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Last Updated: December 11, 2025

Drugs Containing Excipient (Inactive Ingredient) MICROCRYSTALLINE CELLULOSE 112


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Branded drugs containing MICROCRYSTALLINE CELLULOSE 112 excipient, and estimated key patent expiration / generic entry dates

Company Tradename Ingredient NDC Excipient Potential Generic Entry
Mylan Pharmaceuticals Inc CYSTAGON cysteamine bitartrate 0378-9040 MICROCRYSTALLINE CELLULOSE 112
Jazz Pharmaceuticals Inc MODEYSO dordaviprone 68727-250 MICROCRYSTALLINE CELLULOSE 112 2030-08-06
>Company >Tradename >Ingredient >NDC >Excipient >Potential Generic Entry

Generic drugs containing MICROCRYSTALLINE CELLULOSE 112 excipient

Market Dynamics and Financial Trajectory for Microcrystalline Cellulose 112

Last updated: August 3, 2025

Introduction

Microcrystalline Cellulose (MCC) 112 stands as a pivotal excipient in the pharmaceutical and food industries, valued for its multifunctionality, biocompatibility, and stability. As a semi-synthetic, refined cellulose derivative, MCC 112’s role spans tablet formation, capsule filling, and as a stabilizer in various formulations. Understanding its market dynamics and financial trajectory is crucial for stakeholders seeking to capitalize on emerging opportunities or mitigate risks in an evolving landscape.

Market Overview

Global Market Size and Growth

The global market for MCC, valued at approximately USD 1.2 billion in 2022, is projected to grow at a Compound Annual Growth Rate (CAGR) of 5% over the next five years, reaching around USD 1.6 billion by 2027 [1]. MCC 112 accounts for roughly 35-40% of the total MCC market, due to its widespread application in pharmaceuticals.

Key Segments and End-Use Applications

The primary end-use sectors include:

  • Pharmaceuticals: Used extensively as a binder and disintegrant in tablets and capsules. Its regulatory acceptance and established efficacy support sustained demand.
  • Food Industry: Functions as a texturizer and dietary fiber supplement.
  • Personal Care: Incorporated as an anti-caking agent and thickener.

Pharmaceuticals dominate the MCC 112 demand, accounting for over 50% of its consumption, driven by rising drug delivery applications and adherence to stringent safety standards.

Market Drivers

Regulatory Acceptance and Safety Profile

Regulatory approvals, particularly FDA and EMA certifications, bolster MCC 112’s demand as a non-toxic, biocompatible excipient. The material’s GRAS (Generally Recognized As Safe) status encourages its extensive use.

Growing Pharmaceutical R&D and Innovation

The surge in novel drug formulations, including controlled-release tablets and biologics, requires excipients like MCC 112 with excellent binding properties and consistent quality. The trend toward fixed-dose combinations further amplifies MCC usage.

Rising Healthcare Expenditure and Aging Population

An aging global population, particularly in North America and Europe, increases chronic disease prevalence, stimulating pharmaceutical manufacturing and, by extension, MCC consumption.

Stringent Quality Standards and Supply Chain Reliability

Supply chain stability and consistent quality standards, propelled by ISO certifications and Good Manufacturing Practices (GMP), are vital. Suppliers investing in quality assurance infrastructure gain a competitive edge.

Market Restraints

Raw Material Price Volatility

Fluctuations in cellulose raw materials, driven by environmental policies and seasonal variations, can impact manufacturing costs.

Environmental Concerns and Sustainable Sourcing

Growing emphasis on sustainable and eco-friendly sourcing of cellulose may restrain certain suppliers or alter supply chains, impacting prices and availability.

Pricing Pressures

Intense competition, especially among regional manufacturers, exerts downward pressure on prices, affecting profit margins for producers of MCC 112.

Competitive Landscape

Key Players

Major MCC manufacturers include:

  • FMC Corporation
  • Asahi Kasei Corporation
  • DFE Pharma (formerly Shin-Etsu)
  • Sigachi Industries
  • JRS Pharma

These companies leverage scale, advanced manufacturing technologies, and R&D to innovate and maintain market share.

Strategic Trends

  • Vertical Integration: Companies are integrating upstream raw material sourcing to enhance supply control.
  • Product Innovation: Development of high-purity MCC variants and functionalized MCC to meet specialized industry needs.
  • Geographic Expansion: Focused expansion into emerging markets such as India, China, and Latin America.

Financial Trajectory and Investment Outlook

Revenue Growth Potential

Based on current market trends, MCC 112’s revenue is expected to grow robustly, with an estimated CAGR of 4.5-5% over the next five years. Innovations in pharma formulations will likely sustain demand, especially with increasing R&D investments globally.

Profitability Factors

Margins are influenced by raw material costs, manufacturing efficiencies, and competitive dynamics. Companies adopting economies of scale and sustainable sourcing practices are positioned to improve profitability.

Investment Prospects

Investors are increasingly keen on excipient suppliers due to their steadiness relative to active pharmaceutical ingredients (APIs). Emerging markets’ expansion offers additional growth avenues, especially as regulatory barriers lower and local manufacturing increases.

Risks and Considerations

  • Regulatory changes could influence approvals for MCC substitutes or alter quality standards.
  • Supply disruptions from raw material scarcity or environmental restrictions.
  • Price competition leading to squeezed margins.

Emerging Trends and Opportunities

Sustainability Initiatives

Sustainable sourcing and biodegradable manufacturing processes are gaining importance. Companies investing in eco-friendly practices may command premium pricing and stronger stakeholder trust.

Functionalized MCC Variants

Advancements in MCC modifications, such as cross-linked or hydrophilic variants, open niche markets, providing opportunities for premium pricing.

Regulatory Standardization and Certification

Stricter global standards necessitate investments in quality control, fostering innovation in manufacturing and sourcing.

Conclusion

The market dynamics for MCC 112 are characterized by steady growth driven by expanding pharmaceutical applications, regulatory acceptance, and ongoing innovation. While faced with raw material volatility and environmental concerns, strategic investments in quality, sustainability, and technological innovation position MCC 112 as a resilient segment within the excipient landscape. The financial trajectory suggests continued profitability and investment appeal—particularly for firms that adapt swiftly to market shifts and leverage emerging trends.


Key Takeaways

  • The MCC market, especially MCC 112, is poised for compounded growth driven by pharmaceutical demand, with projections estimating USD 1.6 billion valuation by 2027.
  • Regulatory acceptance and rising R&D activities underpin market stability, but raw material costs and sustainability concerns pose challenges.
  • Competitive differentiation through innovation, quality, and sustainable sourcing is critical for market leaders.
  • Investment opportunities are robust, particularly in emerging markets and in developing functionalized MCC variants.
  • Companies that embrace environmental sustainability and technological innovation will enhance profitability and market positioning.

FAQs

1. What are the primary factors driving demand for MCC 112 in the pharmaceutical industry?
Demand primarily stems from MCC 112’s efficacy as a binder, disintegrant, and filler in tablet and capsule formulations, alongside regulatory approvals and a rising trend in complex drug delivery systems.

2. How does raw material price volatility affect the MCC market?
Fluctuations in cellulose raw material prices impact manufacturing costs, influencing profit margins and potentially leading to price fluctuations in MCC products.

3. What are sustainable sourcing strategies for MCC manufacturers?
Procuring cellulose from sustainably managed forests, utilizing eco-friendly processing techniques, and obtaining environmental certifications (e.g., FSC, PEFC) are key strategies.

4. Which regions are experiencing the highest growth for MCC 112 demand?
Emerging markets in Asia-Pacific, notably India and China, are experiencing high growth due to expanding pharmaceutical manufacturing and increasing healthcare investments.

5. How are technological innovations shaping MCC 112’s market?
Developments such as high-purity MCC, functionalized variants, and eco-friendly manufacturing processes expand application scope and enable premium pricing.


References

  1. MarketsandMarkets. "Microcrystalline Cellulose Market by Type, Application, End-Use Industry, Region – Global Forecast to 2027."
    [Note: Please verify with current market reports for precise figures and updates.]

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