청신경초종 시장 : 시장 인사이트, 역학 및 시장 예측(2034년)

Key Highlights:

• Acoustic neuroma (also known as, vestibular schwannoma, or acoustic neurilemoma) is a benign, usually slow-growing tumor that develops from the balance and hearing nerves supplying the inner ear. The tumor comes from an overproduction of Schwann cells-the cells that normally wrap around nerve fibers like onion skin to help support and insulate nerves.
• As the acoustic neuroma grows, it affects the hearing and balance nerves, usually causing unilateral (one-sided) or asymmetric hearing loss, tinnitus (ringing in the ear), and dizziness/loss of balance. As the tumor grows, it can interfere with the face sensation nerve (the trigeminal nerve), causing facial numbness.
• According to our finding, the overall incidence of vestibular schwannoma is approximately 3 to 5 per 100,000 person-years. The incidence rises with advancing age. For patients over 70 years of age, the incidence may be as high as 21 per 100,000 person-years.
• There are currently no FDA-approved drugs or therapies specifically indicated for acoustic neuroma, underscoring a major therapeutic void in neuro-oncology. Despite its potential to cause debilitating symptoms such as hearing loss, imbalance, and facial nerve dysfunction, treatment remains limited to surgery or radiotherapy-both associated with significant risks.
• Bevacizumab is one of the off-label treatment for acoustic neuroma, especially in neurofibromatosis type 2 patients, showing tumor shrinkage and hearing preservation in many cases. Other off-label agents include lapatinib and everolimus, which have shown potential in early studies. These treatments are considered when surgery or radiation isn't suitable.
• The drug development pipeline for acoustic neuroma remains remarkably limited, with only one known candidate in active development-AK-antiVEGF by Akouos. This underscores a significant unmet clinical need in this rare, typically benign tumor that affects the vestibulocochlear nerve.

Report Summary

• The report offers extensive knowledge regarding the epidemiology segments and predictions, presenting a deep understanding of the potential future growth in diagnosis rates, disease progression, and treatment guidelines. It provides comprehensive insights into these aspects, enabling a thorough assessment of the subject matter.
• Additionally, an all-inclusive account of the current management techniques and emerging therapies and the elaborative profiles of late-stage (Phase III and Phase II) and prominent therapies that would impact the current treatment landscape and result in an overall market shift has been provided in the report.
• The report also encompasses a comprehensive analysis of the acoustic neuroma market, providing an in-depth examination of its historical and projected market size (2020-2034). It also includes the market share of therapies, detailed assumptions, and the underlying rationale for our methodology. The report also includes drug outreach coverage in the 7MM region.
• The report includes qualitative insights that provide an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, including experts from various hospitals and prominent universities, patient journey, and treatment preferences that help shape and drive the 7MM acoustic neuroma market.

Acoustic Neuroma Understanding and Treatment

Acoustic Neuroma Overview

Acoustic neuromas are tumors that develop from the sheath of Schwann cells. They tend to occupy the cerebellopontine angle and are usually found adjacent to the cochlear or vestibular nerve, either intracranially or extra-axially. This activity reviews the etiology, evaluation, and management of acoustic neuromas and highlights the collaboration among the interprofessional team in caring for patients with this condition.

Acoustic neuroma is also known by other names such as vestibular schwannoma, acoustic neurinoma, vestibular neuroma, and acoustic neurofibroma. Acoustic neuroma can occur either intracranially or extra-axially.

Bilateral acoustic neuromas can be associated with neurofibromatosis type 2, which is caused by a defect on chromosome 22q12.2 at the location of the neurofibromin 2 gene, responsible for encoding the merlin protein. Studies have indicated a predisposing mutation for the development of acoustic neuroma. Additionally, radiation exposure may increase the likelihood of developing this condition.

Acoustic Neuroma Diagnosis

Early signs of acoustic neuroma include unilateral or asymmetric hearing loss, tinnitus, and balance issues such as dizziness. However, early detection can be challenging, as symptoms may be mild or absent in the initial stages. These signs are also common in other middle and inner ear disorders, but when they occur on one side or unevenly, they raise greater concern.

When symptoms arise, a comprehensive ear evaluation along with hearing and balance tests-such as an audiogram, electronystagmography, and auditory brainstem responses-is crucial for accurate diagnosis. Magnetic resonance imaging (MRI) plays a key role in the early detection of acoustic neuroma, aiding in identifying the tumor's location and size, and guiding surgical planning.

Acoustic Neuroma Treatment

Acoustic neuroma can be treated in several ways. The treatment options may include the following:

• Observation: If the tumor is small and not causing significant symptoms, monitoring the tumor's growth over time is the ideal management. This approach is also considered for older patients with numerous comorbidities.
• Stereotactic radiotherapy: This treatment involves using high-energy radiation to destroy the tumor cells. Gamma Knife, or Cyberknife, is a precise radiation therapy commonly used.
• Surgery: Surgical tumor removal may be necessary for larger tumors or those causing symptoms.

Acoustic Neuroma Epidemiology

The acoustic neuroma epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total Incident cases, total diagnosed incident cases, age-specific cases, and gender-specific cases, in the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• As per Greene J et al. (2024), Schwannomas account for approximately 8% of all clinically manifested intracranial tumors. However, genetic factors contribute to developing bilateral acoustic neuromas, constituting less than 5% of all schwannomas.
• There is a slight female preponderance, and symptoms can worsen during pregnancy. Generally, acoustic neuromas are diagnosed between the fourth to sixth decades of life. Although rare, acoustic schwannomas can occur in children.
• The hereditary form of acoustic neuroma is more commonly associated with NF II than neurofibromatosis type 1 (NF I), despite NFI being more prevalent. NF I is exclusively linked to unilateral acoustic neuroma in 24% of cases, while bilateral acoustic schwannoma is a hallmark feature of NF II.
• As per National Organization for Rare Diseases (NORD):
• Acoustic neuromas are estimated to affect about 1 in 100,000 people in the general population.
• Acoustic neuromas affect women more often than men. Most cases of acoustic neuroma develop in individuals between the ages of 30 and 60. Although quite rare, they can develop in children.
• It is estimated to affect about 1 in 100,000 people in the general population.
• Approximately 2,500 new patients are diagnosed each year. The incidence has risen in the last several years.

Acoustic Neuroma Drug Chapters

The section dedicated to drugs in the acoustic neuroma report provides an in-depth evaluation of late-stage pipeline drugs (Phase III and Phase II) related to acoustic neuroma. The drug chapters section provides valuable information on various aspects related to clinical trials of acoustic neuroma, such as the pharmacological mechanisms of the drugs involved, designations, approval status, patent information, and a comprehensive analysis of the pros and cons associated with each drug. Furthermore, it presents the most recent news updates and press releases on drugs targeting acoustic neuroma.

Emerging Therapies

AK-antiVEGF: Akouos

K-antiVEGF is a gene therapy intended for the treatment of individuals with vestibular schwannoma. Also known as acoustic neuroma, vestibular schwannoma is a benign, usually slow-growing tumor arising from Schwann cells surrounding the vestibulocochlear nerve, the nerve that sends information about hearing and balance to the brain. Symptoms of vestibular schwannoma may range from hearing loss and imbalance to even more serious neurological problems.

Vascular endothelial growth factor (VEGF) is a protein that promotes the growth of blood vessels and plays a role in vestibular schwannoma progression. VEGF inhibitors (anti-VEGF proteins) may slow or reverse the growth of vestibular schwannoma and potentially stabilize or improve hearing. AK-antiVEGF uses an adeno-associated viral (AAV) vector to deliver to the cells of the inner ear a DNA sequence that provides instructions to create an anti-VEGF protein; the goal is to achieve local exposure of an anti-VEGF protein in the vestibular schwannoma environment that could block VEGF production while limiting systemic effects.

A Phase I/II clinical trial of AK-antiVEGF was initiated for individuals with unilateral vestibular schwannoma.

Acoustic Neuroma Market Outlook

During the forecast period (2025-2034), pipeline candidates such as AK-antiVEGF: Akouos and others are expected to drive the rise in acoustic neuroma market size.

The acoustic neuroma market is poised for steady growth driven by improved diagnostic capabilities, increasing awareness, and advancements in treatment modalities such as stereotactic radiosurgery, microsurgical techniques, and targeted therapeutics. The rising prevalence of neurofibromatosis type 2 (NF2)-associated tumors and an aging global population are contributing to the growing patient pool.

Market expansion is further supported by the development of novel therapies targeting tumor growth and hearing preservation, including anti-VEGF agents such as Akouos's AK-antiVEGF currently in clinical development.

While current standard-of-care options include surgical resection, radiation, and active surveillance, the need for treatments that reduce tumor burden while preserving nerve function continues to drive innovation.

In a nutshell, therapies are being investigated to manage acoustic neuroma. Even though it is too soon to comment on the above-mentioned promising candidate to enter the market during the forecast period (2024-2034), it is safe to assume that the future of this market is bright. Eventually, these drugs will create a significant difference in the landscape of acoustic neuroma in the coming years. The treatment space is expected to experience a significant positive shift in the coming years owing to the improvement in healthcare spending worldwide.

Acoustic Neuroma Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2024-2034, which depends on the competitive landscape, safety, and efficacy data along with 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.

Acoustic Neuroma Activities

The report provides insights into different therapeutic candidates in 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 for acoustic neuroma emerging therapies.

KOL Views

To stay abreast of the latest trends in the market, we conduct primary research by seeking the opinions of Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) who work in the relevant field. This helps us fill any gaps in data and validate our secondary research.

We have reached out to industry experts to gather insights on various aspects of acoustic neuroma, including the evolving treatment landscape, patients' reliance on conventional therapies, their acceptance of therapy switching, drug uptake, and challenges related to accessibility. The experts we contacted included medical/scientific writers, professors, and researchers from prestigious universities in the US, Europe, the UK, and Japan.

Our team of analysts at Delveinsight connected with more than 10 KOLs across the 7MM. We contacted institutions such as the University of Munich, the University of Tokyo, Johns Hopkins Acoustic Neuroma Center, and University of Minnesota, etc., among others. By obtaining the opinions of these experts, we gained a better understanding of the current and emerging treatment patterns in the acoustic neuroma market, which will assist our clients in analyzing the overall epidemiology and market scenario.

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 disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, designation, 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 trials for acoustic neuroma, one of the most important primary endpoints was frequency of Adverse Events (AEs) etc. Based on these, the overall efficacy is evaluated.

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 route of administration, order of entry and designation, 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

Because newly authorized drugs are often expensive, some patients escape receiving proper treatment or use off-label, less expensive prescriptions. Reimbursement plays a critical role in how innovative treatments can enter the market. The cost of the medicine, compared to the benefit it provides to patients who are being treated, sometimes determines whether or not it will be reimbursed. Regulatory status, target population size, the setting of treatment, unmet needs, the number of incremental benefit claims, and prices can all affect market access and reimbursement possibilities.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved 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.

Acoustic Neuroma Report Insights

• Patient Population
• Therapeutic Approaches
• Acoustic Neuroma Market Size and Trends
• Existing Market Opportunity

Acoustic Neuroma Report Key Strengths

• Ten-year Forecast
• The 7MM Coverage
• Acoustic Neuroma Epidemiology Segmentation
• Key Cross Competition

Acoustic Neuroma Report Assessment

• Current Treatment Practices
• Reimbursements
• Market Attractiveness
• Qualitative Analysis (SWOT, Conjoint Analysis, Unmet needs)

Key Questions:

• Would there be any changes observed in the current treatment approach?
• Will there be any improvements in acoustic neuroma management recommendations?
• Would research and development advances pave the way for future tests and therapies for acoustic neuroma?
• Would the diagnostic testing space experience a significant impact and lead to a positive shift in the treatment landscape of acoustic neuroma?
• What kind of uptake will the new therapies witness in the coming years in acoustic neuroma patients?

Table of Contents

1. Key Insights

2. Report Introduction

3. Acoustic Neuroma Market Overview at a Glance

• 3.1. Market Share (%) Distribution of Acoustic Neuroma by Country in 2024 in the 7MM
• 3.2. Market Share (%) Distribution of Acoustic Neuroma by Country in 2034 in the 7MM

4. Methodology

5. Executive Summary

6. Key Events

7. Disease Background and Overview

• 7.1. Introduction
• 7.2. Classification
• 7.3. Signs and Symptoms
• 7.4. Risk Factors and Causes
• 7.5. Pathophysiology
• 7.6. Complications
• 7.7. Diagnosis
  • 7.7.1. Diagnostic Guidelines
  • 7.7.2. Differential Diagnosis
  • 7.7.3. Diagnostic Algorithm

8. Treatment and Management

• 8.1. Treatment Guidelines
• 8.2. Treatment Algorithm

9. Epidemiology and Patient Population

• 9.1. Key Findings
• 9.2. Assumptions and Rationale
• 9.3. Total Incident Cases of Acoustic Neuroma in the 7MM
• 9.4. The United States
  • 9.4.1. Total incident Cases of acoustic neuroma in the United States
  • 9.4.2. Total Diagnosed incident Cases of acoustic neuroma in the United States
  • 9.4.3. Age-specific Cases of acoustic neuroma in the United States
  • 9.4.4. Gender-specific Cases of acoustic neuroma in the United States
• 9.5. EU4 and the UK
  • 9.5.1. Total incident Cases of acoustic neuroma in EU4 and the UK
  • 9.5.2. Total Diagnosed incident Cases of acoustic neuroma in EU4 and the UK
  • 9.5.3. Age-specific Cases of acoustic neuroma in EU4 and the UK
  • 9.5.4. Gender-specific Cases of acoustic neuroma in EU4 and the UK
• 9.6. Japan
  • 9.6.1. Total incident Cases of acoustic neuroma in Japan
  • 9.6.2. Total Diagnosed incident Cases of acoustic neuroma in Japan
  • 9.6.3. Age-specific Cases of acoustic neuroma in Japan
  • 9.6.4. Gender-specific Cases of acoustic neuroma in Japan

10. Patient Journey

11. Emerging Therapies

• 11.1. Key Cross Competition
• 11.2. AK-antiVEGF: Akouos
  • 11.2.1. Product Description
  • 11.2.2. Other Developmental Activities
  • 11.2.3. Clinical Development
  • 11.2.4. Safety and Efficacy
  • 11.2.5. Analyst View

12. Acoustic Neuroma- Seven Major Market Analysis

• 12.1. Key Findings
• 12.2. Market Outlook
• 12.3. Conjoint Analysis
• 12.4. Key Market Forecast Assumptions
  • 12.4.1. Cost Assumptions and Rebate
  • 12.4.2. Pricing Trends
  • 12.4.3. Analogue Assessment
  • 12.4.4. Launch Year and Therapy Uptake
• 12.5. Market Size in the 7MM
  • 12.5.1. Total Market Size of Acoustic Neuroma in the 7MM
  • 12.5.2. Market Size of Acoustic Neuroma by Therapies in the 7MM
• 12.6. Market Size in the United States
  • 12.6.1. Total Market Size of Acoustic Neuroma in the United States
  • 12.6.2. Market Size of Acoustic Neuroma by Therapies in the United States
• 12.7. Market Size in EU4 and the UK
  • 12.7.1. Total Market size of Acoustic Neuroma in EU4 and the UK
  • 12.7.2. Market Size of Acoustic Neuroma by Therapies in EU4 and the UK
• 12.8. Market Size in Japan
  • 12.8.1. Total Market Size of Acoustic Neuroma in Japan
  • 12.8.2. Market size of Acoustic Neuroma by Therapies in Japan

13. KOL Views

14. SWOT Analysis

15. Unmet Needs

16. Market Access and Reimbursement

• 16.1. United States
  • 16.1.1. Centre for Medicare and Medicaid Services (CMS)
• 16.2. EU4 and the UK
  • 16.2.1. Germany
  • 16.2.2. France
  • 16.2.3. Italy
  • 16.2.4. Spain
  • 16.2.5. United Kingdom
• 16.3. Japan
  • 16.3.1. MHLW
• 16.4. Reimbursement Senario
  • 16.4.1. United States
  • 16.4.2. EU4 and the UK
  • 16.4.3. Japan

17. Appendix

• 17.1. Bibliography
• 17.2. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer