Enteric Empty Capsule Market

Key data points: Market size in 2027 = $3.5 billion and 2035 = $6.2 billion, growth forecast = 8.5% annually for the next 8 years. Scroll below to get more insights. This market report covers trends, opportunities and forecasts in enteric empty capsule market to 2035 by type (gelatin type and HPMC type), application (pharmaceutical, health supplements, and others), and region (North America, Europe, Asia Pacific, and the Rest of the World) Enteric Empty Capsule Market The future of the global enteric empty capsule market looks promising with opportunities in the pharmaceutical and health supplement markets. The global enteric empty capsule market is expected to reach an estimated $6.2 billion by 2035 from $3.5 billion in 2027 with a CAGR of 8.5% from 2027 to 2035. The major drivers for this market are the increasing demand for oral drug delivery solutions, the rising preference for vegetarian & vegan capsules, and the growing pharmaceutical applications in controlled release formulations. • Lucintel forecasts that, within the type category, HPMC type is expected to witness higher growth over the forecast period due to benefits of HPMC capsules. • Within the application category, pharmaceutical is expected to witness higher growth over the forecast period due to trends in pharmaceutical production and delivery. • In terms of regions, APAC is expected to witness the highest growth over the forecast period due to offshoring of pharmaceutical production in the APAC Region. Gain valuable insights for your business decisions with our comprehensive 150+ page report. Sample figures with some insights are shown below. Emerging Trends in Enteric Empty Capsule Market Between 2025 and 2027, the enteric empty capsule market will transition from a niche market for a couple of protective dosage forms to a market for acid-sensitive APIs, probiotics and other delayed release biologics. Increasing demands on the oral drug formulations will propel the market. Lucintel expects the capsule suppliers to focus on automation and other related areas. • Sustainability: Between 2025 and 2030, use of solvents and by-products of pharmaceutical manufacturing will be key factors for suppliers while making decisions on raw material procurement. In addition, the demand for use of recyclable and lower impact capsules will increase. • Functional Formulations: Enteric empty capsules will be used in other forms of advanced gastric protection and various other forms of protection for release at a pH > 5.5 which will be applied in various formulations. • Automation: Advances in automation will be primarily focused on process control and consistency in manufacturing which in turn will reduce batch-to-batch variability. The automation will also aid in quality control and other forms of inspection of finished products. • Supply Diversification: During the period 2025-2027, drug producers will source capsules from more geographically dispersed locations, and in turn, reduce their dependence on countries. Dual sourcing of capsules will be maintained in order to ensure a continuous and timely supply of drugs. • Digital Quality Systems: Use of electronic batch records and a series-based system of production controls in the manufacture of capsules will replace traditional and poorly defined manufacturing controls. The systems will enhance the overall traceability of pharmaceutical supplies and aid suppliers in meeting the growing quality requirements of multinational pharmaceutical customers. It is increasingly clear that the marketplace will differentiate suppliers based on performance. Suppliers that meet the stringent performance requirements of the pharmaceutical industry in the areas of manufacturing capacity, enterprise sustainability and integrity, and quality assurance will be preferred. The pharmaceutical industry has the upper hand in performance contracting. There will be more M&As among capsule suppliers. Recent Developments in the Enteric Empty Capsule Market The demand for enteric empty capsules is on the rise among developers of oral drugs to create delayed-release formulations from conventional immediate-release drug formulations. Issues of capacity, the performance of polymeric materials, and regulations are expected to remain challenges for the capsule industry in the next few years. Lucintel is of the view that the investment and innovation in pharmaceutical outsourcing and supplements would continue; however, the qualification of the capsule technologies would influence the supply of the capsules. • Capsule Production: The demand for acid-resistant dosage forms has increased and, in turn, has triggered investments in the production of high-barrier and HPMC capsules. Lonza, for example, expected to realize more than CHF 6 billion in 2024 and announced further investments in its capsules business. • M&A Activities: In 2025, the $16.5 billion acquisition of Catalent by Novo Nordisk was one of the largest M&A deals within the pharmaceutical industry. Vertical integration of pharmaceutical manufacturing, including drug shell and formulation, is expected to continue. • Supply Agreements: In 2025, several drug and nutraceutical companies entered into supply and production agreements with CMOs for the development of vegetarian enteric coated capsules to replace gelatin. The agreements required qualification of multiple filling lines, which reduced the time for bringing the new technology to the market and, subsequently, stimulated the use of HPMC capsules. • Polymer Technology: Improvements in enteric polymers allow consistent, lower coating weights, and more precise control over dissolution. The FDA is currently assessing over 100 modified release formulations. Innovations in capsule technology should allow for the development of smaller dosage forms and simplify the manufacturing process in the coming years. • Regulatory Changes: There is increased emphasis on the control of extractables and leachable and consistency of dissolution. The European Pharmacopoeia 2025 contained over 3,000 monographs placing an increased burden on capsule suppliers. There will be a competitive advantage for inspected/licensed manufacturers. Capsule production companies will need to manufacture high quality shells to maintain their customer base and gain new customers. The emphasis will be on reliability and consistency. HPMC and other polymer systems will gain market share in the coming years. Strategic Growth Opportunities in the Enteric Empty Capsule Market Between 2024 and 2026, the market for enteric empty capsules is expected to expand due to increasing usage of biologics, probiotics, and other drugs that are unstable in acid and require enteric coating for protection. Lucintel expects the market for specialty capsules to grow due to increasing preference for controlled release and release performance. • Biologids and Peptides: The use of special enteric coatings provides a means of protecting peptides from stomach acid allowing for an oral delivery method of peptides and biologics, which are usually administered by injection. As of January 2025, oral delivery of diabetes and obesity biologids developed by Novo Nordisk allowed the company to serve over 40 million patients. • Microbiome and Probiotics: The use of special enteric capsules allow for the protection and survival of probiotics and other live cultures. The surviving probiotics are released in the small intestine and increase the efficacy of products targeted for intestinal health and other digestive issues. As of February 2025, the Danone Group, through its specialized nutrition business, served over 1.5 billion consumers. • Veterinary Pharmaceuticals: The pharmaceutical industry has developed several technologies for the creation of delayed-release oral dosage forms. One of the industries that strongly benefits from these technologies is the animal health industry. Analysts predict the animal health industry will surpass the $40 billion mark for 2025. Rising specialization in veterinary pharmaceuticals and the adoption of targeted oral therapies by the animal husbandry industry will fuel the growth of this industry. • Premium Low Moisture Capsules: There is a growing market for specialty capsules for the pharmaceutical industry. In June 2025, the FDA’s drug shortages lists exceeded 100, and the pharmaceutical industry relied on contract manufacturers to meet the demand for various pharmaceutical products. Specialty capsules help reduce drug shortages. There is opportunity for growth in the specialty capsule market. • Contract Manufacturing and Development: Pharmaceutical companies outsource many of their drug development and manufacturing functions to specialize in other aspects of the business. In April 2025, industry analysts forecast that the pharmaceutical industry spent more than $100 billion on contract manufacturing and development. This outsourcing trend will continue. There is a strong market for specialty capsules to alleviate problems in pharmaceutical formulations. Suppliers should create specialty capsules that improve the uniformity of drug release. They should also focus on improving dissolution and creating a better partnership with contract manufacturers. Specializing in these areas will not only accelerate market entry, but also improve their market position. There are regional differences in regulations that impact the business; however, companies that demonstrate release profiles are positioned to increase market prices. Enteric Empty Capsule Market Drivers and Challenges The Enteric Empty Capsules Market is expected to experience trends and cycles in accordance with the state of the global economy and technology. In the near term, we anticipate the market will experience considerable growth. There are numerous formulations that are left unchanged by the passage through the stomach and are meant to be broken down in the intestine. An increasing demand for biologics is also expected to contribute to the growth of the enteric empty capsule market. Lucintel anticipates the market to remain competitive and that companies will make investments based on the aforementioned market trends. The factors responsible for driving this market include: • Increased Use of Targeted Drug Delivery: With biologics and other drug formulations that are unstable in low pH environments becoming more common, there is an increasing demand for drug delivery systems that protect the drug from the stomach and release the drug in the intestine. It is anticipated that this trend will continue in the upcoming years. • Advancements in Enteric Coating and Controlled-Release Technologies: Improvements in polymer and coating technologies have allowed for better control over the uniformity of enteric coatings and the locking of capsules. Enteric coatings can also be formulated to be pH dependent, and dissolution can occur at various stages along the gastrointestinal tract. The increased reliability and control will allow for more accurate, consistent and reproducible release profiles. In addition, 2025 formulation trends show that dissolution studies at multiple pH stages are being performed. • Growing Demand for Pharmaceutical Capsules: Growing pharmaceutical production encompasses the manufacture of generic and prescription drugs as well as nutraceuticals. Increased global production of oral solid dose pharmaceuticals created demand for pharmaceutical capsules with controlled or modified release. It is expected that in the next 3 to 5 years, improved health care and rising standard of living would increase the consumption of pharmaceuticals and further increase the demand for pharmaceutical capsules. • Adoption of Good Manufacturing Practices and Enhanced Traceability: Pharmaceutical companies are also increasingly employing Good Manufacturing Practices to produce drug products that enhance safety and improve traceability of the drug supply. This increases the demand for enteric capsules from pharmaceutical companies. In addition, in 2025, enteric capsule manufacturers focused on improving their production systems to be in compliance with Good Manufacturing Practices. • Sustainability in Pharmaceutical Capsule Manufacturing: Currently, major trends in the industry include the drive for sustainability in drug capsule manufacturing. This includes greater material efficiency, reduced waste, and improved coating processes and raw materials. Simultaneously, the pharmaceutical industry set goals to decrease waste in their production processes. As a result, the emphasis on improved sustainability in drug capsule manufacturing is expected to increase in the next 3-5 years. The challenges facing this market include: • Increased Production Costs and Complexity: The production of drug capsules, especially enteric-coated drug capsules, is not simple or inexpensive, as it requires specialized polymers, coatings and dissolution tests. In 2025, tests to evaluate a drug’s dissolution in three different environments (e.g. stomach, small and large intestines) was the norm and further increased the time and cost of producing the drug. • Lack of Uniformity Among Regulators: This made it difficult for drug manufacturers to sell uniformly throughout the world. As a result, in 2025, drug manufacturers using the same capsules to produce drugs sold in different countries were required to test and perform documentation for the same capsules multiple times. This situation is not likely to improve in the near future. • Raw Material and Supply Chain Constraints: The manufacture of enteric capsules requires materials like specific polymers and gelatin, and specialized equipment. Procurement teams still experienced supply disruptions, long lead times and price-volatility for pharmaceutical intermediates in 2025. It is expected that in the next 3 to 5 years, there will continue to be disruptions in the supply of pharmaceutical industry inputs and increased cost and uncertainty in the pharmaceutical supply. The enteric empty capsules market is expected to have positive growth due to the demand for oral pharmaceutical dosage forms that are safe, effective and patient-friendly. There will also be an increasing demand for pharmaceutical products due to improvement in the field of biotechnology and pharmaceuticals. In addition, enhanced regulatory standards and focus on manufacturing green pharmaceuticals will increase the demand for pharmaceutical products. There will be continued focus on improving and reducing cost of pharmaceutical production. The trade-offs will be between performance and affordability while also maintaining environmental sustainability and ensuring a reliable supply. Suppliers that can also address these challenges will thrive in the market. List of Enteric Empty Capsule Market Companies Companies in the market compete on the basis of product quality offered. Major players in this market focus on expanding their manufacturing facilities, R&D investments, infrastructural development, and leverage integration opportunities across the value chain. Through these strategies enteric empty capsule market companies cater increasing demand, ensure competitive effectiveness, develop innovative products & technologies, reduce production costs, and expand their customer base. Some of the enteric empty capsule market companies profiled in this report include- • Capsugel • CapsCanada • Suheung • Qualicaps • Anhui Huangshan Capsule Enteric Empty Capsule Market by Segment The study includes a forecast for the global enteric empty capsule market by type, application, and region. Enteric Empty Capsule Market by Type [Value ($B) from 2019 to 2035]: • Gelatin Type • HPMC Type Enteric Empty Capsule Market by Application [Value ($B) from 2019 to 2035]: • Pharmaceutical • Health Supplements • Others Enteric Empty Capsule Market by Region [Value ($B) from 2019 to 2035]: • North America • Europe • Asia Pacific • The Rest of the World Country Wise Outlook for the Enteric Empty Capsule Market The market for empty enteric capsules is developing as a result of increased pharmaceutical outsourcing, more stringent delivery and performance requirements, and investment in vegetarian capsule technologies. Around 2025 to 2027, companies will concentrate more on providing a secure and reliable supply of their products. According to Lucintel, these will be significant trends and warrant further evaluation. • United States: There is a focus on domestic production. The U.S. Department of Commerce continued in April 2025 to implement a series of executive orders to produce pharmaceuticals and other medical devices. The orders are expected to result in the qualification and production of capsules within the stated time frame. Additionally, Lonza's facility in North Carolina has multiple capsule production units. • China: Improving Quality and Exports of Capsules. In March 2025, China’s Drug Administration revised their technical requirements for pharmaceutical excipients. Expansion of gelatin and HPMC capacities continued. With improved compliance, China can produce higher quality enteric capsules for pharmaceutical use, domestically and for export. • Germany: Production and Technology. In February 2025, some German companies involved in the production of pharmaceuticals (e.g. packaging) continued to operate according to GMP standards. German capital goods producers invested in automation in the field of capsule filling. Furthermore, the production of enteric coatings, and thus formulations, is expected to improve. • India: Investment and Integration. In June 2025, ACG (a supplier of pharmaceutical intermediates and excipients) announced further global investments for its capsules and pharmaceutical solutions business. Improved integration among India’s supplier base may accelerate the use of enteric coatings for the pharmaceutical industry. • Japan: Focus on Quality and Supply. In January 2025, Japan’s Pharmaceutical Quality assurance standards were in-line with the ICH. Continued investments by Capsugel, and Japanese Pharmaceutical companies, in hard capsules and coatings, are expected to improve the supply of quality enteric coatings. Features of the Global Enteric Empty Capsule Market Market Size Estimates: enteric empty capsule market size estimation in terms of value ($B). Trend and Forecast Analysis: Market trends (2019 to 2026) and forecast (2027 to 2035) by various segments and regions. Segmentation Analysis: enteric empty capsule market size by type, application, and region in terms of value ($B). Regional Analysis: enteric empty capsule market breakdown by North America, Europe, Asia Pacific, and Rest of the World. Growth Opportunities: Analysis of growth opportunities in different types, applications, and regions for the enteric empty capsule market. Strategic Analysis: This includes M&A, new product development, and competitive landscape of the enteric empty capsule market. Analysis of competitive intensity of the industry based on Porter’s Five Forces model. If you are looking to expand your business in this or adjacent markets, then contact us. We have done hundreds of strategic consulting projects in market entry, opportunity screening, due diligence, supply chain analysis, M & A, and more. This report answers following 11 key questions: Q.1. What are some of the most promising, high-growth opportunities for the enteric empty capsule market by type (gelatin type and HPMC type), application (pharmaceutical, health supplements, and others), and region (North America, Europe, Asia Pacific, and the Rest of the World)? Q.2. Which segments will grow at a faster pace and why? Q.3. Which region will grow at a faster pace and why? Q.4. What are the key factors affecting market dynamics? What are the key challenges and business risks in this market? Q.5. What are the business risks and competitive threats in this market? Q.6. What are the emerging trends in this market and the reasons behind them? Q.7. What are some of the changing demands of customers in the market? Q.8. What are the new developments in the market? Which companies are leading these developments? Q.9. Who are the major players in this market? What strategic initiatives are key players pursuing for business growth? Q.10. What are some of the competing products in this market and how big of a threat do they pose for loss of market share by material or product substitution? Q.11. What M&A activity has occurred in the last 8 years and what has its impact been on the industry?