Digital Biomanufacturing – Current Scenario and Future Trends

Breakthroughs in the biotechnology industry, over the last few decades, has provided a considerable boost to the overall development landscape of biopharmaceutical drugs. In 2022, a milestone was witnessed when the number of approvals received by biologics narrowly outpaced those reported by small molecules. Further, in the same year, nearly half of the biologic approvals were allotted to novel class of modalities, including antibody drug conjugates (ADCs), bispecific antibodies, cell therapies and gene therapies. This can be attributed to the fact that the demand for biologics has been constantly increasing and is supported by continuous innovation in this field. Specifically, advancements in niche segments is expected to culminate in accelerated growth of the biologics market. Similar advancements have been observed in the field of manufacturing, as is evident from the rapidly increasing focus on digital biomanufacturing.

Key Advantages of Digital Biomanufacturing

Currently, batch-to-batch variation and product validation are considered as major bottlenecks faced by the biologic industry. Digital biomanufacturing harnesses various advancements, such as real-time monitoring, data analytics, automation, modelling, process optimization and other digital tools to transform the available information into actionable insights. This is expected to help in the creation of a uniform process, which is capable of decreasing the deviation in quality of each batch. Other key benefits of digital biomanufacturing include improved efficiency, higher product yield, better product quality, data integrity, reduced manual intervention and limited risk of contamination. It is worth noting that digitalization in biopharmaceutical manufacturing is becoming an essential requirement, given its potential to develop enhanced quality products, with high speed, agility and sustainability. The below figure provides an illustrative summary of the advantages offered by digital biomanufacturing.

Digital Biomanufacturing: Current Market Landscape

Currently, over 100 firms claim to offer a variety of novel digital manufacturing solutions in order to cater to the rising demand for biopharmaceuticals. The below figure presents the distribution of digital biomanufacturing, based on type of technology.

It is worth highlighting that 140+ platforms, based on PAT, DAS, MES, digital twins and other such technologies, are being offered for digitalization of the biologic production process. Further, as can be observed in the figure, process analytical technologies (52) capture the maximum share of the digital biomanufacturing market, followed by manufacturing execution systems (34), data analysis software (17) and digital twins (11). Notable examples of players that provide more than one type of technology (in alphabetical order) include ABB (PAT, DAS and digital twins), Cytiva (PAT and digital twins) and Sartorius (PAT and DAS).

The escalating interest in digital biomanufacturing domain is also reflected in Partnership Activities

Over the past few years, there has been a steady increase in partnership activity within this domain, during the given period (2018-2022). It is worth highlighting that the maximum number of partnerships were inked in 2021, followed by 24 agreements that were signed in 2022. Further, more than 80% of the deals were forged in the last three years.

As can be observed in the figure, the popularity and dominance of the service alliance model has decreased over the years. For instance, since 2020, there has been a gradual increase in the number of mergers and acquisitions in this domain. Notable examples include (in reverse chronological order) acquisition of ValitaCell by Beckman Coulter Life Sciences (September 2022), Solaris Biotechnology by Donaldson (November 2021), and Resolution Spectra Systems by Merck (July 2020). The considerable share captured by acquisitions in this domain indicates that players are seeking opportunities to consolidate their respective portfolios. Further, technology utilization emerged as another key type of partnership model adopted by players engaged in this domain, over the past four years.

Concluding Remarks

Owing to the increasing popularity of digital biomanufacturing, combined with the attempts to lower its cost, we believe that this market will experience significant growth in the near future. Further, driven by the continuous technological innovations, this domain is anticipated to witness steady growth; technologies focused on digital twins and cloud-based deployment options are expected to gain significant traction in the near future.

You can also download the SAMPLE REPORT on this topic by Roots Analysis by clicking on the link Digital Biomanufacturing Market detail report.