Precision medicine represents a new frontier in healthcare. By stratifying patients based on genomic and phenotypic variations, it addresses the diverse ways individuals respond to treatments. Although initially dominated by oncology, the approach is now expanding to central nervous system (CNS) disorders, musculoskeletal diseases and beyond. According to GlobalData, sales of personalized therapies will skyrocket from $8 billion in 2022 to a projected $106 billion by 2029, a remarkable compound annual growth rate (CAGR) of 44%.
This growth has been fueled by advancements in technology. Artificial intelligence (AI) is revolutionizing target identification, drug design and patient stratification. AI’s integration into precision medicine is poised to dramatically enhance scalability. For instance, the proportion of CNS-related precision medicine trials increased from 2.3% in 2003 to 11.5% by 2023, and musculoskeletal trials tripled in the same timeframe. These developments are transforming treatment paradigms across multiple therapeutic areas.
Despite these successes, personalized medicine’s high production costs and small target populations often make achieving returns on investment difficult. Additionally, growing pressure for sustainable practices adds another layer of complexity to an already challenging landscape. Addressing these challenges requires a refreshed approach to biomanufacturing – crucially, one that takes an innovative stance on the supply chains underpinning it.
Challenges in scaling personalized medicine – and why supply chains matter
Scaling personalized therapies brings unique logistical challenges. Unlike mass-market drugs, these treatments require highly specific materials, stringent cold chain logistics and real-time coordination between multiple stakeholders. Every patient is different; every manufacturing process and supply chain must be specialized alongside them.
Compounding the intrinsic difficulties are a range of additional disruptions hitting global supply chains, geopolitical relations and the regulatory landscape. For example, China’s dominance in the production of active pharmaceutical ingredients (APIs) has come under scrutiny. With geopolitical tensions rising and Chinese Good Manufacturing Practice (GMP) certificates expiring amid espionage fears, pharmaceutical companies face heightened risks of critical shortages. The European Medicines Agency has responded by urging firms to diversify suppliers and stockpile essential medicines. Some are going further; in October 2024, the UK’s Department of Health and Social Care of the United Kingdom banned folinic acid, a cancer medicine, from being exported. Governments are looking inwards to protect patients. Supply chains are taking the hit – and biomanufacturers are scrambling to find alternative solutions.
Indeed, supply chain instability ranked among the top four risks for the pharmaceutical industry in a survey of business decision makers for GlobalData’s 2024 Company Filings Analytics report. The increasing frequency of global disruptions, such as the Red Sea crisis and disputes in the South China Sea, highlights the fragility of traditional supply chain models.
Against this backdrop, companies are adopting novel approaches to ensure reliability while reducing costs and complexity.
The new paradigms in personalized medicine
One example of an approach being taken to address difficulties around manufacturing of novel therapies is decentralization. By leveraging virtual trials, for instance, pharmaceutical companies can reach diverse patient populations, improve recruitment and enhance data collection. According to GlobalData, 5,462 decentralized trials for biologic therapies were ongoing in 2024, with the market for these trials projected to expand.
Sponsors increasingly recognize the value of decentralization in identifying flaws and refining processes, ultimately enhancing efficiency. In manufacturing, decentralization also helps localize production, mitigating reliance on global supply chains. For instance, in a recent GlobalData survey of decision makers in the pharmaceutical industry, 20% of respondents expressed a willingness to shift more API manufacturing to countries where their headquarters or main clients are based, while 40% favored onshoring as a method for enhancing resilience against disruption. “The use of decentralized and virtual trials is projected to increase,” comments Mohamed Abukar, a senior clinical trials analyst at GlobalData. “Continued growth can be attributed to sponsors gaining experience in the use of these technologies and increased confidence in identifying the components that work well.”
Outsourcing, long a staple of pharmaceutical production, is evolving in the era of personalized medicine. Contract manufacturing organizations (CMOs) offer specialized expertise, enabling firms to navigate the complexities of producing advanced therapies. The growing influence of CMOs in manufacturing biologics is clear. Thirty-nine new drug applications to the FDA were outsourced to contract manufacturers in 2023. Between 2018 and 2022, just under half of all new biologic drugs were outsourced. These figures underscore the potential of CMOs as a scalable solution for personalized medicine. By partnering with CMOs, pharmaceutical companies can focus on innovation while ensuring cost-effective and reliable production.
Another key trend is the rise of end-to-end services. In the new age of patient-specific supply chains, these can help biomanufacturers seamlessly manage the transition. Offering a holistic approach that unifies processes from patient onboarding to treatment delivery, end-to-end systems are more than technological tools – they enable pharmaceutical firms to weave a thread of precision throughout their operations, providing a level of coordination previously unimaginable.
The strength of end-to-end services lies in their ability to integrate disparate functions into a cohesive system. By automating workflows and ensuring precise coordination across each step of the supply chain, the platforms can crack down on inefficiencies and streamline operations. Personalized therapies rely on sensitive, patient-specific data and their integrity is safeguarded via robust protocols that track and verify every movement. This ensures that the right treatment reaches the right patient without fail.
Real-time monitoring is a hallmark of these platforms, transforming supply chains from opaque networks into transparent, highly responsive systems. This visibility allows for swift intervention when issues arise, reducing delays and preventing costly errors. End-to-end systems also foster cross-enterprise integration. They bridge silos between procurement, manufacturing and delivery, creating a unified framework that enhances efficiency and accuracy. Smoother operational flows and enhanced compliance with regulatory standards – supported by precise documentation and audit-ready record-keeping – are built in. Reduced costs, minimized errors and accelerated delivery timelines all have profound implications for personalized medicine, putting pharmaceutical companies in the driving seat as they scale up personalized therapies without compromising on quality.
The rise of AI complements these new systems, anticipating bottlenecks in supply chain before they arise so they can be tackled. The pharmaceutical industry faces significant challenges in managing clinical trial supplies, with top pharmaceutical companies experiencing annual losses in the hundreds of millions due to inventory wastage, particularly in high-value segments like cell and gene therapies. Implementing AI and machine learning algorithms can dramatically improve inventory optimization, enhancing enrollment forecast accuracy, reducing wastage and providing visibility into inventory dynamics. Machine learning algorithms can forecast material requirements with unprecedented accuracy, while AI-based quality control systems can detect manufacturing anomalies in real-time to keep waste low and product quality consistent. AI can also actively suggest alternate options to mitigate issues and exceptions, supporting resolutions that both maximize patient access and reduce cost.
One notable example of this approach is SAP’s Cell and Gene Therapy Orchestration solution. By leveraging technology to enhance precision and coordination, SAP’s solution exemplifies how end-to-end services can transform the delivery of personalized medicine. For an industry coming to terms with the challenges of scalability – all against a backdrop of wider supply chain instability – getting to grips with these kinds of innovations is essential.
SAP stands at the forefront of developments in personalized medicine, and their end-to-end solution is already helping trailblazing pharmaceutical firms upgrade their operations. To learn more about the potential benefits on offer, fill in your details and download the whitepaper on this page.
