Biopharmaceutical Excipients Market Size, Share & Trends Analysis Report By Product (Polyols, Solubilizers & Surfactants/Emulsifiers, Carbohydrates), By Region, And Segment Forecasts, 2020 - 2027

Industry Insights

The global biopharmaceutical excipients market size was valued at USD 1.9 billion in 2019 and is anticipated to reach USD 3.0 billion by 2027, registering a CAGR of 5.9% over the forecast period. A gradual expansion of the application of biopharmaceutical excipients to provide better functionality and cutting-edge drug formulations is driving the market growth. The advent of innovative excipients and an increase in the number of distribution agreements between vendors are also projected to drive the market growth over the forecast period.

Maintaining drug stability while reducing overall costs associated with drug development is of utmost importance to achieve large-scale commercial biopharmaceutical manufacturing. Thus, current research and development activities are targeted toward addressing the aforementioned challenges, further offering potential opportunities for start-ups and established pharmaceutical manufacturers.

Active substances of drugs cannot be administered alone and need to be conjugated with an excipient to ensure that the drug is stable. Biopharmaceutical excipients hence play a central role in the overall drug manufacturing process including dosage formulations that are stable for administration. Thus, the use of biopharmaceutical excipients is primarily targeted toward maintaining the properties of pharmaceutical dosage forms during storage and administration in patients.

The presence of a robust legislative framework to regulate drug quality standards has propelled the adoption of excipients across bio-generics and biosimilars. This is also supplemented by declining costs and timelines associated with the development of biosimilars. With the increasing demand for biosimilars as potent affordable alternatives, the use of biopharmaceutical excipients is also expected to rise significantly.

Additionally, a substantial increase in demand for functional excipients has been witnessed in recent years. This is owing to continuous biopharmaceutical manufacturing, which suggests that present monographed active pharmaceutical ingredients (APIs) are insufficient to support the latest novel drug discoveries. Emerging multi-functional excipient products are also targeted toward enhancing drug delivery flexibility and formulation.

Outsourcing of biologics manufacturing is expected to emerge as a major trend over the next few years owing to the need for minimizing monetary investments in drug development. However, a majority of excipient manufacturers also develop biopharmaceuticals, which offers these players the advantage of conducting in-house formulations and production while minimizing dependency on outside suppliers.

Product Insights

Carbohydrate-based excipients dominated the global biopharmaceutical excipients market in 2019 in terms of revenue as well as volume and this trend is expected to continue through the forecast period. The wide use of sucrose, starch, and dextrose across drug formulations has contributed significantly toward the dominant share of the segment. In addition, rapid adoption of carbohydrates as bulking agents for the lyophilization of biomolecules has been a key trend in recent years. They are also widely utilized as organic excipients because of their filling and taste-masking properties. In addition, several carbohydrate products including galactose, sucrose, and glucose are involved in the development of small molecules and proteins.

Dextrose is primarily used as a tonicity agent in biologics. Several forms of dextrose are incorporated in drug formulations, which include dextrose monohydrate, dextrose anhydrous, and maltodextrins. Apart from being a primary ingredient in oral rehydration solution (ORS), dextrose monohydrate is also considered as the preferred biopharmaceutical excipient to be used in pharmaceutical tablets as a sweetener.

Solubilizers and surfactants accounted for the second-largest share of the global market in, terms of value, in 2019 due to their increasing use in drug formulations to maintain hydrophilic-lipophilic balance and overcome challenges related to drug solubility. Furthermore, in terms of revenue, triglycerides are major contributors to the revenue generated by solubilizers and surfactants in the global market.

Triglycerides as solubilizers or emulsifiers are used for the formulation of parenteral drug delivery systems. Incorporation of triglycerides benefits the lipid-based injectable delivery systems where these biopharmaceutical excipients overcome challenges related to poor water solubility and low permeability. Currently, long-chain triglycerides are highly recommended for clinical applications; however, ongoing advancements such as introduction of chain triglycerides drive the segment growth.

Regional Insights

North America accounted for the largest share in 2019 in terms of revenue. The region has witnessed a significant demand for biopharmaceutical production along with the need for maintaining the quality of high-grade raw materials used for the development of biopharmaceuticals. This has compelled several regional excipient manufacturers to expand their production capacities for biopharmaceutical excipients to keep up with the rapid up-scaling of drug development that comply with regulatory standards.

Japan, China, and India were the major contributors to the revenue generated in Asia Pacific in 2019 and this trend is expected to continue over the forecast period. Increasing disease incidences and growing demand for low-cost drugs drive the demand for biopharmaceutical excipients in India and China. Japan is among the top five countries in terms of pharmaceutical production and hence offers lucrative opportunities for foreign players to enter the Japanese biopharmaceutical industry.

Biopharmaceutical Excipients Market Share Insights

Major market players 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.

The market is largely fragmented in nature owing to the presence of a large number of medium- and large-sized players. Several strategic initiatives such as portfolio expansions and collaborations have been adopted by market players to expand their market presence. For instance, in February 2019, ABITEC expanded its excipient portfolio by developing CAPMUL GDB EP/NF. This monographed glyceryl dibehenate is designed for maintaining uniform particle size of multiple formulations such as tablets, soft gels, hard gels, multi-particulates, nano-structured lipids, extrudates, and other formulations.

Moreover, in December 2018, Merck extended its collaboration with Kuraray Europe for the supply of its pharmaceutical Polyvinyl Alcohol (PVA) polymers. Under this collaboration, Kuraray supplied a wide range of PVA polymer grades to Merck for drug formulation and delivery applications.

Report Scope

Segments Covered in the Report

This report forecasts volume and revenue growth at global, regional, and country levels and provides an analysis of latest industry trends in each of the sub-segments from 2016 to 2027. For the purpose of this study, Grand View Research has segmented the global biopharmaceutical excipients market report based on product and region:

• Product Outlook (Volume, Tons; Revenue, USD Million, 2016 - 2027)

  • Solubilizers & Surfactants/Emulsifiers

    • Triglycerides

    • Esters

    • Others

  • Polyols

    • Mannitol

    • Sorbitol

    • Others

  • Carbohydrates

    • Sucrose

    • Dextrose

    • Starch

    • Others

  • Specialty Excipients

• Regional Outlook (Volume, Tons; Revenue, USD Million, 2016 - 2027)

  • 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