Table of Contents
- Executive Summary: Key Takeaways for 2025–2030
- Market Size & Forecast: Growth Projections Through 2030
- Emerging Technologies and Innovations
- Competitive Landscape: Leading Companies and New Entrants
- Regulatory Trends and Compliance Challenges
- Applications: Therapeutic Areas Driving Adoption
- Patient Outcomes and Clinical Benefits
- Manufacturing Advances and Supply Chain Insights
- Investment, Partnerships, and M&A Activity
- Future Outlook: Opportunities and Strategic Recommendations
- Sources & References
Executive Summary: Key Takeaways for 2025–2030
Gastroretentive Drug Delivery Systems (GRDDS) present a dynamic frontier in oral drug formulation, promising enhanced bioavailability for drugs with narrow absorption windows, poor solubility, or instability in less acidic environments. As the pharmaceutical industry pivots toward more sophisticated delivery mechanisms through 2025 and the following years, GRDDS technologies—including floating, mucoadhesive, expandable, and high-density systems—are anticipated to play a pivotal role in both generic and innovative therapies.
Key developments driving the sector include an accelerating pipeline of oral therapies targeting chronic conditions such as diabetes, cardiovascular diseases, and infections, where controlled release and site-specific delivery offer clinical and commercial benefits. Major pharmaceutical manufacturers are actively advancing GRDDS platforms for both new chemical entities and life-cycle management of marketed drugs. Notably, companies such as Pfizer and Novartis have ongoing research and partnerships aimed at optimizing gastroretentive formulations for improved patient adherence and therapeutic outcomes.
Recent years have seen the introduction of commercial products utilizing innovative GRDDS approaches. For example, Lonza has expanded its portfolio of oral drug delivery technologies, supporting clients in the development of customized gastroretentive systems. Additionally, Evonik Industries continues to supply advanced polymers and excipients essential for controlled-release and mucoadhesive formulations, facilitating rapid translation from lab-scale concepts to market-ready products.
From a regulatory and manufacturing perspective, the 2025–2030 outlook is shaped by a growing emphasis on quality-by-design principles and robust in vitro–in vivo correlation (IVIVC) models. This shift is prompting investment in digital twin technologies, process analytical tools, and predictive modeling, with companies like Merck KGaA supporting the integration of these capabilities into pharmaceutical manufacturing pipelines.
Looking ahead, the GRDDS market is poised for continued growth, driven by the rising prevalence of chronic diseases, a maturing pipeline of biologics and peptide drugs requiring protection in the GI tract, and expanding demand for patient-centric oral therapies. Strategic collaborations between drug developers, excipient suppliers, and contract development and manufacturing organizations (CDMOs) are expected to accelerate innovation, improve scalability, and reduce time-to-market for gastroretentive products. By 2030, these systems are projected to be a critical component in the toolkit for differentiated drug delivery, aligning with broader trends in precision medicine and patient-tailored therapy.
Market Size & Forecast: Growth Projections Through 2030
The global market for Gastroretentive Drug Delivery Systems (GRDDS) is poised for robust growth through 2030, underpinned by advances in pharmaceutical formulation technologies, the rising prevalence of chronic gastrointestinal diseases, and a growing demand for improved oral bioavailability of drugs with narrow absorption windows. As of 2025, the adoption of GRDDS is gaining significant traction among pharmaceutical innovators targeting drugs that benefit from prolonged gastric retention, such as antibiotics, antidiabetics, and local gastric therapies.
Key industry participants are actively expanding their product portfolios in this segment. Companies such as AbbVie and Bayer are leveraging their expertise in oral delivery to explore novel gastroretentive formulations that support enhanced patient outcomes and reduce dosing frequency. Furthermore, Pfizer and Novartis are investing in R&D partnerships with technology providers specializing in controlled-release and floating dosage forms, which are central to the GRDDS landscape.
The market is anticipated to exhibit a compound annual growth rate (CAGR) in the mid- to high-single digits through 2030, with North America and Europe retaining leadership due to advanced regulatory frameworks and strong pharmaceutical pipelines. Meanwhile, Asia-Pacific is expected to witness the fastest growth, propelled by increasing healthcare investments and expanding generic drug manufacturing capabilities. Notably, regional pharmaceutical manufacturers such as Sun Pharmaceutical Industries and Dr. Reddy's Laboratories are scaling up their gastroretentive offerings to address unmet needs in chronic disease management.
Recent years have seen a shift towards the development of multiparticulate and expandable systems, which offer improved safety and efficacy profiles. Industry suppliers like Evonik Industries, a leading provider of excipients and controlled-release technologies, report growing demand from pharmaceutical companies for functional polymers and advanced materials tailored for gastroretentive applications. This trend is expected to accelerate as more branded and generic drugs undergo lifecycle extension via gastroretentive reformulation.
Looking to 2030, the outlook for GRDDS remains highly positive, driven by continued innovation, regulatory encouragement for patient-centric drug delivery, and the emergence of new therapeutic areas. Strategic collaborations between pharma companies and excipient specialists will likely yield next-generation platforms that further optimize drug release kinetics and patient adherence, solidifying the gastroretentive segment as a key growth engine within the broader oral drug delivery market.
Emerging Technologies and Innovations
Gastroretentive drug delivery systems (GRDDS) have gained significant attention in recent years for their potential to improve the bioavailability and therapeutic efficacy of drugs with narrow absorption windows in the upper gastrointestinal (GI) tract. As of 2025, the GRDDS landscape is shaped by rapid technological innovation, with a focus on precision, patient-centricity, and enhanced control over drug release profiles.
A major area of innovation is the development of advanced floating and expandable systems. These platforms utilize polymers and novel excipients that enable tablets or capsules to remain buoyant or expand in the stomach for prolonged periods, thereby sustaining drug release. Evonik Industries and BASF are actively advancing polymer technologies tailored for such applications, offering new grades designed for robust gastric retention and controlled release. Their research is centered on improving the mechanical stability and biocompatibility of polymers, which is crucial for both efficacy and patient safety.
Another emerging trend is the integration of smart biomaterials and responsive systems. These next-generation GRDDS leverage stimuli-responsive polymers that alter their properties (such as swelling or gelation) in response to physiological factors like pH or gastric motility. This innovation aims to synchronize drug release with optimal absorption windows. Companies like Lonza are exploring encapsulation techniques and capsule materials that work synergistically with such smart excipients, enhancing the predictability and consistency of drug delivery.
Innovators are also pursuing digital and microelectronic integration in GRDDS. Efforts are underway to incorporate ingestible sensors and microchips to monitor gastrointestinal conditions and trigger on-demand drug release. Although this technology is at a nascent stage, early prototypes and feasibility studies have been reported by organizations including Medtronic, which is exploring partnerships in digital health for integrated delivery and monitoring solutions.
Looking ahead, the outlook for GRDDS is shaped by regulatory encouragement for patient-friendly oral dosage forms and the growing focus on drugs for chronic GI and metabolic conditions. The pipeline includes not only incremental improvements but also disruptive platforms capable of delivering biologics and peptides, previously limited by enzymatic degradation and poor absorption. With continued investment and cross-disciplinary collaboration, the next few years are expected to see GRDDS move from niche applications toward broader clinical adoption, supported by proven safety, scalability, and improved patient outcomes.
Competitive Landscape: Leading Companies and New Entrants
The competitive landscape for gastroretentive drug delivery systems (GRDDS) in 2025 is characterized by the presence of established pharmaceutical companies, innovative biotechnology firms, and a growing number of new entrants focused on advanced oral drug delivery technologies. This market segment is being shaped by the increasing demand for enhanced bioavailability of drugs with narrow absorption windows, as well as the need for improved patient adherence through reduced dosing frequency.
Among the industry leaders, AbbVie Inc. continues to be prominent, leveraging its expertise in oral drug delivery platforms with products and pipeline candidates utilizing gastroretentive technologies for chronic gastrointestinal and metabolic disorders. Similarly, Johnson & Johnson and its pharmaceutical division remain active in developing controlled-release formulations, backed by a robust patent portfolio and ongoing collaborations with technology providers.
A notable player, Zydus Lifesciences Limited, has expanded its range of gastroretentive formulations, particularly for cardiovascular and diabetic indications, utilizing floating and expandable systems to optimize pharmacokinetics. Meanwhile, Sun Pharmaceutical Industries Ltd. invests in advanced polymer-based systems that enable extended gastric retention for both generic and proprietary drugs.
Innovation is also being driven by dedicated drug delivery technology companies such as Accent Therapeutics, which focus on proprietary gastroretentive platforms designed to overcome challenges associated with variable gastric emptying and pH-dependent solubility. These companies often collaborate with larger pharmaceutical manufacturers to co-develop or license gastroretentive solutions for specific APIs.
In addition to established firms, several new entrants are emerging with novel approaches. For example, startups are exploring 3D printing and biodegradable polymers for customizable, patient-specific gastroretentive tablets and capsules. These entrants are often supported by academic partnerships and government innovation grants, targeting both high-value branded therapies and lifecycle management for off-patent drugs.
- Key drivers in the competitive landscape include advancing polymer science, regulatory support for innovative oral formulations, and increasing interest in fixed-dose combinations enabled by gastroretentive platforms.
- Strategic alliances and licensing deals are expected to intensify as larger companies seek to access proprietary technologies developed by specialized firms.
- The entry of contract development and manufacturing organizations (CDMOs), such as Catalent, Inc., is facilitating broader adoption of gastroretentive formulations by providing scalable manufacturing and formulation expertise to both established and emerging players.
Looking ahead, the competitive landscape is expected to remain dynamic, with ongoing innovation, partnership activity, and increased investment in research and development. This will likely accelerate the introduction of next-generation gastroretentive systems addressing unmet clinical needs across a wider spectrum of therapeutic areas.
Regulatory Trends and Compliance Challenges
As gastroretentive drug delivery systems (GRDDS) continue to evolve, regulatory trends and compliance challenges are coming sharply into focus for 2025 and the near future. GRDDS technologies, which include floating, expandable, bioadhesive, and high-density systems, are designed to prolong gastric residence time, enhancing bioavailability and therapeutic efficacy for drugs with narrow absorption windows. Regulatory agencies globally are responding to the complexities these systems present, with the aim of ensuring patient safety and product performance.
The U.S. Food and Drug Administration (FDA) maintains rigorous requirements for GRDDS, emphasizing in vitro-in vivo correlation (IVIVC), device integrity, and consistent drug release profiles in varying gastric conditions. In 2025, the FDA is increasingly prioritizing data from advanced simulation models and human clinical studies that replicate real-world gastric motility and pH variability, reflecting the agency’s commitment to robust safety and efficacy standards. The FDA’s Center for Drug Evaluation and Research (CDER) has also highlighted the need for comprehensive risk assessments related to gastric retention failures and device disintegration, particularly for novel polymeric or expandable systems.
In the European Union, the European Medicines Agency (EMA) is aligning regulatory guidance with the latest pharmaceutical technologies. The EMA’s focus for 2025 includes harmonization of bioequivalence requirements for GRDDS, especially for generic and biosimilar entrants. There is a move toward greater transparency in the assessment of gastroretentive mechanisms and their impact on pharmacokinetic variability across diverse patient populations. Regulatory authorities are also scrutinizing the environmental impact of novel excipients and polymers used in these systems, requiring more extensive safety data and lifecycle analyses.
Manufacturers such as Lonza and Evonik Industries, which supply pharmaceutical excipients and formulation services for GRDDS, are adapting to these regulatory dynamics by investing in quality-by-design (QbD) approaches and advanced material characterization. They are also engaging in early-stage dialogue with regulatory bodies to anticipate compliance requirements and streamline approvals.
Looking forward, regulatory trends suggest increasing emphasis on the personalization of GRDDS, with agencies requiring patient-centric data to support claims of enhanced efficacy or compliance. Authorities are expected to further refine guidelines on device safety, particularly for pediatric and geriatric populations, and to foster international harmonization of standards for cross-border product registrations. Companies operating in this space should anticipate more rigorous post-marketing surveillance obligations and be prepared for evolving requirements related to device traceability and digital health integration.
Applications: Therapeutic Areas Driving Adoption
Gastroretentive drug delivery systems (GRDDS) are gaining significant traction in the pharmaceutical landscape, particularly as the need for targeted, controlled, and sustained drug release in the upper gastrointestinal (GI) tract becomes more pronounced. In 2025, the driving therapeutic areas for GRDDS adoption are primarily those where drugs benefit from extended gastric residence, local gastric action, or improved bioavailability due to site-specific absorption. Key applications include the treatment of Helicobacter pylori infections, diabetes management, central nervous system (CNS) disorders, and chronic pain—each presenting unique clinical needs addressed by innovative GRDDS formulations.
The management of H. pylori-associated peptic ulcers and gastritis remains a major application, as eradication regimens require high local antibiotic concentrations. Floating and mucoadhesive systems are being leveraged for drugs like amoxicillin and clarithromycin, maximizing drug exposure at the infection site. Leading pharmaceutical companies are actively developing such systems to optimize antibacterial efficacy and patient compliance. For instance, current product pipelines from global manufacturers such as AstraZeneca and Takeda Pharmaceutical Company reflect sustained research in this area, with advanced oral formulations targeting gastric retention and localized release.
In diabetes care, the oral delivery of peptide drugs—such as GLP-1 agonists—has historically been hampered by rapid gastric transit and enzymatic degradation. GRDDS platforms are now under investigation to enhance the oral bioavailability of these macromolecules. Companies like Novo Nordisk are investing in gastroretentive technologies to improve the pharmacokinetics of oral semaglutide and related agents, aiming to reduce injection frequency and improve patient adherence.
CNS disorders also present significant opportunities for GRDDS adoption. Drugs like levodopa, used in the management of Parkinson’s disease, exhibit site-dependent absorption in the upper intestine. By employing floating or expandable systems, pharmaceutical developers can achieve more consistent plasma levels and mitigate motor fluctuations. AbbVie continues to explore such strategies for CNS therapeutics, building on its experience with advanced oral delivery platforms.
Looking ahead, the chronic pain management segment is likely to benefit from GRDDS as well, particularly for drugs with narrow absorption windows or those requiring prolonged action, such as gabapentin and certain opioids. The coming years are expected to see a broader integration of GRDDS across these areas, driven by ongoing collaborations between drug formulation specialists and leading pharmaceutical manufacturers. As these technologies mature, their adoption will be further propelled by patient-centric drug design, regulatory support for novel delivery systems, and the potential to extend product lifecycles for established therapies.
Patient Outcomes and Clinical Benefits
Gastroretentive drug delivery systems (GRDDS) have recently gained momentum as a strategic approach to improve patient outcomes by enhancing the bioavailability and therapeutic efficacy of orally administered drugs with narrow absorption windows in the upper gastrointestinal tract. In 2025, the clinical benefits of GRDDS are increasingly evident, particularly for medications treating chronic diseases such as diabetes, hypertension, and infections where controlled and sustained release leads to superior disease management.
Recent clinical studies, including multicenter trials and real-world evidence, demonstrate that GRDDS provide more consistent plasma drug concentrations, reducing the frequency of dosing and minimizing fluctuations that often lead to suboptimal therapeutic effects or side effects. For example, floating tablet technologies and expandable systems have shown marked benefits in improving the pharmacokinetic profiles of drugs like metformin and ciprofloxacin, resulting in better glycemic control and increased eradication rates for Helicobacter pylori infections, respectively.
Patients benefit from reduced pill burden and improved compliance, as some GRDDS formulations can extend dosing intervals to once daily, or even less frequently. This is particularly beneficial for elderly populations and those with polypharmacy concerns. Device and formulation innovators such as Capsugel (a Lonza company) and Evonik Industries have contributed to these advances by supplying specialized polymers, coatings, and encapsulation technologies that enable precise control over gastroretention and drug release kinetics.
Moreover, GRDDS have demonstrated a reduction in gastrointestinal side effects by ensuring drugs are released in the most appropriate segment of the stomach or upper intestine, thereby minimizing irritation and improving tolerability. This is particularly noted with nonsteroidal anti-inflammatory drugs (NSAIDs) and antibiotics, where conventional formulations often cause gastric irritation or variable absorption. Improved retention and targeted delivery have led to higher patient-reported satisfaction and adherence scores in ongoing post-marketing surveillance studies.
Looking ahead, stakeholders such as Pfizer and AbbVie are exploring next-generation GRDDS combining sensor technologies and smart polymers to further personalize and optimize drug regimens, with pilot programs set to expand in the coming years. With regulatory pathways becoming clearer and manufacturing scalability improving, the outlook for patient-centric benefits from GRDDS is highly positive through 2025 and beyond, promising sustained improvements in therapeutic outcomes and quality of life for diverse patient populations.
Manufacturing Advances and Supply Chain Insights
The landscape of manufacturing for gastroretentive drug delivery systems (GRDDS) is experiencing significant advances in 2025, driven by the need for enhanced bioavailability and sustained-release formulations, especially for drugs with narrow absorption windows. The current year has seen a pronounced shift towards more robust, scalable, and quality-centric manufacturing processes, reflecting both regulatory expectations and the growing complexity of GRDDS products.
A notable trend is the adoption of advanced polymer processing technologies, including hot-melt extrusion and solvent-free granulation, to improve the mechanical integrity and gastric retention characteristics of dosage forms. These methods allow for the precise embedding of active pharmaceutical ingredients (APIs) in gastroretentive matrices, contributing to controlled release profiles and improved patient outcomes. Leading pharmaceutical equipment manufacturers such as GEA Group and Bosch are reported to be collaborating with drug developers to optimize continuous manufacturing lines for floating and expandable GRDDS tablets, integrating real-time process analytical technology (PAT) to ensure batch-to-batch consistency.
Supply chain dynamics in 2025 are shaped by increased demand for specialized excipients—such as low-density polymers, swellable hydrogels, and gas-generating agents—that are critical for maintaining gastric retention. Key suppliers in the excipient sector, including Dow and BASF, have expanded their product portfolios to include novel, regulatory-compliant materials tailored for GRDDS applications. These strategic expansions address both the technical requirements of drug developers and the heightened scrutiny from global regulatory bodies regarding excipient safety and traceability.
The integration of digital supply chain management platforms is also gaining momentum. By leveraging IoT-enabled track-and-trace systems, manufacturers can monitor the provenance, storage conditions, and movement of sensitive raw materials. Companies such as Siemens are providing advanced automation and digitalization solutions to pharmaceutical plants, facilitating real-time quality control and predictive maintenance—capabilities that are particularly valuable in the production of complex GRDDS formulations.
Looking forward, the outlook for GRDDS manufacturing remains positive. The sector is expected to benefit from ongoing collaborations between pharmaceutical companies, excipient suppliers, and technology providers aiming to develop scalable, patient-centric solutions. Additionally, as regulatory agencies continue to emphasize quality-by-design (QbD) and data integrity, manufacturers are likely to invest further in process analytical technologies and digital infrastructure to ensure compliant, efficient, and resilient supply chains.
Investment, Partnerships, and M&A Activity
Investment, partnerships, and M&A activity in the gastroretentive drug delivery systems (GRDDS) sector have accelerated into 2025, reflecting the pharmaceutical industry’s ongoing commitment to innovation in oral drug delivery platforms. Key drivers for intensified activity include the rising demand for improved bioavailability of drugs with narrow absorption windows and the push for differentiated therapeutics in crowded markets.
Leading pharmaceutical manufacturers and specialist drug delivery technology companies have continued to forge strategic partnerships to co-develop, license, and commercialize gastroretentive formulations. For example, AbbVie Inc. has expanded collaborations in advanced oral delivery, leveraging its existing expertise in gastroretentive systems for drugs intended for chronic conditions. Similarly, Lonza Group Ltd. has reported increased interest from biotech innovators seeking to utilize its capsule-in-capsule and floating dosage form technologies to enhance product pipelines. These partnerships typically focus on early-stage development, scale-up, and regulatory pathways for gastroretentive technologies.
Investment into GRDDS startups and platform developers is robust, with venture capital and corporate venture arms targeting companies specializing in floating, expandable, and bioadhesive technologies. For instance, Lonza Group Ltd. and Capsugel (now part of Lonza) have both cited gastroretentive systems as a growth area in recent investor communications, highlighting the increasing attractiveness of the segment. Additionally, leading device and formulation specialists like Evonik Industries AG have signaled continued capital allocation toward their oral drug delivery business units, underlining expectations for market expansion.
- Several licensing deals in 2024-2025 have involved proprietary floating tablet technologies and bioadhesive systems intended to prolong gastric residence time, with big pharma companies seeking exclusive rights for select therapeutic assets.
- CDMOs such as Lonza Group Ltd. and Evonik Industries AG have announced facility investments and technical capability upgrades aimed at supporting demand for gastroretentive product development and commercial manufacture.
- Strategic M&A remains active, with large pharmaceutical companies seeking to acquire niche GRDDS technology providers to access proprietary know-how and accelerate time-to-market for new gastroretentive therapies.
Looking ahead, the sector is expected to witness further deal activity as demand for targeted oral delivery rises and as more gastroretentive products approach late-stage clinical development. The competitive landscape will likely be shaped by ongoing collaborations between established drug manufacturers and innovative technology providers, as well as by the increasing sophistication of contract development and manufacturing partners focused on GRDDS.
Future Outlook: Opportunities and Strategic Recommendations
As the pharmaceutical sector continues its drive toward enhanced therapeutic efficacy and patient-centric solutions, gastroretentive drug delivery systems (GRDDS) are positioned for notable expansion and innovation through 2025 and beyond. These systems, designed to prolong gastric residence time and enable targeted release of medications, are increasingly seen as pivotal in addressing challenges associated with drugs that are poorly absorbed in the lower gastrointestinal tract, have narrow absorption windows, or require localized gastric action.
Key opportunities are emerging from the integration of advanced materials science and digital health technologies. Companies such as Evonik Industries AG and DuPont are leading the development of polymers and excipients tailored for sustained gastric retention, buoyancy, and compatibility with a wider range of active pharmaceutical ingredients (APIs). With continuous innovation in functional excipients, manufacturers are now able to design floating and expandable delivery forms that ensure better control over drug release profiles, potentially improving outcomes for drugs treating diabetes, H. pylori infections, and central nervous system disorders.
The landscape is also shaped by strategic collaborations between pharmaceutical companies and technology providers. Sanofi and AbbVie have demonstrated increased interest in licensing and co-development agreements to leverage GRDDS platforms for both existing and pipeline drugs, seeking to extend patent life and enhance market differentiation. Such partnerships are likely to intensify, especially as regulatory bodies encourage patient-friendly, adherence-promoting innovations.
Market growth is forecasted to be strongest in North America and Asia-Pacific, driven by a high prevalence of chronic gastric and metabolic disorders and expanding pharmaceutical manufacturing infrastructure. Furthermore, regulatory agencies—including the U.S. Food and Drug Administration—are supporting the expedited review of novel oral delivery formats, which is expected to accelerate product introductions over the next several years.
To maximize the potential of GRDDS, companies should focus on:
- Investing in research on novel polymers and biodegradable materials that offer optimal retention and release kinetics.
- Pursuing strategic alliances with device manufacturers to integrate sensors or digital monitoring, enabling real-time pharmacokinetic feedback and improved dosing regimens.
- Engaging with regulatory authorities early in development to align on safety, efficacy, and patient acceptability requirements.
- Customizing delivery systems for region-specific disease profiles, particularly in emerging markets where gastrointestinal diseases are prevalent.
In summary, the convergence of materials innovation, strategic partnerships, and regulatory support positions gastroretentive drug delivery systems as a dynamic growth segment in pharmaceutical technology from 2025 onward. Companies that proactively invest in next-generation GRDDS platforms and collaborative R&D are likely to secure significant competitive advantages.
Sources & References
- Novartis
- Evonik Industries
- Dr. Reddy's Laboratories
- BASF
- Medtronic
- Zydus Lifesciences Limited
- Accent Therapeutics
- Catalent, Inc.
- European Medicines Agency
- Takeda Pharmaceutical Company
- Novo Nordisk
- GEA Group
- Bosch
- Siemens
- DuPont