by 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.
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.
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.
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.
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.
Analysts’ Viewpoint
Europe is one of the most lucrative markets for the development of advanced drug delivery systems. However, the absence of regulations in the pharmaceutical excipients market hinders the process of pharmaceutical product development in the region. Hence, companies should adopt new excipients in the production of new drugs to create awareness that the combination of excipients and APIs will lead to groundbreaking drug innovations. This will encourage regulatory authorities to introduce guidelines that support drug innovations. New trends such as the FDA considering a pilot review program to evaluate the toxicology and quality of novel excipients are contributing to market growth.
Pharmaceutical Excipients Market: Overview
The global pharmaceutical excipients market was valued at US$ 6.9 Bn in 2018 and is projected to expand at a high CAGR from 2019 to 2027. In terms of volume, the global pharmaceutical excipients market was valued at 2,108,405 tons in 2018. Rise in adoption of orphan drugs, growing approvals of biosimilars, increase in focus on development of novel excipients, and changing regulatory scenario are expected to drive the global pharmaceutical excipients market.
Research & development in the field of pharmaceutical excipients is focused on the development of novel excipients, mainly of plant origin, owing to their advantages including their biodegradable nature, non-toxicity, biocompatibility, low cost, and ease of availability
Increasing approval of oral solid dosage formulations by the U.S. FDA, owing to the high patient preference for oral medications aids in the growth of the pharmaceutical excipients market
Pharmaceutical Excipients: Market Segmentation
The global pharmaceutical excipients market has been segmented based on product, functionality, formulation, source, and region
In terms of product, the global pharmaceutical excipients market has been categorized into organic chemicals, inorganic chemicals, and others. The organic chemicals segment has been sub-segmented into carbohydrates, petrochemicals, oleochemicals, proteins, and others. The carbohydrates sub-segment has been further segmented into sugars, starch, and cellulose. The petrochemicals sub-segment has been further segmented into glycols, povidones, mineral hydrocarbons, acrylic polymers, and others. The oleochemicals sub-segment has been further segmented into fatty alcohols, mineral stearates, glycerin, and others. The inorganic chemicals segment has been further sub-segmented into calcium phosphate, calcium carbonate, calcium sulfate, halites, metallic oxides, and others.
Based on functionality, the global pharmaceutical excipients market has been segregated into fillers & diluents, viscosity agents, coating agents, binders, disintegrants, flavoring agents & sweeteners, lubricants & glidants, colorants, preservatives, and others
Based on formulation, the global pharmaceutical excipients market has been further segmented into oral, topical, parenteral, and others. The oral segment dominated the global pharmaceutical excipients market in 2018 and it likely to maintain its dominance in the forecast period.
Based on source, the global pharmaceutical excipients market has been divided into plant origin, animal origin, synthetic, and mineral origin
Pharmaceutical Excipients Market: Regional Segmentation
In terms of region, the global pharmaceutical excipients market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa
Europe dominated the global pharmaceutical excipients market in 2018 and the trend is expected to continue throughout the forecast period
The pharmaceutical excipients market in Asia Pacific is anticipated to expand at a high CAGR during the forecast period. Increase in demand for pharmaceuticals due to rise in population in Japan is expected to boost the pharmaceutical industry in the country, thereby driving the growth of the pharmaceutical excipients market.
Pharmaceutical Excipients Market: Major Players
Key players operating in the global pharmaceutical excipients market are
- BASF SE
- Colorcon Inc.
- Ashland, Inc.
- Croda International Plc
- Roquette Frères
- Evonik Industries AG
- DuPont de Nemours, Inc.
- Associated British Foods plc
- Archer Daniels Midland Company
- Lubrizol Corporation
These players are focused on adopting inorganic growth strategies to strengthen their product portfolio. These companies have adopted strategies such as partnerships and acquisitions to strengthen their market position; expand their portfolio of products; and expand their geographical presence.
Key Questions Answered in Pharmaceutical Excipients Market Report
- How much sales revenue would be generated by pharmaceutical excipients across all regions during the forecast period?
- What are key trends in the global pharmaceutical excipients market?
- What are major drivers, restraints, and opportunities in the global pharmaceutical excipients market?
- Which regional market is set to expand at the most rapid CAGR during the forecast period?
- Which segment would generate the maximum revenue by 2027 and which product type segment would expand at the most rapid CAGR during the forecast period?
Pharmaceutical Excipients Market – Segmentation
Product
- Organic Chemicals
- Carbohydrates
- Sugars
- Starch
- Cellulose
- Petrochemicals
- Glycols
- Povidones
- Mineral Hydrocarbons
- Acrylic Polymers
- Others
- Oleochemicals
- Fatty Alcohols
- Mineral Stearates
- Glycerin
- Others
- Proteins
- Others
- Inorganic Chemicals
- Calcium Phosphate
- Calcium Carbonate
- Calcium Sulfate
- Halites
- Metallic Oxides
- Others
- Others
Functionality
- Fillers & Diluents
- Viscosity Agents
- Coating Agents
- Binders
- Disintegrants
- Flavoring Agents & Sweeteners
- Lubricants & Glidants
- Colorants
- Preservatives
- Others
Formulation
- Oral
- Topical
- Parenteral
- Others
Source
- Plant Origin
- Animal Origin
- Synthetic
- Mineral Origin
Region
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East & Africa
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