- The total drug-resistant epilepsy treatment market size is expected to grow positively by 2036 in the leading markets.
- The United States accounts for the largest market size of drug-resistant epilepsy, in comparison to EU4 (Germany, Italy, France, and Spain), the UK, and Japan.
- 20–40% of epilepsy patients in the US are likely have refractory epilepsy. This significant prevalence underscores the need for advanced treatment options.
- Leading drug-resistant epilepsy companies, such as Neurona Therapeutics, IAMA Therapeutics, Bright Minds Bio, and others, are developing new drug-resistant epilepsy treatment drugs that can be available in the drug-resistant epilepsy market in the coming years.
- The promising drug-resistant epilepsy therapies in clinical trials include NRTX-1001, IAMA-6, BM-101, and others.
- Rising Prevalence of Epilepsy and Drug-Resistant Cases: Increasing global incidence of epilepsy, particularly in pediatric and elderly populations, expands the addressable patient pool. A substantial subset of epilepsy patients (~30%) do not respond adequately to first-line antiepileptic drugs (AEDs), driving demand for specialized therapies and interventions.
- Advancements in Therapeutic Approaches: Technologies like vagus nerve stimulation (VNS), responsive neurostimulation (RNS), deep brain stimulation (DBS), and emerging neuromodulation platforms are expanding treatment options.
- Launch of Emerging DRE Therapies: The dynamics of the drug-resistant epilepsy market are anticipated to change in the coming years due to the launch of emerging drugs and devices, including NRTX-1001 (Neurona Therapeutics), IAMA-6 (IAMA Therapeutics), BM-101 (Bright Minds Bio), and others.
- The treatment paradigm for DRE, or more generally, its management strategies, comprises three main categories: pharmacotherapy, surgery, and alternative treatments, including neurostimulation, the ketogenic diet, and lifestyle changes.
- For about one in three people with epilepsy, medications are not sufficient, and seizures that persist despite two appropriate anti-seizure medications meet the definition of drug-resistant epilepsy.
- Vagus nerve stimulation (VNS) therapy, an FDA-approved neurostimulation modality, offers an alternative option when medications fail.
- Currently, no FDA-approved drugs exist specifically for DRE as a distinct condition, and available medications only target seizure reduction within defined seizure types or syndromes.
- Commonly used agents in refractory epilepsy, such as EPIDIOLEX, ZTALMY, XCOPRI, BANZEL, ONFI, and FYCOMPA, are utilized based on seizure phenotype rather than a DRE-specific indication.
- The therapeutic landscape is evolving, with investigational candidates such as NRTX-1001, IAMA-6, and BMB-101 exploring novel mechanisms, including network inhibition, synaptic excitability modulation, and biased receptor signaling.
- In January 2026, Bright Minds Biosciences reported positive Phase II BREAKTHROUGH trial results for BMB-101 in adults with drug-resistant absence seizures and developmental and epileptic encephalopathies, demonstrating up to a 73% median reduction in seizures, improved REM sleep, and favorable tolerability, with preparations underway for global registrational trials.
- In November 2025, Neurona Therapeutics announced that NRTX-1001 received EMA PRIME designation for the treatment of adults with drug-resistant focal epilepsy, supporting accelerated development and regulatory engagement in the EU.
- In April 2025, Neurona Therapeutics reported new results from its early-stage clinical trial of NRTX-1001, an experimental treatment for adults with drug-resistant mesial temporal lobe epilepsy (MTLE). The data was presented at this year’s American Academy of Neurology Annual Meeting in San Diego, offering a glimpse into potential progress for patients with limited treatment options.
- In April 2025, IAMA Therapeutics secured approximately 18 million USD in funding to advance its neuroscience pipeline, including lead candidate IAMA-6, which is currently being evaluated in a Phase I clinical trial (NCT06300398).
- Age- specific Diagnosed Prevalent Cases of Epilepsy
- Treatable Cases of Epilepsy
- DRE Cases
Drug-Resistant Epilepsy Market Forecast Report Metrics | Details |
Study Period | 2022–2036 |
Coverage | 7MM [The United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. |
Drug-Resistant Epilepsy Epidemiology Segmentation | Age- specific Diagnosed Prevalent Cases of Epilepsy, Treatable Cases of Epilepsy, and DRE Cases |
Key Drug-Resistant Epilepsy Companies | Neurona Therapeutics, IAMA Therapeutics, Bright Minds Bio, and others |
Key Drug-Resistant Epilepsy Therapies | NRTX-1001, IAMA-6, BM-101, and others |
- Therapeutic Assessment: Drug-Resistant Epilepsy current marketed and emerging therapies
- Drug-Resistant Epilepsy Market Dynamics: Key Market Forecast Assumptions of Emerging Drug-Resistant Epilepsy Drugs and Market Outlook
- Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Unmet Needs, KOL’s views, Analyst’s views, Drug-Resistant Epilepsy Market Access and Reimbursement
1 | Drug-Resistant Epilepsy Market Key Insights |
2 | Drug-Resistant Epilepsy Market Report Introduction |
3 | DRE Market Overview at a Glance |
3.1 | Market Share (%) Distribution of DRE by Therapies in 2025 |
3.2 | Market Share (%) Distribution of DRE by Therapies in 2036 |
4 | Executive Summary |
5 | Epidemiology and Market Methodology |
6 | Key Events |
7 | Disease Background and Overview |
7.1 | Introduction |
7.2 | Signs and Symptoms |
7.3 | Causes |
7.4 | Potential Mechanisms of Anti-Seizure Drug (ASD) Resistance |
7.5 | Classification |
7.6 | Risk Factors |
7.7 | Pathophysiology of Epilepsy |
7.8 | Diagnosis |
7.9 | Treatment |
8 | Epidemiology and Patient Population |
8.1 | Key Findings |
8.2 | Assumptions and Rationale: The 7MM |
8.3 | Total DRE Cases in the 7MM |
8.4 | United States |
8.4.1 | Age- specific Diagnosed Prevalent cases of Epilepsy |
8.4.2 | Treatable Cases of Epilepsy |
8.4.3 | DRE Cases |
8.5 | EU4 and the UK |
8.6 | Japan |
9 | Drug-Resistant Epilepsy Patient Journey |
10 | Marketed Drug-Resistant Epilepsy Therapies |
10.1 | Key Cross Competition |
10.2 | VNS System: LivoNova |
10.2.1 | Product Description |
10.2.2 | Other Development Activities |
10.2.3 | Clinical Development |
10.2.4 | Clinical Trials Information |
10.2.5 | Safety and Efficacy |
List to be continued in the report… | |
11 | Emerging Drug-Resistant Epilepsy Therapies |
11.1 | Key Cross Competition |
11.2 | NRTX-1001: Neurona Therapeutics |
11.2.1 | Drug Description |
11.2.2 | Other Developmental Activities |
11.2.3 | Clinical Trials Information |
11.2.4 | Safety and Efficacy |
11.2.5 | Analysts’ View |
11.3 | IAMA-6: IAMA Therapeutics |
11.4 | BM-101: Bright Minds Bio |
List to be continued in the report… | |
12 | Drug-Resistant Epilepsy Market: 7MM Analysis |
12.1 | Key Findings |
12.2 | Key Drug-Resistant Epilepsy Market Forecast Assumptions |
12.3 | Drug-Resistant Epilepsy Market Outlook |
12.4 | Attribute Analysis |
12.5 | Market Size of DRE in the 7MM |
12.6 | Total Market Size of DRE by Therapies in the 7MM |
12.7 | United States Drug-Resistant Epilepsy Market Size |
12.7.1 | Total Market Size of DRE |
12.7.2 | Market size of DRE by Therapies in the US |
12.8 | EU4 and the UK Drug-Resistant Epilepsy Market Size |
12.9 | Japan Drug-Resistant Epilepsy Market |
13 | Key Opinion Leaders’ Views on Drug-Resistant Epilepsy |
14 | Drug-Resistant Epilepsy Market SWOT Analysis |
15 | Drug-Resistant Epilepsy Market Unmet Needs |
16 | Drug-Resistant Epilepsy Market Access and Reimbursement |
16.1 | The United States |
16.2 | In EU4 and the UK |
16.3 | Japan |
17 | Bibliography |
18 | Acronyms and Abbreviations |
19 | Drug-Resistant Epilepsy Market Report Methodology |
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