Oral solid dosage forms are pharmaceutical formulations which are administered orally to achieve desired concentration of drug in the blood stream. Oral solid dosage forms are in prominent demand in the pharmaceutical market and these forms are remained dominant in the pharmaceutical market despite increasing number of biologics and small molecules which are administered parenteral or other routes of administration. Majority of these formulations are available in tablets and capsule forms which are widely accepted in the market place. Companies in this market facing mounting pressure for cost effectiveness combined with increasing high potency molecules and competition from generic manufacturers. Oral solid pharmaceutical dosage forms are used across the pharmaceutical candidates and it is one of the most commonly used drug delivery method across the patient groups.
Oral solid dosage pharmaceutical formulation market is driven by increasing approvals for New Molecular Entities (NME) in oral solid dosage format, for instance, in 2014, 46% of the new molecular entities (NMEs) approved by the US Food and Drug Administration’s Centre for Drug Evaluation and Research were solid dosage products. In addition, increasing rationalization of solid-dosage capacity on the pharma side and overall industry consolidation, availability of wider range of formulation methods such as hot-melt extrusion, spray drying, multiparticulate systems, and lipid-based drug delivery for poorly soluble APIs expected drive the oralsolid dosage pharmaceutical formulation market over the forecast period. Apart from aforementioned factors availability of fixed dose combinations, extended release and paediatric forms, traditional blockbuster OSD products which are now off-patented will continue to increase in demand for oral solid dosage pharmaceuticals. However, new chemical entities coming out of discovery continue to have poor solubility and bioavailability challenges, high regulatory requirement for high potency drugs, hard to swallow traditional solid tablets are expected to hinder the market growth over forecast period.
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Oral solid dosage pharmaceutical formulation market has been segmented on the basis of dosage form type, drug releases pattern, distribution channel and region.
Based on the dosage form type, the oral solid dosage pharmaceutical formulation market is segmented into the following:
- Hard Gelatin Capsules
- Soft Gelatin Capsules
Based on the drug releases pattern, the oral solid dosage pharmaceutical formulation market is segmented into the following:
- Instant Release (Dose Dumping)
- Sustained Release
- Extended Release
- Effervescent Tablets
- Chewable Tablets
- Enteric Release
Based on distribution channel type, the oral solid dosage pharmaceutical formulation market is segmented into the following:
- Hospital Pharmacies
- Retail Pharmacies
- Online Pharmacies
- Drug Stores
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Oral solid dosage pharmaceutical formulation market is undergoing market changes due to the higher competition among key players and companies coming up with innovative and differential oral solid dosage forms. Majority of the pharmaceutical companies are looking to more strategic partnerships, acquisitions and mergers to consolidate market position. Companies are striving to increase the production volumes to get advantage of the economies of scale, adoption of multiple continuous unit operations are coupled into an integrated system application in the market place. Contract Manufacturing Originations (CMO) and Contract Development Manufacturing Originations (CDMO) are playing pivotal role in oral solid dosage pharmaceuticals value chain in the market place with its strong expertise in formulation development. By dosage from type, sub segment such as tablets in the oral solid dosage pharmaceutical formulation market is expected to grow in positive traction owing to its wider application, ease of usage, availability and effectiveness in treating various ailments.
Geographically, oral solid dosage pharmaceutical formulation market is segmented into regions viz. North America, Latin America, Europe, Asia Pacific and Japan, Middle East and Africa. North America and Europe region is projected to maintain its lions share over the forecast period. Advanced healthcare infrastructure, availability of newer technologies and increased purchasing power is expected to propel the demand for oral solid dosage pharmaceutical formulation during the forecast period in the above mentioned region. Asia Pacific region is expected to be the fastest growing regional market. Growing healthcare facilities, increased healthcare awareness in the emerging countries like India and China and availability of skilled manpower in oral solids manufacturing are mainly generating the demand for oral solid dosage pharmaceutical formulation products in the region.
The players in oral solid dosage pharmaceutical formulation market include AstraZeneca, Bristol-Myers Squibb Company, Eli Lilly and Company,Gilead Sciences, Merck & Co. Inc., Novartis AG, Pfizer Inc., AbbVie Inc. to name a few.