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Last Updated: April 15, 2025

Drugs Containing Excipient (Inactive Ingredient) EDETATE DISODIUM


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Branded drugs containing EDETATE DISODIUM excipient, and estimated key patent expiration / generic entry dates

CompanyTradenameIngredientNDCExcipientPotential Generic Entry
Merck Sharp & Dohme LLC EMEND fosaprepitant dimeglumine 0006-3061 EDETATE DISODIUM
Merck Sharp & Dohme Corp EMEND fosaprepitant dimeglumine 0006-3884 EDETATE DISODIUM
Wyeth Pharmaceuticals LLC a subsidiary of Pfizer Inc PROTONIX pantoprazole sodium 0008-0923 EDETATE DISODIUM
>Company>Tradename>Ingredient>NDC>Excipient>Potential Generic Entry
Showing 1 to 3 of 3 entries

Generic drugs containing EDETATE DISODIUM excipient

Market Dynamics and Financial Trajectory for the Pharmaceutical Excipient: Disodium Edetate

Introduction to Disodium Edetate

Disodium edetate, a form of ethylenediaminetetraacetic acid (EDTA), is a crucial excipient in the pharmaceutical industry. It is widely used for its chelating properties, which involve binding metal ions to enhance the stability and safety of pharmaceutical formulations.

Market Size and Projections

The disodium edetate market has been valued at USD 5.1 billion in 2023 and is projected to reach USD 7.42 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 4.8% from 2024 to 2031[1].

Key Applications in Pharmaceuticals

Chelation Properties

Disodium edetate is highly valued in the pharmaceutical sector for its ability to chelate metal ions, which is essential for maintaining the stability and efficacy of drug formulations. This property helps in preventing the degradation of active pharmaceutical ingredients (APIs) and ensures the product's safety and shelf life[1].

Formulations and Stability

In pharmaceutical formulations, disodium edetate is used to prevent the formation of insoluble complexes that could affect the bioavailability of the drug. Its inclusion in formulations helps in maintaining the pH balance and preventing oxidation, thereby enhancing the overall stability of the product[1].

Market Drivers

Growing Demand for Pharmaceuticals

The increasing demand for pharmaceuticals, particularly in developing countries, is a significant driver for the disodium edetate market. As the global population grows and healthcare needs increase, the demand for pharmaceutical products rises, consequently boosting the demand for excipients like disodium edetate[1].

Regulatory Clearances and R&D

Regulatory clearances and increasing research and development (R&D) expenditures for specialized and high-purity applications of disodium edetate also drive market growth. Pharmaceutical companies are investing heavily in R&D to develop new formulations that require high-purity excipients, further fueling the market expansion[1].

Consumer Awareness of Health and Safety

Growing consumer awareness of health and safety norms globally is another factor driving the demand for disodium edetate. Consumers are increasingly demanding safer and more stable pharmaceutical products, which in turn increases the demand for excipients that ensure product safety and stability[1].

Market Segmentation

By Type

The disodium edetate market is segmented based on type, including EDTA acid, EDTA disodium, and EDTA tetrasodium. Each type has specific applications and is chosen based on the requirements of the pharmaceutical formulation[1].

By Application

The market is also segmented by application, with key sectors including pharmaceuticals, food and beverages, cosmetics, and cleaning agents. In the pharmaceutical sector, disodium edetate is used extensively due to its chelating properties[1].

Geographical Regions

The market is analyzed across various geographical regions such as North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. Each region has its own set of market dynamics and growth drivers[1].

Financial Incentives and Economic Impact

Economic Development and Incentives

Financial incentives and economic development policies can play a crucial role in the growth of the disodium edetate market. For instance, tax abatements and deductions for industrial and manufacturing equipment can encourage companies to invest in the production of high-purity disodium edetate[2].

Investment in R&D

Investments in R&D are critical for the development of new and improved excipients. Companies that invest in research and development are more likely to produce high-quality disodium edetate, which can command a premium price in the market[3].

Challenges and Barriers

Regulatory Stringency

The pharmaceutical excipients market, including disodium edetate, faces challenges due to growing regulatory stringency. Stricter regulations can increase the cost and complexity of producing and approving new excipients[3].

Availability of Alternatives

The availability of biodegradable alternatives like sodium gluconates and organophosphates can also hinder the market growth of disodium edetate. These alternatives may offer similar chelating properties with potentially fewer environmental and health risks[5].

Industry Trends and Outlook

Patient-Centric Formulations

The pharmaceutical industry is shifting towards patient-centric formulations, which require excipients that can enhance the stability, safety, and bioavailability of drugs. Disodium edetate, with its chelating properties, is well-positioned to meet these demands[3].

Generic Drugs and Pharmaceutical Products

The increasing demand for generic drugs is another trend that benefits the disodium edetate market. Generic drug manufacturers often look for cost-effective excipients, and disodium edetate can be a significant cost-saving measure while maintaining product quality[3].

Conclusion

The disodium edetate market is poised for significant growth driven by its extensive use in the pharmaceutical sector, growing demand for pharmaceuticals, and increasing R&D investments. However, the market must navigate challenges such as regulatory stringency and the availability of alternative chelating agents.

Key Takeaways

  • The disodium edetate market is valued at USD 5.1 billion in 2023 and is expected to reach USD 7.42 billion by 2031.
  • The market is driven by its chelating properties, which are crucial for pharmaceutical formulations.
  • Growing demand for pharmaceuticals, especially in developing countries, and increasing R&D expenditures are key drivers.
  • Regulatory clearances and consumer awareness of health and safety norms also contribute to market growth.
  • The market faces challenges from regulatory stringency and the availability of alternative chelating agents.

FAQs

What is the primary use of disodium edetate in the pharmaceutical industry?

Disodium edetate is primarily used for its chelating properties to bind metal ions, enhancing the stability and safety of pharmaceutical formulations.

What are the key drivers of the disodium edetate market?

The key drivers include growing demand for pharmaceuticals, especially in developing countries, increasing R&D expenditures, regulatory clearances, and consumer awareness of health and safety norms.

What are the challenges faced by the disodium edetate market?

The market faces challenges from growing regulatory stringency and the availability of biodegradable alternative chelating agents.

How is the disodium edetate market segmented?

The market is segmented by type (EDTA acid, EDTA disodium, EDTA tetrasodium), application (pharmaceuticals, food and beverages, cosmetics, cleaning agents), and geographical regions.

What is the projected CAGR of the disodium edetate market from 2024 to 2031?

The disodium edetate market is expected to grow at a CAGR of 4.8% from 2024 to 2031.

Sources

  1. Marketresearchintellect, Global Disodium Edetate Market, November 2024.
  2. Burns Harbor, IN, Financial Incentive Policy & Program, July 2019.
  3. Marketsandmarkets, Pharmaceutical Excipients Market Growth, Drivers, and Opportunities.
  4. ACS Publications, Optimizing Excipient Properties to Prevent Aggregation in Pharmaceutical Formulations, December 2023.
  5. Allied Market Research, Ethylenediaminetetraacetic Acid Market Analysis 2021-2030.

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