Pharmaceutical Excipients Global Market estimated to be worth $9.9 billion by 2025
Pharmaceutical Excipients are non-active substances combined with active pharmaceutical ingredient (API) during formulation to form a desired finished drug product, which helps in modulating solubility, bioavailability, stability and perform a wide range of functions. Pharmaceutical excipients are naturally derived or manufactured through semi-synthetic or synthetic modes. They are classified based on their physio-chemical characteristics in formulating different dosage forms based on nature of active ingredient and intended route of administration. Pharmaceutical excipients may aid in lubricity, disintegration, taste, flowability and may confer some form of antimicrobial function. Choosing the appropriate excipient to support the design of formulation is an important step in drug manufacturing. A carefully chosen excipient may reduce the manufacturing costs by being multifunctional or it may enhance the patient experience by offering taste masking properties. Few decades ago, excipients were not considered as important component due to their inactive nature, but now they are considered as one of the essential components in the production of tablets, injectables, semi-solids and parenteral as excipients impact the stabilization of drug product in various conditions such as change in pressure, temperature and pH.
As estimated by IQ4I Research, the global pharmaceutical excipients market is expected to grow at a CAGR of 6.3% to reach $9,911.2 million by 2025. Some of the factors driving the market are increased demand for OSDF (oral solid dosage form) excipients, increasing demand for multifunctional excipients, growth in generics and biosimilar drugs, increasing demand for solubility enhancing excipients, rising demand for sustained release formulations, novel excipients for biologic drugs, drug coated medical devices and increase in prevalence of chronic diseases. However, there are several obstacles like adverse reactions of excipients, contaminations, pricing pressure, high market fragmentation with low-profit margin and stringent regulations may hinder the growth of the Pharmaceutical excipients market.
The pharmaceutical excipients market is mainly classified into source, product, manufacturing process, functionality, dosage forms, finished products, and geography. In pharmaceutical excipient by source, plant-based excipients held the largest share in 2018 and expected to grow at a high single digit CAGR from 2018 to 2025. In pharmaceutical excipient by-product, organic chemical excipients held the largest share in 2018 and expected to grow at a mid single digit CAGR from 2018 to 2025 due to their increased efficacy in oral delivery and increased compressibility and flowability properties. In pharmaceutical excipients by manufacturing process, granulation held the largest share in 2018 and direct compression is the fastest growing, it is expected to grow a high single digit CAGR from 2018 to 2025. In pharmaceutical excipient by functionality, binders & adhesives held the largest share in 2018 and expected to grow at a high single digit CAGR from 2018 to 2025.
In pharmaceutical excipients by the dosage form, solid dosage form held the largest share in 2018 and expected to grow at a high single digit CAGR from 2018 to 2025 as solid formulations are the most preferred dosages for their ease of administration, dosage accuracy, stability, and cost-effectiveness.
In finished products, prescription drugs held the largest share in 2018 and expected to grow at a mid single digit CAGR from 2018 to 2025, due to the high cost of drugs, as pharmaceutical companies spent a huge amount of money in research and development of the drugs.
Geographically, Pharmaceutical excipients market is segmented into North America, Europe, Asia-Pacific and Rest of the world regions. North America region dominated the global excipients market and is expected to grow at a mid single digit CAGR from 2018 to 2025 due to the increasing demand for functional excipients, implementation of new novelties like nanotechnology, increasing usage of oral solid dosage forms, increasing incidence of chronic disorders, elderly population and favorable reimbursement scenario for drugs. Also, technological innovations in manufacturing procedures of excipients have also propelled the market growth in North America. In North America, United States accounted for the highest revenue in 2018. The factors driving the market are increasing usage of generics, personalized dosage forms, rise in generic drug manufacturers, and hefty investments by the pharmaceutical companies in the development of medicines and increasing usage of oral solid dosage forms.
The Asia-Pacific region is the fastest growing region with a high single digit CAGR from 2018 to 2025. The market is driven by an increasing excipients outsourcing, low manufacturing and labor costs, growing generics market owing to patent cliffs, rising healthcare demand, rising investments, increasing demand for multifunctional excipients, better infrastructure, lower capital overhead costs and tax advantages. Excipients manufacturers in developing countries face major challenges to develop product with quality at an affordable price, due to lower price of excipients and large number of producers, which creates a price sensitive market.
Pharmaceutical drugs are of two types, small molecule and large molecule, where excipients are used in both of these drugs. According to IQ4I analysis, small and large molecule accounts for xx% and xx% share respectively in the market. Some of the most commonly used excipients in small molecules are carbohydrates, oleochemicals, petrochemicals, metallic oxides, silicates, calcium salts, proteins, halites and generally in combinations. Compared to a small molecule, biologics have different requirements with respect to excipient performance in order to prevent aggregation and degradation during the manufacturing process. Hence, choosing appropriate excipient with desired stabilization is not an easy task as it can have a positive or negative impact on therapeutic effect. Some of the most commonly used in excipients in biological drugs include sodium salts, solvents, emulsifiers, amino acids, saccharides, acids, calcium salts, and others.
In 2018, the FDA approved 59 drugs, of that 42 were small molecules and 17 were biologics which accounts to about 28.8% of total approvals which has risen from 26.1% from the year 2017. Biologics continue to expand in the marketplace with a growing number of protein therapeutics and vaccines in development. The group of functional excipients for biologic drugs is limited in comparison to those used in small molecule oral drug delivery. So, novel excipients are required to stabilize biologics and vaccines during processing and storage. In 2018, Dupont developed a new surfactant excipient, FM1000, which is able to better stabilize biologics to interfacial stresses than conventional excipients.
Currently, there is an increasing demand for the development of novel excipients with advanced technologies like new chemically modified grade excipients, multifunctional excipients, new chemical entity excipients, controlled release excipients, existing excipients with the various route of administration and co-processed excipients. For instance, in January 2019, Dr. Reddy’s Laboratories Ltd. and its subsidiary, Promius Pharma, LLC announced the approval of TOSYMRA by the U.S. Food and Drug Administration (FDA). TOSYMRA is used for the acute treatment of migraine and it is a nasal spray, formulated using proprietary novel excipients known as “Intravail”, a permeation enhancing alkylglycoside to achieve blood levels similar to a 4-mg sumatiptan subcutaneous injection, resulting in the rapid onset of action. These novel excipients increase the scope for the development of drug delivery system and new drug formulation which is a major gain for the industry, but the lengthy developmental process and high cost along with the safety and quality issues are delaying the excipients approval.
Multifunctional excipients are the class of excipients which are preferred by the manufacturers as the single excipients do not meet all the functional requirements such as high solubility, stability, and bioavailability. As approval of new excipient is time-consuming and often linked to the approval of new drugs, the suppliers are focused on developing multifunctional excipients. By using multifunctional excipients the developmental cost associated formulation will be reduced as excipients demand toxicity study, the risk of product quality is reduced and productivity is improved. For instance, in April 2019, Lubrizol Corporation launched multifunctional, 2-in-1 rheology modifier, Carbopol Style 2.0 polymer. This novel technology not only provides rheology modification but also offers light to medium styling hold, reducing or eliminating the need for Polyvinylpyrrolidone (PVP) or fixatives.
The global Pharmaceutical excipients production in 2018 was estimated to be xx kilotons (Kt) of which Organic chemical excipients production is xx kilotons, Inorganic chemical excipients production is xx Kt and USP/Pharma water production is xx Kt. Organic chemicals is the fastest growing segment with the high single digit CAGR from 2018 to 2025 to reach xx kilo tons by 2025.
Global top 100 selling drugs based on revenue were considered and analyzed for most common excipients found and categorized into segments such as source, product, functionality and dosage form. According to IQ4I analysis, some of the commonly used excipients in global top 100 selling drugs by revenue are Magnesium Stearate, Titanium Dioxide, Microcrystalline Cellulose, Croscarmellose Sodium, Lactose Monohydrate, Polysorbate 80, Talc, Mannitol, Sodium Hydroxide, Yellow Iron Oxide, Sodium Chloride, Hypromellose, Polysorbate 20, Hydrochloric Acid, Iron Oxide Red, Gelatin, Iron Oxide Black, Shellac, Sucrose, Glycerol, Macrogol 3350 and Polyvinyl Alcohol.
The pharmaceutical excipients global market is a fragmented with the top ten players occupying major share of the market. The existing players in the pharmaceutical excipients market are involved in developing new and advanced products to maintain their market shares. Pharmaceutical excipient manufacturers have also relied on long terms strategical initiatives such as acquisition, partnership, investments, product launch and expansions to gain access to new manufacturing technologies and for improving their market size among its competitors. For instance, in June 2019, Peptidream and poharma Inc. entered into a strategic partnership to use PGC (protected graft co-polymer), which utilizes a PEG (Polyethylene glycol) based excipient that reversibly binds the therapeutic peptides and does not require the peptide to be modified to enable delivery, the excipient also has the ability to protect the peptide from degradataion and provide a longer circulation half-life. Additionally, some of the companies are also applying for the EXCiPACT certification scheme, where it provides detailed information about excipients by the professional for physical audit. For instance, in May 2019 Colorcon Inc. received EXCiPACT good manufacturing practice (GMP) certificate for its site in Stoughton, Wisconsin, U.S. from SGS (EXCIPACT’s internationally recognised certification body). The Certificate demonstrates that the site manufactures pharmaceutical excipients according to the EXCiPACT GMP Standard.
Some of the key players of the pharmaceutical excipient market are Dow DuPont (U.S.), Ashland, Inc. (U.S.), BASF SE (Germany), DFE Pharma (Germany), Evonik Industries AG (Germany), Associated British Foods Plc (U.K.), Merck KGAA (U.S.), Roquette (France), Colorcon (U.S.), JRS Pharma (Germany), Lubrizol Corporation (U.S.), Avantor Performance Materials (U.S.), Croda International Plc (U.K.), and Asahi Kasei (Japan).