Pharmaceutical Excipients Market: Growth, Size, Share, and Trends

Market Growth Outlook Summary

The global pharmaceutical excipients market growth forecasted to transform from USD 10.0 billion in 2023 to USD 13.9 billion by 2028, driven by a CAGR of 6.8%. Growth of this market is mainly due to various factors such as growing emphasis on patient-centric formulations, increasing demand for generic drugs and pharmaceutical products, increased R&D Investments for the development of novel excipients and collaborations and partnerships with pharmaceutical companies for customized excipient solutions. However, the growing high investments and development costs along with the growing regulatory stringency are predicted to cause market growth barriers.

Pharmaceutical Excipients Market Size, Dynamics & Ecosystem

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Pharmaceutical Excipients Market Dynamics

Driver: Increasing demand for generic drugs and pharmaceutical products is propelling the demand for pharma excipients

The pharmaceutical excipients market is expected to benefit from the growing demand for generic drugs. Generic drugs are cheaper than branded drugs, and their entry into the market is expected to boost the volume of drugs sold. There is an increase in the number of generic drug approvals as due to patent cliff. Leading pharmaceutical companies with significant operations in the United States, such as Zydus Lifesciences, Torrent Pharma, Aurobindo Pharma, and Ajanta Pharma, are poised to reap substantial benefits from this development. Generic drug manufacturers are constantly looking for ways to reduce costs, and excipients can be a significant cost-saving measure. As a result, there is a growing demand for high-quality, affordable excipients which propels the pharmaceutical excipient market. This is considered a positive indicator of the growth of the pharmaceutical excipients market.

Restraint: High Development Costs associated with Novel excipients

The approval process for new excipients can be long, expensive and complex. It requires high capital investments and can further delay the time to market for new excipients, which can make it more difficult for pharmaceutical companies to justify the investment in developing new products. New excipients must be approved by regulatory agencies such as the FDA before they can be used in drug products. Additionally these excipients must be manufactured in large quantities to meet the needs of the pharmaceutical industry. This process can be lengthy and costly and thus is predicted to restrain the market.

Opportunity: Increasing growth of functional/Multifunctional Pharmaceutical Excipients

Co-processed multifunctional excipients are a class of pharmaceutical excipients that are created by combining two or more excipients together using a physical process, such as mixing, blending, or granulation. This process alters the physical properties of the individual excipients, resulting in a new excipient with enhanced functionality. These excipients offer several advantages over existing single function excipients such as reduced number of excipients in a formulation thus simplifying the manufacturing process, improved performance of the formulation due to superior flowability, compressibility, binding, and disintegrating properties compared to individual excipients and reduced variability in formulation properties by ensuring consistent batch-to-batch performance of pharmaceutical formulations therefore providing lucrative future market growth opportunities.

Challenge: Stringent Regulatory Requirements.

Stringent regulatory requirements are a significant challenge for the pharmaceutical excipients market. Regulatory bodies, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have implemented strict guidelines for the manufacturing, testing, and use of excipients. These regulations are designed to ensure the safety and efficacy of pharmaceutical products. However, stringent regulatory requirements can also increase the complexity of developing and bringing new excipients to market. This can make it challenging for excipient manufacturers to innovate and keep up with the evolving demands of the pharmaceutical industry. For example, the U.S. FDA's rigorous New Drug Application (NDA) process and the European Medicines Agency's (EMA) regulatory requirements can significantly delay the introduction of innovative excipients.

Pharmaceutical Excipients Market Segmentation & Geographical Spread

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The Oral Formulations segment commanded share of the pharmaceutical excipients industry.

On the basis of formulation, the global pharmaceutical excipients market is segmented into oral formulations (Tablets, Capsules, Liquid formulations and others), topical formulations, parenteral formulations and other formulations. The oral formulations segment dominated the pharmaceutical excipients market during the forecast period. Their wide usage and efficacy against many ailments. are some of the factors driving the market growth.

Lubricants and Glidants is likely to grow at significant CAGR in the pharmaceutical excipients industry during the forecast period

On the basis of functionality, the global pharmaceutical excipients market is segmented into fillers & diluents, suspending & viscosity agents, coating agents, binders, flavoring agents & sweeteners, disintegrants, colorants, lubricants & glidants, preservatives, emulsifying agents, and other functionalities. The fillers & diluents segment dominated the market share in 2022 and the lubricants and glidants segment is further expected to project the market growth at faster pace both due to their use in oral solid dosage forms which are the most popular dosage forms.

Asia Pacific predicted to exhibit highest CAGR in the pharmaceutical excipients industry during the forecast period of 2023-2028.

There are six main regional segmentations for the pharmaceutical excipients market—North America, Europe, the Asia Pacific, Latin America, Middle East and Africa. In 2022, Europe dominated the market share due to the presence of numerous large production capacity pharmaceutical giants which drive the high excipient consumption rates. The growing emphasis on superior generics, pharmaceutical products, and biosimilars has also increased the demand for novel excipients, which is predicted to drive market growth.

Key players in the Market include Ashland Inc. (US), Roquette Frères (France), Evonik Industries AG (Germany), International Flavors & Fragrances, Inc. (US), BASF SE (Germany), Kerry Group Plc (Ireland), Associated British Foods Plc (UK), Merck KGaA (Germany), Wacker Chemie AG (Germany) and ADM (US).

Pharmaceutical Excipients Market Report Scope

This report categorizes the pharmaceutical excipients market to forecast revenue and analyze trends in each of the following submarkets:

By Product

• Organic Chemicals
• Oleochemicals
  • Fatty Alcohols
  • Mineral Stearates
  • Glycerin
  • Other Oleochemicals
• Carbohydrates
  • Sugars
    • Actual Sugars
    • Sugar Alcohols
    • Artificial Sweeteners
  • Cellulose
    • Microcrystalline cellulose
    • Cellulose ethers
    • Carboxymethyl cellulose (CMC) and croscarmellose sodium
    • Cellulose esters
  • Starch
    • Modified Starch
    • Dried Starch
    • Converted Starch
• Petrochemicals
  • Glycols
  • Povidones
  • Mineral Hydrocarbons
  • Acrylic Polymers
  • Other Petrochemical Excipients
• Proteins
• Other Organic Chemicals
• Inorganic Chemicals
• Calcium Phosphate
• Metal Oxides
• Halites
• Calcium Carbonate
• Calcium Sulphate
• Other Inorganic Chemicals
• Other Chemicals

By Functionality

• Fillers & Diluents
• Suspending & Viscosity Agents
• Coating Agents
• Binders
• Flavoring Agents & Sweeteners
• Disintegrants
• Colorants
• Lubricants & Glidants
• Preservatives
• Emulsifying Agents
• Other Functionalities

By Formulation

• Oral Formulations
• Tablets
• Capsules
  • Hard-gelatin Capsules
  • Soft-gelatin Capsules
• Liquid Formulations
• Other Oral Formulations
• Topical Formulations
• Parenteral Formulations
• Other Formulations

By Functionality Application

• Taste Masking
• Stabilizers
• Modified-Release
• Solubility & Bioavailability Enhancement
• Others

By Region

• North America
  • US
  • Canada
• Europe
  • Germany
  • France
  • UK
  • Italy
  • Spain
  • Rest of Europe
• Asia Pacific
  • Japan
  • China
  • India
  • South Korea
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Rest of Latin America
• Middle East
• Africa

Recent Developments of Pharmaceutical Excipients Market

• In June 2023, Ashland introduced Polyplasdone Plus, a co-processed multifunctional direct compression superdisintegrant comprising a glidant and lubricant.
• In October 2023, Lubrizol Life Science Health was awarded the Finished Formulation Award for Apisolex Polymer solubilizing excipient at CPhI Barcelona.
• In July 2022, DFE Pharma announced the broadening of its Dry Powder Inhalation (DPI) portfolio by launching Lactohale 400.

Frequently Asked Questions (FAQ):

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