This analysis highlights the impact that key sectors have on parenteral drug development.
Increased spending on biologics, the need for faster route of drug administration, increasing preference for single-dose administration of vaccines and drugs, and more monoclonal antibodies (mAb) are driving the global parenteral market. Add to this the impact of the COVID-19 pandemic is having on demand for additional capacity and capabilities in the form of CDMOs.
But industry insiders point to the external factors that impact parenteral drug development:
The political landscape has played a key role in parenteral drug development over the past few years in the development of the COVID-19 vaccine. The lines between politics and healthcare continue to blur as discussions around COVID vaccine mandates continue.
Big Pharma companies are acquiring smaller firms in emerging markets to sustain growth. These companies are focusing on geographical expansions and establishing new facilities close to target markets. They are also consolidating existing manufacturing capabilities to capture a larger market share. 1
From 2018-2019, the proportion of drugs in the pipeline requiring parenteral administration rose by approximately 2%. Oncology remains the key research owing to the large population pool that presents a growth opportunity for pharma. 1
This may come in the form of solubility enhancing excipients or excipients that manage release profiles. Additionally, technology advances are being witnessed in parenteral primary packaging such as double-chamber prefilled syringes.
The parenteral industry continues to address issues of sustainability. For instance, single-use technology maintains the quality of biologic parenteral drugs and improved packaging designs lessen waste and carbon footprint.
FDA has issued many policies, guidance, and procedures recently related to GMP and quality. Recent draft guidance include one related to injectable product inspection for visible particulates, and another meant to clarify the key factors in determining the appropriate aluminum content in a small volume parenteral (SVP) drug product and/or a pharmacy bulk package. 2
- Parenteral Drug Market 2019-2029, FACT.MR, https://www.factmr.com/report/3189/parenteral-
- Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations; Draft Guidance for Industry; FDA, Availability, Dec. 7, 2022, https://www.federalregister.gov/documents/2022/12/07/2022-