The global biopharmaceutical excipients market size was valued at USD 2.1 billion in 2020 and is expected to expand at a compound annual growth rate (CAGR) of 6.5% from 2021 to 2028. Excipients play an essential role in biopharmaceuticals by helping the efficient binding of ingredients, modifying the solubility and bioavailability of API, and increasing drug stability in the dosage form. Hence, selecting the right excipient is important for reducing the manufacturing costs and helps in improving the patient’s experience.
The selection of the right excipient helps in overcoming several challenges associated with biopharmaceuticals. For instance, there are several drugs such as protein-based drugs that are commonly associated with the instability that requires the process of lyophilization. However, lyophilization is a highly time and energy-consuming process. Hence, the incorporation of drug-specific excipients contributes significantly to maintaining the stability of a biologically active ingredient which indirectly affects the time needed for lyophilization.
In addition, the gaining popularity of multi-functional biopharmaceutical excipients is further driving the market growth. They are effective and efficient in improving the manufacturing process for biopharmaceuticals. The associated advantages include reducing operating costs, enhancing productivity, and improve product quality. The success of COVID-19 vaccines largely relies on their efficacy that can be improved by using efficient drug delivery systems; this offers immense lucrative opportunities for the market entities.
Companies are focusing on developing specialty biopharmaceutical excipients and adjuvants for improving the stability and effectiveness of novel drugs and vaccines. For instance, Croda International Plc developed a novel biopharmaceutical excipient that is used by Pfizer to manufacture its COVID-19 vaccine candidate. Companies are increasingly focusing on the development of co-processed multifunctional biopharmaceutical excipient formulations and practicing promotional strategies.
Pandemic Impact |
Post COVID Outlook |
Multi-functional excipients have gained significant popularity in recent years, expected to drive the market. |
Biopharmaceutical excipients are expected to gain traction post the pandemic outbreak, with high demand across re-purposing existing drugs & vaccine development for the management of SARS-COV-2 infection. |
Market participants are focusing on the development of co-processed multifunctional excipient formulations anticipated to propel market expansion. |
An array of effective excipient formulations are being introduced for the stabilization of vaccines and biologics during storage & processing, which is set to offer new opportunities to the market players, particularly post the pandemic outbreak. |
For instance, in February 2021, Innophos released a whitepaper on such formulations in tableting owing to its several advantages such as reducing tablet size, simplifying labels, enhancing compressibility, and increasing manufacturing efficiency. There are several complexities associated with manufacturing biopharmaceuticals. The companies are increasingly reliant on external suppliers for biopharmaceutical excipients, hence the disruption in the supply chain will adversely affect the market growth. However, the restructuring of the supply chain will ensure robust and reliable manufacturing and quality assurance.
North America represented the largest market share of 32.1% in 2020; growth in the region can be attributed to several factors such as the presence of key players, increasing drug development, and a large population base.
Companies in this region are doing collaborations to develop biopharmaceutical excipients. For instance, in February 2020, ReForm Biologics LLC, and MilliporeSigma entered in collaboration for commercializing the company’s proprietary excipients that are used in biotherapeutic formulations. Under the collaborating agreement, MilliporeSigma will fund the R&D and commercialize ReForm Biologics’ excipients for promoting drug development.
In Asia Pacific, the market is expected to witness the fastest growth rate of over 7.0% owing to the presence of large CMOs involved in drug development. The countries in this region such as China, India, and South Korea are majorly involved with the development of biosimilars. There are several reasons for the extensive development of biosimilars such as affordability, favorable regulatory framework, cost advantages, and presence of a large population base. Hence, the development of biosimilars requires biopharmaceutical excipients to ensure drug stability.
Carbohydrate-based excipient products dominated the market in 2020, with a share of 36.2%, and this trend is expected to continue through the forecast period. The extensive use of starch, sucrose, and dextrose in various drug formulations can be primarily attributed to the dominant share of the segment. In addition, the increasing adoption of carbohydrates as bulking agents for assisting in the process of lyophilization for biomolecules such as proteins is further contributing to segment growth.
The starch segment is expected to witness the fastest CAGR of 6.6% owing to its wide application in drug development. It can act as an efficient binder, diluent, and disintegrant that can be used for various non-prescription medications, biopharmaceuticals, and food supplements. The increasing application of starch is owing to its advantages such as cost-effectivity, inert nature, and high availability.
The polyols segment is expected to witness a lucrative growth rate of 6.7% from 2021 to 2028. The growth in the segment can be attributed to the increasing protein therapeutics. Polyols are added in protein formulations for increasing tonicity and stability. Moreover, it has also been shown to offer greater thermodynamic stability which is highly essential for protein-based formulations.
Companies are launching new and advanced excipient solutions for supporting pharmaceutical drug development. For instance, in April 2020, DFE Pharma launched a new portfolio of biopharmaceutical excipients for stabilizing biologics. BioHale, the new range of excipient portfolio, consists of the highest purity excipients that can be used in the formulation. It contains BioHale Sucrose and BioHale Trehalose that is currently under development and will be available through online sales. Some of the prominent players in the biopharmaceutical excipients market include:
Merck KGaA
Colorcon
BASF SE
Associated British Foods plc
Signet Excipients Pvt. Ltd (IMCD)
Sigachi Industries Limited
Spectrum Chemical Manufacturing Corp.
Roquette Frères
IMCD
Clariant
DFE Pharma
J. RETTENMAIER & SÖHNE GmbH + Co KG
Evonik Industries AG
Report Attribute |
Details |
Market size value in 2021 |
USD 2.3 billion |
Revenue forecast in 2028 |
USD 3.4 billion |
Growth rate |
CAGR of 6.5% from 2021 to 2028 |
Base year for estimation |
2020 |
Historical data |
2017 - 2019 |
Forecast period |
2021 - 2028 |
Quantitative units |
Volume in Tonnes, Revenue in USD Million and CAGR from 2021 to 2028 |
Report coverage |
Revenue forecast, competitive landscape, growth factors, and trends |
Segments covered |
Product, region |
Regional scope |
North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
Country Scope |
U.S.; Canada; Germany; U.K.; Japan; China; India; Malaysia; South Korea; Philippines; New Zealand; Australia; Singapore; Indonesia; Brazil; South Africa |
Key companies profiled |
Merck KGaA; Colorcon; BASF SE; Associated British Foods plc; Signet Excipients Pvt. Ltd (IMCD); Sigachi Industries Limited; Spectrum Chemical Manufacturing Corp.; Roquette Frères; IMCD; Clariant, DFE Pharma; J. RETTENMAIER & SÖHNE GmbH + Co KG; Evonik Industries AG |
Customization scope |
Free report customization (equivalent to up to 8 analyst’s working days) with purchase. Addition or alteration to country, regional & segment scope |
Pricing and purchase options |
Avail customized purchase options to meet your exact research needs. Explore purchase options |
This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2028. For the purpose of this report, Grand View Research has segmented the global biopharmaceutical excipients market report on the basis of product and region:
Product Outlook (Volume, Tonnes; Revenue, USD Million, 2017 - 2028)
Solubilizers & Surfactants/Emulsifiers
Triglycerides
Esters
Others
Polyols
Mannitol
Sorbitol
Others
Carbohydrates
Sucrose
Dextrose
Starch
Others
Specialty Excipients
Regional Outlook (Volume, Tonnes; Revenue, USD Million, 2017 - 2028)
North America
U.S.
Canada
Europe
Germany
U.K.
Asia Pacific
Japan
China
India
Malaysia
South Korea
Philippines
New Zealand
Australia
Singapore
Indonesia
Latin America
Brazil
Middle East & Africa
South Africa
b. The global biopharmaceutical excipients market size was estimated at USD 2.07 billion in 2020 and is expected to reach USD 2.26 billion in 2021.
b. The global biopharmaceutical excipients market is expected to grow at a compound annual growth rate of 6.49% from 2021 to 2028 to reach USD 3.42 billion by 2028.
b. Carbohydrates dominated the biopharmaceutical excipients market with a share of 36.16% in 2020. This is attributed to the wide use of sucrose, starch, and dextrose across drug formulations along with the rapid adoption of carbohydrates as bulking agents.
b. Some key players operating in the biopharmaceutical excipients market include Merck KGaA, Signet Chemical Corporation Pvt. Ltd., Sigachi Industries Pvt. Ltd., Associated British Foods, Spectrum Chemical Manufacturing Corp., Roquette Frères, IMCD, Clariant, DFE Pharma, Colorcon, J. RETTENMAIER & SÖHNE GmbH + Co KG, BASF SE, and Evonik Industries AG.
b. Key factors that are driving the biopharmaceutical excipients market growth include the advent of innovative excipients, an increase in the number of distribution agreements between vendors, and gradual expansion of the application of biopharmaceutical excipients to provide cutting-edge drug formulations.
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