The pharmaceutical excipients market in the developing economies has lucrative growth opportunities due to the availability of inexpensive raw materials and economical workforce. The global pharmaceutical excipient manufacturers are relocating to the developing economies by adopting strategies such as, agreement & acquisition with the local players. Moreover, lack of stringent regulations for the production of excipients also supports its growth in the developing economies, according to some recent reports.
While developed regions like North America and Europe will show a sluggish growth, emerging markets like Asia-Pacific and Rest of the World is expected to record a strong growth..Countries like India, China, and Brazil will majorly drive the growth of these emerging markets owing to rising number of companies from the developed regions outsourcing their excipients manufacturing activities to these regions due to low manufacturing and labour costs in these countries.
Asia-Pacific, fastest growing market
Asia-Pacific is anticipated to be the fastest growing pharmaceutical excipients market, for both organic and inorganic chemicals, in terms of volume and revenue during 2015 and 2020.North America accounted for about one third of the overall market revenue in 2015 owing to the presence of large number of pharmaceutical companies.
While the factors such as rising demand for pharmaceutical drugs, increasing popularity of functional excipients, drug pipeline, development of novel excipients, and increasing generic drugs market caused by expiration of various best-seller drugs patents are driving the global pharmaceutical excipients market, factors that are likely to impede the market growth include, supply chain issues, high market fragmentation and implementation of stringent regulations, the reports add.
Market size
A new report published by Allied Market Research projects that the world pharmaceuticals excipients market would reach $6.4 billion by 2020 at a CAGR of 7.6 per cent during 2015 and 2020.The world pharmaceutical excipients market size is estimated to reach 728.4 kilo tons in volume by 2020, accounting for a revenue of $6.4 billion.
Swelling utilization of parenteral products owing to rise in the global burden of chronic and lifestyle diseases and heavy investments by the pharmaceutical industry on the development of biologics has propelled the growth of this market. Moreover, development of new APIs is increasing the demand of excipients like solubilizers and disintegrants which will further drive the growth of this market.
The global pharmaceutical excipients market is majorly driven by patent cliffs resulting in increased demand of generic drugs, emergence of novel excipients, and growing demand of functional excipients. Use of modern science like nanotechnology to impart novel functions to the excipients used for target specific functionality of the active ingredients is also expected to propel the market for pharmaceutical excipients during the forecast period. The amalgamation of drug formulation and nanotechnology in excipients have led to the development of nano-coated tablets, nano-derived liposomes, and vaccines
The world pharmaceutical excipients market is driven by the increase in demand for oral solid pharmaceutical drugs and emergence of novel therapeutics on account of the upsurge in the number of pharmaceutical industries. However, higher production cost and stringent government regulations are likely to impede the overall growth.
Some of the prominent players in this market include Ashland Inc. (U.S.), BASF SE (Garmany), The Dow Chemical Company (U.S.), Roquette (France), Colorcon, Inc. (U.S.), Avantor Performance Materials, Inc. (U.S.), FMC Corporation (U.S.), Evonik Industries (Germany), and Lubrizol Corporation (U.S.). Various strategies such as collaborations, expansions, and new product launches have helped these companies maintain their market share and grow in this competitive market.
Enhancing functionality
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. Excipients are widely used in drug formulation to provide long-term stability, add bulkiness to solid formulations and facilitate drug absorption. They also enhance the overall safety or functionality of the product during storage or use.
While excipients may have different functionalities, they generally do not affect the therapeutic action of the active ingredient. The demand for functional excipients is expected to record a strong growth in the forecast period due to its increased use in advanced drug delivery forms.
Excipient acts as a carrier for active ingredients of a medication. It allows convenient and accurate dosage by bulking up the formulation that contains potent active ingredients. Generally, substances are not easily absorbed in the human body. Hence, an active ingredient is mixed or dissolved with an excipient in most cases. Excipients primarily aim to prevent active ingredients from getting denatured and ensure that these do not fall out of the solution. Excipients used in medication are further classified in terms of the route of administration. They also help maintain the purity level of the active ingredient.
Excipients are used in various forms in food, cosmetics, and medicine industries. These act as binders, suspension & viscosity agents, fillers & diluents, coatings, solvents, capsules, flavouring agents, disintegrants, lubricants & glidants, colorants, and preservatives. Besides the pharmaceutical industry, excipients are often manufactured for usage in various industries such as food, cosmetics, and personal care.
Excipients can influence the bioavailability of active ingredients in formulation and thus assist in improving the efficacy of the drug product as a whole. In modern drug delivery systems certain excipients have a well-defined function. The use of transdermal absorption enhancers such as surfactants or solvents such as propylene glycol is well established. Propylene Glycol (PG) has been demonstrated to aid the skin permeation of steroids.
It is possible that PG acts as a penetration enhancer by affecting the integrity of the skin barrier but it may just act as a solvent for drugs during their passage through the stratum corneum. The role of polymers such as the Eudragit series is well known in the design of enteric-coated or modified release oral dosage forms. Hence role of specialized excipients to achieve a certain bioavailability profile, site-specific delivery or therapeutic effect in modern pharmaceutical technology become important with advances in pharmaceutical science.
Revenue-generators
Organic chemicals would continue to be the highest revenue-generating segment during the forecast period. North America and Europe will continue to be the lead revenue generating economies through 2020. These regions collectively accounted for about three-fourth of share in the global pharmaceutical excipients market in 2015.
Binders segment generated highest revenue in 2015 and is anticipated to maintain this trend throughout the forecast period. This is attributed to the higher use of binders in pharmaceutical drugs as compared to fillers and diluents. However, fillers and diluents led this segment in terms of volume (units) in 2015 and accounted for about one fourth of the overall market. Economical cost and high popularity of fillers and diluents across pharmaceutical and excipient industries were the key factors responsible for the dominance of filler and diluents segment.
While binders generated the highest revenue accounting for about two-seventh of the overall market revenue in 2015, in the inorganic chemical category, halites segment is projected to grow at the highest CAGR of 29.2 per cent during the forecast period.
Calcium phosphate (inorganic chemical) segment is projected to reach $539.9 million by 2020 at a CAGR of 10.5 per cent. In the organic chemicals category, carbohydrates generated the highest revenue and is expected to dominate till 2020.
While disintegrants segment is projected to grow at a highest CAGR of 12.6 per cent from 2015 to 2020, proteins segment (Petrochemicals category) generated highest revenue in 2015. However, mineral hydrocarbons segment is expected to grow at the highest CAGR of seven per cent during the period under consideration.
Excipients can optimise the efficacy of a drug in a given formulation but it is also essential that they should not add their own adverse reactions or otherwise compromise the safety of the product. But literature suggest that some commonly used excipients can elicit physiological responses in susceptible individuals. However, risk of adverse reactions to commonly used excipients is negligible.
Regulatory issues
Excipients used in the manufacture of pharmaceuticals products are not approved in their own right either in Europe or the US. They are generally reviewed as part of the overall regulatory evaluation of the safety of pharmaceutical products. Excipients are categorized as compendial or noncompendial materials. Compendial excipients have composition consistent with monographs published in compendia such as USP-NF. They are preferred for pharmaceutical formulations.
Due to advancement in technology, the performance of excipients in the final product has become more critical like development of more sensitive analytical methods, increase in processing speeds for tablet machines, controlled release oral products, Transdermal drug delivery systems and products of recent advances in biotechnology etc.
Sometimes Pharmacopoeial and Extra-pharmacopoeial tests in monographs may be inadequate to control ‘performance quality’ in certain excipients like Magnesium stearate. Besides simple physical or chemical testing, performance specifications for certain critical excipients are required to be ascertained to comply performance specifications of the final product. These issues are addressed by both the USP and Ph. Eur by devising the tests that can measure functionality of excipients used in the formulation. Performance specifications are increasingly being considered to differentiate between grades of the same excipients available from multiple sources.