USA Pharmaceutical Excipients Market Outlook to 2028
Description
USA Pharmaceutical Excipients Market Overview
The USA Pharmaceutical Excipients market is valued at USD 3.7 Bn, based on a five-year historical analysis. This market is primarily driven by the growing demand for pharmaceutical formulations in the U.S., propelled by the expansion of the biopharmaceutical industry, increasing prevalence of chronic diseases, and advancements in drug delivery systems. Excipients play a critical role in the stabilization, bioavailability, and delivery of active pharmaceutical ingredients, which is driving the markets sustained growth.
The USA is a dominant force in the global pharmaceutical excipients market, with cities such as New York, Boston, and San Francisco leading the charge due to their strong concentration of pharmaceutical R&D, cutting-edge manufacturing technologies, and favorable regulatory environment. These cities are home to a large number of pharmaceutical companies and research institutions, which collaborate closely to innovate in drug formulations. Furthermore, regulatory frameworks such as the U.S. FDAs stringent guidelines ensure high standards, giving the U.S. a competitive edge in the market.
Environmental sustainability is becoming a priority for the pharmaceutical industry. In 2024, biodegradable excipients, particularly those derived from renewable sources, have seen a 10% increase in demand. According to the Environmental Protection Agency (EPA), pharmaceutical waste accounts for 2-3% of hazardous waste in the U.S., driving the need for eco-friendly alternatives in drug formulations. Biodegradable excipients are also gaining popularity due to their reduced environmental impact during manufacturing and disposal, positioning them as a key trend in sustainable pharmaceutical development.
USA Pharmaceutical Excipients Market Segmentation
By Product Type: The market is segmented by product type into polymers, sugars, minerals, gelatin, and alcohols. Recently, polymers have dominated the product type segmentation due to their versatility in pharmaceutical formulations. Polymers are widely used in drug delivery systems because of their ability to control the release of active ingredients, ensuring the drug reaches its target more effectively. Polymers like polyethylene glycol (PEG) are frequently used in controlled-release formulations, contributing to their dominant position.
By Application: The market is also segmented by application into oral formulations, topical formulations, parenteral formulations, and inhalation formulations. Oral formulations hold the dominant market share due to their widespread use and patient preference for oral drug delivery methods. Tablets and capsules are the most common forms of oral formulations, and excipients are essential for improving their taste, stability, and bioavailability, making them an indispensable part of the pharmaceutical industry.
USA Pharmaceutical Excipients Market Competitive Landscape
The USA Pharmaceutical Excipients market is dominated by several key players, each contributing significantly to the market's development. This consolidation is marked by established players who have a strong foothold in the market due to their extensive R&D capabilities, strong product portfolios, and collaborations with pharmaceutical manufacturers. The key companies focus on innovation in excipient development to address the evolving needs of the pharmaceutical industry.
Company Name
Establishment Year
Headquarters
Revenue (2023)
Employees
Key Product
R&D Investment
Key Clients
Partnerships
BASF SE
1865
Ludwigshafen, Germany
Evonik Industries AG
2007
Essen, Germany
Ashland Global Holdings Inc.
1924
Wilmington, USA
Roquette Frres
1933
Lestrem, France
The Dow Chemical Company
1897
Midland, USA
USA Pharmaceutical Excipients Industry Analysis
Growth Drivers
Increasing Demand for Generic Drugs: The USA has been witnessing substantial growth in the demand for generic drugs, driven by cost-saving measures and the expiration of patents for several major drugs. In 2022, the FDA approved over 95 generic drugs, contributing to a competitive marketplace that requires large-scale production of excipients. According to the FDAs Office of Generic Drugs, nearly 90% of all prescriptions filled in the U.S. are for generics, amplifying the demand for pharmaceutical excipients in 2024 to maintain quality standards in drug formulation, stability, and delivery.
Growing Biopharmaceutical Industry: The biopharmaceutical sector has expanded significantly in the USA, with biopharmaceuticals accounting for approximately 30% of all new drug approvals by the FDA in 2023. Excipients play a critical role in stabilizing these complex biologics. Macroeconomic data from the U.S. Department of Commerce shows that the biopharmaceutical sector saw employment of over 850,000 professionals in 2023, with research spending exceeding USD 100 billion. This rising demand for biopharmaceuticals has necessitated the use of innovative excipients to ensure product stability and efficacy in advanced therapeutic formulations.
Rising Preference for Novel Drug Delivery Systems: There has been an increasing shift towards novel drug delivery systems such as transdermal, inhalation, and controlled-release formulations. In 2024, over 15% of all new drugs approved by the FDA were in non-oral delivery formats, requiring specialized excipients for targeted delivery. The shift in drug delivery systems is driven by patient preferences for non-invasive methods and improved bioavailability. According to data from the National Institutes of Health (NIH), novel delivery systems have seen increased investment in clinical trials, with over 1,500 ongoing studies in this area by early 2024.
Market Challenges
Regulatory Complexity: The U.S. pharmaceutical industry operates under stringent regulatory guidelines, especially from the FDA, leading to a lengthy and costly approval process for new excipients. In 2023, the average time for new drug and excipient approvals was 14-18 months. The need to adhere to multiple layers of regulatory compliance, including the U.S. Pharmacopoeia standards and international harmonization, has posed significant challenges for manufacturers in 2024. The regulatory complexity also limits innovation, as companies often focus on existing, well-documented excipients rather than risk new, untested options.
High Manufacturing Costs: The cost of producing pharmaceutical excipients has risen sharply due to inflationary pressures and supply chain disruptions. In 2023, energy prices surged by 11%, affecting manufacturing operations across the pharmaceutical supply chain. The U.S. Bureau of Labor Statistics reported that pharmaceutical manufacturing wages have increased by an average of 3.5% annually, pushing up operational costs. This increase in production expenses for excipients, combined with higher raw material costs, has created barriers to market entry for smaller manufacturers in 2024.
USA Pharmaceutical Excipients Market Future Outlook
Over the next five years, the USA Pharmaceutical Excipients market is expected to show significant growth driven by advancements in drug delivery technologies, the rise of biologics, and increasing demand for controlled-release formulations. The growth of the generics and biosimilars market, coupled with innovations in excipient functionality, will create new opportunities for both established and emerging players in the excipients market.
Future Market Opportunities
Emerging Markets for Drug Formulation: With rising healthcare expenditures, especially in the Middle East and Africa, U.S. pharmaceutical companies are eyeing these emerging markets for drug formulations that require tailored excipients. The U.S. Census Bureau reports that exports of pharmaceuticals to emerging markets reached USD 54 billion in 2023. This creates a lucrative opportunity for excipient manufacturers to supply innovative products suited for the specific climatic and storage conditions in these regions. Moreover, increasing regulatory collaboration with emerging economies has reduced barriers for U.S. pharmaceutical exports, enabling further market penetration in 2024.
Advancements in Nanotechnology for Drug Delivery: Nanotechnology has transformed the drug delivery landscape, particularly in targeting cancer and infectious diseases. In 2024, over 60 FDA-approved nanomedicines were being marketed, requiring specialized excipients to stabilize nanoparticles and ensure targeted drug delivery. Data from the National Nanotechnology Initiative (NNI) indicates that nanomedicine investments in the U.S. crossed USD 15 billion in 2023. This growing demand for precision medicine and targeted delivery is creating new opportunities for excipient manufacturers to develop products that improve solubility, bioavailability, and controlled release of nanomedicines.
Please Note: It will take 5-7 business days to complete the report upon order confirmation
The USA Pharmaceutical Excipients market is valued at USD 3.7 Bn, based on a five-year historical analysis. This market is primarily driven by the growing demand for pharmaceutical formulations in the U.S., propelled by the expansion of the biopharmaceutical industry, increasing prevalence of chronic diseases, and advancements in drug delivery systems. Excipients play a critical role in the stabilization, bioavailability, and delivery of active pharmaceutical ingredients, which is driving the markets sustained growth.
The USA is a dominant force in the global pharmaceutical excipients market, with cities such as New York, Boston, and San Francisco leading the charge due to their strong concentration of pharmaceutical R&D, cutting-edge manufacturing technologies, and favorable regulatory environment. These cities are home to a large number of pharmaceutical companies and research institutions, which collaborate closely to innovate in drug formulations. Furthermore, regulatory frameworks such as the U.S. FDAs stringent guidelines ensure high standards, giving the U.S. a competitive edge in the market.
Environmental sustainability is becoming a priority for the pharmaceutical industry. In 2024, biodegradable excipients, particularly those derived from renewable sources, have seen a 10% increase in demand. According to the Environmental Protection Agency (EPA), pharmaceutical waste accounts for 2-3% of hazardous waste in the U.S., driving the need for eco-friendly alternatives in drug formulations. Biodegradable excipients are also gaining popularity due to their reduced environmental impact during manufacturing and disposal, positioning them as a key trend in sustainable pharmaceutical development.
USA Pharmaceutical Excipients Market Segmentation
By Product Type: The market is segmented by product type into polymers, sugars, minerals, gelatin, and alcohols. Recently, polymers have dominated the product type segmentation due to their versatility in pharmaceutical formulations. Polymers are widely used in drug delivery systems because of their ability to control the release of active ingredients, ensuring the drug reaches its target more effectively. Polymers like polyethylene glycol (PEG) are frequently used in controlled-release formulations, contributing to their dominant position.
By Application: The market is also segmented by application into oral formulations, topical formulations, parenteral formulations, and inhalation formulations. Oral formulations hold the dominant market share due to their widespread use and patient preference for oral drug delivery methods. Tablets and capsules are the most common forms of oral formulations, and excipients are essential for improving their taste, stability, and bioavailability, making them an indispensable part of the pharmaceutical industry.
USA Pharmaceutical Excipients Market Competitive Landscape
The USA Pharmaceutical Excipients market is dominated by several key players, each contributing significantly to the market's development. This consolidation is marked by established players who have a strong foothold in the market due to their extensive R&D capabilities, strong product portfolios, and collaborations with pharmaceutical manufacturers. The key companies focus on innovation in excipient development to address the evolving needs of the pharmaceutical industry.
Company Name
Establishment Year
Headquarters
Revenue (2023)
Employees
Key Product
R&D Investment
Key Clients
Partnerships
BASF SE
1865
Ludwigshafen, Germany
Evonik Industries AG
2007
Essen, Germany
Ashland Global Holdings Inc.
1924
Wilmington, USA
Roquette Frres
1933
Lestrem, France
The Dow Chemical Company
1897
Midland, USA
USA Pharmaceutical Excipients Industry Analysis
Growth Drivers
Increasing Demand for Generic Drugs: The USA has been witnessing substantial growth in the demand for generic drugs, driven by cost-saving measures and the expiration of patents for several major drugs. In 2022, the FDA approved over 95 generic drugs, contributing to a competitive marketplace that requires large-scale production of excipients. According to the FDAs Office of Generic Drugs, nearly 90% of all prescriptions filled in the U.S. are for generics, amplifying the demand for pharmaceutical excipients in 2024 to maintain quality standards in drug formulation, stability, and delivery.
Growing Biopharmaceutical Industry: The biopharmaceutical sector has expanded significantly in the USA, with biopharmaceuticals accounting for approximately 30% of all new drug approvals by the FDA in 2023. Excipients play a critical role in stabilizing these complex biologics. Macroeconomic data from the U.S. Department of Commerce shows that the biopharmaceutical sector saw employment of over 850,000 professionals in 2023, with research spending exceeding USD 100 billion. This rising demand for biopharmaceuticals has necessitated the use of innovative excipients to ensure product stability and efficacy in advanced therapeutic formulations.
Rising Preference for Novel Drug Delivery Systems: There has been an increasing shift towards novel drug delivery systems such as transdermal, inhalation, and controlled-release formulations. In 2024, over 15% of all new drugs approved by the FDA were in non-oral delivery formats, requiring specialized excipients for targeted delivery. The shift in drug delivery systems is driven by patient preferences for non-invasive methods and improved bioavailability. According to data from the National Institutes of Health (NIH), novel delivery systems have seen increased investment in clinical trials, with over 1,500 ongoing studies in this area by early 2024.
Market Challenges
Regulatory Complexity: The U.S. pharmaceutical industry operates under stringent regulatory guidelines, especially from the FDA, leading to a lengthy and costly approval process for new excipients. In 2023, the average time for new drug and excipient approvals was 14-18 months. The need to adhere to multiple layers of regulatory compliance, including the U.S. Pharmacopoeia standards and international harmonization, has posed significant challenges for manufacturers in 2024. The regulatory complexity also limits innovation, as companies often focus on existing, well-documented excipients rather than risk new, untested options.
High Manufacturing Costs: The cost of producing pharmaceutical excipients has risen sharply due to inflationary pressures and supply chain disruptions. In 2023, energy prices surged by 11%, affecting manufacturing operations across the pharmaceutical supply chain. The U.S. Bureau of Labor Statistics reported that pharmaceutical manufacturing wages have increased by an average of 3.5% annually, pushing up operational costs. This increase in production expenses for excipients, combined with higher raw material costs, has created barriers to market entry for smaller manufacturers in 2024.
USA Pharmaceutical Excipients Market Future Outlook
Over the next five years, the USA Pharmaceutical Excipients market is expected to show significant growth driven by advancements in drug delivery technologies, the rise of biologics, and increasing demand for controlled-release formulations. The growth of the generics and biosimilars market, coupled with innovations in excipient functionality, will create new opportunities for both established and emerging players in the excipients market.
Future Market Opportunities
Emerging Markets for Drug Formulation: With rising healthcare expenditures, especially in the Middle East and Africa, U.S. pharmaceutical companies are eyeing these emerging markets for drug formulations that require tailored excipients. The U.S. Census Bureau reports that exports of pharmaceuticals to emerging markets reached USD 54 billion in 2023. This creates a lucrative opportunity for excipient manufacturers to supply innovative products suited for the specific climatic and storage conditions in these regions. Moreover, increasing regulatory collaboration with emerging economies has reduced barriers for U.S. pharmaceutical exports, enabling further market penetration in 2024.
Advancements in Nanotechnology for Drug Delivery: Nanotechnology has transformed the drug delivery landscape, particularly in targeting cancer and infectious diseases. In 2024, over 60 FDA-approved nanomedicines were being marketed, requiring specialized excipients to stabilize nanoparticles and ensure targeted drug delivery. Data from the National Nanotechnology Initiative (NNI) indicates that nanomedicine investments in the U.S. crossed USD 15 billion in 2023. This growing demand for precision medicine and targeted delivery is creating new opportunities for excipient manufacturers to develop products that improve solubility, bioavailability, and controlled release of nanomedicines.
Please Note: It will take 5-7 business days to complete the report upon order confirmation
Table of Contents
95 Pages
- 1. USA Pharmaceutical Excipients Market Overview
- 1.1. Definition and Scope (Pharmaceutical Excipients Definition, Functional Categories, Market Boundaries)
- 1.2. Market Taxonomy (Functional Excipients, Formulation Excipients, Specialty Excipients)
- 1.3. Market Growth Rate (CAGR, Revenue Growth)
- 1.4. Market Segmentation Overview (By Product Type, Application, Function, Form, Region)
- 2. USA Pharmaceutical Excipients Market Size (In USD Bn)
- 2.1. Historical Market Size (Past Revenue and Volume)
- 2.2. Year-On-Year Growth Analysis (Annual Performance by Key Metrics)
- 2.3. Key Market Developments and Milestones (FDA Approvals, Innovation in Formulation, New Entrants)
- 3. USA Pharmaceutical Excipients Market Analysis
- 3.1. Growth Drivers
- 3.1.1. Increasing Demand for Generic Drugs
- 3.1.2. Growing Biopharmaceutical Industry
- 3.1.3. Rising Preference for Novel Drug Delivery Systems
- 3.1.4. Expansion in Functional Excipients
- 3.2. Restraints
- 3.2.1. Regulatory Complexity
- 3.2.2. High Manufacturing Costs
- 3.2.3. Raw Material Shortages
- 3.3. Opportunities
- 3.3.1. Emerging Markets for Drug Formulation
- 3.3.2. Advancements in Nanotechnology for Drug Delivery
- 3.3.3. Growth in Specialty Excipients
- 3.4. Trends
- 3.4.1. Shift Towards Biodegradable Excipients
- 3.4.2. Usage of Multifunctional Excipients
- 3.4.3. Growth of Personalized Medicine
- 3.5. Regulatory Impact
- 3.5.1. U.S. FDA Guidelines
- 3.5.2. cGMP Compliance
- 3.5.3. International Harmonization (ICH, USP)
- 3.6. SWOT Analysis (Strengths, Weaknesses, Opportunities, Threats)
- 3.7. Supply Chain Analysis (Raw Material Suppliers, Distributors, End-Use Manufacturers)
- 3.8. Porters Five Forces (Bargaining Power of Suppliers, Threat of Substitutes, Industry Rivalry, etc.)
- 4. USA Pharmaceutical Excipients Market Segmentation
- 4.1. By Product Type (In Value %)
- 4.1.1. Polymers
- 4.1.2. Sugars
- 4.1.3. Minerals
- 4.1.4. Gelatin
- 4.1.5. Alcohols
- 4.2. By Application (In Value %)
- 4.2.1. Oral Formulations
- 4.2.2. Topical Formulations
- 4.2.3. Parenteral Formulations
- 4.2.4. Inhalation Formulations
- 4.3. By Function (In Value %)
- 4.3.1. Binders
- 4.3.2. Fillers and Diluents
- 4.3.3. Lubricants
- 4.3.4. Disintegrants
- 4.3.5. Preservatives
- 4.4. By Form (In Value %)
- 4.4.1. Liquid
- 4.4.2. Solid
- 4.4.3. Semi-Solid
- 4.5. By Region (In Value %)
- 4.5.1. Northeast
- 4.5.2. Midwest
- 4.5.3. South
- 4.5.4. West
- 5. USA Pharmaceutical Excipients Market Competitive Analysis
- 5.1. Detailed Profiles of Major Companies
- 5.1.1. BASF SE
- 5.1.2. Evonik Industries AG
- 5.1.3. Ashland Global Holdings Inc.
- 5.1.4. Roquette Frres
- 5.1.5. The Dow Chemical Company
- 5.1.6. Kerry Group Plc
- 5.1.7. Colorcon Inc.
- 5.1.8. JRS Pharma
- 5.1.9. Avantor, Inc.
- 5.1.10. DuPont de Nemours, Inc.
- 5.1.11. Archer Daniels Midland Company (ADM)
- 5.1.12. Croda International Plc
- 5.1.13. Lubrizol Corporation
- 5.1.14. Merck KGaA
- 5.1.15. Associated British Foods Plc
- 5.2. Cross Comparison Parameters (Revenue, Market Share, Production Capacity, Number of Employees, Product Portfolio)
- 5.3. Market Share Analysis (By Competitor)
- 5.4. Strategic Initiatives (R&D Investments, Partnerships, Product Launches)
- 5.5. Mergers and Acquisitions (Recent Transactions, Synergies)
- 5.6. Investment Analysis (Private Investments, PE and VC Funding)
- 5.7. Government Grants and Support (Subsidies, Research Support)
- 6. USA Pharmaceutical Excipients Market Regulatory Framework
- 6.1. cGMP Requirements (For Excipients)
- 6.2. FDA Regulations (Excipients Safety and Use in Formulations)
- 6.3. Certification Processes (ISO, ICH Guidelines)
- 6.4. Import/Export Compliance (Regulatory Bodies, International Standards)
- 7. USA Pharmaceutical Excipients Market Future Market Size (In USD Bn)
- 7.1. Future Market Size Projections (Revenue Growth Forecast)
- 7.2. Key Factors Driving Future Market Growth (Demand for Drug Formulation, Innovation in Excipients)
- 8. USA Pharmaceutical Excipients Future Market Segmentation
- 8.1. By Product Type (In Value %)
- 8.2. By Application (In Value %)
- 8.3. By Function (In Value %)
- 8.4. By Form (In Value %)
- 8.5. By Region (In Value %)
- 9. USA Pharmaceutical Excipients Market Analysts' Recommendations
- 9.1. Total Addressable Market (TAM) Analysis
- 9.2. Serviceable Available Market (SAM) and Serviceable Obtainable Market (SOM) Analysis
- 9.3. Customer Behavior Analysis (Trends in Drug Development, Buyer Personas)
- 9.4. White Space Opportunity Analysis
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