CDMOs Bring Value to Difficult-to-Formulate Oral Drugs

CDMOs Bring Value to Difficult-to-Formulate Oral Drugs

orange gel caps

The global oral drug delivery market, encompassing solids and liquids, is expected to increase significantly. An aging population around the world, coupled with increasing research and development and key market player partnerships, are expected to expand the growth of oral delivery worldwide.1

Oral solid drugs (OSDs) are cost-effective, easy to manufacture, and patient-friendly, making them the most common dosage form in the pharmaceutical industry. According to Contract Pharma, advances in targeted drug delivery and sustained release are enabling oral solids to achieve even greater levels of bioavailability while reducing dosing frequency. Other benefits include relatively uncomplicated packaging needs, storage, and distribution requirements due to chemical and physical stability. These benefits have led the experts at FACT.MR to value the global oral solid dosage pharmaceutical market at $1.03 trillion by the end of 2032, a significant jump from $524.6 billion in 2021.2

But, as they say, no good deed goes unpunished. Despite the advantages of OSDs, they pose formulation and manufacturing challenges. First and foremost is addressing solubility and bioavailability enhancement by means of a variety of techniques and excipients. Additionally, there are manufacturing difficulties related to OSDs. An unsuitable tablet formulation or process will result in problems during tableting and produce tablets that don’t meet the required quality standards.

brown gel caps

Pharma companies recognize that experienced science-based contract development and manufacturing organizations (CDMOs) can have a profound impact on solving OSD formulation and development challenges by providing invaluable pharmaceutical know how to overcome these difficult-to-formulate drug obstacles. Working with a CDMO that provides multiple process capabilities — from small scale R&D to commercial scale — expertise in solubility enhancement, ability to address challenges for low-dose formulations, overcome compression obstacles, and experience in developing the various targeted profiles for delivering OSD forms, will equate to an expedited pathway for developing and commercializing these OSD drugs. The benefits that a CDMO can provide have led to small-molecule OSD manufacturing comprising 91% of the global CDMO market, a market estimated to reach $117.3 billion in 2023.3

Similarly, CDMOs play a crucial role in formulating non-sterile oral liquids, such as syrups and suspensions, for the pediatric and geriatric populations who find it difficult to swallow oral solids. Scientific formulation expertise will prove beneficial in addressing issues of stability and palatability, parameters that need to be considered in the design. Additionally, experienced CDMOs have the capability and equipment to ensure the scalability of your liquid formulation. According to FACT.MR, the global pharma non-sterile liquids market will witness significant growth through 2032, due in large part to the capabilities of CDMOs.4


  1. Oral Drug Delivery Market, Forecasts from 2022 to 2027, ResearchANDMarkets, April 2022.
  2. Oral Solid Dosage Pharmaceutical Market Outlook (2022-2032), FACT.MR, July 2022.
  3. Outsourcing Outlook: Oral solid dosage (OSD) forms make up a very large portion of the world’s drug delivery formats, Tablets & Capsules, March 1, 2022.
  4. Pharmaceutical Non-Sterile Liquids Market 2022-2032, FACT.MR, 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!