Empty Capsule Market

Market Overview

The global empty capsule market size was valued at USD 2,815.0 million in 2022 and is projected to reach a value of USD 5,352.1 million by 2031, registering a CAGR of 7.4% during the forecast period (2023-2031). Increasing investments in capsule manufacturing plants and increased demand for halal capsules are key market drivers boosting empty capsule market growth.

Empty capsules, also known as gelatin capsules or simply gel caps, are pharmaceutical-grade shells used to hold a variety of therapeutic substances in a solid, dry state. These capsules are intended to be filled with active pharmaceutical ingredients (APIs) or other substances to provide a convenient and effective method of oral drug administration. Currently, the market is witnessing increasing demand for nutrition supplements in the form of capsules and its growing popularity among the geriatric population. The geriatric population is at a high risk of developing chronic diseases such as diabetes and cardiovascular diseases, which further increases their dependency on medications. The global geriatric population is expected to rise from 12% in 2015 to 22% by 2050.

Moreover, a low rate of medication adherence causes nearly 125,000 deaths and imposes USD 290 million in medical costs annually. The growing adoption of dietary supplements in the form of capsules among consumers is boosting the demand for capsules. 

Market Dynamics

Empty Capsule Market Drivers

Growing Geriatric Population

The aging population is a significant driver for many industries, including the pharmaceutical and healthcare sectors. As people get older, the prevalence of chronic diseases rises, as does the demand for medications and healthcare services. According to a United Nations (UN) report for 2023, the global population of people aged 65 and up is expected to double over the next 30 years. The elderly population will number 1.6 billion by 2050, accounting for more than 16% of the global population. Chronic conditions such as cardiovascular disease, diabetes, and osteoarthritis are more common in the aging population. This increases the demand for pharmaceutical interventions and medications to manage and treat these health problems. A sizable proportion of the elderly population is on medication for conditions such as hypertension, diabetes, and arthritis. To meet this demand, the pharmaceutical industry develops and manufactures a wide range of drugs, many of which are encapsulated in empty capsules for oral administration. Geriatric patients frequently require multiple medications to treat various health conditions. Polypharmacy, or the use of multiple medications by a single person, is common among the elderly, necessitating the development of convenient and efficient dosage forms.

Furthermore, Polypharmacy is common among older adults, according to a study published in the Journal of the American Medical Association (JAMA), with more than 40% of people aged 65 and older taking five or more medications. Furthermore, the pharmaceutical industry recognizes older people's unique healthcare needs and develops drugs to address age-related conditions. This includes cognitive health medications, bone health supplements, and nutritional supplements. According to a National Center for Biotechnology Information (NCBI) report, the aging population has increased demand for geriatric-specific medications, contributing to the pharmaceutical market's growth. The aging population significantly impacts the pharmaceutical market, driving demand for medications encapsulated in empty capsules. This demographic shift emphasizes the significance of pharmaceutical innovations and dosage forms that address the unique healthcare needs of older adults. As a result, the Empty Capsule Market trend is influenced.

Empty Capsule Market Restraints

Regulatory Challenges and Compliance

The pharmaceutical industry is highly regulated, and strict quality standards must be met. Changes in regulations or the implementation of new quality requirements can make it difficult for manufacturers to ensure compliance. Regulatory bodies such as the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have recently emphasized the importance of data integrity in pharmaceutical manufacturing. Documentation practices, quality control measures, and ensuring the accuracy and reliability of data throughout the production process are all part of this.

In addition, empty gelatin capsules must comply with Regulation (EC) No 178/2002, which establishes food safety requirements and procedures, according to a 2016 UK document. A veterinarian must also inspect each shipment at a border inspection post. Delays in production timelines, increased costs associated with process adjustments, and the need for comprehensive validation of manufacturing changes to meet regulatory scrutiny are all potential consequences of regulatory challenges. Regional regulatory harmonization efforts aim to standardize and streamline pharmaceutical regulations globally. However, as companies strive to align their processes with evolving international standards, these efforts can present challenges.

Empty Capsule Market Opportunity

Expansion in Nutraceuticals and Dietary Supplements

 The global shift toward healthier lifestyles has increased demand for nutraceuticals and dietary supplements. Consumers actively seek products that promote overall health, fill nutritional gaps, and provide preventive health benefits. Empty capsules provide a quick and easy way to encapsulate vitamins, minerals, and other dietary supplements. Consumer awareness of the role of nutrition in overall health and well-being is growing, driving demand for dietary supplements. Due to their ease of use, precise dosing, and ability to mask the taste of certain ingredients, capsules are a popular choice for encapsulating nutritional supplements.

However, the trend toward personalized nutrition, driven by individual health goals and preferences, opens up opportunities for customized nutraceutical formulations. Empty capsules make specific nutrient combinations easier to encapsulate, catering to personalized nutrition plans. Collaborating with nutritionists or customized nutrition services, an empty capsule manufacturer can create capsules tailored to individual nutritional needs, incorporating vitamins, minerals, and other supplements based on personalized health assessments.

Furthermore, ongoing innovation in nutraceutical formulations, such as new ingredients and delivery systems, provides opportunities for empty capsule manufacturers to contribute to developing advanced and differentiated products. An empty capsule manufacturer can encapsulate ingredients with enhanced bioavailability or time-release properties in collaboration with research-driven nutraceutical companies, offering innovative formulations that set products apart.

Regional Analysis

North America Dominates the Global Market

The global empty capsule market share is bifurcated into North America, Europe, Asia-Pacific, the Middle East and Africa, and Latin America.

North America is the most significant global empty capsule market shareholder and is estimated to grow at a CAGR of 7.1% over the forecast period. North America dominates the global market because of its technologically advanced healthcare system and support for developing novel pharmaceutical therapeutics in the region. Moreover, the U.S. witnesses the highest sales of pharmaceutical products. For instance, the U.S. pharmaceutical industry accounted for over USD 333 billion in 2016, according to ITA Pharmaceuticals Top Markets Report.

Moreover, in the U.S., the observed success rates for drug development in Phase I, II, and III are 75%, 50%, and 59%, respectively. To address the growing needs of the pharma and nutraceutical industry, manufacturers of empty capsules are focusing on increasing their production capacities. For instance, in February 2018, CapsCanada announced that it would invest USD 28 million to expand its production capacity by 50% to meet the rising demand for empty capsules.

Europe is anticipated to exhibit a CAGR of 7.5% over the forecast period. Europe grew significantly, accounting for a significant share in 2022, and is expected to remain one of the most appealing markets throughout the forecast period. During the forecast period, Russia is expected to grow. The market in Russia is expected to be driven by the high demand for vitamin supplements. Vitamins are more stable and effective when taken in capsule form. To meet the requirements of vitamin efficacy and safety, empty capsule manufacturers are developing new, customized offerings.

Furthermore, German manufacturers are pursuing technological advancements to provide unique and versatile offerings for pharmaceutical, nutraceutical, and cosmeceutical applications. Leading German companies are committed to developing innovative products that serve these industries. For example, ACG, a well-known provider of integrated solutions to the global pharmaceutical and nutraceutical sectors, will launch its new ACGcapsTM NTone and ACGcapsTM TSafe capsules for the nutraceutical market in March 2021. The ACGcapsTM TSafe line includes gelatin and HPMC capsules free of titanium dioxide, providing more options to meet the needs of a wide range of customers. German manufacturers gain a competitive advantage by embracing innovation, ensuring their products meet changing market demands and exceed customer expectations. Continuous technological and product advancements drive the growth and success of companies operating in the German pharmaceutical market.

Asia-Pacific is anticipated to grow significantly over the forecast period owing to the region's growing senior population. Empty medicine capsule consumption is expected to rise at a healthy rate in Japan, owing to increased geriatric usage and growing consumer awareness of the advantages of capsules over other forms. Japan has the highest proportion of older adults in the world. As of September 15, 2023, Japan had 36.2 million people aged 65 and up, accounting for 29.1% of the population. This is the first time more than 10% of Japan's population is over 80. 

Similarly, rising healthcare investment and pharmaceutical sector expansion are expected to drive demand in Japan. In addition, the availability of advanced empty capsule filling machines and the rapid growth of the gelation empty capsules market are expected to favor market growth in the country during the forecast period.

The Middle East and Africa is in the developing phase of market growth, according to empty capsule market insights. However, increasing investments in healthcare, growing adoption of dietary supplements, and rising disposable income are expected to change the current market dynamics in the years to come. Various initiatives are being undertaken to support the growth of the pharmaceutical industry in this region. For instance, in 2017, the UAE announced plans to become a global pharmaceutical hub by 2021.

Segmental Analysis

The global empty capsule market is segmented based on type, application, end-user, and region.

The market is further segmented by type into Gelatine and non-gelatine.

Gelatine holds a significant market share. The gelatine capsules segment was the major contributor to the global market in 2022. This can be attributed to the increasing demand for empty gelatine capsules in the pharmaceutical and nutraceutical industry. Moreover, gelatine capsules have been used for years in the pharmaceutical industry for various drug formulations without any critical health issues being reported. In addition, the adoption of gelatine capsules is higher in the U.S., the U.K., and Australia. India manufactures around 120 billion tons of gelatin annually, according to the Chamber of Commerce and Industry.

Non-gelatin capsules are an alternative to traditional gelatin capsules and are intended to meet the dietary needs of vegetarians, vegans, and religious people. These capsules are usually made of plant-based materials like cellulose or other polymers. Non-gelatin capsules address cultural and dietary concerns by providing a plant-based or synthetic option. They are an acceptable alternative for people who prefer or require non-animal sources of medications. Non-gelatin capsules are becoming more popular as the pharmaceutical and nutraceutical industries increase their demand for vegetarian and vegan products.

By application, the segment can be further bifurcated into Antibiotic and antibacterial drugs, Vitamins and dietary supplements, Antacid and antiflatulent preparations, Antianemic preparations, Anti-inflammatory and anti-rheumatic drugs, Cardiac therapy drugs, Cough and cold preparations, and Other therapeutic applications.

Antibiotic and Antibacterial Drugs generate the most revenue. The antibiotic and antibacterial drugs segment is leading the empty capsule market. The growing prevalence of lower respiratory tract infections, tuberculosis, and diarrhoeal diseases drives the demand for antibiotics. Antibiotics and antibacterial drugs are medications used to treat bacterial infections. They target and inhibit or destroy bacteria and thus play an essential role in treating many bacterial illnesses, from common infections to more severe conditions. These medications, widely prescribed in medical settings, are critical in preventing the spread of bacterial diseases.

This category includes capsules that contain vitamins, minerals, and dietary supplements. These capsules provide a convenient and standardized method of delivering specific nutrients to support overall health, address nutritional deficiencies, and promote well-being. They cater to people who want to supplement their diet with specific vitamins or minerals in a targeted way.

Based on end-users, the market is fragmented into Pharmaceuticals, Nutraceuticals, and Cosmetics.

Pharmaceuticals are the major end-users of the market. The pharmaceutical industry dominates the market due to consumers' shifting trend toward capsule dosage forms. Moreover, pharmaceutical manufacturers are likelier to prefer capsules to save manufacturing costs and increase profit margins. Empty capsules are an essential component for drug delivery. Pharmaceutical companies use these capsules to encapsulate various medications, from over-the-counter to prescription pharmaceuticals. The capsules are an effective and convenient oral dosage form that allows for precise dosing and administering a wide range of pharmaceutical formulations.

However, the nutraceutical industry segment is expected to grow at the fastest CAGR during the assessment period. Empty capsules are a standard delivery method for nutraceutical products such as vitamins, minerals, herbal supplements, and other dietary supplements. These capsules provide a standardized and convenient method of encapsulating nutritional ingredients, catering to consumer preferences for ease of use.

Recent Developments

• November 2023- CapsCanada® Corporation received a significant boost in the form of a USD 5 million investment from FedDev Ontario, which will be used to expand operations and meet rising demand for its made-in-Canada hard empty capsules.
• August 2023- Bright Pharma Caps Inc. created Bright-Poly organic capsules, the world's first certified ones. The capsules are made from USDA-certified organic pullulan and NOP-approved and can be used in vegetarian, kosher, and halal products.
• February 2023- Vivion, a global ingredient solutions provider, introduced a new line of empty gelatin, HPMC, and pullulan capsules.