DelveInsight’s ‘AL Amyloidosis Market Insights, Epidemiology, and Market Forecast—2032’ report deliver an in-depth understanding of the AL Amyloidosis, historical and forecasted epidemiology as well as the market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom), and Japan.
The AL Amyloidosis market report provides current treatment practices, AL Amyloidosis emerging drugs, and their AL Amyloidosis market share of the individual therapies, current and forecasted AL Amyloidosis symptoms market size from 2019 to 2032 segmented by seven major markets. The report also covers current AL Amyloidosis symptoms treatment practice/algorithm and AL Amyloidosis unmet medical needs to curate the best opportunities. It assesses the underlying potential of the market.
It covers the details of conventional and current medical therapies and diagnosis available in the AL Amyloidosis market to treat the condition. It also provides the country-wise treatment guidelines and algorithms across the United States, Europe, and Japan. The DelveInsight AL Amyloidosis market report thoroughly understands AL Amyloidosis symptoms by including disease definition, symptoms, causes, physiology, and diagnosis. It also provides AL Amyloidosis treatment algorithms and treatment guidelines for AL Amyloidosis symptoms in the US, Europe, and Japan.
Treatment for AL amyloidosis is highly individualized, determined based on age, organ dysfunction, and regimen toxicities, and should be guided by biomarkers of hematologic and cardiac response. Alkylator-based chemotherapy is effective in almost two-thirds of patients; however, management of AL Amyloidosis is challenging owing to the treatment-emergent side-effects. Novel agents are also active, and trials are ongoing to establish their optimal use.
Few major AL Amyloidosis unmet needs in the market include lack of disease-specific curative therapies, high cost of approved therapies, whereas the need for safer therapies with minimal toxicity profile, high disease, and economic burden, and increasing incidence are driving opportunities in the market.
AL Amyloidosis Emerging Drugs Profile
· Daratumumab: Janssen Pharmaceutical/Genmab
Daratumumab (Darzalex Faspro) is an IgG1k monoclonal antibody, first-CD38 directed targeted therapy, and binds to CD38. Daratumumab binds to a different CD38 epitope amino-acid sequence than causing cell apoptosis via antibody-dependent cellular cytotoxicity, complement-dependent cytotoxicity, or antibody-dependent cellular phagocytosis. These effects are dependent upon fragment crystallizable region immune effector mechanisms. Antibody-dependent cellular cytotoxicity utilizes natural killer cells.
In January 2021, Janssen Biotech announced that the Food and Drug Administration granted accelerated approval to daratumumab plus hyaluronidase in combination with bortezomib, cyclophosphamide, and dexamethasone for newly diagnosed light chain (AL) amyloidosis. Janssen Biotech announced updated positive results from the Phase III ANDROMEDA study, which is evaluating daratumumab and hyaluronidase-fihj for the treatment of patients with newly diagnosed light chain (AL) amyloidosis, a rare blood cell disorder associated with the deterioration of vital organs, most notably the heart, kidneys, and liver. Longer-term results from a median follow-up of 20.3 months showed rates of hematologic complete response (hemCR) remained significantly higher in patients treated with Darzalex Faspro in combination with bortezomib, cyclophosphamide, and dexamethasone (D-VCd) compared to VCd alone.
· Birtamimab: Prothena
Birtamimab, formerly known as NEOD001, is an investigational monoclonal antibody designed to specifically and selectively target and clear the amyloid that accumulates and causes organ dysfunction and failure in patients with AL amyloidosis.
Birtamimab has been tested in nearly 300 patients with AL amyloidosis at the intended clinical dose of 24 mg/kg and was shown to be generally safe and well-tolerated in the clinical studies conducted to date. Birtamimab was previously evaluated in Phase III VITAL Study, a global multi-center, randomized, double-blind, placebo-controlled clinical study of newly diagnosed, treatment naïve patients with AL amyloidosis and cardiac involvement. Results from the analysis of patients categorized as Mayo Stage IV at baseline in the VITAL study revealed a significant survival benefit favoring birtamimab in these patients, with 74% of birtamimab-treated patients alive at 9 months versus 49% of patients in the control group.
The report’s AL Amyloidosis market outlook helps to better understand the historic, current, and forecasted AL Amyloidosis market trends by analyzing the impact of current therapies on the market, AL Amyloidosis unmet needs, drivers and barriers, and demand for better technology. This segment gives a thorough detail of AL Amyloidosis market trend of each marketed drug and early-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria’s, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders.
The calculated market data are presented with relevant tables and graphs to view the market at first sight. According to DelveInsight, the AL Amyloidosis market in 7MM is expected to grow steadily during the study period 2019–2032. Treatment for AL amyloidosis is highly individualized, determined based on age, the severity of organ damage/dysfunction, co-morbidities, and regimen toxicities, and should be guided by biomarkers of hematologic and cardiac response.
Alkylator-based chemotherapy is effective in almost two-thirds of patients. Novel agents are also active, and trials are ongoing to establish their optimal use. Currently, the Bortezomib-based regimen (CyBorD–cyclophosphamide, bortezomib, and dexamethasone) are currently used as first-line therapy in AL amyloidosis. The CyBorD regimens are in wide use in the US, EU, and Japan.
Oral melphalan 1 dexamethasone (MDex) has been a standard of care for many years in treating relapsing and refractory patients. Daratumumab plus hyaluronidase (Darzalex Faspro) in combination with bortezomib, cyclophosphamide, and dexamethasone has been granted accelerated approval, for newly diagnosed light chain (AL) amyloidosis, by US FDA, in January 2021. It is likely to become the next Standard of Care for AL Amyloidosis in the 7MM.
Source: AL Amyloidosis Market Forecast
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