片頭痛用点鼻薬の世界市場-2023年～2030年

概要

片頭痛用点鼻薬は、片頭痛患者を早ければ15分で緩和することができ、吐き気や嘔吐がある場合や注射を避けたい場合に特に有用です。これらの点鼻薬は、さまざまなタイプの片頭痛の治療に最も一般的に使用されています。頭を直立させた状態で鼻孔に噴霧します。しかし、勢いよく鼻をかんだり、頭を後ろに倒したりすると、薬がのどに入り、スプレーが内服薬に変わり、鼻からの迅速な投与の利点が失われます。

さらに、点鼻スプレー治療にはいくつかのカテゴリーがあり、スマトリプタンやゾルミトリプタンなどの点鼻トリプタンや、片頭痛に特異的な治療薬を含むジヒドロエルゴタミン（DHE）などがあります。トリプタン系薬剤とDHEは効果が高いですが、血管の狭窄を引き起こすという危険因子があるため、血管疾患の既知または疑いのある人には使用すべきではありません。第3の点鼻薬は非ステロイド性抗炎症薬（NSAID）スプレーで、片頭痛の炎症をターゲットにした薬を含むケトロラク点鼻薬です。この点鼻薬は片頭痛の治療に非常に有効です。

市場力学：促進要因

新たな進歩に対する需要の増加

片頭痛用点鼻薬における新たな進歩に対する需要の増加は、予測期間にわたって市場を牽引すると予想されます。様々な片頭痛を治療するために、多くの患者に最良の選択肢を提供する新しい進歩した点鼻スプレーが発売されます。進歩はまた、より良い患者の転帰のための代替または補完的な治療オプションを提供することにより、迅速な応答で片頭痛の治療に関連するアンメットニーズに対処することを目指しています。

例えば、2023年3月10日、ファイザー社は、成人における前兆の有無にかかわらず片頭痛の急性期治療薬として、最初で唯一のカルシトニン遺伝子関連ペプチド（CGRP）受容体拮抗点鼻薬であるZAVZPRET（zavegepant）の米国食品医薬品局（FDA）の承認を取得しました。今回のFDA承認は、片頭痛の急性期治療に対するZAVZPRETの有効性、忍容性、安全性プロファイルを確立した2つの重要な無作為化二重盲検プラセボ対照試験に基づいています。

さらに、先進の片頭痛用点鼻薬は、その作用発現の速さが支持されています。鼻孔に噴霧した後、薬剤は鼻粘膜から速やかに吸収されるため、経口薬と比較してより早い緩和が期待できます。多くの片頭痛患者が点鼻薬を好むのは、使いやすく、片頭痛発作時に課題となる錠剤を飲み込む必要がないからです。多くの製薬会社がこうした点鼻薬の開発に注力しています。

例えば、臨床段階のバイオ医薬品会社であるVistagen社は、2023年6月13日、欧州特許庁（EPO）が、当社の5つの迅速発症治験用神経活性フェリン治療薬の1つであるPH80点鼻スプレーの鼻腔内投与による片頭痛治療に関する特許を付与する意向を示したと発表しました。この特許請求の範囲には、片頭痛の症状発現時に投与する治療や、外傷性脳損傷に伴う片頭痛の治療も含まれています。

さらに、片頭痛用点鼻薬の進歩は主に、既存の点鼻薬製剤の一部に見られるめまいなどの副作用を最小限に抑えることに焦点を当てています。こうした副作用を軽減することで、患者の満足度を向上させることができます。これらの進歩により、鼻粘膜からの薬物吸収効率を高めることができます。ドラッグデリバリーを最適化する技術革新は、片頭痛用点鼻薬をより効果的にすることができます。

さらに、片頭痛の有病率の増加、FDA承認などの規制承認の増加、先進的な点鼻薬の市場開拓のための臨床試験の増加、片頭痛に対する点鼻薬の利点に関する意識の高まり、新規点鼻薬の開発における進歩は、予測期間にわたって市場を牽引すると予想される要因です。

阻害要因

点鼻薬の使用に伴う合併症、鼻からの出血やその他の長期的な影響など、片頭痛用点鼻薬を使用することによる副作用、片頭痛用点鼻薬の高コストなどの要因が、市場の妨げになると予想されます。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

• 影響要因
  • 促進要因
    • 新たな進歩に対する需要の増加
  • 抑制要因
    • 片頭痛用点鼻薬に伴う合併症
  • 機会
  • 影響分析

第5章 産業分析

• ポーターのファイブフォース分析
• サプライチェーン分析
• 価格分析
• 規制分析
• パイプライン分析
• アンメットニーズ
• DMIの見解

第6章 COVID-19分析

第7章 化学物質タイプ別

• トリプタン点鼻薬
• ジヒドロエルゴタミン点鼻薬
• ケトロラク点鼻薬
• その他

第8章 用量別

• 5 mg
• 10mg
• 20mg
• その他

第9章 用途別

• 合併片頭痛
• 普通型片頭痛
• 慢性片頭痛
• 眼性片頭痛
• その他

第10章 流通チャネル別

• 病院薬局
• 小売薬局
• オンライン薬局

第11章 地域別

• 北米
  • 米国
  • カナダ
  • メキシコ
• 欧州
  • ドイツ
  • 英国
  • フランス
  • イタリア
  • スペイン
  • その他欧州
• 南米
  • ブラジル
  • アルゼンチン
  • その他南米
• アジア太平洋
  • 中国
  • インド
  • 日本
  • オーストラリア
  • その他アジア太平洋
• 中東・アフリカ

第12章 競合情勢

• 競合シナリオ
• 市況/シェア分析
• M&A分析

第13章 企業プロファイル

• Pfizer Inc.
  • 会社概要
  • 製品ポートフォリオと説明
  • 財務概要
  • 主な動向
• Impel Pharmaceuticals Inc.
• Upsher-Smith Laboratories, LLC.
• Lannett Company
• GlaxoSmithKline plc
• SteriMax Inc.
• Assertio Therapeutics, Inc.
• Cipla Inc.
• AstraZeneca Plc.
• Dr. Reddy's Laboratories Ltd.

第14章 付録

Overview

Migraine nasal sprays can provide relief to migraine patients in as soon as 15 minutes and are especially useful with nausea and vomiting or in those who seek to avoid an injection. These nasal sprays are most commonly used for the treatment of various types of migraine. They are sprayed into the nostril with the head upright. However, vigorous sniffing or tipping the head backward puts the medicine down the throat, turning a spray into an oral medication and losing the advantages of rapid nasal delivery.

Moreover, there are several categories of nasal spray treatment, including nasal triptans such as sumatriptan and zolmitriptan and dihydroergotamine (DHE) which contain migraine-specific treatment. Triptans and DHE are highly effective but it has some risk factors by causing blood vessel narrowing and should not be used in people with known or suspected vascular disease. A third nasal option is a non-steroidal anti-inflammatory (NSAID) spray, nasal ketorolac, containing medicine targeting migraine inflammation. This nasal delivery is very effective for treating migraine.

Market Dynamics: Drivers

Increasing demand for novel advancements

The increasing demand for novel advancements in migraine nasal sprays is expected to drive the market over the forecast period. The novel advanced nasal spray is launched which offers the best options to many patients to treat various migraines. The advancements also aim to address the unmet needs associated with the treatment of migraines with rapid response by providing alternative or complementary treatment options for better patient outcomes.

For instance, on March 10, 2023, Pfizer Inc. cleared the U.S. Food and Drug Administration (FDA) approval of ZAVZPRET (zavegepant), the first and only calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray for the acute treatment of migraine with or without aura in adults. The FDA approval is based on two pivotal randomized, double-blind, placebo-controlled studies that established the efficacy, tolerability and safety profiles of ZAVZPRET for the acute treatment of migraine.

Moreover, advanced migraine nasal sprays are favored for their rapid onset of action. The medication can be absorbed quickly through the nasal mucosa after spraying it into the nostrils, offering faster relief compared to oral medications. Many migraine patients most commonly prefer nasal sprays because they are easy to use and do not require swallowing a pill, which can be challenging during a migraine attack, this increases the demand for novel advancements in migraine nasal sprays. Many pharmaceutical companies focus on developing these nasal sprays.

For instance, on June 13, 2023, Vistagen, a clinical-stage biopharmaceutical company released that the European Patent Office (EPO) issued an intention to grant a patent for the treatment of migraine by nasal administration of PH80 nasal spray, one of the Company's five rapid-onset investigational neuroactive pherine therapeutics. The patent claims also include treatment administered at the onset of migraine symptoms and treatment of migraines associated with traumatic brain injury.

Additionally, advancements in migraine nasal sprays mainly focus on minimizing side effects, such as dizziness, which are associated with some existing nasal spray formulations. Reducing these side effects can improve patient satisfaction. These advancements can enhance the efficiency of drug absorption through the nasal mucosa. Innovations that optimize drug delivery can make migraine nasal sprays more effective.

Further, the increasing prevalence of migraine, rising regulatory approvals such as FDA approvals, increasing clinical trials for the development of advanced nasal sprays, increasing awareness about the advantages of nasal sprays for migraine and advancements in the development of novel nasal sprays are the factors expected to drive the market over the forecast period.

Restraints

Factors such as complications associated with the use of nasal sprays, adverse effects of using migraine nasal sprays such as bleeding from the nose and other long-term effects, and the high cost of the migraine nasal sprays are expected to hamper the market.

Segment Analysis

The global migraine nasal spray market is segmented based on chemical type, dosage, application, distribution channel and region.

The dihydroergotamine nasal sprays segment accounted for approximately 37.9% of the migraine nasal spray market share

The dihydroergotamine nasal spray segment is expected to hold the largest market share over the forecast period. Dihydroergotamine (DHE) nasal sprays are very well known for their effectiveness in providing relief from the various types of migraines. They especially work by constricting blood vessels in the brain, which can help alleviate the severe pain associated with migraines. The FDA approvals are increasing for approving the DHE-based nasal sprays for better patient outcomes. In addition, their wide adoption also increases the demand for the dihydroergotamine-based nasal spray.

For instance, in September 2021, Impel Pharmaceuticals received U.S. Food and Drug Administration (FDA) approval for Trudhesa (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migraine with or without aura in adults. The efficacy of currently approved DHE-based medications is well-established and they are widely used as part of the standard of care for the acute treatment of migraine. DHE, when reaching satisfactory systemic blood levels, is known to have fast onset and lasting effects for up to 48 hours.

Further, their wide availability, rapid effectiveness and acceptability help to hold the largest market share. DHE nasal sprays are favored for their relatively quick onset of action. They can provide faster relief than other migraine medications, making them a valuable option for individuals seeking rapid pain relief during a migraine attack. The nasal spray delivers the medication in a convenient way, especially for individuals who may experience nausea or difficulty swallowing during a migraine attack.

For instance, on May 21, 2020, Cipla Limited received final approval for its Abbreviated New Drug Application for Dihydroergotamine Mesylate Nasal Spray 4mg/mL from the United States Food and Drug Administration (FDA) with a Competitive Generic Therapy (CGT) designation.

Geographical Analysis

North America accounted for approximately 40.2% of the market share

North America region is expected to hold the largest market share over the forecast period owing to the strong presence of major players and increasing adoption of the migraine nasal sprays. North America especially the United States is known for its strong presence of major players such as medical device companies which are actively focusing on developing advanced nasal sprays that show better results in treating various types of migraines.

For instance, on November 16, 2021, Padagis launched its generic version of Zomig zolmitriptan nasal spray for the treatment of migraine headaches in patients aged 12 and older. In addition to the zolmitriptan nasal spray, Padagis markets azelastine, azelastine/fluticasone propionate, olopatadine, sumatriptan, and triamcinolone nasal sprays.

Furthermore, the increasing prevalence of migraine in the region is continuously increasing the adoption of migraine nasal sprays for treatment. For instance, according to the National Institute of Health (NIH), 2020, Migraine headache is a common, debilitating disease that causes significant disability. It affects nearly 1 in 7 Americans each year, with an estimated 40 million people suffering from migraine headaches. Its prevalence is as high as 19% for females and 9% for males. It is more commonly seen in females than males in the United States.

Competitive Landscape

The major global players in the migraine nasal spray market include: Pfizer Inc., Impel Pharmaceuticals Inc., Upsher-Smith Laboratories, LLC., Lannett Company, GlaxoSmithKline plc, SteriMax Inc., Assertio Therapeutics, Inc., Cipla Inc., AstraZeneca Plc. And Dr. Reddy's Laboratories Ltd. Among others.

COVID-19 Impact Analysis

The COVID-19 pandemic significantly impacted the global migraine nasal spray market. During the pandemic, due to the tension and anxiety and the people staying at home increased the chances of migraines, which further increased the demand for nasal sprays for the treatment. For instance, according to the study conducted by the National Institute of Health (NIH) in 2023, the results show that 48.6% of migraine patients experienced worsened symptoms, 15.6% improved, and 35.8% remained unchanged. Worsening migraine symptoms were associated with staying at home during the lockdown. This increased number of migraine cases increased the demand for migraine nasal sprays.

Market Segmentation

By Chemical Type

• Triptan Nasal Sprays
• Dihydroergotamine Nasal Sprays
• Nasal Ketorolac
• Others

By Dosage

• 5 mg
• 10 mg
• 20 mg
• Others

By Application

• Complicated Migraine
• Common Migraine
• Chronic Migraine
• Ocular Migraine
• Others

By Distribution Channel

• Hospital Pharmacies
• Retail Pharmacies
• Online Pharmacies

By Region

• North America
  • U.S.
  • Canada
  • Mexico
• Europe
  • Germany
  • U.K.
  • France
  • Spain
  • Italy
  • Rest of Europe
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • Rest of Asia-Pacific
• Middle East and Africa

Why Purchase the Report?

• To visualize the global migraine nasal spray market segmentation based on chemical type, dosage, application, distribution channel and region as well as understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development
• Excel data sheet with numerous data points of migraine nasal spray market-level with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as excel consisting of key products of all the major players.

The global migraine nasal spray market report would provide approximately 69 tables, 71 figures, and 187 Pages.

Target Audience 2023

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies

Table of Contents

1. Methodology and Scope

• 1.1. Research Methodology
• 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

• 3.1. Snippet by Chemical Type
• 3.2. Snippet by Dosage
• 3.3. Snippet by Application
• 3.4. Snippet by Distribution Channel
• 3.5. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Increasing Demand for Novel Advancements
  • 4.1.2. Restraints
    • 4.1.2.1. Complications Associated with the Migraine Nasal Sprays
  • 4.1.3. Opportunity
  • 4.1.4. Impact Analysis

5. Industry Analysis

• 5.1. Porter's Five Force Analysis
• 5.2. Supply Chain Analysis
• 5.3. Pricing Analysis
• 5.4. Regulatory Analysis
• 5.5. Pipeline Analysis
• 5.6. Unmet Needs
• 5.7. DMI Opinion

6. COVID-19 Analysis

• 6.1. Analysis of COVID-19
  • 6.1.1. Scenario Before COVID
  • 6.1.2. Scenario During COVID
  • 6.1.3. Scenario Post COVID
• 6.2. Pricing Dynamics Amid COVID-19
• 6.3. Demand-Supply Spectrum
• 6.4. Government Initiatives Related to the Market During the Pandemic
• 6.5. Manufacturers Strategic Initiatives
• 6.6. Conclusion

7. By Chemical Type

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Chemical Type
  • 7.1.2. Market Attractiveness Index, By Chemical Type
• 7.2. Triptan Nasal Sprays*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Dihydroergotamine Nasal Sprays
• 7.4. Nasal Ketorolac
• 7.5. Others

8. By Dosage

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Dosage
  • 8.1.2. Market Attractiveness Index, By Dosage
• 8.2. 5 mg*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. 10 mg
• 8.4. 20 mg
• 8.5. Others

9. By Application

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 9.1.2. Market Attractiveness Index, By Application
• 9.2. Complicated Migraine*
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 9.3. Common Migraine
• 9.4. Chronic Migraine
• 9.5. Ocular Migraine
• 9.6. Others

10. By Distribution Channel

• 10.1. Introduction
  • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 10.1.2. Market Attractiveness Index, By Distribution Channel
• 10.2. Hospital Pharmacies*
  • 10.2.1. Introduction
  • 10.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 10.3. Retail Pharmacies
• 10.4. Online Pharmacies

11. By Region

• 11.1. Introduction
  • 11.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 11.1.2. Market Attractiveness Index, By Region
• 11.2. North America
  • 11.2.1. Introduction
  • 11.2.2. Key Region-Specific Dynamics
  • 11.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Chemical Type
  • 11.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Dosage
  • 11.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 11.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.2.7.1. U.S.
    • 11.2.7.2. Canada
    • 11.2.7.3. Mexico
• 11.3. Europe
  • 11.3.1. Introduction
  • 11.3.2. Key Region-Specific Dynamics
  • 11.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Chemical Type
  • 11.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Dosage
  • 11.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 11.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.3.7.1. Germany
    • 11.3.7.2. UK
    • 11.3.7.3. France
    • 11.3.7.4. Italy
    • 11.3.7.5. Spain
    • 11.3.7.6. Rest of Europe
• 11.4. South America
  • 11.4.1. Introduction
  • 11.4.2. Key Region-Specific Dynamics
  • 11.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Chemical Type
  • 11.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Dosage
  • 11.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 11.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.4.7.1. Brazil
    • 11.4.7.2. Argentina
    • 11.4.7.3. Rest of South America
• 11.5. Asia-Pacific
  • 11.5.1. Introduction
  • 11.5.2. Key Region-Specific Dynamics
  • 11.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Chemical Type
  • 11.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Dosage
  • 11.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel
  • 11.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 11.5.7.1. China
    • 11.5.7.2. India
    • 11.5.7.3. Japan
    • 11.5.7.4. Australia
    • 11.5.7.5. Rest of Asia-Pacific
• 11.6. Middle East and Africa
  • 11.6.1. Introduction
  • 11.6.2. Key Region-Specific Dynamics
  • 11.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Chemical Type
  • 11.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Dosage
  • 11.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 11.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channel

12. Competitive Landscape

• 12.1. Competitive Scenario
• 12.2. Market Positioning/Share Analysis
• 12.3. Mergers and Acquisitions Analysis

13. Company Profiles

• 13.1. Pfizer Inc.*
  • 13.1.1. Company Overview
  • 13.1.2. Product Portfolio and Description
  • 13.1.3. Financial Overview
  • 13.1.4. Key Developments
• 13.2. Impel Pharmaceuticals Inc.
• 13.3. Upsher-Smith Laboratories, LLC.
• 13.4. Lannett Company
• 13.5. GlaxoSmithKline plc
• 13.6. SteriMax Inc.
• 13.7. Assertio Therapeutics, Inc.
• 13.8. Cipla Inc.
• 13.9. AstraZeneca Plc.
• 13.10. Dr. Reddy's Laboratories Ltd.

LIST NOT EXHAUSTIVE

14. Appendix

• 14.1. About Us and Services
• 14.2. Contact Us