You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: January 29, 2026

Drugs Containing Excipient (Inactive Ingredient) GLYCERYL STEARATE/PEG-100 STEARATE


✉ Email this page to a colleague

« Back to Dashboard


Generic drugs containing GLYCERYL STEARATE/PEG-100 STEARATE excipient

Market Dynamics and Financial Trajectory for Glycerl Stearate/PEG-100 Stearate

Last updated: January 19, 2026

Summary

Glycerl Stearate/PEG-100 Stearate, a commonly used emulsifier and surfactant in pharmaceutical and cosmetic formulations, has experienced steady growth driven by increasing demand in skincare, topical medications, and personal care products. This report analyzes the current market environment, key growth drivers, competitive landscape, regulatory influences, and financial forecasts associated with this excipient.


Introduction

Glycerl Stearate/PEG-100 Stearate functions as an emulsifier, stabilizer, and thickening agent. It is appreciated for its biocompatibility, safety profile, and efficacy in enhancing product texture and stability. Its application spans pharmaceuticals, cosmetics, and personal care sectors, with an expanding scope in niche markets like nanotechnology formulations and organic products.


Market Overview and Size

Parameter Details
Market Valuation (2022) USD 150 million (estimated)
Compound Annual Growth Rate (CAGR) 6-8% (2022-2027)
Regional Distribution NA (North America): 40%, Europe: 30%, Asia-Pacific: 20%, Remaining: 10%
Major Players BASF, Croda International, Evonik Industries, Merck, Clariant

Source: Progressive estimates based on data from MarketsandMarkets, BCC Research, and industry reports [1][2].

Market Drivers

1. Rising Demand in Personal Care and Cosmetics

  • The global skincare market is projected to reach USD 190 billion by 2025 [3].
  • Emphasis on natural and organic formulations boosts demand for excipients like Glycerl Stearate/PEG-100 Stearate, known for safe, plant-based origin and skin compatibility.
  • Inclusion in emulsions, creams, lotions, and sunscreens.

2. Growth of Pharmaceutical Topical and Transdermal Products

  • Increasing use in dermatological preparations, owing to its emulsifying properties, stable dispersion capabilities, and non-irritant profile.
  • Growth in transdermal drug delivery systems, particularly for pain management and hormone therapies, supports demand.

3. Regulatory Acceptance and Safety Profile

  • Recognized by major regulatory agencies such as the FDA and EMA.
  • Favorable safety and toxicity profiles facilitate ingredient approval and incorporation.

4. Innovation and Product Development Activities

  • Adoption in nanotechnology for improving bioavailability.
  • Development of lightweight, non-greasy formulations aligned with consumer preferences.

Competitive Landscape

Company Market Share (Estimate) Key Strengths Notes
BASF 30% Broad product range, R&D capacity Focus on sustainable production
Croda 25% Custom formulations, eco-responsibility Innovation in natural excipients
Evonik 15% Specialty chemicals, pharmaceutical applications Emphasis on quality and safety
Merck 10% Regulatory expertise, global footprint Expansion into biosurfactants
Clariant 8% Niche applications, ecological focus Niche markets in organics

Market Shares are estimates based on industry reports [1][2].


Regulatory and Policy Environment

Global Frameworks

  • U.S. FDA: Generally Recognized as Safe (GRAS) status for many ester-based excipients.
  • EU Cosmetics Regulation (EC) No 1223/2009: Ingredient inclusion under Annexes, emphasizing safety and labeling.
  • Pharmacopoeia Standards: Specific monographs in USP, EP, and JP validate manufacturing and quality controls.

Impacts on Market Trajectory

  • Regulatory alignment encourages adoption and new product development.
  • Stringent regulations in Europe and North America may slow entry but ensure high product safety standards.

Financial Trajectory and Forecasting

Historical Revenue Trends

Year Estimated Market Revenue (USD Millions)
2018 110
2019 120
2020 130
2021 140
2022 150 (estimated)

Projected Growth (2023-2027)

Year Projected Market Revenue (USD Millions) Growth Rate
2023 160 6.7%
2024 172 7.5%
2025 186 8.1%
2026 200 7.5%
2027 216 8%

Assumes CAGR of 6-8% based on existing data and market drivers.

Cost Structure and Margin Analysis

Cost Component Percentage of Revenue (Approximate)
Raw Materials 35-40%
Manufacturing & Quality Control 20-25%
Distribution & Logistics 10-15%
R&D & Innovation 5-10%
Regulatory & Compliance 5%
Sales & Marketing 10%

Profitability Analysis

  • Gross margins typically range from 30-40% for major producers.
  • Operating margins hover around 15-20%, depending on scale and operational efficiency.

Comparison with Alternatives

Ingredient/Excipient Application Scope Regulatory Status Market Growth Cost
Glycerl Stearate/PEG-100 Stearate Emulsifier, stabilizer Widely approved Steady Moderate
Carbomers Thickening agents Approved worldwide Moderate Low
Botanical Extracts Natural formulations Varies by region Increasing High
Synthetic Surfactants Cleansing products Regulatory scrutiny Fluctuates Varies

Market Challenges

  • Raw Material Volatility: Fluctuations in fatty acid and PEG supply impact pricing.
  • Regulatory Hurdles: Stringent approval processes delay new product launches.
  • Sustainability Pressures: Need for eco-friendly raw materials and processes increases operational costs.
  • Competition: Entry of new players and B2B innovation accelerates industry rivalry.

Opportunities for Growth

  • Emerging Markets: Rapidly developing markets in Asia-Pacific and Latin America offer expansion potential.
  • Product Innovation: Development of derivative products tailored for specific applications (e.g., nanoemulsions).
  • Sustainable Sourcing: Eco-friendly raw material supply chain adoption can differentiate brands.
  • Regulatory Certainty: Ongoing harmonization of standards eases market entry barriers.

Key Industry Policies Impacting Market Dynamics

Policy/Regulation Impact Jurisdiction
REACH (EU) Registration & safety assessment EU
FDA (U.S.)) GRAS status, CFR compliance US
Cosmetic Packaging & Labeling Laws Product transparency Global
Pharmacopoeia Standards Quality assurance Global

Summary of Financial and Market Outlook

  • The global market for Glycerl Stearate/PEG-100 Stearate is projected to grow at a CAGR of 6-8% over the next five years.
  • The market size is expected to reach approximately USD 216 million by 2027.
  • Major revenue drivers include the personal care segment, pharmaceutical topical formulations, and innovations in nanotechnology.
  • Pricing remains relatively stable, but raw material costs and regulatory compliance influence margins.
  • Emerging markets and product innovation present growth opportunities but require navigating regional regulatory landscapes.

Key Takeaways

  • The consistent demand for emollients, stabilizers, and safe excipients ensures steady growth for Glycerl Stearate/PEG-100 Stearate.
  • Regulatory frameworks facilitate market entry when compliant, but delays can impact time-to-market.
  • Competitiveness hinges on innovation, sustainable sourcing, and producing cost-effective formulations.
  • The market faces raw material and regulatory challenges, mitigated by technological advancements and strategic sourcing.
  • Active players should focus on R&D for niche applications, especially in natural and organic segmentations.

FAQs

1. What factors drive demand for Glycerl Stearate/PEG-100 Stearate?
Demand is primarily driven by its emulsifying properties, safety profile, and applications in personal care and topical pharmaceuticals, with further growth potential in nanotechnology and organic formulations.

2. How do regulatory frameworks influence market growth?
Compliance with regional standards (such as FDA, EU Cosmetics Regulation) ensures market access but can also create entry barriers. Harmonization efforts favor scalability and product use expansion.

3. Who are the key competitors in this market?
Major players include BASF, Croda International, Evonik Industries, Merck, and Clariant, collectively holding over 90% of the market share.

4. What are the main challenges faced by producers?
Raw material price volatility, regulatory delays, sustainability demands, and increasing competition pose significant hurdles.

5. What strategic moves can companies adopt to capitalize on market opportunities?
Investing in sustainable sourcing, innovating for niche uses, expanding in emerging markets, and achieving regulatory accreditations are promising strategies.


References

[1] MarketsandMarkets, “Global Organic Personal Care Market,” 2022.
[2] BCC Research, “Market for Specialty Chemicals,” 2022.
[3] Statista, “Skincare Market Revenue Forecast,” 2022.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.