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Abstract
Over the past years, the biopharmaceutical industry has been marked by substantial growth, with key players dominating market sales. A major change in research and development is the onset of digital twin (DT) technology in manufacturing. This work gives an overview of the market and major stakeholders, such as contract development and manufacturing organizations (CDMOs), regulatory bodies, and academia, their functions, and challenges. Fundamental concepts and definitions are reviewed and serve as an overview of the challenges ahead of the full adaptation of DTs in manufacturing. Using established market analysis tools, the environment is analyzed, and a business case is developed. Opportunities and threats for small startups and larger pharmaceutical companies to gain a competitive edge are analyzed and evaluated. Even small groups of 4–16 employees enable significant margins at a return on investment of less than 1 year.
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