While oral administration remains the most preferred drug delivery method worldwide, the parenteral route plays a crucial role in global healthcare due to its ability to bypass the digestive system. According to our report, the global parenteral pharmaceutical market is projected to grow at a remarkable 7.5% rate over the next five years, surpassing the average industry growth in pharmaceuticals. This rise is driven by the increasing FDA approvals of parenteral new molecular entities (NMEs), primarily in the field of oncology, along with steadily rising in infectious diseases, cardiovascular, and diabetes treatment.
Several factors are shaping the market’s trajectory, including:
- Biopharmaceuticals: A World of Opportunities
This parenteral drug delivery market is evolving with novel therapies and innovations in drug substances, with a special focus on biopharmaceuticals. Growing at an impressive rate of 8%–9% annually, this segment is inching closer to capturing half of the revenue share in the global parenteral pharmaceuticals. The year 2020 witnessed an immense boost in biopharmaceutical research and development, especially in mRNA technology for COVID-19 vaccines. Moreover, monoclonal antibodies, recombinant proteins, as well as cell and gene therapies, have an increasingly growing number of candidates in the drug pipeline.
- Growing Role of Contract Manufacturers
Across the pharmaceutical industry, and more so in the parenteral drugs segment, the role of CMOs and CDMOs is increasing. This is evident from the growing number of contract firms, especially in the biopharma industry, specializing in specific technologies or a range of production processes and modalities. Their role as excipient customers is influencing excipient selection and supplier recruitment.
- Formulation Type Impacting Excipient Selection
Parenteral pharmaceuticals are broadly classified into three formulations—liquid solutions, suspensions, and lyophilization. While solutions are the most common type of formulation, the highest growth is seen in the demand for lyophilization formulations, mainly driven by biologics and oncology drugs. Lyophilized formulations provide longer shelf life and increased stability to biopharmaceuticals, thus fueling the demand for excipients with lyoprotectant properties, such as mannitol. In addition, mannitol will also benefit from growth in suspension formulations as a good tonicity-adjusting agent.
Other excipients, such as polysorbates, are benefitting from their use as solubilizers in vaccines, while lipid excipients are gaining ground for their use in formulations requiring bioavailability enhancement of the active pharmaceutical ingredients, mainly in biopharma. Lastly, dextrose, a widely used excipient in all kinds of formulations, is projected to see increased demand in small-volume parental formulations.
- Stringent Quality Standards Shaping Supplier Selection
The parenteral pharmaceuticals industry is highly governed by quality norms and regulations. Fill-finish excipients are required to significantly increase quality standards compared to their counterparts in oral solid pharmaceuticals. This makes the excipients market for pharmaceuticals less fragmented. However, numerous excipient suppliers cater to parenteral formulations, some of whom have successfully established themselves in niche markets with further growth opportunities. For example, Roquette is a global leader in saccharides and polyols, while Croda leads lipid excipients.
- Innovation in New Drugs and Biosimilars Fueling Demand
Growth is expected to remain strong in the United States, where innovation and upcoming drug approvals will majorly drive the market. Likewise, China and India are racing ahead. China’s parenteral drug development is gaining pace in an oral-solid dominant pharmaceuticals industry, while in India, the outsourcing of parenteral drug manufacturing of small molecule generic and biosimilars is set for expansion.
Kline’s recently published study on Specialty Excipients in Parenteral Pharmaceuticals investigates the impact of formulation requirements, quality needs, regulatory trends, product competition, pricing, and supplier landscape to the level of each excipient chemistry in the leading markets such as the United States, Europe, China, India, and Japan. These studies provide a comprehensive assessment of opportunities and challenges to identify success factors in the changing dynamics of the parenteral excipients market.