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Last Updated: April 5, 2025

Drugs Containing Excipient (Inactive Ingredient) MALEIC ACID


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

CompanyTradenameIngredientNDCExcipientPotential Generic Entry
Apotheca Inc METHERGINE methylergonovine maleate 12634-179 MALEIC ACID
Validus Pharmaceuticals LLC PARLODEL bromocriptine mesylate 30698-202 MALEIC ACID
Heron Therapeutics Inc ZYNRELEF bupivacaine and meloxicam 47426-301 MALEIC ACID 2035-04-20
>Company>Tradename>Ingredient>NDC>Excipient>Potential Generic Entry
Showing 1 to 3 of 3 entries

Maleic Acid in the Pharmaceutical and Larger Chemical Markets: Market Dynamics and Financial Trajectory

Introduction to Maleic Acid

Maleic acid is a versatile organic compound that finds extensive use in various industries, including pharmaceuticals, food and beverages, personal care, and textiles. Its unique properties as an acidulant, flavor enhancer, and intermediate in chemical synthesis make it a crucial component in several applications.

Market Size and Growth Projections

The global maleic acid market is anticipated to experience moderate yet steady growth over the coming years. As of 2022, the market size was estimated at USD 216.21 million, and it is projected to reach USD 324.71 million by 2030, growing at a compound annual growth rate (CAGR) of 5.2% from 2023 to 2030[4].

Key Drivers of the Maleic Acid Market

Several factors are driving the growth of the maleic acid market:

Increasing Demand in Food and Beverage Industry

The demand for malic acid in the food and beverage industry is rising due to its excellent blending and flavor-enhancing properties. This is particularly evident in emerging economies such as China, India, Brazil, and Thailand, where the food and beverage processing industries are expanding rapidly[4].

Growing Personal Care and Cosmetics Sector

The personal care and cosmetics industry is another significant driver, with increasing urbanization, rising disposable incomes, and a growing awareness of hygiene and skin care contributing to the demand for malic acid in this sector[1].

Pharmaceutical Applications

In the pharmaceutical industry, malic acid is used as an excipient due to its ability to enhance the stability and bioavailability of drugs. The growing demand for pharmaceutical excipients, particularly in regions like North America and Europe, is expected to boost the market for maleic acid[3].

Regional Market Dynamics

Asia Pacific Dominance

The Asia Pacific region dominates the maleic acid market, accounting for more than 42.50% of the overall revenue in 2022. Countries like China, India, and Japan are key manufacturing hubs, driven by growing populations, increasing income levels, and a rise in the number of food and beverage start-ups[4].

North America and Europe

In North America and Europe, the market is driven by the pharmaceutical and food industries. These regions have stringent safety regulations, which can sometimes pose challenges but also ensure a high standard of product quality[3].

Challenges and Restraints

Despite the growth prospects, the maleic acid market faces several challenges:

Raw Material Price Fluctuations

Price fluctuations of raw materials, such as petrochemical feedstocks for synthetic synthesis or sugar for fermentation, can significantly impact production costs and limit market expansion[2].

Safety Concerns and Regulatory Restrictions

Strict safety regulations and approval procedures for new uses of malic acid can be time-consuming and expensive. Any safety concerns can erode consumer trust and depress sales[2].

Competition from Other Acidulants

Malic acid faces competition from other acidulants like citric acid and tartaric acid, which are established and cost-effective alternatives in food and beverage applications[2].

Technological Advancements

Advances in fermentation techniques, including the use of genetically modified organisms and modified fermentation conditions, are enhancing the efficacy and economic viability of malic acid production. These advancements are expected to propel market growth[2].

Key Market Players

The maleic acid market is characterized by the presence of several key players, including:

  • Thermo Fisher Scientific Inc.
  • Tokyo Chemical Industries
  • The Merck Group (Sigma-Aldrich)
  • Loba Chemie Pvt. Ltd.
  • Glentham Life Sciences Limited
  • Lonza
  • Thirumalai Chemicals Ltd.
  • Nacalai Tesque, Inc.
  • Bartek Ingredients Inc.[1][4].

Downstream Potential

The realization of white spaces in the R&D of malic acid derivatives offers lucrative downstream potential. Malic acid derivatives are used in stereochemistry as resolving agents, ligands, auxiliaries, and chiral four-carbon building blocks, particularly in biomedical and pharmaceutical industries. Functional degradable nanoparticles derived from these chemicals are used for treating cancer cell lines, further propelling the market growth[5].

Financial Trajectory

The financial trajectory of the maleic acid market is positive, with projected growth from USD 227.5 million in 2024 to USD 341.2 million by 2031, at a CAGR of 5%[2].

Revenue Projections by Region

  • Asia Pacific: Expected to continue its dominance, driven by strong economic growth, increasing disposable incomes, and a growing demand for processed foods and beverages.
  • North America and Europe: Expected to grow steadily, driven by the pharmaceutical and food industries, despite facing challenges from regulatory restrictions and competition from other acidulants[4].

Key Takeaways

  • The global maleic acid market is projected to grow at a CAGR of 5.2% from 2023 to 2030.
  • Asia Pacific dominates the market, driven by growing demand in food and beverages, personal care, and pharmaceuticals.
  • Technological advancements in fermentation techniques are enhancing production efficacy.
  • Key challenges include raw material price fluctuations, safety concerns, and competition from other acidulants.
  • The market is characterized by the presence of several key players and significant downstream potential in biomedical and pharmaceutical industries.

FAQs

Q: What is the projected market size of maleic acid by 2030?

A: The global maleic acid market is expected to reach USD 324.71 million by 2030[4].

Q: Which region dominates the maleic acid market?

A: The Asia Pacific region dominates the maleic acid market, accounting for more than 42.50% of the overall revenue[4].

Q: What are the key drivers of the maleic acid market?

A: The key drivers include increasing demand in the food and beverage industry, growing personal care and cosmetics sector, and pharmaceutical applications[4].

Q: What challenges does the maleic acid market face?

A: The market faces challenges such as raw material price fluctuations, safety concerns, regulatory restrictions, and competition from other acidulants[2].

Q: Who are the key players in the maleic acid market?

A: Key players include Thermo Fisher Scientific Inc., Tokyo Chemical Industries, The Merck Group (Sigma-Aldrich), and others[1][4].

Sources:

  1. IndustryARC: Maleic Acid Market Size Report, 2024-2030.
  2. Verified Market Research: In-Depth Industry Outlook: Malic Acid Market Size & Forecast.
  3. Biospace: Pharmaceutical Excipients Market Size USD 14.72 Billion by 2033.
  4. Grand View Research: Malic Acid Market Size, Share, Growth & Trends Report, 2030.
  5. Grand View Research: Malic Acid Downstream Potential Market Size | Industry Report, 2025.

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