ドラッグデリバリーデバイスの世界市場-2025～2033年

ドラッグデリバリーデバイスの世界市場は2023年に857億米ドルに達し、2033年には1,365億米ドルに達すると予測され、予測期間2025年にはCAGR 5.9%で成長する見込みです。

ドラッグデリバリーデバイスは現代医療において極めて重要であり、医薬品化合物を特定の身体部位に輸送し、望ましい治療効果をもたらします。薬物投与を最適化し、有効性を高め、副作用を最小限に抑えるために、さまざまな方法、製剤、技術が用いられています。従来の方法では薬物濃度が変動し、治療効果が損なわれる可能性があります。新規ドラッグデリバリーシステム（NDDS）は、長期間にわたって治療薬物濃度を維持するための制御放出メカニズムを提供します。

市場力学：

促進要因と阻害要因

技術進歩の台頭

技術の進歩はドラッグデリバリー市場を変革し、投薬の効率と精度を向上させています。主な技術革新には、標的ドラッグデリバリーシステムがあり、治療薬を疾患組織に直接投与することで、副作用を最小限に抑え、特にがん領域での治療成績を向上させています。経口ドラッグデリバリー技術もまた、消化管劣化や吸収率の変動といった課題に対処しています。

例えば、埋め込み型ドラッグデリバリーシステム（IDDS）は、慢性疾患を管理するための新しいアプローチであり、制御された標的治療介入を提供します。従来の経口薬とは異なり、IDDSは薬物貯蔵器として機能し、正確な投与量を作用部位や全身循環に直接送達します。IDDSの有望な応用例の一つは慢性疼痛管理で、患者は経口鎮痛剤に伴う複雑な投与スケジュールや潜在的な副作用を避けることができます。鎮痛剤を脳脊髄液に直接投与することで、IDDSは血液脳関門をバイパスし、全身への曝露と副作用を最小限に抑えます。また、プログラム可能なポンプにより、薬剤の放出を制御することができるため、長時間にわたり安定した鎮痛効果が得られます。

厳しい規制要件

世界のドラッグデリバリーデバイス市場は、地域によって異なる要件、明確なガイドラインの欠如、日本のような市場における厳しい規制など、多くの規制上の課題に直面しています。これは、特に医薬品と医療機器を統合した配合剤の開発期間とコストの増加につながる可能性があります。明確なガイドラインがないため、特定の規格への準拠に関してメーカー間で混乱が生じることもあります。

技術の進化に伴い、規制当局はソフトウェアの品質とサイバーセキュリティをより重視するようになり、承認プロセスは複雑さを増しています。企業はまた、製造品質とデバイスの性能に関する監視の強化に備える必要があり、これは世界の規制機関の焦点になりつつあります。これらの課題は、製品開発と市場開拓を成功させるために、メーカーと規制当局の戦略的な計画と協力を必要とします。

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
    • 技術進歩の高まり
  • 抑制要因
    • 厳格な規制要件
  • 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 デバイスタイプ別

• 注射器
  • 注射器
  • 自動注射器
  • ペン型注射器
  • 輸液ポンプ
• 吸入器
  • ネブライザー
  • ドライパウダー吸入器（DPI）
  • 定量噴霧式吸入器（MDI）
• 経皮吸収デバイス
  • 経皮パッチ
  • 経口ドラッグデリバリーデバイス
  • 口腔内崩壊錠（ODT）
  • 経口溶解性フィルム
• 埋め込み型ドラッグデリバリーデバイス
  • マイクロインプラント
  • 薬剤溶出ステント
• 眼科ドラッグデリバリーデバイス
  • 目薬
  • 眼インプラント
• 経鼻ドラッグデリバリーデバイス
  • 鼻スプレー
  • 点鼻薬
• その他

第7章 用途別

• がん
• 呼吸器疾患
• 疼痛管理
• 神経疾患
• ホルモン障害
• その他

第8章 エンドユーザー別

• 病院
• クリニック
• ホームケア設定
• 外来手術センター（ASC）

第9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
  • その他欧州地域
• 南米
  • ブラジル
  • アルゼンチン
  • その他南米
• アジア太平洋地域
  • 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10章 競合情勢

• 競合シナリオ
• 市況・シェア分析
• M&A分析

第11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概要
  • 財務概要
  • 主な発展
• Johnson & Johnson
• Novartis AG
• F. Hoffmann-La Roche AG
• Becton, Dickinson and Company
• Sanofi
• Boehringer Ingelheim
• Merck & Co., Inc.
• Boston Scientific Corporation
• Teva Pharmaceuticals Industries Ltd

第12章 付録

The global drug delivery devices market reached US$ 85.7 billion in 2023 and is expected to reach US$ 136.50 billion by 2033, growing at a CAGR of 5.9% during the forecast period 2025-2033.

Drug delivery devices are crucial in modern medicine, transporting pharmaceutical compounds to specific body sites for desired therapeutic effects. They use various methods, formulations, and technologies to optimize drug administration, enhance efficacy, and minimize side effects. Traditional methods can cause fluctuations in drug levels, compromising treatment effectiveness. Novel Drug Delivery Systems (NDDS) provide controlled release mechanisms to maintain therapeutic drug concentrations over extended periods.

Market Dynamics: Drivers & Restraints

Rise in the Technological Advancements

Technological advancements are transforming the drug delivery devices market, improving medication administration efficiency and precision. Key innovations include targeted drug delivery systems, which direct therapeutic agents to diseased tissues, minimizing side effects and improving treatment outcomes, especially in oncology. Oral drug delivery technologies are also addressing challenges like gastrointestinal tract degradation and variable absorption rates.

For instance, Implantable drug delivery systems (IDDS) are a new approach to managing chronic conditions, offering a controlled and targeted therapeutic intervention. Unlike traditional oral medications, IDDS function as internal drug repositories, delivering precise doses directly at the site of action or into the systemic circulation. One promising application of IDDS is in chronic pain management, where patients can avoid complex dosing schedules and potential side effects associated with oral pain relievers. By delivering analgesic agents directly into the cerebrospinal fluid, IDDS bypasses the blood-brain barrier, minimizing systemic exposure and side effects. Programmable pumps also allow for controlled medication release, ensuring consistent pain relief for extended periods.

Stringent Regulatory Requirements

The global drug delivery devices market faces numerous regulatory challenges, including varying regional requirements, lack of clear guidelines, and stringent regulations in markets like Japan. This can lead to increased development times and costs, especially for combination products that integrate drugs and devices. The lack of clear guidelines can cause confusion among manufacturers regarding compliance with specific standards.

As technology evolves, regulators place greater emphasis on software quality and cybersecurity, adding complexity to the approval process. Companies must also be prepared for increasing scrutiny on manufacturing quality and device performance, which is becoming a focal point for regulatory bodies globally. These challenges require strategic planning and collaboration between manufacturers and regulators for successful product development and market entry.

Segment Analysis

The global drug delivery devices market is segmented based on device type, application, end user and region.

Device Type:

Injectable devices segment is expected to dominate the drug delivery devices market share

The injectable devices segment holds a major portion of the drug delivery devices market share and is expected to continue to hold a significant portion of the drug delivery devices market share during the forecast period.

Injectable devices are a key player in the global drug delivery market, driven by the increasing prevalence of chronic diseases like diabetes, cancer, and autoimmune disorders. These devices offer advantages like targeted administration, rapid absorption, and improved patient compliance. Technological advancements have led to the development of self-injectable devices and smart injectors, improving convenience and accuracy in medication delivery. The introduction of biologics and biosimilars further expands the market, as injectable systems provide precise dosing for these therapies. With rising healthcare expenditures, injectable devices are expected to become a cornerstone of modern therapeutic strategies.

For instance, in October 2024, UPM Biomedicals has launched FibGel, a natural injectable hydrogel for permanent implantable medical devices. Made from birch wood cellulose and water, FibGel is a safe, sustainable, and biocompatible alternative for medical device developers. Designed and manufactured under ISO 13485 standards in Finland, it is poised to transform soft tissue repair, orthopaedics, and regenerative medicine fields.

Application:

Cancer segment is the fastest-growing segment in drug delivery devices market share

The cancer segment is the fastest-growing segment in the drug delivery devices market share and is expected to hold the market share over the forecast period.

Cancer is driving the global drug delivery devices market, requiring advanced and targeted treatment methods. Innovative technologies like implantable pumps, transdermal patches, and nanoparticle-based carriers are being developed to improve therapeutic efficacy and minimize side effects. The integration of personalized medicine and immunotherapy in cancer care has accelerated advancements in devices delivering monoclonal antibodies, chemotherapy agents, and gene-editing solutions. These innovations aim to improve patient compliance, pharmacokinetics, and outcomes, bolstering the market's growth trajectory.

For instance, in November 2024, TriSalus Life Sciences Inc has launched the TriNav LV Infusion System and TriGuide Guiding Catheter, two advanced oncology innovations designed to optimize therapeutic delivery for liver and pancreatic tumor treatment, potentially improving patient outcomes and enhancing treatment options.

Geographical Analysis

North America is expected to hold a significant position in the drug delivery devices market share

North America holds a substantial position in the drug delivery devices market and is expected to hold most of the market share due to the novel product launches, adoption of innovative medical technologies, and the prevalence of chronic diseases like diabetes and cancer. Regulatory support from organizations like the FDA encourages innovation and expedites the approval of advanced drug delivery systems. The presence of leading pharmaceutical and biotechnology companies and substantial R&D investments contribute to the development and commercialization of cutting-edge drug delivery solutions, making North America a major driver of growth.

For instance, in December 2024, NuGen Medical Devices has launched its InsuJet needle-free insulin delivery device in Canada, generating $670,000 in revenue. Launched on November 15, the device uses a simple spring-loaded mechanism to release the drug as a fine jet stream of liquid, allowing it to penetrate the skin through a microscopic entrance. The device dispenses the drug safely and evenly in less than one-tenth of a second, with minimal pain or skin damage. The device is approved for sale in 42 countries.

Europe is growing at the fastest pace in the drug delivery devices market

Europe holds the fastest pace in the drug delivery devices market and is expected to hold most of the market share due to the significant advancements, product launches, established healthcare system, patient-centric care, and rising prevalence of chronic diseases. The European Medicines Agency (EMA) and strong pharmaceutical and biotechnology industry, along with government initiatives to boost healthcare innovation, facilitate the development and approval of innovative drug delivery solutions. This combination, along with the rising prevalence of chronic diseases, contributes to Europe's pivotal role in the global drug delivery devices market.

For instance, in November 2024, Sol-Millennium Medical Group has launched the InsuJet Needle-free Device, a needle-free insulin administration device designed to improve the quality of life for Billions of diabetic patients by eliminating discomfort associated with traditional needle-based injections.

Moreover, in July 2024, Smithers opened a new laboratory near Frankfurt, Germany, focusing on testing medical devices and pharmaceutical products. The facility, part of the Smithers Medical Device Testing Division, will offer drug delivery device testing services to clients worldwide. The 800 square meters facility will be equipped with state-of-the-art equipment and is located 12 km from Frankfurt Airport, allowing for quicker transport of samples and regular client visits. The new facility will increase testing capabilities and capacity.

Competitive Landscape

The major global players in the drug delivery devices market include Pfizer Inc, Johnson & Johnson, Novartis AG, F. Hoffmann-La Roche AG, Becton, Dickinson and Company, Sanofi, Boehringer Ingelheim, Merck & Co., Inc., Boston Scientific Corporation, Teva Pharmaceuticals Industries Ltd and among others.

Key Developments

• In October 2024, Researchers from the Institute of Nano Science and Technology (INST) Mohali have developed a novel drug delivery system for treating Central Nervous System Tuberculosis (CNS-TB). The system uses the nasal route to deliver anti-TB drugs directly to the brain, bypassing the blood-brain barrier (BBB) limitations. CNS-TB, a life-threatening condition, affects the brain and spinal cord, causing symptoms like headaches, fever, neck stiffness, seizures, and neurological impairments. Untreated CNS-TB can lead to severe complications.
• In January 2024, Kindeva Drug Delivery, a global leader in drug-device combination products, has launched a new business unit to provide integrated analytical support to the pharmaceutical, biopharmaceutical, and medical device sectors. The new unit will use Kindeva's 32,000-square-foot laboratories to support inhaled, injectable, and transdermal drug delivery development programs and cGMP commercial supply. The company also has deep expertise in cGMP analytical services supporting its product development and supply partners. This expansion will further expand Kindeva's global analytical footprint.

Emerging Players

The emerging players in the drug delivery devices market include Portal Instruments, Eyenovia, Inc, Credence MedSystems 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 drug delivery devices 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 Device Type
• 3.2. Snippet by Application
• 3.3. Snippet by End User
• 3.4. Snippet by Region

4. Dynamics

• 4.1. Impacting Factors
  • 4.1.1. Drivers
    • 4.1.1.1. Rise in the Technological Advancements
  • 4.1.2. Restraints
    • 4.1.2.1. Stringent Regulatory Requirements
  • 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 Device Type

• 6.1. Introduction
  • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
  • 6.1.2. Market Attractiveness Index, By Device Type
• 6.2. Injectable Devices*
  • 6.2.1. Introduction
  • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 6.2.3. Syringes
  • 6.2.4. Auto-Injectors
  • 6.2.5. Pen Injectors
  • 6.2.6. Infusion Pumps
• 6.3. Inhalation Devices
  • 6.3.1. Nebulizers
  • 6.3.2. Dry Powder Inhalers (DPIs)
  • 6.3.3. Metered Dose Inhalers (MDIs)
• 6.4. Transdermal Devices
  • 6.4.1. Transdermal Patches
  • 6.4.2. Oral Drug Delivery Devices
  • 6.4.3. Oral Disintegrating Tablets (ODTs)
  • 6.4.4. Oral Soluble Films
• 6.5. Implantable Drug Delivery Devices
  • 6.5.1. Micro-Implants
  • 6.5.2. Drug-eluting Stents
• 6.6. Ocular Drug Delivery Devices
  • 6.6.1. Eye Drops
  • 6.6.2. Ocular Implants
• 6.7. Nasal Drug Delivery Devices
  • 6.7.1. Nasal Sprays
  • 6.7.2. Nasal Drops
• 6.8. Others

7. By Application

• 7.1. Introduction
  • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 7.1.2. Market Attractiveness Index, By Application
• 7.2. Cancer*
  • 7.2.1. Introduction
  • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 7.3. Respiratory Diseases
• 7.4. Pain Management
• 7.5. Neurological Disorders
• 7.6. Hormonal Disorders
• 7.7. Others

8. By End User

• 8.1. Introduction
  • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 8.1.2. Market Attractiveness Index, By End User
• 8.2. Hospitals*
  • 8.2.1. Introduction
  • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
• 8.3. Clinics
• 8.4. Homecare Settings
• 8.5. Ambulatory Surgical Centers (ASCs)

9. By Region

• 9.1. Introduction
  • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
  • 9.1.2. Market Attractiveness Index, By Region
• 9.2. North America
  • 9.2.1. Introduction
  • 9.2.2. Key Region-Specific Dynamics
  • 9.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
  • 9.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 9.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 9.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.2.6.1. U.S.
    • 9.2.6.2. Canada
    • 9.2.6.3. Mexico
• 9.3. Europe
  • 9.3.1. Introduction
  • 9.3.2. Key Region-Specific Dynamics
  • 9.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
  • 9.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 9.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 9.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.3.6.1. Germany
    • 9.3.6.2. U.K.
    • 9.3.6.3. France
    • 9.3.6.4. Spain
    • 9.3.6.5. Italy
    • 9.3.6.6. Rest of Europe
• 9.4. South America
  • 9.4.1. Introduction
  • 9.4.2. Key Region-Specific Dynamics
  • 9.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
  • 9.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 9.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 9.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.4.6.1. Brazil
    • 9.4.6.2. Argentina
    • 9.4.6.3. Rest of South America
• 9.5. Asia-Pacific
  • 9.5.1. Introduction
  • 9.5.2. Key Region-Specific Dynamics
  • 9.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
  • 9.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 9.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
  • 9.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
    • 9.5.6.1. China
    • 9.5.6.2. India
    • 9.5.6.3. Japan
    • 9.5.6.4. South Korea
    • 9.5.6.5. Rest of Asia-Pacific
• 9.6. Middle East and Africa
  • 9.6.1. Introduction
  • 9.6.2. Key Region-Specific Dynamics
  • 9.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By Device Type
  • 9.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
  • 9.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User

10. Competitive Landscape

• 10.1. Competitive Scenario
• 10.2. Market Positioning/Share Analysis
• 10.3. Mergers and Acquisitions Analysis

11. Company Profiles

• 11.1. Pfizer Inc*
  • 11.1.1. Company Overview
  • 11.1.2. Product Portfolio and Description
  • 11.1.3. Financial Overview
  • 11.1.4. Key Developments
• 11.2. Johnson & Johnson
• 11.3. Novartis AG
• 11.4. F. Hoffmann-La Roche AG
• 11.5. Becton, Dickinson and Company
• 11.6. Sanofi
• 11.7. Boehringer Ingelheim
• 11.8. Merck & Co., Inc.
• 11.9. Boston Scientific Corporation
• 11.10. Teva Pharmaceuticals Industries Ltd

LIST NOT EXHAUSTIVE

12. Appendix

• 12.1 About Us and Services
• 12.2 Contact Us