Computer system validation involves documenting the planning, design, development, implementation and maintenance activities carried out by an organization to provide continued confidence that computer systems are validated to meet the requirements. It ensures that systems are adequately tested, perform consistently and are capable of delivering the intended results reliably and accurately. Computer systems play a crucial role in the manufacturing and distribution of pharmaceutical products. From tracking and managing clinical trials, maintaining compliance with regulations to streamlining financial transactions, computer systems handle complex operations while mitigating risks. The global computer system validation market involves validation of computer systems used across various applications such as manufacturing execution systems, laboratory information management systems, quality management systems and supply chain management systems.
The global computer system validation Market is estimated to be valued at US$ 3.73 Bn in 2023 and is expected to exhibit a CAGR of 10% over the forecast period 2023 to 2030, as highlighted in a new report published by Coherent Market Insights.
Market Dynamics:
The adoption of cutting-edge technologies such as artificial intelligence, machine learning, cloud computing and big data analytics across industries has created the need for computer systems capable of handling large volumes of complex data and deploying advanced algorithms in real-time. This, in turn, has accelerated investments in validating computer systems and ensuring compliance with stringent regulatory guidelines. Additionally, the rising demand for automation and need to optimize manufacturing processes has prompted pharmaceutical companies to incorporate new-age technologies which require rigorous validation protocols. Growing R&D expenditure, increasing complexity of drug development and stringent regulatory oversight have further propelled the demand for established validation procedures to maintain quality standards.
Segment Analysis
The computer system validation market can be segmented based on type, end-use and region. Based on type, the market can be divided into equipment/hardware, systems, software and others. The equipment/hardware segment dominates the market currently due to continuous need for advanced hardware to validate complex computer systems. Based on end-use, the market is segmented into pharmaceutical companies, CROs, CMOs and others. The pharmaceutical companies segment holds the largest market share owing to stringent regulations regarding CSV for drug development and manufacturing.
PEST Analysis
Political: Stringent regulations regarding CSV by regulatory bodies like FDA, EMA boost the market. However, non-uniform regulations globally pose challenges.
Economic: Growing pharmaceutical industry globally and rising R&D expenditure fuels market growth. Developed economies dominate the market due to high healthcare expenditure.
Social: Increasing awareness about patient safety and benefits of CSV in reducing bugs and risks in systems drive growth. However, shortage of skilled professionals hampers the market.
Technological: Advancements in technologies like artificial intelligence, IoT, big data and cloud computing aid in automating CSV process and propel growth. However, high costs associated with latest technologies restrict the market.
Key Takeaways
The Global Computer System Validation Market Growth is expected to witness high over the forecast period due to rising need for systematic testing and validation of new computerized systems used in critical functions.
Regional analysis: North America, particularly the US, holds the largest market share owing to presence of key players and stringent regulations regarding CSV. Furthermore, growing focus on developing technologically advanced equipment/systems for critical processes fuels demand.
Key players operating in the computer system validation market are QIAGEN, Dicerna Pharmaceuticals Inc., Phio Pharmaceuticals Corp., Arcturus Therapeutics, Ionis Pharmaceuticals Inc., Sigma Aldrich (Merck KGaA), Benitec Biopharma Ltd., Silence Therapeutics PLC, SBI Biotech Co. Ltd., Alnylam Pharmaceuticals Inc., and Thermo Fisher Scientific Inc. Key players are mainly focusing on new product launches, collaborations and mergers & acquisitions to strengthen their market position. For instance, in 2022, QIAGEN launched new solutions to automate CSV process using IoT and artificial intelligence.
*Note:
1. Source: Coherent Market Insights, Public sources, Desk research
2. We have leveraged AI tools to mine information and compile it
Money Singh is a seasoned content writer with over four years of experience in the market research sector. Her expertise spans various industries, including food and beverages, biotechnology, chemical and materials, defense and aerospace, consumer goods, etc.