Enteric Empty Capsules Market By Material Type (Gelatin Capsules, Non-Gelatin Capsules [HPMC and Others]); By Release Mechanism (pH-Dependent Release, Time-Dependent Release, Enzyme-Triggered Release); By End User (Pharmaceutical Companies, Nutraceutical Companies, CMOs/CDMOs); By Geography, Segment Revenue Estimation, Forecast, 2024–2030.

Introduction And Strategic Context

The Global Enteric Empty Capsules Market will witness a robust CAGR of 4.56 % , valued at USD 995 million in 2024, expected to appreciate and reach about USD 1.45 billion by 2030, confirms Strategic Market Research.

 

Definition and Strategic Relevanc

Enteric empty capsules are specialized capsules designed to resist the acidic environment of the stomach and dissolve only in the higher pH environment of the intestine. This ensures protection for acid-sensitive drugs, precise drug release, and improved bioavailability for numerous therapeutics including enzymes, probiotics, peptides, and certain anti-inflammatory drugs.

 

In the pharmaceutical manufacturing ecosystem, enteric capsules have become strategically critical due to:

• Growth of biologics and sensitive APIs requiring targeted delivery

• Patient-centric trends favoring dosage forms that reduce gastrointestinal side effects

• Increasing prevalence of chronic diseases demanding precise drug delivery systems

 

Key Macro Forces Shaping the Market (2024–2030)

• Technological Advances: Progress in polymer science and capsule engineering is fueling development of capsules with highly customizable release profiles.

• Regulatory Momentum: Regulatory bodies like the FDA and EMA continue emphasizing patient safety and efficacy, stimulating innovations in enteric dosage forms.

• Growth in Nutraceuticals: The nutraceutical sector is rapidly adopting enteric capsules to deliver probiotics and botanical extracts, driving new demand outside traditional pharmaceuticals.

• Global Demographic Shifts: An aging population worldwide is increasing consumption of chronic therapies, fueling demand for sophisticated drug delivery systems.

 

Key Stakeholders in This Market Include:

• Pharmaceutical and nutraceutical manufacturers

• Capsule OEMs and suppliers

• Contract Development and Manufacturing Organizations (CDMOs)

• Regulatory authorities

• Healthcare providers and pharmacies

• Investors focusing on drug delivery technologies

Experts emphasize that enteric empty capsules are no longer a niche product but a pivotal enabler of modern pharmaceutical formulations, as the market witnesses increased R&D spending and new therapeutic launches requiring gastro-resistant technologies.

 

Market Segmentation And Forecast Scope

The enteric empty capsules market can be segmented along several strategic dimensions, reflecting both technical product attributes and end-user adoption patterns. For the period 2024–2030 , Strategic Market Research estimates that the market will experience diversified growth across these segments.

By Material Type

• Gelatin Capsules: Traditionally the dominant segment, gelatin enteric capsules are manufactured using a gelatin shell combined with enteric polymer coatings. They remain favored in cost-sensitive applications due to lower raw material costs and widespread manufacturing infrastructure.

• Non- Gelatin (HPMC and Others): Capsules made from hydroxypropyl methylcellulose (HPMC) or other plant-based polymers are increasingly preferred for vegetarian, vegan, and religious dietary considerations. These also provide enhanced stability for moisture-sensitive APIs.

In 2024, non- gelatin capsules are estimated to hold around 37% of the market share and are projected as the fastest-growing sub-segment due to rising demand for plant-based and allergen-free formulations.

 

By Release Mechanism

• pH-Dependent Release Capsules: Designed to dissolve only above certain pH levels, commonly used for drugs sensitive to gastric acid.

• Time-Dependent Release Capsules: Utilize polymers that erode over time, delaying release until the capsule reaches the intestine.

• Enzyme-Triggered Capsules: A newer innovation where capsule disintegration is triggered by specific intestinal enzymes for precise targeting.

The pH-dependent release capsules segment dominates in revenue and clinical adoption, given its proven performance for gastro-resistant therapies.

 

By End User

• Pharmaceutical Companies: The primary consumers, using enteric capsules for both generic and innovative drug formulations.

• Nutraceutical Companies: Rapidly growing segment adopting enteric capsules for probiotics, enzymes, and herbal extracts.

• Contract Manufacturing Organizations (CMOs/CDMOs): Serving clients across pharma and nutraceutical sectors, demanding flexibility in enteric capsule production.

Pharmaceutical companies accounted for nearly 58% of the market in 2024, reflecting strong R&D pipelines and demand for reliable drug delivery solutions.

 

By Region

• North America

• Europe

• Asia Pacific

• LAMEA (Latin America, Middle East & Africa)

Asia Pacific is projected to exhibit the fastest CAGR, driven by pharmaceutical production shifts, favorable regulations, and rising consumer health trends in countries like China and India.

 

Forecast Scope (2024–2030)

• Analysis covers market size estimations for all segments.

• Regional splits include North America, Europe, Asia Pacific, and LAMEA.

• Growth rates, trends, and revenue contribution assessed for key sub-segments.

• Detailed insights into fastest-growing niches and emerging opportunities.

Industry analysts believe that non- gelatin enteric capsules and nutraceutical applications will drive significant new revenue streams, reshaping competitive dynamics in the market.

 

Market Trends And Innovation Landscape

The enteric empty capsules market is experiencing an era of remarkable innovation and transformative trends, shaped by advances in material science, regulatory tightening, and expanding applications across pharmaceutical and nutraceutical industries. Between 2024 and 2030 , several technological and strategic developments are expected to redefine the market’s growth trajectory.

Key Innovation Drivers

Material Science Advancements

• Continuous research in polymer technology has led to next-generation enteric coatings that are more precise in their dissolution profiles.

• Innovations such as multi-layer coatings are improving protection for highly sensitive APIs and biological molecules.

• Demand for non-animal-derived materials is fostering new formulations using HPMC , pullulan, and other plant-based polymers, enhancing capsule performance while catering to ethical and dietary trends.

Experts predict that breakthroughs in bio-based enteric materials will drive cost efficiencies and broaden adoption, especially in regions where vegetarian capsules are rapidly gaining consumer favor .

 

Rise of Complex Oral Formulations

• Biologics, peptides, and microbiome therapeutics are increasing the need for enteric capsules that can withstand harsh gastric conditions.

• Enteric delivery systems are now essential in drug development pipelines, particularly for molecules that degrade in acidic environments.

R&D pipelines are shifting toward formulations that demand precise gastro-resistance, positioning enteric capsules as critical enablers of next-generation therapies.

 

Digital Integration in Manufacturing

• Smart manufacturing technologies, including real-time monitoring and digital twins, are being integrated into capsule production lines to ensure precise coating thickness and uniformity.

• Process analytical technology (PAT) tools are becoming more prevalent, enabling faster scale-up and higher quality assurance in enteric capsule production.

Industry insiders note that digitalization is not only improving manufacturing efficiency but also ensuring compliance with increasingly strict regulatory standards.

 

Strategic Partnerships and M&A Activity

Over the past two years, several players in the capsule manufacturing ecosystem have pursued mergers, acquisitions, and partnerships to expand capabilities:

• Collaborations between capsule manufacturers and pharmaceutical companies to co-develop customized enteric solutions.

• Acquisition of niche coating technology firms by major capsule producers to integrate innovative polymer technologies.

• Expansion of manufacturing capacity in Asia-Pacific to meet growing regional demand.

Market experts highlight that strategic alliances are helping companies diversify portfolios, enhance technical capabilities, and penetrate emerging markets more rapidly.

 

Emerging Applications in Nutraceuticals

• The nutraceutical sector is rapidly adopting enteric capsules for delivering probiotics, enzymes, and herbal extracts that require protection from gastric acid.

• Consumers are increasingly demanding evidence-backed efficacy, driving nutraceutical brands toward enteric delivery systems to ensure active ingredients reach the intestine intact.

The line between pharmaceutical-grade and nutraceutical-grade enteric capsules is blurring, opening significant revenue streams for capsule manufacturers willing to invest in quality and certification.

 

Outlook

The innovation landscape signals that enteric empty capsules will transition from being primarily pharmaceutical excipients to becoming sophisticated drug delivery vehicles in both pharma and consumer health segments.

Analysts believe that the convergence of biotechnology, digital manufacturing, and clean-label consumer trends will accelerate adoption and create significant differentiation opportunities for manufacturers over the forecast period.

 

Competitive Intelligence And Benchmarking

The enteric empty capsules market is moderately consolidated, with a mix of global giants and specialized players striving for market share through technological innovation, capacity expansions, and strategic collaborations. Between 2024 and 2030 , competition is expected to intensify as demand rises in both pharmaceutical and nutraceutical sectors.

Below is a snapshot of 7 key players shaping the competitive landscape:

Capsugel (Lonza Group)

• Strategy: Lonza’s Capsugel business remains the global leader in capsule technology, leveraging advanced polymer science to deliver diverse enteric solutions. The company’s strategy includes significant R&D investment and co-development agreements with pharmaceutical companies for custom enteric applications.

• Global Reach: Operates in over 30 countries with strong manufacturing presence in North America, Europe, and Asia-Pacific.

• Differentiation: Known for high-quality non- gelatin capsules and proprietary enteric coating technologies that support complex drug formulations.

 

ACG Worldwide

• Strategy: Focused on cost-effective, high-volume manufacturing while expanding its high-performance polymer portfolio for enteric applications. The company actively partners with generic and nutraceutical firms to provide tailored solutions.

• Global Reach: Manufacturing hubs in India, Europe, and Brazil, serving clients worldwide.

• Differentiation: Competitive pricing, large-scale production capacity, and growing reputation in plant-based capsule offerings.

 

Qualicaps

• Strategy: Emphasizes premium capsule manufacturing for pharmaceutical clients, maintaining strict compliance with international regulatory standards. The company is expanding its product lines to serve emerging biologics markets.

• Global Reach: Strong footprint in Japan, North America, and Europe.

• Differentiation: Focus on quality and regulatory compliance makes it a preferred partner for critical drug delivery projects.

 

Suheung Co., Ltd.

• Strategy: A leading South Korean capsule manufacturer investing in R&D for enteric capsules and specialized coating processes. Suheung is positioning itself as a key partner for both pharma and nutraceutical markets in Asia.

• Global Reach: Strong presence in Asia-Pacific, expanding into North America and Europe.

• Differentiation: Competitive advantage in flexible production lines for custom capsule solutions.

 

Farmacapsulas S.A.

• Strategy: South America’s largest capsule manufacturer, focused on expanding its portfolio into enteric capsules to serve regional demand. The firm emphasizes rapid delivery and close customer collaboration.

• Global Reach: Predominantly Latin America, with growing exports to Europe and the U.S.

• Differentiation: Strategic proximity to Latin American pharmaceutical clients, ensuring fast supply and localized support.

 

Erkang Pharma

• Strategy: Chinese manufacturer pursuing aggressive market expansion into enteric capsules for both pharmaceutical and nutraceutical clients. The company is scaling its production facilities to serve the rising domestic demand and export markets.

• Global Reach: Dominant in China with expanding footprint in Asia-Pacific.

• Differentiation: Cost-competitive products with increasing quality standards aligned to international regulations.

 

Bright Pharma Caps, Inc.

• Strategy: U.S.-based manufacturer focusing on custom capsule solutions, including enteric empty capsules tailored for niche pharmaceutical applications.

• Global Reach: Primarily North America, with growing interest from European clients.

• Differentiation: Flexibility in small-batch production and custom formulations for specialized client needs.

 

Competitive Dynamics

Competition revolves around:

• Material innovation (non- gelatin , bio-based polymers)

• Regulatory compliance for complex drug applications

• Production scalability and cost efficiencies

• Strategic partnerships to secure proprietary formulations

Industry observers suggest that while market leaders like Capsugel (Lonza) and ACG hold significant share, regional players such as Suheung and Farmacapsulas are gaining ground through competitive pricing and agile manufacturing capabilities.

 

Regional Landscape And Adoption Outlook

The enteric empty capsules market exhibits a highly diverse regional landscape, shaped by pharmaceutical manufacturing footprints, regulatory standards, and the growth of consumer health industries. Between 2024 and 2030 , adoption rates and market dynamics will vary significantly across global regions.

North America

Market Drivers:

• High concentration of pharmaceutical R&D and advanced manufacturing capabilities.

• Strong demand for innovative drug delivery technologies, particularly for biologics and specialty pharmaceuticals.

• Growing nutraceutical market, especially probiotics and enzyme supplements requiring gastro-resistant delivery.

Key Trends:

• Regulatory rigor by the FDA drives demand for high-quality enteric capsule solutions.

• Increasing collaborations between U.S. pharmaceutical companies and capsule manufacturers for custom solutions.

The U.S. dominates the North American market, representing over half the regional revenue share due to the country’s robust pipeline of enteric-sensitive drugs and advanced production infrastructure.

 

Europe

Market Drivers:

• Significant adoption of enteric capsules in generic and branded pharmaceuticals.

• Rising demand for vegetarian and vegan capsule options in line with consumer preferences and EU regulations.

• Nutraceutical manufacturers expanding product lines with enteric formats for enhanced efficacy.

Key Trends:

• Germany, France, and the UK lead in adoption, driven by innovation in specialty pharma and consumer health products.

• Regulatory frameworks like the European Pharmacopoeia emphasize stringent quality standards for enteric formulations.

Experts note that Europe’s nutraceutical sector is increasingly overlapping with pharmaceutical-grade manufacturing, creating new opportunities for capsule producers with advanced certification capabilities.

 

Asia Pacific

Market Drivers:

• Rapid growth in generic pharmaceutical production, especially in China and India .

• Increasing local demand for high-quality nutraceutical products.

• Growing investment in biopharmaceuticals, requiring sophisticated drug delivery systems.

Key Trends:

• Manufacturers are expanding production facilities in the region to meet both local consumption and export demand.

• Rising middle-class incomes and health awareness are fueling consumption of probiotics and specialty supplements.

Asia Pacific is projected to achieve the highest CAGR globally, as local players enhance manufacturing capabilities and international firms establish regional production hubs.

 

LAMEA (Latin America, Middle East & Africa)

Market Drivers:

• Pharmaceutical industry expansion, especially in Latin America.

• Emerging awareness of the benefits of gastro-resistant delivery systems.

• Government healthcare initiatives improving drug access in certain countries.

Key Trends:

• Brazil leads the Latin American market, driven by a strong pharmaceutical manufacturing base and growing nutraceutical industry.

• Middle East markets remain relatively untapped but show interest in halal-certified, non- gelatin enteric capsules.

Analysts identify significant white space in LAMEA, where local manufacturing capabilities for enteric capsules remain limited, leading to opportunities for regional expansion and partnerships.

 

White Space and Underserved Regions

While major markets are well-served, gaps remain in:

• Regulatory-compliant enteric capsule supply for smaller manufacturers in Latin America and Africa.

• Affordable plant-based enteric capsules for cost-sensitive markets in Asia and the Middle East.

• Specialized enteric solutions for emerging biotherapeutics in developing economies.

Industry observers believe that localized manufacturing and technology transfer initiatives will be crucial to unlocking these underserved markets.

 

End-User Dynamics And Use Case

The enteric empty capsules market serves diverse end-user segments, each with specific requirements based on product types, regulatory standards, and patient outcomes. The demand dynamics vary between pharmaceutical applications and the rapidly expanding nutraceutical sector.

Pharmaceutical Companies

Drivers:

• Enteric capsules are vital for formulating drugs that degrade in gastric acid or cause gastric irritation.

• Increasing adoption for complex therapeutics like biologics, peptides, and microbiome-targeted therapies.

• Pharmaceutical firms value customizable capsule solutions to protect intellectual property through unique release profiles.

Trends:

• Co-development partnerships with capsule manufacturers to create proprietary enteric solutions.

• Greater emphasis on patient-centric formulations for improved adherence and reduced side effects.

Pharma companies prioritize regulatory compliance and technical performance, leading to strong demand for high-precision enteric capsules.

 

Nutraceutical Companies

Drivers:

• Surge in probiotic, enzyme, and botanical supplement markets, many requiring gastro-resistant delivery for efficacy.

• Rising consumer demand for clean-label and plant-based products, propelling non- gelatin enteric capsule usage.

• Nutraceutical firms increasingly adopt pharmaceutical-grade standards to ensure product quality and differentiate in crowded markets.

Trends:

• Companies launching new SKUs marketed specifically for targeted intestinal release.

• Growing willingness to invest in enteric technologies previously reserved for pharma applications.

Industry experts observe that nutraceutical brands are positioning enteric capsules as a marker of premium product quality and efficacy.

 

Contract Manufacturing Organizations (CMOs/CDMOs)

Drivers:

• Provide flexibility and scale for pharmaceutical and nutraceutical clients without in-house capsule manufacturing.

• Rising demand for specialized manufacturing capabilities, including custom enteric coatings and small-batch production.

Trends:

• CMOs expanding service offerings to include technical support for enteric capsule selection and formulation.

• Increasing presence in Asia-Pacific to serve regional clients seeking cost-effective solutions.

CMOs/CDMOs are emerging as critical enablers of market growth, especially for smaller firms needing rapid access to enteric delivery technologies.

 

Use Case Example

In a prominent case, a tertiary hospital in South Korea partnered with a domestic pharmaceutical company to deliver an oral enzyme therapy for pancreatic insufficiency using enteric empty capsules. Prior formulations led to high rates of gastric acid degradation, resulting in inconsistent therapeutic outcomes and patient discomfort. By switching to customized enteric capsules with pH-dependent release, the hospital reported a 35% improvement in patient-reported symptom control and reduced dosing frequency. This transformation not only enhanced patient adherence but also significantly lowered treatment costs associated with therapeutic failures.

 

End-User Outlook

All end-user groups are increasingly converging toward:

• Enhanced drug stability

• Controlled release profiles

• Regulatory compliance for patient safety

• Clean-label and allergen-free products in nutraceuticals

Analysts believe that as therapeutic and consumer demands grow more sophisticated, end-users will become even more reliant on advanced enteric capsule technologies to achieve clinical efficacy and commercial differentiation.

 

Recent Developments + Opportunities & Restraints

Recent Developments (Last 2 Years)

Several notable events have shaped the enteric empty capsules market between 2023 and 2025 , signaling growing investment, innovation, and strategic realignment:

• Lonza expanded its Capsugel plant in Greenwood, South Carolina (2024)

• The facility upgrade included advanced manufacturing lines for plant-based enteric capsules, aiming to meet the growing demand from both pharma and nutraceutical clients.

• ACG launched its HPMC-based enteric capsules under a new brand identity (2023)

• The company introduced capsules capable of withstanding highly variable gastric pH levels, catering to biologics and complex formulations.

• Qualicaps announced collaboration with a European biotech company to develop customized enteric capsule solutions for microbiome therapies (2025)

• The partnership targets precise intestinal release of live bacterial therapeutics, an emerging area in biopharma.

• Suheung Co., Ltd. secured regulatory approval in the U.S. for its new line of enteric capsules (2024)

• Suheung’s plant-based enteric capsules passed rigorous U.S. FDA compliance tests, positioning the company for North American expansion.

• Erkang Pharma announced new manufacturing capacity for enteric capsules in Hunan province (2025)

• This capacity expansion aims to support China’s fast-growing pharmaceutical and nutraceutical markets, reducing reliance on imports.

 

Opportunities

• Emerging Biotherapeutics New biologics, peptides, and microbiome therapies demand sophisticated gastro-resistant delivery systems, creating strong opportunities for enteric capsule manufacturers.

• Nutraceutical Boom The exploding global demand for probiotics and botanical supplements is driving the nutraceutical sector toward premium enteric solutions for proven efficacy.

• Plant-Based Innovation Rising consumer demand for vegetarian, vegan, and allergen-free products is propelling non- gelatin enteric capsules into the mainstream, opening new markets for manufacturers willing to invest in alternative polymers.

Experts forecast that the convergence of pharma-grade technologies into nutraceutical applications will be a significant revenue accelerator for capsule manufacturers.

 

Restraints

• Regulatory Complexities Strict global standards for enteric capsule performance and material safety raise compliance costs and extend product development timelines.

• High Manufacturing Costs Producing enteric capsules, especially non- gelatin types, requires specialized technology and complex manufacturing processes, creating a cost barrier for smaller manufacturers.

Industry analysts caution that while the market outlook remains bright, successful players will be those able to balance regulatory compliance with cost-efficient production.

 

7.1. Report Coverage Table

Report Attribute	Details
Forecast Period	2024 – 2030
Market Size Value in 2024	USD 995 million
Revenue Forecast in 2030	USD 1.45 billion
Overall Growth Rate	CAGR of 4.56% (2024 – 2030)
Base Year for Estimation	2024
Historical Data	2019 – 2023
Unit	USD Million, CAGR (2024 – 2030)
Segmentation	By Material Type, By Release Mechanism, By End User, By Geography
By Material Type	Gelatin Capsules, Non-Gelatin Capsules (HPMC and Others)
By Release Mechanism	pH-Dependent Release, Time-Dependent Release, Enzyme-Triggered Release
By End User	Pharmaceutical Companies, Nutraceutical Companies, CMOs/CDMOs
By Region	North America, Europe, Asia-Pacific, LAMEA
Country Scope	U.S., UK, Germany, China, India, Japan, Brazil, etc.
Market Drivers	- Surge in demand for advanced drug delivery systems - Growth of nutraceutical applications - Innovation in plant-based capsule materials
Customization Option	Available upon request