Global migraine sales are expected to grow to $8.7 billion by 2026, at a compound annual growth rate (CAGR) of 10.3% across the seven major markets (7MM), according to GlobalData, a recognised leader in providing business information and analytics.
The US will continue to dominate the market with a 77% share of total sales by 2026 followed by Germany (5.6%) and Italy (5.2%).
The company’s latest report: PharmaPoint: Migraine Global Drug Forecast and Market Analysis to 2026 confirms that market growth will be driven by the launch of several late-stage pipeline products, particularly the calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) erenumab, galcanezumab, fremanezumab, and eptinezumab, developed by Amgen, Eli Lilly, Teva and Alder, respectively.
The current migraine treatment landscape is mainly dominated by generic drugs, as the majority of migraine drugs have seen their patents expire.
However current treatments leave a large number of patients undertreated; many of the drugs, for both acute and preventive treatment, have poor efficacy profiles, which are ineffective in a large number of patients. In addition to this, many of these drugs are contraindicated in patients with certain comorbidities.
Rahael Maladwala, Healthcare Analyst at GlobalData, commented: ‘‘Comorbidities exacerbate the economic and social burden of migraine due to increased utilisation of healthcare resources and lower quality of life. Understanding the association between migraine and comorbid conditions is essential for better management of migraine.’’
GlobalData’s analysis has also revealed a number of major unmet needs which include acute drugs that work for patients who are either unresponsive to triptans or who have, or are at risk of, cardiovascular problems, improving physician education in diagnosing and treating migraine and specific tolerable, and effective prophylactic treatments for patients suffering from highly frequent and chronic migraine.
The diagnosis rate of migraine is low, approximately 50% for episodic migraine and 40% for chronic migraine. KOLs stated that physicians often misdiagnosis patients with migraine, confusing it with cluster or tension headaches.
Maladwala added: ‘‘The largest remaining unmet need is the lack of physician education and training which is unlikely to be met in the forecast period. What is needed here is a concerted effort by governments and pharmaceutical companies to provide more funding to improve physician education about the condition.’’
The migraine therapeutics pipeline is large, with eight pipeline assets in ongoing Phase IIb or III trial. In the acute treatment market, the majority of drugs available consist of largely inexpensive genericized triptans which makes the market competitive and crowded.
Therefore, the acute drugs in the pipeline are from novel classes which look to address unmet needs. The drugs, lasmiditan (a ditan) and ubrogepant (a gepant), focus on treating patients who suffer from, or are at risk of, cardiovascular disorders and those who are unresponsive to triptans.
These two drugs are the most promising in the acute drugs late-stage pipeline, which GlobalData expects to be launched by 2026.
In the preventive market, the majority of treatments are off-label, meaning there are no medications on the market that were originally developed for migraine prevention.
Therefore, a lot of research has gone into the development of a specific and effective preventative treatment, and currently there are five drugs in the late-stage pipeline that GlobalData expects to be approved by 2026.
Four of these are CGRP mAbs, which are expected to revolutionise the migraine market, as clinical trials have shown they have far superior efficacy and safety profiles to any drug currently available.
Maladwala confirmed: ‘‘There are three novel classes CGRP mAb with four products, ditans with one product, and gepants with two products in the late stage pipeline, which are expected be the main driver of market growth – meeting a significant amount of unmet need. The CGRP mAb in particular are expected to drive combined sales of $4 billion by 2026.’’