Reflecting on 2023, there is one word that comes to mind: resilience. Global unrest, strained economic conditions, and natural disasters tested the mettle of the U.S., but it’s clear as we begin 2024 that healthcare remains on solid footing. New, innovative treatments were delivered, and individuals demonstrated a reinvigorated commitment to their health.

As always, the turn of the year brings a sense of possibility – and it feels especially heightened for 2024. The explosive arrival of generative artificial intelligence (GenAI) and advancements in treatment modalities have the potential to improve patient outcomes. In an increasingly data-driven world, protecting patient privacy is paramount to progress, and that feels possible – even probable – with responsibly developed and stringently tested AI algorithms. Hurdles remain; enactment of the Inflation Reduction Act will continue to impact portfolios and pipeline decisions, the launch environment will remain harsh, and there’s uncertainty around election outcomes. But there’s a positive trajectory for 2024.

Here are the top trends for 2024 – areas of growth and evolution – that will impact the pharma industry and healthcare.

1. The missed trend of 2023 that we won’t forget: Generative AI

GenAI arrived on the global scene in 2023 – an important, yet somewhat unexpected inflection point in tech. This subsect of AI is already being integrated into the everyday. Bringing so many possibilities (and pitfalls), its integration into healthcare is an exciting new frontier. As AI becomes more routine, it’s important to consider the unique needs of the healthcare industry and ensure healthcare-grade AI is the gold standard.

The speed of innovation in and via AI is currently unparalleled, and application of AI algorithms and decisions based on their outputs are set to outpace regulatory guidance. Even so, responsible investment in internal AI capabilities is prudent and will increase over the coming years. Investments in internal operating efficiency are the first applications, but more creative uses are also being identified. There will likely be increased partnerships with companies seeking to implement AI, but early implementation of internal safeguards must be performed. Algorithms must be constantly reevaluated to ensure amplification of bias doesn’t seep into clinical decisions by both payers and healthcare providers (HCPs). Knowing who to trust to aggregate data, build algorithms, and interpret ambiguous findings to ultimately deliver healthcare-grade AI is a vital step for 2024.

2. A renewed commitment to privacy

As healthcare-grade AI continues to come into its own in 2024, there must be a renewed and elevated commitment to protect the privacy of consumers – providers and patients alike. Importantly, protecting the privacy of patients is not limited to their current health information; it includes their everyday information, such as social determinants of health and data collected from wearable and remote monitoring devices. In an era when AI can detect your heart health through your voice, serious discussions need to be had around protecting any individual’s data, even if the connection to health seems tangential.

As a result, the expectations of safeguarding privacy must be carefully considered in any data strategy. Planning for privacy upfront potentially avoids costly errors and potential breaches. Any consumer whose data is being used in any algorithm, whether HCP or patient, must be secured. Especially in healthcare, where protecting an individual’s privacy is sacrosanct; the minimum expectation must be maximum protection. 

3. The obesity market finds its medical footing in preventive care

With the emergence of effective weight loss medications, the obesity market is poised to become one of the largest markets in coming years. Specifically, the GLP-1s are ushering in a new era of medicine, where treatments are not only efficacious for a single indication, like weight loss, but also deliver cardioprotective effects distinct from the ancillary benefits of weight loss itself. Suddenly, preventive care is no longer a foregone era of medicine, gone with the genericization of statins.

Preventive care – and coverage for it – may well experience a resurgence as patients, providers, and payers look to improve overall health. The potential for delaying onset of serious progressive diseases (such as diabetes and cardiovascular disease) may well be worth cost of obesity treatments now. The catch, however, is now the threshold of necessary and sufficient data to demonstrate positive outcomes is higher than ever for healthcare stakeholders. Still, GLP-1s and next-generation obesity treatments may prove to be heralds of health.

4. Patients will better harness their voice and demand convenience

Pharma has long focused on meeting patients where they are, and ensuring they are at the center of healthcare. Now, more than ever, patients are letting the healthcare system know exactly what they want: convenience. Once thought to be artifacts of pandemic lock-down, the expectations of grocery delivery, Prime shipping, and vaccines at retail pharmacies have persisted. Discerning patients are wondering if they can receive birth control or erectile dysfunction medicines online, why can’t they do the same for psoriasis treatments? Or even weight loss drugs?

With the flurry of telemedicine platforms lowering an access barrier for certain treatments, patients revealed they are interested – and wanting – to receive medical care on their own terms. Remaining focused on only traditional medical avenues of care is short-sighted as individuals seek more accessible and convenient care avenues. Patients are ready for a seamless, easy, and worthwhile experience in healthcare. Companies who can successfully meet patients where they want to be met will benefit by creating trust with patients, furthering their ability to hear and respond to patient needs and ultimately improve patient outcomes.

5. Rare disease treatments are about to reach broadscale commercial viability

To much excitement, cell and gene therapies (CAGT) are reaching the U.S. healthcare market, offering new treatments to individuals with few, if any, treatment options. Some of the challenges of bringing CAGTs to market, like identifying small patient populations and manufacturing capacity, are beginning to abate. With predictive analytics and other AI algorithms, at-risk patient identification is more efficient and accurate, meaning reduced time to diagnosis and treatment initiation. Companies in the CAGT space have, or are, increasing internal manufacturing capabilities or structuring long-term partnerships with contract development and manufacturing organizations (CDMOs).

As a result, stronger commercial performance is expected to arise in 2024. Commercialization challenges remain – chief among them is coverage and reimbursement models for these costly treatments. CAGT companies are experimenting with a warranty model based on performance of their product over time. Whether this model will successfully assuage payer and system fears of price is unclear, but it demonstrates a willingness to make life-changing treatments available. Excitingly, longer-term durability data is expected in 2024 for a currently available gene therapy, which will further inform how to best commercialize these treatments.

6. Nurse practitioners take center stage

The pressures HCPs continue to face in the aftermath of the pandemic have led to burnout and worsened shortages globally. The shortage in the U.S. is expected to only grow as population growth coupled with an aging population create strains on healthcare capacity. The result: an astounding physician deficit of 38,800 to 125,100 by 2034. Bolstering the physician workforce today is a critical task to ensure future healthy generations.

Mid-level providers, like nurse practitioners (NPs), are expert, highly-skilled HCPs whose role will continue to grow in treating patients in the U.S. NPs currently have full practice authority in 27 states, meaning they can open and run a practice without physician oversight. More than that, they are already managing complex diseases, like diabetes, in a primary care setting. Supporting this foundational force of practitioners is critical. The Biden Administration also approved $100 million in training funds for the nursing workforce. Understanding how to best interact with this workforce will undoubtedly improve healthcare.

7. Is the blockbuster dead? The definition of launch success is evolving

Launch, the lifeblood of pharma, is more difficult to get right in this pressurized environment. The number of launches and their first-year sales performance have not recalibrated to pre-pandemic norms, and it’s unclear if they will. What is clear, however, is the launch playbook companies have relied on for decades is in desperate need of a rewrite. Following traditional launch dogma will produce a modicum of financial success, but sustainable success requires novel, thoughtful planning and strategy execution focused on one stakeholder: patients.

Expect a new playbook to take hold, with new metrics and a near real-time understanding of shifting market dynamics. Preliminary analyses suggest building a sustainable patient population may need to take precedence over short-term financial interests. This tradeoff, when done responsibly and with proper planning, can set up a long-term success trajectory. By focusing investments in early launch activities on patient acquisition (i.e., investing in transitional assistance programs), and knowing when and how to redirect resources, launch success can be course-corrected. Launch strategies then inform and promote mature brand success.

8. The Inflation Reduction Act continues to impact portfolio and pipeline decisions

The impacts of the Inflation Reduction Act (IRA) are becoming a reality. The highly anticipated list of the 10 drugs in the Medicare Drug Price Negotiation Program was released. Consumer price index (CPI) penalties were assessed for 27 products whose list price increases exceeded inflation, with manufacturers expected to pay these penalties in 2025. As IRA implementation continues, its implications and downstream consequences are becoming a known entity. The link between profit, gross-to-net, and launch is tighter than ever, and requires careful financial planning.

Thus, 2024 will continue to be a year of pipeline curation, discerning deal-making, assessment of market entry order, and market feasibility. The Medicare Part D liability ramifications and pricing pressures from the IRA will likely shape markets across therapy areas and patient age strata. But there may be meaningful benefits for patients, including lower out-of-pocket costs. This important access facet may lead to improved adherence, a key goal for manufacturers. While the ongoing impacts are just now unfolding, scenario planning can be more definitive and guide strategic decisions. 

9. The reality of chronic, specialty pharmacy biosimilars will appear

Due to smart competitive foresight, adalimumab biosimilars are off to a slow start. Even with interchangeability, formulary coverage was limited for adalimumab biosimilars throughout 2023. However, their market performance in 2024 is expected to reveal whether biosimilars in chronic diseases – where providers are hesitant to switch patients from a stable regimen – will exert competitive pressure. Interestingly, pharmacist opinion will be a factor, an untested dynamic in the biosimilar market, as most biosimilar are available through buy-and-bill channels, not specialty pharmacies.

This will be a make-or-break year for biosimilars that treat chronic diseases and are distributed through specialty pharmacies. Even moderate uptake of adalimumab biosimilars may allow for growing momentum and ease provider and patient concerns as outcomes are assessed. With at least one interchangeable Stelara (ustekinumab) biosimilar slated for availability in 2025, the biosimilar market can’t be discounted just yet.

10. Deeper reliance on Medical Affairs for commercial strategy

Over the last decade, the conversation around Medical Affairs has shifted from bridge, to pillar, to downright necessity. Companies have made the shift to incorporate the power this function can bring, but its importance has only scratched the surface. As providers, patients, and payers call for greater understanding of diseases, clinical treatment options, outcomes, and options, Medical Affairs is the trusted scientific voice that can answer. Their ability to develop, disseminate, and drive evidence-based decisions and conversations can lead to improved health outcomes.

Evidence is not just for regulatory anymore; infusing evidence throughout the product lifecycle is crucial to reach as many patients as possible. At its best, the insights generated by Medical Affairs will be quickly, smartly, and of course, compliantly utilized to drive innovation in both development and delivery of treatments. As the shift to precision and personalized medicine continues, Medical Affairs continues to be a cornerstone of building physician, and in turn, patient trust in the exciting, new treatments coming to market.

As 2024 begins, there is a sense of calibration, even stability. Challenges undoubtedly remain, but they feel surmountable as each of these trends point to a resilient, compassionate, and evidence-based healthcare system. The transformation trajectory may be steep, but we’re on track to deliver progress every step of the way.

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