Pharmaceutical excipients are designed to interact and enhance the properties of active pharmaceutical ingredients (APIs). Excipients are made to promote various ingredient qualities and have become a valuable asset for drug formulators. Excipients can be included for long-term stabilization, bulking up solid formulations that contain APIs in small amounts, or to provide an enhancement of the active ingredient in the final dosage form. Moreover, excipients are used to improve properties of the drug formulation such as increasing drug absorption, reducing viscosity, and improving solubility of APIs in the formulation.
Furthermore, patient compliance and formulation safety is offered by the use of pharmaceutical excipients in drug formulation. Excipients such as sweeteners and flavoring agent are used in the pharmaceutical formulation to mask the bitter taste of API’s, and helps to increase patient compliance for drug formulation. For instance, the International Pharmaceutical Excipient Councils (IPE) governs the global pharmaceutical excipients manufacturing by providing harmonized excipient guidelines to manufacturers. IPE provide general guideline such as Good Manufacturing Practices implementation for excipient, guideline for manufacturing site selection, safety manufacturing and others
The global pharmaceutical excipients market size was valued at US$ 6,557.6 Million in 2018, and is expected to exhibit a CAGR of 6.9% over the forecast period (2019–2027).
Figure 1. Global Pharmaceutical Excipients Market Value (US$ Mn), by Region, 2018
Source: Coherent Market Insights Analysis (2019)
Oral and topical segment is driving pharmaceutical excipients market growth
Excipients are largely used in the production of oral dosage forms such as tablets, capsules, and liquids owing to formulation stability and shelf-life of oral dosage drugs. Moreover, based on application, the pharmaceutical excipients market is segmented into oral, topical, and parenteral. Currently, there is growing focus on using liposomes for the delivery of topical drugs. Liposomes are used as models for artificial cells. It naturally neutralizes the pH of drug itself by protons mechanism and allowing it to freely pass through a membrane. These liposomes deliver drug by diffusion process rather than direct cell fusion. Such novel drug delivery approaches helps to propel growth of the global pharmaceutical excipients market.
Furthermore, increasing demand for novel drug formulations is a factor that is propelling growth of the global pharmaceutical excipients market. For instance, according to the research article published by The National Center for Biotechnology Information (NCBI) on June 2019, researchers from the University of Sussex developed a new oral dosage form to tackle bioavailability challenges such as drug absorption, drug metabolism and first pass metabolism of oral dosage forms. They developed Liqui-pellet oral dosages for drug delivery by using liquisolid technology that involves extrusion-spheronization process.
Figure 2. Global Pharmaceutical Excipients Market Share (%), by Application
Source: Coherent Market Insights Analysis (2019)
Patent expiries to provide opportunities for pharmaceutical excipients manufacturers
According to the McKinsey’s Global Generics report 2017, Symbicort (budesonide/formoterol fumarate dihydrate), Cialis (tadalafi), Velcade (bortezomib), Alimta (pemetrexed), Vytorin (ezetimibe and simvastatin), Cubicin (daptomycin), Reyataz (atazanavir), and Sandostatin LAR (octreotide acetate) are some of the major brands that went off-patent in 2017. This will pave way for generic brands, boosting the demand for pharmaceutical excipients
Moreover, according to the McKinsey’s Global Generics report, around US$ 97 billion worth of drugs will go off-patent over 2017 – 2019.
Furthermore, most of the key players are focusing on strategic collaboration in order to expand their product portfolio in the global pharmaceutical excipients market. For instance, in March 2019, BASF collaborated with Nuritas, a startup based in Ireland, for the launched of PeptAIde a sport nutrition product in china. PeptAIde helps to modulate inflammation for post-workout recovery, it contains a unique set of plant-based peptides, identified using artificial intelligence.
Moreover advent of biosimilars would further propel growth of the pharmaceutical excipients market. Companies are investing in development of biosimilars to capitalize on this billion dollar market opportunity. However, strict regulatory hold over approval of biosimilars is slowing the approval of biosimilars being developed, in turn hampering growth of the pharmaceutical excipients market.
Major players operating in the global pharmaceutical excipients market include BASF SE, DOW Chemical Company, FMC Corporation, Evonik Industries AG, Croda International PLC, Ashland Inc., Roquette Group, Lubrizol Corporation, Innophos Holdings Inc., MEGGLE Excipients & Technology, and others.
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