This 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.
Since the outbreak of COVID-19, 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).
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.
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 Systemes, FUJIFILM Diosynth Biotechnologies, GE Healthcare, Korber, 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.
Key Topics Covered:
1. PREFACE
2. EXECUTIVE SUMMARY
3. INTRODUCTION
4. MARKERT LANDSCAPE 4.1. Chapter Overview 4.2. List of Process Analytical Technology (PAT) Providers 4.2.1. Analysis by Year of Establishment 4.3. List of Data Analysis Software (DAS) Providers 4.4. List of Manufacturing Execution Systems (MES) Providers 4.5. List of Digital Twins Providers
5. TECHNOLOGY COMPETITIVENESS ANALYSIS 5.1. Chapter Overview 5.2. Assumptions and Key Parameters 5.3. Methodology 5.4. Technology Competitiveness Analysis: Process Analytical Technologies 5.5. Technology Competitiveness Analysis: Data Analysis Software 5.6. Technology Competitiveness Analysis: Manufacturing Execution Systems 5.7. Technology Competitiveness Analysis: Digital Twins
6. COMPANY PROFILES 6.1. Chapter Overview 6.2. AspenTech 6.2.1. Company Overview 6.2.2. Financial Information 6.2.3. Technology Portfolio 6.2.4. Recent Developments and Future Outlook 6.3. FUJIFILM Diosynth Biotechnologies 6.3.1. Company Overview 6.3.2. Financial Information 6.3.3. Technology Portfolio 6.3.4. Recent Developments and Future Outlook 6.4. Merck 6.4.1. Company Overview 6.4.2. Financial Information 6.4.3. Technology Portfolio 6.4.4. Recent Developments and Future Outlook 6.5. Thermo Fisher Scientific 6.5.1. Company Overview 6.5.2. Financial Information 6.5.3. Technology Portfolio 6.5.4. Recent Developments and Future Outlook 6.6. Bioreactors.net 6.6.1. Company Overview 6.6.2. Technology Portfolio 6.6.3. Recent Developments and Future Outlook 6.7. Sartorius 6.7.1. Company Overview 6.7.2. Financial Information 6.7.3. Technology Portfolio 6.7.4. Recent Developments and Future Outlook 6.8. Dassault Systemes 6.8.1. Company Overview 6.8.2. Financial Information 6.8.3. Area(s) of Application 6.8.4. Recent Developments and Future Outlook 6.9. GE Healthcare 6.9.1. Company Overview 6.9.2. Technology Portfolio 6.9.3. Recent Developments and Future Outlook 6.10. Korber 6.10.1. Company Overview 6.10.2. Financial Information 6.10.3. Technology Portfolio 6.10.4. Recent Developments and Future Outlook
7. BENCHMARKING ANALYSIS
8. PARTNERSHIPS AND COLLABORATIONS
9. MARKET CONCENTRATION ANALYSIS
10. INDUSTRY LIFECYCLE ANALYSIS
11. MARKET FORECAST AND OPPORTUNITY ANALYSIS
12. CONCLUDING REMARKS
13. INTERVIEW TRANSCRIPTS
14. APPENDIX I: TABULATED DATA
15. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS
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