Last updated: January 7, 2026
Executive Summary
Succinic acid, an emerging pharmaceutical excipient, is witnessing increasing demand driven by its multifaceted roles in both pharmaceutical and industrial applications. This comprehensive analysis explores the current market landscape, growth drivers, challenges, and future prospects for succinic acid as a pharmaceutical excipient. It highlights the key factors influencing supply and demand dynamics, anticipates financial trajectories, and compares succinic acid with benchmark excipients, guiding stakeholders in strategic decision-making.
What Is Succinctly Succinct Acetic Acid’s Role in Pharmaceuticals?
Succinic acid (C₄H₆O₄) is a naturally occurring dicarboxylic acid with versatile applications in the pharmaceutical industry. As an excipient, it functions primarily as a pH adjuster, an stabilizer, and a precursor in the synthesis of active pharmaceutical ingredients (APIs). Its biocompatibility, biodegradability, and low toxicity underpin its rising acceptance in drug formulations, especially in sustained-release tablets, injectables, and topical agents.
Key Characteristics:
| Parameter |
Specification |
| Molecular Weight |
118.09 g/mol |
| Appearance |
White, crystalline powder or granules |
| Purity Levels |
Typically ≥99% in pharmaceutical-grade succinic acid |
| Regulatory Status |
Recognized as safe (GRAS), with FDA status for some applications |
| Source |
Both synthetic (petrochemical-based) and bio-based (fermentation) |
What Are the Current Market Dynamics for Succinic Acid as a Pharmaceutical Excipient?
Market Size & Growth Trends
| Parameter |
2022 Estimate |
Predicted 2028 |
CAGR (2023–2028) |
| Global succinic acid market |
$150 million |
$290 million |
11.7% |
| Pharma-grade succinic acid share |
~35% of total market |
Growing at similar CAGR |
|
Note: Data sourced from MarketsandMarkets [1], Grand View Research [2], and industry reports.
Drivers of Market Expansion
- Rising demand for biodegradable excipients: Increasing focus on green chemistry and strict regulatory frameworks promote bio-based succinic acid production.
- Growth in pharmaceutical formulations: The expanding pipeline of advanced therapies (biologics, controlled-release drugs) uses succinic acid for formulation stability.
- Regulatory support: Agencies like the FDA recognize succinic acid as safe (GRAS); EU directives support biodegradable excipients.
- Technological advancements: Fermentation processes using renewable feedstocks lower cost and improve sustainability.
Supply Chain & Key Players
| Major Producers |
Production Method |
Geographic Presence |
| BioAmber (acquired by TC BioPharm) |
Bio-based fermentation (renewable sugars) |
North America, Europe |
| Anhui Jinhe Industrial Co. |
Petrochemical synthesis |
China |
| Reverdia (now part of Royal DSM) |
Bio-based via yeast fermentation |
Europe, Asia |
Note: The shift towards bio-based production is impacting supply stability and pricing structures.
What Challenges Are Affecting the Market?
Price Volatility
- Feedstock Costs: Fluctuations in biomass or petrochemical feedstocks directly affect production costs.
- Competition from Synthetic Alternatives: Petrochemical-derived succinic acid remains cheaper in some regions, pressuring bio-based suppliers.
Regulatory & Quality Standards
- Quality Consistency: Pharmaceutical applications demand high purity (>99%), imposing stringent manufacturing controls.
- Regulatory Approvals: Diverse regulatory pathways complicate the global acceptance process.
Technological Barriers
- Scale-up Challenges: Bio-fermentation processes require optimization for commercial-scale production.
- Downstream Processing: Purification and stabilization techniques can increase costs and complexity.
How Does Succinic Acid Compare With Other Pharmaceutical Excipients?
| Criteria |
Succinic Acid |
Common Excipient Alternatives |
| Biodegradability |
Yes |
Yes (e.g., citric acid, tartaric acid) |
| Toxicity |
Low (GRAS status) |
Low |
| Functional Roles |
pH buffer, stabilizer, precursor |
Buffering agents, fillers, plasticizers |
| Cost Effectiveness |
Moderate |
Usually lower for synthetic counterparts |
| Regulatory Approval |
Growing, with cases approved |
Well-established for traditional excipients |
Potential Advantages of Succinic Acid:
- Environmentally friendly profile
- Multifaceted functionality
- Compatibility with sensitive APIs
Limitations:
- Higher production costs compared to traditional acids
- Market penetration still in nascent stage
What Is the Future Financial Trajectory for the Succinate Market?
Forecast Summary
| Year |
Estimated Market Size |
Predicted CAGR |
Key Growth Segments |
| 2023 |
$180 million |
— |
Bio-based succinic acid, sustained-release formulations |
| 2028 |
$290 million |
11.7% |
Bio-based production, high-purity applications |
Drivers of Future Growth
- Pharmaceutical Innovation: Development of novel drug delivery systems enhances succinic acid usage.
- Bio-economy Policies: Governments incentivize bio-based chemicals, supporting market growth.
- Cost Reduction Technologies: Advances in fermentation and downstream processing lower prices.
Market Segment Analysis
| Segment |
2023 Share |
2028 Projection |
Growth Rate |
Notes |
| Bio-based succinic acid |
70% |
85% |
13.8% |
Driven by sustainability policies |
| Synthetic succinic acid |
30% |
15% |
-9.1% |
Declining due to sustainability concerns |
What Are Strategic Implications for Industry Stakeholders?
- Manufacturers: Invest in bio-based fermentation technology to capitalize on sustainability trends.
- Pharmaceutical Companies: Evaluate succinic acid as a compatible excipient for innovative formulations.
- Investors: Consider early engagement with bio-based succinic acid companies poised for growth.
- Regulators: Develop clear guidelines to facilitate approval processes for succinic acid applications.
Key Takeaways
- The global succinic acid market for pharmaceutical excipients is projected to grow at a CAGR of approximately 11.7% through 2028, fueled by sustainability initiatives and technological advances.
- Bio-based production methods are gaining prominence, with a target to surpass petrochemical synthesis in market share.
- Regulatory acceptance is expanding, with succinic acid increasingly recognized as a safe excipient, though standardization remains essential.
- Price volatility and process scalability are primary challenges impacting wider adoption; ongoing innovation is critical.
- Succinate's multifunctionality offers competitive advantages over traditional excipients, especially in environmentally conscious formulations.
FAQs
Q1: What advantages does succinic acid offer over traditional pH buffers in pharmaceuticals?
Succinic acid provides a biodegradable, low-toxicity alternative with high compatibility, especially beneficial in formulations requiring gentle pH adjustment without adversely affecting drug stability.
Q2: How does bio-based succinic acid impact sustainability goals in pharma manufacturing?
Bio-based succinic acid, produced via fermentation of renewable feedstocks, reduces reliance on petrochemicals, lowering carbon footprint and aligning with green chemistry principles.
Q3: What are the primary regulatory hurdles for succinic acid as an excipient?
While generally recognized as safe (GRAS), extensive documentation, purity standards, and data on batch consistency are required for pharmaceutical approval across different regions.
Q4: Will succinic acid replace existing excipients in the short term?
Current adoption remains limited; it is more likely to complement or replace specific functions in specialized formulations as market understanding and acceptance grow.
Q5: Who are the leading players investing in bio-based succinic acid for pharmaceuticals?
BioAmber (now part of TC BioPharm), Reverdia, and Anhui Jinhe Industrial Co. are prominent players employing fermentation technologies toward bio-based succinic acid production.
References
[1] MarketsandMarkets. “Succinic Acid Market by Source (Bio-based, Petrochemical), End-Use (Pharmaceutical, Bioplastics, Food & Beverages), and Region — Global Forecast to 2028,” 2022.
[2] Grand View Research. “Bio-Based Succinic Acid Market Size, Share & Trends Analysis Report,” 2021.
[3] U.S. Food and Drug Administration (FDA). “GRAS Notice Inventory,” 2022.
[4] European Medicines Agency (EMA). “Guidelines on pharmaceutical excipients,” 2021.
Disclaimer: Market figures and projections are based on publicly available industry reports and may vary according to technological developments and regulatory changes.
