Pharmacor

November 2013

Migraine - 2013

Report Authors
Bethany A. Kiernan, Ph.D.
Anne-Elise Tobin, Ph.D.
Andrea S. Witt, Ph.D.
Jonathan W. Searles
Michelle P. Sosa, Sc.M.
  • Pages:200
  • Tables:42
  • Figures:20
  • Citations:297
  • Drugs:72
  • Interviews:36

Introduction:

Last Updated 18 November 2013
The migraine market consists of a multitude of therapies that either acutely treat migraine attacks or serve as prophylactic treatment. Among acute antimigraine therapies, triptans and NSAIDs/general analgesics are most extensively prescribed. All the available triptan products, which constitute more than 70% of the total migraine major-market sales in 2012, have or will face generic competition during our 2012-2022 forecast period. However, the sales losses accompanying such generic competition will be countered by the uptake of emerging acute therapies—including several reformulations of existing products—and, coupled with forecasted increases in both the acute and prophylactic drug-treated populations, the migraine market will grow from nearly $3.6 billion in 2012 to more than $5.4 billion in 2022. Despite the widespread genericization of the acute treatment market—the greatest extent will occur by the midyear of our forecast period—opportunity remains for acute antimigraine therapies that can offer improved efficacy over available triptans or that can offer nontriptan pharmacological options to patients who do not respond to triptans or in whom triptans are contraindicated (e.g., those with cardiovascular risks). The most commercially promising emerging therapies, Allergan’s orally inhaled dihydroergotamine (DHE; Levadex) and CoLucid’s 5-HT1F receptor agonist lasmiditan, will only partially fill the unmet need for acute, nontriptan agents, yet each is forecast to garner significant peak-year sales. At the same time, although a greater unmet need exists for new prophylactic therapies, we do not forecast any new prophylactic therapies to launch during the forecast period. Allergan’s onabotulinumtoxinA (Botox) is the remaining branded prophylactic therapy available, and, even though its use will largely be restricted to the chronic migraine population, we expect the drug will garner nearly $850 million in major-market sales by 2022, demonstrating the commercial opportunity for premium-priced therapies that offer alternatives (particularly with improved tolerability) in the otherwise generic prophylactic market.

Questions Answered in This Report:

  *   With the 2013 launches of generic versions of zolmitriptan (AstraZeneca/Impax Pharmaceuticals’ Zomig, Zomig-ZMT) and rizatriptan (Merck & Co.’s Maxalt, Maxalt MLT), the genericization of the triptan class, which began with the generic entry of sumatriptan (beginning in 2007 in Europe), continues. All available triptans—including most available reformulations—will experience generic competition during the 2012-2022 study period. What impact has the expanding generic competition within the triptan class had and will have on physician prescribing of the agents in this class? How influential is cost in the prescribing of migraine treatments? What opportunities remain for new acute agents seeking premium pricing in this genericizing market? How receptive will prescribers be to premium-priced agents, and what factors will be most influential to prescribing such therapies?

  *   Interviewed experts continue to express enthusiasm about emerging nontriptan options (e.g., Allergan’s orally inhaled dihydroergotamine [DHE; Levadex] and CoLucid’s 5-HT1F receptor agonist lasmiditan). In general, what is the clinical and commercial potential for new nontriptan therapies in the acute treatment of migraine? How do interviewed experts expect orally inhaled DHE and lasmiditan to be incorporated into the migraine treatment algorithm in the face of strong generic competition from many time-tested products?

  *   Many drug developers in the migraine space are focusing on reformulations (e.g., transdermal patches, oral films, oral or nasal inhalation) of available products to target patients who do not respond adequately to available formulations or who experience severe nausea, vomiting, and gastric stasis (symptoms commonly associated with migraine). How popular are nonoral tablet formulations in the current market? How are such agents utilized, and what are the barriers to uptake of current nontablet and nonoral formulations? Do any emerging reformulations offer additional advantages over available triptan formulations (e.g., more rapid onset or improved efficacy)? What is the commercial potential for novel triptan reformulations?

  *   Despite competing in an otherwise generic prophylactic market, onabotulinumtoxinA (Allergan’s Botox) will experience increased commercial success across the major markets during the study period for prevention of chronic migraine. Although this therapy faces reimbursement restrictions and must be administered by trained professionals, it offers an efficacious and tolerable alternative for patients who do not respond to available oral prophylactics. How large is the market for chronic migraine prophylaxis across the seven major markets under study? How efficacious and tolerable are current prophylactic agents, and what are the remaining unmet needs in this market? How well is chronic migraine understood, diagnosed, and treated across the different regions?

  *   Despite the high prevalence of migraine, the major-market acute and prophylactic drug-treated populations constituted only a subset of their respective prevalent populations. What factors currently constrain diagnosis and drug-treatment rates, and what factors will influence growth potential in these rates over the study period?

Scope:

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 36 country-specific interviews with neurologists and headache specialists.

Epidemiology: Number of total prevalent cases of episodic migraine (EM) and chronic migraine (CM). Number of total 12-month, diagnosed, and acutely drug-treated prevalent cases of EM and CM. Number of total 12-month, diagnosed, and prophylactically drug-treated prevalent cases of EM and CM. EM and CM prevalence by age. Number of total EM events.

Population segments in market forecast: Four populations are covered, comprising acute treatment and prophylactic treatment among episodic migraineurs and chronic migraineurs.

Emerging therapies: Phase II: 11 drugs; Phase III/IV: 2 drugs; preregistered/registered: 3 drugs. Coverage of 10 preclinical/discovery and Phase I products.

Market forecast features: We forecast future trends in the markets for the acute and prophylactic treatment of episodic migraine and chronic migraine from 2012 to 2022, taking into account several anticipated new product launches and impending generics competition.

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Mentioned in this report:

  • - Abbott Laboratories
  • - AbbVie
  • - Actavis
  • - Aegis Therapeutics
  • - Alder Biopharmaceuticals
  • - Allergan
  • - Almirall
  • - Amgen
  • - APR Applied Pharma Research
  • - Arteaus Therapeutics
  • - Astellas Pharma
  • - AstraZeneca
  • - Avanir Pharmaceuticals
  • - Biofrontera
  • - Bristol-Myers Squibb
  • - CoLucid Pharmaceuticals
  • - Desitin Arzneimittel
  • - D-Pharm
  • - Elan Pharmaceuticals
  • - Eli Lilly and Company
  • - Endo Pharmaceuticals
  • - GlaxoSmithKline
  • - Glide Pharma
  • - Impax Pharmaceuticals
  • - IntelGenx
  • - Janssen-Cilag
  • - Kyowa Hakko Kirin
  • - Labrys Biologics
  • - Mallinckrodt Pharmaceuticals
  • - Meditor Pharmaceuticals
  • - Menarini
  • - Merck & Co.
  • - Mission Pharmacal
  • - MonoSol Rx
  • - Nautilus Neurosciences
  • - NeurAxon
  • - Nichi-Iko Pharmaceutical
  • - NovaDel Pharma
  • - Novartis
  • - NuPathe
  • - OptiNose
  • - Ortho-McNeil
  • - Paladin Labs
  • - Pfizer
  • - Pozen
  • - Provalis
  • - RedHill Biopharma
  • - Revance Therapeutics
  • - Roche
  • - Sanofi
  • - Shin Nippon Biomedical Laboratories
  • - Solvay Pharmaceuticals
  • - Suda
  • - tesa Labtec
  • - Trigemina
  • - Valeant Pharmaceuticals
  • - Vastrata
  • - Vernalis
  • - Zogenix
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