U.S. Softgel Capsules Market Size, Share & COVID-19 Impact Analysis, By Type (Gelatin Capsules and Non-Animal Softgel Capsules {Starches, Pullulan, and Others}), By Application (Prescription Medicines and Health & Dietary Supplements), By Manufacturers (Pharmaceutical Companies, Nutraceutical Companies, and Others), and Country Forecast, 2023-2030

The U.S. softgel capsules market size was worth USD 2.14 billion in 2022 and is projected to grow at a CAGR of 6.2% during the forecast period.

Softgel capsules have several advantages over tablets or hard-shell capsules. They can be easily swallowed and can disintegrate quickly. These capsules considerably enhance the bioavailability of active ingredients. It is considered a precise and uniform dosage and provides greater stability, purity, and consistency of encapsulated nutrients. These significant benefits are expected to create strong demand in the U.S. industry. Also, growing cases of vitamin deficiencies and chronic conditions, such as cardiovascular diseases, immunological diseases, and others, contributes to the demand for these capsules in the U.S. market.

• For instance, as per an article published by Cleveland Clinic in 2022, about 35.0% of adults in the U.S. have vitamin D deficiency.

Moreover, growing partnerships and launches by key players to offer innovative products in the U.S. are expected to propel market growth during the forecast period. Similarly, the trend of vegetarian softgel capsules production is a lucrative opportunity in the market.

The COVID-19 pandemic positively impacted the U.S. market growth due to the vast demand for these capsules to offer protection from viral infection.

U.S. Softgel Capsules Market Trends

Rising Awareness toward Plant-based Capsules to Aid Market Growth

One of the most significant trends in the U.S. market is the growing demand for plant-based capsules due to their various benefits. The plant-based supplements are derived from natural ingredients. Similarly, these are better absorbed in the body and assimilated easily. In addition, plant-based or vegan supplements do not contain preservatives, genetically modified organisms (GMOs), artificial sugars, or synthetic chemicals. Therefore, plant-based supplements are safe to consume.

Such growing demand for these new softgel capsules contributed to strong attention by key players to introduce new products in the market. Such factors are expected to drive the market expansion in the U.S.

• For instance, in November 2021, Roquette launched LYCAGEL PREMIX, a ready-to-use, pharmaceutical-grade vegetarian soft gelatin capsule formulation solution. It is developed by the company’s market-first pea starch technology – LYCAGEL.

U.S. Softgel Capsules Market Growth Factors

Rising Number of Clinical Trials Promoting Usage of Softgel Capsules to Augment Market Growth

The demand for soft gelatin capsules has increased significantly over the last few decades. This has led to an increased focus of key players to initiate clinical trials to launch safe and efficient products. The growing focus on R&D initiatives to introduce innovative and safe products which drives lucrative opportunities during the forecast period. The rising prevalence of chronic diseases is also driving the growth of the U.S. softgel capsule market.

• For instance, in March 2022, Clarus Therapeutics Holdings, Inc. announced the initiation of screening for the first patient in an investigator-initiated Phase 4 clinical trial. This trial evaluates the efficacy and safety of JATENZO (testosterone undecanoate) oral soft gelatin capsules for treating adult hypogonadal men with chronic kidney disease (CKD). As a result, the market is expected to experience strong growth in the coming years.

According to statistics published by the biostation, about 8 out of 10 individuals in the U.S. are deficient in vitamin E.

RESTRAINING FACTORS

Certain Limitations on the Drug Formulations to Deter the Market Growth

Despite the strong demand for and adoption of soft gelatin capsules, there are certain hindrances to market growth. These dosage forms are more susceptible to microbial infection and humidity than solid ones. There is certain product stability, and these medications should be stored in sealed containers or a cool, dry place. Also, manufacturers require high temperatures and humidity to encapsulate probiotic bacteria formulations in softgels. This can damage probiotic formulations. Such manufacturing challenges are expected to limit the market growth.

• According to an article by the National Institutes of Health (NIH) published in 2021, soft gelatin capsule technologies are considered relatively expensive. Thus, they can increase prices to consumers. Also, many pharmaceutical companies lack the specialized equipment to fill SGCs. So, it creates dependence on contract laboratories/manufacturers for their supplies. These substantial limitations are expected to hinder market expansion.

U.S. Softgel Capsules Market Segmentation Analysis

By Type Analysis

By type, the market is divided into gelatin capsules and non-animal softgel capsules.

The gelatin capsules segment accounted for the maximum U.S. softgel capsules market share in 2022. Capsules are traditionally made from gelatin, an animal protein derived from collagen. The growing initiatives by several market players to boost their capsule production capacity are expected to drive the segment's growth during 2023-2030.  

• For instance, in October 2020, Lonza invested CHF 85.0 million (USD 93.0 million) in its Capsules and Health Ingredients (CHI) Division. The company's production capacity will be increased across Lonza's global manufacturing and supply chain network.

In terms of non-animal softgel capsules, the market can be further segmented into starches, pullulan, and others. The non-animal softgel segment is expected to witness steady growth over the forecast period. The demand for vegan products is increasing due to the fact that they are non-toxic. Such positive parameters support the segmental growth during the forecast period.

By Application Analysis

By application, the market is divided into prescription medicines and health & dietary supplements.

The health & dietary supplements segment dominated the revenue share in 2022. These capsules are gaining popularity and have become a standard choice in the nutraceutical and supplement industry. The growing prevalence of chronic disease increases the demand for these capsules to maintain health. The robust usage of health supplements among the adult and older age groups is expected to propel segmental growth.

• For instance, according to the National Center for Health Statistics published in 2021, dietary supplement usage increased with age. During the study period of 2017-2018, about 57.6% of adults aged 20 and over reported using any dietary supplement in the past 30 days.

The prescription medicines segment is expected to grow at a high CAGR due to the growing number of chronic health conditions and the ever-increasing demand for prescription medicines in the U.S.

By Manufacturers Analysis

Based on manufacturers, the market is segmented into pharmaceutical companies, nutraceutical companies, and others.

The pharmaceutical companies segment held a major share in 2022. The rising focus of pharmaceutical companies on expanding their production and distribution facilities contributes to the segment’s growth. Also, key players' increasing initiatives to launch new technologies to develop softgel capsules are favoring segmental growth.

• For instance, in October 2020, Catalent launched OptiGel DR technology to formulate and manufacture delayed/enteric release softgels. This technology allows soft gelatin capsules to be formed by combining pectin with gelatin, eliminating the need for a separate capsule coating step.

In 2022, the nutraceutical companies segment accounted for a suitable market share and is expected to continue to grow at a healthy pace over the forecast period. The steady growth of this segment can be attributed to the growing number of health and diet supplements launched by leading nutraceutical companies in the U.S.

List of Key Companies in U.S. Softgel Capsules Market

The market's competitive landscape depicts a consolidated nature, comprising few dominant players. Capsugel (Lonza) and Catalent, Inc. are dominant players holding the maximum share in the U.S. softgel capsules market growth. Robust product offerings and constant initiatives to launch new products and technologies in the market contribute to these companies’ market dominance in the U.S.

• For instance, in April 2022, Catalent installed and commissioned its four new high throughput ‘high-bay’ CGMP manufacturing suites in Kansas City, Missouri. This development will boost the company’s capabilities for producing oral solid dose forms.

Some other key players include Aenova Holding GmbH, EuroCaps Ltd, CAPTEK Softgel International Inc., and others. The growing focus of these players on strategic activities and distribution channel expansion is expected to upscale their market shares in the U.S.

LIST OF KEY COMPANIES PROFILED:

• Capsugel (Lonza) (U.S.)


• Sirio Pharma Co., Ltd. (China)


• Catalent, Inc. (U.S.)


• Aenova Holding GmbH (Germany)


• CAPTEK Softgel International Inc. (U.S.)


• EuroCaps Ltd (U.K.)

KEY INDUSTRY DEVELOPMENTS:

• August 2022 – Swander Pace Capital, a U.S.-based private equity firm, announced the closing of a continuation fund transaction with Captek Softgel International. The new Fund includes substantial capital investment to drive organic growth initiatives and strategic acquisitions for Captek.


• January 2022 – Procaps Group acquired an 86,000 sq. ft. pharmaceutical production facility in West Palm Beach, Florida. It has a production capacity of approximately 1.8 billion capsules per year for its iCDMO (integrated Contract and Manufacturing Organization) business unit. This acquisition is expected to enhance Procaps Group’s product development capabilities by more than 70.0%.


• April 2020 – ISDIN launched SunISDIN Soft Gelatin Capsules in the U.S. market. It is an oral dietary supplement designed to help the skin fight photoaging from the inside out.

REPORT COVERAGE

The U.S. softgel capsules market report provides a detailed market analysis. It highlights the insights, including the new product launches, an overview of regulatory scenarios, key industry development, and the impact of the COVID-19 pandemic on the U.S. market. The analysis report encompasses segments such as type, application, and manufacturer. Moreover, the U.S. softgel capsules market analysis report provides insights into market player company profiles, dynamics, and other growth factors in the market.

Report Scope & Segmentation