Digital Biomanufacturing Market - Distribution by Type of Technology, Deployment Options, Types of Biologics Manufactured, and Key Geographical Regions: Industry Trends and Global Forecasts, 2023-2035

Since the outbreak of COVID-19 infection, there has been immense pressure on the biopharmaceutical industry to reduce production timelines and increase the manufacturing capacity, without compromising on the quality of the final product. Further, a surge in morbidity across the globe and enhanced interconnectivity of equipment and technologies has led to an increased burden on manufacturing operations. Other factors that influenced the market include higher competition, competitive pricing, inflation rate, technological advancements and evolving regulatory guidelines. These factors demanded a fundamental shift from conventional manufacturing operations, which subsequently led to the introduction of industry 4.0 technologies. Digital biomanufacturing or digital bioprocessing has emerged as a promising alternative to mitigate a number of bioprocessing related concerns, as well as significantly promote process robustness and product quality.

Digital biomanufacturing, popularly known as bioprocessing 4.0, refers to the integration of physical equipment with digital software and platforms, such as process analytical technologies (PAT), data analysis software (DAS), manufacturing execution systems (MES) and digital twins, in order to streamline the overall biomanufacturing process. Implementation of these technologies in monitoring, analytics and computing capabilities is expected to revolutionize current biomanufacturing practices. Further, digital bioprocessing is believed to have transformed manufacturing principles in areas, such as process development, operational activities, logistics and supply chain management, when used in combination with advanced technologies, including artificial intelligence (AI), machine learning and internet of things (IoT).

Key Market Insights

The Digital Biomanufacturing Market: Distribution by Type of Technology (PAT, DAS, MES and Digital Twins), Deployment Options (Cloud-based and On-premises), Type(s) of Biologic(s) Manufactured (Antibodies, Cell Therapies and Gene Therapies, Proteins, Vaccines, and Others), and Key Geographical Regions (North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa): Industry Trends and Global Forecasts, 2023-2035 report features an extensive study of the current market landscape and the likely future potential of the digital biomanufacturing market, over the next 12 years. It highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry. Key inclusions of the report are briefly discussed below:

Growing Demand for Biologics

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. 

Need for Digital Biomanufacturing 

According to a recent report, the development of a new drug takes 10-15 years, with an overall investment of USD 1-2 billion. Despite the significant investment of resources, over 90% of the candidates fail at different stages of clinical trials, resulting in huge financial losses for biomanufacturers. 

As a direct consequence of the consistently growing demand for biologics and the existing challenges, there is an increase in the requirement for solutions that help in establishment of a digitally enabled and connected end-to-end process, in order to optimize bioprocess operations. Research suggests that, at present, 20% of the organizations have already adopted digitalized approaches for biomanufacturing. Such approaches are expected to enable an uninterrupted and accessible supply of cost-effective drugs that are likely to be launched commercially, with reduced development timelines. In fact, several leading biopharma players have claimed to achieve 40% increase in quality, 15% reduction in cost, 80% decrease in process variability and 20% shorter operational timelines by leveraging digital biomanufacturing advances. 

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. 

Current Market Landscape of Digital Biomanufacturing

The digital biomanufacturing providers landscape features a mix of large, mid-sized and small companies, which have the required expertise and offer various digital services for the production of biologics. At present, more than 140 digital technologies have been / are being developed by over 100 industry stakeholders to enable the manufacturing of biologics. Further, various types of technologies currently facilitate smart biomanufacturing; of these, 48% are based on the principles of PAT, followed by those using MES (28%), DAS (14%) and digital twins (10%). 

Key Trends in the Digital Biomanufacturing Market

Many stakeholders are undertaking initiatives to forge alliance with other industry / non-industry players. It is worth highlighting that over 75 strategic partnerships related to digital biomanufacturing have been inked since 2018, indicating that software providers are actively upgrading their technology related capabilities and accommodating the current and anticipated demand for digital biomanufacturing. Given the inclination towards cutting-edge technologies, along with innovative approaches to tailor the bioprocessing, we believe that the digital biomanufacturing technologies market is likely to evolve at a rapid pace, over the coming years. , 

Market Size of the Digital Biomanufacturing Market

Driven by improved data analytics, better product yield, faster production timelines, access to real time operations and rising interest in paperless manufacturing amongst innovators, lucrative opportunities are expected to emerge for players offering bioprocessing 4.0 services. The digital biomanufacturing market is anticipated to grow at a CAGR of 11%, during the period 2023-2035. In terms of type of technology, the digital biomanufacturing market for digital twins is expected to grow at a relatively faster pace (19%), till 2035. Further, currently, the market for on-premise deployment options is expected to capture the majority share, however, this trend is likely to change in the foreseen future with the rising popularity of cloud-based technologies. 

Example Players in the Digital Biomanufacturing Market

Examples of players engaged in this domain include (which have also been captured in this report) AspenTech, Bioreactors.net, Dassault Systèmes, FUJIFILM Diosynth Biotechnologies, GE Healthcare, Körber, Merck, Sartorius and Thermo Fisher Scientific.

Scope of the Report

The study presents an in-depth analysis of the various firms / organizations that are engaged in this domain, across different segments.

The report presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain, across different regions. Amongst other elements, the report includes:

• An executive summary of the insights captured during our research, offering a high-level view on the current state of the digital biomanufacturing market and its likely evolution in the mid-long term.
• A general introduction to digital biomanufacturing, featuring a detailed discussion on various types of technologies that support digital bioprocessing. In addition, it presents the key challenges and future perspectives associated with the employment of digital technologies in the field of biomanufacturing. 
• A detailed assessment of the overall market landscape of companies offering digital biomanufacturing technologies (PAT, DAS, MES and digital twins), based on several relevant parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, type of company (CDMO provider and software provider), number of platforms offered, deployment options (cloud based, on-premises, corporate datacenter and hybrid), platform capabilities (process automation, bioprocess optimization and controls, process connectivity, scalability, data integration, process monitoring and visualization, performance analysis, report generation and documentation, smart manufacturing, document control, production tracking, performance analysis and data integration), software capabilities (process intelligence, data integration, real-time process monitoring, data visualization, performance analysis and control prediction, reporting and data management), type(s) of biologic(s) manufactured, other compatible platforms (artificial intelligence / machine learning / cloud based, big data, internet of things, augmented reality and virtual reality) and type of end user(s) (industry and non-industry), integrating software (enterprise resource planning (ERP), manufacturing operation management (MOM), product lifecycle management (PLM), human resource management (HRM)), type of service(s) offered (training, implementation / upgradation and general support), area(s) of application (asset / process management, clinical trials, personalized treatment, medical training, surgical planning, health monitoring and diagnosis).
• A detailed competitiveness analysis of digital biomanufacturing technologies (PAT, DAS, MES and digital twins), based on supplier strength (in terms of years of experience and company size), technology portfolio (considering deployment options, number of platform capabilities, type of end user(s), software capabilities, area(s) of application, type(s) of twin(s)) and type(s) of biologic(s) manufactured.
• Elaborate profiles of key players (companies offering more than one platform and established before 2012) engaged in the digital biomanufacturing domain, which are actively providing software based on PAT, DAS, MES and digital twins. Each profile includes a brief overview of the company, along with information on capabilities of digital technologies offered by these firms, recent developments and an informed future outlook. 
• A benchmark analysis highlighting the capabilities of companies (in terms of their expertise across various platforms related to the manufacturing of biologics) engaged in this domain, across key peer groups.
• An analysis featuring information on recent partnerships inked between stakeholders engaged in this domain, based on several relevant parameters, such as year of partnership, type of partnership, type of technology, most active players (in terms of number of deals inked) and regional distribution of partnership activity, during the period 2018-2022.
• A detailed analysis highlighting the market concentration of key industry stakeholders (companies offering more than one platform) across various regions, based on prevalent parameters, such as years of entrance, company size, type of technology, number of platforms offered and number of partnerships inked. 
• A detailed industry lifecycle analysis that indicates various stages, including emergence, growth, maturation and eventual decline for the digital biomanufacturing industry. The primary purpose of this analysis is to develop a better understanding of the current position / phase of the industry on the lifecycle chart (based on historical trends, partnership activity and various investments made by players engaged in this domain) and predict the upcoming events that are likely to drive the growth of this domain. Further, it presents short-term and long-term impacts of various key parameters that are expected to highly impact the wider adoption of digitalization in the field of biomanufacturing.

One of the key objectives of the report was to estimate the current opportunity and future growth potential of the digital biomanufacturing market. We have provided an informed estimate on the likely evolution of the market for the period, 2023-2035. Our year-wise projections of the current and forecasted opportunity have been further segmented based on relevant parameters, such as type of technology (PAT, DAS, MES and digital twins), deployment options (cloud based and on-premises), type(s) of biologic(s) manufactured (antibodies, cell therapies and gene therapies, proteins, vaccines and others) and key geographical regions (North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America). In order to account for future uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios, portraying the conservative, base and optimistic scenarios of the industry’s evolution.

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders in this domain.

The report features detailed transcripts of interviews held with the following individuals:

• Joel Sirois (President and Chief Executive Officer, BioIntelligence Technologies)
• Klaus Mauch (Managing Director and Chief Executive Officer, Yokogawa Insilico Biotechnology)
• Ciaran O'Keeffe (Director, Business Development and Channel Sales, MasterControl) and Isura Sirisena (Quality and Manufacturing Digitization Specialist, MasterControl)
• Yaron Halfon (Director of Sales, Trunovate)
• Barbara Holtz (Business Consultant, Dassault Systèmes)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

Frequently Asked Questions

Question 1: What is the global market size of digital biomanufacturing?

Answer: The current global digital biomanufacturing market is anticipated to be worth around USD 15 billion. 

Question 2: Which are the top players in the global digital biomanufacturing market?

Answer: Presently, more than 100 companies are engaged in digital biomanufacturing, worldwide. The top players engaged in this domain (which have also been captured in this report) include AspenTech, Bioreactors.net, Dassault Systèmes, FUJIFILM Diosynth Biotechnologies, GE Healthcare, Körber, Merck, Sartorius and Thermo Fisher Scientific.

Question 3: What are the factors driving the digital biomanufacturing market?

Answer: Increasing number of approved biologics, growing number of biologics-related clinical trials, rise in R&D activity and a shift in preference for cloud-based processes, over the traditional biomanufacturing operations, has bolstered the demand for digital biomanufacturing software.

Question 4: Which region has the highest market share in the global digital biomanufacturing market?

Answer: North America and Europe capture around 75% share in the current global digital biomanufacturing market, followed by Asia-Pacific.

Question 5: What are the leading market segments in digital biomanufacturing market?

Answer: Currently, in terms of type of technology, process analytical technology captures the largest share (close to 50%) in the global digital biomanufacturing market. However, digital twins are likely to witness higher annual growth rates in the upcoming years, owing to their rising popularity. Further, in terms of type of company, software providers hold the largest share in the digital biomanufacturing market as compared to CDMOs.

Question 6: Which segment, in terms of deployment options, accounts for the largest share in the global digital biomanufacturing market?

Answer: At present, the global biomanufacturing market is dominated by the players providing on-premises deployment options, while the market is anticipated to shift towards the use of cloud-based technologies in the near future.

Question 7: What are the partnership and collaboration trends in the digital biomanufacturing domain?

Answer: At present, service alliances, technology utilization agreements and acquisitions are the most prominent types of partnerships inked between various stakeholders engaged in the digital biomanufacturing domain.

Question 8: What is the growth rate (CAGR) in the global digital biomanufacturing market?

Answer: The global digital biomanufacturing market size is projected to grow at a CAGR of ~11% in the coming years.