Biologic excipients are substances other than the pharmacologically active drug component, which 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. An excipient being a pharmacologically inert substance is used as a delivery vehicle for APIs, or as flavor that is essential for obtaining improved palatability of medicines.
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.
Market Value and Forecast
In terms of revenue, the global biologic excipients market is projected to expand at a CAGR of 3.6% during the forecast period and is expected to be valued at US$ 1,706.2 million by the end of 2028.
Growth of global biologic excipients market is primarily driven by rising demand for medicines from emerging economies pushing local drug production, greater uptake of biologics driving demand for parenteral formulation, increasing acquisition of contract research organizations (cros), increasing demand for oral solid liquid formulation, patent-expiration of major blockbuster drugs and growing adoption of advanced drug delivery technologies.
The ability of biologic excipients to offer increased efficacy of biologics through enhancement of solubility and bioavailability, enabling controlled/sustained release delivery performance coupled with introduction of innovative technologies focused to target pediatric and geriatric patient populations has made biologic excipients a key preference for biologic drug manufacturers.
Also, oral dosage forms generally require more amount of excipients than other forms during the drug manufacturing process and is being promoted due to adoption of increased patient-centricity approaches by drug manufacturers. However, 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.
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Market Segmentation, by Excipient Type
Based on excipient type, the global biologic excipients market is segmented into polymers, sugar alcohols, polysorbates, inorganic salts, amino acids, surfactants and others. Polymers excipient type segment is expected to witness relatively higher growth rates in terms of value in the global biologic excipients market over the forecast period.
Market Segmentation, by End User
Based on end user, the biologic excipients market is segmented into biopharmaceutical manufacturers, contract research organizations/contract manufacturing organizations and research organizations. Currently, biopharmaceutical manufacturers segment accounts for relatively higher revenue share, followed by hospitals segment in 2017.
The global biologic excipients market is segmented into seven major regions: North America, Latin America, Western Europe, Eastern Europe, Asia Pacific (Asia-Pacific excluding Japan), Japan and Middle East & Africa (MEA). In terms of value, North America is expected to be the dominant regional market by 2018 end and is expected to expand at a CAGR of 3.6% over the forecast period. Western Europe and Asia Pacific excluding Japan is expected to be the fastest growing market in terms of revenue growth in the global biologic excipients market, registering a CAGR of 3.9% and 4.2% respectively over the forecast period.
The global biologic excipients market is segmented on the basis of excipient type into:
- Sugar Alcohols
- Inorganic Salts
- Amino Acids
The report begins with definition of biologic excipients market, followed by definition of different biologic excipients product types. The market dynamics section includes FMI’s analysis on key trends, drivers, restraints, opportunities and macro-economic factors influencing the growth of the global biologic excipients market.
The report analyses biologic excipients market on the basis of end users and presents forecast in terms of value for the next 10 years. On the basis of end users, the global biologic excipients market is categorized into:
- Biopharmaceutical Manufacturers
- Contract Research Organizations/Contract Manufacturing Organizations
- Research Organizations
Next, the report analyses biologic excipients market on the basis of regions and presents forecast in terms of value for the next 10 years. On the basis of regions, the global biologic excipients market is segmented into:
- North America
- Latin America
- Rest of Latin America
- Western Europe
- Rest of Western Europe
- Eastern Europe
- Rest of Eastern Europe
- Asia Pacific
- Australia & New Zealand
- Rest of APAC
- GCC Countries
- South Africa
- Rest of MEA