Dosage Form Focus - 2 By The Numbers - August 2023
More than 2/3 of the drugs prescribed worldwide are oral solids
A recent report explores the current market landscape and future opportunity of the oral solid dosage contract manufacturing market, spanning 12 years. Over the years, rising complexity of active pharmaceutical ingredients (APIs) has led to the development of a myriad of novel formulations that enable efficient drug delivery to the intended site of action. Nonetheless, the demand for oral solid dosage (OSD) forms, including tablets and capsules, remains unparalleled.1
In fact, more than two-thirds of the total drugs prescribed worldwide are dispensed in the form of oral solids.1 In addition to being cost effective and relatively more stable as compared to their large molecule counterparts, these orally administered small molecules are patient centric, and therefore play a critical role in fixing the drug adherence problem.
Since the demand for oral solid drugs is rising, the development of modified oral solid dosage formulations (including disintegrating tablets (ODTs), combination products and prolonged-, controlled-, and sustained-release dosage forms) that can improve API solubility and enhance bioavailability can offer the drug developers a huge opportunity to stand out in this mature and competitive market.
However, the manufacturing of specialized solid doses, especially those containing highly potent APIs, from early development formulations to scale-up is a complex process that requires multidisciplinary expertise. Consequently, drug developers are increasingly relying on contract service providers with specialized equipment and a trained workforce to navigate the technical and routine operations-related challenges, including those associated with complex formulations, stringent regulatory requirements and multiple suppliers.
Immediate-release drugs held 57.9% of market share in 2021
A rise of usability and patient compliance are key aspects driving global demand for oral solid dosage medications. According to Fact.MR, tablets held the largest market share of 53.1% in 2021. And within that sector, by drug release mechanism, immediate-release held the largest market share of 57.9% at the end of 2021. The segment is expected to see a 6.1% CAGR between 2022 and 2032.1 The immediate release mechanism is used to release the drug for faster absorption to show immediate effect. These quick action products are especially important to help in pain relief in a short time span.
Modified-release oral solid dosage solutions are experiencing a sharp increase in demand due to growing patient-centric drug demand. By sustaining therapeutic blood concentrations for a longer period, modified-release medications can prolong the time a medicine is active in the body. It is possible to postpone the effect until the medication reaches a particular location by using unique coatings. Considering the popularity of oral solid dosage forms, especially amongst the pediatric and geriatric populations, a new report claims that the demand for conventional as well as modified oral solid dosage formulations is likely to drive commendable growth within the contract manufacturing market in the coming years. 2
Additionally, growing awareness regarding controlled-release tablets is expected to stimulate the market, according to Fact.MR. The global controlled release market will jump from $51 billion in 2022 to more than $124 billion in 2032. 3 Controlled-release drug administration enables a significant decrease in dose and dosing frequency, minimizes aberrant variations in plasma drug levels, increases efficacy, boosts patient compliance, and provides uniform medication effects.
Drugs are delivered at the target site at predetermined times with predictable drug release kinetics, offering a prolonged therapeutic impact.
But it is the sustained-release coating market that will experience only incremental growth of $207.64 million from 2022-2027, according to a report from Technavio. 4 Market fragmentation and a need for developers to differentiate product offerings are attributed to the slower-paced segment.
- Oral Solid Dosage Pharmaceutical Market Outlook (2022-2032), Fact.MR.
- Global Oral Solid Dosage Manufacturing Market to 2035, ResearchAndMarkets.com,
April 11, 2023.
- Controlled Release Drug Delivery Market, Precedence Research, Jan. 2023.
- Slow Growth Projected for Sustained Release Coating Market, Tablets & Capsules, May
Pediatric indications of approved adult dosage forms add 180 days of IP protection
According to a recent article in Pharmaceutical Technology, pharma companies are looking to pediatric indications of approved adult dosage forms (ADFs) to sustain and fuel growth. The desire to develop pediatric dosage forms (PDFs) of drugs with existing adult indications is being driven by two main drivers: the Food and Drug Administration’s (FDA) role in limiting off-label use in pediatric patients, which aligns with the FDA’s role in ensuring the safety and efficacy of approved products for all patients; and sustaining revenue growth through pediatric exclusivity that typically adds 180 days of intellectual property protection and almost six additional months of branded drug sales. This could, in some cases, translate to billions of dollars in revenue.
The article points out the differences between adult and pediatric dosage forms, and that hiring an experienced contract development and manufacturing organization (CDMO) is critical for helping to develop often complex formulations. Additionally, while drugs for pediatric patients typically involve lower doses than those given to adults, concerns in minimizing drug toxicity in young patients are always paramount, the article continues. This can be overcome during formulation of PDFs by carefully choosing the dosage form, excipients, and concentrations used during the manufacture of the drug product.
- Rising demand for pediatric dosage forms requires reformulation, expertise, and to-scale
manufacturing capabilities, Pharmaceutical Technology, Nov. 25, 2022.
Pharmaceutics International, Inc. (Pii) is a US-based contract development and manufacturing organization (CDMO) located in Hunt Valley, Maryland. The experienced scientists, engineers, and staff at Pii pride themselves on adroitly employing a phase appropriate method of drug development for the prudent use of their customer’s resources as they solve challenging problems. In addition to offering end-to-end development services, Pii manufactures a variety of dosage forms to include complex parenteral drugs and has a wealth of analytical testing capabilities. Its Hunt Valley campus has four aseptic suites with lyophilization capabilities. Our talented professionals stand ready to help!