The migraine market across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) is poised to grow at a compound annual growth rate (CAGR) of 6.0% from $9.2bn in 2023 to $16.4bn in 2033, according to GlobalData’s recently published report, ‘Migraine: Seven-Market Drug Forecast and Market Analysis’. This growth will be primarily driven by increased prescription of calcitonin gene-related peptide (CGRP) antagonists—monoclonal antibodies (mAbs) for migraine prevention and oral gepants for both acute and preventive treatment. When compared with the cheap generic drugs dominating current standard-of-care drug classes, such as triptans in the acute setting, and non-migraine-specific treatment classes, such as antidepressants, anticonvulsants, and beta blockers for prevention, CGRP antagonists have significantly higher annual costs of therapy. Therefore, the growth in these drug classes will be limited by reimbursement restrictions, as well as the patent expiries of all these branded drugs towards the end of the forecast period. With one of the later patent expiry dates, GlobalData expects AbbVie’s Ubrelvy (ubrogepant) to be the top-selling drug in the migraine market in 2033 with sales of $1.07bn. However, Pfizer’s Nurtec, the only product currently approved for both acute and preventive therapy, is expected to peak with the highest sales of $1.96bn in 2029 before its patent expires in 2030 in the US and Japan, and 2032 in Europe, where significant generic erosion is expected.
Despite the entry of the anti-CGRP mAbs and gepants, access to these drugs remains a key unmet need. Although it is widely recognised that the mAbs are significantly more effective than the old oral preventive therapies, they remain second-line or third-line options for many patients due to reimbursement restrictions requiring failure with the oral preventives before the mAbs can be prescribed. Many countries, particularly in Europe, have stricter reimbursement rules than the guidelines recommend, meaning that access will be an ongoing challenge. It had been hoped that the introduction of the gepants would help meet this unmet need as in general, oral therapies are cheaper and easier to prescribe than mAb therapies. However, gepants being launched at prices similar to that of the annual cost of mAbs in most countries has resulted in a similar barrier to their uptake, with similar restrictions to their reimbursement. This is in contrast to the US, where a 2024 statement was published by the American Headache Society recommending that the anti-CGRP mAbs and gepants should be used as first-line preventive options due to their superior efficacy and tolerability compared with the oral preventive options, although whether this recommendation will be implemented by insurance companies remains to be seen.
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GlobalData anticipates that seven products in the late-stage pipeline will enter the migraine market in the 7MM during the forecast period, which will be another driver of growth for the market. Five of these are targeting acute treatment, however, there is a lack of novelty among these products, with a focus on reformulations and combination therapies meaning that the triptans will not be displaced as first-line acute therapies. The other two late-stage pipeline drugs are targeting migraine prevention with only one of these drugs having a novel mechanism of action.
The launch of the CGRP-targeting drugs has significantly impacted the migraine market, however, key opinion leaders (KOLs) interviewed by GlobalData highlighted that not all patients respond to these new therapies and therefore an unmet need remains for novel preventive therapies. KOLs viewed Lundbeck’s anti-pituitary adenylate cyclase-activating polypeptide (PACAP) mAb, LuAG-09222, as a promising therapy to meet this unmet need and the most exciting late-stage pipeline product. Like CGRP, the neuropeptide PACAP is believed to be a key signalling molecule in the pathophysiology of migraine. GlobalData forecasts that LuAG-09222 could generate 7MM sales of approximately $836.3m by 2033.
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