Gastroretentive Drug Delivery Systems Outsourcing Market Size and Outlook 2031

Report Description

Forecast Period	2027-2031
Market Size (2025)	USD 1.41 Million
CAGR (2026-2031)	5.73%
Fastest Growing Segment	Capsule
Largest Market	North America
Market Size (2031)	USD 1.97 Million

Market Overview

The Global Gastroretentive Drug Delivery Systems Outsourcing Market will 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. The global outsourcing market for these systems 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 that possess the niche technical expertise required to engineer these complex retention mechanisms.

However, the sector faces a significant challenge regarding the high inter-subject variability of gastric physiology, which complicates the in vivo, in vitro correlation and regulatory validation of these formulations. This technical complexity reinforces the reliance on specialized external partners. According to the CPHI Annual Report, in 2024, 49% of surveyed pharmaceutical professionals predicted a very positive outlook for contract services growth over the near term. This statistic underscores the critical and expanding role of outsourcing partners in navigating the development hurdles associated with advanced delivery technologies like GRDDS.

Key Market Drivers

The increasing complexity of gastroretentive formulations requiring 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, demands niche capabilities in polymer science and process engineering that many pharmaceutical companies lack internally. Consequently, manufacturers utilize contract development and manufacturing organizations (CDMOs) to navigate these technical intricacies and access proprietary technologies without heavy internal capital investment. According to DCAT Value Chain Insights, January 2024, in the 'New Drug Approvals' review, the US FDA approved 55 new molecular entities in the preceding year, a high volume that necessitates advanced formulation technologies to address solubility and stability challenges. This surge in complex molecule pipelines compels firms to secure external partners possessing the requisite technical infrastructure.

Simultaneously, the escalating prevalence of chronic diseases accelerates the demand for bioavailability enhancement in oral therapeutics. As the burden of long-term conditions grows, there is a critical need for medication that maintains consistent plasma drug concentrations, a key benefit of gastroretentive systems for drugs with narrow absorption windows. According to the American Cancer Society, January 2024, in the 'Cancer Facts & Figures 2024' report, 2,001,140 new cancer cases are projected to occur in the United States, driving the requirement for effective oral oncolytics with optimized absorption profiles. To meet such global health needs, the industry is witnessing significant consolidation to bolster manufacturing capacity. For instance, according to Reuters, in 2024, Novo Holdings moved to acquire the major contract manufacturer Catalent for $16.5 billion, signaling the high strategic value placed on specialized production assets within the global supply chain.

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Key Market Challenges

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. The necessity for larger, more expensive clinical trials to prove efficacy across diverse patient populations escalates the cost of bringing these specialized formulations to market. According to the European Federation of Pharmaceutical Industries and Associations, in 2024, the pharmaceutical industry invested approximately €55 billion in R&D in Europe, a figure that underscores the immense capital resources now required to navigate the intensifying regulatory and technical complexities associated with advanced drug delivery systems. This escalating cost burden disproportionately affects niche segments like GRDDS, restricting the volume of active outsourcing contracts.

Key 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. According to Pharmaceutical Technology, July 2024, Triastek entered a strategic collaboration worth up to $1.2 billion with BioNTech to develop 3D-printed oral therapeutics, signaling a major shift toward utilizing digital manufacturing platforms for enhancing the delivery of complex macromolecules.

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. According to BioSpectrum India, November 2024, the CPHI & PMEC India event hosted 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.

Segmental Insights

According to recent market intelligence from Lucintel, the Capsule segment is projected to witness the highest growth rate within the Global Gastroretentive Drug Delivery Systems Outsourcing Market. This accelerated expansion is primarily driven by the dosage form's exceptional versatility in accommodating complex formulations, such as floating multiparticulates and liquid-filled systems, which are essential for optimizing gastric residence time. Pharmaceutical developers increasingly prioritize capsules for their ability to enhance the bioavailability of unstable molecules while ensuring superior patient compliance. Consequently, contract manufacturing organizations are rapidly scaling their advanced encapsulation capabilities to meet the rising demand for these specialized, high-efficacy oral therapies.

Regional Insights

North America secures a leading share of the Global Gastroretentive Drug Delivery Systems Outsourcing Market, supported by a mature pharmaceutical industry and extensive research initiatives. The region benefits from the presence of major contract development and manufacturing organizations capable of handling complex formulation challenges. High prevalence rates of gastrointestinal disorders further stimulate the demand for specialized drug delivery solutions. Additionally, companies increasingly outsource production to navigate rigorous regulatory frameworks established by the U.S. Food and Drug Administration, leveraging external expertise to ensure compliance and accelerate product timelines.

Recent Developments

In January 2025, Lyndra Therapeutics announced a strategic collaboration with Thermo Fisher Scientific to advance the development and manufacturing of long-acting oral therapies. Under this agreement, the partner company will provide clinical research and commercial manufacturing services to support Lyndra's proprietary LYNX drug delivery platform, which is designed to reside in the stomach for extended periods. This partnership aims to leverage the contract development and manufacturing organization's (CDMO) global network and capabilities to scale up the production of these novel gastroretentive dosage forms for broad market access.
In December 2024, Lonza launched a new tailored service offering for companies developing smart capsules, designed to deliver biologics and other complex drugs to specific regions such as the stomach or intestine. The service, available at the company's Innovaform Accelerator in France, utilizes advanced bi-layer manufacturing technology to create customized capsule designs with electronic or mechanical elements. This development addresses the growing demand for precise oral delivery systems that can enhance bioavailability and patient compliance for innovative therapeutic agents.
In October 2024, Amneal Pharmaceuticals received approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application for Pyridostigmine Bromide Extended-Release Tablets. This product was developed utilizing the company's proprietary GRANDE drug delivery technology, which is an advanced gastric retention system designed to allow for the sustained release of medication. The approval marked a significant milestone for the technology, which aims to improve dosing regimens and therapeutic outcomes by maintaining the drug in the stomach for a prolonged duration.
In January 2024, Triastek received clearance from the U.S. FDA for its Investigational New Drug (IND) application for T22, a 3D-printed gastric retention product. This clearance recognized T22 as the first 3D-printed gastric retention formulation to reach this regulatory stage globally. The product utilizes the company's Melt Extrusion Deposition (MED) technology to create a sophisticated structure that remains in the stomach to release the active ingredient over an extended period, demonstrating the potential of 3D printing in the field of gastroretentive drug delivery.

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.

By Dosage Form	By Region
Tablets Liquid Microspheres Capsule Others	North America Europe Asia Pacific South America Middle East & Africa

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).

Global Gastroretentive Drug Delivery Systems Outsourcing Market is an upcoming report to be released soon. If you wish an early delivery of this report or want to confirm the date of release, please contact us at [email protected]

Table of content

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

17. About Us & Disclaimer

Report Description

Table of content

Figures and Tables

Frequently asked questions

What was the market size of the Global Gastroretentive Drug Delivery Systems Outsourcing Market in 2025?

Which is the dominating region in the Global Gastroretentive Drug Delivery Systems Outsourcing Market?

Which is the fastest growing segment in the Global Gastroretentive Drug Delivery Systems Outsourcing Market?

What is the expected growth rate of the Global Gastroretentive Drug Delivery Systems Outsourcing Market?

Gastroretentive Drug Delivery Systems Outsourcing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Dosage Form (Tablets, Liquid, Microspheres, Capsule, Others) Region and Competition, 2021-2031F

Report Description

Table of content

Figures and Tables

Frequently asked questions

What was the market size of the Global Gastroretentive Drug Delivery Systems Outsourcing Market in 2025?

Which is the dominating region in the Global Gastroretentive Drug Delivery Systems Outsourcing Market?

Which is the fastest growing segment in the Global Gastroretentive Drug Delivery Systems Outsourcing Market?

What is the expected growth rate of the Global Gastroretentive Drug Delivery Systems Outsourcing Market?