The concept of bioequivalence development is being highly publicized in the pharmaceutical excipients market.
Increased R&D Spending and Bioequivalence Drive Pharmaceutical Excipients Market
The concept of bioequivalence development is being highly publicized in the pharmaceutical excipients market. Hence, manufacturers are addressing the challenges of solubility and bioavailability of excipients in order to improve manufacturing efficiency. The growing bioequivalence sector is flourishing with high prevalence of chronic diseases and increased access to medication, especially through online sales and e-Commerce platforms. Increased R&D spending and emergence of new technologies are bringing about a change in the market for pharmaceutical excipients.
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Treatment of rare diseases and need for better functioning excipients are some of the key drivers for the pharmaceutical excipients market. Strict regulations by the FDA in the U.S. has given rise to the concept of ‘novel excipient’ that has been newly formulated and not included in earlier-approved drugs. As such, the pharmaceutical excipients market in North America is anticipated for aggressive growth during the forecast period. The global market volume is estimated to reach a production of ~3,155,500 tons by 2027.
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Use of High-quality Excipients Leads to Innovations in Drug Delivery
High-quality excipients are revolutionizing the pharmaceutical excipients market. Pharmaceutical companies are combining active pharmaceutical ingredients (APIs) with novel excipients to introduce ground-breaking innovations in the drug development process. It has been found that the right choice of pharmaceutical excipients can help manufacturers establish a stable dosage form and improve the shelf life of drugs. Moreover, promotion of excipients by various institutions such as the International Pharmaceutical Excipient Council (IPEC) has influenced the choice of excipients used in drug formulations.
With the help of novel excipients, companies in the pharmaceutical excipients market are bolstering their credibility by complying with globally vetted standards. Growing awareness about GMP regulations is helping manufacturers to develop new orphan drugs. Furthermore, increased cooperation from the IPEC has encouraged pharmaceutical companies to adopt new excipients in their production activities. On the other hand, vitamin E TPGS and polyamino acids are steering innovations in drug delivery.
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Holistic Approach in Specialized Dosage Formulations Create Incremental Opportunities
The pharmaceutical excipients market is expected to expand at a CAGR of ~5% during the forecast period. However, there are certain challenges such as poor solubility of active pharmaceutical ingredients (APIs) in the formulation of oral solid dosage drugs. Hence, companies in the market for pharmaceutical excipients are increasing R&D in spray drying, lipid-based drug delivery, and multiparticulate systems to overcome the limitations of traditional approaches. This is evident since the oral formulation segment is predicted for exponential growth. The global pharmaceutical excipients market is projected to reach ~US$ 10.7 Bn by the end of 2027.
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Pharmaceutical companies are capitalizing on the demand for specialized dosage forms such as pediatric/geriatric and controlled-release formulations. Since traditional solid tablets are hard to swallow, companies in the market for pharmaceutical excipients are using this opportunity with the full potential to meet consumer needs. They are increasing their production capabilities to develop innovative dosage forms such as orally disintegrating granules (ODGs), effervescent tablets, lozenges, and the likes that are designed to swallow easily.
Lipid Excipients and Polymers Overcome Issues in Drug Development
Companies in the pharmaceutical excipients market are developing excipients that improve the dissolution of APIs and enhance API permeability across the biological membrane in order to innovate in drug delivery. Likewise, lipid excipients are acquiring popularity as multifunctional excipients, since they fulfill the requirements in dose and formulation. Companies in the market for pharmaceutical excipients are increasing their production capacities to develop excipients that are suitable for low-temperature melt granulation and melt extrusion. As such, there is a growing demand for excipients that solubilize APIs in the gastric media and enhance lymphatic transport, which is desirable for drugs that are subject to hepatic elimination.
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Innovative lipid excipients help disperse the drug in the lipid matrix, thus providing protection for drugs against the incidence of hydrolysis or oxidation for sensitive APIs. In order to achieve bioavailability, companies are adopting the approach of amorphous solid dispersions. This innovative approach is being combined with polymers, which contribute toward amorphous embedding and prevent recrystallization during storage.
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