역형성 성상세포종 시장 : 인사이트, 역학, 시장 예측(-2034년)

Key Highlights:

• Diffuse and anaplastic astrocytomas are among the most prevalent of all malignant brain and other CNS tumors.
• The available treatment options for anaplastic astrocytoma are surgery, radiation therapy, and chemotherapy. However, it's a malignant, fast-growing tumor that often infiltrates surrounding brain tissue, making complete surgical removal difficult. Additionally, these tumors can be resistant to standard treatments like chemotherapy and radiation.
• Currently, there is only one therapy approved for anaplastic astrocytoma, i.e., TEMODAR/TEMODAL (Merck).
• The pipeline is limited to only a few drugs in the pipeline including eflornithine (+ lomustine [Orbus Therapeutics], zotiraciclib (Cothera Bioscience), ONC206 (Jazz Pharmaceuticals/ Chimerix), CAN-3110 (Candel Therapeutics), and others.
• Candel Therapeutics is anticipating to report overall survival data in patients with recurrent high-grade glioma (rHGG) (basket trial having patients of anaplastic astrocytoma) from Phase Ib trial evaluating multiple doses of CAN-3110 in the fourth quarter of 2025.
• A pattern of trial failures for evaluating therapies for anaplastic astrocytoma has been observed in the past few years, creating a weakness and a threat for the industry to invest in further evaluations.
• The approval of emerging therapies in the coming years is expected to change the landscape for anaplastic astrocytoma, giving rise to many potential clinical trials and anaplastic astrocytoma treatment market.

DelveInsight's "Anaplastic Astrocytoma - Market Insight, Epidemiology and Market Forecast - 2034" report delivers an in-depth analysis of anaplastic astrocytoma epidemiology, market, and clinical development in anaplastic astrocytoma. In addition to this, the report provides historical and forecasted epidemiology and market data as well as a detailed analysis of the anaplastic astrocytoma market trends in the United States, EU4 (Germany, France, Italy, and Spain ), the United Kingdom, and Japan.

The anaplastic astrocytoma market report provides real-world prescription pattern analysis, emerging drugs assessment, market share, and uptake/adoption pattern of individual therapies, as well as historical and forecasted anaplastic astrocytoma market size from 2020 to 2034 in 7MM. The report also covers current anaplastic astrocytoma treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's underlying potential.

Geography Covered:

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

Anaplastic Astrocytoma Understanding and Treatment Algorithm

Anaplastic Astrocytoma Overview

Anaplastic astrocytoma is a rare malignant brain tumor. It originates from astrocytes, which are star-shaped cells in the brain that, along with similar cell types, make up the supportive tissue surrounding and protecting nerve cells in the brain and spinal cord. These supportive cells are known as glial cells, and the tissue they form is called glial tissue. Tumors that develop from this tissue, such as astrocytomas, are grouped under the term gliomas. Symptoms of anaplastic astrocytoma can differ based on the tumor's size and location within the brain. The exact cause of this tumor remains unknown.

Anaplastic Astrocytoma Diagnosis

Anaplastic astrocytoma is diagnosed through a comprehensive clinical assessment, a detailed medical history, and the use of various imaging methods such as Computerized Tomography (CT) and Magnetic Resonance Imaging (MRI). CT scans use X-rays and computer technology to generate cross-sectional images of internal tissues, while MRI employs magnetic fields and radio waves to produce detailed images of specific organs and body tissues. These imaging techniques help determine the tumor's size, location, and extent, and are also valuable in planning future surgical interventions.

Anaplastic Astrocytoma Treatment

The treatment of anaplastic astrocytoma typically involves a multidisciplinary team and is based on factors such as tumor location, size, grade, and the patient's overall health. The main treatment options include surgery, radiation therapy, and chemotherapy, which may be used alone or in combination. Surgery is often the first step to remove as much of the tumor as possible, followed by radiation and chemotherapy to target remaining cancer cells. In cases where surgery is not feasible, radiation may be used alone. Radiation therapy works by damaging the DNA of rapidly dividing cancer cells, while chemotherapy, though generally limited in effectiveness, may also be used, with only one drug currently approved for adults and none for children. Treatment plans are tailored to each patient through careful consultation with the healthcare team.

Anaplastic Astrocytoma Epidemiology

The anaplastic astrocytoma epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total incident cases of glioma, total incident cases of anaplastic astrocytoma, age-specific incident cases of anaplastic astrocytoma, mutation-specific incident cases of anaplastic astrocytoma, and treatable cases of anaplastic astrocytoma in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034.

• Anaplastic astrocytoma and glioblastoma multiforme are estimated to affect 5-8 people per 100,000 in the general population. Anaplastic astrocytomas are more common in adults than in children. In adults, anaplastic astrocytomas usually develop between 30 and 50 years of age.
• In anaplastic astrocytoma, there is substantial dominance in men, with a man-to-woman incidence reported as 1.87:1.
• The frequency of IDH-wildtype is slightly more than IDH-mutant in anaplastic astrocytomas.
• The incidence rate of anaplastic astrocytoma is higher in patients with 40 years and above.
• Japan reported 390 cases of anaplastic astrocytoma from 2016-2019.

Anaplastic Astrocytoma Drug Chapters

The drug chapter segment of the anaplastic astrocytoma report encloses a detailed analysis of anaplastic astrocytoma marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also deep dives into anaplastic astrocytoma's pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Marketed Drugs

TEMODAR/TEMODAL (temozolomide): Merck

The active pharmaceutical ingredient in TEMODAR/TEMODAL, is an imidazotetrazine derivative of the alkylating agent dacarbazine. Temozolomide is used for treating several brain cancer forms, e.g., as a second-line treatment for astrocytoma and a first-line treatment for GBM. TEMODAR/TEMODAL was initially commercialized by Merck in different countries, whereas Baxter Oncology was responsible for manufacturing TEMODAR injection. However, due to patent expiry, the market holds the generic version of the drug. Later, the gel formulation of temozolomide has also been approved by Double Bond Pharmaceuticals.

In September 2023, the US FDA approved updated labeling for TEMODAR under Project Renewal. The new indications included adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma and treatment of adults with refractory anaplastic astrocytoma.

Emerging Drugs

Eflornithine (+ Lomustine): Orbus Therapeutics

Eflornithine, also known as a-difluoromethylornithine (DFMO), is the only irreversible, metabolic inhibitor targeting ODC. This unique and precise mechanism of action inhibits production of a key enzyme that can cause tumor growth in certain types of cancer. Unlike multi-targeted tyrosine kinase inhibitors on the market or in development, eflornithine targets only one specific enzyme, ODC. Eflornithine was first approved by the FDA in 1990 for African trypanosomiasis but was never marketed in the US. In 2000, a topical cream was approved for reducing unwanted facial hair in women. It later gained approval in 2023 as maintenance therapy for high-risk neuroblastoma. In 2014, Orbus Therapeutics received Breakthrough Therapy Designation (BTD) for eflornithine in anaplastic glioma.

In 2024, Orbus Therapeutics completed the STELLAR Phase III study, which evaluated the efficacy and safety of eflornithine in combination with lomustine compared to lomustine alone in patients with anaplastic astrocytoma that recurs after surgery, irradiation, and adjuvant temozolomide chemotherapy. The combination achieved a clinically meaningful improvement in Overall Survival (OS) and Progression Free Survival (PFS) compared to lomustine as a single agent for those patients with Grade 3 IDH mutant astrocytoma who have progressed after irradiation and adjuvant temozolomide treatment.

Zotiraciclib (TG-02): Cothera Bioscience

Zotiraciclib is a potent oral CDK9 inhibitor that crosses the blood-brain barrier and down-regulates short-lived, anti-apoptotic oncogene proteins such as Myc. TG-02 is being developed for the treatment of high-grade glioma and diffuse intrinsic pontine glioma, both brain cancers characterized by Myc overexpression.

Zotiraciclib has completed a Phase Ib clinical trial sponsored and conducted by the US National Cancer Institute (NCI) to confirm the safety and demonstrate initial efficacy of zotiraciclib in combination with temozolomide in patients with recurrent high-grade glioma. The trial included patients with anaplastic astrocytoma as well. Currently, the product is getting evaluated in the Phase I/II for recurrent high-grade astrocytomas.

Drug Class Insights

In the indication of glioma, stage III has multiple indications including anaplastic astrocytoma. Anaplastic astrocytoma also has multiple mutations under it which can be utilized as biomarkers. However, currently, only a few drug classes can be observed in the pipeline like ODC inhibitor, CDK inhibitor, and DRD2 antagonist.

ODC inhibitors

ODC is a key enzyme in polyamine synthesis, essential for cell growth and DNA stability. Polyamines also affect cell communication and tumor suppression. ODC is often upregulated in cancers due to oncogenes like ras and myc. Its inhibition can reduce tumor growth and trigger cancer cell death. Eflornithine is a major asset in the Phase III being evaluated for recurrent anaplastic astrocytoma. The company is planning to get it launched in Europe and North America in the future.

Anaplastic Astrocytoma Market Outlook

Surgery is the first-line treatment for astrocytoma, enabling both diagnosis and maximal safe tumor removal. Advanced tools like neuronavigation, awake surgery, motor mapping, and fluorescent dyes help improve precision and safety. Adjuvant therapies include steroids (to reduce swelling), TEMODAR/TEMODAL (an approved DNA-damaging chemotherapy), radiation, bevacizumab (to reduce tumor blood supply), tumor-treating fields (scalp-applied electric fields), and antiseizure drugs. Experimental strategies under investigation include targeted therapies, immunotherapy, and virus-based approaches to selectively attack tumor cells.

There are few companies in the pipeline, evaluating their therapies for anaplastic astrocytoma. Among these, a major therapy is eflornithine. It is a Phase III therapy being investigated in combination with lomustine. However, the last updation by Orbus Therapeutics was in September 2024, which reported that in the STELLAR Phase III study, eflornithine and lomustine achieved a clinically meaningful improvement in Overall Survival (OS) and Progression Free Survival (PFS) compared to lomustine as a single agent for those patients with Grade 3 IDH mutant astrocytoma who have progressed after irradiation and adjuvant temozolomide treatment. Since then, no major updates have been observed regarding the product's development and transition to regulatory filing. Moreover, the trial status as per clinicaltrials.gov is being updated to "Unknown status" making the path to approval a bit anonymous. Henceforth, the future of astrocytoma treatment markets looks a bit challenging. Similarly, the Phase I/II trial of zotiraciclib is completed however, as per the Cothera Bioscience' s current showcased pipeline and website there are no updates regarding the further trials. This creates an uncertainty regarding the therapy. Some emerging therapies, like CAN-3110, are in their early Phases and that too with basket trial including some patients with anaplastic astrocytoma. This highlights the need for emerging therapies that specifically target anaplastic astrocytoma.

Key players, such as Orbus Therapeutics, Cothera Bioscience, Jazz Pharmaceuticals, and others, are evaluating their candidates in different stages of clinical development. They aim to investigate their products for the treatment of anaplastic astrocytoma.

Key Findings

• In April 2025, Jazz Pharmaceuticals announced the successful completion of its acquisition of Chimerix for approximately USD 935 million in cash.

Anaplastic Astrocytoma Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2025-2034, which depends on the competitive landscape, safety, and efficacy data, along with the order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Further detailed analysis of emerging therapies' drug uptake in the report...

Anaplastic Astrocytoma Activities

The report provides insights into different therapeutic candidates in the Phase III and Phase II stages. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details of anaplastic astrocytoma therapies.

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including Medical/scientific writers, Professors, and Others.

DelveInsight's analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as University of Florida, Charite University Hospital Berlin, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or anaplastic astrocytoma market trends.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.

Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug. In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs including Medicare, Medicaid, Health Insurance Program (CHIP), and the state and federal health insurance marketplaces are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs) and third-party organizations that provide services and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report:

• The report covers a segment of key events, an executive summary, a descriptive overview of anaplastic astrocytoma, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
• Additionally, an all-inclusive account of both the current and emerging therapies, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
• A detailed review of the anaplastic astrocytoma market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM anaplastic astrocytoma market.

Anaplastic Astrocytoma Report Insights

• Patient Population
• Therapeutic Approaches
• Anaplastic Astrocytoma Pipeline Analysis
• Anaplastic Astrocytoma Market Size and Trends
• Existing and future Market Opportunity

Anaplastic Astrocytoma Report Key Strengths

• Ten-year Forecast
• 7MM Coverage
• Anaplastic Astrocytoma Epidemiology Segmentation
• Key Cross Competition
• Conjoint analysis
• Drugs Uptake and Key Market Forecast Assumptions

Anaplastic Astrocytoma Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

• What is the historical and forecasted anaplastic astrocytoma patient pool/patient burden in the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan?
• Which combination of treatment approaches will have a significant impact on the anaplastic astrocytoma drug treatment market size?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?
• What are the current and emerging options for the treatment of anaplastic astrocytoma?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?
• How many key players are developing therapies for anaplastic astrocytoma?
• Which drug is the major contributor anaplastic astrocytoma market by 2034?

Reasons to buy:

• The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the anaplastic astrocytoma market.
• Insights on patient burden/disease Incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Table of Contents

1. Key Insights

2. Report Introduction of Anaplastic Astrocytoma

3. Executive Summary of Anaplastic Astrocytoma

4. Key Events of Anaplastic Astrocytoma

5. Epidemiology and Market Methodology of Anaplastic Astrocytoma

6. Anaplastic Astrocytoma: Market Overview at a Glance

• 6.1. Total Market Share (%) Distribution of Anaplastic Astrocytoma by Therapies in 2024
• 6.2. Total Market Share (%) Distribution of Anaplastic Astrocytoma by Therapies in 2034

7. Disease Background and Overview: Anaplastic Astrocytoma

• 7.1. Introduction
• 7.2. Risk Factors
• 7.3. Symptoms
• 7.4. Pathophysiology and disease pathways
• 7.5. Diagnostic Tests

8. Treatment and Guidelines of Anaplastic Astrocytoma

• 8.1. Current Treatment Landscape

9. Epidemiology and Patient Population of Anaplastic Astrocytoma

• 9.1. Key Findings
• 9.2. Assumptions and Rationale
• 9.3. Total Incident Cases of Anaplastic Astrocytoma in the 7MM
• 9.4. The United States
  • 9.4.1. Total Incident Cases of Glioma in the United States
  • 9.4.2. Total Incident Cases of Anaplastic Astrocytoma in the United States
  • 9.4.3. Age-specific Incident Cases Of Anaplastic Astrocytoma in The United States
  • 9.4.4. Mutation-specific Incident Cases of Anaplastic Astrocytoma in the United States
• 9.45. Total Treatable Cases of Anaplastic Astrocytoma
• 9.5. EU4 and the UK
  • 9.5.1. Total Incident Cases of Glioma in EU4 and the UK
  • 9.5.2. Total Incident Cases of Anaplastic Astrocytoma in EU4 and the UK
  • 9.5.3. Age-specific Incident Cases Of Anaplastic Astrocytoma in EU4 and the UK
  • 9.5.4. Mutation-specific Incident Cases of Anaplastic Astrocytoma in EU4 and the UK
  • 9.5.5. Total Treatable Cases of Anaplastic Astrocytoma in EU4 and the UK
• 9.6. Japan
  • 9.6.1. Total Incident Cases of Glioma in Japan
  • 9.6.2. Total Incident Cases of Anaplastic Astrocytoma in Japan
  • 9.6.3. Age-specific Incident Cases Of Anaplastic Astrocytoma in Japan
  • 9.6.4. Mutation-specific Incident Cases of Anaplastic Astrocytoma in Japan
  • 9.6.6. Total Treatable Cases of Anaplastic Astrocytoma in Japan

10. Patient Journey of Anaplastic Astrocytoma

11. Marketed Therapies of Anaplastic Astrocytoma

• 11.1. Key Competitors
• 11.2. TEMODAR/TEMODAL (temozolomide): Merck
  • 11.2.1. Product Description
  • 11.2.2. Regulatory Milestones
  • 11.2.3. Clinical Development
    • 11.2.3.1. Clinical Trials Information
  • 11.2.4. Safety and Efficacy
  • 11.2.5. Analyst Views

12. Emerging Therapies of Anaplastic Astrocytoma

• 12.1. Key Competitors
• 12.2. Eflornithine (+ Lomustine): Orbus Therapeutics
  • 12.2.1. Product Description
  • 12.2.2. Other Developmental Activities
  • 12.2.3. Clinical Development
    • 12.2.3.1. Clinical Trials Information
  • 12.2.4. Safety and Efficacy
  • 12.2.4. Analyst Views
• 12.3. Zotiraciclib (TG-02): Cothera Bioscience
  • 12.3.1. Product Description
  • 12.3.2. Other Developmental Activities
  • 12.3.3. Clinical Development
    • 12.3.3.1. Clinical Trials Information
  • 12.3.4. Safety and Efficacy
  • 12.3.5. Analyst Views

13. Anaplastic Astrocytoma: Seven Major Market Analysis

• 13.1. Key Findings
• 13.2. Market Outlook of Anaplastic Astrocytoma
• 13.3. Conjoint Analysis of Anaplastic Astrocytoma
• 13.4. Key Market Forecast Assumptions
  • 13.4.1. Cost Assumptions and Rebates
  • 13.4.2. Pricing Trends
  • 13.4.3. Analogue Assessment
  • 13.4.4. Launch Year and Therapy Uptakes
• 13.5. Total Market Size of Anaplastic Astrocytoma in the 7MM
• 13.6. United States
  • 13.6.1. Total Market Size of Anaplastic Astrocytoma in the United States
  • 13.6.2. Total Market Size of Anaplastic Astrocytoma by Therapies in the United States
• 13.7. EU4 and the UK
  • 13.7.1. Total Market Size of Anaplastic Astrocytoma in EU4 and the UK
  • 13.7.2. Total Market Size of Anaplastic Astrocytoma by Therapies in EU4 and the UK
• 13.8. Japan
  • 13.8.1. Total Market Size of Anaplastic Astrocytoma in Japan
  • 13.8.2. Total Market Size of Anaplastic Astrocytoma by Therapies in Japan

14. Unmet Needs of Anaplastic Astrocytoma

15. SWOT Analysis of Anaplastic Astrocytoma

16. KOL Views of Anaplastic Astrocytoma

17. Market Access and Reimbursement of Anaplastic Astrocytoma

18. Appendix

• 18.1. Bibliography
• 18.2. Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight