Summary

Overview
Global Refractory Status Epileptics Drugs Market reached US$ XX billion in 2022 and is expected to reach US$ XX billion by 2030, growing with a CAGR of XX% during the forecast period 2023-2030.
Refractory status epilepticus are referred to as persistent seizures that are resistant to two intravenous drugs, one of which is a benzodiazepine. Up to 40% of status epilepticus instances exhibit it, with acute symptomatic etiology being the most likely reason.
Drugs used for the the treatment of refractory status epileptics are benzodiazepines which include lorazepam and diazepam. Moreover, antiepileptic drugs include phenytoin, fosphenytoin, and valproic acid. Furthermore, anaesthetic agents such as midazolam and propofol. Lastly, barbiturates such as pentobarbital and thiopental are some of the treatments available in the market used for the treatment of refractory status epileptics.
Some of the other emerging drugs and methods used for the treatment of refractory status epileptics according to the National Library of Medicines(NLM), include hypothermia, steroids, immunosuppressive agents, electrical and magnetic stimulation therapies, emergent respective epilepsy surgery, ketogenic diet, pyridoxine infusion, cerebrospinal fluid drainage, and magnesium infusion.
Dynamics
Increase in the Announcement of New Methods by the Companies for the Status Epilepticus
An increase in the announcement of new methods by the companies for status epilepticus is expected to drive the market's growth.. For instance, on June 21, 2023, Marinus Pharmaceuticals announced a new method of use patent granted for IV Ganaxolone by the USPTO in status epilepticus.
Increase In FDA Clearance Of Companies' Software With The Inclusion Of Centers for Medicare and Medicaid Services (CMS) NTAP Coverage
An increase in FDA clearance of companies' software with the inclusion of CMS NTAP Coverage is expected to foster the growth of the global refractory status epileptics drugs market.
For instance, in August 2023, the FDA granted 510(k) clearance to Ceribell’s new software, named ClarityPro, for the diagnosis of electrographic status epilepticus (ESE) in adults above the age of 18, which became the first tool available in the market. Moreover, CMS gave new technology add-on payment (NTAP) for ClarityPro for up to $913.90 per eligible medicare patient case. Thus, owing to the above factors it is expected to drive the market's growth over the forecast period.
Stringent Regulatory Requirements
The pharmaceutical sector is governed by a number of laws and regulations, particularly when it comes to creating medications for severe illnesses such as refractory status epilepticus. It can be difficult and time-consuming to obtain regulatory approvals from organizations like the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). The availability of new RSE medications on the market may be delayed as a result of meeting these requirements, thus reducing treatment for patients options.
Segment Analysis
The global refractory status epileptics drugs market is segmented based on drug type, route of administration, distribution channel and region.
Benzodiazepines From The Drug Type to Hold a Dominant Position in the Market over the Forecast Period.
benzodiazepines from the drug type are expected to dominate the refractory status epileptics drugs market with a market share of 34.5%. For instance, In June 2022, anticonvulsant therapies in the benzodiazepine class successfully suppressed nearly 62% of all episodes of status epilepticus in children. First-line approaches usually include BZDs, which act to slow the excessive nerve cell activity that causes seizures.
Geographical Penetration
North America Holds The Largest Market Share In The Global Refractory Status Epileptics Drugs Market
North America dominates the global refractory status epileptics drugs market with a market share of around 41.3% in 2022. Furthermore, In March 2022, the FDA approved Ztalmy (ganaxolone) to treat seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older. CDD is a rare developmental epileptic encephalopathy (dysfunction of the brain) caused by CDKL5 gene mutations. Thus, owing to the above factors North America is expected to hold the largest share in the market over the forecast period.
Competitive Landscape
The major global players in the market include Pfizer, Almatica Pharma LLC., Teva Pharmaceuticals USA, Inc., Genentech, Inc., Viatris Inc., NAYZILAM, SiNi Pharma Pvt Ltd, H. Lundbeck A/S, Wellona Pharma and Bausch Health Companies Inc among others.
Market Segmentation
By Drug Type
• Benzodiazepines
o Lorazepam
o Diazepam
• Antiepileptic Drugs
o Phenytoin
o Fosphenytoin
o Valproic acid
o Others
• Anesthetic Agents
o Midazolam
o Propofol
• Barbiturates
o Pentobarbital
o Thiopental
o Others
By Route of Administration
• Oral
• Intravenous (IV)
• Intramuscular (IM)
• Sublingual or Buccal
• Others
By Distribution Channel
• Hospital Pharmacy
• Retail Pharmacy
• Online Pharmacy
By Region
• North America
o U.S.
o Canada
o Mexico
• Europe
o Germany
o UK
o France
o Italy
o Spain
o Rest of Europe
• South America
o Brazil
o Argentina
o Rest of South America
• Asia-Pacific
o China
o India
o Japan
o Australia
o Rest of Asia-Pacific
• Middle East and Africa
Key Developments
• In February 2021, Marinus Pharmaceuticals stated that they have enrolled their first patient in the phase 3 RAISE clinical trial of intravenous (IV) ganaxolone.
Why Purchase the Report?
• To visualize the global refractory status epileptics drugs market segmentation based on drug type, route of administration, distribution channel and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of cement market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.
The global refractory status epileptics drugs market report would provide approximately 61 tables, 61 figures and 227 Pages.
Target Audience 2023
• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

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Table of Contents

1. Methodology and Scope
1.1. Research Methodology
1.2. Research Objective and Scope of the Report
2. Definition and Overview
3. Executive Summary
3.1. Snippet by Drug Type
3.2. Snippet by Route of Administration
3.3. Snippet by Distribution Channel
3.4. Snippet by Region
4. Dynamics
4.1. Impacting Factors
4.1.1. Drivers
4.1.1.1. Increase in the Announcement of New Methods by the Companies for the Status Epilepticus
4.1.1.2. Increase In FDA Clearance Of Companies' Software with The Inclusion of CMS NTAP Coverage
4.1.2. Restraints
4.1.2.1. Stringent Regulatory Requirements
4.1.3. Opportunity
4.1.3.1.1. Emerging Treatment Options
4.1.4. Impact Analysis
5. Industry Analysis
5.1. Porter's Five Force Analysis
5.2. Supply Chain Analysis
5.3. Pricing Analysis
5.4. Regulatory Analysis
6. COVID-19 Analysis
6.1. Analysis of COVID-19
6.1.1. Scenario Before COVID
6.1.2. Scenario During COVID
6.1.3. Scenario Post COVID
6.2. Pricing Dynamics Amid COVID-19
6.3. Demand-Supply Spectrum
6.4. Government Initiatives Related to the Market During Pandemic
6.5. Manufacturers Strategic Initiatives
6.6. Conclusion
7. By Drug Type
7.1. Introduction
7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Type
7.1.2. Market Attractiveness Index, By Drug Type
7.2. Benzodiazepines *
7.2.1. Introduction
7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
7.2.3. Lorazepam
7.2.4. Diazepam
7.3. Antiepileptic Drugs
7.3.1. Phenytoin
7.3.2. Fosphenytoin
7.3.3. Valproic acid
7.3.4. Others
7.4. Anesthetic Agents
7.4.1. Midazolam
7.4.2. Propofol
7.5. Barbiturates
7.5.1. Pentobarbital
7.5.2. Thiopental
7.5.3. Others
8. By Route of Administration
8.1. Introduction
8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
8.1.2. Market Attractiveness Index, By Route of Administration
8.2. Oral *
8.2.1. Introduction
8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
8.3. Intravenous (IV)
8.4. Intramuscular (IM)
8.5. Sublingual or Buccal
8.6. Others
9. By Distribution Channel
9.1. Introduction
9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
9.1.2. Market Attractiveness Index, By Distribution Channel
9.2. Hospitals
9.2.1. Introduction
9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
9.3. Retail Pharmacy
9.4. Online Pharmacy
10. By Region
10.1. Introduction
10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
10.1.2. Market Attractiveness Index, By Region
10.2. North America
10.2.1. Introduction
10.2.2. Key Region-Specific Dynamics
10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Type
10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
10.2.6.1. U.S.
10.2.6.2. Canada
10.2.6.3. Mexico
10.3. Europe
10.3.1. Introduction
10.3.2. Key Region-Specific Dynamics
10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Type
10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
10.3.6.1. Germany
10.3.6.2. UK
10.3.6.3. France
10.3.6.4. Italy
10.3.6.5. Spain
10.3.6.6. Rest of Europe
10.4. South America
10.4.1. Introduction
10.4.2. Key Region-Specific Dynamics
10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Type
10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
10.4.5. Treatment Type
10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
10.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
10.4.7.1. Brazil
10.4.7.2. Argentina
10.4.7.3. Rest of South America
10.5. Asia-Pacific
10.5.1. Introduction
10.5.2. Key Region-Specific Dynamics
10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Type
10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
10.5.6.1. China
10.5.6.2. India
10.5.6.3. Japan
10.5.6.4. Australia
10.5.6.5. Rest of Asia-Pacific
10.6. Middle East and Africa
10.6.1. Introduction
10.6.2. Key Region-Specific Dynamics
10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Drug Type Market Size Analysis and Y-o-Y Growth Analysis (%), By Route of Administration
10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
11. Competitive Landscape
11.1. Competitive Scenario
11.2. Market Positioning/Share Analysis
11.3. Mergers and Acquisitions Analysis
12. Company Profiles
12.1. Pfizer *
12.1.1. Company Overview
12.1.2. Product Portfolio and Description
12.1.3. Financial Overview
12.1.4. Key Developments
12.2. Almatica Pharma LLC.
12.3. Teva Pharmaceuticals USA, Inc.
12.4. Genentech, Inc.
12.5. Viatris Inc.
12.6. NAYZILAM
12.7. SiNi Pharma Pvt Ltd
12.8. H. Lundbeck A/S
12.9. Wellona Pharma
12.10. Bausch Health Companies Inc.
LIST NOT EXHAUSTIVE
13. Appendix
13.1. About Us and Services
13.2. Contact Us