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2048349

胃滯留給藥系統外包市場－全球產業規模、佔有率、趨勢、機會與預測：按劑型、地區和競爭格局分類，2021-2031年

Gastroretentive Drug Delivery Systems Outsourcing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Dosage Form (Tablets, Liquid, Microspheres, Capsule, Others) By Region & Competition, 2021-2031F
出版日期: | 出版商: TechSci Research | 英文 185 Pages | 商品交期: 2-3個工作天內

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簡介目錄

全球胃滯留藥物輸送系統 (GRDDS) 外包市場預計將從 2025 年的 141 萬美元成長到 2031 年的 197 萬美元，複合年成長率為 5.73%。

胃滯留給藥系統（GRDDS）是一種特殊的口服固體製劑，旨在延長藥物在胃中的滯留時間，從而提高吸收窗口窄或作用於局部的藥物的生物利用度。全球外包市場的主要驅動力是製藥業透過重新配製專利到期藥物來加強生命週期管理的策略重點，以及透過減少給藥頻率來提高患者遵守用藥的需求。這些根本因素使得利用擁有設計這些複雜滯留機制所需專業技術的合約研發生產機構（CDMO）變得至關重要。儘管仍有許多挑戰，例如個體間胃生理的顯著差異，這會使體內外相關性分析和監管檢驗變得複雜，但對專業外部合作夥伴的依賴正在不斷增強。在2024年接受調查的製藥專業人士中，有49%的人對合約服務的成長持非常樂觀的態度。

市場概覽
預測期 2027-2031
市場規模：2025年 141萬美元
市場規模：2031年 197萬美元
複合年成長率：2026-2031年 5.73%
成長最快的細分市場 膠囊
最大的市場 北美洲

市場促進因素

胃內給藥製劑日益複雜，需要專業技術，這是推動外包業務擴張的主要動力。開發先進的給藥系統，例如本體成型製劑和懸浮製劑，需要聚合物科學和製程工程的專業能力，而許多製藥公司本身缺乏這些能力。因此，製造商擴大利用合約研發生產機構（CDMO）來克服這些技術挑戰，並利用其獨特的技術，而無需進行大量的內部投資。新藥認證的增加進一步強化了這一趨勢。去年，美國FDA核准了55種新的分子實體，這需要先進的製劑技術來解決溶解度和穩定性的挑戰。同時，慢性病盛行率的快速成長加速了對提高口服療法生物利用度的需求，對於吸收窗口較窄的藥物而言，需要穩定的血漿藥物濃度——這是胃內給藥系統（GRDDS）的關鍵優勢。這其中包括預計到2024年美國將新增2,001,140例癌症病例，將進一步推動對有效口服抗癌藥物的需求。為了滿足這些全球醫療保健需求，該行業正在經歷大規模的重組，例如 Novo Holdings 在 2024 年以 165 億美元收購 Catalent，這凸顯了專業生產資產的戰略價值。

市場挑戰

胃生理功能的個體間高度差異已成為阻礙全球胃滯留給藥系統（GRDDS）外包市場成長的重大挑戰。這種生物學變異性，即由於飲食、壓力和疾病狀態等因素導致患者排放速率存在顯著差異，使得建立可靠的體外-體外相關性（IVIVC）變得困難。因此，合約研發生產機構（CDMO）難以設計可預測的製劑，導致研發週期延長，臨床檢驗階段的失敗率增加。這種技術上的不確定性迫使製藥公司在投資這些複雜項目時猶豫不決，因為生物有效性差異導致監管部門不予批准的風險仍然極高。克服這些生理障礙所帶來的經濟負擔是市場擴張的主要障礙，需要進行更大規模、更昂貴的臨床試驗來證明其在不同患者群體中的療效。歐洲製藥業預計到2024年將在研發領域投入約550億歐元，凸顯了應對先進藥物遞送系統相關的監管和技術複雜性所需的巨額資金。日益成長的成本負擔對GRDDS等細分領域的影響尤其嚴重，並限制了有效外包合約的規模。

市場趨勢

3D列印技術的應用正在從根本上改變胃滯留製劑的研發，它能夠製造傳統壓片技術無法實現的複雜形狀。這種積層製造方法使合約研發生產機構（CDMO）能夠設計複雜的內部結構，例如擴充性基質和剛性懸浮系統，這些結構對於延長藥物在胃中的停留時間和精確控制藥物釋放動力學至關重要。對於那些尋求克服生物有效性障礙的關鍵產業參與者而言，這項技術在難以配製的治療方法的商業性可行性正日益受到認可。一個典型的例子是Triastek和BioNTech於2024年7月簽署的價值高達12億美元的策略合作協議，旨在利用3D列印技術開發口服療法。同時，為了充分利用日益成熟的高科技供應鏈，生產和研發活動正策略性地大幅轉移至新興的亞洲中心，特別是印度。西方製藥公司如今與這些區域供應商的合作模式已不再局限於簡單的成本套利，而是旨在獲取新型藥物遞送系統方面的專業技術以及固定劑量組合藥物的大規模生產能力。這項擴張得益於支撐全球外包需求的工業基礎設施的快速發展。 2024年11月舉辦的印度國際製藥工業展（CPHI & PMEC India）吸引了超過2,000家參展，創歷史新高。這表明該地區滿足全球製藥市場技術要求和生產規模需求的能力正在不斷增強。

目錄

第1章概述

第2章：調查方法

第3章執行摘要

第4章：客戶心聲

第5章：胃保留藥物輸送系統外包的全球市場展望

  • 市場規模及預測
    • 按金額
  • 市佔率及預測
    • 劑型（片劑、液體、微球、膠囊、其他）
    • 按地區
    • 按公司（2025 年）
  • 市場地圖

第6章：北美胃保留藥物輸送系統外包市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 北美洲：國別分析
    • 美國
    • 加拿大
    • 墨西哥

第7章：歐洲胃保留給藥系統外包市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 歐洲：國別分析
    • 德國
    • 法國
    • 英國
    • 義大利
    • 西班牙

第8章：亞太地區胃保留藥物輸送系統外包市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 亞太地區：國別分析
    • 中國
    • 印度
    • 日本
    • 韓國
    • 澳洲

第9章：中東和非洲胃保留藥物輸送系統外包市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 中東與非洲：國別分析
    • 沙烏地阿拉伯
    • 阿拉伯聯合大公國
    • 南非

第10章：南美胃滯留給藥系統外包市場展望

  • 市場規模及預測
  • 市佔率及預測
  • 南美洲：國別分析
    • 巴西
    • 哥倫比亞
    • 阿根廷

第11章 市場動態

  • 促進因素
  • 任務

第12章 市場趨勢與發展

  • 併購
  • 產品發布
  • 近期趨勢

第13章：全球胃保留給藥系統外包市場：SWOT分析

第14章：波特五力分析

  • 產業競爭
  • 新進入者的潛力
  • 供應商的議價能力
  • 顧客權力
  • 替代品的威脅

第15章 競爭格局

  • Catalent, Inc
  • Lonza Group
  • Evonik Industries AG
  • Colorcon Inc.
  • Quotient Sciences Holding Limited
  • AptarGroup, Inc.
  • Aenova Holding GmbH
  • Evotec SE
  • Vectura Group Ltd
  • Ashland Inc.

第16章 策略建議

第17章：關於研究公司及免責聲明

簡介目錄
Product Code: 20738

The Global Gastroretentive Drug Delivery Systems Outsourcing Market is anticipated to grow from USD 1.41 Million in 2025 to USD 1.97 Million by 2031, at a 5.73% CAGR. Gastroretentive Drug Delivery Systems (GRDDS) are specialized oral solid dosage forms engineered to prolong gastric residence time, thereby enhancing the bioavailability of therapeutics with narrow absorption windows or localized stomach activity. This global outsourcing market is primarily driven by the pharmaceutical industry's strategic focus on lifecycle management through the reformulation of off-patent drugs and the imperative to improve patient adherence via reduced dosing frequencies. These fundamental drivers necessitate the utilization of contract development and manufacturing organizations (CDMOs) that possess the niche technical expertise required to engineer these complex retention mechanisms. Despite facing significant challenges due to high inter-subject variability of gastric physiology, which complicates in vivo-in vitro correlation and regulatory validation, the reliance on specialized external partners is reinforced, with 49% of surveyed pharmaceutical professionals in 2024 predicting a very positive outlook for contract services growth.

Market Overview
Forecast Period2027-2031
Market Size 2025USD 1.41 Million
Market Size 2031USD 1.97 Million
CAGR 2026-20315.73%
Fastest Growing SegmentCapsule
Largest MarketNorth America

Market Driver

The increasing complexity of gastroretentive formulations, demanding specialized expertise, serves as a primary catalyst for the expansion of the outsourcing sector. Developing sophisticated delivery systems, such as expandable or floating dosage forms, requires niche capabilities in polymer science and process engineering often lacking internally within many pharmaceutical companies. Consequently, manufacturers increasingly utilize CDMOs to navigate these technical intricacies and access proprietary technologies without heavy internal capital investment. This trend is amplified by the high volume of new drug approvals, with 55 new molecular entities approved by the US FDA in the preceding year, necessitating advanced formulation technologies to address solubility and stability challenges. Simultaneously, the escalating prevalence of chronic diseases accelerates the demand for bioavailability enhancement in oral therapeutics, requiring consistent plasma drug concentrations, a key benefit of GRDDS for drugs with narrow absorption windows. This includes the projected 2,001,140 new cancer cases in the United States in 2024, driving the need for effective oral oncolytics. To meet such global health needs, the industry is witnessing significant consolidation, exemplified by Novo Holdings' $16.5 billion acquisition of Catalent in 2024, underscoring the strategic value placed on specialized production assets.

Market Challenge

The high inter-subject variability of gastric physiology stands out as a formidable challenge that directly hampers the growth of the Global Gastroretentive Drug Delivery Systems (GRDDS) Outsourcing Market. This biological inconsistency, wherein gastric emptying rates differ significantly among patients due to factors such as diet, stress, and disease state, complicates the establishment of a reliable In Vitro In Vivo Correlation (IVIVC). Consequently, contract development and manufacturing organizations (CDMOs) struggle to design predictive formulations, leading to extended development timelines and higher attrition rates during clinical validation. This technical uncertainty forces pharmaceutical sponsors to hesitate before committing capital to these complex programs, as the risk of regulatory rejection due to inconsistent bioavailability remains prohibitively high. The financial impact of overcoming these physiological hurdles creates a significant barrier to market expansion, necessitating larger, more expensive clinical trials to prove efficacy across diverse patient populations. The pharmaceutical industry's approximately €55 billion investment in R&D in Europe in 2024 underscores the immense capital resources required to navigate the intensifying regulatory and technical complexities associated with advanced drug delivery systems, with this escalating cost burden disproportionately affecting niche segments like GRDDS and restricting the volume of active outsourcing contracts.

Market Trends

The adoption of 3D printing is fundamentally transforming the development of gastroretentive formulations by enabling the fabrication of complex geometries that traditional compression techniques cannot achieve. This additive manufacturing approach allows contract development and manufacturing organizations to engineer intricate internal structures, such as expandable matrices or rigid floating systems, which are essential for prolonging gastric residence time and controlling drug release kinetics with high precision. The commercial viability of this technology for difficult-to-formulate therapies is increasingly recognized by major industry players seeking to overcome bioavailability barriers, exemplified by Triastek's strategic collaboration worth up to $1.2 billion with BioNTech in July 2024 to develop 3D-printed oral therapeutics. Simultaneously, there is a pronounced strategic migration of manufacturing and development activities to emerging Asian hubs, particularly India, to leverage a maturing high-tech supply chain. Western pharmaceutical sponsors are moving beyond simple cost-arbitrage models, now partnering with these regional vendors to access specialized capabilities in novel drug delivery systems and large-scale capacity for fixed-dose combinations. This expansion is evidenced by the rapid growth of industrial infrastructure dedicated to supporting global outsourcing mandates, with the CPHI & PMEC India event in November 2024 hosting over 2,000 exhibitors, a record number that underscores the region's deepening capacity to handle the technical and volume requirements of the global pharmaceutical market.

Key Market Players

  • Catalent, Inc
  • Lonza Group
  • Evonik Industries AG
  • Colorcon Inc.
  • Quotient Sciences Holding Limited
  • AptarGroup, Inc.
  • Aenova Holding GmbH
  • Evotec SE
  • Vectura Group Ltd
  • Ashland Inc.

Report Scope

In this report, the Global Gastroretentive Drug Delivery Systems Outsourcing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Gastroretentive Drug Delivery Systems Outsourcing Market, By Dosage Form

  • Tablets
  • Liquid
  • Microspheres
  • Capsule
  • Others

Gastroretentive Drug Delivery Systems Outsourcing Market, By Region

  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • France
    • United Kingdom
    • Italy
    • Germany
    • Spain
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
  • South America
    • Brazil
    • Argentina
    • Colombia
  • Middle East & Africa
    • South Africa
    • Saudi Arabia
    • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Gastroretentive Drug Delivery Systems Outsourcing Market.

Available Customizations:

Global Gastroretentive Drug Delivery Systems Outsourcing Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

  • Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

  • 1.1. Market Definition
  • 1.2. Scope of the Market
    • 1.2.1. Markets Covered
    • 1.2.2. Years Considered for Study
    • 1.2.3. Key Market Segmentations

2. Research Methodology

  • 2.1. Objective of the Study
  • 2.2. Baseline Methodology
  • 2.3. Key Industry Partners
  • 2.4. Major Association and Secondary Sources
  • 2.5. Forecasting Methodology
  • 2.6. Data Triangulation & Validation
  • 2.7. Assumptions and Limitations

3. Executive Summary

  • 3.1. Overview of the Market
  • 3.2. Overview of Key Market Segmentations
  • 3.3. Overview of Key Market Players
  • 3.4. Overview of Key Regions/Countries
  • 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Gastroretentive Drug Delivery Systems Outsourcing Market Outlook

  • 5.1. Market Size & Forecast
    • 5.1.1. By Value
  • 5.2. Market Share & Forecast
    • 5.2.1. By Dosage Form (Tablets, Liquid, Microspheres, Capsule, Others)
    • 5.2.2. By Region
    • 5.2.3. By Company (2025)
  • 5.3. Market Map

6. North America Gastroretentive Drug Delivery Systems Outsourcing Market Outlook

  • 6.1. Market Size & Forecast
    • 6.1.1. By Value
  • 6.2. Market Share & Forecast
    • 6.2.1. By Dosage Form
    • 6.2.2. By Country
  • 6.3. North America: Country Analysis
    • 6.3.1. United States Gastroretentive Drug Delivery Systems Outsourcing Market Outlook
      • 6.3.1.1. Market Size & Forecast
        • 6.3.1.1.1. By Value
      • 6.3.1.2. Market Share & Forecast
        • 6.3.1.2.1. By Dosage Form
    • 6.3.2. Canada Gastroretentive Drug Delivery Systems Outsourcing Market Outlook
      • 6.3.2.1. Market Size & Forecast
        • 6.3.2.1.1. By Value
      • 6.3.2.2. Market Share & Forecast
        • 6.3.2.2.1. By Dosage Form
    • 6.3.3. Mexico Gastroretentive Drug Delivery Systems Outsourcing Market Outlook
      • 6.3.3.1. Market Size & Forecast
        • 6.3.3.1.1. By Value
      • 6.3.3.2. Market Share & Forecast
        • 6.3.3.2.1. By Dosage Form

7. Europe Gastroretentive Drug Delivery Systems Outsourcing Market Outlook

  • 7.1. Market Size & Forecast
    • 7.1.1. By Value
  • 7.2. Market Share & Forecast
    • 7.2.1. By Dosage Form
    • 7.2.2. By Country
  • 7.3. Europe: Country Analysis
    • 7.3.1. Germany Gastroretentive Drug Delivery Systems Outsourcing Market Outlook
      • 7.3.1.1. Market Size & Forecast
        • 7.3.1.1.1. By Value
      • 7.3.1.2. Market Share & Forecast
        • 7.3.1.2.1. By Dosage Form
    • 7.3.2. France Gastroretentive Drug Delivery Systems Outsourcing Market Outlook
      • 7.3.2.1. Market Size & Forecast
        • 7.3.2.1.1. By Value
      • 7.3.2.2. Market Share & Forecast
        • 7.3.2.2.1. By Dosage Form
    • 7.3.3. United Kingdom Gastroretentive Drug Delivery Systems Outsourcing Market Outlook
      • 7.3.3.1. Market Size & Forecast
        • 7.3.3.1.1. By Value
      • 7.3.3.2. Market Share & Forecast
        • 7.3.3.2.1. By Dosage Form
    • 7.3.4. Italy Gastroretentive Drug Delivery Systems Outsourcing Market Outlook
      • 7.3.4.1. Market Size & Forecast
        • 7.3.4.1.1. By Value
      • 7.3.4.2. Market Share & Forecast
        • 7.3.4.2.1. By Dosage Form
    • 7.3.5. Spain Gastroretentive Drug Delivery Systems Outsourcing Market Outlook
      • 7.3.5.1. Market Size & Forecast
        • 7.3.5.1.1. By Value
      • 7.3.5.2. Market Share & Forecast
        • 7.3.5.2.1. By Dosage Form

8. Asia Pacific Gastroretentive Drug Delivery Systems Outsourcing Market Outlook

  • 8.1. Market Size & Forecast
    • 8.1.1. By Value
  • 8.2. Market Share & Forecast
    • 8.2.1. By Dosage Form
    • 8.2.2. By Country
  • 8.3. Asia Pacific: Country Analysis
    • 8.3.1. China Gastroretentive Drug Delivery Systems Outsourcing Market Outlook
      • 8.3.1.1. Market Size & Forecast
        • 8.3.1.1.1. By Value
      • 8.3.1.2. Market Share & Forecast
        • 8.3.1.2.1. By Dosage Form
    • 8.3.2. India Gastroretentive Drug Delivery Systems Outsourcing Market Outlook
      • 8.3.2.1. Market Size & Forecast
        • 8.3.2.1.1. By Value
      • 8.3.2.2. Market Share & Forecast
        • 8.3.2.2.1. By Dosage Form
    • 8.3.3. Japan Gastroretentive Drug Delivery Systems Outsourcing Market Outlook
      • 8.3.3.1. Market Size & Forecast
        • 8.3.3.1.1. By Value
      • 8.3.3.2. Market Share & Forecast
        • 8.3.3.2.1. By Dosage Form
    • 8.3.4. South Korea Gastroretentive Drug Delivery Systems Outsourcing Market Outlook
      • 8.3.4.1. Market Size & Forecast
        • 8.3.4.1.1. By Value
      • 8.3.4.2. Market Share & Forecast
        • 8.3.4.2.1. By Dosage Form
    • 8.3.5. Australia Gastroretentive Drug Delivery Systems Outsourcing Market Outlook
      • 8.3.5.1. Market Size & Forecast
        • 8.3.5.1.1. By Value
      • 8.3.5.2. Market Share & Forecast
        • 8.3.5.2.1. By Dosage Form

9. Middle East & Africa Gastroretentive Drug Delivery Systems Outsourcing Market Outlook

  • 9.1. Market Size & Forecast
    • 9.1.1. By Value
  • 9.2. Market Share & Forecast
    • 9.2.1. By Dosage Form
    • 9.2.2. By Country
  • 9.3. Middle East & Africa: Country Analysis
    • 9.3.1. Saudi Arabia Gastroretentive Drug Delivery Systems Outsourcing Market Outlook
      • 9.3.1.1. Market Size & Forecast
        • 9.3.1.1.1. By Value
      • 9.3.1.2. Market Share & Forecast
        • 9.3.1.2.1. By Dosage Form
    • 9.3.2. UAE Gastroretentive Drug Delivery Systems Outsourcing Market Outlook
      • 9.3.2.1. Market Size & Forecast
        • 9.3.2.1.1. By Value
      • 9.3.2.2. Market Share & Forecast
        • 9.3.2.2.1. By Dosage Form
    • 9.3.3. South Africa Gastroretentive Drug Delivery Systems Outsourcing Market Outlook
      • 9.3.3.1. Market Size & Forecast
        • 9.3.3.1.1. By Value
      • 9.3.3.2. Market Share & Forecast
        • 9.3.3.2.1. By Dosage Form

10. South America Gastroretentive Drug Delivery Systems Outsourcing Market Outlook

  • 10.1. Market Size & Forecast
    • 10.1.1. By Value
  • 10.2. Market Share & Forecast
    • 10.2.1. By Dosage Form
    • 10.2.2. By Country
  • 10.3. South America: Country Analysis
    • 10.3.1. Brazil Gastroretentive Drug Delivery Systems Outsourcing Market Outlook
      • 10.3.1.1. Market Size & Forecast
        • 10.3.1.1.1. By Value
      • 10.3.1.2. Market Share & Forecast
        • 10.3.1.2.1. By Dosage Form
    • 10.3.2. Colombia Gastroretentive Drug Delivery Systems Outsourcing Market Outlook
      • 10.3.2.1. Market Size & Forecast
        • 10.3.2.1.1. By Value
      • 10.3.2.2. Market Share & Forecast
        • 10.3.2.2.1. By Dosage Form
    • 10.3.3. Argentina Gastroretentive Drug Delivery Systems Outsourcing Market Outlook
      • 10.3.3.1. Market Size & Forecast
        • 10.3.3.1.1. By Value
      • 10.3.3.2. Market Share & Forecast
        • 10.3.3.2.1. By Dosage Form

11. Market Dynamics

  • 11.1. Drivers
  • 11.2. Challenges

12. Market Trends & Developments

  • 12.1. Merger & Acquisition (If Any)
  • 12.2. Product Launches (If Any)
  • 12.3. Recent Developments

13. Global Gastroretentive Drug Delivery Systems Outsourcing Market: SWOT Analysis

14. Porter's Five Forces Analysis

  • 14.1. Competition in the Industry
  • 14.2. Potential of New Entrants
  • 14.3. Power of Suppliers
  • 14.4. Power of Customers
  • 14.5. Threat of Substitute Products

15. Competitive Landscape

  • 15.1. Catalent, Inc
    • 15.1.1. Business Overview
    • 15.1.2. Products & Services
    • 15.1.3. Recent Developments
    • 15.1.4. Key Personnel
    • 15.1.5. SWOT Analysis
  • 15.2. Lonza Group
  • 15.3. Evonik Industries AG
  • 15.4. Colorcon Inc.
  • 15.5. Quotient Sciences Holding Limited
  • 15.6. AptarGroup, Inc.
  • 15.7. Aenova Holding GmbH
  • 15.8. Evotec SE
  • 15.9. Vectura Group Ltd
  • 15.10. Ashland Inc.

16. Strategic Recommendations

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