Biologic Excipients Market size was valued at $1,089 million by 2020, and is anticipated to reach $1,685 Million by the end of 2026 growing at a CAGR of 5.8% during the forecast period 2021-2026. The biologic excipients industry growth rate is attributed to the need for urgent development of effective vaccines, the presence of an expansive pharmaceutical industry and is expected to create new market opportunities. Biologic excipients are substances other than the pharmacologically active drug component, are included in the biologic drug manufacturing process or are contained in a finished pharmaceutical product dosage form. They facilitate formulation design and perform a range of functions such as increasing lubricity, enhancing flow ability, and improving compressibility, among others. Increasing demand for biologic excipients coupled with growing demand for extended-release or sustained-release formulations are driving the growth of the biologic excipients market globally. Biologic excipients product types include polymers, sugar alcohols, polysorbates, inorganic salts, amino acids, surfactants and others. Excipients are small molecules but critical part of every biologic drug. The key accomplishment in unlocking the potential for manufacturing pharmaceutical grade excipients to be used in developing biologics has been attained by initiating mass manufacturing of biologic excipients for pharmaceutical applications. Besides, leading companies in the biologic excipients industry are actively manufacturing various excipients for formulation development of biologics and other small and large molecule pharmaceuticals. Polymer excipients are mostly preferred over other biologic excipients available in the industry.
Biologic Excipients Market Segment Analysis – By Product Type
On the basis of product type, organic segment accounted for the largest segmental revenue of the biologic excipients market in 2020 and is expected to witness significant growth along the forecast period 2021-2026. The considerable segmental growth can be associated with the specificity of organic excipients that aids drug delivery process. Organic biologic excipients enhance the bioavailability of the final drug. Furthermore, organic excipients cost less as compared to the inorganic excipients and also have commendable binding properties. Moreover, these excipients are majorly plant based and free from any side-effects that increases their preference thereby, fostering the segmental growth.
Biologic Excipients Market Segment Analysis – By Formulation Type
On the basis of formulation type, oral formulations segment accounted for the largest segmental revenue of the biologic excipients market in 2020 and is poised to hold the highest growth rate with a CAGR of 6.89% over the forecast period 2021-2026. The growth is accredited owing to the fact that the oral formulations generally require more amount of excipients than other forms during the drug development process and is being promoted owing to adoption of increased patient-centricity approach by drug manufacturers. According to a survey, around 90% of the formulations available in the market are in the solid tablet form. Industry players have focused on integrating technology for facilitating the process of manufacturing oral formulations of improved quality. Furthermore, people usually prefer administering drugs through oral route since, it is convenient. Additionally, pharmacogenetics study suggests that efficacy of the oral formulations is considerably higher as compared to the topical formulations that positively influences the business growth. All these factors are anticipated to stimulate market growth during the forecast period 2021-2026.
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Biologic Excipients Market Segment Analysis – By Geography
North America is the major region dominating the Biologic Excipients market with a market share of 37.16% in the year 2020. This can be attributed to several factors such as the presence of key players, increasing drug development, and a large population base. U.S. biologic excipients industry is estimated to grow rapidly during the analysis period due to increasing prevalence of chronic disorders such as cancer and diabetes. According to National Cancer Institute, in 2018, over 1.7 million new cases of cancer were diagnosed and the number is still projected to increase in the near future. This scenario proves beneficial for the industry growth as it raises the demand for biological drugs. Furthermore, improving regulatory scenario will have a positive impact on the industry growth. Regulatory authorities are developing laws and regulations that has ensured availability of defect-free drugs in the market. Above mentioned factors propels the country growth.
However, Asia-Pacific is projected to be the significant-growing market during the forecast period 2021-2026 owing to 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.
Biologic Excipients Market Drivers
Increasing Demand for Generic Drugs
The Biologic Excipients market is poised to receive upswing owing to increasing demand for generic drugs development. Generic drugs are the exact copy of novel drugs that are available at lower prices in the market. These drugs provide same dosage, strength as well as quality of medication and make up for more than 80% prescriptions filled in the U.S. This scenario proves beneficial for biologic excipients industry growth as it increases the demand for biological excipients for manufacturing the generic drugs. Moreover, Asian countries with high disease prevalence project soaring demand for generics. For instance, Indian population majorly relies on the generic drugs as they are available at low prices and have showcased maximum efficacy in treating chronic diseases that has raised the demand for biologic excipients.
Biologic Excipients Market Challenges
Lack of Proper Data Documentation
Despite several drivers, lack of proper data documentation on GRAS status of excipients, regulatory audits restricting supply capacity, regulatory hurdles deterring novel excipient development, and stability testing of excipients imposing cost liabilities on drug manufacturers limit the growth of biologic excipients market over the forecast period 2021-2026.
Biologic Excipients Market Landscape
Product launches, mergers and acquisitions, joint ventures and geographical expansions are key strategies adopted by players in the Biologic Excipients Market. In 2020, Biologic Excipients Market share is fragmented by the top ten players present in the market. Biologic Excipients Market top 10 companies are B. Braun Melsungen AG, Medline Industries, Inc., Stryker Corporation, Ackermann Instrumente GmbH, ASFS Medic’s company, Medino GmbH, Peters Surgical, Medtronic, Mediflex Surgical Products and Grena LTD and others.
In January 2019, In January 2019, DuPont has recently invested fresh sums towards the development of a specialised excipient, FM1000 which could double the shelf life of surfactants.
North America dominated the Biologic Excipients Market with a share of 37.16% in the year 2020.
The factors such as rising global demand for medicines, greater uptake of biologics driving demand for parenteral formulations, increasing acquisition of contract research organizations are amongst the major factor projected to impel growth of Biologic Excipients Market.
The patent expiration of major blockbuster drugs, growing adoption of advanced drug delivery technologies, increasing research in pediatric formulations, growing demand for extended-release or sustained release formulations are to create opportunities paving a way for the growth in the market during forecast period 2021-2026.
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