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Last Updated: April 19, 2025

Drugs Containing Excipient (Inactive Ingredient) FD&C RED NO. 40


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Branded drugs containing FD&C RED NO. 40 excipient, and estimated key patent expiration / generic entry dates

Market Dynamics and Financial Trajectory for FD&C Red No. 40 (Allura Red AC)

Introduction

FD&C Red No. 40, commonly known as Allura Red AC, is a synthetic food dye widely used in the food and beverage industry. While it is primarily recognized as a food colorant, its applications and market dynamics are intertwined with various sectors, including pharmaceuticals, although its primary use is not as a pharmaceutical excipient.

Market Size and Growth

The global market for Allura Red AC is significant, particularly within the food colorants sector. As of 2022, the Allura Red AC market was valued at approximately USD 140 million and is projected to grow to USD 245 million by 2032, with a Compound Annual Growth Rate (CAGR) of 6.01% during this period[1].

Regional Market Share

North America, particularly the USA, dominates the market for Allura Red AC. In 2021, the USA accounted for about 26% of the global Allura Red AC market, with sales totaling USD 40 million. Other significant markets include Europe and Latin America, with countries like Mexico and Brazil also showing substantial demand[1].

Usage in Food Industry

Allura Red AC is extensively used in various food products such as bakeries, snacks, cereals, beverages, soups, sauces, and dressings. Its widespread use in these sectors drives the demand for this color additive. However, the increasing consumer preference for natural food ingredients is expected to restrain the growth of synthetic colorants like Allura Red AC[1].

Pharmaceutical Context

Although Allura Red AC is not primarily used as a pharmaceutical excipient, its certification and usage data can provide insights into the broader regulatory and market environment for color additives.

  • Regulatory Framework: The FDA strictly regulates the use of color additives, including Allura Red AC. The certification process for these additives is rigorous, and the FDA publishes quarterly reports on the certification of color additives, which includes data on the pounds of each color additive certified during the period[2][4].

  • Volume and Trends: While the primary data on Allura Red AC pertains to its use in food, the FDA reports indicate significant volumes of this color additive being certified. For instance, in the third quarter of the fiscal year 2024, over 1.4 million pounds of FD&C Red No. 40 were certified[2].

Financial Trajectory

The financial trajectory of Allura Red AC is closely tied to its demand in the food industry.

  • Revenue Projections: The market for Allura Red AC is expected to grow steadily, driven by its continued use in food products. However, the shift towards natural food colors may impact its long-term growth prospects[1].

  • Regional Contributions: The USA and other North American markets are expected to continue driving the revenue for Allura Red AC, given the strong commercial footprint of key food color manufacturers in these regions[1].

Challenges and Opportunities

Several factors influence the market dynamics and financial trajectory of Allura Red AC:

  • Consumer Preferences: The increasing demand for natural food ingredients poses a significant challenge to the sales of synthetic colorants like Allura Red AC. This trend may lead to a slower growth rate or even a decline in certain segments[1].

  • Regulatory Compliance: The stringent regulatory environment surrounding color additives requires significant investment in research and testing, which can be a barrier to entry for new market players and a continuous challenge for existing ones[2][4].

  • Market Expansion: Despite the challenges, the expansion of food processing industries in regions like Latin America presents opportunities for growth. Countries such as Brazil and Mexico are expected to contribute to the increasing demand for food colorants, including Allura Red AC[1].

Key Takeaways

  • Market Size and Growth: The Allura Red AC market is valued at USD 140 million in 2022 and is projected to reach USD 245 million by 2032, with a CAGR of 6.01%.
  • Regional Dominance: North America, particularly the USA, dominates the market for Allura Red AC.
  • Usage Trends: The dye is widely used in the food industry, but faces challenges from the increasing demand for natural food ingredients.
  • Regulatory Environment: Strict FDA regulations govern the use of Allura Red AC, with significant volumes certified each quarter.
  • Financial Trajectory: The market is expected to grow steadily, though at a slower pace due to consumer preferences shifting towards natural products.

FAQs

  1. What is the primary use of FD&C Red No. 40 (Allura Red AC)?

    • The primary use of FD&C Red No. 40, or Allura Red AC, is as a synthetic food dye in the food and beverage industry.
  2. What is the projected market size of Allura Red AC by 2032?

    • The market for Allura Red AC is projected to reach USD 245 million by 2032[1].
  3. Which region dominates the market for Allura Red AC?

    • North America, particularly the USA, dominates the market for Allura Red AC, accounting for approximately 26% of the global market in 2021[1].
  4. How does the trend towards natural food ingredients affect the market for Allura Red AC?

    • The increasing demand for natural food ingredients is expected to restrain the growth of synthetic colorants like Allura Red AC, potentially leading to slower growth or decline in certain segments[1].
  5. What are the key regulatory challenges for Allura Red AC?

    • The key regulatory challenges include strict FDA regulations and the requirement for significant investment in research and testing to ensure compliance[2][4].

Sources

  1. Future Market Insights - Allura Red AC Market Size, Industry Share & Trends - 2032
  2. FDA - Report on the Certification of Color Additives: 3rd Quarter Fiscal Year 2024
  3. BCC Research - Understanding the Future of Pharmaceutical Excipients
  4. FDA - Report on the Certification of Color Additives: 2nd Quarter Fiscal Year 2023
  5. PubChem - Allura Red AC | C18H14N2Na2O8S2 | CID 33258

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