11 trends in the biopharmaceutical industry in 2020

Over the past decade or so, a number of trends affecting bioprocessing and biopharmaceutical production have emerged, most of which are expected to yield positive results.
and the New Crown Outbreak (COVID-19) has accelerated many of the trends that continue to develop and may lead to permanent change.
identified eleven trends for 2020 that are likely to remain at the top of the list in BioPlan Associates' 17th Annual Survey and Review of the BioProcessing Industry released this year.
when considering the impact of pandemics on the global population, many of these trends will be conducive to future public health strategic planning.
these trends are mainly driven by the continuous development of technology and industry.
cost cuts and mergers and acquisitions that are usually associated with them are one of the main trends, but this trend appears to be slowing.
, on the other hand, the human problem will only get worse as the pandemic continues, especially with the rapid growth of bioprocessing and capacity associated with new cell and gene therapies around the world.
most activities, including research and development, bioprocessing capacity and markets, will not decrease by 2020, but will accelerate further.
this includes $10 billion in new investments in the biopharmaceutical industry, most of which will be invested in new and expanded capacity and the expansion of development pipelines for pandemic-related products, often in new facilities and research and development.
biopharmaceutical industry is strengthening and playing its part, including the rapid implementation of research and development and production programs related to COVID-19 vaccines and treatments, as well as the construction of related facilities.
research and development companies are taking a number of potentially successful vaccine candidates online in record time and expanding and accelerating production in record time. The
report briefly discusses each sustainable development trend in the context of the current pandemic: 1. The increase in the number of biopharmaceutical sites worldwide: bioprocessing enterprises and suppliers are further expanding product production globally, providing additional manufacturing sites in more regions and acting as a back-up/second source for other manufacturing sites, following disruptions and identification of weaknesses in the supply chain.
, for example, in China, the United States and Western Europe, more and more factories will be available to serve these specific markets.
this will further accelerate the trend of more and more smaller bioprocessing sites.
2. Expanded possibilities for biological products, but usually smaller markets for these products: pandemics have significantly expanded the number and type of products in development pipelines, including products based on new technologies, such as RNA vaccines.
trend in smaller markets will continue (e.g., more orphan drugs).
, however, the industry's response to the pandemic is completely different, with new products having an unprecedentedly common market.
, everyone around the world may need multiple vaccinations to maintain their immunity, producing more than 10 billion doses of the vaccine each year in addition to current demand.
3. A wide range of follow-up products and manufacturers of biosimilars: The trend towards more follow-up biosimilars will continue and is likely to accelerate as more companies move into biopharmaceutical development, usually initially for pandemic-related products.
, however, opportunities are growing globally as most current market leaders, those that already have the most references to biologics and biosypolytes, are focused on bringing pandemic vaccines and therapeutic drugs to market.
4. More flexibility in site design and more modular facilities in production: the flexibility of bioprocessing is now becoming increasingly important.
this includes the plant's ability to produce a wide range of products, typically of different sizes, including rapid conversion to the production of other products, faster construction, and on-line through fully validated facilities that reduce the need for capital investment.
the production of pandemic vaccines and therapeutic drugs in particular has also d'walked into the same cloning facilities around the world, the use of modular structures and prefabribriated modular units will increase.
. Continue to use one-time systems on a research, clinical and commercial scale: as facility flexibility increases, more one-time systems will be used.
use has reached the pre-commercial manufacturing limit, with BioPlan estimating that 85% of preclinical and clinical manufacturing is currently a one-time system.
The expansion of the
one-time system will involve the adoption of ≥ 2,000 commercial production lines based on single-use bioreacters, including scale-out using multiple bioreacters or parallel operation of the entire production line, rather than traditional vertical expansion using large stainless steel bioreacters and production lines.
, if not most, of the production facilities for new pandemic products available around the world, many of which were previously stainless steel, will be disposable systems.
6. Bioprocessing efficiency has improved as prices and yields have increased: this is a relative anomaly and one of the few trends that has not accelerated significantly with the industry's response to pandemics.
, as described below, will make greater use of novel and often more effective expression systems.
7. The use of continuous processes, including downstream ends, is increasing: continuous upstream perfusion and downstream continuous chromatography will accelerate adoption over the next few years, complementing the growing demand for biotechnology flexibility.
addition to lower costs, continuous manufacturing will also make production lines and facilities smaller, and less money invested in faster online production.
8. Opportunities for the development of high-tech expression systems and other genetic technologies multiplied: rapidly expanding production and reducing the cost of providing vaccines and therapeutic drugs to the majority of the population would lead to the spread of expression systems other than common CHO and E. coli.
this may include increased use of plant, insect, new mammalian and microbial host cell line and, ultimately, synthetic biology/cellless systems.
that need to produce unprecedented large doses/product units will use non-CHO and non-E. coli expression systems.
9. Further automation, monitoring and process control: With the development of the pandemic, there is an increasing interest in the automation of bioprocessing and an incentive to adopt higher bioprocessing automation, often with the aim of reducing or even eliminating field staff.
bioprocessing facilities for many of the new pandemic-related products will be highly automated, requiring only automation to achieve the required capacity and reduce costs and time-to-market.
10. Wider use of bio-process modeling, including a focus on downshing: world-class super-large plants and a large number of smaller facilities associated with more pandemic products are available worldwide, and as production scale increases, the importance of bio-process modeling increases, especially in scale-down process models.
requires process design, testing, and validation capabilities on a smaller scale than proven scale-downs and more traditional scale-ups.
, for example, testing upstream processing of cultures on a full commercial scale can cost millions of dollars.
need to use a scaled-down process to prove virus inactivation (relative to full scale) to demonstrate to regulators a full understanding and control of bioprocessing.
. Increasingly complex regulations (which are the most definitive trend): pandemic-related regulations will change.
many of these issues are related to accelerating product development, approval, and distribution.
Langer, E.S., et al., BioPlan Associates, 17th Annual Report and Survey of Biopharmaceutical Capacity and Manufacturing, BioPlan Associates, April 2020, 528 pages (see forest-bluewood