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Last Updated: April 14, 2025

Drugs Containing Excipient (Inactive Ingredient) GLYCERYL PALMITOSTEARATE


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Branded drugs containing GLYCERYL PALMITOSTEARATE excipient, and estimated key patent expiration / generic entry dates

Generic drugs containing GLYCERYL PALMITOSTEARATE excipient

Market Dynamics and Financial Trajectory for the Pharmaceutical Excipient: Glycerol Monostearate (Glyceryl Palmitostearate)

Introduction to Glycerol Monostearate

Glycerol monostearate, also known as glyceryl monostearate or glyceryl palmitostearate in some contexts, is a versatile excipient used in various industries, including pharmaceuticals, food, and cosmetics. This glyceride is produced through the glycerolysis reaction of triglycerides and glycerol, and it serves multiple functions such as an emulsifier, thickening agent, and stabilizer.

Market Size and Growth

The global glycerol monostearate market, which includes glyceryl palmitostearate, was valued at USD 989.23 million in 2022 and is projected to reach USD 1,314.76 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 3.62% during the forecast period of 2023 to 2030[1][4].

Key Market Segments

Product Type

Glycerol monostearate is utilized in various forms, including as an emulsifier, thickening agent, anti-caking agent, stabilizer, and in other applications. The emulsifier segment is particularly significant due to its widespread use in food and pharmaceutical products[1].

Application

The primary application areas for glycerol monostearate include:

  • Food and Beverages: This segment dominates the market due to the extensive use of glycerol monostearate as a food additive and emulsifier in dairy products, bakery items, convenience foods, and other processed foods.
  • Personal Care and Cosmetics: It is used in hair-care products and cosmetics for its moisturizing and stabilizing properties.
  • Pharmaceuticals: Here, it serves as a lubricant, flow aid, and coating agent, particularly in tablet and capsule formulations[1][2].

Market Drivers

Increased Utilization Across End-Users

The growing demand for processed foods, especially in developing economies, drives the market. Glycerol monostearate's role in improving texture and stability in food products is crucial. Additionally, its use in pharmaceuticals as a lubricant and coating agent, and in personal care products, contributes to market growth[1].

Surging Awareness and Investments

Increased research and development investments by pharmaceutical companies create opportunities for market players. The rising awareness about the benefits of glycerol monostearate, such as its use in patient-centric formulations, further expands its market potential[1].

Market Restraints and Challenges

Health Consciousness and Veganism Trends

Rising health consciousness among consumers and the increasing adoption of veganism and meat-free diets pose challenges to the market, particularly in the food and beverages segment. These trends can limit the growth of glycerol monostearate in certain end-use industries[1].

Regulatory Stringency

Stringent regulatory requirements can act as a barrier to market growth. High development costs and the need for compliance with various regulations can hinder the expansion of the glycerol monostearate market[3].

Geographical Analysis

Dominant Regions

North America currently dominates the glycerol monostearate market due to the high demand for processed foods and the growing beauty and personal care sector. However, the Asia-Pacific region is expected to show significant growth during the forecast period, driven by the expansion of the dairy industry and the presence of major glycerol monostearate manufacturers[1].

Pharmaceutical Excipients Market Context

Integration with Pharmaceutical Excipients

The global pharmaceutical excipients market, which includes glycerol monostearate, is forecasted to grow from USD 10.0 billion in 2023 to USD 13.9 billion by 2028, at a CAGR of 6.8%. The increasing demand for generic drugs, R&D investments, and the emphasis on patient-centric formulations are key drivers for this market[3].

Functional and Multifunctional Excipients

The rising demand for functional and multifunctional excipients, such as glycerol monostearate, is a significant opportunity. These excipients can serve multiple roles in pharmaceutical formulations, making them highly valuable in the industry[3].

Key Characteristics and Applications in Pharmaceuticals

Product Form and Functionality

Glycerol monostearate, such as Precirol® ATO 5, is used as a lubricant and flow aid in powder blends for capsule filling and as a coating agent for taste masking. It has an intermediate melting point and is used in various pharmaceutical formulation technologies, including tablet compression and melt processes[2].

Safety and Regulatory Status

The safety of use for glycerol monostearate is inferred by its Generally Recognized as Safe (GRAS) status and its precedence of use in approved pharmaceutical products. This regulatory approval is crucial for its widespread adoption in pharmaceutical applications[2].

Financial Trajectory

Revenue Growth

The projected growth of the glycerol monostearate market from USD 989.23 million in 2022 to USD 1,314.76 million by 2030 indicates a steady financial trajectory. This growth is supported by increasing demand across various end-use industries and the expanding use of glycerol monostearate in pharmaceutical formulations[1][4].

Investment Opportunities

The market offers opportunities for investors through increased research and development investments and the rising awareness about the benefits of glycerol monostearate. Collaborations and partnerships with pharmaceutical companies for customized excipient solutions also present lucrative investment avenues[1].

Conclusion

The market for glycerol monostearate, including its form as glyceryl palmitostearate, is poised for steady growth driven by its versatile applications in food, pharmaceuticals, and personal care. Despite challenges such as health consciousness and regulatory stringency, the market is expected to flourish due to increasing demand and investments in research and development.

Key Takeaways

  • Market Growth: The global glycerol monostearate market is expected to grow at a CAGR of 3.62% from 2022 to 2030.
  • Dominant Segment: The food and beverages segment dominates the market due to extensive use as a food additive and emulsifier.
  • Pharmaceutical Applications: Glycerol monostearate is used as a lubricant, flow aid, and coating agent in pharmaceutical formulations.
  • Geographical Growth: Asia-Pacific is expected to show significant growth due to the expansion of the dairy industry and the presence of major manufacturers.
  • Regulatory Status: Glycerol monostearate has a GRAS status, ensuring its safety for use in pharmaceutical products.

FAQs

What is the primary application of glycerol monostearate?

The primary application of glycerol monostearate is in the food and beverages sector, where it is used as a food additive and emulsifier.

How is glycerol monostearate used in pharmaceuticals?

In pharmaceuticals, glycerol monostearate is used as a lubricant, flow aid, and coating agent, particularly in tablet and capsule formulations.

What are the key drivers of the glycerol monostearate market?

The key drivers include the increasing demand for processed foods, growing awareness about its benefits, and increased research and development investments.

Which region is expected to show significant growth in the glycerol monostearate market?

The Asia-Pacific region is expected to show significant growth due to the expansion of the dairy industry and the presence of major glycerol monostearate manufacturers.

What are the challenges faced by the glycerol monostearate market?

Challenges include rising health consciousness, veganism trends, and stringent regulatory requirements.

Sources

  1. Data Bridge Market Research: Global Glycerol Monostearate Market Size & Industry Trends By 2030.
  2. Gattefossé: Precirol® ATO 5 - Gattefossé.
  3. MarketsandMarkets: Pharmaceutical Excipients Market Growth, Drivers, and Opportunities.
  4. Data Bridge Market Research: Global Glycerol Monostearate Market Trends.
  5. MDPI: Dual Nanostructured Lipid Carriers/Hydrogel System for Delivery of Curcumin for Topical Skin Applications.

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