Global Enteric Softgel Capsules Market By Product Type (Gelatin (Type-A & Type-B), Fish Bone Gelatin, Starch Material and Cellulose Derivatives), By Application (Health Supplements, Anti-Inflammatory Drugs, Vitamin and Dietary Supplements, Antibiotic & Antibacterial Drugs and Others), By End-User (Pharmaceutical Companies, Cosmeceutical Companies, Nutraceutical Companies and Food Industry), Region and Companies – Industry Segment Outlook, Market Assessment, Competition Scenario, Trends and Forecast 2025-2034

Report Overview

The Global Enteric Softgel Capsules Market size is expected to be worth around US$ 4.0 Billion by 2034 from US$ 2.8 Billion in 2024, growing at a CAGR of 3.7% during the forecast period 2025 to 2034. In 2024, North America led the market, achieving over 41.9% share with a revenue of US$ 0.3 Billion.

Growing demand for targeted delivery systems spurs pharmaceutical and nutraceutical manufacturers to utilize enteric softgel capsules that shield acid-sensitive actives from gastric degradation, ensuring optimal intestinal absorption. Formulators increasingly encapsulate probiotics within these capsules to enhance microbial viability during gastrointestinal transit, supporting gut health initiatives in dietary supplements.

These capsules protect omega-3 fatty acids from oxidation and reflux, delivering essential lipids effectively for cardiovascular wellness programs. Clinicians prescribe enteric softgels for non-steroidal anti-inflammatory drugs, minimizing stomach irritation in arthritis and pain management therapies. Nutraceutical developers employ them for enzyme formulations, preserving activity for digestive aid applications.

Between 2024 and 2025, Sirio Pharma introduced a clean-label enteric softgel approach that removes the need for a separate enteric coating step. By embedding enteric functionality directly into gelatin or plant-based shells, the company simplified manufacturing while improving stability for sensitive ingredients such as probiotics and omega-3 oils. To support growing demand, Sirio Pharma expanded production capacity across its facilities in Asia and Europe, positioning these coating-free softgels as a solution for reducing common consumer complaints like gastric discomfort associated with conventional supplements.

Manufacturers identify opportunities to engineer plant-based enteric softgels that cater to vegan preferences, broadening applications in botanical extract delivery for immune support supplements. Developers create multi-chamber designs that separate incompatible fills, enabling combination therapies for metabolic health with sustained vitamin release. These innovations facilitate customized dosing for pediatric nutritional deficiencies, incorporating flavored shells that dissolve precisely in the duodenum.

Opportunities arise in oncology supportive care, where enteric capsules protect chemotherapeutic adjuvants from premature breakdown during oral regimens. Companies advance low-moisture variants for tropical climates, ensuring shelf stability in herbal anti-inflammatory products. Firms leverage automation in shell formulation to scale production for high-volume probiotic blends targeting microbiome restoration.

Industry developers pioneer seamless enteric polymers that integrate pH-responsive dissolution directly into shells, eliminating post-processing for enzyme therapeutics in pancreatic insufficiency treatments. Formulators incorporate microencapsulation within softgels to boost probiotic strain diversity, enhancing efficacy in irritable bowel syndrome management.

Market leaders refine burp-free omega-3 formulations with enhanced oxidation barriers, appealing to consumers seeking cardiac protection without sensory drawbacks. Innovators prioritize biosimilar NSAID encapsulations that match originator bioavailability, supporting cost-effective arthritis interventions. Companies emphasize transparent shells for visual appeal in premium vitamin complexes aimed at preventive wellness. Ongoing refinements target hybrid gelatin-pectin matrices, optimizing release kinetics across diverse gastrointestinal therapeutic landscapes.

Key Takeaways

• In 2024, the market generated a revenue of US$ 2.8 Billion, with a CAGR of 3.7%, and is expected to reach US$ 4.0 Billion by the year 2034.
• The product type segment is divided into gelatin (type-a & type-b), fish bone gelatin, starch material and cellulose derivatives, with gelatin (type-a & type-b) taking the lead in 2024 with a market share of 58.6%.
• Considering application, the market is divided into health supplements, anti-inflammatory drugs, vitamin and dietary supplements, antibiotic & antibacterial drugs and others. Among these, health supplements held a significant share of 42.4%.
• Furthermore, concerning the end-user segment, the market is segregated into pharmaceutical companies, cosmeceutical companies, nutraceutical companies and food industry. The pharmaceutical companies sector stands out as the dominant player, holding the largest revenue share of 47.8% in the market.
• North America led the market by securing a market share of 41.9% in 2024.

Product Type Analysis

Gelatin type A and type B accounted for 58.6% of the growth share within product type and remains the foundation of enteric softgel capsule manufacturing. Manufacturers increasingly rely on gelatin due to its strong film forming ability and predictable dissolution behavior under enteric coating conditions. This material supports precise control over shell thickness, which improves resistance to gastric acids.

Pharmaceutical formulators prefer gelatin because it enables stable encapsulation of oils and semi solid fills without leakage. The segment benefits from decades of processing know how and validated production lines. Regulatory familiarity with gelatin based capsules reduces approval complexity for new formulations. Cost efficiency compared to synthetic polymers supports widespread adoption. Gelatin adapts well to high speed rotary die processes, which improves output consistency. Suppliers continue to enhance gelatin purity to meet pharmaceutical grade standards.

The material supports uniform coating adhesion, which remains critical for delayed release performance. Global availability of bovine and porcine sources strengthens supply continuity. Manufacturers achieve reliable scalability using gelatin across large batch volumes. Patient acceptance remains high due to smooth texture and easy swallowing.

Enteric gelatin softgels support improved bioavailability for sensitive actives. Innovation in cross linking control reduces variability risks. The segment aligns well with both prescription and over the counter products. Stability under controlled storage conditions enhances shelf life. Contract manufacturers standardize gelatin shells to optimize turnaround times. The segment is expected to sustain dominance due to performance reliability. Overall growth reflects manufacturing efficiency, regulatory trust, and formulation versatility.

Application Analysis

Health supplements contributed 42.4% of the growth share within application and represent the largest demand driver for enteric softgel capsules. Consumers increasingly prefer supplements that protect ingredients from stomach acid and improve intestinal absorption. Enteric softgels enhance delivery of probiotics, enzymes, omega fatty acids, and botanical extracts. Supplement brands differentiate products through delayed release claims supported by enteric technology.

Rising focus on digestive health strengthens demand for gut targeted formulations. Aging populations drive sustained consumption of preventive nutrition products. Enteric softgels reduce gastrointestinal discomfort, which improves user compliance. Manufacturers position these capsules as premium dosage forms within wellness portfolios. Online retail and specialty nutrition channels amplify product visibility.

Brand owners invest in clinical substantiation to support absorption benefits. The segment benefits from repeat purchase behavior due to daily supplementation routines. Product innovation includes combination supplements requiring targeted release profiles. Enteric softgels protect moisture sensitive and acid labile ingredients. Global wellness trends support higher per capita supplement intake. Improved taste masking enhances consumer experience.

Packaging innovations extend shelf stability for supplement products. Regulatory frameworks for supplements support formulation flexibility. Manufacturers scale production to meet high volume consumer demand. The segment is anticipated to expand with preventive healthcare adoption. Overall growth reflects consumer preference for effective and comfortable supplementation formats.

End-User Analysis

Pharmaceutical companies held 47.8% of the growth share within end user categories and remain the primary adopters of enteric softgel capsules. Drug developers increasingly select enteric softgels to protect acid sensitive active pharmaceutical ingredients. These capsules support targeted intestinal release, which improves therapeutic efficacy.

Pharmaceutical pipelines emphasize patient friendly oral dosage forms to enhance adherence. Enteric softgels reduce gastric irritation for anti inflammatory and pain management drugs. Companies use this technology to reformulate existing drugs and extend product lifecycles. Strong research and development investment supports innovation in enteric delivery systems. Regulatory pathways for enteric softgels remain well established for pharmaceutical use. Quality control standards align well with gelatin based softgel production.

Pharmaceutical companies leverage contract manufacturing to accelerate commercialization. Enteric softgels enable precise dosing for potent formulations. Clinical performance consistency strengthens physician confidence. Companies integrate enteric capsules into differentiated product strategies. Improved bioavailability reduces variability in patient response.

Pharmaceutical branding benefits from advanced delivery claims. Manufacturing scalability supports global distribution strategies. Stability data supports longer shelf life for prescription products. Pharmaceutical firms prioritize technologies that improve patient outcomes. The segment is projected to grow alongside chronic disease prevalence. Overall dominance reflects clinical necessity, regulatory alignment, and innovation driven drug development.

Key Market Segments

By Product Type

• Gelatin (Type-A & Type-B)
• Fish Bone Gelatin
• Starch Material
• Cellulose Derivatives

By Application

• Health Supplements
• Anti-inflammatory Drugs
• Vitamin and Dietary Supplements
• Antibiotic & Antibacterial Drugs
• Others

By End-user

• Pharmaceutical Companies
• Cosmeceutical Companies
• Nutraceutical Companies
• Food Industry

Drivers

Rising demand for nutraceutical products is driving the market

The enteric softgel capsules market is substantially driven by the rising demand for nutraceutical products, which require specialized encapsulation to protect sensitive ingredients from gastric degradation. Healthcare providers increasingly recommend enteric softgels for delivering probiotics and omega-3 supplements, enhancing bioavailability in consumer health applications.

Regulatory bodies support the growth of nutraceuticals through guidelines that favor advanced dosage forms like enteric coatings. Pharmaceutical companies invest in enteric technology to meet consumer preferences for targeted release in dietary supplements. Clinical studies demonstrate improved efficacy of nutraceuticals in enteric softgels, supporting market expansion. Global health trends emphasize preventive care, boosting the need for enteric capsules in wellness products.

Academic research on ingredient stability contributes to innovations in enteric formulations for nutraceuticals. Patient adoption of self-care products drives demand for convenient enteric softgel options. Economic factors, such as the cost-effectiveness of enteric encapsulation for long-term use, further propel market growth. According to Lonza’s Full-Year Report 2024, the nutraceutical capsules business returned to pre-COVID volumes in late 2024, reflecting sustained demand despite overall segment challenges.

Restraints

Customer destocking in pharma capsules is restraining the market

The enteric softgel capsules market is restrained by customer destocking in pharma capsules, which reduces inventory levels and impacts sales volumes for enteric products. Manufacturers face decreased orders as clients adjust stock to align with demand fluctuations, leading to underutilization of production capacity. Regulatory compliance for enteric formulations adds complexity when destocking disrupts supply planning.

Pharmaceutical firms prioritize cost control, exacerbating destocking trends in enteric capsule segments. Clinical supply chains experience delays, affecting the availability of enteric softgels for therapeutic applications. Global economic uncertainties contribute to cautious purchasing behaviors among customers. Academic analyses of supply dynamics highlight the ripple effects on enteric market stability.

Patient care indirectly suffers from potential shortages in enteric-delivered medications. Ethical considerations in manufacturing emphasize sustainable practices amid destocking pressures. According to Lonza’s Full-Year Report 2024, Capsules & Health Ingredients reported sales of -9.2% (-6.6% in constant exchange rate) due to soft demand for pharma capsules from customer destocking.

Opportunities

Growth in dosage form solutions is creating growth opportunities

The enteric softgel capsules market offers growth opportunities through the expansion in dosage form solutions, which enable customized enteric coatings for diverse pharmaceutical and nutraceutical applications. Developers can innovate enteric softgels to support extended-release profiles, addressing unmet needs in chronic disease management. Regulatory advancements facilitate approvals for advanced dosage forms, encouraging investment in enteric technologies.

Healthcare providers benefit from enteric solutions that improve patient compliance in oral therapies. Pharmaceutical partnerships focus on integrating enteric capsules into multi-drug regimens for enhanced efficacy. Clinical research explores enteric applications in targeted delivery for gastrointestinal conditions. Global market expansions target regions with rising healthcare infrastructure for enteric product distribution.

Academic collaborations refine dosage form designs to optimize enteric performance. Patient outcomes improve with enteric solutions reducing side effects from acid-sensitive compounds. According to Lonza’s Full-Year Report 2024, Dosage Form Solutions benefited from solid growth in 2024, providing avenues for enteric softgel diversification.

Impact of Macroeconomic / Geopolitical Factors

Global economic growth accelerates the enteric softgel capsules market through heightened demand for nutritional supplements and delayed-release medications, prompting manufacturers to boost output and explore new applications in digestive health. Company leaders actively pursue partnerships to tap into expanding consumer bases in emerging economies, where rising incomes fuel purchases of premium wellness products. Inflation, though, jacks up expenses for gelatin, excipients, and energy, forcing firms to recalibrate budgets and postpone capacity expansions in volatile periods.

Geopolitical disputes, from escalating U.S.-Russia tensions to supply blockades in the Middle East, regularly stall shipments of critical oils and polymers, escalating risks for producers dependent on foreign vendors. Current U.S. tariffs apply duties reaching 25% on Chinese-sourced pharmaceutical capsules via Section 301 as of December 2025, hiking landed prices for domestic importers and narrowing profit edges in tight competitions. These impositions spark counter-tariffs from abroad, blocking American companies from key export markets and stalling shared innovation projects.

Nonetheless, the trade barriers push executives toward ramping up U.S.-based factories and regional collaborations, solidifying logistics and cutting vulnerabilities. This forward-thinking approach sparks fresh efficiencies, unlocks domestic opportunities, and primes the sector for thriving, adaptive success over the horizon.

Latest Trends

Introduction of proprietary capsule manufacturing technology is a recent trend

In 2024, the enteric softgel capsules market has exhibited a prominent trend toward the introduction of proprietary capsule manufacturing technology, which enhances production efficiency and product quality for enteric applications. Manufacturers implement these technologies to achieve superior capsule integrity, supporting advanced enteric coatings.

Healthcare sectors adopt the trend to meet demands for high-performance enteric softgels in nutraceutical delivery. Regulatory evaluations accommodate innovations that demonstrate improved manufacturing consistency. Clinical implementations benefit from technologies reducing variability in enteric release profiles. Academic studies assess the impact of new manufacturing on enteric capsule performance. Global supply chains integrate these technologies to streamline enteric production processes.

Patient therapies gain from enhanced reliability in enteric softgel formulations. Ethical protocols ensure the technologies align with sustainability goals in capsule production. According to Lonza’s Full-Year Report 2024, the early positive impact of the newly-introduced superior proprietary D90 capsule manufacturing technology contributed to productivity initiatives in 2024.

Regional Analysis

North America is leading the Enteric Softgel Capsules Market

In 2024, North America held a 41.9% share of the global enteric softgel capsules market, driven by heightened consumer preference for targeted release formulations that protect sensitive ingredients from gastric acid, particularly in nutraceuticals and over-the-counter pharmaceuticals for digestive health and chronic condition management. Pharmaceutical companies expanded production of these capsules to encapsulate omega-3 supplements, probiotics, and non-steroidal anti-inflammatory drugs, responding to regulatory emphasis on bioavailability enhancement and reduced gastrointestinal side effects.

Innovations in gelatin alternatives, such as plant-based coatings, catered to vegan and allergen-free demands, boosting adoption in dietary supplement sectors amid rising health consciousness. Clinical guidelines promoted their use for hormone replacement therapies, aligning with demographic trends toward aging populations seeking convenient, effective delivery systems.

Retail channels, including e-commerce platforms, facilitated wider distribution with user-friendly packaging, supporting self-care trends in busy lifestyles. Collaborative R&D efforts refined multi-layer encapsulation techniques, ensuring stability for volatile compounds like vitamins. Supply chain improvements guaranteed compliance with stringent quality standards, enabling scalable manufacturing in high-demand categories. The U.S. Food and Drug Administration approved 50 novel drugs in 2024, many leveraging advanced capsule technologies to improve therapeutic outcomes.

The Asia Pacific region is expected to experience the highest CAGR during the forecast period

Industry observers predict vigorous escalation in enteric softgel capsule applications throughout Asia Pacific over the forecast period, propelled by burgeoning nutraceutical demands and policy pushes for localized pharmaceutical manufacturing. Formulators integrate these delivery systems into vitamin and mineral supplements, optimizing nutrient absorption for malnutrition-prone cohorts in developing economies.

Governments incentivize domestic production through subsidies, equipping facilities to encapsulate herbal extracts for traditional medicine integrations amid cultural health practices. Biotech ventures customize acid-resistant variants for anti-inflammatory agents, addressing arthritis prevalences in humid climates that exacerbate joint issues.

Regional trade blocs standardize quality controls, enabling exporters to meet international bioavailability requirements for probiotic formulations. Pharmaceutical alliances accelerate clinical validations for hormone therapies, tailoring release profiles to ethnic metabolic differences.

Community health drives promote awareness of digestive aids, fostering uptake in urban wellness markets. The National Medical Products Administration approved 83 new drugs in China during 2024, underscoring the region’s accelerating pharmaceutical innovation that bolsters capsule utilization.

Key Regions and Countries

North America

• US
• Canada

Europe

• Germany
• France
• The UK
• Spain
• Italy
• Russia
• Netherland
• Rest of Europe

Asia Pacific

• China
• Japan
• South Korea
• India
• Australia
• New Zealand
• Singapore
• Thailand
• Vietnam
• Rest of APAC

Latin America

• Brazil
• Mexico
• Rest of Latin America

Middle East & Africa

• South Africa
• Saudi Arabia
• UAE
• Rest of MEA

Key Players Analysis

Key players in the Enteric Softgel Capsules market drive growth by advancing polymer science and coating technologies that protect acid-sensitive actives while improving bioavailability and patient tolerance. Companies expand adoption through formulation services that tailor release profiles for nutraceuticals and prescription drugs, helping brands differentiate crowded portfolios.

Commercial strategies emphasize partnerships with pharma and supplement companies to co-develop lifecycle extensions and line expansions with predictable timelines. Innovation priorities include cleaner excipients, solvent-free processes, and scalable manufacturing that meet global regulatory expectations and sustainability goals.

Market expansion targets regions with rising demand for GI-friendly dosing and premium wellness products distributed through retail and e-commerce channels. Catalent anchors the space with its global softgel manufacturing network, deep formulation expertise, and end-to-end development services that enable reliable, compliant commercialization of enteric softgel solutions.

Top Key Players

• Catalent Inc.
• Lonza Group
• Aenova Group
• Sirio Pharma
• Procaps Group
• Fuji Capsule
• EuroCaps
• Strides Pharma Science
• Soft Gel Technologies
• HealthCaps India

Recent Developments

• During 2025, Catalent progressed the development of its OptiGel Bio technology, which is designed to support oral delivery of complex macromolecules, including peptides. The enteric softgel system protects active compounds from degradation in the stomach and enables release in the small intestine. This advancement supports a shift toward non-invasive treatment options, offering an alternative to injectable therapies and potentially improving adherence for patients managing chronic conditions that rely on protein-based drugs.
• In 2024, Lonza expanded its EnteCap capsule portfolio to further support enteric drug delivery without the need for functional coating. The company focused on optimizing these capsules for early clinical development, allowing drug developers to bypass additional coating steps and accelerate trial timelines. The capsule shells are engineered to withstand acidic gastric conditions and dissolve at higher intestinal pH levels, enabling controlled and targeted release while improving efficiency in formulation development.

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