点鼻薬の単位用量無菌包装の世界市場（2025年～2033年）

世界の点鼻薬の単位用量無菌包装の市場規模は、2023年に208億5,000万米ドルに達し、2033年には1,251億米ドルに達すると予測され、予測期間2025年～2033年のCAGRは12.8%で成長する見込みです。

点鼻薬の単位用量無菌包装は、単回使用の無菌容器に点鼻薬製剤を包装する方法であり、薬剤の完全性、安全性、正確な投与を保証します。この包装は、製薬業界、特にアレルギー性鼻炎、喘息、副鼻腔炎などの慢性呼吸器疾患の患者にとって特に有益です。すぐに使用できる製品を提供し、患者のコンプライアンスを高め、投与ミスや交差汚染を最小限に抑えます。

さらに、自己投与療法の増加と非侵襲的ドラッグデリバリーシステムに対する需要が、経鼻ドラッグデリバリーにおける単位用量無菌包装の採用を後押ししています。ハイバリアプラスチックやガラス代替品などの材料の先進包装も、軽量で持続可能な、改ざん防止包装ソリューションの創出につながり、世界市場の成長をさらに促進しています。

市場力学：

促進要因と抑制要因

鼻ポリープの増加

慢性炎症性疾患である鼻ポリープの増加が、点鼻薬の無菌包装の需要を促進しています。この包装は、正確なドラッグデリバリーを保証し、無菌状態を維持し、特に慢性疾患の二次汚染リスクを最小限に抑えます。また、治療レジメンに対する患者のアドヒアランスも向上します。鼻ポリープに対する認識が高まり、診断率が向上するにつれて、安全で効率的な患者中心のドラッグデリバリー・ソリューションに対する需要が、この市場における単位用量無菌包装の成長を促進すると予想されます。

例えば、鼻ポリープは鼻や副鼻腔にできる炎症性腫瘤で、閉塞感、分泌物、不快感などの症状を引き起こします。慢性鼻副鼻腔炎のサブタイプです。成人における有病率は2.7％で、加齢とともに増加し、50歳以上でピークに達します。鼻ポリープは小児および青年ではまれです。

鼻ポリープを伴う慢性鼻副鼻腔炎（CRSwNP）は、症状、病歴、身体検査によって診断されます。主な検査は、経鼻内視鏡検査とCT検査の2つです。その他の検査が行われることもあります。患者/介護者の78％が25年後に診断を受けており、診断時の平均年齢である40～60歳に近いです。

単位用量包装に関する課題

単位用量ドラッグデリバリーシステムは、多回投与リザーバーシステムに比べ、その本質的な複雑さにより、製造と包装に大きな課題をもたらします。正確な液体充填と計量は、製剤を含む小さなコンパートメント内で正確な投与量を送達するために必要です。末端滅菌戦略は、活性薬剤成分を劣化させ、製剤化を不可能にする可能性があります。このような場合、製造者は単位用量コンパートメントを無菌条件下で充填する必要があります。無菌液体充填工程では、制御された熱または照射を使用してデリバリーシステム構成成分を予備滅菌し、一方、ろ過その他の方法により薬剤製剤を無菌化します。予備滅菌されたコンポーネントは、自動化された操作により、バリア・アイソレーター・システム内の厳重に管理された無菌環境で組み立てられ、防腐剤を含まない医薬品の無菌性を確保します。

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
    • 鼻ポリープの罹患率の上昇
  • 抑制要因
    • 単位用量包装に関連する課題
  • 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 製品タイプ別

• 使い捨て鼻スプレーボトル
• 単位用量経鼻バイアル
• プレフィルド鼻用注射器
• アンプル

第7章 材料タイプ別

• プラスチック
• ポリエチレン（PE）
• ポリプロピレン（PP）
• ポリエチレンテレフタレート（PET）
• ガラス
• アルミニウム
• その他

第8章 用途別

• アレルギー性鼻炎
• 副鼻腔炎
• 鼻づまり
• 片頭痛
• ワクチン
• その他

第9章 エンドユーザー別

• 病院
• クリニック
• 在宅ケア環境
• その他

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
• 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

• AptarGroup, Inc
  • 会社概要
  • 製品ポートフォリオと概要
  • 財務概要
  • 主な発展
• Nemera
• Berry Global, Inc.
• Gerresheimer AG
• West Pharmaceutical Services, Inc.
• Catalent, Inc.
• Bormioli Pharma S.p.A.
• Amcor plc
• Airnov Healthcare Packaging
• SGD Pharma

第12章 付録

The global unit-dose aseptic packaging of nasal drugs market reached US$ 20.85 billion in 2023 and is expected to reach US$ 125.1 billion by 2033, growing at a CAGR of 12.8% during the forecast period 2025-2033.

Unit-Dose Aseptic Packaging of Nasal Drugs is a method of packaging nasal drug formulations in single-use, sterile containers, ensuring the integrity, safety, and precise dosing of the medication. This packaging is particularly beneficial in the pharmaceutical industry, particularly for patients with chronic respiratory conditions like allergic rhinitis, asthma, and sinusitis. It provides a ready-to-use application, enhancing patient compliance and minimizing dosing errors or cross-contamination.

Moreover, the rise in self-administration therapies and demand for non-invasive drug delivery systems has boosted the adoption of unit-dose aseptic packaging in nasal drug delivery. Advances in materials like high-barrier plastics and glass alternatives have also led to the creation of lightweight, sustainable, and tamper-proof packaging solutions, further driving the global market growth.

Market Dynamics: Drivers & Restraints

Rise in the Prevalence of Nasal Polyps

The rise in nasal polyps, a chronic inflammatory condition, is driving the demand for unit-dose aseptic packaging for nasal drugs. This packaging ensures precise drug delivery, maintains sterility, and minimizes cross-contamination risks, especially for chronic conditions. It also enhances patient adherence to treatment regimens. As awareness of nasal polyps increases and diagnostic rates improve, the demand for safe, efficient, and patient-centric drug delivery solutions is expected to drive the growth of unit-dose aseptic packaging in this market.

For instance, Nasal polyps are inflammatory masses in the nose and paranasal sinuses, causing symptoms like obstruction, discharge, and discomfort. They are a subtype of chronic rhinosinusitis. The prevalence in adults is 2.7%, increasing with age, with a peak in patients over 50 years old. Nasal polyps are uncommon in children and adolescents.

Chronic rhinosinusitis with nasal polyps (CRSwNP) is diagnosed through symptoms, medical history, and physical examinations. Two main procedures are nasal endoscopy and CT scan. Additional tests may be used. 78% of patients/caregivers receive a diagnosis after 25 years, resembling the average age at diagnosis of 40-60.

Challenges associated with the Unit Dose Packaging

Single dose drug delivery systems pose greater challenges for production and packaging than multi-dose reservoir systems due to their inherent complexity. Accurate liquid filling and weighing are necessary for precise dose delivery in small compartments containing the drug formulation. Terminal sterilization strategies may degrade the active drug component(s), making formulation non-feasible. In such cases, manufacturers may need to fill unit-duse compartments under aseptic conditions. Aseptic liquid filling processes use controlled heat or irradiation to pre-sterilize delivery system components, while filtration and other methods render the drug formulation sterile. Pre-sterilized components are assembled in a tightly controlled aseptic environment in a barrier isolator system using automated manipulations to ensure sterility of the preservative-free drug product.

Segment Analysis

The global unit-dose aseptic packaging of nasal drugs market is segmented based on product type, material type, application, end user and region.

Product type:

Single-use nasal spray bottles segment is expected to dominate the unit-dose aseptic packaging of nasal drugs market share

The single-use nasal spray bottles segment holds a major portion of the unit-dose aseptic packaging of nasal drugs market share and is expected to continue to hold a significant portion of the unit-dose aseptic packaging of nasal drugs market share during the forecast period.

Single-use nasal spray bottles are a crucial part of the global unit-dose aseptic packaging of nasal drugs market. They offer a safe, sterile, and patient-friendly solution for drug delivery, eliminating contamination risks and ensuring accurate dosing. These bottles are ideal for sensitive formulations like vaccines, corticosteroids, and biologics. The increasing prevalence of respiratory and nasal disorders has increased the demand for reliable nasal drug delivery systems. Single-use nasal spray bottles are hygienic, portable, and lightweight, catering to on-the-go lifestyles. As healthcare systems prioritize safety and convenience, single-use nasal spray bottles are becoming a cornerstone of innovation in unit-dose aseptic packaging.

For instance, in August 2024, Aptar Group, a global leader in drug and consumer product dosing, dispensing, and protection technologies, has announced that its Unidose Liquid System (Unidose) is the delivery system approved with neffyO, the first needle-free treatment approved by the U.S. FDA for emergency treatment of patients with allergic reactions, including anaphylaxis. Unidose is a single-use, ready-to-use, one-step nasal delivery system used to administer neffy to a patient during a severe allergic reaction.

Material Type:

Plastic segment is the fastest-growing segment in unit-dose aseptic packaging of nasal drugs market share

The plastic segment is the fastest-growing segment in the unit-dose aseptic packaging of nasal drugs market share and is expected to hold the market share over the forecast period.

Plastic is a key component in the global unit-dose aseptic packaging of nasal drugs market due to its versatility, durability, and cost-effectiveness. Materials like polyethylene, polypropylene, and polyethylene terephthalate are used for creating single-use nasal spray bottles, ampoules, and vials that meet precision and safety requirements. High-barrier plastics protect sensitive pharmaceutical formulations against moisture, oxygen, and contaminants. The recyclability and biodegradability of advanced plastic materials align with the growing demand for sustainable packaging solutions. Plastic's adaptability in designing ergonomic and user-friendly packaging formats makes it an indispensable material in the aseptic packaging of nasal drugs.

Geographical Analysis

North America is expected to hold a significant position in the unit-dose aseptic packaging of nasal drugs market share

North America holds a substantial position in the unit-dose aseptic packaging of nasal drugs market and is expected to hold most of the market share due to the high prevalence of respiratory and nasal disorders in the region. This has led to a demand for safe and effective delivery systems that prioritize sterility and precise dosing. The region's advanced healthcare infrastructure and substantial investment in pharmaceutical research have enabled the rapid adoption of innovative packaging solutions. Moreover, the rising trend of self-administered therapies further fuels the demand for user-friendly packaging options. The regulatory environment in the US and Canada supports stringent standards for pharmaceutical packaging, encouraging manufacturers to adopt high-quality unit-dose solutions.

For instance, in September 2024, Renaissance Lakewood, LLC, a global CDMO, is manufacturing neffy, the first needle-free, intranasal spray treatment for Type I allergic reactions, including anaphylaxis in adults and children. The FDA approved Renaissance Lakewood's drug application in August, marking the first regulatory approval worldwide for epinephrine delivered as an intra-nasal spray. The six-year partnership between Renaissance and ARS Pharmaceuticals involved every stage of development, from initial research and clinical trials to full-scale manufacturing and commercialization.

Europe is growing at the fastest pace in the unit-dose aseptic packaging of nasal drugs market

Europe holds the fastest pace in the unit-dose aseptic packaging of nasal drugs market and is expected to hold most of the market share due to the aging population and increasing prevalence of chronic respiratory diseases. Europe's strong emphasis on patient safety and product quality, coupled with stringent regulatory frameworks, has created a favourable environment for the adoption of unit-dose packaging. This packaging offers benefits such as sterility, dosage accuracy, and enhanced shelf life.

Europe's focus on sustainability has also influenced the market, with pharmaceutical companies adopting eco-friendly materials and manufacturing processes. The robust pharmaceutical and biotechnology sectors in Germany, the UK, and France have contributed to market growth, with advanced technologies like high-barrier plastics and smart packaging solutions. The demand for non-invasive, patient-friendly drug delivery systems, particularly for geriatric and pediatric populations, further drives the adoption of unit-dose aseptic packaging.

Competitive Landscape

The major global players in the unit-dose aseptic packaging of nasal drugs market include AptarGroup, Inc, Nemera, Berry Global, Inc, Gerresheimer AG, West Pharmaceutical Services, Inc., Catalent, Inc., Bormioli Pharma S.p.A. Amcor plc, Airnov Healthcare Packaging, SGD Pharma among others.

Key Developments

• In March 2024, Aptar Pharma, part of AptarGroup, Inc., has announced its next phase of its global capacity expansion plan in North America at its Aptar Congers, New York site. The investment aims to meet the growing demand for proprietary drug delivery systems in North America. The facility, which began manufacturing in 2002, now manufactures a wide range of proprietary drug delivery products for nasal and injectable delivery routes. The expansion will offer more product solutions and increased production capacity to Aptar Pharma customers in North America.
• In March 2023, Renaissance has installed and qualified a high-speed nasal spray assembly line capable of assembling and packaging unit-dose and bi-dose nasal spray devices at speeds of up to 200 units per minute. This state-of-the-art line combines nasal spray assembly, labeling, blister packaging, cartoning, serialization, and case packing for efficient and high-quality manufacturing.

Emerging Players

The emerging players in the unit-dose aseptic packaging of nasal drugs market include Biocorp, Stevanato Group, Pylote, WestRock and among others.

Why Purchase the Report?

• Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
• Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
• Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
• Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
• Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
• Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
• Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
• Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
• Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
• Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
• Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
• Post-market Surveillance: Uses post-market data to enhance product safety and access.
• Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global unit-dose aseptic packaging of nasal drugs market report delivers a detailed analysis with 60+ key tables, more than 50 visually impactful figures, and 176 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2023

• Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
• Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
• Component & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
• Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
• Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
• Supply Chain: Distribution and Supply Chain Managers.
• Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
• Academic & Research: Academic Institutions.

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 Product Type
• 3.2. Snippet by Material Type
• 3.3. Snippet by Application
• 3.4. Snippet by End User
• 3.5. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Rise in the Prevalence of Nasal Polyps
  • 4.1.2. Restraints
    • 4.1.2.1. Challenges associated with the Unit Dose Packaging
  • 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 Product type

• 6.1. Introduction
  • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Product type
  • 6.1.2. Market Attractiveness Index, By Product type
• 6.2. Single-Use Nasal Spray Bottles*
  • 6.2.1. Introduction
  • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 6.3. Unit-Dose Nasal Vials
• 6.4. Prefilled Nasal Syringes
• 6.5. Ampoules

7. By Material Type

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material Type
  • 7.1.2. Market Attractiveness Index, By Material Type
• 7.2. Plastic*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Polyethylene (PE)
• 7.4. Polypropylene (PP)
• 7.5. Polyethylene Terephthalate (PET)
• 7.6. Glass
• 7.7. Aluminum
• 7.8. Others

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. Sinusitis
• 8.4. Nasal Congestion
• 8.5. Migraine
• 8.6. Vaccines
• 8.7. Others

9. By End User

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 9.1.2. Market Attractiveness Index, By End User
• 9.2. Hospitals*
  • 9.2.1. Introduction
  • 9.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 9.3. Clinics
• 9.4. Homecare Settings
• 9.5. Others

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 Product Type
  • 10.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material Type
  • 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 End User
  • 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 Product Type
  • 10.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material Type
  • 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 End User
  • 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 Product Type
  • 10.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material Type
  • 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 End User
  • 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 Product Type
  • 10.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material Type
  • 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 End User
  • 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 Product Type
  • 10.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Material Type
  • 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 End User

11. Competitive Landscape

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

12. Company Profiles

• 12.1. AptarGroup, 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. Nemera
• 12.3. Berry Global, Inc.
• 12.4. Gerresheimer AG
• 12.5. West Pharmaceutical Services, Inc.
• 12.6. Catalent, Inc.
• 12.7. Bormioli Pharma S.p.A.
• 12.8. Amcor plc
• 12.9. Airnov Healthcare Packaging
• 12.10. SGD Pharma

LIST NOT EXHAUSTIVE

12. Appendix

• 12.1 About Us and Services
• 12.2 Contact Us