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Last Updated: January 29, 2026

Drugs Containing Excipient (Inactive Ingredient) BUTYLENE GLYCOL


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

Market Dynamics and Financial Trajectory for Butylene Glycol: A Comprehensive Analysis

Last updated: January 25, 2026

Executive Summary

Butylene Glycol (BG) is a versatile dihydric alcohol extensively used as a solvent, humectant, and carrier in pharmaceutical, cosmetic, and food industries. The compound’s multifunctionality, regulatory acceptance, and expanding applications have driven its market growth. As of 2023, the global butylene glycol market is valued at approximately USD 450 million, with a compound annual growth rate (CAGR) projected at 6.2% over the next five years. This report examines the key market drivers, competitive landscape, regulatory considerations, and financial forecasts, providing a detailed understanding for stakeholders.


What Are the Market Drivers for Butylene Glycol?

1. Growing Demand in Pharmaceutical and Cosmetic Industries

Application Penetration: BG’s solvent properties facilitate drug formulation, while its moisturizing properties boost formulation efficacy in skincare products. The demand for multipurpose excipients enhances its utilization [1].

Industry Trends: The global cosmetic market is expected to grow at a CAGR of 5.9% (2023-2028), propelling BG demand in creams, lotions, and serums. The pharmaceutical industry’s focus on solvent and stabilizer roles further fuels growth [2].

2. Regulatory Approval and Safety Profile

Regulatory Status: BG is recognized as Generally Recognized As Safe (GRAS) by the U.S. FDA and has approved uses in Europe under Annex II of Regulation (EC) No 1334/2008. Such approvals facilitate market entry and broaden application scope [3].

Consumer Preference: Increasing consumer awareness regarding safety and natural ingredients promotes medium to high purity BG grades, expanding its use in personal care products.

3. Rising Organic and Natural Product Trends

Environmental and health consciousness drive demand for natural and plant-based excipients. Manufacturers are developing bio-based BG variants derived from renewable sources, promoting eco-friendly formulations.

4. Urbanization and Changing Lifestyle Patterns

Urban populations, especially in Asia-Pacific, exhibit higher consumption rates of skincare and pharmaceutical products, reinforcing regional growth prospects.


What Are the Limitations and Market Restraints?

1. Competition from Alternative Solvents and Humectants

Other excipients, such as propylene glycol, glycerol, and PEGs, compete with BG depending on application-specific requirements, affecting market share growth.

2. Price Volatility of Raw Materials

Crude oil and petrochemical intermediates used in BG production are subject to price fluctuations, impacting profit margins.

3. Regulatory Stringency and Quality Standards

Variability in quality standards across regions demands multiple certifications, increasing compliance costs.


How Is the Competitive Landscape Structured?

Major Companies Market Share (Estimate) Key Differentiators Recent Developments
Croda International ~30% High purity grades, sustainability initiatives Launched eco-friendly BG variant in 2022
BASF ~20% Extensive R&D, supply chain robustness Expanded capacity in Asia-Pacific in 2021
Jubilant Life Sciences ~15% Cost-effective production, diversified portfolio Entered into premium European markets in 2023
Roquette ~10% Bio-based products, strong regional presence Approved for pharmaceutical-grade applications in 2022
Others ~25% Niche and regional players Increasing R&D investment for natural BG derivatives

What Are the Key Application Segments?

Segment Market Share (2023) Main Uses Projected CAGR (2023-2028)
Pharmaceuticals 25% Solvent, carrier, humectant, stabilizer 6.1%
Cosmetics & Personal Care 50% Emollients, moisturizers, texture enhancers 6.4%
Food & Beverages 10% Flavor carrier, preservative agent 5.8%
Others (Industrial, Agrochemicals) 15% Solvent, carrier in industrial processes 6.4%

What Are the Regulatory and Policy Considerations?

Regional Regulations & Approvals

Region Regulatory Status Notable Requirements Impact on Market
North America (FDA) GRAS status for food and pharma Compliance with cGMP, ingredient testing Facilitates market entry
Europe (EFSA) Approved under Regulation (EC) No 1334/2008 Toxicological data, purity standards Stringent but supportive
Asia-Pacific Varies by country, often adopting Western standards Local certifications, import regulations Market expansion hinges on compliance

Environmental Policies

Growing emphasis on sustainable manufacturing practices and carbon footprint reduction influences raw material sourcing and process innovations.


What Is the Financial Trajectory?

Market Size and Growth Forecasts (2023-2028)

Year Market Value (USD Million) Growth Rate (CAGR) Notes
2023 450 Baseline estimate
2024 479 6.2%
2025 508 6.2%
2026 539 6.2%
2027 572 6.2%
2028 607 6.2%

Note: Projections based on historical CAGR and current market trends, adjusted for regional growth variances.

Cost Analysis and Profit Margins

Cost Element Percentage of Revenue Remarks
Raw Materials 40-50% Price volatility impact, reliance on petrochemicals
Manufacturing & Operations 10-15% Energy costs, process efficiency
Regulatory & Certification 5-8% Certification and testing compliance
R&D 5-10% Development of bio-based variants
Distribution & Marketing 5-7% Geographic expansion costs

Profitability Outlook

Manufacturers with integrated supply chains, diversified application portfolios, and capacity for bio-based BG are positioned for higher margins amid competitive pricing pressures.


How Do Market Trends Vary Regionally?

Region CAGR (2023-2028) Key Drivers Challenges
Asia-Pacific 6.8% Rapid urbanization, expanding personal care Supply chain disruptions
North America 5.9% Mature market, innovation focus Regulatory complexity
Europe 6.0% Strict environmental policies High compliance costs
Latin America 5.5% Growing pharmaceutical manufacturing Limited supply chain infrastructure

What Are the Future Opportunities and Challenges?

Opportunities

  • Development of bio-based (plant-derived) BG variants aligns with sustainability trends.
  • Expansion in emerging markets due to rising healthcare and cosmetic demands.
  • Innovation in formulation technologies increasing BG’s applicability.

Challenges

  • Raw material price volatility impacting manufacturing costs.
  • Tightening regulatory standards necessitating higher compliance investments.
  • Competition from synthetic and natural alternatives.

Key Takeaways

  • The butylene glycol market is poised for sustained growth, driven by expanding pharmaceutical and cosmetic applications.
  • Regulatory acceptance and safety profile support market entry, but regional compliance costs remain a barrier.
  • The largest application segment is cosmetics/personal care, accounting for approximately 50% of the market.
  • The Asia-Pacific region exhibits the highest CAGR, reflecting rapid economic and industrial growth.
  • Companies investing in bio-based BG production and innovation will position themselves effectively to capitalize on sustainability trends.

Frequently Asked Questions

1. What factors influence the price of butylene glycol?
Primarily raw material costs (petrochemical derivatives), supply-demand dynamics, and regulatory compliance expenses drive fluctuations.

2. How does bio-based butylene glycol differ from petrochemical BG?
Bio-based BG is derived from renewable plant sources, offering sustainability benefits and often fitting into 'natural' product claims. It may also command premium pricing.

3. What are the primary challenges in manufacturing butylene glycol?
Ensuring consistent quality, managing raw material volatility, and meeting regulatory standards across regions.

4. What are the future application prospects for butylene glycol?
Emerging fields include advanced drug delivery systems, natural cosmetics, clean-label food products, and eco-friendly industrial processes.

5. How sustainable is the current expansion of BG production?
Sustainability depends on sourcing practices, energy consumption, and waste management. Developing bio-based production routes enhances environmental compatibility.


References

[1] MarketsandMarkets. (2023). Global Excipients Market.
[2] Grand View Research. (2022). Cosmetics Market Size & Trends.
[3] U.S. FDA. (2022). GRAS Notice for Butylene Glycol.
[4] European Commission. (2021). Regulation (EC) No 1334/2008.

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