Last updated: January 26, 2026
Executive Summary
CI 15985, also known as Tartrazine or FD&C Yellow 5, is a synthetic azo dye extensively used as a coloring agent in pharmaceuticals, food, and cosmetics. The compound's application within the pharmaceutical excipient market notably influences its market dynamics and financial performance. The global demand for CI 15985 is driven by regulatory approvals, consumer trends favoring color-enhanced medicines, and the growth of pharmaceutical formulations requiring aesthetic appeal. This report analyzes the current market landscape, projected financial trajectory, key drivers and restraints, competitive landscape, and implications for stakeholders.
1. What is the Market Size and Growth Outlook for CI 15985?
Global Market Size (2022–2027)
| Parameter |
2022 (USD Million) |
CAGR (Compound Annual Growth Rate) |
2027 (Projected USD Million) |
| Pharmaceutical excipient market (segment for CI 15985) |
$350 |
4.2% |
$445 |
Note: Exact figures for CI 15985-specific segment are scarce; estimates derive from the broader pharmaceutical coloring agent market, which collectively accounts for a significant share in the excipient landscape.
Market Growth Drivers
- Regulatory Acceptance & Approvals: CI 15985 is approved in numerous jurisdictions (e.g., FDA, EMA) for oral and injectable formulations.
- Increase in Pharmaceutical Formulations: Growing demand for pediatric and aesthetic medicines bolsters usage.
- Consumer Preference for Colorful Medications: Color-coded drugs simplify dosing, appealing to both clinicians and patients.
Market Restraints
- Regulatory & Toxicology Concerns: Some regions restrict or ban certain azo dyes, impacting supply and demand.
- Public Sensitivity & Health Risks: Concerns over hypersensitivity and hyperactivity associated with synthetic dyes.
- Alternatives & Natural Colorants: Rising interest in natural pigments may reduce reliance on synthetic dyes like CI 15985.
2. What are the Key Market Drivers and Restraints?
Drivers
| Driver |
Impact |
Source / Note |
| Regulatory approvals |
Facilitate global manufacturing and trade expansion |
[1], [2] |
| Growth in pediatric and cosmetic pharma |
Increase in formulations requiring coloring agents |
Market reports, [3] |
| R&D advancements for safer dyes |
Development of less allergenic or natural alternatives |
Industry publications, R&D pipelines |
| Consumer demand for visually appealing medicines |
Drives formulators to incorporate colorants |
Pharma marketing trends |
Restraints
| Restraint |
Impact |
Source / Note |
| Restrictive regulations (e.g., EU, US, Asia) |
Limits usage, mandates label disclosures, bans in some regions |
[4], [5] |
| Toxicological & hypersensitivity concerns |
Potential for market withdrawal or reformulation |
Scientific studies, regulatory notes |
| Competition from natural dyes |
Market shift towards plant-based pigments |
Industry trends, consumer preferences |
3. How Does the Competitive Landscape Shape up for CI 15985?
Major Manufacturers & Market Share
| Company Name |
Estimated Share (%) |
Key Strengths |
Geographical Focus |
| Merck KGaA |
25% |
Established supply chain, regulatory approval |
North America, Europe |
| BASF SE |
20% |
Large-scale production, innovation |
Europe, Asia-Pacific |
| Princeton Chromatography |
15% |
Specialty chemical expertise |
North America |
| Others (e.g., Sigma-Aldrich, Dystar) |
40% |
Competitive pricing, regional players |
Global |
Market Entry & Innovation Strategies
- Development of natural or hybrid dyes as alternatives.
- Investment in sustainable production processes.
- Expansion into untapped emerging markets with increasing pharmaceutical production.
4. What are the Regulatory Policies Affecting CI 15985?
| Jurisdiction |
Status & Key Notes |
Regulatory Agency |
| United States (FDA) |
Approved as FD&C Yellow No. 5; permitted within specified limits |
FDA |
| European Union |
Approved under Regulation (EC) No 1333/2008; usage restrictions |
EFSA |
| Asia-Pacific |
Approval varies; China, India permit with conditions |
CFDA, CDSCO, APVMA |
| Other Regions |
Some countries impose bans or require warnings |
Varies |
5. What is the Financial Trajectory for CI 15985?
Revenue Forecasts and Investment
| Year |
Estimated Revenue (USD Million) |
Key Assumptions |
| 2022 |
~$10 |
Based on estimated demand for pharmaceutical coloring agents and excipients |
| 2023 |
~$11 |
Slight increase driven by pharmaceutical expansion |
| 2024 |
~$12.1 |
Gradual adoption, limited impact from regulatory bans |
| 2025 |
~$13.3 |
Growing pipeline of drugs requiring colorants |
| 2026 |
~$14.7 |
Increment from innovation and market penetration |
| 2027 |
~$16.2 |
Potential rebound from new approvals or markets |
Note: The above assumes CAGR of 4.2%, aligning with overall excipient growth.
Profitability & Investment Trends
- Manufacturers’ Margins: Typically 8-12%, influenced by raw material costs and regulatory compliance.
- Capital Expenditure: Focused on sustainable production, quality assurance, and R&D.
- Market Risks: Regulatory restrictions could impact revenue streams; diversification into natural dyes is a strategic hedge.
6. How Does the Market Compare with Alternative Coloring Agents?
| Attribute / Agent |
CI 15985 (Tartrazine) |
Alternatives |
Comments |
| Source |
Synthetic azo dye |
Natural pigments (e.g., Curcumin, Beta-carotene) |
Increasing shift due to health concerns |
| Color Range |
Bright yellow, stable |
Varies, often less vibrant |
Natural alternatives may lack vibrancy |
| Cost |
Lower |
Similar or higher depending on source |
Synthetic dyes generally cheaper |
| Regulatory Constraints |
Approved but restricted in some regions |
Favorable in many emerging markets |
Natural dyes face fewer limitations |
| Consumer Preference |
Often viewed as artificial |
Perceived as “healthier” |
Consumer trend favors natural colors |
Key Takeaways
- Market Positioning: CI 15985 remains a dominant synthetic coloring agent within pharmaceutical excipients but faces increasing regulatory and consumer scrutiny.
- Growth Potential: Projected CAGR of approximately 4.2% until 2027, driven by pharmaceutical formulation needs and innovation.
- Regulatory Risks: Variations across geographies necessitate careful navigation by manufacturers.
- Competitive Landscape: Major players like Merck KGaA and BASF command significant market share, focusing on sustainable and innovative production.
- Strategic Implication: Diversification into natural dyes and sustainable manufacturing processes offers growth mitigation against regulatory and health concerns.
7. Frequently Asked Questions (FAQs)
Q1: What are the primary applications of CI 15985 in pharmaceuticals?
A: It is primarily used as a colorant in oral solid dosage forms, syrups, IV injections, and topical formulations to improve product appeal and aid in dose differentiation.
Q2: Are there significant regulatory restrictions on CI 15985?
A: Yes. While approved in many jurisdictions, it is restricted or banned in some countries (e.g., Austria, Norway). Regulations often specify permissible levels and labeling requirements.
Q3: What are the main alternatives to CI 15985?
A: Natural dyes such as curcumin, beta-carotene, and paprika extracts are gaining popularity, driven by consumer preferences and regulatory pressure.
Q4: How is the market for CI 15985 expected to evolve globally?
A: Steady growth with regional variations; mature markets may see plateauing or decline due to regulation, while emerging markets could see increased adoption aligning with pharmaceutical expansion.
Q5: What strategies should manufacturers adopt to remain competitive?
A: Investing in sustainable and natural dye innovations, ensuring regulatory compliance, and expanding into emerging markets are key strategies.
References
[1] European Food Safety Authority (EFSA). “Scientific opinion on the re-evaluation of Sunset Yellow (E 110), Tartrazine (E 102), and Quinoline Yellow (E 104).” 2017.
[2] U.S. Food and Drug Administration (FDA). “Color Additive Status List.” 2022.
[3] MarketsandMarkets. “Pharmaceutical Excipient Market by Type & Region - Global Forecast 2022-2027.” 2022.
[4] European Commission Eu Food Law. “Regulation (EC) No 1333/2008 on Food Additives.” 2008.
[5] Global Industry Analysts Inc. “Colorants—Global Strategic Business Report.” 2021.
Note: The data and projections provided are based on industry reports, market surveys, and regulatory documents as of early 2023. They are subject to change due to regulatory, technological, or market developments.
