Digital Manufacturing Market

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

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Digital Transformation In Biologic Manufacturing Overview

The global digital manufacturing market for biologics is anticipated to grow at a compounded annual growth rate (CAGR) of 18% during the forecast period, driven mainly by the increased focus on industry 4.0 technologies.

Digital Biomanufacturing Market, By Type of Technology, 2023-2035 (USD Billion)

Digital transformation has also garnered the interest of pharmaceutical industry. It involves incorporating digital technologies across all functions / operations. Digital technologies have been impacting drug discovery to clinical development as well as manufacturing, amongst other functions. 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 transformation in pharma / biopharma manufacturing 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 manufacturing of biologics, popularly known as digital biomanufacturing or bioprocessing 4.0, refers to the integration of physical equipment with digital software and platforms, such as process analytical technology(PAT), data analysis software (DAS), manufacturing execution systems (MES) and digital twin, 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 Manufacturing Market for Biologics: Distribution by Type of Technology (Process Analytical Technology, Data Analysis Software, Manufacturing Execution System and Digital Twin), 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, market size and the likely future potential of the digital biomanufacturing market, over the forecast period. It highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry. Key inclusions of the research 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 Manufacturing of Biologics 

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. All these factors will drive the digital biomanufacturing market growth during the forecast period.

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 benefits offered by digital tools in manufacturing will drive the market growth over the forecast period.

Digital Biomanufacturing Market Landscape: Digital Twin Companies Have Launched Process Digital Twin to Support Biologic Manufacturing

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 Process Analytical Technology, followed by those using Manufacturing Execution System (28%), Data Analysis Software (14%) and digital twin (10%). 

Another digital tool supporting digital transformation of biologic manufacturing are the data analysis software. They offer wide spectrum of technical competencies, including process intelligence and data integration. We have identified more than 15 data analysis software companies established across the globe, offering 20+ data analysis software solution developed for biologic manufacturing applications.

Digital Manufacturing Market Size: Process Analytical Technology Market Segment Holds the Largest Market Share

The global digital manufacturing market for biologics is anticipated to be worth around USD 15 billion. 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 18%, during the forecast period 2023-2035. 

In terms of type of technology, the process analytical technology market holds 35% share of the digital biomanufacturing market. Over 85% of the process analytical technology platforms are capable of offering process automation and bioprocess optimization and controls. Majority of the PAT platforms support the manufacturing of proteins and antibodies. However, in terms of market growth, the digital twin market is expected to grow at a relatively high CAGR of 27%, during the forecast period. 

Key Trends in the Digital Manufacturing of Biologics: A Number of Manufacturing Execution System are Offering Cloud-Based Deployment Options

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 forecast period. ,  

Further, currently, the market for on-premise deployment options is expected to capture the majority market share; however, this trend is likely to change in the foreseen future with the rising popularity of cloud-based technologies. Nearly 80% of the manufacturing execution system companies are offering cloud-based MES solutions that can be integrated with numerous types of software to carry out production tracking, performance analysis and data integration functions. The availability of such cloud-based manufacturing execution system will drive the market size of MES market over the forecast period.

Key Digital Manufacturing Companies With Capability for Biologics

Examples of leading digital manufacturing companies engaged in this industry 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. This market report includes an easily searchable excel database of all the companies providing process analytical technology, manufacturing execution system, data analysis software and digital twin for biologic manufacturing

Recent Developments in Digital Manufacturing Market

Several recent developments have taken place in the field of digital manufacturing. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

  • In June 2023, Kaia Health launched Angela, a HIPAA-compliant, AI-powered voice-based digital care assistant, companion, and guide with the aim to enhance physical therapy experience of the patients.
  • In March 2023, MindMaze launched a proprietary medical device called Izar across the US and Europe with an aim to improve the hand recovery post-stroke.
The snapshot higlights digital manufacturing market overview. 140+ platforms, based on PAT, DAS, MES, digital twins and other such technologies, are being offered for digitalization of the biologic production process The image provides digital biomanufacturing market distribution. Over 85% of the process analytical technologies are capable of offering process automation and bioprocess optimization and controls; majority of these platforms support manufacturing of proteins and antibodies The image provides digital manufacturing software analysis. Data analysis software offer a wide spectrum of technical competencies, including process intelligence and data integration; predominantly, these platforms are compatible with artificial intelligence-based programs


Scope of the Report

The market report presents an in-depth analysis of the various firms / organizations that are engaged in this market, across different segments as defined in the below table:

Key Report Attributes Details
Base Year

2023 

Forecast Period

2023 – 2035

CAGR

18%

Type of Technology

  • Process Analytical Technology(PAT)
  • Data Analysis Software(DAS)
  • Manufacturing Execution Systems(MES)
  • Digital Twins

Deployment Options

  • Cloud-based
  • On-premises

Type(s) of Biologic(s)Manufactured

  • Antibodies
  • Cell and Gene Therapies
  • Proteins
  • Vaccines
  • Others

Key Geographical Regions

  • North America
  • Europe
  • Asia-Pacific
  • Middle East and North Africa (MENA)
  • Latin America

Key Companies Profiled

  • AspenTech
  • Bioreactors.net
  • Dassault Systèmes
  • FUJIFILM Diosynth Biotechnologies
  • GE Healthcare
  • Körber
  • Merck
  • Sartorius
  • Thermo Fisher Scientific

Customization Scope

  • 15% Free Customization Option

PowerPoint Presentation (Complimentary)

  • Available

Excel Data Packs(Complimentary)

  • Market Landscape Analysis
  • Technology Competitiveness Analysis
  • Benchmark Analysis
  • Partnerships and Collaborations
  • Market Forecast and Opportunity

 

This image highlights integration of digital manufacturing with manufacturing execution systems. Leveraging their expertise, ~80% players are offering cloud-based MES solutions that can be integrated with numerous types of software to carry out production tracking, performance analysis and data integration functions This image highlights integration of digital manufacturing with digital twin. The developer landscape is dominated by the presence of established players; asset / process management emerged as the prominent application areas for digital twin technologies This infographic provides details on where the digital manufacturing market is concentrated. Being a relatively concentrated market, players are focused on developing unique selling propositions for their technology platforms and become strategic partners for biologic developers


The market report presents an in-depth analysis, highlighting the capabilities of various companies engaged in this industry, across different regions. Amongst other elements, the research 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 digital manufacturing companies (offering digital biomanufacturing technologies - Process Analytical Technology, Data Analysis Software, Manufacturing Execution System and Digital Twin), 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 (Process Analytical Technology, Data Analysis Software, Manufacturing Execution System and Digital Twin), 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 digital manufacturing companies (companies offering more than one platform and established before 2012) engaged in the digital biomanufacturing industry, which are actively providing software based on Process Analytical Technology, Data Analysis Software, Manufacturing Execution System and Digital Twin. 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 industry, 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.
The image highlights digital biomanufacturing industry lifecycle analysis. Fundamental advancements in the field of smart biomanufacturing will promote process robustness and product quality; this will inevitably culminate in accelerated growth of the market The image provides an estimated of digital manufacturing market size. Driven by the continuous technological innovations, this domain is anticipated to witness steady growth; technologies focused on digital twins are expected to gain significant traction with an annualized growth of 19% This image provides digital manufacturing market segmentations. The projected opportunity for digital bioprocessing platforms is expected to be well distributed across different types of biologics and key geographical regions


One of the key objectives of the market 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 forecast 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 (Process Analytical Technology, Data Analysis Software, Manufacturing Execution System and Digital Twin), 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:

  • President and Chief Executive Officer, Small Company, Canada
  • Managing Director and Chief Executive Officer, Small Company, Germany
  • Vice President of Operations and Strategic Initiatives, Mid-Sized Company, US
  • Director, Business Development and Channel Sales, Very Larrge Company, US
  • Director of Sales, Small Company, Israel
  • Business Consultant, Very Large Company, France

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 18% in the coming years

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