Pandemic Like Never Before – Continuous Manufacturing to the Rescue
The coronavirus outbreak and the drop in economy that we are facing today is unlike anything that most of us have seen in our lifetime. The pandemic has threatened the whole world to such an extent that life has come to a standstill. In fact, the initial stage of lockdown featured the fragile nature of pharmaceutical supply chain as a result of plant shutdowns and subsequent drug shortages. However, in order to deal with this situation, the medical agencies came up with the option of advanced technologies, such as continuous manufacturing technology. Specifically, in the pharmaceutical industry, the standstill days are over. In fact, drug manufacturers are moving faster than ever to cope up with the drug shortages.
It is a known fact that, the adoption of continuous manufacturing started even before the arrival of pandemic. The drug manufacturers adopted this technology either as a full replacement of batch process or as a part of hybrid. The process allows the manufacturing of pharmaceutical products 24×7 without any hold time. The continuous manufacturing technology offers cost saving and manufacturers can do more with less space required by the equipment. As a result, many success stories have come into the light which involves continuous manufacturing of a drug.
Early Adopters of Continuous Manufacturing Technology
As of April 2020 , the FDA has approved six continuously manufactured drugs, namely ORKAMBI® (2015, Vertex Pharmaceuticals), PREZEISTA® (2016, Johnson and Johnson), VERZENIO® (2017, Eli Lilly), SYMDEKO® (2018, Vertex Pharmaceuticals), DAURISMO™ (2018, Pfizer) and TRIKAFTA® (2019, Vertex Pharmaceuticals). Whereas, two drugs received the PMDA approval, namely TRAMACET by Johnson and Johnson and VERZENIO® by Eli Lilly.
What is the Roadmap Adopted by the Existing Players to Implement this Process?
Over the past few years, the process of continuous manufacturing is continuously gaining momentum in the pharmaceutical and biotech industry. This technology provides a product with improved quality assurance and high product consistency. Improved product quality helps in decreasing the cost of product and significantly speeding up the time to market. In fact, the companies are reviewing the possibilities of implementing continuous processes to certain products. However, the road for transition from the conventional batch to continuous manufacturing requires a shift in variety of parameters and is still quite unclear to many of the pharmaceutical companies.
What are the Recent Initiatives Taken by The Continuous Drug Manufacturers in this Domain?
In the last three years, several players have collaborated to enhance their continuous manufacturing portfolio. In fact, more than 35% of the collaborations inked during the period, 2017-2019, were research agreements. The field has also witnessed various expansion initiatives undertaken by industry players during the period 2013-2020 (till January). Of these, maximum number of expansions (54%) were carried out for the establishment of facility / plant; of these, most of the instances were focused on facility / plant expansion, followed by those undertaken for technology enhancement (29%).
Capacity with the Companies (in Kgs)- Enough to Meet the Demand?
At this point, majority of the capacity is with the well-established players, including in-house manufacturers and contract service providers.
Likely Growth of the Continuous Manufacturing Market
In 2020, the major contribution to the market is expected to be made by North America (53%), followed by Europe (38%) and Asia-Pacific (9%). However, in 2030 as well, North America and Europe are likely to contribute an equal amount of share to the market.
To get a detailed information on the key players, recent developments, number of grants awarded, number of patents filed, capacity available in this domain and the likely market evolution, visit this link