塩酸セチリジンの世界市場：2024年～2031年

レポート概要

塩酸セチリジンの世界市場は2023年に67億9,790万米ドルに達し、2031年には88億8,250万米ドルに達すると予測され、予測期間2024-2031年のCAGRは3.4%で成長する見込みです。

塩酸セチリジンは第二世代の抗ヒスタミン薬であり、アレルギー反応の際に体内で放出される化学物質であるヒスタミンの作用を選択的に阻害することで効果を発揮します。ヒスタミンは標的細胞上のH1受容体に結合し、くしゃみ、目のかゆみや涙、鼻水、じんましんなど、アレルギーの典型的な症状を引き起こす一連の現象を引き起こします。

セチリジンはH1受容体に結合することにより、ヒスタミンがその作用を発揮するのを阻害し、アレルギー症状を緩和します。第一世代の抗ヒスタミン薬に比べ、セチリジンはH1受容体への親和性が高く、血液脳関門を通過しにくいため、眠気などの中枢神経系の副作用が少ないです。

セチリジンは、その良好な安全性プロファイルとともに、様々なアレルギー症状に幅広く適用できることから、幼児から高齢者まであらゆる年齢層の患者に対して、ヘルスケアプロバイダーの間で広く好まれる選択肢となっています。

市場力学：

促進要因

アレルギー疾患の有病率の増加

世界の塩酸セチリジン市場の需要は、複数の要因によって牽引されています。主な要因の1つは、アレルギー疾患の有病率の増加です。アレルギー性鼻炎、湿疹、アレルギー性結膜炎などのアレルギー疾患の増加は、セチリジン市場の主要促進要因です。

現在、1億5,000万人以上の欧州人が慢性アレルギー性疾患に苦しんでいます。この数は増加すると予想されており、2025年までにEU人口の50％以上がアレルギー性鼻炎、喘息、湿疹などのアレルギー疾患に罹患する可能性があると予測されています。アレルギーや利用可能な治療法に関する一般市民の意識は高まっており、セチリジンに対する需要の増加につながっています。より多くの人々がアレルギーの症状に精通するにつれ、不快感を和らげるために効果的な薬を求める傾向が強まっています。

さらに、業界の主要企業が研究開発に一層注力し、臨床試験の件数が増加していることも、この市場の成長を後押ししています。例えば、2024年1月、UCB社は、皮膚炎に苦しむ被験者を対象に、ザイザル（レボセチリジン）の有効性と安全性をジルテック（セチリジン）と比較評価することを目的とした無作為化第III相試験を発表しました。この種の調査は、皮膚の炎症、発赤、かゆみを特徴とすることが多い皮膚炎に対して、これらの薬剤がどの程度有効であるかについての確かなデータを提供するものであり、臨床研究において極めて重要です。

阻害要因

医薬品に関連する副作用や有害反応、厳しい規制要件などの要因が市場の妨げになると予想されます。

市場セグメンテーション

塩酸セチリジンの世界市場は、剤形、年齢層、用途、流通チャネル、地域によって区分されます。

錠剤セグメントは塩酸セチリジン世界市場シェアの約64.3%を占める

予測期間中、錠剤セグメントが最大の市場シェアを占めると予想されます。塩酸セチリジン錠剤は、アレルギー性鼻炎、慢性蕁麻疹、アレルギー性結膜炎などの様々なアレルギー症状に対する信頼性の高い治療薬として、世界市場で必要不可欠です。アレルギーの有病率の増加と、効果的なアレルギー管理戦略に対する意識の高まりは、予測期間にわたってセチリジン錠剤の需要を維持すると予想されます。

さらに、パートナーシップや提携といった業界戦略の主要企業が、この市場の成長を後押ししています。例えば、2023年8月、国家医療品監督管理局（NMPA）は、新華医薬の完全子会社である新華医薬（高美）有限公司に、塩酸セチリジン錠の追加申請承認書を交付しました。この承認は、ジェネリック医薬品に要求される品質と有効性の整合性評価に合格したことを意味します。

市場地域別シェア

塩酸セチリジンの世界市場シェアは北米が約43.9%を占める

北米地域は、アレルギー性鼻炎、慢性蕁麻疹、アレルギー性結膜炎などのアレルギー疾患の増加により、予測期間を通じて最大の市場シェアを占めると予想され、これが同地域における塩酸セチリジンの需要を促進する主な要因となっています。

一般に花粉症として知られるアレルギー性鼻炎は、世界人口のかなりの部分が罹患する有病状態で、有病率は10％から30％と推定されています。米国では近年、かなりの割合の大人と子供が季節性アレルギーを経験していると報告されています。CDCのデータによると、2021年には米国成人の約25.7％、小児の18.9％が季節性アレルギーに悩まされていると回答しています。

米国人口におけるアレルギー性鼻炎のこの高い有病率は、くしゃみ、鼻水、目のかゆみなど、この症状に関連する一般的な症状の緩和に効果的なセチリジンのような抗ヒスタミン薬に対する大きな需要を生み出しています。さらに、アレルギーに対する一般市民の意識の高まりと、アクセス可能な治療オプションが、セチリジンに対する需要の高まりにつながっています。

さらに、この地域では、多くの主要企業が進出していること、ヘルスケアのインフラが整備されていること、M&Aがこの地域の市場成長を後押ししています。例えば、2022年6月、Glenmark Pharmaceuticals Ltd.の完全子会社である米国のGlenmark Pharmaceuticals Inc.は、米国のWockhardt Limitedから複数の一般用医薬品（OTC）の承認済み新薬承認申請（ANDA）を取得しました。

取得したANDAには、胃や腸の潰瘍の治療や予防に使用されるファモチジン錠USP、10mgおよび20mg（OTC）、抗ヒスタミン薬の塩酸セチリジン錠USP、5mgおよび10mg（OTC）、アレルギー性結膜炎およびアレルギー性鼻炎に適応のあるオロパタジン塩酸塩点眼液USP、0.1％（OTC）が含まれます。

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
    • アレルギー疾患の増加
  • 抑制要因
    • 薬剤に伴う副作用と有害反応
  • 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

第6章 剤形別

• 錠剤
• 溶液
• シロップ剤

第7章 年齢層別

• 成人
• 小児

第8章 用途別

• アレルギー性鼻炎
• アレルギー性結膜炎
• 慢性蕁麻疹
• 湿疹
• その他

第9章 流通チャネル別

• 病院薬局
• 小売薬局
• オンライン薬局

第10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
  • スペイン
  • イタリア
  • 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
  • 韓国
  • その他アジア太平洋地域
• 中東・アフリカ

第11章 競合情勢

• 競合シナリオ
• 市況/シェア分析
• M&A分析

第12章 企業プロファイル

• Johnson & Johnson Services, Inc.
  • 会社概要
  • 製品ポートフォリオと説明
  • 財務概要
  • 主な発展
• GSK plc
• UCB S.A.
• Teva Pharmaceutical Industries Ltd.
• Pfizer Inc.
• Major Pharmaceuticals
• Cipla
• Dr. Reddys Laboratories Ltd.
• AdvaCare Pharma
• Aden Healthcare（*LIST NOT EXHAUSTIVE）

第13章 付録

Report Overview

The Global Cetirizine Hydrochloride Market reached US$ 6,797.9 million in 2023 and is expected to reach US$ 8,882.5 million by 2031 growing with a CAGR of 3.4% during the forecast period 2024-2031.

Cetirizine hydrochloride is a second-generation antihistamine that works by selectively blocking the action of histamine, a chemical released by the body during an allergic reaction. Histamine binds to H1 receptors on target cells, triggering a cascade of events that leads to the typical symptoms of allergies such as sneezing, itchy and watery eyes, runny nose, and hives.

By binding to the H1 receptors, cetirizine prevents histamine from exerting its effects, thereby alleviating allergy symptoms. Compared to first-generation antihistamines, cetirizine has a higher affinity for the H1 receptor and is less likely to cross the blood-brain barrier, resulting in fewer central nervous system side effects like drowsiness.

The broad applicability of cetirizine for various allergic conditions, along with its favorable safety profile, has made it a widely preferred option among healthcare providers for patients spanning all age groups, from young children to the elderly.

Market Dynamics: Drivers

Increasing prevalence of allergic diseases

The demand for the global cetirizine hydrochloride market is driven by multiple factors. One of the key factors is the increasing prevalence of allergic diseases. The rise in allergic conditions, such as allergic rhinitis, eczema, and allergic conjunctivitis, is a primary driver for the cetirizine market.

Currently, over 150 million Europeans suffer from chronic allergic diseases. This number is expected to rise, with predictions indicating that by 2025, more than 50% of the EU population could be affected by allergies, including conditions like allergic rhinitis, asthma, and eczema. There is a growing awareness among the public regarding allergies and the available treatment options, which is leading to an increased demand for cetirizine. As more individuals become familiar with the symptoms of allergies, they are more inclined to seek effective medications to alleviate their discomfort.

Moreover, key players in the industry more focus on research & development, and a rising number of clinical trials are helping to propel this market growth. For instance, in January 2024, UCB announced the randomized Phase III Study aims to assess the efficacy and safety of Xyzal (levocetirizine) compared to Zyrtec (cetirizine) in subjects suffering from dermatitis. This type of study is crucial in clinical research as it provides robust data on how well these medications perform in treating dermatitis, which is often characterized by inflammation, redness, and itching of the skin.

Restraints

Factors such as side effects & adverse reactions associated with the drugs, and stringent regulatory requirements, are expected to hamper the market.

Market Segment Analysis

The global cetirizine hydrochloride market is segmented based on dosage form, age group, application, distribution channels, and region.

The tablets segment accounted for approximately 64.3% of the global cetirizine hydrochloride market share

The tablets segment is expected to hold the largest market share over the forecast period. Cetirizine hydrochloride tablets are essential in the global market as a reliable treatment for various allergic conditions, such as allergic rhinitis, chronic urticaria, and allergic conjunctivitis. The increasing prevalence of allergies and growing awareness of effective allergy management strategies are anticipated to sustain the demand for cetirizine tablets over the forecast period.

In addition, key players in the industry strategies such as partnerships and collaborations are helping to propel this market growth. For instance, in August 2023, the National Medical Products Administration (NMPA) granted Xinhua Pharmaceutical (Gaomi) Co., Ltd., a wholly-owned subsidiary of Xinhua Pharmaceutical, the Approval Letter of Supplementary Application for Cetirizine Hydrochloride Tablets. This approval signifies that the product has successfully passed the quality and efficacy consistency evaluation required for generic drugs.

Market Geographical Share

North America accounted for approximately 43.9% of the global cetirizine hydrochloride market share

North America region is expected to hold the largest market share over the forecast period owing to the rise in allergic disorders, such as allergic rhinitis, chronic urticaria, and allergic conjunctivitis, which is a major factor propelling the demand for cetirizine hydrochloride in this region.

Allergic rhinitis, commonly known as hay fever, is a prevalent condition that affects a significant portion of the global population, with prevalence estimates ranging from 10% to 30%. In the United States, a substantial percentage of adults and children have reported experiencing seasonal allergies in recent years. According to data from the CDC, approximately 25.7% of U.S. adults and 18.9% of children stated they suffered from seasonal allergies in 2021.

This high prevalence of allergic rhinitis in the U.S. population creates a significant demand for antihistamine medications like cetirizine, which are effective in alleviating common symptoms associated with this condition, such as sneezing, runny nose, and itchy eyes. Moreover, growing public awareness of allergies and the treatment options accessible has led to a heightened demand for cetirizine.

Additionally, in this region, a major number of key player's presence, well-advanced healthcare infrastructure, and mergers & acquisitions are helping to propel this market growth in the region. For instance, in June 2022, Glenmark Pharmaceuticals Inc., USA, a fully owned subsidiary of Glenmark Pharmaceuticals Ltd., acquired the approved Abbreviated New Drug Applications (ANDAs) for several over-the-counter (OTC) drugs from Wockhardt Limited in the United States.

The acquired ANDAs include famotidine tablets USP, 10 mg and 20 mg (OTC) - used to treat and prevent ulcers in the stomach and intestine, cetirizine hydrochloride Tablets USP, 5 mg and 10 mg (OTC) - an antihistamine medication, and olopatadine hydrochloride ophthalmic solution USP, 0.1% (OTC) - indicated for allergic conjunctivitis and allergic rhinitis.

Market Segmentation

By Dosage Form

Tablets

Solutions

Syrups

By Age Group

Adult

Pediatric

By Applications

Allergic Rhinitis

Allergic Conjunctivitis

Chronic Urticaria

Eczema

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

The rest of South America

Asia-Pacific

China

India

Japan

South Korea

Rest of Asia-Pacific

Middle East and Africa

Market Competitive Landscape

The major global players in the cetirizine hydrochloride market include Johnson & Johnson Services, Inc., GSK plc, UCB S.A., Teva Pharmaceutical Industries Ltd., Pfizer Inc., Major Pharmaceuticals, Cipla, Dr. Reddys Laboratories Ltd., AdvaCare Pharma, and Aden Healthcare among others.

Key Developments

In April 2023, Nicox SA announced that its exclusive partner in China, Ocumension Therapeutics, has submitted a New Drug Application (NDA) to obtain approval for the commercialization of Zerviate (cetirizine ophthalmic solution) at a concentration of 0.24%. This application is specifically for treating ocular itching associated with allergic conjunctivitis.

Why Purchase the Report?

To visualize the global cetirizine hydrochloride market segmentation based on dosage form, age group, application, distribution channels, and region and understand key commercial assets and players.

Identify commercial opportunities by analyzing trends and co-development.

Excel data sheet with numerous data points of the cetirizine hydrochloride market with all segments.

PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.

Product mapping is available in Excel consisting of key products of all the major players.

The global cetirizine hydrochloride market report would provide approximately 70 tables, 63 figures, and 183 pages.

Target Audience 2024

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 Dosage Form
• 3.2. Snippet by Age Group
• 3.3. Snippet by Application
• 3.4. Snippet by Distribution Channels
• 3.5. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Increasing Prevalence of Allergic Diseases
  • 4.1.2. Restraints
    • 4.1.2.1. Side Effects and Adverse Reactions Associated with the Drugs
  • 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

6. By Dosage Form

• 6.1. Introduction
  • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Dosage Form
  • 6.1.2. Market Attractiveness Index, By Dosage Form
• 6.2. Tablet *
  • 6.2.1. Introduction
  • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 6.3. Solutions
• 6.4. Syrups

7. By Age Group

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Age Group
  • 7.1.2. Market Attractiveness Index, By Age Group
• 7.2. Age Group*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Adult
• 7.4. Pediatric

8. By Application

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 8.1.2. Market Attractiveness Index, By Application
• 8.2. Allergic Rhinitis*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Allergic Conjunctivitis
• 8.4. Chronic Urticaria
• 8.5. Eczema
• 8.6. Others

9. By Distribution Channels

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channels
  • 9.1.2. Market Attractiveness Index, By Distribution Channels
• 9.2. Hospital Pharmacies *
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 9.3. Retail Pharmacies
• 9.4. Online Pharmacies

10. By Region

• 10.1. Introduction
  • 10.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 10.1.2. Market Attractiveness Index, By Region
• 10.2. North America
  • 10.2.1. Introduction
  • 10.2.2. Key Region-Specific Dynamics
  • 10.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Dosage Form
  • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Age Group
  • 10.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channels
  • 10.2.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.2.7.1. U.S.
    • 10.2.7.2. Canada
    • 10.2.7.3. Mexico
• 10.3. Europe
  • 10.3.1. Introduction
  • 10.3.2. Key Region-Specific Dynamics
  • 10.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Dosage Form
  • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Age Group
  • 10.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channels
  • 10.3.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.3.7.1. Germany
    • 10.3.7.2. U.K.
    • 10.3.7.3. France
    • 10.3.7.4. Spain
    • 10.3.7.5. Italy
    • 10.3.7.6. Rest of Europe
• 10.4. South America
  • 10.4.1. Introduction
  • 10.4.2. Key Region-Specific Dynamics
  • 10.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Dosage Form
  • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Age Group
  • 10.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channels
  • 10.4.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.4.7.1. Brazil
    • 10.4.7.2. Argentina
    • 10.4.7.3. Rest of South America
• 10.5. Asia-Pacific
  • 10.5.1. Introduction
  • 10.5.2. Key Region-Specific Dynamics
  • 10.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Dosage Form
  • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Age Group
  • 10.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channels
  • 10.5.7. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 10.5.7.1. China
    • 10.5.7.2. India
    • 10.5.7.3. Japan
    • 10.5.7.4. South Korea
    • 10.5.7.5. Rest of Asia-Pacific
• 10.6. Middle East and Africa
  • 10.6.1. Introduction
  • 10.6.2. Key Region-Specific Dynamics
  • 10.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Dosage Form
  • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Age Group
  • 10.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 10.6.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Distribution Channels

11. Competitive Landscape

• 11.1. Competitive Scenario
• 11.2. Market Positioning/Share Analysis
• 11.3. Mergers and Acquisitions Analysis

12. Company Profiles

• 12.1. Johnson & Johnson Services, Inc.*
  • 12.1.1. Company Overview
  • 12.1.2. Product Portfolio and Description
  • 12.1.3. Financial Overview
  • 12.1.4. Key Developments
• 12.2. GSK plc
• 12.3. UCB S.A.
• 12.4. Teva Pharmaceutical Industries Ltd.
• 12.5. Pfizer Inc.
• 12.6. Major Pharmaceuticals
• 12.7. Cipla
• 12.8. Dr. Reddys Laboratories Ltd.
• 12.9. AdvaCare Pharma
• 12.10. Aden Healthcare (*LIST NOT EXHAUSTIVE)

13. Appendix

• 13.1. About Us and Services
• 13.2. Contact Us