The global biopharmaceutical excipients market size is expected to reach USD 3.4 billion by 2028, according to a new report by Grand View Research, Inc. The market is expected to expand at a CAGR of 6.5% from 2021 to 2028. The factors driving the market growth include increasing development of biosimilars, instability associated with drugs & vaccines, and growing focus on the development of novel drugs, among others.
The changing regulatory scenarios by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have impacted drug development. Several legislative proposals are addressing new ways for lowering the cost of prescription drugs. Similarly, in recent years there is an increasing focus on drug-manufacturing quality has led to several recalls by FDA and the EMA. Hence, the stringent investigations related to an examination of drugs are likely to promote the use of specific excipients for developing efficient drugs.
In addition, companies are collaborating with government authorities for increasing the application of novel compounds. For instance, in December 2019, U.S. FDA started a pilot program to evaluate novel biopharmaceutical excipients. Later, the initiative was supported by several companies such as AstraZeneca, Regeneron, and Janssen for FDA’s plan to review novel biopharmaceutical excipients. Regeneron highlighted different novel compounds that can potentially help in improving public health for example hydrophobic salts can reduce the viscosity of highly concentrated antibody formulations.
Moreover, the rising focus on the rapid development of COVID-19 vaccines and therapeutic drugs is further driving the market growth. Excipients have an essential role in the development of biologics as it helps in stabilizing the drug during storage and processing. The use of appropriate biopharmaceutical excipients enables the development of novel therapies and robust pharmaceutical products for fighting against the pandemic.
Large-scale pharmaceutical companies signed a long-term supply agreement with companies for supporting the development of COVID-19 vaccines. For instance, in November 2020, Pfizer Inc. signed a five-year contract with Croda International for lipid-based excipients that will be used for manufacturing Pfizer’s COVID-19 vaccine candidate. Similarly, in May 2020, Moderna signed a supply agreement with CordenPharma for the large-scale production of lipid excipient for the development of mRNA-1273, Moderna's COVID-19 vaccine candidate.
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Carbohydrates accounted for the largest revenue share of 36.2% in 2020 owing to the increasing use of carbohydrates owing to their several advantages
The advantages include it helps the efficient binding of tablet ingredients, enables accurate dosing and protecting the tablet from harsh environmental conditions, among others
Sucrose amongst the carbohydrates dominated with a market share of 32.8% owing to its increasing application in stabilizing proteins
Starch is expected to witness the fastest CAGR of 6.6% from 2021 to 2028 owing to the increasing launch of new starch excipients
For instance, in May 2019, Colorcon Inc. launched STARTAB, a new starch tableting excipient. It is developed by directly compressible starch for enhancing the stability of moisture sensitive API
North America has emerged as the highest revenue-generating region, representing a market share of 32.0% in 2020
Large pharmaceutical companies are entering in collaboration with the companies in the region which can be attributed to market growth
For instance, in February 2020, MilliporeSigma entered in an agreement with ReForm Biologics LLC for commercializing ReForm’s excipients that are used in biotherapeutic formulations
In Asia Pacific, the market is expected to witness a lucrative CAGR of 7.0% from 2021 to 2028 owing to the increasing production of biosimilar drugs in the region
The government in this region is promoting biosimilar development. For instance, the government of South Korea provided regulatory guidance to local biosimilars companies for aiming to develop around 22.0% of global biosimilars by 2020
Grand View Research has segmented the global biopharmaceutical excipients market on the basis of product and region:
Biopharmaceutical Excipients Product Outlook (Volume, Tonnes; Revenue, USD Million, 2017 - 2028)
Solubilizers & Surfactants/Emulsifiers
Biopharmaceutical Excipients Regional Outlook (Volume, Tonnes; Revenue, USD Million, 2017 - 2028)
Middle East & Africa
List of Key Players of Biopharmaceutical Excipients Market
Signet Excipients Pvt. Ltd
Sigachi Industries Limited
Associated British Foods plc
Spectrum Chemical Manufacturing Corp.
Evonik Industries AG
J. RETTENMAIER & SÖHNE GmbH + Co KG
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