Pharmaceutical excipients market is classified as organic and inorganic based on the type of pharmaceutical excipient products commercially available. Rise in healthcare expenditures, demand for new drug delivery systems along with need for enhanced medications are generating impetuous on pharmaceutical excipients market. Various pharmaceutical excipients are used for different drugs depending up on the complexity of the diseases. Another trend that drives the growth of this market is extensive research on the excipients that has given a better understanding of their functional benefits, thus their inclusion in the drug formulation has increased.
The pharmaceutical excipient production has been boosted with the advent in industries particularly pharmaceutical industry. Excipient quality plays a vital role in assuring safety, quality and efficacy of dosage forms. Standardization of excipients usually assures the customers of uniform quality across pharmaceutical products, while manufactures are assured of standardized prices of these excipients. The increased spending on healthcare by developing countries is set to increase the utilization of pharmaceutical excipients.
Binders segment is poised to dominate this market during 2017-2023.The pharmaceutical excipients market had total revenue estimated to $4256.3 million in 2017 which is expected to grow at rate of 6% till forecasted year 2023. The enormous potential for pharmaceutical excipients is also indicated by growing healthcare expenditures, rising income levels and improving health awareness amongst peoples.
What are Pharmaceutical Excipients?
An excipient can be defined as pharmacologically inactive substance in the drug delivery system which is formulated with the active pharmaceutical ingredient of a medication to prepare the product in a consumable form. Pharmaceutical excipients are inert substances, other than the pharmacologically active drug, which are included in the manufacturing process or are present in the pharmaceutical product dosage form. They enhance the properties such as bulkiness of the pharmaceutical formulation so that it can be consumed in proper manner. It also promotes the drug absorption quality of the pharmaceutical product. They do not react unwillingly with the drug and help to achieve desired drug functionality. Novel and increasingly complex excipients have been developed as the novel drug formulation delivery systems have emerged and evolved.
What are the major applications for Pharmaceutical Excipients?
Excipients are vital in formulating a dosage form of the drug or any pharmaceutical product, for adding bulk to solids (formulas) and also to facilitate proper absorption. These ingredients make up the dosage forms along with active pharmaceutical ingredients. They act as protective agents, bulking agents, flavoring and coloring agents and can also be used to improve bioavailability of drugs in some instances.
Many excipients are potential toxicants at high doses in animals, though safe in humans at therapeutic doses, including commonly used excipients such as cyclodextrins, dextran, and polyethylene glycol. Pharmaceutical excipients are vital in processing stage as they help to improve the processing of the drug delivery system during its manufacture itself. They protect, support, or enhance stability, or patient acceptability of the drug. They also assist in product identification, and enhance attributes of the overall safety in storage and also in maintaining the integrity of the drug product during storage.
Market Research and Market Trends of Pharmaceutical Excipients Ecosystem
- New technologies related to the controlled release of small molecule drugs have been introduced in recent developments. Lubrizol LifeScience Polymers (LSP) has introduced its Pathway pharmaceuticalgrade thermoplastic polyurethane (TPU) excipients which offer controlled release in drug delivery systems and other applications. Lubrizol is now producing the materials under GMP conditions, which allows their use as excipients.
- EMD Millipore introduced Parteck SRP 80 which is a new polyvinyl alcohol (PVA)-based functional excipient. It is specifically designed for oral sustained-release formulations, particularly direct-compression processes. Manufacturers have promised its reliable performance profile and ability to facilitate the development of robust and cost-efficient manufacturing processes.
- MannKind Corporation has developed (AFREZZA) a non-injectable (orally inhaled) mealtime insulin therapy for improving glycemic control in adult patients with diabetes mellitus. MannKind is exploring the potential application of this technology for the pulmonary delivery of other drug substances. A novel excipient–fumaryl diketopiperazine (FDKP)–is inert and serves as a particle matrix (crystalline or amorphous) enhances effectiveness of the inhaled form of insulin. It carries the active drug and dissolves at the prevailing physiological pH in the lungs, where it is absorbed into the systemic circulation. Cipla tied with MannKind recently and will be responsible for obtaining regulatory approvals to distribute Afrezza in India, including approval from the Drug Controller General of India (DCGI).
- The material ‘Upsalite’ has been developed by company Disruptive Materials. It was first synthesized by researchers at Uppsala University; it is highly porous with a very large surface area and enables the controlled release of APIs including ibuprofen. It has been commercialized as a water-free, disordered, amorphous magnesium carbonate. It is thought that trapping of the drug molecules in the narrow pores of the material prevents them from adopting a poorly soluble, crystalline form.
- Pharmaceutical formulation experts are continuously working to improve the manufacturing process and product quality by using multi-functional excipients. It can help pharma manufacturing by improving flowability, enhancing compressibility, improving bioavailability, particle size distribution and reduced dust generation, etc. Evonik’s newly launched EUDRAGIT FS 100 is a solid version of existing EUDRAGIT FS 30 D. It allows pharmaceutical companies to use the polymer in various applications, such as hot melt extrusion, solvent spray-drying and solvent coating, which was impossible to achieve in prior decades where only the aqueous version was available. This multi-functionality approach allows overall new development possibilities within the pharmacy industry.
Who are the Major Players in Pharmaceutical Excipients market?
The players profiled in the report include BASF SE, Dow Chemical, FMC Chemical and Nutrition, Fuji Chemical Industry, Evonik, Ashland Inc., Roquette Group, The Lubrizol Corp., Colorcon, Croda International Plc.
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