Neuroblastoma Market

Key Highlights

• According to a study conducted by Shohet et al. (2017), the median time to relapse is around 1.5 years from diagnosis. Up to 20% of patients with high-risk disease will have the primary refractory disease, and nearly 60% of patients who complete therapy get relapsed. Overall survival after relapse depends on risk stratification. INSS stage 1 patients have an overall survival rate approaching 70%, compared with an overall survival rate of 40% in stage 2 patients and 2% in stage 4 patients.

• Neuroblastoma epidemiology is segmented as Total Neuroblastoma Incident Cases, Neuroblastoma Gender-specific Incident Cases, Neuroblastoma Age-specific Incident Cases, and Incident Patient Population of Neuroblastoma by Risk Groups] in the Neuroblastoma market report.

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DelveInsight's "Neuroblastoma Market Insights, Epidemiology, and Market Forecast 2032" report delivers an in-depth understanding of the Neuroblastoma, historical and forecasted epidemiology as well as the Neuroblastoma market trends in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom and Japan.

The Neuroblastoma market report provides current treatment practices, emerging drugs, Neuroblastoma market share of the individual therapies, current and forecasted Neuroblastoma market Size from 2019 to 2032 segmented by seven major markets. The Report also covers current Neuroblastoma treatment practice/algorithm, and unmet medical needs to curate best of the opportunities and assesses the underlying potential of the market.

Geography Covered

• The United States
• EU4 (Germany, Spain, Italy, and France) and the United Kingdom
• Japan

Study Period: 2019–2032

Neuroblastoma Market Disease Understanding and Treatment Algorithm

The DelveInsight’s Neuroblastoma market report gives a thorough understanding of Neuroblastoma by including details such as disease definition, symptoms, causes, pathophysiology, diagnosis, and treatment. Neuroblastoma is an embryonal malignancy of the sympathetic nervous system arising from neuroblasts (pluripotent sympathetic cells). It is derived from two words i.e. “neuro” means nerves and “blastoma” refers to the tumor affecting the immature or developing cells. It originates in the adrenal medulla and paraspinal or periaortic regions where sympathetic nervous system tissue is present.

Neuroblastoma is sometimes caused by a gene mutation (change) passed from the parent to the child. Children with certain gene mutations or hereditary syndromes should be checked for signs of neuroblastoma until they are 10 years old.

The symptoms of neuroblastoma are often vague and can include abdominal mass, either felt during an examination or seen as a swollen abdomen, dark circle around the eyes, unexplained fevers, constant diarrhea, bone pain, weight-loss, fatigue and many more.

Neuroblastoma Diagnosis

Neuroblastoma often spreads to the bone marrow (the soft inner parts of certain bones). If blood or urine levels of catecholamines are increased, then finding cancer cells in a bone marrow sample is enough to diagnose neuroblastoma (without getting a biopsy of the main tumor). A bone marrow aspiration or a bone marrow biopsy are the primary methods of diagnosis. If neuroblastoma has already been diagnosed by a biopsy done elsewhere in the body, bone marrow tests are done to help determine the extent of the disease.

Iodine 123 (123I) metaiodobenzylguanidine (MIBG) is the first-line functional imaging agent used in neuroblastoma imaging. MIBG uptake is seen in 90% of neuroblastomas, identifying both the primary tumor and sites of metastatic disease. The addition of single photon emission computed tomography (SPECT) and SPECT/computed tomography to 123I-MIBG planar images can improve identification and characterization of sites of uptake.

Stages of neuroblastoma determine the extent of spread of the tumor in the patients, and the disease is staged on the basis of results of physical exams, imaging tests, and biopsies of the main tumor and other tissues. Staging of neuroblastoma is based on two classification systems: International Neuroblastoma Staging System (INSS) and International Neuroblastoma Risk Group Staging System (INRGSS). In some patients, the return of neuroblastoma is observed and is often referred to as Relapsed neuroblastoma. Almost all cases of neuroblastoma happen in infants and children younger than 5 years old.

Neuroblastoma Treatment

Different types of treatment are available for patients with neuroblastoma. Some treatments are standard (the currently used treatment), and some are being tested in Neuroblastoma clinical trials. Treatment for neuroblastoma is largely based on which risk group a child is in. Standardized risk groups are: Low risk group, intermediate risk group, high risk group, and recurrent neuroblastoma group. Generally, younger children with smaller tumors are in the lower risk groups, while older children, children with tumors that have spread throughout the body, and children whose tumors have unfavorable features or extra copies of the MYCN gene are in the high-risk group. Some infants with neuroblastoma that has spread throughout the body can still be considered low risk, especially if their tumor does not have extra copies of MYCN or other unfavorable features.

Neuroblastoma Epidemiology

The Neuroblastoma epidemiology section provides insights about historical and current Neuroblastoma patient pool and forecasted trends for individual seven major countries. It helps to 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 along with assumptions undertaken.

Key Findings

• According to a study conducted by Shohet et al. (2017), the median time to relapse is around 1.5 years from diagnosis. Up to 20% of patients with high-risk disease will have the primary refractory disease, and nearly 60% of patients who complete therapy get relapsed. Overall survival after relapse depends on risk stratification. INSS stage 1 patients have an overall survival rate approaching 70%, compared with an overall survival rate of 40% in stage 2 patients and 2% in stage 4 patients.

• The disease epidemiology covered in the report provides historical as well as forecasted Neuroblastoma epidemiology [segmented as Total Incident Cases of Neuroblastoma, Gender-specific Incident Cases of Neuroblastoma, Age-specific Incident Cases of Neuroblastoma, and Incident Patient Population of Neuroblastoma by Risk Groups] in the 7MM covering the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan from 2019 to 2032.

Country Wise- Neuroblastoma Epidemiology

This section provides a glimpse of the Neuroblastoma epidemiology in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, and Japan.

Learn more about the evolving epidemiology trends and development: Neuroblastoma Epidemiology Forecast

Neuroblastoma Drug Chapters

The drug chapter segment of the Neuroblastoma report encloses the detailed analysis of Neuroblastoma marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Neuroblastoma 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.

Neuroblastoma Marketed Drugs

UNITUXIN (dinutuximab): United Therapeutics

It was first approved in 2015 by the US FDA for use in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (retinoic acid) for the treatment of pediatric patients with high-risk neuroblastoma who achieved at least a partial response to prior first-line.

QARZIBA (dinutuximab beta): EUSA Pharma

Qarziba (EUSA Pharma), was approved by the European Commission in May 2017. Indicated for high-risk neuroblastoma in patients aged 12 months and above, who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with a history of relapsed or refractory neuroblastoma, with or without the residual disease. In patients with a history of relapsed/refractory disease and patients who have not achieved a complete response after first-line therapy, Dinutuximab beta should be combined with interleukin-2 (IL-2). The company is currently evaluating the drug in phase Ib in combination with induction chemotherapy regimens in patients with newly diagnosed high-risk neuroblastoma. Additionally, phase II trial is being conducted as monotherapy in patients with relapsed or refractory (R/R) neuroblastoma, sponsored by University Medicine Greifswald.

Note: Detailed Current therapies assessment will be provided in the the full report of Neuroblastoma

Neuroblastoma Emerging Drugs

Omburtamab (Y-mabs therapeutics) is in phase II/III Neuroblastoma clinical trial stage for the treatment of Neuroblastoma (Pediatrics). The drug act by binding to FG loop-dependent conformation on the B7-H3 molecule, a domain critical for its biologic function. Omburtamab is proven to extend survival among high-risk patients with solid tumors suffering from central nervous system (CNS) metastasis. It is also proven safe when injected intraperitoneally in young adults with desmoplastic small round cell tumor of the peritoneum. In November 2021 the company provided update about pre-BLA meeting, which is to be held in January 2022 as the company is resubmitting the BLA for omburtamab. The FDA had granted Rare Pediatric Disease, Breakthrough, and Orphan designation to the drug. In May 2022, the company announced that the BLA for OMBLASTYS (omburtamab) for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma has been accepted for priority review by the FDA. The FDA set an action date of November 30, 2022, under the PDUFA. The company has also submitted a MAA to the EMA for omburtamab.

Clarity Pharmaceuticals is developing its lead product SARTATE which can target SSTR 2, combined with the pairing of copper radionuclides. By tailoring dose and delivering the optimal amount of radiation to the tumor site, SARTATE increases the likelihood of treatment efficacy, minimizes the side effects of the therapy, and thus improves patients’ quality of life. Currently the company is conducting phase I/II trial to evaluate the safety and efficacy of 67Cu-SARTATE in pediatric patients with high-risk neuroblastoma. The trial has been advanced to the Cohort 3. In April 2020, the US FDA granted Orphan Drug Designation for 67Cu-SARTATE, for the Neuroblastoma clinical management of neuroblastoma.

Note: Detailed emerging therapies assessment will be provided in the full report of Neuroblastoma

Neuroblastoma Market Outlook

Survival rates for neuroblastoma have gotten better as doctors have found ways to improve on current treatments, but survival rates for children with high-risk neuroblastoma are not as good as they are for children with low- or intermediate-risk disease. Most research studies about high-risk neuroblastoma (more aggressive and hard to treat tumors) focus on finding the best combinations of chemotherapy drugs, stem cell transplant regimens, immunotherapies, and other new treatments to try to cure more children. Current studies of low- and intermediate-risk neuroblastoma are trying to figure out if children can get less treatment and still do as well.

Current treatment for high-risk neuroblastomas can be divided into three distinct phases: induction of remission, consolidation of the remission, and finally a maintenance phase focused on the eradication of the minimal residual disease. Available data indicate that increasing the intensity of induction chemotherapy is associated with improvements in response rates and overall survival rates.

The initial step of treatment for Neuroblastoma patients in low & intermediate-risk groups is surgery followed by chemotherapies, radiation, and retinoid therapies (Isotretinoin). Radiations and Retinoid therapies are used only in intermediate-risk groups. The discussed therapies along with Stem Cell Transplantation and Immunotherapies (Qarziba and Unituxin) are also advised in high-risk groups of Neuroblastoma. Here, only the therapeutic Neuroblastoma market is estimated which includes all the treatments except Surgery, Radiation, and Transplantation.

Companies across the globe are working toward the development of new treatment therapies for Neuroblastoma, but few companies have made it to the Neuroblastoma clinical stage of development. Various companies are thoroughly working towards the development of potential therapies for Neuroblastoma. While some of the companies have recently shifted their focus towards this indication, yet others are expected to create a significant influence on the market size during the forecast period [2022–2032]. Some of the key players with products currently in the pipeline are Omburtamab (Y-mabs therapeutics), SARTATE (Clarity Pharmaceuticals), Racotumomab (Laboratorio Elea Phoenix) and several others.

According to DelveInsight, Neuroblastoma market in 7MM is expected to witness a major change in the study period 2019-2032.

Analyst Commentary

• The pipeline of Neuroblastoma is very robust, many potential therapies are being investigated for the treatment of Neuroblastoma, and it is safe to predict that the treatment space will experience a significant impact on the market during the forecast period.
• The expected introduction of emerging therapies with improved efficacy, more awareness initiatives programs, and further improvement in the diagnosis rate, are likely to boost the growth of the Neuroblastoma market in the 7MM. Aside from that, the market size of Neuroblastoma may flourish due to increased research and development, label-expansion of approved therapies into other epilepsy in this field.
• The market growth of Neuroblastoma may offset by failures and/or discontinuation of the emerging therapies, unaffordable pricing, market access and reimbursement issues, and a scarcity of healthcare specialists.

Neuroblastoma Drugs Uptake

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

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

Note: Detailed emerging therapies assessment will be provided in the full report of Neuroblastoma.

Neuroblastoma Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase II and Phase III stage. It also analyses Neuroblastoma key players involved in developing targeted therapeutics.

Neuroblastoma Clinical Trial Development Activities

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

Get an in-depth assessment of the emerging therapies and key companies: Neuroblastoma Pipeline Insight

Reimbursement Scenario in Neuroblastoma

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In a report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

KOL- Views

To keep up with current market trends, we take KOLs and SMEs ' opinions working in the Neuroblastoma domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or Neuroblastoma 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

We perform Competitive and Market Intelligence analysis of the Neuroblastoma Market by using various Competitive Intelligence tools that include - 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 Neuroblastoma Market Report

• The report covers the descriptive overview of Neuroblastoma, explaining its causes, signs and symptoms, pathophysiology, diagnosis, and currently available therapies
• Comprehensive insight has been provided into the Neuroblastoma epidemiology and treatment in the 7MM
• Additionally, an all-inclusive account of both the current and emerging therapies for Neuroblastoma are provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape
• A detailed review of the Neuroblastoma market; historical and forecasted is included in the report, covering drug outreach in the 7MM
• Detailed Patient Based Market Forecasting determines the trends shaping and driving the global Neuroblastoma market

Neuroblastoma Market Report Highlights

• In the coming years, the Neuroblastoma market is set to change due to the rising awareness of the disease, and incremental healthcare spending across the world; which would expand the size of the market to 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 Neuroblastoma 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 Neuroblastoma. The launch of emerging therapies will significantly impact the Neuroblastoma market
• A better understanding of disease pathogenesis will also contribute to the development of novel therapeutics for Neuroblastoma
• Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, 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

Neuroblastoma Report Insights

• Patient Based Market Forecasting
• Neuroblastoma Therapeutic Approaches
• Neuroblastoma Pipeline Analysis
• Neuroblastoma Market Size and Trends
• Neuroblastoma Market Opportunities
• Impact of upcoming Neuroblastoma Therapies

Neuroblastoma Report Key Strengths

• 11 Years Forecast
• 7MM Coverage
• Neuroblastoma Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Neuroblastoma Market
• Neuroblastoma Drugs Uptake

Neuroblastoma Report Assessment

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

Key Questions

Neuroblastoma Market Insights:

• What was the Neuroblastoma drug class share (%) distribution in 2019 and how it would look like in 2032?
• What would be the Neuroblastoma total market size as well as 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 Neuroblastoma market size during the forecast period (2019-2032)?
• At what CAGR, the Neuroblastoma market is expected to grow by 7MM during the forecast period (2019-2032)?
• What would be the Neuroblastoma market outlook across the 7MM during the forecast period (2019-2032)?
• What would be the Neuroblastoma market growth till 2032, and what will be the resultant market Size in the year 2032?
• How would the unmet needs affect the market dynamics and subsequent analysis of the associated trends?

Neuroblastoma Epidemiology Insights:

• What are the disease risk, burden, and regional/ethnic differences of Neuroblastoma?
• What are the key factors driving the epidemiology trend for seven major markets covering the United States, EU4 (Germany, Spain, Italy, and France) and the UK, and Japan?
• What is the historical Neuroblastoma patient pool in seven major markets covering the United States, EU4 (Germany, Spain, Italy, and France) and the UK, and Japan?
• What would be the forecasted patient pool of Neuroblastoma in seven major markets covering the United States, EU4 (Germany, Spain, Italy, and France) and the UK, and Japan?
• Where will be the growth opportunities in the 7MM concerning the patient population about Neuroblastoma?
• Out of all 7MM countries, which country would have the highest incident population of Neuroblastoma during the forecast period (2019-2032)?
• At what CAGR the patient population is expected to grow by 7MM during the forecast period (2019-2032)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

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

Reasons to buy

• The Patient Based Market Forecasting analysis will help in developing business strategies by understanding trends shaping and driving the Neuroblastoma market
• Organize sales and marketing efforts by identifying the best opportunities for Neuroblastoma in the US, Europe (Germany, Spain, Italy, and France) and the United Kingdom, and Japan
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors
• Organize sales and marketing efforts by identifying the best opportunities for the Neuroblastoma market
• To understand the future market competition in the Neuroblastoma market