in FLT3-AML cell lines. The administration of gilteritinib to patients with refractory or relapsed acute myeloid leukemia during early clinical trials indicated desirable FLT3 inhibition. Some of the adverse reactions observed by researchers during clinical trials included myalgia or arthralgia, fatigue, noninfectious diarrhea, fever, edema, dyspnea and rash. More
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