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Last Updated: March 13, 2025

Drugs Containing Excipient (Inactive Ingredient) FUMARIC ACID


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

CompanyTradenameIngredientNDCExcipientPotential Generic Entry
STAT RX USA LLC AVINZA morphine sulfate 16590-594 FUMARIC ACID
Takeda Pharmaceuticals America Inc INTUNIV guanfacine 54092-513 FUMARIC ACID
Pharmaceutical Associates Inc NAPROSYN naproxen 0121-0899 FUMARIC ACID
>Company>Tradename>Ingredient>NDC>Excipient>Potential Generic Entry
Showing 1 to 3 of 3 entries

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

Introduction

Fumaric acid, a dicarboxylic acid with the chemical formula HOOCCH=CHCOOH, has diverse applications across various industries, including the pharmaceutical sector. As a pharmaceutical excipient, fumaric acid plays a crucial role in enhancing the properties of active pharmaceutical ingredients (APIs). Here, we delve into the market dynamics and financial trajectory of fumaric acid in the pharmaceutical industry.

Global Market Size and Growth

The fumaric acid market is experiencing steady growth, driven by its increasing use in various sectors, including pharmaceuticals. As of 2022, the global fumaric acid market was valued at US$ 266.4 million and is projected to reach US$ 381.6 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 4.6% during the forecast period[1].

Regional Market Share

The regional distribution of the fumaric acid market is significant, with North America holding a dominant position in 2020, accounting for 38.5% of the market share in terms of volume. However, the Asia Pacific region is expected to account for the largest market share during the forecast period due to the growing demand for convenience foods and beverages, and the increasing per capita disposable income in the region[1].

Applications in Pharmaceutical Formulations

Fumaric acid is used as an excipient in pharmaceutical formulations for several purposes:

  • Acidulant: It serves as an acidity regulator, enhancing the stability and bioavailability of APIs.
  • Antioxidant: Fumaric acid can act as an antioxidant, protecting the formulation from oxidative degradation.
  • Flavoring Agent: It is used to add a sour taste to certain pharmaceutical products.
  • Therapeutic Agent: Fumaric acid, particularly its ester dimethyl fumarate, is used in the treatment of autoimmune conditions such as psoriasis and multiple sclerosis[2][5].

Market Drivers

Several factors are driving the demand for fumaric acid in the pharmaceutical sector:

  • Increasing Chronic Diseases: The rise in chronic diseases like diabetes, hypertension, cancer, and HIV necessitates the development of more effective and patient-friendly drug formulations, where excipients like fumaric acid play a critical role[3].
  • Growing Demand for Convenience Foods: The increasing demand for convenience foods and beverages, especially in the Asia Pacific region, also drives the demand for fumaric acid as a food acidulant, which indirectly benefits its use in pharmaceuticals[1].
  • Innovation in Drug Formulations: The need for innovative excipients that enhance the solubility, bioavailability, and stability of APIs is a significant driver for the fumaric acid market[3].

Market Restraints

Despite the growth potential, there are some restraints to consider:

  • Health Hazards: High doses of fumaric acid can be nephrotoxic after long-term use, which is a significant health hazard and a restraining factor for the market[4].
  • Regulatory Compliance: Ensuring compliance with pharmacopeial standards and regulatory requirements can be challenging and may act as a restraint[5].

Key Players

The fumaric acid market is dominated by several key players:

  • Bartek Ingredients Inc.
  • XST Biological Co. Ltd.
  • Changmao Biochemical Engineering Company Limited
  • Fuso Chemical Co. Ltd
  • Polynt

These companies are pivotal in driving innovation and sustainability in the production and application of fumaric acid[4].

Financial Trajectory

The financial trajectory of the fumaric acid market is positive, with steady growth projected over the next few years. Here are some key financial metrics:

  • Market Value: Expected to grow from US$ 266.4 million in 2022 to US$ 381.6 million by 2030[1].
  • Volume: The market size is estimated at 285.43 kilotons in 2024 and is expected to reach 346.43 kilotons by 2029, growing at a CAGR of 3.95%[4].

Impact of COVID-19

The COVID-19 pandemic had a negative impact on the fumaric acid market in 2020 due to disruptions in manufacturing activities and supply chains. However, the market started recovering in 2021 and is expected to continue its growth trajectory during the forecast period[4].

Future Opportunities

The emergence of new potential application areas for fumaric acid is likely to act as an opportunity for the market. For instance, its use in the manufacture of polyester resins and polyhydric alcohols, as well as its role in reducing methane production in livestock, could expand its market scope[2][4].

Safety and Precautions

While fumaric acid is generally considered safe, high doses can be nephrotoxic. The European Commission Scientific Committee on Animal Nutrition found that fumaric acid is "practically non-toxic" but high doses are probably nephrotoxic after long-term use. Therefore, careful handling and dosing are essential[2].

Conclusion

Fumaric acid is a versatile excipient with significant applications in the pharmaceutical industry. Its market is driven by the growing demand for effective drug formulations, convenience foods, and innovative excipients. Despite some health hazards and regulatory challenges, the financial trajectory of the fumaric acid market is promising, with steady growth projected over the next few years.

Key Takeaways

  • Market Growth: The fumaric acid market is expected to grow at a CAGR of 4.6% from 2022 to 2030.
  • Regional Dominance: Asia Pacific is expected to dominate the market during the forecast period.
  • Pharmaceutical Applications: Fumaric acid is used as an acidulant, antioxidant, flavoring agent, and therapeutic agent in pharmaceutical formulations.
  • Market Drivers: Increasing chronic diseases, growing demand for convenience foods, and innovation in drug formulations drive the market.
  • Health Hazards: High doses of fumaric acid can be nephrotoxic, necessitating careful handling and dosing.

FAQs

1. What is the current market size of the fumaric acid market? The fumaric acid market was valued at US$ 266.4 million in 2022[1].

2. What is the expected CAGR of the fumaric acid market from 2022 to 2030? The fumaric acid market is expected to grow at a CAGR of 4.6% from 2022 to 2030[1].

3. Which region is expected to dominate the fumaric acid market during the forecast period? Asia Pacific is expected to dominate the fumaric acid market during the forecast period[1].

4. What are the primary applications of fumaric acid in pharmaceutical formulations? Fumaric acid is used as an acidulant, antioxidant, flavoring agent, and therapeutic agent in pharmaceutical formulations[2][5].

5. What are the potential health hazards associated with fumaric acid? High doses of fumaric acid can be nephrotoxic after long-term use, making careful handling and dosing essential[2].

References

  1. Coherent Market Insights - Fumaric Acid Market - Share, Size and Industry Analysis
  2. Wikipedia - Fumaric acid
  3. BCC Research - Understanding the Future of Pharmaceutical Excipients
  4. Mordor Intelligence - Fumaric Acid Market - Size, Share & Trends
  5. PharmaCentral - Fumaric Acid Excipient | Uses, Suppliers, and Specifications

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