In 2026, we expect the healthcare landscape to be defined by technology breakthroughs, market access disruption, and profound policy changes. In 2025, the rapidly evolving political and policy environment has forced manufacturers to fundamentally restructure how they discover, commercialize, and deliver care.

Advanced Technology as the Foundation for Future Care

The integration of advanced AI and data integration is no longer a future trend; it is the engine driving the industry’s rapid evolution. Generative AI and machine learning are actively transforming drug discovery, clinical trial design, and precision medicine, enabling faster breakthroughs and improved patient outcomes. AI is also streamlining operations and predictive analytics, demanding new regulatory considerations around the use of synthetic and real-world evidence (RWE). 

This directly affects patient care through digital transformation and remote care. Virtual and decentralized clinical trials are improving trial access and efficiency, while telehealth and real-time remote patient or therapeutic monitoring are continuing to redefine the care landscape. For providers, significant investments in AI will continue to drive rapid growth and innovation, helping time-crunched primary care providers more efficiently manage patient care, from test ordering and symptom analysis to treatment plans and follow-up. This increased uptake of smart agent AI will allow providers to focus more intently on their patients’ unique health needs.

Next-Generation Breakthroughs and the Expansion of Precision Medicine

The proliferation in innovation and payer adoption of precision medicine is something on the forefront of everyone’s mind. Clinical use of technologies like CRISPR, genetic sequencing, and multi-omics data integration is enabling highly customized, personalized therapies and diagnostics, especially in oncology and rare disease therapeutic areas. Payer movement in WGS and WES as well as MCED is promising but insufficient; the journey is not complete and greater advocacy to ensure payer receptivity coupled with greater clinical utility understanding is needed. 

Next-Gen Cell and Gene Therapy (CGT) and RNA Platforms

From a patient access standpoint, there has been a large push to expand cell and gene therapy access in community settings. It is important to get these new tailor treatments to the people who need them most. Beyond access considerations, there have been many scientific breakthroughs that are rapidly expanding the ways we can leverage these treatments:

First-in-class in vivo gene editing is shifting expectations from one-off rare-disease fixes to scalable platforms that can be reapplied across multiple genetic conditions, including common diseases.
Next-wave CAR-T and engineered cell therapies, allogeneic, dual-target, solid-tumor–focused, are expanding beyond hematologic cancers toward solid tumors and autoimmune and fibrotic diseases, widening the future beneficiary/patient pool and commercial opportunity.
RNA and mRNA platform expansion is moving from COVID-era vaccines into oncology, cardio-metabolic, and autoimmune indications.

Oncology, Neuroscience, and Metabolic Advances

Precision oncology continues to be an area of excitement, marked by highly specific small molecules, like KRAS or G12C, and mutation-defined indications. Lab and pharmaceutical companies should collaborate to leverage the power of next-generation sequencing to pair the right diagnostic with the right drug, confirming that tightly targeted therapies are worthwhile when biomarkers and companion diagnostics are scaled and utilized. Targeted protein degradation has been a point of interest because of its ability to systematically go after previously inaccessible targets.

When addressing chronic diseases, the success of next-generation incretin-based obesity and cardio-metabolic drugs has reshaped expectations, with biopharma exploring adjacent indications such as NASH/MASH, heart failure, and kidney disease. Progress in disease-modifying approaches for Alzheimer’s and Parkinson’s is reviving a once-avoided area, with biomarkers and imaging advances making future expansion into earlier stages and broader populations more realistic.

Policy Overhang and the Market Access Battlefield

The industry will operate in a landscape where value and affordability are paramount. Rising development costs and affordability pressures mean only therapies demonstrating clear, payer-accepted clinical utility will maintain pricing power and contracting dominance.

IRA, MFN, and the Reshaping of Pricing

Implementation of the Inflation Reduction Act (IRA) Medicare Drug Price Negotiation Program and parallel international reference prcing threats will fundamentally push manufacturers to rethink global pricing, contracting, and channel strategies. The negotiated prices for the first cohort of Part D drugs are scheduled to take effect in 2026, affecting launch and lifecycle strategies across classes. 

The threat of a Most-Favored-Nation (MFN) model, which links US drug prices to international benchmarks, continues to pose a significant risk to innovation and patient access to existing therapies.  

The New Market Access Challenge

The regulatory and policy overhang, combined with expanding price-transparency and PBM reforms,will continue to make securing practical access a challenge for manufacturers. Payers will most likely demand more robust value demonstration and RWE for high-cost therapies across oncology, CGTs, and GLP-1s, driven by budget impact concerns and new scrutiny frameworks.

Payers, IDNs, and pathway vendors will exert greater influence over which cancer brands get used, not just which get covered. Pathway placement, site-of-care economics, and regimen-level cost are becoming as important as simple formulary status.
Manufacturers will need deeper engagement not only with payers and PBMs but also with IDNs, GPOs, specialty pharmacies, and pathway vendors, each with different incentives and data needs, raising the bar for coordinated market access strategy.

The Rise of Direct-to-Patient and Transparency

Manufacturers will face pressure to manage launch pricing and gross-to-net dynamics. This has led to a rise in patient empowerment; many patients want to be more active participants in controlling their own health, seeking more personalized and proactive experiences. We are seeing biopharma responding by investing in direct-to-patient (DTP) platforms and omni-channel patient engagement strategies, effectively offering a counter-channel to the traditional rebate-driven model controlled by PBMs.

The Future: Expansion, Synergy, and Value

The promise of these breakthroughs for future indications and patients is that once a platform, regulatory pathway, and access model are established, manufacturers can systematically expand into adjacent mutations, earlier lines of therapy, or larger, more common therapeutic areas. This is great for patients as it may open earlier opportunities for therapeutic intervention and better combinations of targeted and immune-modulating approaches that increase response rates and durability. High-tech innovation, consumer empowerment, new regulatory models, and a sharper focus on value and trust are reshaping the life sciences industry. 

The healthcare landscape in 2026 will not be defined by a single breakthrough, but by all of the different areas we are heavily tracking here at ADVI Health. The engine of advanced AI, the revolution of next-generation cell and gene therapies, and the policy shifts from initiatives like the IRA are coming together to create an environment of unprecedented opportunity. For manufacturers to thrive, a cohesive strategy is essential, one that tightly integrates technological innovation with a proactive, evidence-based approach to value demonstration and market access. 

We are hopeful about what the year ahead has in store for all of our clients, the providers who treat using their products and services, the patients they serve, and the regulators who oversee the patient journey and business relationships. If any of these issues resonated with you and you would like to learn more, get in touch at innovate@advi.com. 

ADVI offers expert advice and influential solutions, informed by data and guided by a clear vision of the complex intersection of life sciences/healthcare innovation, economics, policy, and patient impact. Get in touch to receive insights from our Market Access, Precision Medicine team.