The biopharmaceutical industry is undergoing rapid change that is expected to accelerate even further in 2024. In this first installment of Vistatec’s Life Sciences – In Focus series, leading industry experts share insights and explore the trends set to reshape the Life Sciences industry.

The inaugural episode in the series featured a presentation from Amanda Murphy, Senior Director of Data Intelligence and Solutions at GlobalData, on the organization’s 2023 State of the Biopharmaceutical Industry report. A lively discussion about current trends, challenges, and anticipated developments in the biopharmaceutical industry between the presenter and panelists Kalyan Olampalli of Clin.AI and Brad Pruitt, MD of Alethium Health, moderated by host María Mateos of Vistatec followed. The event yielded valuable insights into the industry’s outlook for the upcoming year, focusing on the clinical trials landscape, including decentralized clinical trials and diversity.

Life Sciences – In Focus: Speaker and Panelists

• Amanda Murphy, Senior Director of Data Intelligence and Solutions, GlobalData Plc
• Kalyan Obalampalli, Founder, Clin.AI
• Brad Pruitt, MD, CMO, Alethium Health
• María Mateos, Strategic Account Director – Life Sciences, Vistatec

Leveraging Data and Trends for 2024

In her presentation on GlobalData’s State of the Biopharmaceutical Industry Report for 2023, special guest and data scientist Amanda Murphy shared the data and trends at play in the biopharmaceutical industry and analyzed the outlook for 2024. She began by sharing the results of a survey of more than 250 leading industry executives on the outlook for 2023 conducted in Q4 of 2022.

In this survey, 47% of respondents had expressed optimism specifically about the following topics for 2023:

• Cell and gene therapy
• Precision medicine, genomics, immuno-oncology
• Clinical and manufacturing outsourcing
• Patient centricity in clinical trials
• AI and Big Data

Respondents were pessimistic about:

• Inflation
• Drug pricing

Viewed through the lens of this 2022 outlook, the results for 2023 were particularly interesting as panelists discussed anticipated trends for 2024.

Key Takeaways

Cell and Gene Therapy

There is a robust pipeline of cell and gene therapy products across therapeutic areas, emphasizing oncology, CNS, and metabolic disorders. Five of the 23 products currently approved in the US were approved this year, a clear indicator of this trend. While these products are unlikely to be blockbusters in the near term, with US$ 6 billion in revenue anticipated by 2025, every company is discussing cell and gene therapy products due to the projected annual growth rate of over 50% and a market poised to be valued at US$ 80 billion by 2029.

Patient Centricity in Clinical Trials

The trends toward decentralization and diversity in clinical trials are having a lasting impact on the clinical trial space.

• Decentralized Clinical Trials (DCTs): DCTs are becoming more prevalent every year. In 2023, around 15% of DCTs had virtual components vs. 5-7% a few years ago. Mobile healthcare is involved in 24% of cases, and telemedicine is involved in 22%. Overall, flexibility in trial design should be emphasized, and patient-centric approaches should be prioritized.
• Diversity in Clinical Trials: A focus on diversity has led to more trials specifically targeting non-white populations, showing a commitment to inclusivity and improved patient outcomes. While data is challenging to track before trial completion, among US trials that disclose race, 73% do not include white patients and instead target black/African American or Asian American patients. This bodes well for effectiveness and access to future treatments.

Inflation, Investment Strategies, and the IRA

Inflation has affected the industry’s venture capital funding, IPOs, and hiring, leading to budgetary constraints that may potentially limit innovation. While the number of trials and VC deals is down, the average size of the latter has increased by 42% since 2018. This trend could be partially explained by the increased expense associated with developing biologics, especially in cell and gene therapies. In the US, the Inflation Reduction Act (IRA) and the associated restrictions are also anticipated to have some fallout for pharma companies. Overall, organizations need to strike a balance between innovation and funding challenges, with due diligence and leveraging data being crucial in securing appropriate investments.

Outsourcing

In general, we are seeing a landscape where fewer clinical trials are being outsourced while manufacturing outsourcing is on the rise. In particular, outsourcing of biologic APIs has seen an upward trend, notably in cell and gene therapy, with over half of cell and gene therapy API manufacturing being outsourced.

Impact of AI and Big Data

In late 2022, industry experts were most optimistic about AI and Big Data for 2023, a trend that is set to continue in 2024. However, inflation concerns might lead to decreased investments in new technologies. While companies had planned to conduct AI and Big Data in-house, many realized they lacked the necessary skill sets and thus began to outsource, which could explain the reduced number of job postings. Overall, AI has indeed yet to reach its full potential.

Panel Discussion

AI- Where to Start? 
Host María Mateos kicked off the panel discussion with the uppermost topic in everyone’s minds: AI. Amanda Murphy noted that companies are finding it challenging to determine where to start, given the many possible applications, and will need to determine not only where AI will be the most impactful but also where it will be most realistic. Kalyan Obalampalli agreed but pointed out that adding value is critical and that the amount and quality of data available can strongly impact the effectiveness of AI. He also noted that automation continues to be underused. Returning to AI, Amanda Murphy remarked that its use in the biopharmaceutical industry has been a “mixed bag,” some companies have progressed a great deal, and others are just beginning to learn about the possibilities.

AI in R&D:
On tighter R&D budgets in “Big Pharma,” Amanda Murphy shared that corporations use AI to prioritize pipelines and inform investment decisions, whereas smaller and mid-sized biotechs working in biologics manufacturing tend to apply AI to manufacturing and the supply chain. AI, she added, might also be helpful in drug discovery. Overall, investors are looking more closely at more granular clinical trial data and using algorithms to obtain data to inform investment decisions.

Decentralized Clinical Trials:
DCTs contribute to increased diversity and make clinical trials more accessible to patients regardless of geographical location. Brad Pruitt suggested that qualitative data from patients could be used to enhance the quantitative data gathered through mobile technology to improve data quality. While it was originally thought that DCTs would reduce the cost of clinical trials, this has not always been the case. However, increased diversity, compliance, enrollment, and retention offset this, which enhances data quality and volume. It is hoped that this will also improve what is known as the “rule of thirds” (a third of patients won’t take the drug, a third receives benefit, and a third experiences more harm than good).

Key Takeaways

As host María Mateos concluded, AI and Big Data are vital topics for 2024, with inflation potentially impacting the “digital party.” Diversity and decentralization in clinical trials are making great strides and leading to significant changes. They hold the potential for tremendous progress in research, development, treatment, outcomes, and accessibility. In this changing landscape, one lasting factor is that quality translation and localization will continue to help ensure inclusivity, bridge language barriers, and make research more accessible to diverse populations. Exactly how these parts will fit together going forward will be explored in the coming episodes.

Overall, the first of our Life Sciences – In Focus series showcased an industry at a crossroads, with biopharmaceutical companies navigating through financial and technological shifts but being generally optimistic about opportunities and advancements in 2024.

Watch the recording of the full event here, and watch this space for the next episode in our Life Sciences – In Focus series in January 2024.

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