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Last Updated: January 15, 2025

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Drugs Containing Excipient (Inactive Ingredient) STEARIC ACID


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Branded drugs containing STEARIC ACID excipient, and estimated key patent expiration / generic entry dates

CompanyTradenameIngredientNDCExcipientPotential Generic Entry
Genentech Inc BONIVA ibandronate sodium 0004-0186 STEARIC ACID
ER Squibb & Sons LLC EVOTAZ atazanavir and cobicistat 0003-3641 STEARIC ACID 2032-10-06
Genentech Inc VALCYTE valganciclovir 0004-0038 STEARIC ACID
>Company>Tradename>Ingredient>NDC>Excipient>Potential Generic Entry
Showing 1 to 3 of 3 entries

Market Dynamics and Financial Trajectory for Stearic Acid as a Pharmaceutical Excipient

Introduction to Stearic Acid in Pharmaceuticals

Stearic acid is a versatile and essential excipient in the pharmaceutical industry, serving multiple critical functions in drug formulations. It acts as a lubricant, binder, emulsifier, and stabilizer, making it a cornerstone in the production of tablets, capsules, creams, and ointments[1][3].

Pharmaceutical Applications of Stearic Acid

Lubrication and Binding

Stearic acid is primarily used as a lubricant in tablet and capsule manufacturing, ensuring smooth compression and ejection from die cavities. It prevents the sticking of granules or powder to tablet punches and dies, enhancing tablet hardness and reducing issues like capping and lamination[1][3].

Emulsification and Solubilization

Stearic acid facilitates the incorporation of hydrophobic drugs into water-based formulations, improving their stability and enhancing drug delivery. It also forms micelles and liposomes, which are nano-sized carriers that enhance the solubility and bioavailability of water-insoluble drugs[1][3].

Targeted Drug Delivery

Researchers are exploring stearic acid for its potential in targeted drug delivery. By modifying the stearic acid molecule, it can be used to create specialized carriers that target specific cell receptors and deliver drugs to designated cells or tissues[3].

Market Size and Growth Projections

Global Market Value

The global stearic acid market is projected to grow significantly, from an estimated value of USD 40.5 billion in 2024 to over USD 71.3 billion by 2034, with a strong compound annual growth rate (CAGR) of 7.6%[2][5].

Regional Market Dynamics

  • United States: Expected to exhibit a CAGR of 3.4%, with revenue projected to reach USD 14.7 billion by 2034.
  • China: Forecast to grow at a robust CAGR of 8.4%, reaching a valuation of USD 11.6 billion by 2034.
  • India: Anticipated to register the highest CAGR of 10.6%, with a market value of USD 6.5 billion by 2034[2][5].

Key Drivers of Market Growth

Increasing Demand in Personal Care and Pharmaceuticals

The personal care segment is a major driver, with stearic acid being a critical component in soaps, detergents, and other personal care products. The growing demand for organic and sustainable products in this sector further boosts the market[5].

Expanding Industrial Applications

Stearic acid's use in the rubber, automotive, and textile industries is also on the rise, driven by the demand for biodegradable products and favorable government initiatives, particularly in China and India[2][5].

Advancements in Pharmaceutical Formulations

The ongoing research and development in pharmaceuticals, including the use of stearic acid in targeted drug delivery and the creation of solid lipid nanoparticles (SLNs), are expected to unlock new applications and expand market opportunities[3].

Challenges and Limitations

Low Water Solubility

One of the limitations of stearic acid is its low water solubility, which can result in a residual film on surfaces and skin. However, this is often mitigated by using it as an additive rather than a primary ingredient[5].

Regulatory Standards

USP-NF and EP Monographs

The quality and purity of pharmaceutical-grade stearic acid are governed by monographs from the United States Pharmacopeia-National Formulary (USP-NF) and the European Pharmacopoeia (EP), ensuring its suitability for use in drug formulations[1].

Competitive Landscape

Leading Manufacturers

The global stearic acid market is dominated by key players such as P&G Chemicals, BASF SE, AkzoNobel N.V., Kao Corporation, VVF LLC, and Godrej Industries. These companies are focusing on mergers and acquisitions, sustainable practices, and innovative product development to strengthen their market position[2][5].

Future Outlook

Emerging Applications

The discovery of new uses for stearic acid, such as in the treatment of specific diseases, could create new market fronts and opportunities. Ongoing research may lead to stearic acid being used in exclusive medicated drugs for particular ailments[2].

Sustainable and Multifunctional Applications

The rising demand for sustainable and multifunctional applications across various industries is expected to drive the market growth significantly. This includes its use in metal cleaning, candle manufacturing, and other industrial processes[5].

Key Takeaways

  • Stearic acid is a crucial excipient in pharmaceuticals, serving as a lubricant, binder, emulsifier, and stabilizer.
  • The global stearic acid market is projected to grow from USD 40.5 billion in 2024 to over USD 71.3 billion by 2034.
  • Regional markets, especially in the United States, China, and India, are expected to drive significant growth.
  • Increasing demand in personal care and pharmaceuticals, along with expanding industrial applications, are key drivers of market growth.
  • Regulatory standards from USP-NF and EP ensure the quality and purity of pharmaceutical-grade stearic acid.

FAQs

What are the primary functions of stearic acid in pharmaceutical formulations?

Stearic acid serves as a lubricant, binder, emulsifier, and stabilizer in pharmaceutical formulations, ensuring smooth tablet compression, enhancing cohesion and compressibility of powdered ingredients, and improving drug delivery.

What is the projected growth rate of the global stearic acid market?

The global stearic acid market is projected to grow at a CAGR of 7.6% from 2024 to 2034.

Which regions are expected to lead the consumption of stearic acid?

The United States and China are predicted to remain top consumers, with estimated valuations of USD 14.7 billion and USD 11.6 billion, respectively, by 2034.

What are the challenges associated with the use of stearic acid?

One of the main challenges is its low water solubility, which can result in a residual film on surfaces and skin.

Who are the leading manufacturers in the global stearic acid market?

Key players include P&G Chemicals, BASF SE, AkzoNobel N.V., Kao Corporation, VVF LLC, and Godrej Industries.

Sources

  1. Pharma Excipients: Introduction to Stearic Acid as a pharmaceutical Excipient.
  2. Future Market Insights: Stearic Acid Market Trends: Insights & Future Outlook 2024.
  3. Pishrochem: The Role of Stearic Acid in Modern Medicine.
  4. Research and Markets: Pharmaceutical Excipients Global Market Report 2024.
  5. GlobeNewswire: Global Stearic Acid Market to Exceed USD 71.3 Billion by 2034.

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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.