Pharmaceutical Excipient Market by Type, Formulation, Function

Description

List of Tables

[194 Pages Report] The Pharmaceutical Excipient Market size was estimated at USD 8.62 billion in 2023 and expected to reach USD 9.22 billion in 2024, at a CAGR 7.62% to reach USD 14.42 billion by 2030.

Pharmaceutical excipients are added to pharmaceutical products for various purposes, including improving the manufacturing process, enhancing stability, ensuring the bioavailability of the drug, and facilitating the administration and dosing of the final product. Excipients are essentially inactive components that support the overall formulation and delivery of the active ingredient. The market for pharmaceutical excipients is primarily driven by the increasing demand for pharmaceutical products due to the rising global population and chronic diseases. Technological advancements in drug formulation and developing novel excipients also contribute to market growth. Furthermore, the expansion of the generic pharmaceuticals sector and the trend toward self-medication for minor health issues provide a strong impetus for the excipient market. However, stringent regulatory requirements leading to lengthy approval processes can impede the introduction of new excipients, and the high cost associated with developing and producing advanced excipients hamper its market growth. The shift toward multifunctional and co-processed excipients and ongoing advancements and research activities for developing biobased excipients opens significant opportunities for market players, offering benefits such as improved product performance and production efficiency.

KEY MARKET STATISTICS
Base Year [2023]	USD 8.62 billion
Estimated Year [2024]	USD 9.22 billion
Forecast Year [2030]	USD 14.42 billion
CAGR (%)	7.62%

Type: Potential demand and utilization of organic excipients

Inorganic excipients are substances not of organic origin and are included in pharmaceutical formulations to serve various functions. These excipients include calcium carbonate, widely used as a filler or diluent, and a source of calcium in pharmaceutical tablets. It is favored for its high purity, non-toxic nature, and cost-effectiveness. Calcium phosphate excipients, including dicalcium phosphate and tricalcium phosphate, are utilized for their excellent compressibility and flow properties, making them ideal for tableting operations. Calcium sulfate is used in pharmaceuticals as a tablet excipient and a co-processed excipient to improve the mechanical strength of tablets. Halites, especially sodium chloride, create isotonic solutions and are used as stabilizers and taste-masking agents in oral medications. In pharmaceutical formulations, metal oxides such as magnesium and zinc oxide function as pH adjusters, colorants, and nutrient supplements. Organic excipients refer to substances of organic (carbon-based) origin that are included in pharmaceutical formulations. Carbohydrates are fillers, binders, and stabilizers in oral solid dose formulations. Cellulose derivatives, including microcrystalline cellulose, are prolific in the excipient market, valued for their binding, disintegrating, and film-forming properties. Starch and its derivatives are used as disintegrants, binders, and fillers in tablets, providing good mechanical properties to pharmaceutical forms. Sugars such as sucrose are often used in syrups and lozenges as sweeteners and crystalline bases for water-soluble drugs.

Fatty alcohols are non-ionic surfactants and emollients in topical formulations, aiding in skin penetration of APIs. Glycerin is used as a solvent, humectant, and preservative in various pharmaceutical preparations, including oral, topical, and parenteral formulations. Mineral stearates such as magnesium are predominantly used as lubricants in tablet manufacture, ensuring the efficient running of tablet presses. In tablet formulations, petrochemicals such as acrylic polymers, including polymethyl methacrylate, serve as film coatings, binders, and sustained-release matrix formers. Glycols such as propylene glycol are versatile solvents for APIs and are used in many pharmaceutical preparations, including injectables, topical formulations, and syrups. Mineral hydrocarbons such as paraffin are used for their lubricating properties in capsules and as bases in various ointments and creams. Furthermore, povidones are used as binders in tablet formulations, as solubilizers in liquids, and as bioadhesives for buccal applications. Proteins such as gelatin and collagen are used to form drug capsules and as film-forming agents. Their biodegradability and compatibility with the human body make them vital for specific pharmaceutical applications.

Formulation: Significant demand for oral formulations owing to its convenient drug delivery

Oral formulations are dosage forms administered through the oral route, one of the most convenient and commonly used drug delivery methods. This segment includes a variety of excipients designed to aid the active pharmaceutical ingredient's stability, release, and bioavailability (API). Hard gelatin capsules are solid dosage forms in which one or more drug substances and excipients are enclosed within a small shell. They also offer advantages such as dose precision and good stability. Soft gelatin capsules (soft gels) are an oral dosage form for medicine similar to capsules; however, they consist of a gelatin-based shell surrounding a liquid fill. They are favored for their ease of swallowing and ability to enhance the bioavailability of poorly soluble APIs. Liquid formulations include solutions, suspensions, and emulsions that are taken orally. The choice of excipients in these formulations is critical to ensure stability, palatability, and proper absorption of the API. Tablets are a popular oral dosage form, and the excipient market for tablets remains robust. The ingredients used in tablet manufacturing bind the compound, aid in disintegration, and enhance stability. Parenteral formulations are sterile preparations intended to be administered directly into the body tissues. Topical formulations are applied to the skin or mucous membranes to deliver active ingredients directly to the site of action or systemic circulation.

Function: Coating agents provide physical and chemical protection for the drug

Binders are adhesive materials used in tablet formulations to agglomerate and hold the powder particles together, enhancing the strength and integrity of the tablet. Coating agents are applied to the exterior of various dosage forms to mask unpleasant tastes, provide physical and chemical protection for the drug, and control the release of the drug substance. Colorants are added to pharmaceuticals to facilitate product identification and enhance aesthetic appeal. Disintegrants are critical excipients that promote the breakup of a tablet in the digestive tract after administration, permitting the rapid release and absorption of the active pharmaceutical ingredient. Their functionality ensures the tablet disintegrates efficiently into smaller fragments when it enters a fluid environment. Emulsifying agents assist in the formation and stabilization of emulsions by reducing surface tension at the interface between the immiscible liquids. They are crucial for formulations such as creams, ointments, and suspension-based systems and facilitate the homogeneous distribution of the drug substance within the system. Fillers and diluents are inert additives that increase a tablet or capsule's bulk volume, making it practical to produce and easy to handle. Flavoring agents and sweeteners improve the palatability of oral medications, masking any unpleasant flavors and odors from the active drug or other excipients. Lubricants are added to formulation blends to prevent ingredients from clumping and to ensure a smooth ejection of the tablet from the die during compression. Preservatives contain the growth of microbes in pharmaceutical products, extending their shelf life and ensuring safety during use. Suspending and viscosity agents help maintain a uniformly dispersed state of insoluble particles in a liquid dosage form and can modulate liquid preparations' flow properties (viscosity). This ensures a uniform dose of medication with each administration and improves the stability of the practice.

Regional Insights

The Americas region has a significant landscape in the pharmaceutical excipient market as countries exhibit a high demand for excipients, directed by stringent regulatory environments, advanced healthcare systems, and strong intellectual property frameworks. Having a significant landscape in pharmaceutical innovation, the countries in the region strongly focus on advanced and novel excipients for drug formulations. The EMEA region, which encompasses Europe, the Middle East, and Africa, shows diverse market characteristics. The stringent regulatory environment in the European Union drives the demand for compliant and high-quality excipients, whereas markets in the Middle East and Africa are burgeoning, with increasing investment in pharmaceutical manufacturing infrastructure and regulation. The EU market demonstrates a high need for cutting-edge pharmaceutical excipients that cater to complex drugs and sophisticated drug delivery systems. Moreover, the EU's investment in biopharmaceuticals and biosimilars is complemented by the growing demand for novel excipients in these areas. Countries in the Asia-Pacific region are key players in the pharmaceutical excipient sector experiencing substantial growth due to a large patient pool, increasing healthcare expenditures, and supportive government initiatives. The region focuses on innovating high-functional excipients with ongoing research and development, reducing its historical reliance on imports.

FPNV Positioning Matrix

The FPNV Positioning Matrix is pivotal in evaluating the Pharmaceutical Excipient Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

Market Share Analysis

The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Pharmaceutical Excipient Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

Key Company Profiles

The report delves into recent significant developments in the Pharmaceutical Excipient Market, highlighting leading vendors and their innovative profiles. These include ABITEC Corporation, Aceto Corp., Archer Daniels Midland Company, ARMOR PROTEINES S.A.S., Asahi Kasei Corporation, Ashland Inc., BASF SE, BIOGRUND GmbH, Chemische Fabrik Budenheim KG, Clariant AG, Colorcon Inc., Corel Pharma Chem Private Limited, Croda International Plc, Darling Ingredients, Inc., DFE Pharma GmbH & Co KG, DuPont de Nemours, Inc., Evonik Industries AG, Fuji Chemical Industries Co., Ltd., GATTEFOSSE SAS, Innophos Holdings, Inc., International Flavors & Fragrances Inc., JRS PHARMA GmbH + Co. KG, Kerry Group P.L.C., Lipoid GmbH, Lubrizol Corporation, L'AIR LIQUIDE S.A., Mallinckrodt plc, MEGGLE GmbH & Co. KG, Merck KGaA, Nagase & Co., Ltd., Nipon Soda Co., Ltd., NOF Corporation, Omya International AG, Peter Greven GmbH & Co. KG, R.T. Vanderbilt Holding Company, Inc., Resonac Holdings Corporation, Roquette Freres S.A., Shin-Etsu Chemical Co., Ltd., Solvay S.A., SPI Pharma, Inc., and Thermo Fisher Scientific Inc..

Market Segmentation & Coverage

This research report categorizes the Pharmaceutical Excipient Market to forecast the revenues and analyze trends in each of the following sub-markets:

Type
- Inorganic
  - Calcium Carbonate
  - Calcium Phosphate
  - Calcium Sulfate
  - Halites
  - Metal Oxides

Organic
- Carbohydrates
  - Cellulose
  - Starch
  - Sugars

Oleochemicals
- Fatty Alcohols
- Glycerin
- Mineral Stearates

Petrochemicals
- Acrylic Polymers
- Glycols
- Mineral Hydrocarbons
- Povidones

Proteins

Formulation
- Oral Formulations
  - Hard Gelatin Capsules
  - Liquid Formulations
  - Soft Gelatin Capsules
  - Tablets

Parenteral Formulations
Topical Formulations

Function
- Binders
- Coating Agents
- Colorants
- Disintegrants
- Emulsifying Agents
- Fillers & Diluents
- Flavoring Agents & Sweeteners
- Lubricants & Glidants
- Preservatives
- Suspending & Viscosity Agents

Region
- Americas
  - Argentina
  - Brazil
  - Canada
  - Mexico
  - United States
    - California
    - Florida
    - Illinois
    - New York
    - Ohio
    - Pennsylvania
    - Texas
- Asia-Pacific
  - Australia
  - China
  - India
  - Indonesia
  - Japan
  - Malaysia
  - Philippines
  - Singapore
  - South Korea
  - Taiwan
  - Thailand
  - Vietnam

Europe, Middle East & Africa
- Denmark
- Egypt
- Finland
- France
- Germany
- Israel
- Italy
- Netherlands
- Nigeria
- Norway
- Poland
- Qatar
- Russia
- Saudi Arabia
- South Africa
- Spain
- Sweden
- Switzerland
- Turkey
- United Arab Emirates
- United Kingdom

The report offers valuable insights on the following aspects:

1. Market Penetration: It presents comprehensive information on the market provided by key players.

2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.

3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.

4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.

5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.

The report addresses key questions such as:

1. What is the market size and forecast of the Pharmaceutical Excipient Market?

2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Pharmaceutical Excipient Market?

3. What are the technology trends and regulatory frameworks in the Pharmaceutical Excipient Market?

4. What is the market share of the leading vendors in the Pharmaceutical Excipient Market?

5. Which modes and strategic moves are suitable for entering the Pharmaceutical Excipient Market?

Product Code: MRR-030EE48515E2

1. Preface

1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders

2. Research Methodology

2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

5.1. Market Dynamics
- 5.1.1. Drivers
  - 5.1.1.1. Rising incidence of cancer and other chronic and infectious diseases worldwide
  - 5.1.1.2. Growth of the pharmaceuticals industry coupled with significant demand for generics & orphan drugs
  - 5.1.1.3. Significant emphasis on the production of multifunctional excipients
- 5.1.2. Restraints
  - 5.1.2.1. High cost associated with the production of advanced excipient
- 5.1.3. Opportunities
  - 5.1.3.1. Technological advancements in nanotechnology for excipients
  - 5.1.3.2. Ongoing research and development of excipients with numerous properties (Biobased)
- 5.1.4. Challenges
  - 5.1.4.1. Increasing regulatory stringency and issues regarding the compatibility of excipients
5.2. Market Segmentation Analysis
- 5.2.1. Type: Potential demand and utilization of organic excipients
- 5.2.2. Formulation: Significant demand for oral formulations owing to its convenient drug delivery
- 5.2.3. Function: Coating agents provide physical and chemical protection for the drug
5.3. Market Trend Analysis
- 5.3.1. Substantial investments to increase drug manufacturing to propel the demand for pharmaceutical excipient in the Americas
- 5.3.2. Supportive government initiatives to encourage exports of pharmaceutical products in the Asia-Pacific
- 5.3.3. Flourishing pharmaceutical sector, coupled with a growing focus on localizing drug manufacturing in the EMEA region
5.4. Cumulative Impact of High Inflation
5.5. Porter's Five Forces Analysis
- 5.5.1. Threat of New Entrants
- 5.5.2. Threat of Substitutes
- 5.5.3. Bargaining Power of Customers
- 5.5.4. Bargaining Power of Suppliers
- 5.5.5. Industry Rivalry
5.6. Value Chain & Critical Path Analysis
5.7. Regulatory Framework Analysis

6. Pharmaceutical Excipient Market, by Type

6.1. Introduction
6.2. Inorganic
6.3. Organic

7. Pharmaceutical Excipient Market, by Formulation

7.1. Introduction
7.2. Oral Formulations
7.3. Parenteral Formulations
7.4. Topical Formulations

8. Pharmaceutical Excipient Market, by Function

8.1. Introduction
8.2. Binders
8.3. Coating Agents
8.4. Colorants
8.5. Disintegrants
8.6. Emulsifying Agents
8.7. Fillers & Diluents
8.8. Flavoring Agents & Sweeteners
8.9. Lubricants & Glidants
8.10. Preservatives
8.11. Suspending & Viscosity Agents

9. Americas Pharmaceutical Excipient Market

9.1. Introduction
9.2. Argentina
9.3. Brazil
9.4. Canada
9.5. Mexico
9.6. United States

10. Asia-Pacific Pharmaceutical Excipient Market

10.1. Introduction
10.2. Australia
10.3. China
10.4. India
10.5. Indonesia
10.6. Japan
10.7. Malaysia
10.8. Philippines
10.9. Singapore
10.10. South Korea
10.11. Taiwan
10.12. Thailand
10.13. Vietnam

11. Europe, Middle East & Africa Pharmaceutical Excipient Market

11.1. Introduction
11.2. Denmark
11.3. Egypt
11.4. Finland
11.5. France
11.6. Germany
11.7. Israel
11.8. Italy
11.9. Netherlands
11.10. Nigeria
11.11. Norway
11.12. Poland
11.13. Qatar
11.14. Russia
11.15. Saudi Arabia
11.16. South Africa
11.17. Spain
11.18. Sweden
11.19. Switzerland
11.20. Turkey
11.21. United Arab Emirates
11.22. United Kingdom

12. Competitive Landscape

12.1. Market Share Analysis, 2023
12.2. FPNV Positioning Matrix, 2023
12.3. Competitive Scenario Analysis
- 12.3.1. Roquette Introduces New Advancement in Moisture Protection
- 12.3.2. Clariant Launches New Range Of Excipients To Improve Stability And Solubility of Apis at CPHI Barcelona
- 12.3.3. BASF, IFF Partner on Virtual Pharma Assistant Platform ZoomLab
- 12.3.4. Lubrizol Licenses Award-Winning Apisolex Excipient to Welton Pharma to Develop a Novel Cancer Therapeutic
- 12.3.5. Ingredion Announces Strategic Investments Expanding Into High-Value Pharmaceutical Ingredients
- 12.3.6. DFE Pharma Expands its Inhalation Portfolio with the Launch of Lactohale 400
- 12.3.7. Evonik invests USD 220 million in partnership with the U.S. Government to build a new lipid production facility for mRNA-based therapies in the U.S.
- 12.3.8. Lubrizol Launches Apisolex Technology
- 12.3.9. Univar Solutions Expands Pharmaceutical Products Portfolio Through New Distribution Agreement with Ashland
- 12.3.10. Azelis Strengthens Its Pharmaceutical Presence in India By Expanding its Partnership With Roquette
- 12.3.11. Roquette Expands Global Reach of Plant-Based Excipients Portfolio with Complete Acquisition of Crest Cellulose

13. Competitive Portfolio

13.1. Key Company Profiles
13.2. Key Product Portfolio