The latest market report published by Credence Research, Inc. “Pharmaceutical Excipients Market – Growth, Future Prospects, and Competitive Analysis, 2018 – 2026,” the global pharmaceutical excipients market was valued at US$ 6,615.7 Mn in 2017 and expected to reach US$ 11,938.1 Mn by 2026 expanding at a CAGR of 6.87 % from 2018 to 2026.
Polymers segment currently dominates the pharmaceutical excipients market due to its vast application in drug formulation from conventional to novel drug delivery systems. Over the last two decades, polymers have undergone tremendous structural modification to improve the bioavailability and solubility properties of the API. In this research report, proper emphasis is given to decipher the current research being conducted in drug formulation and development studies entirely focusing on the use of polymers to effectively decouple the reduced intrinsic solubility of APIs by using various technologies that would disrupt the crystal lattice of drug candidate to increase their solubility.
Fillers and diluents comprises nearly 42% of the pharmaceutical excipients market and is the leading segment by function. Binders segment will be making a significant growth owing to the latest trend observed in the pharmaceutical industries investing huge in the excipients co-processing to overcome several obstacles in drug formulation and reducing the development costs.
Domicile of key players such as BASF SE and Roquette Group in the Western European region mainly define the pharmaceutical excipients market in Europe. In addition, flexible regulatory guidelines stipulated by the European Medical Agency (EMA) for the manufacturing of pharmaceutical excipients contribute to the dominance of Europe. Asia Pacific is set to register significant growth during the forecast period from 2018 to 2026, owing to low cost of raw material and efficient workforce. Moreover, emergence of local manufacturers has created a competitive environment for the key players, which contributes to the growth of pharmaceutical excipients market in Asia Pacific.
As per the research findings of the International Federation of Pharmaceutical Manufacturers Association (IFPMA) 2016 report, approximately 10% of the drugs currently marketed are poorly soluble. Moreover, 40% of the new chemical moieties are rejected due to their solubility issues. To overcome such challenges, excipients play a major role in determining the bioavailability of the API, change their gastrointestinal motility and even membrane permeability. Rise in chronic diseases due to unhealthy lifestyle and huge investments made by pharmaceutical industries in the formulation and development segment will drive the pharmaceutical excipients market growth. It is noteworthy to understand that due to incompatibility between excipients and API has resulted in the drug related adverse events which makes it mandatory for the manufacturers to maintain quality standards as per cGMP guidelines and maintain accuracy in accelerated stability testing studies. Key players are currently emphasizing on developing ecofriendly manufacturing processes as the production of excipients in large quantities causes environmental pollution, a major challenge faced by the pharmaceutical manufacturers.
The key players spearheading the pharmaceutical excipients market are Archer Daniels Midland Company, Associated British Foods Plc., Ashland, Inc., BASF SE, Croda International Plc., The Dow Chemical Company, Evonik Industries AG, FMC Corporation, Lubrizol Corporation and Roquette Group. However, entry of local players, particularly in developing countries is observed to be challenging the dominance of the top players.
Key Market Movements:
- Availability of cheap labor and raw material drives the pharmaceutical excipients market in emerging economies such as APAC and LATAM
- Pharmaceutical companies are investing huge in drug F&D in the co-processing and on line extensions of excipients to improve their functionality
- Stringent cGMP regulatory guidelines has resulted in rising demand for high grade pharmaceutical excipients
- Biopharmaceutical industries are focusing more on protein and peptide drugs that results in the growth of protein derived polymers market
- With drug solubility reducing significantly in the last 15 years (increased BCS Class IV and II compounds), the demand for surfactants, co-solvents etc. has increased drastically
pharmaceutical industry is ever thirsty to satisfy patient’s therapeutical needs and apart from active ingredients, inactive excipients play a major role in formulation development. Pharmaceutical excipients are substances other than the pharmacologically active drug or prodrug which are included in the manufacturing process or are contained in a finished pharmaceutical product dosage form.
In addition to transporting the active drug to the site in the body where the drug is intended to exert its action, excipients play an important part in the manufacturing process. They may also be important for keeping the drug from being released too early in the assimilation process in places where it could damage tender tissue and create gastric irritation or stomach upset.
Others help the drug to disintegrate into particles small enough to reach the blood stream more quickly and still others protect the product’s stability so it will be at maximum effectiveness at time of use. In addition, some excipients are used to aid the identification of a drug product.
Last, but not least, some excipients are used simply to make the product taste and look better. This improves patient compliance, especially in children. Although technically “inactive” from a therapeutic sense, pharmaceutical excipients are critical and essential components of a modern drug product. In many products, excipients make up the bulk of the total dosage form (1). Apart from the drug’s active ingredient, other essential components include diluents or fillers, binders, disintegrants, lubricants, coloring agents and preservatives (3). Diluents or fillers are inert ingredients that can significantly affect the chemical and physical properties of the final tablet thus affecting the biopharmaceutical profile.
One classic example of this are calcium salts, which can be utilized as fillers, which interfere with the absorption of tetracycline from the gastrointestinal tract. (4) This example emphasizes that excipients may not always be inert, as they may be perceived.
Usually tablets are designed so that the smallest tablet size which can be conveniently compressed is formed. Thus, if the dose is small more diluents are required and if the dose is high less diluents are required as not to increase the tablet size, which might make it difficult to swallow.