North America Pharmaceutical Excipients Market, By Functionality (Binders and Adhesives, Disintegrants, Coating Material, Disintegrants, Solubilizers, Flavors, Sweetening Agents, Diluents, Lubricants, Buffers, Emulsifying Agents, Preservatives, Antioxidants, Sorbents, Solvents, Emollients, Glidients, Chelating Agents, Antifoaming Agents, Others), Dosage Form (Solid, Semi-Solid, Liquid), Route of Administration (Oral Excipients, Topical Excipients, Parenteral Excipients, Other Excipients), End User (Pharmaceutical and Biopharmaceutical Companies, Contract Formulators, Research Organization and Academics, Others), By Distribution Channel (Direct Tender, Retail Sales, Others) - Industry Trends and Forecast to 2030.
North America Pharmaceutical Excipients Market Analysis and Insights
Pharmaceutical excipients play a major role in drug formulation and its development. These substances involve substances other than the pharmacologically active drug or prodrug. Pharmaceutical excipients provide the drug with efficient drug delivery to the target site. These molecules prevent the drug from being released too early while assimilation and enhancing the drug efficacy. Some pharmaceutical excipients promote drug integration which boosts drug absorption in the bloodstream.
Data Bridge Market Research analyzes that the North America pharmaceutical excipients market is expected to reach the value of USD 6,894.31 million by 2030, at a CAGR of 6.6% during the forecast period. Functionality accounts for the largest type segment in the market due to the rapid demand for IT solutions and services in North America. This market report also covers pricing analysis, patent analysis, and technological advancements in depth.
2023 to 2030
Revenue in USD Million, Pricing in USD
By Functionality (Binders and Adhesives, Disintegrants, Coating Material, Disintegrants, Solubilizers, Flavors, Sweetening Agents, Diluents, Lubricants, Buffers, Emulsifying Agents, Preservatives, Antioxidants, Sorbents, Solvents, Emollients, Glidients, Chelating Agents, Antifoaming Agents, Others), Dosage Form (Solid, Semi-Solid, Liquid), Route of Administration (Oral Excipients, Topical Excipients, Parenteral Excipients, Other Excipients), End User (Pharmaceutical and Biopharmaceutical Companies, Contract Formulators, Research Organization and Academics, Others), By Distribution Channel (Direct Tender, Retail Sales, Others)
U.S., Canada, Mexico
Market Players Covered
Kerry Group plc., DFE Pharma, Cargill, Incorporated, Pfanstiehl, Colorcon, MEGGLE GmbH & Co. KG, Omya AG, Peter Greven GmbH & Co. KG, Ashland., Evonik, Dow, Croda International Plc, Roquette Frères., The Lubrizol Corporation, BASF SE, Avantor, Inc., BENEO, among others
North America Pharmaceutical Excipients Market Definition
Pharmaceutical excipients involve everything in a drug except the active pharmaceutical ingredients. These molecules don’t possess medicinal properties and are ultimately used to enhance the drug's physiological absorption. Pharmaceutical excipients are inert, allowing the drug molecule to apply to patients in the right form. Traditionally pharmaceutical excipients were simple molecules, but technological innovation and increasing demand for novel drug delivery systems enhanced the pharmaceutical excipient's complexity. Pharmaceutical excipients promote the patient’s drug acceptability and boost the drug's stability and bioavailability.
The future of excipients science and technology has changed and continues to change. Better progress has been made in such areas as harmonizing excipient pharmacopeial monographs and applying new analytical methods to characterize excipients better.
North America Pharmaceutical Excipients Market Dynamics
This section deals with understanding the market drivers, advantages, opportunities, restraints, and challenges. All of this is discussed in detail below:
- Rise in Generic Drug Production and Uses
According to the U.S. Food and Drug Administration (U.S. Food and Drug Administration). FDA) and the National Center for Biotechnology Information (NCBI), a generic drug is a drug that has been created to look like an approved brand-name drug that is available in dosage form, with safety, strength, route of administration, quality, and performance. After the drug's patent expires, the cost savings associated with conventional drug use are not immediately apparent. Generic drugs, like brand-name drugs, require competition in the generic drug market before reducing costs; two to three years after the loss of exclusivity, the price of a generic drug is usually 60-70% lower than that of a brand-name drug. Since India has the highest per capita spending, these generic drugs will save a lot of money that can be used for other health problems. Nationally, the use of generic drugs has increased significantly in recent years. The fact that cheap substitutes for branded drugs are a major reason likely to spur the growth of the pharmaceutical industry. The generic drug industry in the near future.
Thus, increasing demand for generic drugs and rising production are expected to drive the North America pharmaceutical excipients market growth. Also, the cost of generic drugs is less, which increases the use of generic drugs.
- The Surge in Demand for Excipients
Pharmaceutical excipients are substances in pharmaceutical dosage forms not for direct therapeutic use but to facilitate the manufacture, protection, support, or improvement of stability and availability. With the increased development of the North America pharmaceutical industry, excipients also have a light part. Recently, there has been an increasing demand for generic drugs, which has led to an increase in the excipients demand. In addition, there has been a sharp increase in cases of chronic diseases.
Excipients are inert substances, other than pharmaceutically active drugs, introduced into the manufacturing process or included in the dosage form of pharmaceutical products. Excipients are widely used in drug formulations to add bulk to solid formulations, provide long-term stability, and facilitate drug absorption. Furthermore, it also improves the product's overall safety or functional properties during use or storage.
Thus, wide uses of excipients in drug formulation and applications of excipients are expected to drive the North America pharmaceutical excipients market.
- Increasing Regulatory Stringency Regarding The Approval of Drugs and Excipients
Generic drug approval rules are largely the same worldwide, with little difference in developing countries. This is because he is not required to undergo bioequivalence (BE) study in this part of the world to obtain generic drug approval. Governments must ensure consistent quality of all generic drugs, medical experts say. Only then will doctors be happy and confident in prescribing generic drugs. A major reason for physicians' (and even patients') lack of confidence in generic drugs has been the lack of strict regulatory requirements regarding the number of generic drugs and the number of impurities allowed.
Controlling the manufacture and distribution of excipients is now considered a top priority by regulators and drug manufacturers, as mixing excipients has resulted in adverse patient events. Furthermore, with the emergence of new excipients and delivery systems, better control of the quality and supply of pharmaceutical excipients has become increasingly important in the context of in vivo activity. Recognizing the important role of excipients in pharmaceutical dosage forms requires excipient suppliers to meet the quality requirements of the pharmaceutical industry, and the pharmaceutical industry, in general, must work to ensure the product's safety. The integrity of use or storage in the supply chain. Hence, the Increasing Regulatory Stringency Regarding the Approval of Drugs and Excipients is expected to restrain the North America pharmaceutical excipients market growth.
Strategic Initiatives by Market Players
The rise in the pharmaceutical excipients market increases the need for strategic business ideas. It includes a partnership, business expansion, and other development. The rising demand for pharmaceuticals is significantly increasing the demand for pharmaceutical excipients, and to cope with this demand, companies are building new manufacturing sites, among other strategic initiatives.
These strategic initiatives, such as product launches, acquisitions, agreements, and business expansion by the major market player, will boost the pharmaceutical excipients market growth and are expected to act as an opportunity for the North America pharmaceutical excipients market.
- Associated Side Effects
Adverse effects due to pharmaceutical excipients in drug formulations are generally uncommon, but the potential for toxicity is increased at high mg per kg doses, especially in neonates and infants. Methyl and Propyl para-hydroxybenzoate (Parabens), Benzyl Alcohol, Sodium Benzoate, Benzoic Acid, and Propylene Glycol, among others, are some of the common pharmaceutical excipients that have reported side effects.
Pharmaceutical excipients are not always the inert substances that we presume. They are intolerant to an individual or, if not properly screened, can cause chemical changes in the drug, causing the side-effect. This can affect the demand for the excipient and is expected to act as a challenge for the North America pharmaceutical excipients market.
Post-COVID-19 Impact on North America Pharmaceutical Excipients Market
The pharmaceutical industry has been severely affected by the COVID-19 pandemic. Lockdowns imposed due to the epidemic have disrupted the supply of raw materials from manufacturing centers such as India and China. This slowed drug development and production, severely affecting companies that relied heavily on outsourcing. Initially, the entire pharmaceutical ecosystem was disrupted. In addition, regulatory agencies had to draft and draft new laws to ensure maximum patient safety after using drugs. After the shutdowns ended, the pharmaceutical industry gained steam, especially due to the demand for drugs such as hydroxychloroquine and Remdesivir, which showed positive results against COVID-19. The growing demand for these drugs boosted the turnover of some companies.
Manufacturers are making various strategic decisions to bounce back post-COVID-19. The players are conducting multiple R&D activities, product launches, and strategic partnerships to improve the technology in the pharmaceutical excipients market.
- In February 2022, Kerry Group Plc., the world’s leading taste and Nutrition Company, announced that it had made two significant biotechnology acquisitions that have expanded its expertise, technology portfolio, and manufacturing capabilities. The company has announced that it has acquired the leading biotechnology Innovation Company, c-LEcta, and Mexican-based enzyme manufacturer, Enmex. c-LEcta is a leading biotechnology innovation company specializing in precision fermentation, optimized bio-processing, and bio-transformation. Also, Enmex is a well-established enzyme manufacturer based in Mexico, supplying multiple bio-process solutions for food, beverage, and animal nutrition markets. This has helped the company to increase its revenue
- In September 2022, DFE Pharma, a North America leader in pharma- and nutraceutical excipient solutions, opened its new “Closer to the Formulator” (C2F), a Center of Excellence, in Hyderabad, India. C2F helped pharmaceutical companies to shorten the time from concept to finished commercial product through its expertise in all phases of pharmaceutical development. This has helped the company to showcase its progress
North America Pharmaceutical Excipients Market Scope
The North America pharmaceutical excipients market is segmented into functionality, dosage forms, route of administration, end-user, and distribution channel. The growth among segments helps you analyze niche pockets of growth and strategies to approach the market and determine your core application areas and the difference in your target markets.
NORTH AMERICA PHARMACEUTICAL EXCIPIENTS MARKET, BY FUNCTIONALITY
- Binders And Adhesives
- Coating Material
- Coloring Agents
- Sweetening Agents
- Emulsifying Agents
- Chelating Agents
- Antifoaming Agents
On the basis of functionality, the North America pharmaceutical excipients market is segmented into binders and adhesives, disintegrants, coating material, coloring agents, solubilizers, flavors, sweetening agents, diluents, lubricants, buffers, emulsifying agents, preservatives, antioxidants, sorbents, solvents, emollients, glidents, chelating agents, antifoaming agents, and others.
NORTH AMERICA PHARMACEUTICAL EXCIPIENTS MARKET, BY DOSAGE FORM
On the basis of dosage forms, the North America pharmaceutical excipients market is segmented into solid, semi-solid, and liquid
NORTH AMERICA PHARMACEUTICAL EXCIPIENTS MARKET, BY ROUTE OF ADMINISTRATION
- Oral Excipients
- Topical Excipients
- Parenteral Excipients
- Other Pharmaceutical Excipients
On the basis of the route of administration, the North America pharmaceutical excipients market is segmented into oral pharmaceutical excipients, topical pharmaceutical excipients, parenteral pharmaceutical excipients, and other pharmaceutical excipients.
NORTH AMERICA PHARMACEUTICAL EXCIPIENTS MARKET, BY END-USER
- Pharmaceutical And Biopharmaceutical Companies
- Contract Formulators
- Research Organizations And Academics
On the basis of end user, the North America pharmaceutical excipients market is segmented into pharmaceutical and biopharmaceutical companies, contract formulators, research organizations and academics, others
NORTH AMERICA PHARMACEUTICAL EXCIPIENTS MARKET, BY DISTRIBUTION CHANNEL
- Direct Tender
- Retail Sales
On the basis of distribution channel, the North America pharmaceutical excipients market is segmented into direct tender, retail sales, and others.
North America Pharmaceutical Excipients Market Regional Analysis/Insights
The North America pharmaceutical excipients market is analyzed, and market size information is provided functionality, dosage forms, route of administration, end-user, and distribution channel.
The countries covered in this market report are U.S., Canada, and Mexico.
North America is dominating due to the presence of key market players in the largest consumer market with high GDP. U.S. is expected to grow due to the rise in technological advancement in Healthcare IT.
North America is dominating the market. The increasing investment in R&D is expected to boost the market growth. The U.S. dominates the North America region due to the strong presence of key players Evonik, Dow, Croda International Plc, and others. U.K. dominates Europe due to the mass production of drugs, increasing demand from emerging markets, and expansion of healthcare industries. China dominates the Asia-Pacific region due to the rapidly growing pharmaceuticals market coupled with the rise in generics production.
The country section of the report also provides individual market-impacting factors and changes in regulation in the market domestically that impact the current and future trends of the market. Data points such as new sales, replacement sales, country demographics, regulatory acts, and import-export tariffs are some of the major pointers used to forecast the market scenario for individual countries. Also, the presence and availability of North America brands and their challenges faced due to large or scarce competition from local and domestic brands, and the impact of sales channels are considered while providing forecast analysis of the country data.
Competitive Landscape and North America Pharmaceutical Excipients Market Share Analysis
North America pharmaceutical excipients market competitive landscape provides details by the competitor. Details included are company overview, company financials, revenue generated, market potential, investment in R&D, new market initiatives, production sites and facilities, company strengths and weaknesses, product launch, product trials pipelines, product approvals, patents, product width and breath, application dominance, technology lifeline curve. The above data points provided are only related to the company’s focus on the North America pharmaceutical excipients market.
Some of the major players operating in the North America pharmaceutical excipients market are Kerry Group plc., DFE Pharma, Cargill, Incorporated, Pfanstiehl, Colorcon, MEGGLE GmbH & Co. KG, Omya AG, Peter Greven GmbH & Co. KG, Ashland., Evonik, Dow, Croda International Plc, Roquette Frères., The Lubrizol Corporation, BASF SE, Avantor, Inc., BENEO, among others.