Cluster Headache Market

• The Cluster Headache Treatment Market Landscape encompasses a range of therapeutic options, including Triptans, Analgesics, and Verapamil, as well as others such as Ergot alkaloids and Lithium. Advanced treatments include Corticosteroids, VYEPTI, CIVAMIDE, and EMGALITY, reflecting a diverse and evolving market. 
• The total Cluster Headache Prevalent Cases were estimated at nearly 885 thousand cases in 2023 in the 7MM.
• The increasing Cluster Headache Prevalence is driven by rising awareness, improved diagnostic techniques, and potential environmental factors. The 7MM of Cluster Headaches are projected to grow at a significant Compound Annual Growth Rate (CAGR), highlighting its expanding impact on healthcare for the study period (2020–2034).
• According to DelveInsight's estimations, the United States accounted for the highest number of Cluster Headache Diagnosed Prevalent Cases among the 7MM in 2023, reaching approximately 203 thousand, underscoring its dominant share in the market.

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DelveInsight's “Cluster Headaches Market Insights, Epidemiology, and Market Forecast – 2034” report delivers an in-depth understanding of Cluster Headaches, historical and forecasted epidemiology as well as the Cluster Headaches market trends in the United States, EU4 (Germany, Spain, Italy, and France), the United Kingdom, and Japan.

Cluster Headaches Treatment Market Report provides current treatment practices, emerging drugs, and market share of the individual therapies, current and forecasted 7MM Cluster Headaches market size from 2020 to 2034. The report also covers current Cluster Headaches Treatment Market Practices/algorithms and unmet medical needs to curate the best of the opportunities and assess the underlying potential of the market.

Cluster Headaches Treatment Market: Understanding and Algorithm

Cluster headaches are an uncommon and excruciating form of primary neurovascular headaches, recognized as the most painful type. Characterized by unilateral pain typically located behind or above the eye or at the temple, cluster headaches manifest with clock-like regularity, often striking during the night. Cluster headaches are categorized into episodic (ECH) and chronic (CCH) forms, distinguished by the duration and frequency of attacks. Patients frequently exhibit trigeminal-autonomic symptoms such as ptosis, sweating, and miosis, alongside migraine-like features like photophobia and osmophobia. Misdiagnosis as migraine is common, leading to diagnostic delays of 5 to 7 years or more.

Cluster Headaches Diagnosis

For the diagnosis of secondary headaches with a cluster phenotype, it is recommended to perform magnetic resonance imaging (MRI) with or without contrast enhancement, focusing on fine slices through the pituitary gland region. This imaging technique is crucial, as pituitary tumors can present with symptoms resembling cluster headaches. In cases where a pituitary gland lesion is suspected or confirmed through imaging, a comprehensive laboratory evaluation of pituitary hormone levels should be conducted to assess any hormonal imbalances or dysfunctions that may be contributing to the headache phenotype. This combined approach ensures a thorough assessment, enabling accurate diagnosis and targeted treatment.

Further details related to diagnosis are provided in the report…

Cluster Headaches Treatment

Cluster headache treatment involves two key phases: fast-acting abortive therapy and preventive pharmacotherapy, with the primary focus on preventing attacks. Triptans, particularly injectable and intranasal sumatriptan, are central to acute management, while intranasal zolmitriptan also shows effectiveness. Recently, the FDA approved EMGALITY (galcanezumab-gnlm) as the first therapy specifically for episodic cluster headaches in adults. Emerging treatments like VYEPTI and Civamide are under development, potentially expanding future options for managing cluster headaches.

Cluster Headaches Epidemiology

As the market is derived using a patient-based model, the Cluster Headaches epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total Prevalence of Cluster Headaches, Diagnosed Cases of Cluster Headaches, Type-specific Cases of Cluster Headaches, Gender-specific Cases of Cluster Headaches, and Age-specific Cases of Cluster Headaches in the 7MM covering, the United States, EU4 countries (Germany, France, Italy, and Spain), United Kingdom, and Japan from 2020 to 2034. 

• Among EU4 and the UK, Germany had the highest prevalent cases of Cluster Headaches, with 98 thousand cases and Spain had the lowest cases which were 62 thousand, in 2023.
• According to DelveInsight's estimates, the type-specific cases of cluster headaches in the US were categorized into episodic and chronic forms. In 2023, the episodic type accounted for the majority of cases, with 162 thousand, compared to 41 thousand cases of the chronic type.
• Based on Gender-specific instances, there were 41 thousand males and 17.7 thousand females affected by Cluster Headaches in Germany in 2023.
• In Japan, based on age, the prevalent cases of Cluster Headaches were categorized into two groups: Below 18 and 18 and above age group, from which 18 and above accounted for the highest number of cases, approximately 72 thousand in 2023.

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Cluster Headaches Recent Developments

• In May 2025, shares of Amneal Pharmaceuticals (AMRX) rose slightly after the FDA approved its Brekiya autoinjector for treating migraines and cluster headaches in adults. The device enables self-administration of dihydroergotamine (DHE), typically given intravenously in clinical settings.
• In May 2025, Amneal Pharmaceuticals (Nasdaq: AMRX) announced FDA approval of Brekiya® (dihydroergotamine mesylate) autoinjector for the acute treatment of migraine with or without aura and cluster headaches in adults. Brekiya is the first and only DHE autoinjector, offering hospital-grade medication in a convenient, ready-to-use, self-administered device that requires no refrigeration or assembly. It provides sustained pain relief and may benefit patients who cannot tolerate or respond poorly to oral migraine therapies.

Cluster Headaches Drugs Market Chapters

The drug chapter segment of the Cluster Headaches drugs market report encloses a detailed analysis of Cluster Headaches off-label drugs and late-stage (Phase-III and Phase-II) Cluster Headache pipeline drugs analysis. It also helps to understand the Cluster Headaches clinical trials details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest Cluster Headache news and press releases.

Cluster Headache Marketed Drugs

• EMGALITY (Galcanezumab-gnlm): Eli Lilly and Company

EMGALITY (galcanezumab-gnlm) is a humanized IgG4 monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) ligand and blocks its interaction with the receptor. It is formulated as a sterile, preservative-free solution for subcutaneous injection, with a molecular weight of approximately 147 kDa.

Approved by the US FDA in June 2019 for treating episodic cluster headaches in adults, EMGALITY is the first CGRP antibody to receive such approval. It was initially approved in September 2018 for migraine prevention and has also been approved in the European Union for migraine prophylaxis. In March 2019, the FDA granted Priority Review and Breakthrough Therapy Designation for its use in episodic cluster headaches. 

Cluster Headache Emerging Drugs

VYEPTI (Eptinezumab): Lundbeck Seattle BioPharmaceutical

Eptinezumab is a monoclonal immunoglobulin G1 (IgG1) antibody that exhibits high specificity and affinity for both the α- and β-forms of human calcitonin gene-related peptide (CGRP). CGRP plays a critical role in the pathophysiology of migraine and cluster headaches by modulating neurogenic inflammation. Eptinezumab is currently in Phase III development, with recent advancements focusing on its efficacy and safety profile. The latest data highlights its potential to provide significant relief for cluster headache sufferers, with ongoing trials aimed at further validating its therapeutic benefit and optimizing its clinical application.

Cluster Headaches Market Outlook

Cluster Headache Treatment involves acute and preventive phases. Acute treatments include triptans (sumatriptan, zolmitriptan), high-flow oxygen, somatostatin, and its analogs, with triptans being the most commonly used. Analgesics like lidocaine and dihydroergotamine are additional options, while opioids and NSAIDs are not recommended due to questionable efficacy. Preventive therapy includes maintenance and transitional prophylaxis. Verapamil is the primary maintenance medication, valued for its safety and effectiveness. Corticosteroids, such as methylprednisolone, provide rapid control at treatment onset, while transitional prophylaxis supports maintenance therapy. Other options include methysergide, melatonin, and gabapentin, although methysergide is not available in the USA.

• EMGALITY (galcanezumab-gnlm), a CGRP antagonist, is FDA-approved for episodic cluster headaches but has not been approved for this indication in Europe. Clinical trials show that EMGALITY significantly reduces weekly attacks. Ongoing Phase III trials for new treatments like VYEPTI (Eptinezumab), and others aim to address existing therapy limitations and enhance efficacy.
• The total Cluster Headache Treatment Market Size in the 7MM was around USD 890 Million in 2023. This is estimated to increase by 2034 at a significant CAGR.
• In 2023, among the 7MM, the US captured the highest Cluster Headache Market Share which was around USD 467 Million.

Cluster Headaches Drugs Uptake

This section focuses on the uptake rate of potential Cluster Headache drugs expected to launch in the market during 2020–2034. For example, VYEPTI is expected to launch in the US in XXX. We expect the drug uptake to be XXX with a probability-adjusted peak share of around X%, and years to the peak are expected to be X years from the year of launch.

Cluster Headaches Pipeline Development Activities

The Cluster Headache therapeutics market report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key Cluster Headache Companies involved in developing targeted therapeutics. 

Pipeline Development Activities

The Cluster Headache therapeutics market report covers information on collaborations, acquisitions and mergers, licensing, and patent details for Cluster Headaches' emerging therapies. 

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KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate the secondary research. Industry Experts were contacted for insights on Cluster Headaches evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake along with challenges related to accessibility, including KOL from the Department of Neurology, Mayo Clinic, Scottsdale, Arizona, USA; Universitätsklinikum Essen, Neurologische Klinik Hufelandstr, Essen, Germany; Department of Basic and Clinical Neuroscience, Headache Group, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK, and others. Delveinsight’s analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapies, treatment patterns, or Cluster Headaches market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Cluster Headache Drugs Market: Qualitative Analysis

We perform Qualitative and Cluster Headache Drugs Market Intelligence analysis using various approaches, such as SWOT 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, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

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. 

Cluster Headache Therapeutics Market Access and Reimbursement

The high cost of therapies for the Cluster Headache Treatment is a major factor restraining the growth of the global drug market. Because of the high cost, the economic burden is increasing, leading the patient to escape from proper treatment. The Cluster Headache therapeutics market 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.

Cluster Headache Therapeutics Market Report Scope

• The Cluster Headache therapeutics market report covers a segment of key events, an executive summary, and a descriptive overview, explaining its causes, signs and symptoms, and currently available therapies.
• Comprehensive insight has been provided into the Cluster Headache Epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current Cluster Headache Treatment Market Landscape.
• A detailed review of the Cluster Headaches Treatment Market, historical and forecasted Cluster Headache Market Size, Cluster Headache Drugs Market Share by therapies, detailed assumptions, and rationale behind the approach is included in the report covering the 7MM drug outreach.
• The Cluster Headache Therapeutics Market 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 shape and drive the 7MM Cluster Headaches Drugs Market.

Cluster Headaches Therapeutics Market Report Insights

• Patient-based Cluster Headache Market Forecasting
• Cluster Headache Therapeutic Approaches
• Cluster Headaches Pipeline Drugs Analysis
• Cluster Headaches Market Size and Trends
• Existing and Future Cluster Headache Drugs Market Opportunity 

Cluster Headaches Therapeutics Market Report Key Strengths

• 11 years Cluster Headache Market Forecast
• The 7MM Coverage 
• Cluster Headaches Epidemiology Segmentation
• Key Cross Competition 
• Conjoint Analysis
• Drugs Uptake and Key Cluster Headache Market Forecast Assumptions

Cluster Headaches Therapeutics Market Report Assessment

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

Key Questions

Cluster Headache Treatment Market Insights

• What was the Cluster Headaches treatment market size, the Cluster Headache market size by therapies, and Cluster Headache drugs market share (%) distribution in 2020, and how it would all look in 2034? What are the contributing factors for this growth?
• Will the coverage of drugs depend on their efficacy in Cluster Headaches?
• What will be the impact on the market with the launch of emerging drugs?
• Which is going to be the largest contributor to the market in 2034?
• What are the pricing variations among different geographies for approved and off-label therapies?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Cluster Headache Epidemiology Insights

• What are the disease risks, burdens, and Cluster Headache Unmet Needsx? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Cluster Headaches?
• What is the historical and forecasted Cluster Headaches patient pool in the United States, EU4 (Germany, France, Italy, and Spain) the United Kingdom, and Japan?
• Why do patients develop persistent Cluster Headaches symptoms? Why is the current year diagnosis rate not high?
• Which type of severity is the largest contributor in patients affected with Cluster Headaches?
• What factors are affecting the increase in the diagnosis of Cluster Headaches?

Current Cluster Headache Treatment Market Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the Cluster Headaches treatment? What are the current treatment guidelines for the treatment of Cluster Headaches in the US and Europe?
• How many companies are developing therapies for the treatment of Cluster Headaches?
• How, many emerging therapies are in the mid-stage and late stage of development for the treatment of Cluster Headaches?
• What are the recent novel therapies, targets, Cluster Headache Mechanisms of Action, and technologies developed to overcome the limitations of existing therapies? 
• What are the key designations that have been granted for the Cluster Headache Emerging Therapies?
• What will be the impact on the market after the expected patent expiry of the emerging drug?
• What is the cost burden of off-label therapies on patients?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of recommended therapies? Focus on reimbursement policies.
• What are the 7MM historical and forecasted Cluster Headache Drugs Market?

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