By: Paul Dupont, Head of Digital Marketing at Pii
Firms with in-house aseptic fill-finish capacity outsource 39% of their fill and finish requirements, according to contract pharma, with lyophilization accounting for 24% of the overall market.1
According to Fact. MR, trends driving the need for lyophilization include:
- Biopharmaceuticals: In the last 15 years, there has been significant growth in the approval of various lyophilized drugs. It is known that many biopharmaceuticals cannot be commercially viable without undergoing lyophilization, so there is a need to spend more on the research and development of the lyophilization process for further advancement and refinement. The quality of biopharmaceutical products like antibodies, vaccines, peptides, enzymes, chemical API, and others remains unchanged once it undergoes freeze drying, which enables an increase in the shelf life of the product.
- Scalability: Freeze drying for pharmaceutical applications is that freeze drying technology has adapted for scalability, allowing larger batches of products to be produced more quickly, efficiently, and cost effectively, with fewer errors.2
- Growing Geriatric Population: In 2020, there were an estimated 727 million persons aged 65 years or over worldwide. This number is projected to more than double by 2050, reaching over 1.5 billion people. The share of older people in the global population is expected to increase from 9.3% in 2020 to 16% in 2050, by which point one in six people globally will be aged 65 years or older. As the prevalence of various diseases is increasing day by day, mainly due to the rise in the geriatric population, the pharmaceutical industry has experienced growing demand, leading to strong growth prospects for the overall sector.
- Rising Chronic Diseases: Chronic diseases are the leading causes of death and disability worldwide. Disease rates from these conditions are accelerating globally, advancing across every region and pervading all socioeconomic classes. According to the World Health Organization, in 2020, major chronic diseases were expected to rise to 73% of all deaths and 60% of the global burden of diseases. And the International Federation of Pharmaceutical Manufacturers and Associations Facts and Figures 2021 shows there were approximately 2,740 cancer drugs, 1,535 immunology drugs, 1,498 neurology drugs and 1,213 infectious diseases drugs in development in 2020. This is directly linked with the growth of the lyophilization market because lyophilization is one of the essential steps in the development and manufacturing of products from the pharmaceutical industry.
- Cold chain and storage: The industry requires drugs that are easy to store and transport without being degraded and have a good shelf life. Freeze drying is the most widespread method to preserve protein drugs and vaccines in a dry form facilitating their storage and transportation without a laborious and expensive cold chain.3 Additionally, the growing demand for biotherapeutics, which are expensive to produce, is causing manufacturers to focus on producing bulk quantities of biological materials to reduce production costs. Owing to the challenges of how to store bulk drug solutions safely and effectively for long durations, companies are leveraging lyophilization to prevent drug chemicals degradation and increase product shelf life.
This lyophilization article from Pharmaceuticals International, Inc (Pii) demonstrates the importance of lyophilization in addressing each of these trends and highlights how to perform lyophilization most efficiently and cost effectively.
- Global Fill-finish Pharmaceutical Contract Manufacturing Market Report to 2030, Research and Markets, July 18, 2022.
- Advancements in Freeze Drying Production & the Impacts on Scale, Sustainability and Compliance, Aimee Blakemore, LabMate Online, Nov. 5, 2021.
- Preservation of biomaterials and cells by freeze-drying: Change of paradigm, Arto Merivaara, et. al., Journal of Controlled Release, Aug. 10, 2021.
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!
ABOUT THE AUTHOR
Paul Dupont has 25 years of experience leading commercial operations in companies that offer complex technical solutions to solve the most pressing issues for businesses in an impactful way. His expertise includes strategic planning, new product development, implementing new business initiatives, guiding marketing activities to include direct and digital methods, optimizing sales operations, and creating remarkable customer experiences. His involvement as a business leader has delivered an immediate and long-term return on investment. He has used his Outcomes Driven Marketing strategy in a variety of organizations with extraordinary results.