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Migraine Market Enters New Era Following Satsuma Pharmaceuticals' ATZUMI and Amneal Pharmaceuticals' BREKIYA Regulatory Approval | DelveInsight
Current migraine management involves a dual approach—acute treatment to relieve symptoms during an attack, and preventive strategies to reduce the frequency and intensity of future episodes. Acute therapies generally include , which target symptoms like pain and nausea. Recently, more focus has been placed on preventive care for patients with frequent or debilitating migraines. This includes the use of medications such as beta-blockers, antiepileptic drugs, and CGRP (calcitonin gene-related peptide) inhibitors, along with lifestyle changes to identify and avoid migraine triggers.
Preventive or prophylactic treatments aim to decrease the frequency, severity, and duration of migraine attacks, as previously discussed. FDA-approved preventive agents include . While other migraine medications have demonstrated efficacy, they lack formal FDA approval for migraine prevention. For forecasting purposes, these therapies are grouped into classes such as antiepileptics, antihypertensives, and neurotoxins. Notably, Botox stands out as the only FDA-approved non-daily injectable option for chronic migraine, offering fewer side effects compared to daily oral medications.
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, marketed as , is approved for the preventive treatment of migraines in adults. , developed by , was the first FDA-approved migraine prevention therapy from a new drug class that blocks CGRP, a key molecule involved in migraine episodes.
FDA approved in September 2019 for preventing migraine in adults, but it's contraindicated for those hypersensitive to galcanezumab-gnlm or its components. In November 2019 , the EU approved galcanezumab for adults with ≥4 migraine days/month.
In September 2019 , the FDA sanctioned for adult migraine prevention. By January 2020 , an autoinjector for Fremanezumab received FDA approval. In March 2019 , AJOVY earned European Commission approval for adult migraine prophylaxis. Teva's AJOVY gained approval in Japan in June 2021 .
In September 2021 , gained FDA approval for , a nasal spray formulation of dihydroergotamine mesylate (0.725 mg per spray), intended for the acute treatment of migraines with or without aura in adults.
In March 2023 , received FDA approval. It is the first CGRP receptor antagonist nasal spray approved for acute migraine treatment in adults, with or without aura, and uniquely utilizes Precision Olfactory Delivery (POD) technology, targeting the upper nasal cavity for drug delivery.
The FDA also approved in April 2023 for chronic migraine prevention in adults. It stands out as the first oral CGRP receptor antagonist approved for both episodic and chronic migraine prevention. In the same month, announced FDA approval of , designed for the acute treatment of migraines.
Additionally, in January 2025 , the FDA approved , an oral multi-mechanistic treatment for acute migraine attacks, developed by . Branded as , it is expected to launch in the U.S. approximately four months after FDA acceptance of the company's NDA resubmission in September 2024 .
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On April 30, 2025 , the FDA approved , a nasal powder formulation of dihydroergotamine (DHE), developed by , for the acute treatment of migraines in adults. Satsuma is a subsidiary of .
ATZUMI is a drug-device combination that uses Satsuma's proprietary Simple MucoAdhesive Release Technology (SMART) platform. The medication is administered through a squeezable device inserted into the nostril, delivering DHE in powder form.
The FDA had previously rejected ATZUMI's marketing application last year, citing concerns related to chemistry, manufacturing, and controls. However, no issues were raised about the clinical data, nor were additional trials requested.
The recent approval was supported by results from a Phase I pharmacokinetics study and the . These trials showed that ATZUMI is rapidly absorbed, maintains high and sustained DHE plasma levels, and is safe for individuals with migraines. Over one-third of patients experienced pain relief within two hours of use.
Recently, in May 2025 , Amneal Pharmaceuticals, Inc. announced that the FDA had approved , the first and only autoinjector form of dihydroergotamine (DHE) for the acute treatment of migraine with or without aura, as well as cluster headaches in adults. The product is expected to become available to eligible patients in the second half of 2025.
The BREKIYA autoinjector offers the possibility of sustained pain relief† in a convenient, self-administered format. It delivers the same DHE medication traditionally used in hospital settings but in a prefilled, ready-to-use device. The autoinjector does not require refrigeration, assembly, or priming, and is designed for subcutaneous injection into the middle of the thigh. This delivery method may be especially useful for patients who have a poor response to oral medications, experience nausea or vomiting during migraine attacks, have delayed gastric emptying, or tend to postpone treatment until symptoms have worsened.
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Although standardized treatment guidelines are widely available and a range of mostly affordable options for both acute and preventive migraine therapies exist, there remains a significant unmet need, contrary to common belief. Many of the currently used treatments are not universally effective, may pose cardiovascular risks for some patients, and are either too general or poorly tolerated. Response rates remain suboptimal, breakthrough migraines are frequent, and patients often rely on multiple medications to manage symptoms. Additionally, side effects contribute to poor compliance and adherence. Studies indicate that about half of patients are dissatisfied with the ability of their current therapy to prevent recurring pain, and nearly 80% are open to trying new acute or preventive options.
Looking ahead, the migraine treatment landscape is poised for major transformation, driven by shifts in market dynamics that began around 2020. Advances in novel drug development and biomarker-based targeting are expected to significantly enhance revenue potential across the 7MM during the forecast period of 2025 to 2034. Some of the migraine drugs in the pipeline include (Axsome Therapeutics), (AEON Biopharma, Inc.), (Lundbeck), and others.
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, developed by , is an injectable formulation containing a 900 kDa botulinum toxin type-A complex derived from . At therapeutic doses, it induces chemical denervation of muscles, leading to a localized decrease in muscle activity. The drug is currently undergoing Phase II clinical trials for the treatment of episodic and chronic migraine.
, produced by , is a monoclonal antibody that targets and blocks the calcitonin gene-related peptide receptor (CGRP-R). Already approved for preventive migraine treatment, it is now being evaluated for migraine prevention in pediatric patients, covering both episodic and chronic forms.
, an investigational monoclonal antibody from Lundbeck, is designed to bind to and inhibit pituitary adenylate cyclase-activating polypeptide (PACAP). PACAP is a neuropeptide involved in migraine pathophysiology, making it a promising novel target. Lu AG09222 is being explored as a preventive therapy for individuals suffering from migraine.
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The anticipated launch of these emerging migraine treatments are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the migraine market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
DelveInsight estimates that the migraine market size in the 7MM is expected to grow from in 2023 at a significant CAGR by 2034. This expansion across the 7MM will be due to the rising awareness of the disease and incremental healthcare spending across the world, which would expand the migraine market size to enable the drug manufacturers to penetrate more into the migraine market.
DelveInsight's latest published market report titled will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the migraine country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The migraine market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into:
The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM migraine market. Highlights include:
Download this migraine market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the migraine market. Also, stay abreast of the mitigating factors to improve your market position in the migraine therapeutic space.
report delivers an in-depth understanding of the disease, historical and forecasted migraine epidemiology in the 7MM, i.e., the United States , EU5 ( Germany , Spain , Italy , France , and the United Kingdom ), and Japan .
report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key migraine companies, including among others.
report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key cluster headache companies including among others.
report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key cluster headache companies, including among others.
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve
Shruti Thakur
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