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Last Updated: March 14, 2025

Drugs Containing Excipient (Inactive Ingredient) GLYCOL DISTEARATE


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Branded drugs containing GLYCOL DISTEARATE excipient, and estimated key patent expiration / generic entry dates

CompanyTradenameIngredientNDCExcipientPotential Generic Entry
Johnson & Johnson Consumer Inc McNeil Consumer Healthcare Division NIZORAL ketoconazole 50580-895 GLYCOL DISTEARATE
Kramer Laboratories NIZORAL ketoconazole 55505-191 GLYCOL DISTEARATE
Kramer Laboratories NIZORAL ketoconazole 55505-192 GLYCOL DISTEARATE
>Company>Tradename>Ingredient>NDC>Excipient>Potential Generic Entry
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Pharmaceutical Excipients: The Market Dynamics and Financial Trajectory of Glycol Distearate

Introduction

Pharmaceutical excipients, including glycol distearate, play a crucial role in the formulation and delivery of drugs. This article delves into the market dynamics, financial trajectory, and key factors influencing the glycol distearate segment within the pharmaceutical excipients market.

Market Overview of Pharmaceutical Excipients

The global pharmaceutical excipients market is projected to grow from USD 10.0 billion in 2023 to USD 13.9 billion by 2028, at a CAGR of 6.8%[1]. This growth is driven by several factors, including the increasing demand for generic drugs, rising R&D investments, and the development of novel excipients.

Role of Glycol Distearate in Pharmaceutical Formulations

Glycol distearate, also known as ethylene glycol distearate (EGDS), is a waxy solid derived from the reaction of ethylene glycol and stearic acid. It is widely used as an emulsifier and thickening agent in various pharmaceutical and cosmetic formulations.

Emulsification and Thickening Properties

EGDS effectively stabilizes emulsions, preventing the separation of oil and water phases, which is crucial for the texture and performance of pharmaceutical products. It also adds viscosity to formulations, allowing for a luxurious texture in creams, ointments, and other topical preparations[2].

Skin Conditioning

In addition to its emulsifying and thickening properties, EGDS provides a smooth and soft feel on the skin, enhancing the overall user experience of pharmaceutical topical products.

Market Dynamics for Glycol Distearate

Drivers

  • Increasing Demand for Generic Drugs: The growing demand for generic drugs is a significant driver for the pharmaceutical excipients market, including glycol distearate. Generic drug manufacturers seek high-quality, affordable excipients to reduce costs and improve product quality[1].
  • Rising R&D Investments: Increased investments in R&D for novel excipients and collaborations with pharmaceutical companies for customized excipient solutions are driving the market forward[1].
  • Growing Emphasis on Patient-Centric Formulations: The focus on patient-centric formulations, which require specialized excipients like glycol distearate, is another key driver[1].

Restraints

  • High Development Costs: The high costs associated with developing novel excipients, including glycol distearate, can act as a barrier to market growth[1].
  • Regulatory Stringency: Increasing regulatory requirements imposed by bodies such as the FDA and EMA can also hinder market growth[1].

Opportunities

  • Rising Demand for Multifunctional Excipients: The increasing demand for multifunctional excipients that can perform multiple roles in drug formulations presents a significant opportunity for glycol distearate[4].
  • Advancements in Nanotechnology: Innovations in nanotechnology can enhance the functionality and delivery efficiency of glycol distearate in pharmaceutical formulations[1].

Regional Market Analysis

The pharmaceutical excipients market, including glycol distearate, is segmented into several regions:

  • Europe: Dominated the market share in 2022 due to the presence of numerous large pharmaceutical companies. Europe is expected to continue its significant contribution to the market[1].
  • Asia Pacific: Predicted to exhibit the highest CAGR during the forecast period due to the expanding generic market and high volume of unmet medical needs in the region. The Asia Pacific region also offers low-cost manufacturing processes and is a good source for raw materials[1][4].

Financial Trajectory

The financial trajectory of glycol distearate is closely tied to the overall pharmaceutical excipients market. Here are some key financial indicators:

  • Market Size: The global pharmaceutical excipients market, which includes glycol distearate, is expected to grow from USD 10.0 billion in 2023 to USD 13.9 billion by 2028[1].
  • CAGR: The market is projected to grow at a CAGR of 6.8% from 2023 to 2028[1].
  • Revenue Growth: The increasing usage of generic medicines and the rising demand for multifunctional excipients are expected to drive revenue growth. The global excipients market is estimated to grow at a CAGR of 4.03% from 2023 to 2030[4].

Trends and Innovations

Several trends and innovations are shaping the market for glycol distearate:

  • Clean Beauty and Personal Care Trends: The clean beauty movement, which emphasizes the use of natural and safe ingredients, is driving the demand for glycol distearate in both cosmetic and pharmaceutical formulations[2].
  • Advancements in Formulation Technologies: Recent advancements in formulation technologies have made it easier for manufacturers to integrate glycol distearate into various products, enhancing their performance and stability[2].
  • Strategic Collaborations: Collaborations between ingredient suppliers and pharmaceutical manufacturers are increasing, focusing on developing innovative products that leverage the benefits of glycol distearate[2].

Key Players and Market Ecosystem

The market for glycol distearate involves several key players and a complex ecosystem:

  • Key Players: Companies such as Ashland Inc., Roquette Frères, Evonik Industries AG, and BASF SE are significant players in the pharmaceutical excipients market, including glycol distearate[1].
  • Supply Chain and Value Chain Analysis: The supply chain for glycol distearate involves the sourcing of raw materials like ethylene glycol and stearic acid, followed by manufacturing and distribution. The value chain includes various stages from raw material sourcing to the final formulation of pharmaceutical products[1].

Safety and Regulatory Considerations

The safety and regulatory aspects of glycol distearate are crucial:

  • Safety Assessment: Studies have shown that glycol distearate is generally safe for use in pharmaceutical and cosmetic formulations. It does not exhibit significant toxicity and is well-tolerated by the skin[5].
  • Regulatory Compliance: Manufacturers must comply with stringent regulatory requirements imposed by bodies such as the FDA and EMA to ensure the safety and efficacy of glycol distearate in pharmaceutical products[1].

Conclusion

The market for glycol distearate is poised for significant growth, driven by increasing demand for generic drugs, rising R&D investments, and the growing emphasis on patient-centric formulations. Despite challenges such as high development costs and regulatory stringency, the opportunities presented by advancements in nanotechnology and the rising demand for multifunctional excipients are expected to drive the market forward.

Key Takeaways

  • Growing Demand: Increasing demand for generic drugs and patient-centric formulations drives the market for glycol distearate.
  • R&D Investments: Rising R&D investments and collaborations for novel excipients are key drivers.
  • Regional Growth: Asia Pacific is expected to exhibit the highest CAGR due to expanding generic markets and low-cost manufacturing.
  • Financial Trajectory: The market is projected to grow at a CAGR of 6.8% from 2023 to 2028.
  • Trends and Innovations: Clean beauty trends, advancements in formulation technologies, and strategic collaborations are shaping the market.

FAQs

1. What is glycol distearate, and how is it used in pharmaceutical formulations?

Glycol distearate, or ethylene glycol distearate (EGDS), is a waxy solid used as an emulsifier and thickening agent in pharmaceutical formulations, stabilizing emulsions and adding viscosity to products.

2. What are the key drivers of the glycol distearate market?

The key drivers include the increasing demand for generic drugs, rising R&D investments, and the growing emphasis on patient-centric formulations.

3. What are the main challenges facing the glycol distearate market?

Challenges include high development costs for novel excipients and the growing stringency of regulatory requirements.

4. Which region is expected to witness the highest growth in the glycol distearate market?

The Asia Pacific region is expected to exhibit the highest CAGR due to the expanding generic market and low-cost manufacturing processes.

5. What is the projected financial growth of the glycol distearate market?

The market is projected to grow at a CAGR of 6.8% from 2023 to 2028, with the global pharmaceutical excipients market expected to reach USD 13.9 billion by 2028.

Sources

  1. MarketsandMarkets: Pharmaceutical Excipients Market Growth, Drivers, and Opportunities[1].
  2. Market Research Intellect: Smoothing the Way: The Rising Demand for Cosmetic Grade Ethylene Glycol Distearate[2].
  3. Market Research Intellect: Ethylene Glycol Distearate (EGDS) Sales Market Size, Scope And Forecast[3].
  4. Grand View Research: Excipients Market Size, Share & Trends Analysis Report 2030[4].
  5. CIR Safety: Safety Assessment of Monoalkylglycol Dialkyl Acid Esters as Used in Cosmetics[5].

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.