Boston, MA, September 22, 2016 --(PR.com
)-- Excipients are a broad range of non-active components combined with active pharmaceutical ingredient (API) during formulation to form a desired finished drug product and perform a wide range of functions. It is usually identified as a substance that aid to function API with better functionality such as bioavailability, stability, good taste, texture and patient acceptability with safety and efficacy of pharmaceuticals to improve the quality-of-life of the patient at a lower cost. In fact, a few decades ago, excipients were not considered important due to their inactive nature, but now they are considered as one of the essential components in the production of tablets, liquid orals, powders, semi-solids and parenteral as excipients impact the stabilization of drug product in various conditions such as change in pressure, temperature, pH etc. Oral (tablets and capsule) dosage forms are mostly preferred due to ease of manufacturing and patient compliance and the development of these oral dosage forms involves direct compression and granulation process. The majority of vertically integrated companies develop in-house excipients and small formulators often rely on external suppliers to outsource specialised co-processed functionality excipients.
Presently, there is demand for the development of novel excipients with technological advancements like new chemical entity excipients, new chemically modified grade excipients, existing excipients with the various route of administration and co-processed excipients. These novel excipients increase the scope for the development of new formulations and drug delivery system which is a major gain for the industry, but high cost and lengthy developmental process along with the safety and quality issues are delaying the excipients approval. Combination excipients are mostly preferred by the manufacturers as the single excipients do not meet all the functional requirements such as high solubility, stability and bioavailability. As estimated by IQ4I Research, the global pharmaceutical excipients market is expected to grow at mid range single digit CAGR to reach $7,716 million by 2022.
Development of highly soluble excipients for sustained and controlled release formulations, global pharmaceutical excipient outsourcing, manufacturing of co-processed excipients using nano- and liposome-mediated technologies, strategic partnership/alliance among excipient manufacturers are some of the factors driving pharmaceutical excipient market whereas less interest in developing novel excipients, contamination issues in formulations, and delay in approval of novel excipients are the factors restraining market growth. Recently in 2015, IPEC-Americas calls FDA to review process for novel excipients and create new regulations to relieve the uncertainties around the use of new excipients. The most commonly used excipients in the small molecule are carbohydrates, oleochemicals, petrochemicals, metallic oxides, silicates etc whereas in large molecules sodium salts, solvents, emulsifiers and amino acids etc are used.
The pharmaceutical excipients market is mainly classified into source/origin, material type, manufacturing process, functionality, application, finished products and geography. The pharmaceutical excipient source/origin market includes animal-, plant-, mineral- and synthetic-based excipients. By material type the pharmaceutical excipient is classified into inorganic chemicals, organic chemicals and others. Inorganic chemical segment divided into calcium salts, halites, metallic oxides, silicates and others. Likewise, organic chemicals are further divided into carbohydrates including sugar (actual sugar, sugar alcohol, artificial sweetener), starch (modified, converted, dried) and cellulose (cellulose ether, cellulose ester, croscarmellose sodium, microcrystalline cellulose), petrochemicals including glycol (polyethylene, propylene glycol), povidone, mineral hydrocarbons (petrolatum, mineral waxes, mineral oils), acrylic polymers, others (antimicrobials, antioxidants, dyes & lakes), oleochemicals including fatty alcohol, mineral stearate, glycerin and others (alcohol, citric acid, lactic acid, polysaccharide gums, Shellac), proteins including gelatin and others including water for injection and purified water.
The pharmaceutical excipients manufacturing process market includes granulation and direct compression. The pharmaceutical excipient by functionality is segmented into fillers & diluents, binders & adhesives, suspension & viscosity agents, coatings, colorants, flavoring agents & sweeteners, disintegrants, lubricants & glidants, preservatives, solvents, solubilizers and others (anti-adherents, buffering agents, chelating agents, compression aids, foam control agents, sorbents, antioxidants, gelling agents, emulsifiers, emollients & humectants and plasticizers).
The pharmaceutical excipients by the application is divided into oral formulations (tablets, capsules & liquids), topical, parenteral and advanced delivery system. By finished products, the excipient market is classified into prescription and over-the-counter.
Geographical wise, North America is the largest market followed by Europe, Asia and Rest of the World. The Asia Pacific region is the fastest growing region with a highest single digit CAGR from 2015 to 2022 suggesting an array of opportunities for growth and likely to be getting into the eyes of new investors in the pharmaceutical excipients market.
The pharmaceutical excipients global market is a highly fragmented market and all the existing players in this market are involved in developing new and advanced products to maintain their market shares. Some of the key players of the pharmaceutical excipient market are Ashland, Inc (U.S.), Associated British Foods Plc (U.K.), Avantor Performance Materials, Inc (U.S.), BASF SE (Germany), Croda International Plc (U.K.), Dow Chemical Company (U.S.), Evonik Industries AG (Germany), FMC Corporation (U.S.), Lubrizol Corporation (U.S.) and Roquette (France).