Lyophilization Pestel Analysis
LYOPHILIZATION PESTEL ANALYSIS
This analysis highlights the impact that key sectors have on the lyophilization industry and practices.
As lyophilization enhances the shelf life of drugs, in particular vaccines, the freeze drying technique will experience significant market growth, according to Bloomberg. One of the most important impacts on the industry is COVID-19. The rise in the incidence of COVID-19 is leading to a growing demand for novel and improved drugs and therapies. This has led to a growing demand for proper and safe storage and transportation solutions for several cell-based substances or hormonal drugs, among others. This has further increased the adoption of the lyophilizers for freeze drying to provide higher stability to the drugs. Furthermore, a viable method of storing and transporting sensitive products has become essential during the COVID-19 pandemic, which has been addressed by freeze drying equipment and accessories. Hence, the lyophilization market has enjoyed a positive impact due to COVID-19.
However, industry experts point to the high cost of processing and maintenance of lyophilization machines, the complexity of method requirements, use restrictions, and strict regulatory guidelines will restrain market growth. With regard to the latter, manufacturers of freeze dryers are obliged to follow GMP guidelines because lyophilization equipment stabilizes drug molecules used for improving human health or animal health. The regulatory bodies governing lyophilization include the FDA, European Regulatory bodies, and the Therapeutic Goods Administration in Australia.
Finally, alternatives to batch-based vial drying are continuous vial freeze drying and spray freeze, which could negatively impact the growth of the lyophilization market.
Politics
COVID-19 has had an immediate and direct influence throughout the world. The COVID-19 epidemic has also changed the way governments and private stakeholders want to reform the healthcare sector. Governments are putting increasing emphasis on improving and spending GDP on the healthcare sector. Governments have banned drugs or therapies which may cause health hazards.
Economic
COVID-19 has had a negative impact on the world economy. According to the IMF's World Economic Outlook report, the global economy will grow 4.9% in 2022. This is attributed to a decrease in both advanced economies (due to supply interruptions) and low-income emerging countries (due to deteriorating pandemic dynamics). Some studies show that there are inconsistencies between countries in the use of cost-effectiveness analysis to support decision-making, which leads to inequalities in drug access.
Social
The ever-increasing demand for lyophilized products and preserved food will drive the market growth, providing enormous potential for lyophilization equipment businesses that provide breakthrough technology.
Technological
The market is moving toward wider adoption of lyophilization techniques for achieving improved quality in biopharmaceuticals as well as food and beverages. Advancements in the accessories of freeze-drying systems have helped in reducing the time and money required for lyophilization.
Environmental
Globally, governments are pursuing a variety of methods for sustainability. Companies are taking measures to include environmental sustainability in their growth strategies. For instance, the GEA Group aims to reduce its greenhouse gas emissions by 18% by 2030. In addition, it aims to use 100% sustainable packaging materials by 2030.
Legal
Regulatory bodies such as the Food and Drug Administration (FDA) in the U.S., the European Union in Europe, the Therapeutic Goods Administration (TGA) in Australia, and the PMA Act in Japan have presented regulations for lyophilization equipment manufacturers.
