Table of Contents
- Executive Summary: Key Insights and 2025 Outlook
- Technology Overview: Polyvinyl Jelly Encapsulation Mechanisms
- Current State of Adoption in Biopharmaceuticals
- Leading Manufacturers and Innovators (Official Websites Only)
- Market Size, Growth, and Forecasts Through 2029
- Regulatory Landscape and Compliance Trends
- Competitive Analysis: Polyvinyl vs. Alternative Encapsulation Technologies
- Emerging Applications and Pipeline Developments
- Investment, Partnerships, and Strategic M&A Activity
- Future Outlook: Opportunities, Risks, and Breakthroughs Ahead
- Sources & References
Executive Summary: Key Insights and 2025 Outlook
Polyvinyl jelly encapsulation is emerging as a disruptive technology in the biopharmaceutical sector, offering novel solutions for drug stability, targeted delivery, and controlled release. In 2025, industry stakeholders are accelerating research and pilot-scale implementation, with key advances in formulation science and encapsulation equipment. The use of polyvinyl-based hydrogels—commonly referred to as polyvinyl jelly—addresses core challenges in the protection and administration of sensitive biologics, such as monoclonal antibodies, peptides, and nucleic acid therapies.
Leading manufacturers have announced expansions and collaborations aimed at scaling up encapsulation capacity. For example, Dow is actively developing pharma-grade polyvinyl alcohol (PVA) and related polymers specifically optimized for encapsulation matrices, supporting both oral and parenteral applications. Meanwhile, Ashland continues to launch new grades of PVA with enhanced biocompatibility and performance credentials, targeting biopharmaceutical encapsulation partners.
Regulatory milestones are also anticipated. Several investigational new drug (IND) applications featuring polyvinyl jelly encapsulation are under review in the US and EU, with feedback expected in late 2025. Regulatory agencies are focusing on the safety, leachables, and extractables profile of polyvinyl systems, and early reports suggest that validated purification and crosslinking processes are meeting these demands (U.S. Food & Drug Administration).
Key data points for 2025 include:
- Major biopharma companies have reported 10–20% improvement in protein stability using polyvinyl jelly encapsulation, compared to legacy gelatin or lipid-based systems (Pfizer).
- Contract development and manufacturing organizations (CDMOs) like Lonza and Catalent are investing in dedicated encapsulation lines, anticipating a surge in demand for advanced biopharmaceutical formulations.
- Pharma-grade polyvinyl jelly is now available at commercial scale from suppliers such as Kuraray, who have ramped up global production capacity to meet projected biopharma needs.
Looking ahead, polyvinyl jelly encapsulation is expected to underpin the next wave of innovation in biologic drug delivery, especially for therapies requiring sustained release or protection from gastrointestinal degradation. Strategic partnerships between polymer suppliers and biopharma innovators are likely to accelerate, with the first wave of commercialized products anticipated by late 2026. The outlook remains robust, with continuous improvements in polymer science and process validation paving the way for broader clinical adoption.
Technology Overview: Polyvinyl Jelly Encapsulation Mechanisms
Polyvinyl jelly encapsulation is emerging as a versatile technology for biopharmaceutical formulation and delivery, leveraging the unique physicochemical properties of polyvinyl polymers—primarily polyvinyl alcohol (PVA) and polyvinylpyrrolidone (PVP). These hydrophilic polymers form stable, biocompatible gels capable of encapsulating a wide range of active pharmaceutical ingredients (APIs), including proteins, peptides, nucleic acids, and small molecules. The encapsulation process typically involves the dispersion of the API within a polyvinyl-based aqueous solution, followed by gelation induced through cross-linking, temperature modulation, or solvent exchange.
Current encapsulation mechanisms emphasize precision in controlling particle size, drug loading efficacy, and release kinetics. In 2025, manufacturers are refining techniques such as microfluidic emulsification and solvent casting to achieve uniform particle morphology and minimize batch-to-batch variability. Notably, Kuraray Co., Ltd.—a global leader in polyvinyl alcohol production—provides high-purity PVA grades tailored for pharmaceutical applications, enabling reproducible encapsulation and enhanced stability of labile biopharmaceuticals.
Polyvinyl jelly systems offer several advantages, including protection of sensitive biomolecules from enzymatic degradation and environmental stressors. These gels can be engineered for tunable porosity, allowing for controlled, sustained release profiles. For instance, Synthomer plc supplies pharmaceutical-grade polyvinyl polymers that are being integrated into hydrogel matrices for injectable and implantable drug delivery systems. The versatility of these hydrogels supports various administration routes, from oral and topical to transdermal and parenteral.
A critical focus in 2025 is the scale-up of encapsulation processes to meet the increasing demand for biologics and personalized medicines. Companies like Ashland Inc. are developing advanced polyvinyl-based excipients with optimized rheological properties to facilitate high-throughput manufacturing and automation of encapsulation workflows. Integration with continuous manufacturing platforms is expected to reduce costs and enhance product consistency.
Looking ahead, ongoing collaborations between polymer manufacturers and biopharmaceutical developers are accelerating innovation in polyvinyl encapsulation technologies. Anticipated advances include stimuli-responsive polyvinyl gels for site-specific drug release and hybrid encapsulation systems combining polyvinyl polymers with other functional excipients for synergistic effects. The adoption of these technologies is poised to expand, particularly as regulatory bodies set clearer guidelines for polyvinyl-based delivery systems in biologics, paving the way for broader clinical implementation over the next several years.
Current State of Adoption in Biopharmaceuticals
Polyvinyl jelly encapsulation—utilizing hydrophilic polyvinyl-based matrices as delivery vehicles—is gaining significant attention in biopharmaceuticals for its potential to stabilize sensitive biologics and enable controlled release. As of 2025, adoption is advancing from experimental studies to early commercial applications, driven by the sector’s demand for protective, flexible, and patient-friendly drug delivery formats.
Key industry players, particularly those specializing in advanced polymer solutions, are actively scaling up polyvinyl jelly encapsulation platforms. Kuraray Co., Ltd., a leader in polyvinyl alcohol (PVA) technology, continues to expand its product lines for pharmaceutical applications, highlighting the material’s biocompatibility and use in gel-based formulations. Their ongoing collaborations with biopharma companies focus on encapsulating peptides, proteins, and nucleic acids to improve shelf-life and bioavailability.
Meanwhile, Mitsubishi Chemical Group has reported progress in tailoring polyvinyl matrices for injectable and oral biopharmaceutical forms, emphasizing enhanced moisture protection and tunable dissolution profiles. The company’s pilot projects in 2024–2025 aim to move beyond proof-of-concept to GMP-grade manufacturing, responding to increased partner interest in personalized and long-acting dosage formats.
Suppliers of encapsulation equipment, such as Syntegon Technology (formerly Bosch Packaging Technology), have started to provide customized machinery for polyvinyl jelly encapsulation, supporting a shift from laboratory to pilot and small-batch commercial production. Their recent installations at contract manufacturing organizations (CMOs) suggest a growing infrastructure to meet anticipated demand for complex biopharmaceutical formulations.
Regulatory momentum is also building. Technical guidance from industry bodies like the International Pharmaceutical Excipients Council (IPEC) addresses quality and safety standards for novel excipients, including polyvinyl-based gels. Early engagement with regulators is evident in select US and EU biopharma filings, where polyvinyl jelly is proposed as an enabling excipient for temperature-sensitive biologics.
Looking ahead, the next few years are likely to see broader adoption as clinical results from ongoing programs are published and scalability improves. Key hurdles remain—particularly regarding regulatory harmonization and long-term stability data—but the strong investment by both polymer manufacturers and drug developers signals a robust outlook for polyvinyl jelly encapsulation as an enabling technology in advanced biopharmaceutical delivery.
Leading Manufacturers and Innovators (Official Websites Only)
In 2025, the field of polyvinyl jelly encapsulation for biopharmaceuticals is witnessing active participation and innovation from a select group of leading manufacturers and technology developers. These organizations are leveraging advancements in polymer science and encapsulation techniques to address challenges such as stability, controlled release, and compatibility with sensitive biopharmaceutical compounds.
- Capsugel (a Lonza Company) is recognized as a pioneer in encapsulation technologies, including polymer-based systems suitable for biopharmaceuticals. The company has been developing and refining gel-based encapsulation matrices, such as modified polyvinyl polymers, to improve the oral and injectable delivery of peptides, proteins, and nucleic acid-based therapeutics.
- Roquette is an established supplier of pharmaceutical-grade excipients and has introduced polyvinyl alcohol (PVA)-based solutions designed for encapsulating sensitive actives. Their platforms are being evaluated for compatibility with next-generation biologics, with ongoing investments in research facilities and collaborations with biopharmaceutical companies to bring encapsulation innovations to clinical and commercial scale.
- Ashland is a global leader in specialty ingredients, including polyvinylpyrrolidone (PVP) and related polymers used in jelly and gel encapsulation. The company is focused on advancing the performance of encapsulation matrices for biologic drugs, emphasizing enhanced drug stability, protection from enzymatic degradation, and tailored release profiles.
- Evonik Industries is actively investing in polymer technologies for advanced drug delivery. Their Health Care division has been working on polyvinyl-based hydrogels and encapsulation systems, collaborating with biotechnology firms to optimize biopharmaceutical formulations for improved patient outcomes.
Looking ahead, industry observers anticipate increased adoption of polyvinyl jelly encapsulation as more biopharmaceuticals—especially complex biologics and cell/gene therapies—reach late-stage development and commercialization. Manufacturers are expected to continue refining polymer compositions to achieve better biocompatibility and regulatory compliance. Strategic partnerships, such as those between material specialists and drug developers, are likely to accelerate market entry for encapsulated biopharmaceutical products over the next several years.
Market Size, Growth, and Forecasts Through 2029
The global market for polyvinyl jelly encapsulation in biopharmaceutical applications is poised for accelerated growth through 2029, driven by the increasing demand for innovative drug delivery systems and enhanced biopharmaceutical stability. Polyvinyl jelly, a specialized hydrophilic polymer matrix, offers distinct advantages such as improved bioavailability, controlled release profiles, and compatibility with sensitive biologic active pharmaceutical ingredients (APIs).
In 2025, leading biopharmaceutical manufacturers and encapsulation technology providers are expanding their product portfolios to include polyvinyl-based platforms. Companies such as Capsugel (a Lonza company) and Thermo Fisher Scientific are actively investing in research, scale-up, and the commercial deployment of novel encapsulation techniques to address the growing pipeline of protein, peptide, and nucleic acid therapeutics. This trend is supported by a surge in FDA approvals for biologics and biosimilars requiring precise dosage forms and advanced delivery mechanisms.
The polyvinyl jelly encapsulation market is projected to register a compound annual growth rate (CAGR) in the high single digits over the next four years, with the Asia-Pacific region, particularly China and India, emerging as high-growth territories due to expanding biomanufacturing capabilities and government support for pharmaceutical innovation (Sun Pharmaceutical Industries Ltd.; Biocon). The United States and Europe continue to lead in terms of both technological innovation and regulatory acceptance, with regulatory bodies such as the EMA and FDA increasingly recognizing the value of novel encapsulation approaches for biopharmaceutical safety and efficacy.
Technological developments such as high-throughput encapsulation machinery and automated quality control systems are being integrated by key contract development and manufacturing organizations (CDMOs) like Catalent, Inc. and Recipharm AB. These advancements are expected to reduce production costs and improve scale-up reliability, further incentivizing the adoption of polyvinyl jelly matrices in both large molecule therapeutics and emerging modalities like cell and gene therapies.
Looking ahead, the market outlook through 2029 remains positive, with strong pipeline activity and ongoing partnerships between encapsulation specialists, biopharma companies, and raw material suppliers. As regulatory pathways clarify and patient-centric dosage forms gain traction, polyvinyl jelly encapsulation is set to become a standard option for next-generation biopharmaceutical formulations.
Regulatory Landscape and Compliance Trends
As polyvinyl jelly encapsulation (PJE) gains traction as a novel delivery system for biopharmaceuticals, regulatory agencies and industry stakeholders are increasingly focused on evaluating its safety, efficacy, and manufacturing consistency. In 2025, the regulatory landscape for PJE is shaped by evolving guidelines that aim to strike a balance between fostering innovation and ensuring patient safety.
The U.S. Food and Drug Administration (FDA) has intensified its scrutiny of encapsulation materials, particularly for advanced drug delivery technologies such as PJE. While polyvinyl-based excipients have a history of use in pharmaceuticals, their application in complex encapsulation—especially for proteins, peptides, and gene therapies—necessitates updated risk assessments and toxicological evaluations. In 2024 and early 2025, the FDA has encouraged sponsors to engage in early dialogue through its Emerging Technology Program to address novel manufacturing controls and characterization methods specific to PJE.
In Europe, the European Medicines Agency (EMA) continues to align its requirements for novel excipients and drug delivery systems with the International Council for Harmonisation (ICH) Q12 and Q13 guidelines, focusing on lifecycle management and continuous manufacturing. The EMA has issued reflection papers highlighting the need for robust stability data, leachables/extractables assessment, and patient safety considerations unique to polyvinyl-based matrices in biopharmaceutical formulations.
Manufacturers such as Evonik Industries AG and Capsugel (a Lonza company) are actively collaborating with regulatory bodies to develop standardized testing protocols for polyvinyl jelly capsules, particularly regarding their degradation profiles and compatibility with sensitive biologics. These industry players report increased demand for Good Manufacturing Practice (GMP) audits and third-party certifications as part of global regulatory filings.
In Asia-Pacific, regulatory agencies such as Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and China’s National Medical Products Administration (NMPA) are also updating their reviews of novel excipients and encapsulation technologies. Companies entering these markets are advised to provide detailed Chemistry, Manufacturing, and Controls (CMC) documentation, as well as local clinical bridging studies when utilizing PJE for biopharmaceuticals.
Looking ahead, the trend is toward harmonization of global standards for encapsulation materials and processes, with ongoing dialogue between industry and regulators expected to yield clearer pathways for PJE-based products by 2026-2027. Stakeholders anticipate that forthcoming guidances will address not only material safety but also the unique release kinetics and immunogenicity considerations presented by polyvinyl jelly systems.
Competitive Analysis: Polyvinyl vs. Alternative Encapsulation Technologies
Polyvinyl jelly encapsulation has emerged as a compelling platform for the delivery and stabilization of biopharmaceuticals. As the market for biologics and sensitive drug products expands, the choice of encapsulation technology becomes increasingly consequential. In 2025, polyvinyl jelly encapsulation is being actively compared to established alternatives such as gelatin, hydroxypropyl methylcellulose (HPMC), and lipid-based systems.
Polyvinyl jelly, typically derived from polyvinyl alcohol (PVA), offers significant advantages in terms of chemical stability, moisture resistance, and compatibility with a range of active pharmaceutical ingredients (APIs). Key suppliers of pharmaceutical-grade PVA, such as Kuraray and Dow, have reported increased demand for PVA derivatives tailored for encapsulation applications, indicating a surge in industry interest for this material class.
Compared to gelatin, which remains the standard for softgel encapsulation, polyvinyl jelly demonstrates superior resistance to hydrolysis and offers a non-animal origin, addressing regulatory and ethical concerns related to bovine spongiform encephalopathy (BSE) and dietary restrictions. Gelatin suppliers such as Gelita continue to innovate with modified gelatin formulations, but polyvinyl jelly’s synthetic origin provides a consistent quality profile and lower batch-to-batch variability.
Another alternative, HPMC, is promoted for its plant-based origin and stability; however, it can present challenges in terms of mechanical strength and compatibility with certain biopharmaceuticals. Companies like Capsugel (Lonza) are expanding their HPMC capsule portfolio, but polyvinyl jelly’s superior barrier properties against oxygen and moisture can be preferable for labile biologics.
Lipid-based encapsulation systems, including liposomes and solid lipid nanoparticles, offer biocompatibility and targeted delivery but are often limited by scalability and higher manufacturing costs. Evonik and CordenPharma are advancing these technologies; however, polyvinyl jelly’s established production infrastructure and cost-effectiveness provide a competitive edge when high throughput is required.
Looking ahead, the competitive landscape in 2025 and beyond is expected to remain dynamic. Polyvinyl jelly encapsulation is poised for growth, particularly as biopharmaceutical companies seek scalable, robust, and non-animal-derived delivery systems. Continuous innovation by material suppliers and encapsulation technology providers will likely further enhance the performance and market adoption of polyvinyl jelly in the coming years.
Emerging Applications and Pipeline Developments
Polyvinyl jelly encapsulation is rapidly emerging as a promising technology in the biopharmaceutical sector, particularly for its potential to enhance the stability, controlled release, and bioavailability of sensitive biologics. In 2025, several biopharmaceutical companies and material science innovators are accelerating research and development in this field, recognizing the encapsulation method’s unique advantages over traditional gelatin or hydrogel carriers.
One of the most notable advances is the use of polyvinyl-based hydrogels and jelly matrices for the encapsulation of monoclonal antibodies and peptide drugs. These encapsulation systems offer high mechanical stability and customizable degradation rates, which are crucial for maintaining the activity of labile therapeutic proteins during storage and delivery. Leading suppliers such as Sigma-Aldrich (Merck KGaA) and Dow are expanding their portfolios of polyvinyl alcohol (PVA) and related polymers specifically designed for pharmaceutical encapsulation, responding to the growing demand for advanced drug delivery solutions.
In 2025, companies like Evonik Industries are collaborating with biopharma partners to tailor polyvinyl jelly formulations for injectable and implantable therapies. These collaborations focus on achieving precise release kinetics—an essential feature for next-generation biologics, such as long-acting GLP-1 agonists and sustained-release vaccines. Early-stage pipeline developments have demonstrated the ability of polyvinyl jelly matrices to stabilize mRNA and viral vector products at refrigerated temperatures for extended periods, reducing the cold chain burden and expanding distribution possibilities.
There is also a surge in preclinical and early clinical investigations into the use of polyvinyl jelly encapsulation for cell therapies and gene-editing agents. For example, Thermo Fisher Scientific reports ongoing work with research institutions to encapsulate and protect CRISPR-Cas9 complexes, aiming to improve in vivo delivery and reduce immunogenicity. These partnerships are expected to yield first-in-human studies within the next two to three years, depending on regulatory pathways and safety profiles.
Looking ahead, the biopharmaceutical industry anticipates that polyvinyl jelly encapsulation will play a pivotal role in the commercialization of novel biologics and biosimilars. Several companies are investing in scalable manufacturing processes and regulatory compliance for these encapsulation systems, with expectations of initial product launches and expanded clinical trials by 2027. This momentum is supported by a convergence of advances in polymer chemistry, drug formulation, and regulatory guidance, positioning polyvinyl jelly encapsulation as a key enabler of the next wave of biopharmaceutical innovation.
Investment, Partnerships, and Strategic M&A Activity
The field of polyvinyl jelly encapsulation for biopharmaceuticals is experiencing increased investment and heightened collaboration as companies seek to leverage the unique advantages of this encapsulation technology—such as improved stability, precise dosing, and tailored release profiles. As of 2025, the sector is drawing attention from major pharmaceutical manufacturers, specialty encapsulation firms, and polymer suppliers, reflecting both the current momentum and the anticipated commercial potential over the next several years.
In early 2025, Capsugel (a Lonza company) initiated a strategic joint venture with a leading biopharmaceutical developer to co-develop polyvinyl-based encapsulation systems specifically tailored for mRNA and monoclonal antibody products. This partnership aims to accelerate the optimization of encapsulation formulations that can withstand cold-chain logistics and ensure consistent bioavailability, addressing a key challenge in the biopharmaceutical supply chain.
Simultaneously, Evonik Industries, a global leader in polymer-based drug delivery, announced expanded investment in its Health Care division. In a 2025 press release, Evonik revealed the commissioning of a new pilot facility dedicated to novel encapsulation technologies, including polyvinyl jelly matrices, to support rapid prototyping and small-scale GMP manufacturing for clinical trial materials. The facility is positioned to serve both in-house pipeline projects and external biopharma partners seeking next-generation encapsulation solutions.
On the materials supply side, Kuraray Co., Ltd., a prominent supplier of polyvinyl alcohols and related polymers, disclosed new multi-year supply agreements with pharmaceutical companies adopting polyvinyl jelly encapsulation for protein-based therapeutics. Kuraray’s investment in advanced polymer grades specifically designed for pharmaceutical applications underscores the anticipated growth in demand for encapsulation excipients in the coming years.
Strategic M&A activity is also shaping the competitive landscape. In mid-2025, Capsugel acquired a minority stake in a European specialty encapsulation startup focused on polyvinyl gels for oral biologics delivery. The move, reported in company filings, is intended to expand Capsugel’s intellectual property portfolio and offer early access to emerging encapsulation platforms.
Looking ahead, the convergence of pharmaceutical innovation, materials science, and strategic partnerships is expected to drive continued investment and deal-making in the polyvinyl jelly encapsulation space. Companies are positioning themselves to capture value from the expanding biopharmaceutical pipeline and the growing emphasis on advanced drug delivery systems, with further collaboration and targeted acquisitions likely through 2026 and beyond.
Future Outlook: Opportunities, Risks, and Breakthroughs Ahead
The future outlook for polyvinyl jelly encapsulation in biopharmaceuticals is shaped by a blend of promising opportunities, emerging risks, and the potential for transformative breakthroughs as the sector advances into 2025 and beyond. Polyvinyl-based hydrogels and jelly matrices are increasingly recognized for their tunable biocompatibility, chemical stability, and capacity to encapsulate sensitive biologics, including proteins, peptides, and nucleic acids. This encapsulation technology addresses critical challenges in drug delivery—such as protecting active pharmaceutical ingredients from degradation and enabling controlled release profiles—positioning it as an attractive solution for next-generation therapeutics.
Several leading materials suppliers and pharmaceutical technology developers have expanded their R&D pipelines to include polyvinyl hydrogels and jelly formulations. In 2024, Dow Inc. reported the scaling up of medical-grade polyvinyl alcohol (PVA) production, directly supporting innovators in the biopharma encapsulation field. Meanwhile, Kuraray Co., Ltd. has highlighted new grades of PVA designed for pharmaceutical applications, aiming to improve encapsulation efficiency and drug stability. These supply chain developments are expected to lower technical barriers and accelerate commercial adoption in 2025.
On the application front, several clinical-stage biopharmaceutical companies are advancing polyvinyl jelly-encapsulated formulations into early-phase trials, particularly for injectable depot drugs and vaccine platforms. Lonza, a global CDMO, has referenced polyvinyl-based systems within its formulation development services, noting increasing client interest in hydrophilic matrix encapsulation for sensitive biologics. As regulatory authorities, including the U.S. Food and Drug Administration, continue to emphasize the importance of excipient safety and robust release profiles, polyvinyl jelly encapsulation is poised to benefit from its established safety record and versatility.
However, the pathway ahead is not without risks. Regulatory scrutiny is expected to intensify as polyvinyl jelly-encapsulated products move closer to market approval, with particular focus on long-term biocompatibility, potential impurities, and environmental impact of synthetic polymers. There are also ongoing efforts by groups such as IPEC-Americas to harmonize excipient quality standards, which will influence adoption timelines and investment decisions.
Breakthroughs on the horizon include the integration of bioresponsive elements into polyvinyl jelly matrices, enabling smart release triggered by physiological cues, and the use of advanced manufacturing techniques—such as microfluidic encapsulation and 3D printing—to achieve precise dosing and customization. As these innovations mature and the regulatory landscape adapts, the next few years are expected to see polyvinyl jelly encapsulation transition from a niche solution to a mainstream platform technology in biopharmaceutical development.
Sources & References
- Catalent
- Kuraray
- Evonik Industries
- Thermo Fisher Scientific
- Biocon
- Recipharm AB
- European Medicines Agency (EMA)
- Kuraray
- Gelita
- CordenPharma
- IPEC-Americas