Pharmaceutical Excipients Global Market is estimated to be worth $15,439.6 million by 2029

Pharmaceutical excipients are inactive substances in the drug which help in modulating the solubility, bioavailability, and stability of active substances for formulating final drug dosage forms. The excipients form the major part of any medicinal product and the proportion of it, when compared to Active Pharmaceutical Ingredient (API), exceeds two to three folds in any pharmaceutical preparations. Hence, various characteristics such as functionality, regulatory status, sources, cost, consistency, bioavailability, physicochemical properties, stability, pharmacokinetic parameters, etc. play a major role in determining the suitability of a substance as an excipient.

As estimated by IQ4I Research, the pharmaceutical excipients global market is expected to grow at mid single-digit CAGR from 2022 to 2029 to reach $15,439.6 million by 2029. The pharmaceutical excipients market is segmented based on source, products, functionality, and dosage forms.

The pharmaceutical excipients market based on the source is segmented as animal-based, plant-based, mineral-based, and synthetic-based excipients. Among them, plant-based excipients contributed the largest revenue in 2022 and it is the fastest growing segment at a high single digit CAGR from 2022 to 2029 due to plant-based excipients are cost-effective, low toxic with the better patient tolerance, bio-compatible and they are easily available. Based on products, excipients are segmented into inorganic chemicals, organic chemicals, and others. The organic chemical segment contributed the largest revenue in 2022 and it is expected to grow at mid single digit CAGR from 2022 to 2029 due to the use of these excipients in majorly all of the pharmaceutical formulations as they offer advantages such as increased efficacy in oral delivery of poorly soluble molecules along with increased compressibility and flowability properties.

The inorganic chemical excipients market based on product type is further divided into calcium salts, halites, metallic oxides, silicates, and other inorganic chemicals, among which metallic oxides contributed a major revenue in 2022 and the calcium salts segment is the fastest growing segment with a high single digit CAGR 2022 to 2029. Calcium salts are further sub-segmented into calcium phosphate, calcium carbonate, and others, among which, calcium phosphate contributed the largest revenue in 2022, and the calcium carbonate segment is expected to grow at a high single digit CAGR from 2022 to 2029. Calcium carbonate is further classified into GCC and PCC, among which PCC contributed the largest revenue in 2022 and it is expected to grow at a high single digit CAGR from 2022 to 2029. The metallic oxides segment is further segmented into titanium dioxide and others (Iron Oxide, Magnesium Oxide & Aluminum Hydroxide). Titanium Dioxide contributed the largest revenue in 2022 and it is expected to grow at mid single digit CAGR from 2022 to 2029.

The organic chemical excipients market by product type is further divided into carbohydrates, petrochemicals, oleochemicals, proteins, and other organic chemicals. Carbohydrates contributed major revenue in 2022 and it is expected to grow at mid single digit CAGR from 2022 to 2029.

The Carbohydrate excipients market based on product type is further segmented into sugar, starch, and cellulose, among which, cellulose contributed the largest revenue in 2022 and is expected to grow at a high single digit CAGR from 2022 to 2029. The sugar segment is further divided into actual sugar, sugar alcohol, and artificial sweeteners, where actual sugar contributed the largest revenue in 2022 and the sugar alcohol segment is expected to grow at high single digit CAGR from 2022 to 2029.

The actual sugar segment is further sub-segmented into lactose, sucrose, and dextrose, where lactose contributed the largest revenue in 2022, and the sucrose segment is expected to grow at high single digit CAGR from 2022 to 2029. The sugar alcohol segment is further classified into sorbitol, mannitol, and other sugar alcohols, where mannitol contributed the largest revenue in 2022 and it is expected to grow at high single digit CAGR from 2022 to 2029. The starch segment is further divided into modified starch, dried starch, and converted starch, where modified starch contributed the largest revenue in 2022 and dried starch is expected to grow at mid single digit CAGR from 2022 to 2029. The cellulose segment is further sub-segmented into cellulose ethers, cellulose esters, croscarmellose sodium, and microcrystalline cellulose, where microcrystalline cellulose holds the largest revenue in 2022 and is expected to grow at high single digit CAGR from 2022 to 2029.

The petrochemical excipients market based on product type is further segmented into glycols, povidones, mineral hydrocarbons, acrylic polymers, and other petrochemical excipients. Glycol contributed the largest revenue in 2022 and povidones are the fastest growing segment with a mid single digit CAGR from 2022 to 2029. The Glycol is further segmented into Polyethylene Glycol and Propylene Glycol, where Polyethylene Glycol contributed the largest revenue in 2022 and it is expected to grow at mid single digit CAGR from 2022 to 2029.

The Oleochemicals excipients market based on product type is further segmented into Fatty Alcohols, Mineral stearates, Glycerin, and Other Oleochemical Excipients. Fatty Alcohol contributed the largest revenue in 2022 and is expected to grow at mid single digit CAGR from 2022 to 2029 while mineral stearates is the fastest growing segment with mid single digit CAGR from 2022 to 2029.

Other excipients market based on product type is further segmented into the water for injections and purified water. Water for injections contributed the largest revenue in 2022 and it is expected to grow at low single digit CAGR from 2022 to 2029.

The pharmaceutical excipients market based on functionality is segmented as preservatives, solvents, binders & adhesives, fillers & diluents, suspending agents, coatings, solubilizers, disintegrants, colorants, flavoring & sweeteners, lubricants & glidants, and others. Binders & Adhesives contributed the largest revenue in 2022 and it is expected to grow at mid single digit CAGR from 2022 to 2029.

The pharmaceutical excipients market based on dosage forms is segmented as solid dosage forms, injectables and semisolids, and others. Solid dosage forms hold the largest revenue in 2022 and it is expected to grow at mid single digit CAGR from 2022 to 2029. Based on the manufacturing process solid dosage forms are segmented into granulation and direct compression. Granulation contributed the largest revenue in 2022 and direct compression is expected to grow at mid single digit CAGR from 2022 to 2029. Some of the factors driving the solid dosage forms market are cost-effectiveness, solid dosage provides increased physical and chemical stability, controlled-release options, and superior ease of handling.

The pharmaceutical excipients market based on region is segmented into North America (U.S. and the Rest of North America), Europe (Germany, France, Italy, and the Rest of Europe), Asia-Pacific (China, India, Japan, and Rest of APAC) and Rest of the world (Brazil, Rest of Latin America and the Middle East & others). North America contributed the largest revenue in 2022 due to increasing demand for functional excipients, implementation of novelties like lipid nano particles, increasing usage of oral solid dosage forms, increasing incidence of chronic disorders, elderly population, and favorable reimbursement scenario for drugs. Also, technological innovations in the manufacturing procedures of excipients have propelled the market growth in North America. Stringent cGMP regulatory guidelines have resulted in a rising demand for high-grade excipients. In North America, the United States and Canada are the major markets observed due to its increasing investments in biopharmaceuticals, the growth in the demand for customized products, and advancements in multifunctional excipients in the market. Excipients manufacturers in developing countries face major challenges to develop a product with quality at an affordable price, due to the lower price of excipients and a large number of producers, which creates a price-sensitive market. Some manufacturers may compromise the quality of the product to keep prices low and boost sales, while some of the manufacturers having a larger market for their products, can sell their higher volume excipients at a slightly lower price. Asia-Pacific is the fastest-growing segment and is expected to grow at high single digit CAGR from 2022 to 2029.

Even though excipients are considered an essential component and have a major role in the drug delivery system, the lack of specific regulations, standardized tests, protocols, and guidelines is affecting the quality evaluation of excipients. Excipient manufacturers should follow WHO initiatives (GTDP, GMP), ICH Q3D, ICH Q1B, QBD requirements, PDG monograph harmonization, Good pharmacopeia practices, US FDA FDASIA, Title VII, E-DMF, and EU FMD. These regulations are compelling pharmaceutical manufacturers to develop a quality product by adopting various standard testing methods. EXCiPACT is a pharmaceutical excipients certification scheme to provide independent third-party certification of manufacturers, suppliers, and distributors of pharmaceutical excipients worldwide. EXiPACT certification enables to demonstrate that operations meet the minimum Good Manufacturing Practice (GMP) and/or Good Distribution Practice (GDP) requirements for excipients.

Presently, there is demand for the development of novel excipients with technological advancements like new chemical entity excipients, new chemically modified grade excipients, and existing excipients with the various route of administration and co-processed excipients. These novel excipients increase the scope for the development of new formulations and drug delivery systems which are a major gain for the industry, but the high cost and lengthy developmental process along with the safety and quality issues are delaying the excipients approval. Combinational excipients are mostly preferred by the manufacturers as the single excipients do not meet all the functional requirements such as high solubility, stability, and bioavailability.

The pharmaceutical excipients global market is highly competitive hence all the existing players in this market are involved in developing new and advanced therapeutics to maintain their market shares. Some of the key players contributing at the global level to pharmaceutical excipients market growth are IFF (U.S.), Ashland, Inc. (U.S.), BASF SE (Germany), DFE Pharma (Germany), Evonik Industries AG (Germany), Croda International Plc (U.K.), Merck KGAA (Germany), Roquette (France), Colorcon (U.S.), and Asahi Kasei (Japan).

The report provides an in-depth market analysis of the above-mentioned segments across the following regions:

• North America

• The U.S.
• Rest of North America

• Europe

• Germany
• France
• Italy
• Rest of Europe

• Asia-Pacific 

• China
• India
• Japan
• Rest of APAC

• Rest of the World (RoW)

• Brazil
• Rest of Latin America
• The Middle East and Others