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Last Updated: December 22, 2024

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

Generic drugs containing BUTYLENE GLYCOL excipient

BUTYLENE GLYCOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Butylene Glycol as a Pharmaceutical Excipient

Introduction

Butylene glycol, specifically 1,3-butylene glycol (CAS 107-88-0), is a versatile chemical compound that plays a crucial role in various industries, including pharmaceuticals, cosmetics, and personal care. This article delves into the market dynamics and financial trajectory of butylene glycol, particularly focusing on its application as a pharmaceutical excipient.

Market Size and Growth

The global market for 1,3-butylene glycol is experiencing significant growth. In 2023, the market size was valued at USD 269.53 million and is projected to reach USD 287.64 million in 2024. By 2032, the market is expected to grow to USD 483.98 million, with a Compound Annual Growth Rate (CAGR) of 6.72% from 2024 to 2032[1].

Key Drivers of Growth

Pharmaceutical Industry

The pharmaceutical industry is a major driver of the 1,3-butylene glycol market. The compound is used as a solvent and cosolvent for injectables, topical ointments, creams, and lotions, as well as in transdermal patches. Its anti-bacterial properties and ability to enhance the stability and efficacy of active pharmaceutical ingredients make it an essential component in drug formulations[2][3].

Cosmetics and Personal Care

The cosmetics and personal care sector also significantly contributes to the demand for 1,3-butylene glycol. The compound is widely used in skincare products due to its moisturizing and antimicrobial properties. The global e-commerce boom has further increased the accessibility of these products, driving up demand for 1,3-butylene glycol[1].

Sustainability and Regulatory Frameworks

The trend towards sustainability and eco-friendly formulations is another key driver. 1,3-butylene glycol's low toxicity and biodegradability make it a preferred choice in green formulations. Favorable regulatory frameworks in regions like Europe and North America are also enhancing market confidence and growth[1].

Regional Market Dynamics

Asia-Pacific

The Asia-Pacific region is expected to exhibit the highest growth rate in the coming years. The rising disposable income in emerging economies such as India and China is driving the demand for beauty care and pharmaceutical products, which in turn is boosting the sales of 1,3-butylene glycol[2].

North America and Europe

In North America and Europe, the market is expected to grow steadily due to the increasing use of 1,3-butylene glycol in cosmetics, skincare products, and pharmaceuticals. Regulatory support and clear guidelines for the use of this compound in consumer products are also contributing to market growth in these regions[1].

Market Trends

E-commerce and Distribution

The rise of e-commerce as a major distribution platform for personal care and cosmetic products is significantly impacting the market. Online platforms have made it easier for consumers to access a wide range of products, thereby increasing the demand for 1,3-butylene glycol-based products[1].

Innovations in Pharmaceutical Formulations

Innovations in the pharmaceutical industry, such as the development of new drug delivery systems and formulations, are driving the demand for solvents like 1,3-butylene glycol. The growing need for more effective and patient-friendly drug formulations is supported by increasing investments in research and development[1].

Biopharmaceutical Industry

The expanding biopharmaceutical industry is another significant trend. Biopharmaceutical formulations often require specialized solvents to ensure the stability and effectiveness of complex biological molecules. This trend is expected to further accelerate the demand for 1,3-butylene glycol[1][4].

Market Restraints

Raw Material Price Volatility

One of the primary challenges facing the 1,3-butylene glycol market is the volatility in raw material prices. The production of 1,3-butylene glycol is heavily dependent on petrochemical-based raw materials, the prices of which can fluctuate due to geopolitical tensions, supply chain disruptions, and changing trade policies[1].

Regulatory Challenges

While regulatory frameworks are generally favorable, there are still regulatory challenges that can impact the market. Ensuring compliance with varying regional regulations can be a hurdle for manufacturers, especially in the pharmaceutical sector where stringent standards apply[4].

Safety and Stability

Safety Profile

1,3-butylene glycol is generally regarded as a relatively nontoxic material. It is mildly toxic by oral and subcutaneous routes and minimally irritant in topical preparations. However, it can cause allergic contact dermatitis and local irritation upon eye contact[3].

Storage and Stability

The compound is hygroscopic and should be stored in a well-closed container in a cool, dry, well-ventilated place. When heated to decomposition, it emits acrid smoke and irritating fumes[3].

Financial Trajectory

Revenue Projections

By 2032, the global 1,3-butylene glycol market is expected to generate significant revenue, with projections indicating a market size of USD 483.98 million. This growth is driven by the increasing demand from the pharmaceutical and cosmetics industries[1].

CAGR and Growth Rate

The market is expected to grow at a CAGR of 6.72% from 2024 to 2032, indicating a robust financial trajectory. This growth rate is supported by the expanding pharmaceutical industry, the boom in cosmetic product sales, and favorable regulatory environments[1].

Key Takeaways

  • The 1,3-butylene glycol market is driven by its increasing use in the pharmaceutical and cosmetics industries.
  • The compound's anti-bacterial properties and role as a solvent in drug formulations are critical factors in its market growth.
  • Regional growth is particularly strong in the Asia-Pacific region due to rising disposable incomes and demand for beauty care and pharmaceutical products.
  • E-commerce and innovations in pharmaceutical formulations are significant market trends.
  • Raw material price volatility and regulatory challenges are key restraints.
  • The compound has a relatively safe profile but requires careful storage and handling.

FAQs

What are the primary applications of 1,3-butylene glycol?

1,3-butylene glycol is primarily used as a solvent and cosolvent in pharmaceuticals, particularly in injectables, topical ointments, creams, and lotions, as well as in transdermal patches. It is also widely used in cosmetics and personal care products.

What drives the growth of the 1,3-butylene glycol market?

The growth of the 1,3-butylene glycol market is driven by the expanding pharmaceutical industry, the boom in cosmetic product sales, and favorable regulatory environments. Additionally, the trend towards sustainability and eco-friendly formulations contributes to its growth.

What are the challenges facing the 1,3-butylene glycol market?

The primary challenges include volatility in raw material prices and regulatory challenges. Ensuring compliance with varying regional regulations can be a hurdle for manufacturers.

How is the market expected to grow in the Asia-Pacific region?

The Asia-Pacific region is expected to exhibit the highest growth rate due to the rising disposable income in emerging economies such as India and China, driving the demand for beauty care and pharmaceutical products.

What is the safety profile of 1,3-butylene glycol?

1,3-butylene glycol is generally regarded as a relatively nontoxic material. It is mildly toxic by oral and subcutaneous routes and minimally irritant in topical preparations, but it can cause allergic contact dermatitis and local irritation upon eye contact.

Sources

  1. Global Growth Insights: 1,3-butylene Glycol (CAS 107-88-0) Market - Global Growth Insights.
  2. Markets Business Insider: Booming Pharmaceutical Industry Driving 1,3-Butylene Glycol Market says P&S Intelligence.
  3. CD Formulation: Butylene Glycol.
  4. Biospace: Pharmaceutical Excipients Market Size USD 14.72 Billion by 2033 and CAGR 5.81 percent.

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