Global Bioprocess Automation and Control Software Market

Market Size

The Global Bioprocess Automation and Control Software Market reached US$ 1.6 billion in 2024 and is expected to reach US$ 2.7 billion by 2033, growing at a CAGR of 6.2% during the forecast period 2025-2033.

Bioprocess automation and control software is a specialized category of software designed to automate, monitor and control various stages of bioprocessing in industries such as biotechnology, pharmaceuticals and bio-manufacturing. These software systems are used to optimize complex bioprocess workflows, from cell culture and fermentation to downstream purification and quality control. The primary goal of bioprocess automation and control software is to improve process efficiency, ensure consistency, maintain high product quality and comply with regulatory standards.

The bioprocess automation and control software market is expanding rapidly, driven by rising demand in biotechnology, pharmaceuticals and biomanufacturing. For instance, according to the OECD, the United States continues to be a dominant force in the biotech sector, with the most active biotech businesses (2,840) and an R&D intensity added value of 17%. Belgium's remarkable 35.7% biotech R&D added value or the UK's strong 2023 third quarter, which solidified its position as a European innovation driver, demonstrates an uneven but promising biotechnology environment.

Market Dynamics: Drivers & Restraints

Rising demand for biopharmaceuticals and biologics

The rising demand for biopharmaceuticals and biologics is significantly driving the growth of the bioprocess automation and control software market and is expected to drive over the forecast period. The rising demand for biopharmaceuticals and biologics including products like monoclonal antibodies, cell and gene therapies, vaccines and recombinant proteins drives significant growth in the bioprocess automation and control software market. Biopharmaceuticals are highly complex and sensitive products, making consistent quality, precise control and scalability essential for successful production. This has created a strong push toward automation and advanced control systems in bioprocessing.

For instance, according to the Pharmaceutical Research and Manufacturers of America, as of the end of 2022, 40 biosimilars have been approved and there are 27 biosimilars on the market in the U.S. Additionally, data published by PhRMA indicate that there are more than 7,800 biopharmaceutical products in clinical development globally, of which over 1,000 have reached phase 3 trials. This rising demand for biopharmaceuticals and biologics boosting the market growth.

Cybersecurity concerns

Cybersecurity concerns are a significant challenge for the bioprocess automation and control software market, potentially hindering its growth and adoption. As biomanufacturing facilities increasingly integrate automation systems, the reliance on data-driven, connected technologies such as cloud-based platforms, IoT devices and real-time monitoring opens them up to a wide range of cyber risks.

For instance, according to the HHS Cybersecurity Program, 630+ total healthcare organizational breaches and 29 million healthcare records were breached. These vulnerabilities can expose critical systems to cyberattacks, data breaches and operational disruptions, which can have severe consequences for both the manufacturing process and regulatory compliance.

Market Segment Analysis

The global bioprocess automation and control software market is segmented based on software type, deployment mode, application, end-user and region.

Software Type:

The bioprocess control software segment is expected to dominate the global bioprocess automation and control software market share

The bioprocess control software segment holds a major portion of the bioprocess automation and control software market share and is expected to continue to hold a significant portion of the market share over the forecast period due to its critical role in optimizing, monitoring and controlling complex biomanufacturing processes. As the demand for biologics and biopharmaceuticals continues to grow, the need for highly precise control systems becomes more vital. Bioprocess control software ensures the accuracy, repeatability and efficiency required to produce high-quality bioproducts while maintaining compliance with stringent regulatory standards.

For instance, Strict control of bioreactor conditions is necessary for the manufacture of monoclonal antibodies (mAbs), as even minor variations might result in decreased output or problems with product quality. Bioprocess control software optimizes the process to attain optimum efficiency by automating the real-time modification of critical variables such as temperature, pH and oxygen concentration.

The quality management software segment is the fastest-growing segment in the bioprocess automation and control software market

The quality management software segment is expected to be the fastest-growing segment in the bioprocess automation and control software market over the forecast period largely driven by the increasing complexity and regulatory scrutiny in the biopharmaceutical and biotechnology sectors. Quality management systems ensure that bioprocesses are executed under controlled conditions, maintain high standards of product quality and comply with stringent regulatory requirements.

For instance, according to the National Institute of Health, in a Quality Benchmarking Study (QBS), more than 200 pharmaceutical manufacturing facilities from across the world contributed information on their production performance and self-evaluations of their compliance with quality standards. These can increase the demand for quality management software in pharmaceutical manufacturing facilities.

Market Geographical Share

North America is expected to hold a significant position in the global bioprocess automation and control software market

North America region is expected to hold the largest share in the bioprocess automation and control software market over the forecast period owing to the rising demand for biopharmaceuticals. The growing shift toward biopharmaceuticals as the preferred treatment option for a variety of diseases is boosting the need for advanced biomanufacturing capabilities. North America especially in the United States and Canada is the largest market and is expected to maintain this position, fueling the demand for bioprocess automation software in the region.

According to the Government of Canada, Canada is the eighth largest pharmaceutical market in the world, with a 2.2% share worldwide. In Canada, brand-name goods make up 25.7% of prescriptions by quantity and 80.5% of sales by value. Generics make up 74.3% of the share by prescriptions and 19.5% of sales by value.

Asia Pacific is growing at the fastest pace in the bioprocess automation and control software market

The Asia Pacific region is experiencing the fastest growth in the bioprocess automation and control software market. The biopharmaceutical market in APAC is experiencing rapid growth, especially in India, Japan and China. The increasing demand for biologics such as monoclonal antibodies, vaccines, biosimilars and gene therapies is driving the need for advanced biomanufacturing solutions, including automation software for both upstream and downstream processing.

For instance, according to Invest India, a total of 22 mergers and acquisitions (M&A) deals have occurred in the life sciences sector in India. The percentage share of the biotechnology segments is biopharmaceuticals at 62%, bioagriculture at 13%, bioindustry at 15% and bioIT & bioservices at 10%.

Major Global Players

The major global players in the bioprocess automation and control software market include Thermo Fisher Scientific Inc., Merck KGaA, Sartorius AG, SECURECELL AG, Resea Biotec GmbH, Getinge AB, Vimachem, Danaher Corporation, Eppendorf SE, Waters Corporation and among others.

Emerging Players

The emerging players in the bioprocess automation and control software market include TetraScience, Inc., Körber AG, Infors AG and among others.

Why Purchase the Report?

• Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.

• Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.

• Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.

• Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.

• Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.

• Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.

• Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.

• Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.

• Regional Growth & Investment: Highlights high-growth regions and investment opportunities.

• Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.

• Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.

• Post-market Surveillance: Uses post-market data to enhance product safety and access.

• Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global Bioprocess Automation and Control Software market report delivers a detailed analysis with 70 key tables, more than 68 visually impactful figures, and 179 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2024

• Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.

• Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.

• Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.

• Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.

• Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.

• Supply Chain: Distribution and Supply Chain Managers.

• Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.

• Academic & Research: Academic Institutions.