2024 advanced therapy industry report
Trends shaping the future of personalized medicine
What’s on the horizon for the advanced therapy (AT) market? Our survey of advanced therapy developers (ATDs), advanced therapy manufacturing organizations (ATMOs), and health care providers (HCPs) and payers reveals a shared optimism and pinpoints key areas to watch. Explore cell and gene therapy insights that can help steer decision-making in the future of personalized medicine.
Insights from the frontlines of advanced therapy
Dive into the findings from our 2024 state of the advanced therapy industry report, highlighting important trends and insights from 376 industry stakeholders across the cell and gene therapy market. Our survey, expanded this year to capture diverse viewpoints, sheds light on optimism in the industry, growth strategies, and pressing challenges.
We found that nearly 90% of leaders feel positive/very positive about the next 12–18 months. Positivity remains high among all stakeholders suggesting expected ongoing progress and confidence in the market. More than 80% of respondents had a favorable outlook for gene therapies and 77% for autologous cell therapies. As organizations invest in their AT portfolios, results showed rising interest in novel treatment modalities with 25% of ATDs looking into RNA-based therapies.
Key survey highlights
Factors for successful clinical trials
Optimizing trial design and maximizing patient recruitment and retention continue to be issues of concern for clinical organizations. Surprisingly, site selection has decreased in concern compared to last year. This could be a result of having sufficient experienced treatment centers to meet demand, yet many organizations continue to struggle with meeting patient enrollment numbers in the clinical setting.
Scaling challenges affect confidence
Survey results revealed that more than 40% of respondents lack confidence in meeting the next two to three years of demand. This reflects sustained uncertainty coming from scaling challenges cited as lack of talent; capital access; and lack of standardized processes.
Nearly 90% of ATDs have contracted with external manufacturing organizations, a 30% increase from last year.
Transforming challenge into opportunity
While “payer and reimbursement challenges” remains the top force affecting the commercialization of advanced therapies in the next 12–18 months, this year it tied with “improved manufacturing technology,” underscoring a push toward consistency and lower cost of goods sold.
However, more than 30% of ATDs are actively considering partnerships for growth. Almost a quarter of the respondents demonstrate a high level of interest for RNA-based therapies, as opposed to only 1% for induced pluripotent stem cells. Radiopharmacy was an emerging area of interest with 8% of respondents.
The potential of artificial intelligence
More than two-thirds of all ATDs and ATMOs have established an AI strategy. The trend is mostly driven by increased interest in Generative AI capabilities; however, the value of which remains nebulous.
Respondents cited the top AI goals their organizations are targeting as improving efficiency and productivity; reducing costs; and encouraging innovation and growth.
Ambiguity clouds the landscape
Manufacturing continues to be at the top of the list in terms of areas of regulatory ambiguity in the AT value chain. Vector or plasmid chemistry, manufacturing, and control (CMC) guidelines and clinical data analytics come up second and third.
These areas present major challenges in developmental timelines due to the rapid evolution of technology in ATs. Plus, varying regulatory guidelines across geographies further complicate compliance. Regulatory agencies have been willing to support developers in navigating the available pathways.
Propel your AT business toward transformative growth
Overall, results show a sector poised for transformative growth, driven by optimism and strategic innovation. Stakeholders industry-wide share a positive outlook, fueled by scientific advancements. With reimbursement hurdles, scalability of manufacturing operations, and regulatory ambiguities as ongoing challenges, the industry is increasingly adopting collaborative approaches and using digital tech to enhance automation for operational efficiencies and innovation.
Embracing innovative payment models, enhancing patient education, and establishing robust clinical trial designs are strategies needed for the AT sector to overcome financial, adherence, and regulatory challenges. As the AT sector approaches a crossroads in its growth, the industry’s ability to navigate these challenges will define its future in revolutionary treatment paradigms.
