Bioavailability - 1 By The Numbers - June 2023
More Than 75 Bioavailability Enhancement Technologies Are Available
The process of bioavailability enhancement is both time and cost intensive to perform in house. This is giving rise to outsourcing the activity to contract development and manufacturing organizations (CDMOs) that have the on-site expertise to improve the pharmacokinetic properties of novel molecules.
This summation is based on a recent study performed by Roots Analysis. The same study projects that the bioavailability enhancement services market will grow at an annualized rate of 11.12% from 2021-2035. Drug developers will rely on enhancement service providers to address the continued concerns of solubility and biocompatibility and their impact on drug safety and patient compliance, according to the study.
These enhancement providers have more than 75 bioavailability enhancement technologies available to them. Most (55%) of these technologies support solubility enhancement, followed by those that support sustained release delivery (46%). And nearly 70% of the technologies on the market provide bioavailability enhancement for solids, followed by liquids and fine particles/powders.
Looking ahead, the Roots Analysis indicates that there will be a shift in focus of drug developers toward developing lipophilic drug compounds, which will drive the demand further for bioavailability enhancement technologies.
The Global Lipid Nanoparticles Market Will Reach $887.2 Million in 2023
Lipid nanoparticles (LNPs) have been one of the most successful nano-delivery vehicles that enable efficient delivery of cytotoxic chemotherapy agents, antibiotics, and nucleic acid therapeutics. During the coronavirus disease (COVID-19) pandemic, LNP-based COVID-19 messenger RNA (mRNA) vaccines from Pfizer/BioNTech and Moderna have been successfully developed, resulting in global sales of $37 billion and $17.7 billion, respectively, in 2021. Based on this success, the development of multiple LNP-based RNA therapeutics is gaining momentum due to its potential in vaccines and therapeutics for various genetic diseases and cancers. 1
As a result, the global lipid nanoparticles market is expected to be valued at $887.2 million in 2023, up from $781 million just a year earlier. Overall demand is projected to grow at a CAGR of 13.6% between 2023 and 2033, totaling around $3.2 billion by 2033. 2
Contributing to the growth is the demand for LNPs in the dietary supplement, functional food and beverage, and personal care sectors, particularly for their high content of omega 3 and 6. However, the increasing costs of fatty acids could potentially negatively impact the global LNP market. 2
LNPs are also playing a role in personalized medicine as carriers in delivering oncology- and neurology-related drugs.
Approximately 70% of Technologies Enhance Oral Solids
According to the Food & Drug Administration, CDER scientists are seeking ways to improve the bioavailability of drugs that on their own do not dissolve well in water. Today’s contract development and manufacturing organizations (CDMOs) have access to a myriad of bioavailability enhancement technologies. As oral solids continue to dominate the dose delivery field, 70% of those enhancement technologies on the market provide bioavailability enhancement for solids, followed by liquids and fine particles/powders. 1
Bioavailability enhancers technologies for oral solids include hot melt extrusion (HME), amorphous solid
dispersion (ASD), spray dried dispersion, and particle engineering. With every drug substance
being unique in its physicochemical properties and its pharmacokinetics, Pharmaceutical
Manufacturer magazine reports that a CDMO must provide these technologies and pair them
with the respective formulation and process know-how. This is key to selecting and applying the
most suitable technology and formulation and deliver rapid and risk-mitigated development and
- Bioavailability Enhancement Market, Roots Analysis, Nov. 2022.
- Innovations in oral solid dosage forms, By Klaus Pollinger and Martina Breuer, Pharmaceutical Manufacturer, Dec. 2, 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!