Market Spotlight: Migraine
Market Spotlight: Migraine
$1,318.00
This Market Spotlight report covers the migraine market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming and regulatory events, probability of success, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
Author: Informa Pharma Intelligence
Publisher: Datamonitor Healthcare
- Description
- Contents
This Market Spotlight report covers the Migraine market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, upcoming and regulatory events, probability of success, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals, as well as presenting drug-specific revenue forecasts.
KEY TAKEAWAYS
- Datamonitor Healthcare estimates that in 2019, there were 554.6 million prevalent cases of migraine in adults aged 20 years and older worldwide, and forecasts that number to increase to 619.8 million prevalent cases by 2028.
- Latin America and the Caribbean is estimated to have the highest disease prevalence (16.4%), while the Northern America region has the lowest prevalence (9.7%).
- The majority of approved drugs in the migraine space target the serotonin 5-HT1 receptor or calcitonin gene-related peptide/receptor. These are commonly administered via the oral route, with a smaller number of products being available in intravenous, intranasal, intramuscular, intradermal, intraarticular, intravesical, rectal, sublingual, oral transmucosal, and subcutaneous formulations.
- There are equal proportions of industry-sponsored drugs in active clinical development for migraine in Phase II and Phase III, with four drugs in the NDA/BLA stage.
- Drugs in development for migraine focus on a wide variety of targets. Approximately half of the drugs in development for migraine are administered via the oral route, with the remainder being intranasal, inhaled, subcutaneous, topical, transdermal, sublingual, and oral transmucosal formulations.
- High-impact upcoming events for drugs in the migraine space comprise topline Phase III trial results for INP-104, atogepant, AXS-07, STS101, and Vyepti; topline Phase IIIb trial results for Vyepti; topline Phase II trial results for TRV250; estimated PDUFA dates for DFN-15 and Qtrypta; and an updated response to complete response letter for Rizaport.
- The overall likelihood of approval of a Phase I migraine and other headaches asset is 16.3%, and the average probability a drug advances from Phase III is 94.4%. Drugs, on average, take 7.8 years from Phase I to approval, compared to 9.8 years in the overall neurology space.
- There have been 29 licensing and asset acquisition deals involving migraine drugs during 2015–20. The largest deal was the $573.5m exclusive agreement between Bristol Myers Squibb and Biohaven in 2016 to develop and commercialize rimegepant and BHV-3500, as well as for rights to other CGRP-related intellectual property.
- The distribution of clinical trials across Phase I–IV indicates that the majority of trials for migraine have been in the early and mid-phases of development, with 54% of trials in Phase I–II, and 46% in Phase III–IV.
- The US has a substantial lead in the number of migraine clinical trials globally. Germany leads the major European markets, while Japan has the top spot in Asia.
- Clinical trial activity in the migraine space is dominated by completed trials. GlaxoSmithKline has the highest number of completed clinical trials for migraine, with 95 trials.
- GlaxoSmithKline leads the industry sponsors with by far the highest overall number of clinical trials for migraine, followed by Eli Lilly and Merck & Co
CONTENTS
7 OVERVIEW
8 KEY TAKEAWAYS
9 DISEASE BACKGROUND
9 Migraine without aura
9 Migraine with aura
10 TREATMENT
10 Analgesics
10 NSAIDs
10 Serotonergic drugs
11 CGRP inhibitors
11 Prophylactic agents for migraine
12 EPIDEMIOLOGY
15 MARKETED DRUGS
20 PIPELINE DRUGS
28 RECENT EVENTS AND ANALYST OPINION
28 AXS-07 for Migraine (April 6, 2020)
29 NURTEC ODT for Migraine (March 30, 2020)
31 AXS-07 for Migraine (December 30, 2019)
33 Vazegepant for Migraine (December 17, 2019)
34 Emgality for Migraine (August 5, 2019)
36 Multiple Drugs for Migraine (June 25, 2019)
37 Emgality for Migraine (May 8, 2019)
38 Ubrelvy for Migraine (May 8, 2019)
40 Vyepti for Migraine (May 8, 2019)
41 NURTEC ODT for Migraine (May 7, 2019)
43 Atogepant for Migraine (May 6, 2019)
44 Emgality for Migraine (May 6, 2019)
45 Vyepti for Migraine (May 6, 2019)
47 Ajovy for Migraine (April 23, 2019)
48 Emgality for Migraine (April 1, 2019)
50 KEY UPCOMING EVENTS
51 KEY REGULATORY EVENTS
51 FDA Issues Response Letter For Rizaport
51 Relief For Migraine as England’s NICE Reverses Ajovy Knockback
51 Yes For Shionogi But No For Lilly In Latest EMA Recommendations
51 Biohaven’s Oral CGRP Inhibitor Nurtec ODT Approved In The US For Acute Migraine
52 Pricing Could Help Lundbeck’s Vyepti In Slow-Growing CGRP Market
52 Triptan Switches Offer Hope For Australia’s OTC Market
52 Allergan’s Oral CGRP Inhibitor Ubrelvy Approved For Migraine Attacks
52 Lilly Expands Migraine Franchise With Reyvow Approval
53 IntelGenx Takes A Fourth Try At Rizaport Approval
53 Global Device Approvals Snapshot: 9-15 July 2019
53 CGRP Inhibitor Review Pipeline Grows With Biohaven’s Rimegepant Submission
53 Theranica’s Smartphone-Controlled Migraine Device Earns FDA De Novo
54 CMC Issues Derail Rizaport. Again.
55 PROBABILITY OF SUCCESS
56 LICENSING AND ASSET ACQUISITION DEALS
56 Currax Gains NA License To Optinose’s Onzetra Xsail Migraine Treatment
56 Deals Shaping The Medical Industry, October 2019
57 Lundbeck CEO: Alder Buy Will Boost Pipeline
57 Upsher-Smith Completes Acquisition Of Dr Reddy’s Two Migraine Treatments
57 Kurve, Seurat Collaborate On Nasal Spray For Migraines
57 Upsher-Smith Snaps Up Migraine Assets As Dr Reddy’s Hones Focus
58 No More Deal? Novartis, Amgen Trade Lawsuits Over Aimovig Agreements
59 PARENT PATENTS
60 REVENUE OPPORTUNITY
62 CLINICAL TRIAL LANDSCAPE
63 Sponsors by status
64 Sponsors by phase
65 Recent events
66 BIBLIOGRAPHY
66 Prescription information
69 APPENDIX
LIST OF FIGURES
13 Figure 1: Trends in prevalent cases of migraine, 2019–28
20 Figure 2: Overview of pipeline drugs for migraine in the US
21 Figure 3: Pipeline drugs for migraine, by company
21 Figure 4: Pipeline drugs for migraine, by drug type
21 Figure 5: Pipeline drugs for migraine, by classification
29 Figure 6: AXS-07 for Migraine (April 6, 2020): Phase III – INTERCEPT (Early)
31 Figure 7: NURTEC ODT for Migraine (March 30, 2020): Phase II/III – BHV3000-305 (Migraine Prevention)
33 Figure 8: AXS-07 for Migraine (December 30, 2019): Phase III – MOMENTUM (Acute)
34 Figure 9: Vazegepant for Migraine (December 17, 2019): Phase II/III – 201
36 Figure 10: Emgality for Migraine (August 5, 2019): Phase III – CONQUER
40 Figure 11: Ubrelvy for Migraine (May 8, 2019): Phase III – ACHIEVE II (UBR-MD-02)
41 Figure 12: Vyepti for Migraine (May 8, 2019): Phase III – PROMISE 1 (High Frequency; IV)
43 Figure 13: NURTEC ODT for Migraine (May 7, 2019): Phase III – BHV3000-303 (ODT Formulation)
45 Figure 14: Emgality for Migraine (May 6, 2019): Phase III – EVOLVE-1 (Episodic Migraine), Phase III – EVOLVE-2 (Episodic Migraine)
47 Figure 15: Vyepti for Migraine (May 6, 2019): Phase III – PROMISE 2 (Chronic; IV)
50 Figure 16: Key upcoming events in migraine
55 Figure 17: Probability of success in the migraine pipeline
56 Figure 18: Licensing and asset acquisition deals in migraine, 2015–20
59 Figure 19: Parent patents in migraine, 2019–28
59 Figure 20: Parent patents in migraine, 2028–37
62 Figure 21: Clinical trials in migraine
62 Figure 22: Top 10 drugs for clinical trials in migraine
63 Figure 23: Top 10 companies for clinical trials in migraine
63 Figure 24: Trial locations in migraine
64 Figure 25: Migraine trials status
65 Figure 26: Migraine trials sponsors, by phase
LIST OF TABLES
12 Table 1: Prevalent cases of migraine, 2019–28
14 Table 2: Prevalence proportions, 2019–28
16 Table 3: Marketed drugs for migraine
23 Table 4: Pipeline drugs for migraine in the US
28 Table 5: AXS-07 for Migraine (April 6, 2020)
30 Table 6: NURTEC ODT for Migraine (March 30, 2020)
31 Table 7: AXS-07 for Migraine (December 30, 2019)
33 Table 8: Vazegepant for Migraine (December 17, 2019)
35 Table 9: Emgality for Migraine (August 5, 2019)
36 Table 10: Multiple Drugs for Migraine (June 25, 2019)
38 Table 11: Emgality for Migraine (May 8, 2019)
39 Table 12: Ubrelvy for Migraine (May 8, 2019)
40 Table 13: Vyepti for Migraine (May 8, 2019)
42 Table 14: NURTEC ODT for Migraine (May 7, 2019)
43 Table 15: Atogepant for Migraine (May 6, 2019)
44 Table 16: Emgality for Migraine (May 6, 2019)
46 Table 17: Vyepti for Migraine (May 6, 2019)
48 Table 18: Ajovy for Migraine (April 23, 2019)
49 Table 19: Emgality for Migraine (April 1, 2019)
60 Table 20: Historical global sales, by drug ($m), 2014–18
61 Table 21: Forecasted global sales, by drug ($m), 2020–24
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