Automation in Biopharma Industry Market - Global Industry Size, Share, Trends, Opportunity, & Forecast 2018-2028

The Global Automation in Biopharma Industry Market was valued at USD 1775.20 million in 2022 and is anticipated to witness an impressive growth in the forecast period with a CAGR of 5.80% through 2028, reaching USD 2468.19 million. Automation in the biopharmaceutical (biopharma) industry refers to the use of advanced technology, systems, and processes to perform various tasks, experiments, and manufacturing processes with minimal human intervention. The primary goals of automation in the biopharma industry are to improve efficiency, accuracy, consistency, and safety in research, development, and manufacturing activities. In biopharmaceutical manufacturing, process automation is crucial. It involves the use of automated systems and instruments for tasks such as cell culture, fermentation, purification, and fill-finish operations. Process automation ensures the precise control of critical parameters (e.g., temperature, pH, and agitation) to maintain product quality and consistency. Robotic systems are employed for a wide range of tasks, from drug discovery and sample handling to filling and packaging in manufacturing. Robots can be programmed to handle samples, reagents, and labware, performing tasks with precision and repeatability.

Automation systems provide advanced quality control and assurance in biopharma manufacturing. They monitor and control critical parameters and offer real-time feedback to ensure that products meet stringent quality standards. The biopharma industry is subject to rigorous quality and safety regulations. Automation systems aid in compliance by providing accurate data, traceability, and documentation, which are crucial for regulatory approval. Ongoing technological innovations in automation, such as the use of artificial intelligence, machine learning, and robotics, are driving the adoption of cutting-edge systems for research and production. Biopharmaceutical products are becoming more complex, requiring advanced automation to produce biologics, cell therapies, and gene therapies.

Key Market Drivers

Technological Advancements

Robotics and automation have become increasingly sophisticated, with the integration of advanced robotics in laboratories and production facilities. These robots can perform a wide range of tasks, from liquid handling and sample preparation to cell culture maintenance. Automation systems have improved the efficiency of High-Throughput Screening (HTS) in drug discovery. Automated liquid handling and data analysis tools allow for the rapid screening of thousands of compounds for potential drug candidates. Lab-on-a-Chip (LOC) Technology integrates various laboratory functions onto a single chip, reducing the need for manual interventions. This technology is particularly useful for sample preparation and analysis. Advancements in software and data analytics enable real-time monitoring and analysis of experimental data. This facilitates quicker decision-making in drug development and manufacturing processes. Artificial Intelligence (AI) and Machine Learning (ML) are being used for data analysis, predictive modeling, and optimization of bioprocessing. They can help identify potential drug candidates and optimize manufacturing processes.

Process Analytical Technology (PAT) integrates sensors, process control, and data analysis to monitor and control bioprocesses in real time. This technology ensures product quality and consistency. Single-use bioreactors and disposable equipment have advanced, providing more cost-effective and flexible solutions for biopharma manufacturing. Continuous biopharma manufacturing processes are gaining traction. Automation enables continuous production of biologics, reducing the time and cost associated with batch manufacturing. Automated systems for quality control, including high-resolution imaging, mass spectrometry, and chromatography, improve product quality assurance and reduce the need for manual testing. Integrated automation platforms that combine various laboratory instruments, software, and data management systems provide a seamless workflow for biopharma researchers and manufacturers.

IoT-enabled devices and automation systems allow for remote monitoring and control of bioprocesses. This is especially valuable for ensuring consistent production and reducing the need for on-site presence. The use of nanotechnology in drug delivery and diagnostics has advanced. Automated systems can handle and analyze nanoparticles for various applications in biopharma. Automation has streamlined gene editing and CRISPR-Cas9 technologies, allowing for more precise and efficient genome editing for drug discovery and development. Automated bioprocessing systems are increasingly adaptable and customizable, allowing companies to tailor their systems to the specific needs of their products. Blockchain technology is being explored for secure data storage and sharing in the biopharma industry, ensuring the integrity and security of critical data. This factor will help in the development of the Global Automation in Biopharma Industry Market.

Increasing Complexity of Biopharmaceuticals

Biopharmaceuticals, such as monoclonal antibodies, gene therapies, and cell-based therapies, often involve intricate and multi-step manufacturing processes. Automation is essential to maintain precision and consistency throughout these complex processes. Complex biopharmaceuticals are subject to stringent regulatory requirements. Automation helps ensure compliance by providing accurate data, traceability, and documentation, which are crucial for regulatory approval. Complex biopharmaceuticals must meet exceptionally high-quality standards. Automation systems can consistently maintain product quality, ensuring that processes stay within the desired parameters and minimizing variability.

The complexity of biopharmaceutical production leaves room for errors in manual processes. Automation minimizes the influence of human error, which is crucial when dealing with complex and high-value biologics. Complex biopharmaceuticals generate large volumes of data. Automation facilitates data collection, storage, and analysis, enabling the handling of complex datasets and the extraction of valuable insights. The complexity of biopharmaceuticals necessitates continuous monitoring and control. Automation provides real-time monitoring of critical parameters, ensuring that the production process stays within the specified ranges. Many complex biopharmaceuticals need to be produced at various scales to meet market demand. Automation systems are designed to be scalable, allowing companies to adapt to changing production volumes.

Complex biopharmaceuticals are often high-value products, making the cost of errors or product loss significant. Automation minimizes the risk of errors and maximizes product yield. The trend toward personalized medicine, where treatments are customized for individual patients, involves the production of complex and patient-specific therapies. Automation helps tailor the manufacturing process for each patient, ensuring precision and consistency. Emerging biopharmaceuticals, including gene and cell therapies, are highly complex and innovative. Automation is essential to advance the development and production of these groundbreaking therapies. The market demand for complex biopharmaceuticals is on the rise due to the increasing prevalence of complex diseases and the need for more effective treatments. Automation is critical to meeting this demand efficiently. This factor will pace up the demand of Global Automation in Biopharma Industry Market.

Rising Demand of High-Throughput Screening

High-Throughput Screening (HTS) involves the rapid and automated testing of many compounds for various biological activities. HTS allows biopharmaceutical companies to test a vast library of compounds quickly. This accelerates the drug discovery process by identifying potential drug candidates in a fraction of the time it would take with manual testing. Automation in HTS reduces the cost per test, making it more economically feasible for biopharma companies to screen large numbers of compounds. This cost efficiency is vital for research and development budgets. HTS generates a significant amount of data in a short time. Automation enables efficient data collection and analysis, leading to the discovery of promising drug candidates and more precise drug development. The complexity of assays in biopharma research has increased as scientists seek to address more intricate biological questions. Automation is essential for handling these complex assays efficiently. Biopharma companies have access to extensive compound libraries. Automation is necessary to manage and screen these libraries effectively.

Automation is used in target identification and validation processes. HTS enables researchers to identify novel drug targets quickly, speeding up the early stages of drug discovery. After identifying potential drug candidates, HTS automation plays a crucial role in hit validation, where promising compounds are confirmed for their activity against specific targets. Automation enables the miniaturization of assays, reducing the number of reagents and compounds needed for testing. This not only saves costs but is also environmentally friendly. Automation systems ensure that screening assays are conducted consistently and with high precision, reducing the risk of experimental variability and errors.

Promising hits discovered through HTS can be scaled up for further research and development, ultimately leading to the production of biopharmaceuticals. Automation supports this scaling process. Automation is crucial for efficiently screening existing drugs for new therapeutic uses. This process, known as drug repurposing, can lead to the discovery of innovative treatments. HTS automation also plays a role in the safety assessment of potential drugs. It enables the testing of compounds for adverse effects and toxicity. Automation supports the discovery of targeted therapies that are tailored to specific diseases or patient populations. This is especially relevant in the era of personalized medicine. This factor will accelerate the demand of Global Automation in Biopharma Industry Market.

Key Market Challenges

Cost of Implementation

The purchase of automation equipment, software, and related technologies requires a substantial capital investment. This includes the costs of acquiring hardware, robotics, sensors, and other automation components. Tailoring automation systems to the specific needs of biopharmaceutical processes often involves customization. Custom solutions are typically more expensive than off-the-shelf products. Integrating automation systems with existing processes and infrastructure can be complex and costly. Compatibility and interoperability with legacy systems may require additional investments. Ensuring that automation systems meet regulatory standards and industry-specific validation requirements adds to the cost. Extensive testing, documentation, and validation processes are necessary to ensure compliance. Employees must be trained to operate and maintain automation systems effectively. Training programs come with associated costs, including staff time and external training resources. Automation systems require ongoing maintenance and technical support. This includes software updates, equipment maintenance, and troubleshooting, all of which have associated costs.

Maintaining Quality Assurance

Biopharmaceutical manufacturing processes can be intricate, involving multiple steps, and the complexity can make it challenging to maintain consistent product quality. Automation systems must be carefully designed and configured to ensure that every step is performed accurately. Variability can arise from various sources, including raw materials, environmental conditions, and equipment. Automation systems need to account for and minimize variability to ensure product consistency. The biopharma industry is subject to strict regulatory requirements. Maintaining compliance with Good Manufacturing Practices (GMP) and other regulations is a continuous challenge, as automation systems must adhere to these standards and provide documentation for audits and inspections. The validation of automated systems is a time-consuming and costly process. It is essential to validate automation systems thoroughly to ensure they consistently produce products of the desired quality. Automated instruments and sensors require regular calibration to maintain accuracy and reliability. Ensuring proper calibration is a critical aspect of quality assurance. In an automated environment, data integrity is essential. Automation systems must capture, store, and manage data accurately to support quality control and regulatory compliance. Automation systems must be designed to prevent cross-contamination of products or samples. This can be particularly challenging in multi-product manufacturing facilities.

Key Market Trends

Lab Automation

Lab automation systems enable high-throughput screening of compounds, allowing researchers to quickly test many potential drug candidates. This is essential in the early stages of drug discovery. Automation systems in the lab provide precise and accurate handling of samples, reducing the risk of human error and ensuring consistent and reliable results. Automation simplifies data collection, storage, and analysis. It enables real-time monitoring and data processing, facilitating faster decision-making in research and development. Automated processes are more efficient and can run continuously, reducing the time and effort required for experiments and assays. This accelerates research and development timelines. Automation reduces the need for manual labor in repetitive and time-consuming tasks, resulting in cost savings and the redeployment of human resources to more strategic activities. Automation optimizes the use of resources, such as reagents, consumables, and equipment, making laboratory operations more cost-effective.

Segmental Insights

Technology Insights

In 2022, the Global Automation in Biopharma Industry Market largest share was held by Digitization Technology segment and is predicted to continue expanding over the coming years. In the biopharma industry, data is critical. Digitization technology enables the collection, storage, analysis, and utilization of vast amounts of data. This data-driven approach empowers biopharmaceutical companies to make informed decisions, optimize processes, and enhance product quality. Digitization technology allows for real-time monitoring and control of biopharma processes. It provides a comprehensive view of all aspects of production, enabling immediate adjustments and ensuring that the production process stays within specified parameters. Biopharmaceutical manufacturing is subject to rigorous quality standards and regulatory requirements. Digitization technology helps ensure compliance by providing a robust record-keeping system and enabling automated audit trails, which simplifies the tracking and reporting of data required for compliance. Digitization technology optimizes workflows, increases operational efficiency, and minimizes downtime. It streamlines and automates various tasks, reducing the risk of errors and increasing productivity.

Application Insights

In 2022, the Global Automation in Biopharma Industry Market largest share was held by Production Phase segment and is predicted to continue expanding over the coming years. The production phase in the biopharma industry is where large-scale manufacturing of biopharmaceutical products, such as vaccines, biologics, and other therapeutic agents, takes place. Due to the scale and complexity of production, automation is essential to meet demand efficiently and ensure consistent product quality. The biopharmaceutical industry is highly regulated, with strict quality and safety standards. Automation in the production phase helps ensure compliance with these regulations and reduces the risk of errors or contamination, which can lead to costly recalls and regulatory actions. Automated systems offer precise control over manufacturing processes, which is vital for achieving consistent product quality and maintaining the reproducibility of biopharmaceuticals. This is especially important for products like monoclonal antibodies and vaccines. Automation minimizes the influence of human error in critical manufacturing processes. Even small deviations in biopharma production can have significant consequences, making automation a key tool in maintaining product consistency.

Component Insights

In 2022, the Global Automation in Biopharma Industry Market largest share was held by Automation Software segment in the forecast period and is predicted to continue expanding over the coming years. Automation software serves as the core element that manages and controls various automation processes within the biopharmaceutical industry. It orchestrates the functions of hardware, robotics, and other equipment, making it an essential component of any automation system. Automation software provides a unified platform for integrating and controlling diverse automation components and systems. It allows for seamless communication between different devices and equipment, streamlining operations and ensuring data consistency. Automation software can be tailored to the specific needs of biopharmaceutical companies. It offers flexibility to adapt to evolving processes, which is crucial in a dynamic industry like biopharma. Automation software enables real-time monitoring of bioprocesses and analytics. This capability is vital for quality control, process optimization, and data-driven decision-making, all of which are fundamental in biopharma.

Regional Insights

The North America region dominates the Global Automation in Biopharma Industry Market in 2022. North America, particularly the United States, is home to a significant number of leading biopharmaceutical companies, research institutions, and academic centers. These organizations invest heavily in automation to improve their research, development, and manufacturing processes. The region has a well-developed technological infrastructure and a strong industrial base, making it easier for companies to adopt and integrate automation solutions. The region is known for its innovation in automation technologies. North American biopharmaceutical companies often have greater access to financial resources for investing in automation due to well-established financial markets, venture capital, and government funding opportunities. The United States has a regulatory environment that encourages innovation and investment in the biopharma industry. Regulatory agencies like the FDA work closely with the industry to facilitate the adoption of new technologies, including automation.

Report Scope

In this report, the Global Automation in Biopharma Industry Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Automation in Biopharma Industry Market, By Technology:

• Automation Technology
• Digitization Technology

Automation in Biopharma Industry Market, By Application:

• Clinical Phase
• Drug Discovery Phase
• Production Phase

Automation in Biopharma Industry Market, By Component:

• Automation Hardware
• Automation Software
• Services Project Phase
• Services Operation Phase

Automation in Biopharma Industry Market, By region:

• North America
• United States
• Canada
• Mexico
• Asia-Pacific
• China
• India
• South Korea
• Australia
• Japan
• Europe
• Germany
• France
• United Kingdom
• Spain
• Italy
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Automation in Biopharma Industry Market.

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