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Last Updated: December 28, 2024

Drugs Containing Excipient (Inactive Ingredient) 2-(N-MORPHOLINO)ETHANESULFONIC ACID


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2-(N-MORPHOLINO)ETHANESULFONIC ACID Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for 2-(N-Morpholino)ethanesulfonic Acid (MES) in the Pharmaceutical Industry

Introduction

2-(N-Morpholino)ethanesulfonic acid, commonly known as MES, is a crucial buffering agent in the fields of biology, biochemistry, and pharmaceuticals. Its unique properties make it an essential component in various pharmaceutical formulations. Here, we will delve into the market dynamics and financial trajectory of MES within the pharmaceutical industry.

Properties and Applications of MES

MES is characterized by its molecular weight of 195.2 g/mol and a pKa value of 6.15 at 20 °C, making it highly effective as a buffering agent in mid-range pH solutions. It is highly soluble in water and chemically stable, which are key criteria for Good's buffers developed in the 1960s[1].

Role in Pharmaceutical Formulations

In pharmaceuticals, MES is used to maintain the stability and bioavailability of active pharmaceutical ingredients (APIs). Its ability to buffer pH levels is critical in formulations, especially for drugs that require specific pH conditions to remain effective. MES is also preferred because it does not readily form coordination complexes with metal ions, unlike other common buffers like phosphate and acetate[1].

Market Growth Drivers

The demand for MES is closely tied to the overall growth of the pharmaceutical excipients market. Several factors drive this growth:

  • Increasing Demand for Generic Drugs: The rise in generic drug approvals due to the patent cliff has led to an increased demand for high-quality, affordable excipients. Generic drug manufacturers seek to reduce costs, and excipients like MES play a significant role in this cost-saving strategy[2][3].
  • Rise in Chronic Diseases: The increasing prevalence of chronic diseases such as diabetes, hypertension, cancer, and HIV necessitates the development of more effective and patient-friendly drug formulations. Excipients like MES are crucial in enhancing the solubility, bioavailability, and stability of APIs[3].
  • Innovation and R&D: Leading companies in the pharmaceutical excipients market, such as ADM, BASF SE, and Roquette Frères, are investing heavily in R&D to develop innovative excipients. This drive for innovation is expected to further boost the demand for MES and other excipients[3].

Market Size and Financial Projections

The global pharmaceutical excipients market, which includes MES, is projected to grow significantly in the coming years.

  • Current Market Size: The global pharmaceutical excipients market was valued at approximately $9.2 billion in 2023[3].
  • Future Projections: This market is expected to grow to $12.4 billion by 2029, with a compound annual growth rate (CAGR) of 5.1% from 2024 to 2029[3].
  • Organic Excipients Segment: The organic pharmaceutical excipients market, which includes natural and sustainable ingredients like MES, is expected to grow from $10.36 billion in 2023 to $16.07 billion in 2028, with a CAGR of 9.0%[5].

Challenges and Barriers

Despite the positive growth outlook, there are several challenges that could impact the market:

  • Regulatory Stringency: Increasing regulatory requirements can pose barriers to market growth. Compliance with these regulations can be costly and time-consuming[2].
  • High Development Costs: The development of new excipients, including those like MES, involves significant investments. These high costs can be a deterrent for some manufacturers[2].

Safety and Handling Considerations

While MES is a valuable excipient, it also comes with safety considerations. It is hazardous upon contact, and exposure to the skin or eyes should be treated promptly. Ingestion, inhalation of dust, or combustion can lead to serious health issues, including the emission of toxic fumes like carbon monoxide, nitrogen oxide, and sulfur oxides[1].

Effect of Impurities

Commercial preparations of MES can contain contaminants such as oligo(vinylsulfonic acid) (OVS), which can inhibit RNA binding proteins and enzymes. Ensuring the purity of MES is crucial for its effective use in pharmaceutical formulations[1].

Conclusion

The market for 2-(N-Morpholino)ethanesulfonic acid (MES) is closely aligned with the broader trends in the pharmaceutical excipients market. With the increasing demand for generic drugs, the rise in chronic diseases, and ongoing R&D investments, the demand for MES is expected to grow significantly. However, manufacturers must navigate regulatory challenges and ensure the purity and safety of MES to fully capitalize on this growth.

Key Takeaways

  • MES is a critical buffering agent in pharmaceutical formulations due to its stability and buffering capabilities.
  • The global pharmaceutical excipients market, including MES, is projected to grow from $9.2 billion in 2023 to $12.4 billion by 2029.
  • The organic pharmaceutical excipients segment, which includes MES, is expected to grow with a CAGR of 9.0% from 2023 to 2028.
  • Regulatory compliance and high development costs are significant challenges in the market.
  • Ensuring the purity and safety of MES is crucial for its effective use.

FAQs

Q: What is the primary use of MES in the pharmaceutical industry? A: MES is primarily used as a buffering agent to maintain the stability and bioavailability of active pharmaceutical ingredients (APIs) in various drug formulations.

Q: How does the growth in generic drugs impact the demand for MES? A: The growth in generic drugs increases the demand for high-quality, affordable excipients like MES, as generic drug manufacturers seek to reduce costs.

Q: What are the safety concerns associated with MES? A: MES is hazardous upon contact and can cause serious health issues if ingested, inhaled, or if its dust is combusted, emitting toxic fumes.

Q: Can MES contain impurities that affect its performance? A: Yes, commercial preparations of MES can contain contaminants like oligo(vinylsulfonic acid) (OVS), which can inhibit RNA binding proteins and enzymes.

Q: What is the projected growth rate of the organic pharmaceutical excipients market, which includes MES? A: The organic pharmaceutical excipients market is expected to grow with a CAGR of 9.0% from 2023 to 2028.

Sources

  1. Wikipedia - MES (buffer)
  2. MarketsandMarkets - Pharmaceutical Excipients Market Growth, Drivers, and Opportunities
  3. BCC Research - Understanding the Future of Pharmaceutical Excipients
  4. F1000Research - Effect of environmental and cultural conditions on medium pH and ...
  5. The Business Research Company - Organic Pharmaceutical Excipients Global Market Report 2024

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