AL Amyloidosis - Market Insight, Epidemiology and Market Forecast - 2032

This ‘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, emerging drugs, and their 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 unmet medical needs to curate the best opportunities. It assesses the underlying potential of the market.

Geography Covered

• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2019-2032

AL Amyloidosis Disease Understanding and Treatment Algorithm

AL Amyloidosis Overview

Amyloid light-chain (AL) amyloidosis, also known as primary amyloidosis, is the most common form of systemic amyloidosis. It starts in the bone marrow, the soft tissue inside the bones that makes blood-forming cells, including cells that create antibodies to fight infections. These cells can grow abnormally, causing an excess type of protein called light chains, which clump together and form amyloid deposits in major organs. Progressive organ dysfunction (Heart, Kidney, Liver, etc.) is driven by amyloid deposition, and the risk of early death is the hallmark of severe AL amyloidosis.

AL Amyloidosis Diagnosis and Treatment

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 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 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 Epidemiology

The AL Amyloidosis symptoms epidemiology division provides insights into the historical and current patient pool and the forecasted trend for every seven major countries. It helps recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of The report also provides the diagnosed patient pool and their trends and assumptions.

Key Findings

The total incident cases of AL Amyloidosis patients in the 7MM are increasing during the study period, i.e., 2019-2032.

The disease epidemiology covered in the report provides historical as well as forecasted AL Amyloidosis symptoms epidemiology segmented as the total Incident cases of AL Amyloidosis, gender-specific cases of AL Amyloidosis, and age-specific cases of AL Amyloidosis. The report includes the Incident cases scenario of AL Amyloidosis in 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom), and Japan from 2019 to 2032.

Country-wise AL Amyloidosis Epidemiology

The epidemiology segment also provides the AL Amyloidosis epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

The total number of Incident cases of AL Amyloidosis associated in 7MM countries was approximately 8,600 in 2021.

AL Amyloidosis Drug Chapters

The AL Amyloidosis report's drug chapter segment encloses the detailed analysis of AL Amyloidosis early-stage (Phase I, II, and III) pipeline drugs. It also helps understand the AL Amyloidosis clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug, and the latest news and press releases.

AL Amyloidosis Emerging Drugs

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.

Other Products detailed in the report…

AL Amyloidosis Market Outlook

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, 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 the publisher, 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.

Key Findings

This section includes a glimpse of the AL Amyloidosis market in 7MM.

AL Amyloidosis market size in the seven major markets was ~USD 920 million in 2021.

The United States Market Outlook

This section provides the total AL Amyloidosis market size and market size by therapies in the United States.

The United States accounts for the largest market size of AL Amyloidosis compared to the EU5 (the United Kingdom, Germany, Italy, France, and Spain) and Japan.

EU-5 Countries: Market Outlook

The total AL Amyloidosis market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.

Japan Market Outlook

The total AL Amyloidosis market size and market size by therapies in Japan are also mentioned.

AL Amyloidosis Drugs Uptake

This section focuses on the uptake of the potential drugs recently launched or expected to get launched in the market during the study period 2019-2032. The analysis covers the AL Amyloidosis market uptake by drugs, patient uptake by therapies, and sales of each drug.

This helps understand the drugs with the most rapid uptake, reasons behind the maximal use of new drugs, and the comparison of the drugs based on market share and size, which will again be useful in investigating factors important in the market uptake and in making financial and regulatory decisions.

AL Amyloidosis Pipeline Development Activities

The report provides insights into the therapeutic candidate in Phase I, II, and III stages. It also analyses AL Amyloidosis key players involved in developing targeted therapeutics.

Major market players include Janssen Pharmaceutical, Alexion Pharmaceutical, Bristol-Myers Squibb, and others.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition, and merger, licensing, and patent details for AL Amyloidosis emerging therapies.

In September 2021, AstraZeneca's Alexion acquired Caelum Biosciences, including its pipeline drug, CAEL-101, a potentially first-in-class fibril-reactive mAb, being developed for the treatment of light chain amyloidosis.

Reimbursement Scenario in AL Amyloidosis

Proactively approaching reimbursement can induce a positive impact both during the early stages of product development and well after product launch. The report considers reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with better market access can be a critical business and price strategy.

Clinical practice guidelines by NCCN, UKMF provide a list of drug therapy/disease management options for AL Amyloidosis; however, none had FDA or EMA approval until 2021. This treatment landscape of AL amyloidosis is mostly derived from multiple myeloma, and none are deemed optimal due to insufficient data. High-dose melphalan followed by autologous hematopoietic stem cell transplant (ASCT) is included in the guidelines. As per one of the Canadian-based studies that extrapolated survival and costs of the ASCT with melphalan and prednisone group, ASCT improved life expectancy, and the incremental cost-effectiveness of transplantation was 25,710 Canadian dollars per life-year gained, including follow-up costs. Compared with melphalan and prednisone, ASCT appears to be cost-effective in patients less than 65 years old. Nevertheless, it is associated with significant morbidity and mortality; therefore, only about 20% of patients are eligible for ASCT.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the AL Amyloidosis domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps understand and validate current and emerging therapies treatment patterns or AL Amyloidosis market trends. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

The publisher performs a Competitive and Market Intelligence analysis of the AL Amyloidosis Market by using various Competitive Intelligence tools: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

• The report covers the descriptive overview of AL Amyloidosis, explaining its causes, signs and symptoms, physiology, and currently available therapies.
• Comprehensive insight has been provided into the AL Amyloidosis epidemiology and treatment in the 7MM.
• Additionally, an all-inclusive account of both the current and emerging therapies for AL Amyloidosis is provided, along with the assessment of new therapies, which will impact the current treatment landscape.
• A detailed review of the AL Amyloidosis market, historical and forecasted, is included in the report, covering drug outreach in the 7MM.
• The report provides an edge while developing business strategies by understanding trends shaping and driving the global AL Amyloidosis market.

Report Highlights

• In the coming years, the AL Amyloidosis market is set to change due to the rising awareness of the disease, development of diagnostic techniques, and the favorable environment from regulators, for innovative first-in-class curative drugs, as there were no approved therapies until recently and are likely to expand the market's size and enable the drug manufacturers to penetrate more into the market.
• The companies and academics are working to assess challenges and seek opportunities that could influence AL Amyloidosis R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Major players are involved in developing therapies for AL Amyloidosis. The launch of emerging therapies will significantly impact the AL Amyloidosis market.
• Our in-depth analysis of the pipeline assets across different stages of development (Phase I, II, and III), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, and launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

AL Amyloidosis Report Insights

• Patient Population
• Therapeutic Approaches
• AL Amyloidosis Pipeline Analysis
• AL Amyloidosis Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

AL Amyloidosis Report Key Strengths

• 11-Year Forecast
• 7MM Coverage
• AL Amyloidosis Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

AL Amyloidosis Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness

Key Questions Answered

Market Insights:

• What was the AL Amyloidosis Market share (%) distribution in 2019, and how would it look in 2032?
• What would be the AL Amyloidosis total market size and market size by therapies across the 7MM during the forecast period (2019-2032)?
• What are the key findings of the market across 7MM, and which country will have the largest AL Amyloidosis market Size during the forecast period (2019-2032)?
• At what CAGR, the AL Amyloidosis market is expected to grow in 7MM during the forecast period (2019-2032)?
• What would be the AL Amyloidosis market outlook across the 7MM during the forecast period (2019-2032)?
• What would be the AL Amyloidosis market growth till 2032, and what will be the resultant market size in the year 2032?

Epidemiology Insights:

• What are the disease risk, burden, and unmet needs of AL Amyloidosis?
• What is the historical AL Amyloidosis patient pool in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
• What would be the forecasted patient pool of AL Amyloidosis in seven major markets covering the United States, EU5 (Germany, Spain, France, Italy, UK), and Japan?
• What will be the growth opportunities in the 7MM concerning the patient population about AL Amyloidosis?
• Out of all 7MM countries, which country would have the largest incident population of AL Amyloidosis during the forecast period (2019-2032)?
• At what CAGR is the population expected to grow in 7MM during the forecast period (2019-2032)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the treatment of AL Amyloidosis along with the approved therapy?
• What are the current treatment guidelines for treating AL Amyloidosis in the USA, Europe, and Japan?
• What are the AL Amyloidosis marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
• How many companies are developing therapies for the treatment of AL Amyloidosis?
• How many therapies are developed by each company for the treatment of AL Amyloidosis?
• How many emerging therapies are in the mid-stage and late stages of development to treat AL Amyloidosis?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to AL Amyloidosis therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for AL Amyloidosis and their status?
• What key designations have been granted for the emerging therapies for AL Amyloidosis?
• What are the global historical and forecasted markets of AL Amyloidosis?

Reasons to Buy

• The report will help develop business strategies by understanding trends shaping and driving the AL Amyloidosis market.
• To understand the future market competition in the AL Amyloidosis market and an Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for AL Amyloidosis in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
• Identifying strong upcoming players in the market will help devise strategies that will help get ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the AL Amyloidosis market.
• To understand the future market competition in the AL Amyloidosis market.