Demand for High-End COVID-19 Vaccines to Drive Growth of Excipients Market

The COVID-19 pandemic has infected 247 million people and killed five million others as of November 01, 2021 the situation still looks grim due to the high infection rates, the prolonged SARS-CoV-2 virus incubation period and persistent shortage of mature treatments or protective jabs. (1) 

Although there is an increase in manufacture and distribution of new biopharmaceuticals, drug products, vaccines, and efforts to re-purpose older pharmaceutical drugs to effectively tackle the deadly COVID-19 globally, demand, especially for vaccine continues to rise hence triggering spike in the production and supply of appropriate excipients for the stabilization of biologics and vaccines during processing and storage.

For example, with only 77 million people having been vaccinated in Africa, the region is in need of nearly 275 million COVID-19 vaccines to enable it meet its target of fully immunizing 40% of the continent’s nearly 1.2 billion people. (ibid)

This number of immunized people in Africa is an equivalent of 6% of the continent’s population compared to more than 40% vaccinated in nearly 70% of high-income countries. (ibid)

For pharmaceutical companies and surgical supply companies such as Johnson & Johnson, Moderna, AstraZeneca and Pfizer, some of the leading vaccine suppliers globally, the demand for millions of COVID-19 vaccine doses could translate into an expanded order book for excipients such as thimerosal, stabilizers, diluents, gels and antibiotics.

A case in point is the recent realization that fatty droplets or lipid nanoparticles, are suitable in protecting the active ingredient messenger RNA (mRNA) and help it easily enter cells. The realization paved way for the commercial production of the mRNA COVID-19 vaccine, which was the first mRNA product to receive approval from Food and Drug Administration (FDA) in the US and now the most widely used vaccine globally according to US biotechnology firm Biopharma PEG Scientific Inc. (2)

The use of lipid nanoparticles in the mRNA COVID-19 vaccine has a direct impact on the demand for excipients such as solid lipids, liquid lipids (oils), surfactants, and surface modifying agents that support the stabilization mRNA during its processing and subsequent storage. (ibid)

“In mRNA vaccines, the mRNA is encapsulated in lipid delivery technology, which provides protection for the mRNA and safely delivers it to human cells where it can be released and the vaccine can take effect,” says Biopharma PEG.

Apart from COVID-19 vaccine production, demand for excipients is expected to grow as the global generic drugs market expands with reports projecting the market size to hit $533 billion by the end of this year according to US-based market research firm BCC Research. (3)

The anticipated growth of the generic market is driven by “pharmaceutical drugs facing patent expiry, the pressure to control healthcare costs, the rise of biosimilar drug technologies, and high-growth market activity in emerging regions.” (ibid)

Furthermore, Aztrazenica, the manufacturer of COVID-19 Vaccine AstraZeneca, says currently “demand for generics is high”. This is due to the products being “lower priced because generic manufacturers are largely spared the costs of research and development and market development.” (4)

At least 85.3% of the prescriptions dispensed in the US in 2020, were generics an indication of how the products would drive the future market growth for excipients. (ibid)

However, generic drug manufacturing as a driver in the growth of the global excipients market continues to grapple with the unresolved issue of how switching branded to generic pharmaceutical drugs is impacting the global healthcare system.

The US’ FDA proposes more tests to confirm the effectiveness levels of some excipients on for example their efficiency in aiding drug absorption alimentary canal. (5)

“Therefore, laboratory studies are needed to understand the potential differences in excipients contained in brand name versus generic drug products,” FDA says.

Elsewhere, the global excipients market received a major boost in September 2021 when the International Pharmaceutical Excipients Council Federation promulgated the revised IPEC Good Distribution Practices Audit Guide for Pharmaceutical Excipients to support a seamless supply chain management and control of pharmaceutical starting materials. (6)

The Guide, which consolidates and revises IPEC Europe’s GDP Audit guideline (2011) and IPEC-Americas GDP Audit Guide for North American distribution of pharmaceutical excipients (2011), “provides a comprehensive tool for companies auditing the supply chain of pharmaceutical excipients.”

“Several incidents in the past were caused by a lack of supply chain security and inappropriate handling of pharmaceutical excipients,” IPEC said in a statement.

The revised guidelines, which has the support of excipient regulators, users, manufacturers and distributors “serves as a valuable tool to help the auditor conduct a complete audit of all relevant GDP principles for pharmaceutical excipients.” (ibid)

The document outlines the role of various excipient value chain players such as “re-processors, re-packagers, transport and warehousing companies, forwarding agents, brokers, traders, and suppliers other than the original manufacturer.” (ibid)
The release of the excipient GDP principles coincides with a projected global pharmaceutical sales growth. AstraZeneca estimates the growth at 3.8% in 2020 with the international healthcare spending expected increase at an annual rate of 4.2% from 2019 to 2024.

With an anticipated increase in global demand for  healthcare, particularly in Africa, the Commonwealth of Independent States, the Indian subcontinent and Latin America, pharmaceutical drug production is expected to grow as would the rate of excipient consumption.

REFERENCES;

1. https://www.afro.who.int/news/less-10-african-countries-hit-key-covid-19-vaccination-goal

2. https://www.biochempeg.com/article/186.html

3. https://www.biosimilardevelopment.com/doc/patent-cliff-for-blockbuster-drugs-energizing-global-generics-0001

4. Annual Reports (astrazeneca.com)

5. https://www.fda.gov/science-research/advancing-regulatory-science/effects-excipients-generic-drugs-products-intestinal-drug-transporters

About the Author:

With great honor and pleasure, PharmaSources.com has now invited Shem Oirere as one of the original writers. He graduated from the University of South Africa with a bachelor’s degree in International Relations and Diplomacy and also holds a Diploma in Journalism from the London School of Journalism. He previously worked for the Kenya Times, Nation Media Group and The People Daily over a twenty-year span as a business writer and Sub-editor. He wishes to share a view of the scenes behind Africa's latest pharma market trends with the rest of the world.