Refractory Mesial Temporal Lobe Epilepsy (MTLE) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032

Refractory Mesial Temporal Lobe Epilepsy (MTLE) Market Outlook and Forecast

Refractory Mesial Temporal Lobe Epilepsy (MTLE) – Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032

Published Date : 2022-08-22

Updated On : 2023-07-06

Pages : 155

Refractory Mesial Temporal Lobe Epilepsy (MTLE) Market Outlook

Thelansis’s “Refractory Mesial Temporal Lobe Epilepsy (MTLE) Market Outlook, Epidemiology, Competitive Landscape, and Market Forecast Report – 2022 To 2032" covers disease overview, epidemiology, drug utilization, prescription share analysis, competitive landscape, clinical practice, regulatory landscape, patient share, market uptake, market forecast, and key market insights under the potential Refractory Mesial Temporal Lobe Epilepsy treatment modalities options for eight major markets (USA, Germany, France, Italy, Spain, UK, Japan, and China).

Refractory Mesial Temporal Lobe Epilepsy (MTLE) Overview

Refractory mesial temporal lobe epilepsy (MTLE), also known as drug-resistant or intractable MTLE, is a type of epilepsy that primarily affects the mesial temporal lobe of the brain and is characterized by seizures that do not respond well to standard antiepileptic medications. The mesial temporal lobe, which includes structures like the hippocampus and amygdala, plays a crucial role in memory and emotions. When these areas are affected by epilepsy, it can lead to a range of seizure types and cognitive impairments. The seizures observed in MTLE patients exhibit shared semiological traits with various other epileptic conditions, such as absence, insular, and occipital lobe seizures. In instances of absence seizures, patients often display a vacant gaze and subtle automatisms that can resemble MTLE seizures. Similarly, those experiencing insular seizures may present with epigastric auras and oro-alimentary automatisms akin to TLE. Furthermore, some individuals with occipital lobe epilepsy may have seizures that swiftly propagate anteriorly into the temporal lobes, yielding semiological features highly reminiscent of TLE. Notably, several medical conditions can also mimic temporal lobe seizures, including panic attacks, tardive dyskinesia, excessive daytime sleepiness, periodic limb movement disorder, transient psychotic episodes, and psychogenic non-epileptic seizures (PNES). As the primary therapeutic approach for MTLE, the initial course of action involves commencing appropriately selected antiepileptic drug (AED) treatment. Among AEDs employed for MTLE patients, those commonly used to address focal epilepsies include carbamazepine, oxcarbazepine, levetiracetam, lamotrigine, and topiramate. These agents may be administered individually or, more frequently, in combination to attain sufficient seizure control. Nonetheless, it is well-established that many MTLE patients exhibit an inadequate response to antiepileptic drugs, and some who initially respond may eventually become medically refractory within a few years. In cases of medically refractory or drug-resistant MTLE, non-pharmacological approaches become pivotal in patient management. These encompass both surgical and neurostimulation techniques. Surgical options for MTLE encompass open resection as well as less invasive procedures. Standard open resective surgery is widely regarded as the most effective and safe treatment for TLE, surpassing prolonged medical therapy in terms of long-term outcomes. Various surgical procedures have been employed, including standard anterior temporal lobectomy, anteromedial temporal lobectomy, selective amygdalohippocampectomy, and temporal pole resection.

Geography Covered:

North America- the United States and Canada

Europe- EU5 (Germany, France, Italy, Spain, and the United Kingdom)

Other countries- Japan & China

Study Period: 2022-2032

Current Clinical Practice and Treatment Algorithm

This section of the study covers country-specific current clinical practice, the standard of care, and significant limitations around addressing the unmet needs. Retrospective analysis and bench-marking of clinical study outcomes are presented in terms of Pre-treatment & post-treatment clinical and demographic patient characteristics. Essentially, this section will cover the evolution of the current competitive landscape and its impact on the future treatment paradigm.

KOL Insights:

KOLs across 8 MM markets from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs

Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

- Data Inputs with sourcing

- Market Event and Product Event

- Country-specific Forecast Model

- Market uptake and patient share uptake

- Attribute Analysis

- Analog Analysis

- Disease burden and pricing scenario

- Summary and Insights

NPV/ IRR Calculator-

Optimization of cash flow/ revenue flow concerning all fixed and variable investments throughout the product development process. The rate of return on an investment is a critical indicator to ensure the profitability and break-even of the project.

Competitive Landscape:

The competitive landscape includes country-specific approved as well as pipeline therapies. Any asset/product-specific designation or review such as Orphan drug designation, Fast track, Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation, and Accelerated Approval are tracked and supplemented with analyst commentary.

Clinical Trial Assessment-

Detailed clinical trial data analysis and critical product positioning include trial design, primary outcomes, secondary outcomes, dosing and schedules, inclusion and exclusion criteria, recruitment status and essentially covers the reported adverse events. Majorly the trial analysis helps determine the potential of the critical assets and their probable filing and launch date.

Unmet Medical Needs Overview-

This report presents the most important clinical unmet needs in the treatment, according to Thelansis research and analysis. Other essential unmet needs identified through our study include decreased cost burden on patients, improved administration convenience, and improved patient compliance.

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Refractory Mesial Temporal Lobe Epilepsy (MTLE) Competitive Landscape

S. no Asset Company Stage
1 AMT-260 uniQure N.V. Phase 1/2a

 

KOLs across 8 MM market from the center of Excellence/ Public/ Private hospitals participated in the study. Insights around current treatment landscape, epidemiology, clinical characteristics, future treatment paradigm, and Unmet needs.

COUNTRY No. Of KOLs
USA 17
GERMANY 4
UK 4
SPAIN 3
FRANCE 2
ITALY 3
JAPAN 3
CHINA 4

Refractory Mesial Temporal Lobe Epilepsy (MTLE) Market Forecast: Patient Based Forecast Model (MS. Excel Based Automated Dashboard)

Data Inputs with sourcing, Market Event, Product Event, Country specific Forecast Model, Market uptake and patient share uptake, Attribute Analysis, Analog Analysis, Disease burden, and pricing scenario, Summary, and Insights.

Refractory Mesial Temporal Lobe Epilepsy (MTLE) Market Forecast

1.  Refractory Mesial Temporal Lobe Epilepsy (MTLE) – Key Findings Summary

         1.1.    Clinical findings
                     1.1.1. Disease overview
                     1.1.2. Therapeutic practices
                     1.1.3. Future outlook
         1.2.    Commercial findings
                     1.2.1. Refractory Mesial Temporal Lobe Epilepsy (MTLE) market scenario 2022
                     1.2.2. Refractory Mesial Temporal Lobe Epilepsy (MTLE) market scenario 2025
                     1.2.3. Refractory Mesial Temporal Lobe Epilepsy (MTLE) market scenario 2032

2. Refractory Mesial Temporal Lobe Epilepsy (MTLE) Overview

         2.1.    Disease Introduction
         2.2.    Pathophysiology
         2.3.    Signs and Symptoms
         2.4.    Risk Factors
         2.5.    Etiology
         2.6.    Classification
         2.7.    Pathogenesis
         2.8.    Diagnosis
         2.9.    Complications
         2.10. Treatment Algorithm
                     2.10.1.    Treatment in US (guidelines)
                     2.10.2.    Treatment in EU-5 (guidelines)
                     2.10.3.    Treatment in Japan (guidelines)
                     2.10.4.    Treatment in China (guidelines)
         2.11. Treatment Goals for Refractory Mesial Temporal Lobe Epilepsy (MTLE)
         2.12. Referral Patterns
                     2.12.1.    Referral Scenario in US
                     2.12.2.    Referral Scenario in EU-5
                     2.12.3.    Referral Scenario in Japan
                     2.12.4.    Referral Scenario in China
         2.13. Refractory Mesial Temporal Lobe Epilepsy (MTLE) Prognosis
         2.14. Healthcare burden
                     2.14.1.    Healthcare burden in US
                     2.14.2.    Healthcare burden in EU-5
                     2.14.3.    Healthcare burden in Japan
                     2.14.4.    Healthcare burden in China
         2.15.  Unmet Needs in Refractory Mesial Temporal Lobe Epilepsy (MTLE) management
         2.16.  Market Opportunity for Refractory Mesial Temporal Lobe Epilepsy (MTLE)
         2.17. KOL Comments on current and upcoming/expected treatment practices in Refractory Mesial Temporal Lobe Epilepsy (MTLE)

3.       Epidemiology

         3.1.    Epidemiology Overview
         3.2.    Epidemiology by Geography
                     3.2.1. Refractory Mesial Temporal Lobe Epilepsy (MTLE) Epidemiology in US (2022-2032)
                             3.2.1.1.              Incidence of Refractory Mesial Temporal Lobe Epilepsy (MTLE)
                             3.2.1.2.              Diagnosed cases
                             3.2.1.3.              Treatable Patient Pool
                             3.2.1.4.              Epidemiology Trends
                     3.2.2. Refractory Mesial Temporal Lobe Epilepsy (MTLE) Epidemiology in EU-5 (2022-2032)
                             3.2.2.1.              Incidence of Refractory Mesial Temporal Lobe Epilepsy (MTLE)
                             3.2.2.2.              Diagnosed cases
                             3.2.2.3.              Treatable Patient Pool
                             3.2.2.4.              Epidemiology Trends
                     3.2.3. Refractory Mesial Temporal Lobe Epilepsy (MTLE) Epidemiology in Japan (2022-2032)
                             3.2.3.1.              Incidence of Refractory Mesial Temporal Lobe Epilepsy (MTLE)
                             3.2.3.2.              Diagnosed cases
                             3.2.3.3.              Treatable Patient Pool
                             3.2.3.4.              Epidemiology Trends
                     3.2.4. Refractory Mesial Temporal Lobe Epilepsy (MTLE) Epidemiology in China (2022-2032)
                             3.2.4.1.              Incidence of Refractory Mesial Temporal Lobe Epilepsy (MTLE)
                             3.2.4.2.              Diagnosed cases
                             3.2.4.3.              Treatable Patient Pool
                             3.2.4.4.              Epidemiology Trends
         3.3.    Epidemiology Trends (World-wide)

4.       Market Outlook

         4.1.    US Refractory Mesial Temporal Lobe Epilepsy (MTLE) Market Forecast 2022-2032
                     4.1.1. Market Progression (Futuristic)
                     4.1.2. Market Trends and Expectations
                             4.1.2.1.              Worst case scenario
                             4.1.2.2.              Base Case Scenario
                             4.1.2.3.              Best Case Scenario
                     4.1.3. Drivers and Barriers
         4.2.    UK Refractory Mesial Temporal Lobe Epilepsy (MTLE) Market Forecast 2022-2032
                     4.2.1. Market Progression (Futuristic)
                     4.2.2. Market Trends and Expectations
                             4.2.2.1.              Worst case scenario
                             4.2.2.2.              Base Case Scenario
                             4.2.2.3.              Best Case Scenario
                     4.2.3. Drivers and Barriers
         4.3.    France Refractory Mesial Temporal Lobe Epilepsy (MTLE) Market Forecast 2022-2032
                     4.3.1. Market Progression (Futuristic)
                     4.3.2. Market Trends and Expectations
                             4.3.2.1.              Worst case scenario
                             4.3.2.2.              Base Case Scenario
                             4.3.2.3.              Best Case Scenario
                     4.3.3. Drivers and Barriers
         4.4.    Germany Refractory Mesial Temporal Lobe Epilepsy (MTLE) Market Forecast 2022-2032
                     4.4.1. Market Progression (Futuristic)
                     4.4.2. Market Trends and Expectations
                             4.4.2.1.              Worst case scenario
                             4.4.2.2.              Base Case Scenario
                             4.4.2.3.              Best Case Scenario
                     4.4.3. Drivers and Barriers
         4.5.    Italy Refractory Mesial Temporal Lobe Epilepsy (MTLE) Market Forecast 2022-2032
                     4.5.1. Market Progression (Futuristic)
                     4.5.2. Market Trends and Expectations
                             4.5.2.1.              Worst case scenario
                             4.5.2.2.              Base Case Scenario
                             4.5.2.3.              Best Case Scenario
                     4.5.3. Drivers and Barriers
         4.6.    Spain Refractory Mesial Temporal Lobe Epilepsy (MTLE) Market Forecast 2022-2032
                     4.6.1. Market Progression (Futuristic)
                     4.6.2. Market Trends and Expectations
                             4.6.2.1.              Worst case scenario
                             4.6.2.2.              Base Case Scenario
                             4.6.2.3.              Best Case Scenario
                     4.6.3. Drivers and Barriers
         4.7.    Japan Refractory Mesial Temporal Lobe Epilepsy (MTLE) Market Forecast 2022-2032
                     4.7.1. Market Progression (Futuristic)
                     4.7.2. Market Trends and Expectations
                             4.7.2.1.              Worst case scenario
                             4.7.2.2.              Base Case Scenario
                             4.7.2.3.              Best Case Scenario
                     4.7.3. Drivers and Barriers
         4.8.    China Refractory Mesial Temporal Lobe Epilepsy (MTLE) Market Forecast 2022-2032
                     4.8.1. Market Progression (Futuristic)
                     4.8.2. Market Trends and Expectations
                             4.8.2.1.              Worst case scenario
                             4.8.2.2.              Base Case Scenario
                             4.8.2.3.              Best Case Scenario
                     4.8.3. Drivers and Barriers
         4.9.    Key Expected Milestones (world-wide) Impacting the Market

5.       Competitive Landscape

         5.1.    Pipeline Therapies Overview
                     5.1.1. Phase III Therapies
                                      5.1.1.1.                     Current Status
                                      5.1.1.2.                     Trial details, results
                                      5.1.1.3.                     Approval Timeline
                                      5.1.1.4.                     Likelihood of approval
                                      5.1.1.5.                     Expected Product Positioning
                             5.1.1.2.              All other Phase III Therapies …..
                             5.1.1.3.              Attribute Analysis of Phase III molecules
                     5.1.2.  Phase II and Phase I/II Therapies
                                      5.1.2.1.                     Current Status
                                      5.1.2.2.                     Trial details, results
                                      5.1.2.3.                     Approval Timelines
                     5.1.3. List of active Pre-clinical Therapies
                                      5.1.3.1.                     Status in Refractory Mesial Temporal Lobe Epilepsy (MTLE)
                                      5.1.3.2.                     Company positioning
                             5.1.3.2.              All other pre-clinical therapies
                     5.1.4. List of Inactive/discontinued assets
                             5.1.4.1.              Business impact of discontinuations on current pipeline
                     5.1.5. Potential winners from Refractory Mesial Temporal Lobe Epilepsy (MTLE) Pipeline
                             5.1.5.1.              Potential Blockbusters across the pipeline

6.       Regulatory/Approval Scenario

         6.1.    Regulatory/Approval Framework in US
                     6.1.1. Policy Framework
                     6.1.2. Payer Expectations
         6.2.    Regulatory/Approval Framework in UK
                     6.2.1. Policy Framework
                     6.2.2. Payer Expectations
         6.3.    Regulatory/Approval Framework in France
                     6.3.1. Policy Framework
                     6.3.2. Payer Expectations
         6.4.    Regulatory/Approval Framework in Germany
                     6.4.1. Policy Framework
                     6.4.2. Payer Expectations
         6.5.    Regulatory/Approval Framework in Italy
                     6.5.1. Policy Framework
                     6.5.2. Payer Expectations
         6.6.    Regulatory/Approval Framework in Spain
                     6.6.1. Policy Framework
                     6.6.2. Payer Expectations
         6.7.       Regulatory/Approval Framework in Japan
                     6.7.1. Policy Framework
                     6.7.2. Payer Expectations
         6.8.       Regulatory/Approval Framework in China
                     6.8.1. Policy Framework
                     6.8.2. Payer Expectations

7.       Clinical Trial Assessment – Current and Future Paradigm

         7.1.    Distribution of Primary Endpoints across trials
         7.2.    Distribution of Secondary Endpoints across trials
         7.3.    Evolution and acceptance of surrogate endpoints
         7.4.    Key Investigator initiated trials
         7.5.    Attrition analysis
                     7.5.1. Suspended/Discontinued Assets
                     7.5.2. Failed Trials, Reasons and Business Impact
                     7.5.3. Terminated Trials, Reasons and Business Impact
                     7.5.4. Withdrawn Trials, Reasons and Business Impact
         7.6.    Trial enrollment scenario and challenges
         7.7.    Clinical Trial Guidance (across geographies)

8.       Thelansis Commentary

         8.1.    Key Unmet needs in Refractory Mesial Temporal Lobe Epilepsy (MTLE)
         8.2.    Possible Best-case Clinical Trial Strategies
         8.3.    Possible Best Case Targeted Product Profile (TPP)
         8.4.    Possible Best-case Market positioning strategies
         8.5.    Possible Best-case Market Access Strategies
         8.6.    Possible Best-case LCM Strategies
         8.7.    Overall View on Refractory Mesial Temporal Lobe Epilepsy (MTLE) Market in Dollar Value

9.       Report Methodology

         9.1.    Secondary research
         9.2.    Primary research
         9.3.    Data collation
         9.4.    Insight Generation

10.   About Thelansis

         10.1.    Our Capabilities
         10.2.    Our Services
         10.3.    Our Contacts
         10.4.    Disclaimer