Gastroretentive Drug Delivery Systems Outsourcing Market By Delivery System Type (Floating Drug Delivery Systems, Mucoadhesive Systems, High-Density Systems, Expandable Systems, Superporous Hydrogel Systems); By Drug Type (Branded Drugs, Generic Drugs); By Outsourcing Type (Formulation Development, Process Optimization and Scale-Up, Analytical Testing and Regulatory Filing, Manufacturing and Packaging); By Geography, Segment Revenue Estimation, Forecast, 2024–2030

Introduction And Strategic Context

The Global Gastroretentive Drug Delivery Systems Outsourcing Market is poised to grow at a robust CAGR of 9.7% , valued at USD 1.43 billion in 2024 , and is projected to reach USD 2.78 billion by 2030 , confirms Strategic Market Research.

 

This market revolves around the contract development and manufacturing of gastroretentive drug delivery systems (GRDDS) —a class of advanced oral delivery technologies designed to prolong gastric residence time and enhance drug bioavailability. Outsourcing these systems allows pharmaceutical companies to optimize R&D expenditure, leverage specialized know-how, and accelerate time to market for complex drug formulations.

 

Strategically, this market sits at the convergence of pharma innovation, chronic disease prevalence, and cost containment imperatives . GRDDS offers tailored drug release for treating disorders like peptic ulcers, Helicobacter pylori infections, gastroesophageal reflux, and Parkinson’s disease—conditions that demand sustained gastric retention for improved therapeutic impact.

 

From a macroeconomic standpoint, the demand is buoyed by three core forces:

• Therapeutic precision : GRDDS can significantly reduce dosing frequency, improving patient compliance in chronic treatments.

• CDMO evolution : As CDMOs (Contract Development and Manufacturing Organizations) move up the value chain, more pharmaceutical companies outsource formulation complexity to specialized vendors.

• Global burden of gastrointestinal diseases : The rise in gastric disorders in aging populations, especially across Asia-Pacific and North America, necessitates advanced drug delivery technologies.

 

Key stakeholders in this market include:

• Pharmaceutical companies developing gastroretentive formulations

• CDMOs and CROs offering formulation, scale-up, and regulatory services

• Healthcare providers adopting patient-centric therapies

• Government bodies regulating bioequivalence and compliance

• Investors backing high-growth outsourced pharma solutions

According to leading pharmaceutical formulation experts, GRDDS outsourcing enables mid-sized pharma companies to bring niche drugs to market without incurring excessive infrastructure costs.

With increased focus on bioavailability optimization , regulatory compliance , and fast-track development models , gastroretentive drug delivery outsourcing is becoming an indispensable component of drug commercialization strategies between 2024 and 2030.

 

Market Segmentation And Forecast Scope

The gastroretentive drug delivery systems outsourcing market is segmented based on four key dimensions to provide a comprehensive view of the sector’s evolution between 2024 and 2030:

By Delivery System Type

• Floating Drug Delivery Systems (FDDS)

• Mucoadhesive Systems

• High-Density Systems

• Expandable Systems

• Superporous Hydrogel Systems

Among these, Floating Drug Delivery Systems accounted for the largest share in 2024 , driven by their relative ease of formulation and established bioavailability advantages. Meanwhile, Expandable Systems are projected to be the fastest-growing sub-segment , thanks to their capacity to retain in the stomach for prolonged durations without dosage form degradation.

 

By Drug Type

• Branded Drugs

• Generic Drugs

The generic drugs segment is experiencing growing demand due to patent expirations and a rising preference for cost-effective therapies. However, branded drugs continue to lead in revenue terms, backed by innovative gastroretentive formulations for CNS and anti-ulcer therapeutics.

 

By Outsourcing Type

• Formulation Development

• Process Optimization and Scale-Up

• Analytical Testing and Regulatory Filing

• Manufacturing and Packaging

The formulation development segment contributed over 38% of the total market revenue in 2024 , as companies seek customized release profiles and GRDDS optimization. The manufacturing and packaging segment is anticipated to gain traction, particularly in late-phase outsourcing models and ANDA preparation.

 

By Region

• North America

• Europe

• Asia-Pacific

• LAMEA (Latin America, Middle East & Africa)

North America continues to dominate the global landscape, driven by extensive CDMO networks, strict regulatory compliance requirements, and the widespread use of advanced drug delivery technologies. However, Asia-Pacific is the fastest-growing region , supported by a rising pharma base in India and China, competitive pricing models, and expanding infrastructure for oral solid dosage outsourcing.

Experts predict that over 65% of new GRDDS launches by 2027 will involve partial or full outsourcing of formulation development and regulatory support services, particularly in Europe and Asia.

This layered segmentation reveals the diverse technological and commercial opportunities available within the GRDDS outsourcing market, offering tailored services across the product lifecycle and global geographies.

 

Market Trends And Innovation Landscape

The gastroretentive drug delivery systems outsourcing market is experiencing a surge in innovation, characterized by technology convergence , process optimization , and regulatory harmonization . As pharmaceutical pipelines become more targeted and complex, outsourcing partners are integrating novel technologies to improve drug retention, absorption, and patient adherence.

R&D Evolution: Shift Toward Mechanistic Design

Recent years have witnessed a move from empirical formulation to mechanistic modeling and design-based development , allowing more predictable and reproducible gastroretentive drug behaviors . CDMOs now employ physiologically based pharmacokinetic (PBPK) modeling , computational fluid dynamics (CFD) , and AI-enhanced bio-simulation tools to refine drug behavior in the gastric environment.

“GRDDS innovation has shifted from simple buoyancy to mechanosensory design, where material and geometry play central roles in gastric residence time,” notes a lead formulation scientist at a global CDMO.

 

? Material Science Advancements

There is growing interest in smart polymers , biodegradable hydrogels , and responsive excipients that adapt to pH and gastric motility changes. These materials enhance the safety and efficacy of mucoadhesive and expandable systems, especially for drugs with narrow absorption windows.

New excipients like carbopol 974P , polyvinyl alcohol (PVA) , and low-substituted hydroxypropyl cellulose (L-HPC) have enabled longer retention without irritating the gastric lining—improving patient tolerance and increasing formulation complexity.

 

Strategic Collaborations and CDMO Integration

Several pharmaceutical companies are forging long-term strategic partnerships with CDMOs for integrated end-to-end solutions, from preformulation to commercial manufacturing. These agreements often include co-development of IP, shared regulatory submission responsibilities, and joint market launch strategies.

Recent trends include:

• Establishing GRDDS Centers of Excellence within large CDMOs.

• Tech-sharing partnerships between pharma innovators and academia for material testing and prototyping.

• Increased focus on de-risked outsourcing models , offering milestone-based pricing and scalability options.

 

Digital Twin & AI Tools in Formulation

The use of digital twins —virtual replicas of the drug in gastric conditions—is gaining traction, allowing real-time simulation of pharmacokinetics and mechanical behavior of GRDDS. AI-driven platforms now assist in excipient selection, floating behavior prediction, and bioavailability optimization.

 

Pipeline Expansion and Regulatory Alignment

More than 150 GRDDS candidates are currently in clinical or pre-clinical pipelines globally. Regulatory agencies such as the FDA and EMA have released updated guidance on bioequivalence studies, floating system validation, and gastric retention data , accelerating product approvals.

One notable development includes hybrid outsourcing models where smaller biotech firms conduct early R&D in-house and outsource scale-up and filing to Asian CDMOs for faster approvals and reduced CAPEX.

Together, these trends indicate a mature yet fast-evolving innovation ecosystem , where GRDDS outsourcing acts as both a cost-containment and a capability-expansion tool for pharmaceutical manufacturers across the globe.

 

Competitive Intelligence And Benchmarking

The gastroretentive drug delivery systems outsourcing market is moderately consolidated, characterized by a mix of global contract manufacturing leaders and specialized formulation partners. Companies in this space differentiate through formulation expertise, regulatory compliance strength, proprietary technologies, and long-term pharma partnerships .

Below are key players shaping the competitive landscape:

Lonza Group

A global CDMO giant, Lonza has invested significantly in advanced oral delivery technologies, including GRDDS. The company leverages its Capsugel platform , offering multiparticulate systems and floating capsules tailored for delayed release. Its strength lies in end-to-end services from early development to commercial manufacturing, particularly for complex molecules.

“Lonza’s modular GRDDS platform allows rapid customization based on gastric pH profiles and drug solubility patterns,” notes a senior development manager.

 

Catalent, Inc.

Catalent stands out for its integrated service model and deep expertise in controlled-release technologies . The company’s OptiForm ® Solution Suite includes gastroretentive development pathways for insoluble APIs. Catalent maintains robust global manufacturing capabilities and a well-established regulatory track record, making it a go-to partner for mid-sized pharma firms.

 

Recipharm AB

Headquartered in Sweden, Recipharm focuses on oral solid dose innovation , with a growing portfolio in gastroretentive systems. The firm collaborates closely with biopharma clients during Phase I and II trials and offers formulation-to-filing support . Its expertise in mucoadhesive tablets and floating mini-tablets adds competitive diversity.

 

Evonik Industries AG

Through its Health Care division , Evonik provides specialized excipients, formulation design, and manufacturing for gastroretentive drugs. The company’s proprietary EUDRAGIT® polymers are extensively used in floating and expandable GRDDS. Evonik is known for high-volume batch scalability and custom release profiles , especially in CNS and anti-infective therapies.

 

Aenova Group

Aenova is a European CDMO with strong capabilities in high-density and swellable matrix tablets . The company excels in regulatory dossier preparation and clinical-scale manufacturing , with a growing footprint in Asia-Pacific and North America. Aenova is also pursuing technology licensing collaborations to co-develop platform-based GRDDS solutions.

 

AbbVie Contract Manufacturing

While AbbVie primarily operates as a biopharmaceutical leader, its contract manufacturing arm provides advanced oral delivery support for complex formulations, including gastroretentive systems. Its vertical integration, combined with validated supply chains and FDA-inspected sites, gives AbbVie a distinctive position for high-barrier formulations.

 

Siegfried Holding AG

Siegfried is emerging as a reliable partner in the formulation and scale-up of GRDDS , with capabilities in floating layer tablets and hydrophilic matrix design . The company differentiates through its compliance-first philosophy , making it attractive for clients seeking regulatory-ready submissions in the U.S. and EU.

In benchmarking terms, leading players offer:

• Flexible engagement models (fee-for-service, FTE-based, co-development)

• Specialized excipient libraries for gastric retention enhancement

• Global GMP-compliant facilities and strong audit histories

• In-house regulatory affairs teams supporting FDA/EMA submissions

Mid-tier companies are increasingly investing in IP-backed delivery platforms to capture niche demand from biotechs and regional pharma innovators, ensuring that competition remains both dynamic and innovation-centric.

 

Regional Landscape And Adoption Outlook

The gastroretentive drug delivery systems outsourcing market reveals diverse regional dynamics, with varying adoption rates, technological maturity, and regulatory support across geographies. While North America leads in revenue, Asia-Pacific is gaining momentum as a high-growth, cost-efficient outsourcing hub.

North America

North America , led by the United States , accounted for the largest market share in 2024 , owing to its advanced pharmaceutical ecosystem, deep CDMO penetration, and high demand for innovative oral dosage forms.

Key enablers include:

• A mature regulatory framework that encourages outsourced bioequivalence and GRDDS safety studies.

• Leading CDMOs like Catalent and Lonza operating sophisticated formulation centers .

• A high burden of chronic gastric and neurological conditions , creating a consistent demand for long-retaining drugs.

Furthermore, U.S. biotech startups are increasingly relying on outsourced formulation development to de-risk early-stage investments and comply with FDA expectations for extended-release oral forms.

 

Europe

Europe maintains a strong presence, especially in Germany , Switzerland , and the United Kingdom , where robust pharmaceutical manufacturing meets innovation-focused outsourcing models.

• European CDMOs like Recipharm and Siegfried are leveraging their formulation know-how and EU-compliant GMP facilities to serve both regional and global clients.

• GRDDS outsourcing demand in Europe is driven by the aging population , high prevalence of gastric ulcers and Parkinson’s disease , and cross-border clinical trial networks .

European regulators have streamlined mutual recognition procedures , which further enhances the appeal of contract-based GRDDS development for multinational firms.

 

Asia-Pacific

Asia-Pacific is the fastest-growing region , projected to register a CAGR above 11.5% between 2024 and 2030 . The region benefits from a cost-efficient labor force , rising domestic pharma production, and increasing investment in oral solid dosage R&D facilities .

Key growth drivers include:

• Expansion of Indian CDMOs offering low-cost, high-quality GRDDS manufacturing with global regulatory approvals (USFDA, MHRA).

• Government incentives in China and South Korea to promote advanced drug delivery technologies through public-private partnerships .

• Rapid rise in GERD, ulcer, and H. pylori infection rates , necessitating site-specific drug delivery solutions.

For example, a South Korean CDMO recently partnered with a U.S. mid-cap pharma company to develop a once-daily floating GRDDS for metoclopramide, reducing pill burden in Parkinson’s patients.

 

LAMEA (Latin America, Middle East & Africa)

This region is still emerging , with Brazil and South Africa at the forefront of pharmaceutical outsourcing growth. Limited infrastructure and regulatory complexity slow broader adoption, yet opportunities remain in:

• Import-substitution policies promoting local contract development.

• Partnerships between Gulf-based firms and Indian CDMOs for generic GRDDS formulations.

• Expanding public healthcare initiatives increasing awareness of patient-compliant drug delivery technologies.

However, lack of skilled workforce and variable GMP enforcement remain significant constraints in some areas.

In summary, while North America and Europe dominate the value-based market , Asia-Pacific offers volume-based growth and strategic cost advantages . Future investment strategies are likely to blend regulatory reliability with cost competitiveness , making dual-region outsourcing models increasingly attractive to global pharma firms.

 

End-User Dynamics And Use Case

The end-user landscape for the gastroretentive drug delivery systems outsourcing market is defined by the diversity of stakeholders relying on outsourced formulation and manufacturing services to reduce time-to-market, lower development costs, and access advanced delivery technologies. Primary end users include:

1. Pharmaceutical Companies (Branded and Generic)

These are the primary clients of GRDDS outsourcing services. Branded drug manufacturers rely on CDMOs for:

• Complex formulation development of once-daily tablets or delayed-release systems

• Clinical trial material (CTM) production

• Bioequivalence and FDA/EMA-compliant documentation

Generic drug firms use outsourcing to reformulate expiring-patent drugs into GRDDS to extend lifecycle value or enter niche therapy areas with fewer competitors.

 

2. Biotechnology Firms

Small- and mid-sized biotechs with limited in-house infrastructure increasingly outsource GRDDS activities to:

• Access specialized formulation platforms (e.g., floating matrix, mucoadhesive tablets)

• Focus on molecule discovery while relying on CDMOs for drug delivery engineering

• Navigate early-phase clinical development more cost-effectively

These firms often form co-development partnerships , especially for CNS and GI applications requiring gastric targeting or extended gastric retention.

 

3. Research Institutions and Academia

Universities and public research labs, often funded by government grants or private consortia , engage CDMOs to:

• Translate lab-scale GRDDS prototypes into scalable clinical candidates

• Conduct pilot-scale manufacturing for Phase I and II trials

• Perform stability and dissolution testing

These engagements usually focus on innovative polymers , pH-sensitive systems , and mechanical expandables under investigation.

 

4. Government and Military Health Agencies

Certain military health units and public health agencies require gastroretentive formulations for time-sensitive, critical therapies—such as malaria prophylaxis or neuroprotective treatments —where once-daily or gastric-retained dosing can ensure higher compliance in field conditions. Outsourcing enables rapid development and controlled supply in mission-critical deployments.

Real-World Use Case

A tertiary hospital research affiliate in Seoul, South Korea, collaborated with a U.S.-based pharmaceutical company to evaluate a once-daily gastroretentive formulation of levodopa/carbidopa for Parkinson’s disease patients experiencing motor fluctuations. The formulation was developed and manufactured by an Indian CDMO using a floating dual-layer matrix design. Over a 6-month clinical trial, patients reported a 42% reduction in "off" periods and greater adherence, with the convenience of a single daily dose.

This case demonstrates how outsourcing:

• Enabled rapid formulation iteration

• Leveraged cross-continental expertise

• Delivered measurable improvements in therapeutic adherence

The GRDDS outsourcing market's flexibility supports diverse end users —from global pharma giants to local hospitals—making it a critical enabler for advanced drug delivery transformation.

 

Recent Developments + Opportunities & Restraints

Recent Developments (2022–2024)

The gastroretentive drug delivery systems outsourcing market has witnessed several notable developments over the past two years, highlighting momentum across innovation, regulatory acceleration, and international partnerships:

• Catalent opened a dedicated oral solid dosage R&D center in Somerset, NJ, focused on advanced controlled-release and gastroretentive formulations (2023).

• Lonza launched a floating multiparticulate capsule platform aimed at improving gastric retention time for narrow absorption window APIs (2024).

• Evonik’s EUDRAGIT polymers were validated in a joint study with a European university for use in swellable and expandable GRDDS applications.

• Recipharm signed a co-development agreement with a mid-sized U.S. biotech to design and scale-up a mucoadhesive formulation targeting peptic ulcers in elderly patients (2023).

• Siegfried expanded its oral formulation site in Malta , with upgraded GMP capabilities specifically for gastric-retentive tablets and pilot-scale production (2022).

 

Opportunities

• Emerging Market Penetration Rising prevalence of GI and neurological disorders in India, Brazil, and Southeast Asia presents a vast opportunity for outsourced GRDDS development tailored to region-specific disease patterns.

• Integration of AI in Formulation Design AI-powered tools for release profile prediction , polymer interaction mapping , and bioavailability optimization offer contract providers new differentiation points, especially for complex CNS and metabolic drugs.

• Lifecycle Extension via GRDDS Re-engineering Pharma companies are increasingly turning to GRDDS reformulation as a strategy to extend the commercial life of expiring-patent molecules, offering CDMOs an avenue for high-margin, value-added services.

 

Restraints

• High Initial Development Cost for GRDDS Although outsourcing reduces infrastructure burden, GRDDS formulation still requires specialized excipients, complex design iterations, and extended testing , elevating development costs—especially in early phases.

• Regulatory Ambiguity in Some Regions While the FDA and EMA have clear pathways for GRDDS validation, regulatory clarity remains low in parts of Latin America and Africa , delaying market entry for outsourced products.

This balanced mix of technological momentum and regulatory variability underscores the need for CDMOs and pharmaceutical clients to build region- and indication-specific strategies that align innovation with compliance efficiency.

 

7.1. Report Coverage Table

Report Attribute	Details
Forecast Period	2024 – 2030
Market Size Value in 2024	USD 1.43 Billion
Revenue Forecast in 2030	USD 2.78 Billion
Overall Growth Rate	CAGR of 9.7% (2024 – 2030)
Base Year for Estimation	2024
Historical Data	2019 – 2023
Unit	USD Million, CAGR (2024 – 2030)
Segmentation	By Delivery System Type, By Drug Type, By Outsourcing Type, By Geography
By Delivery System Type	Floating Drug Delivery Systems, Mucoadhesive Systems, High-Density Systems, Expandable Systems, Superporous Hydrogel Systems
By Drug Type	Branded Drugs, Generic Drugs
By Outsourcing Type	Formulation Development, Process Optimization and Scale-Up, Analytical Testing and Regulatory Filing, Manufacturing and Packaging
By Region	North America, Europe, Asia-Pacific, Latin America, Middle East & Africa
Country Scope	U.S., UK, Germany, China, India, Japan, Brazil, South Korea
Market Drivers	- Rising demand for bioavailability-enhancing drug delivery - Increasing reliance on CDMOs for complex formulations - Growth in gastrointestinal and neurological disease burden
Customization Option	Available upon request