Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) | Primary Research (KOL's Insight) | Market Intelligence | Epidemiology & Market Forecast-2035

After receiving initial treatment for acute myeloid leukemia (AML), the majority of patients experience remission (no signs or symptoms). However, some patients continue to have leukemia cells in their bone marrow even after receiving extensive treatment. Refractory acute myeloid leukemia (AML) is frequently identified in patients who do not experience complete remission following two cycles of induction chemotherapy. Patients with acute (r/r) relapsed or refractory acute myeloid leukemia have a poor prognosis, and treatment is still difficult. Allogeneic hematopoietic stem cell transplantation (HSCT) is the only effective treatment for the majority of R/r patients. Patients with acute (r/r) relapsed or refractory acute myeloid leukemia have a poor prognosis, and treatment is still difficult. The only effective treatment for the majority of R/r patients is allogeneic hematopoietic stem cell transplantation (HSCT).

Description

After receiving initial treatment for acute myeloid leukemia (AML), the majority of patients experience remission (no symptoms or signs). But some patients still harbor leukemia cells in their bone marrow even after receiving intensive therapy. Refractory acute myeloid leukemia (AML) is frequently identified in patients who have undergone two cycles of induction chemotherapy and have not experienced a complete remission. For some patients, remission is followed by a return of myeloid cells and a deficiency in healthy blood cells. Relapsed leukemia is the term used to describe this. The "standard of care" during a relapse is repeated genetic testing of the leukemia cells due to the possibility that the mutation pattern differs from that of the initial diagnosis. Treatment choices may be impacted by this. Blood stem cells are where acute myeloid leukemia (AML) develops. Acute nonlymphocytic leukemia (ANLL), acute myeloid leukemia, acute myeloid leukemia, and acute myeloid leukemia are all common names for it. AML is classified as untreated, in remission, or relapsed at the time of diagnosis. Hematopoietic precursors are suppressed at an early stage of development in acute myeloid leukemia (AML), a malignant disease of the bone marrow. More than 20% myeloid blasts distinguish the majority of acute myeloid leukemia (AML) subtypes from other blood disorders that are closely related to leukemia. The early development of myeloid cell maturation is stopped in AML, which is its underlying pathophysiology. Acute myelogenous leukemia (AML) is caused by a variety of factors, including preexisting blood disorders, familial syndromes, exposure to the environment, and drug use. Most patients with new AML, however, do not have any particular risk factors. The symptoms of acute myeloid leukemia (AML) are brought on by either bone marrow failure, leukemia cells invading the organs, or both. The speed of time changes. Blood tests, bone marrow aspiration and biopsy (the gold standard diagnostic test), and genetic abnormality analysis are all part of the AML investigation process.

Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) (Epidemiology)

With a potential growth rate of 1.09% over the forecast period, the global incidence of AML will rise from 105,842 cases in 2019 to 119,247 cases in 2030. Incidence of diagnosed acute myelogenous leukemia (AML) in the US will rise to 21,530 cases by 2030. Similar to this, 17,139 cases of AML will be diagnosed in the EU by 2030. In the US and the EU, respectively, the 5-year survival rate for AML is 28.7% and 24%. Acute myeloid leukemia (AML) is more common as people age. The typical onset age is around 70 years old. However, everyone is impacted by acute myeloid leukemia (AML). Men are more likely than women to develop acute myeloid leukemia (AML), particularly as they age. This may be due to the fact that MDS is more prevalent in men and that advanced MDS frequently develops into AML. Some have hypothesized that occupational exposure may be responsible for men developing acute myelogenous leukemia at a higher rate.

Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) -Current Market Size & Forecast Trends

The market for relapsed or refractory (R/R) acute myeloid leukemia (AML) is projected to grow significantly, with estimates indicating a value of approximately USD 3.7 billion in 2025, expected to increase to around USD 12.63 billion by 2037, reflecting a compound annual growth rate (CAGR) of 10.6% during this period. The growth is driven by the rising incidence of AML, particularly among the aging population, and advancements in treatment options, including chemotherapy, targeted therapies, and immunotherapies. The increasing number of drug approvals and ongoing clinical trials are also contributing to market expansion. As the demand for effective therapies continues to rise, the R/R AML market is well-positioned for substantial growth through 2035 as new treatment strategies emerge and improve patient outcomes.

The prognosis for patients with acute (r/r) relapsed or refractory acute myeloid leukemia is poor, and the disease is still difficult to treat. Allogeneic hematopoietic stem cell transplantation (HSCT) is the only curative option for the majority of R/r patients. To lessen the impact of leukemia before transplantation, salvage therapy is administered. Before receiving allogeneic HSCT, patients who achieved complete remission had better results. High-dose cytarabine and anthracycline are typically used in intensive recovery regimens. After allogeneic HSCT, patients who relapse have shown success with donor lymphocyte infusion. Results are frequently poor in patients who cannot receive intensive therapy (for example, elderly AML patients), and combinations with new drugs are being researched. To find abnormalities that new medications can target, mutational analysis should be repeated in the event of a relapse. Gilderitinib fared better than intensive salvage regimens in patients with AML r/r and FLT3 mutations. Gilderitinib has been approved by both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) for use in people with FLT3-mutated r/r AML. IDH1/IDH2 r/r mutant AML has FDA (not EMA) approval for the use of the IDH inhibitors Ivosidenib and enasidenib, which target specific IDH mutations 1 and 2, respectively. Early results are encouraging and show that APR-246 restores mutant TP53 function. It is being studied to develop additional medications that target CD47, menin, developmentally regulated neural precursor cells 8, and bispecific antibodies that target T cells or chimeric antigens. For AML patients who relapse after chemotherapy, allogeneic HSCT is the preferred course of action.

Report Highlights

Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) - Current Market Trends

Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) - Current & Forecasted Cases across the G8 Countries

Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) - Market Opportunities and Sales Potential for Agents

Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) - Patient-based Market Forecast to 2035

Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) - Untapped Business Opportunities

Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) - Product Positioning Vis-a-vis Competitors' Products

Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) - KOLs Insight