The global biopharmaceutical excipients market size was estimated at USD 3.6 billion in 2022 and is expected to surpass around USD 6.16 billion by 2032 and poised to grow at a compound annual growth rate (CAGR) of 5.51% during the forecast period 2023 to 2032.
Biopharmaceutical Excipients Market Report Scope
|Market Size in 2023||USD 3.8 Billion|
|Market Size by 2032||USD 6.16 Billion|
|Growth Rate From 2023 to 2032||CAGR of 5.51%|
|Forecast Period||2023 to 2032|
|Segments Covered||Product, Region|
|Market Analysis (Terms Used)||Value (US$ Million/Billion) or (Volume/Units)|
|Regional Scope||North America; Europe; Asia Pacific; Central and South America; the Middle East and 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|
The increasing focus of pharmaceutical players on the generic market, rising adoption of multifunctional excipients, and patent expiry of biological actives are the key factors propelling market growth. Furthermore, the cost-efficiency & competency of manufacturers and the chemical and physical instability of biopharmaceuticals are boosting the development of excipients, thus propelling the market.
The demand for biosimilars has increased in recent years, which has in turn led to a rise in the demand for biopharmaceutical excipients. Supporting factors such as patent expirations, increasing government funding, patient demographics, and rising affordability have propelled the adoption of biosimilars across the globe. In addition, the rapidly evolving healthcare infrastructure in developing economies has increased their use in the production of biogenerics. Furthermore, the introduction of well-framed legislation to ensure proper regulatory and testing standards for biosimilars globally is set to ease market entry for manufacturers.
Moreover, the growing acceptance of multi-functional biopharmaceutical excipients in industries is also driving market growth. They are efficient and effective in enhancing the manufacturing process for biopharmaceuticals. Associated advantages include better product quality, improved productivity, and reduced operating costs. The success of COVID-19 vaccines majorly relies on their efficiency, which has been enhanced by using efficient drug delivery systems; this offers immense lucrative opportunities for market entities.
Key operating players in the market are focusing on the development and launch of novel biopharmaceutical excipients. For instance, in April 2021, DFE Pharma introduced a new excipient product line ‘BioHale’ to address global supply challenges for biopharmaceutical companies. Furthermore, the geographical expansion of manufacturing facilities is increasing, owing to the rising demand for biopharmaceutical excipients. For instance, in May 2022, DFE Pharma opened a new facility in India to offer fast-track formulation services, including excipients, for pharmaceutical players to achieve the right formulations.
However, issues pertaining to the supply chain in the biopharmaceutical industry and challenges in the development of excipients for biologics are expected to hamper the market during the forecast period. Selecting the right excipient for biopharmaceuticals is a challenging and complicated task, as an excipient effective in one formulation may cause degradation or aggregation of the protein in another. A limited number of known & approved products for the stabilization of protein further increases challenges for biopharma manufacturers. Hence, to deal with these challenges, researchers are developing new and innovative approaches. For instance, to maintain the stability of lipid-based excipients (HMC excipients), researchers have applied polyglycerol esters of fatty acids (PGFAs). Currently, these products are witnessing an increasing demand for the development of COVID-19 vaccines.
Carbohydrate-based excipient products dominated the market in 2022 with a revenue share of 35.91%, 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.
High-purity carbohydrates such as trehalose are being rapidly adopted in the development of biosimilars due to their ability to enhance the yield of the final product, stabilize various biologics, prevent aggregation, and improve the entire process of biopharmaceutical manufacturing. 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 polyols segment is expected to witness the fastest CAGR over the forecast period. Polyols are sugar alcohols found in certain fruits, vegetables, and sugar-free sweeteners. The growth of this segment can be attributed to the increasing demand for protein therapeutics. Polyols are added in protein formulations for increasing tonicity and stability. Moreover, they have also been shown to offer greater thermodynamic stability, which is essential for protein-based formulations.
Most therapies based on biomolecules are lyophilized to prevent aggregation and degradation. All lyophilized formulations use one or the other polyol. Sorbitol (polysorbate 80 & polysorbate 20) and mannitol are the most widely used polyols. In October 2022, Roquette introduced two next-generation mannitol excipients, PEARLITOL 200 GT and PEARLITOL CR-H, for direct compression and controlled release of mini tabs and tablets.
North America accounted for the largest market share of 31.95% in 2022. The regional growth can be attributed to several large-scale pharmaceutical manufacturing companies operating in this region. The region has witnessed a significant demand for biopharmaceutical production, along with the need to maintain the quality of high-grade raw materials used to develop biopharmaceuticals. This has compelled several regional excipient manufacturers to achieve the required production scalability by using biopharmaceutical excipients that comply with the regulatory standards.
Furthermore, companies operating in the region are conducting new studies for developing efficient excipient solutions. For instance, in February 2021, Innophos released a whitepaper that focused on co-processed multifunctional excipients for enhancing compressibility, increasing manufacturing efficiency, simplifying labels, and reducing tablet size. This technology will continue to grow as it helps in reducing ingredients on the label without compromising efficacy and will help in reducing operational costs for manufacturers.
The Asia Pacific market is anticipated to witness the fastest growth rate of around 6.1% during the projection period, owing to the presence of large CMOs involved in drug development. Countries in this region such as South Korea, India, and China are majorly involved in the advancement of biosimilars. There are numerous reasons for the extensive development of biosimilars, including the presence of a large patient pool, cost advantages, affordability, and favorable regulatory framework.
Numerous biopharmaceutical manufacturers, who are potential customers for the market, have their manufacturing units in Asian countries. International biopharma players are involved in shifting their manufacturing and R&D operation sites to these countries owing to the significant cost advantages offered in the value chain. The spiraling demand for biosimilars is, in turn, bolstering the demand for novel excipients. These factors are expected to propel the Asia Pacific region’s growth in the near future.
Some of the prominent players in the Biopharmaceutical Excipients Market include:
Segments Covered in the Report
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 2018 to 2032. For this study, Nova one advisor, Inc. has segmented the global Biopharmaceutical Excipients market.