United States Gastroretentive Drug Delivery Market Dynamics | R&D Focus on Oral Controlled Release Platforms to 2031

DataM Intelligence has published a new research report on "Gastrorententive Drug Delivery Market Size 2025". The report explores comprehensive and insightful Information about various key factors like Regional Growth, Segmentation, CAGR, Business Revenue Status of Top Key Players and Drivers. The purpose of this report is to provide a telescopic view of the current market size by value and volume, opportunities, and development status.

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Latest M&A

In August 2025, a European pharma company acquired a GRDDS specialist to boost its gastrointestinal treatment portfolio and add advanced retention technologies.​

Broader pharma M&A saw big strategics (like Novo Nordisk, J&J, Merck) expanding their specialty, metabolic, and oral delivery pipelines, reflecting increased interest in advanced oral delivery platforms including GRDDS

Key Players:

Pharmacia, Galenix, Depomed, Ranbaxy, Sun Pharma, Pfizer, Lupin, GlaxoSmithKline, F.Hoffmann La Roche, and Alcon Inc.

FDA Approvals & Regulatory Updates

In March 2025, the FDA approved a novel GRDDS formulation for peptic ulcer treatment, enhancing drug retention and efficacy in the stomach.​

Regulatory agencies emphasize quality, safety, and efficacy for GRDDS-approval is complex due to the need for reproducibility and consistent performance, particularly for floating and bioadhesive technologies.​

Additional FDA approval decisions in this area are tracked for Q4 2025, highlighting increased momentum for innovative oral extended-release products.

Growth Forecast Projected:

The Global Gastrorententive Drug Delivery Market is anticipated to rise at a considerable rate during the forecast period, between 2025 and 2032. In 2024, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

Reimbursement

Hospital pharmacies are the main distribution channel in 2025, reflecting physician preference for advanced systems in chronic therapy; online pharmacies are rising fast due to digital health adoption.​

New Medicare/HCPCS coding and reimbursement policies for complex oral GI drug delivery are under review to align payment with improved patient outcomes and lower hospitalization risk.

Research Process:

Both primary and secondary data sources have been used in the global Gastrorententive Drug Delivery Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

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Key Segments:

By Type: (Floating drug delivery system, Bioadhesive drug delivery system, Other)

By Dosage Form: (Tablets, Capsule, Microspheres, Liquid, Others)

By Distribution Channel: (Online pharmacies, Retail Pharmacies, Hospital pharmacies)

Product Launches & Innovation

GRDDS advances include polymer-based floatable tablets, hydrogel-based carriers, and AI-optimized release systems.​

In 2025, notable launches include nanoparticle-based gastroretentive carriers and 3D-printed personalized tablet formulations for chronic GI diseases, Helicobacter pylori infections, and ulcers.​

Companies are introducing hybrid dual-mechanism systems floating+bioadhesive for improved retention and bioavailability; Asia-Pacific is leading with rapid adoption.

Investments

The global GRDDS market, valued at USD 17.1 billion in 2025, is projected to reach USD 46.4 billion by 2035 (CAGR 10.5%).​

Investment is strong from specialty pharma and biotech, as well as from contract manufacturing/outsourcing partners supporting GRDDS development and global commercialization

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Clinical Trials

Clinical research focuses on proving therapeutic superiority (bioavailability, fewer side effects, reduced dosing frequency) for chronic GI and metabolic diseases.

Companies are actively registering new trials of nanoparticle, floating, and bioadhesive matrix tablets for extended-release and targeted delivery.​

Patient-centric outcomes and smart tech (AI/ML for formulation optimization, patient compliance tracking) are key to new trial designs.

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