Introduction
As we enter 2026, the precision medicine landscape is moving from a phase of broad exploration to one of focused execution. The market is increasingly separating into distinct tiers, where platforms that can demonstrate clinical utility, manufacturing scalability, and commercial viability are gaining significant advantages.
From the industrialization of RNA therapeutics to the practical application of AI in digital health, 2026 will be defined by how effectively companies can operationalize innovation. Across our newsletter ecosystem, we observe a consistent trend: success in 2026 will depend on navigating the interplay of regulation, reimbursement, and consolidation.
Below is a preview of the top trends defining 2026 across our coverage areas.
Table of Contents
- Next Generation Therapeutics
- Liquid Biopsy
- Digital Health
- Pharma Services
- Financial Services & Dealmaking (PE, VC, M&A)
- EU/UK Regulation and Policy
1. Next Generation Therapeutics
Consolidation in RNA and Gene-Directed Therapeutics
In 2026, we expect the landscape for RNA and gene-directed therapeutics to consolidate further around major platform hubs. Recent deals, such as AbbVie–ADARx and Novartis–Arrowhead (focusing on ARO-SNCA), highlight how big pharma is locking in platform-level capacity for complex delivery into CNS and metabolic targets. While not a closed oligopoly, high barriers to entry, driven by differentiated delivery data and manufacturing scale, are emerging. We anticipate that these consolidated entities will increasingly dictate the clinical agenda, particularly in long-acting cardiometabolic (e.g., ANGPTL3, Lp(a)) and neuro (alpha-synuclein) programs.
Obesity, Cardiometabolic, and the GLP-1 Adjacency
Oligonucleotides are becoming a core pillar of the cardiometabolic revolution, serving as essential complements to the GLP-1 ecosystem. In 2026, we expect "obesity-adjacent" RNAi programs (e.g., INHBE) to be positioned not just for weight loss, but for lifecycle management, preserving lean mass and maintaining weight loss post-GLP-1. However, this therapeutic area is becoming exceptionally competitive, with next-generation programs across oligonucleotides and mRNA gene editing vying for market share. This saturation will drive significant clinical trial complexity; demonstrating superior cardiovascular outcomes will be increasingly difficult against a backdrop where patients are already managed on potent background therapies like GLP-1s. Concurrently, platforms are expanding into high-prevalence CNS and muscle indications. The strategic focus is shifting toward combination regimens where RNAi serves as a long-acting backbone to reduce cardiometabolic risk in population-scale markets.
"Manufacturing Sovereignty" as Precision Medicine Infrastructure
Manufacturing capabilities are shifting from a back-office function to a central strategic asset. This trend extends beyond RNA enzymatic ligation to include "manufacturing sovereignty" in complex modalities like radiopharma and cell therapies. In 2026, we expect acquirers to prioritize "buying the factory," securing isotope supply or sterile fill-finish capacity. As payers increasingly scrutinize the cost-effectiveness of chronic treatments, the ability to deliver long-interval dosing with scalable Cost of Goods Sold (COGS) will be a primary competitive moat.
2. Liquid Biopsy
Expansion of MRD into High-Volume Workflows
In 2026, the conversation around Minimal Residual Disease (MRD) in the U.S. shifts from "gaining coverage" to "workflow integration." Coverage has already materially expanded in colorectal cancer (CRC) and is actively moving into lung and immunotherapy monitoring, paving the way for emerging companies to secure reimbursement alongside established incumbents. With NCCN guidelines now explicitly recognizing ctDNA as a prognostic tool in colon, rectal, and Merkel cell carcinoma, we anticipate a significant uptick in clinical volume. The focus for 2026 will be on operationalizing these tests within routine surveillance pathways rather than just proving technical feasibility.
Pilot Screening Programs and Health Economic Validation for MCED
The Multi-Cancer Early Detection (MCED) market is entering a pivotal phase of evidence generation. With the expected readout of the NHS-Galleri trial in 2026 and GRAIL’s ongoing PMA process, the industry is moving toward regulatory milestones. However, we do not anticipate mass commercial rollout in 2026. Instead, momentum will be driven by targeted pilot programs in integrated health systems designed to generate the health-economic and budget-impact data necessary to support eventual broad coverage.
Global Adoption and Decentralized Models
Liquid biopsy adoption is rapidly becoming global, though with distinct regional models. In 2026, we expect therapy selection testing to move toward routine use in guideline-aligned indications (e.g., advanced NSCLC) across key EU markets and Japan. Unlike the centralized service model dominant in the U.S., international adoption, particularly for MRD in the UK, Germany, and France, will likely be driven by decentralized, kit-based solutions that integrate into existing hospital lab infrastructures, though reimbursement remains a key hurdle.
3. Digital Health
AI as Embedded Infrastructure (Payer & Provider)
In 2026, AI in digital health will transition from standalone tools to invisible, embedded infrastructure. We expect this to be particularly visible in payer operations, driven by interoperability rules (CMS-0057-F) that force AI-enabled prior authorization and claims auto-adjudication. Similarly, on the provider side, AI will integrate directly into EHRs for ambient documentation and coding. Success will be defined by "workflow integration" that reduces burnout and administrative friction, rather than by novel user interfaces.
Reimbursement Reality Check & Code Evolution
The digital health market is bifurcating. While standalone "Digital Therapeutics" (DTx) requiring a prescription continue to face high commercial barriers, "Digital Care Management" platforms are finding a sustainable path. In 2026, we expect these platforms to leverage evolving reimbursement codes, specifically the 2026 changes to RPM and RTM that lower time thresholds, to scale within provider workflows. Payers will demand hard ROI, favoring platforms that extend provider reach and reduce utilization over those that simply offer an app.
Digital Biomarkers for Stratification and Monitoring
Digital biomarkers are moving from "nice-to-have" to core components of clinical development. In 2026, we anticipate these tools will be used extensively for patient stratification and continuous response monitoring, particularly in immunology and neurology. Regulators now expect early engagement on digital health technology (DHT) endpoints, driving partnerships between pharma and sensor companies. These digital endpoints are becoming critical for generating the "real-world" evidence packages needed for differentiation and value-based pricing.
4. Pharma Services
AI as a Differentiator in Functional Service Deals
AI adoption in pharma services is moving beyond experimentation to become a key differentiator in large Functional Service Provider (FSP) deals. 2026 will be a "put up or shut up" moment for AI: rather than revolutionizing upstream drug design, we expect its primary near-term value to be in easing logistical frictions. Sponsors will increasingly score RFPs based on AI capabilities that deliver measurable efficiency, such as automated monitoring, protocol optimization, and faster recruitment. Providers that can embed AI into these labor-intensive workflows to demonstrate proof of value on timelines and cost will capture market share from traditional, labor-only models.
Real-World Data Expands Beyond Oncology
Demand for real-world data (RWD) is broadening outside of oncology as pharma investment accelerates in metabolic, cardiovascular, and other chronic diseases, including GLP-1–related indications. Compared to oncology, these areas require larger, more heterogeneous datasets and longer longitudinal follow-up, increasing the need for data integration and harmonization. This shift is fueling growth for service providers that can consolidate fragmented data sources and deliver analysis-ready RWD at scale.
Regulatory Pressure Accelerates Alternative Models (NAMs)
The shift away from animal testing is now structurally driven by regulation, following the FDA Modernization Act 2.0 and the 2025 roadmap for biologics. In 2026, this will accelerate demand for New Approach Methodologies (NAMs) like organoids and AI toxicity models. As these technologies are still in the standardization phase, we expect near-term value to accrue to specialized CROs with deep assay development capabilities, as pharma looks to outsource technical complexity while building internal confidence in these new models.
5. Financial Services & Dealmaking (PE, VC, M&A)
Consolidation and "Platform + Infrastructure" Deals
We expect 2026 to be defined by consolidation that combines therapeutic platforms with critical infrastructure. In addition to private equity rolling up fragmented services (CROs/CDMOs), large pharma will pursue "programmatic M&A" that secures both the drug and the means to make it. This is particularly relevant in radiopharma and obesity, where "buying the factory" (manufacturing capacity) is as important as buying the asset. We expect pharma to be highly asset-focused in these pursuits, prioritizing de-risked assets over broad, early-stage platforms. We anticipate a concentration of ownership among global leaders, raising barriers for sub-scale competitors.
Selectivity and the "Data Flywheel"
Venture Capital funding in 2026 will remain highly selective. In classic biotech, funding will be tight outside of specific "hot pockets" such as in vivo cell therapy, cardiovascular, and select CNS indications, with investors prioritizing logical pipelines of assets rather than broad, undefined platforms. Simultaneously, for "Tech-Bio," investors are looking for companies with proprietary data generation capabilities (e.g., closed-loop labs) that feed AI models, creating a competitive moat that purely computational or pure wet-lab companies cannot replicate. Valuations will diverge sharply between these asset-native or data-native companies and those relying on early-stage platform promise without clinical or data assets.
"Ecosystem Sovereignty" and Vertical Integration
Deal structures are shifting toward "ecosystem sovereignty," where acquirers seek control over the entire patient journey. In 2026, we expect to see vertical integration, such as radiopharma companies acquiring logistics networks, or metabolic franchises acquiring diagnostic/monitoring partners. This allows the strategic acquirer to own the "digital wrapper" and patient management infrastructure around the therapeutic. Concurrently, we expect continued use of secondary transactions and continuation funds to provide liquidity while assets mature.
6. EU/UK Regulation and Policy
IVDR Transition and Market Reshaping
The transition to the In Vitro Diagnostic Regulation (IVDR) continues to reshape the European market, with staggered deadlines extending to 2027–2029 preventing a hard "cliff edge." However, the compliance burden is creating a "survival of the fittest" dynamic. In 2026, we expect legacy tests to be withdrawn where costs outweigh revenue, benefiting larger players with established regulatory infrastructure. Notified Body constraints will persist, forcing companies to prioritize high-margin assays and potentially delaying EU launches of novel biomarkers.
The "Regulatory Lasagna" and Divergence (EU vs. UK)
Companies developing AI-driven diagnostics face a complex "regulatory lasagna" in Europe, with the EU AI Act classifying many medical AI tools as "high-risk." In 2026, we anticipate a divergence between the EU and the UK. The UK (MHRA) may leverage a more flexible, sandbox-style approach to attract rapid iteration of AI diagnostics, while the EU prioritizes harmonization and strict conformity assessments. This may lead some innovators to launch in the UK first to generate evidence before tackling the broader EU market.
Joint Clinical Assessment (JCA) Operationalization
With the EU Joint Clinical Assessment (JCA) becoming fully operational for cancer medicines in 2025, its impact will be felt strongly in 2026. We expect the JCA to raise the evidentiary bar for precision medicine, influencing national pricing and reimbursement decisions. Manufacturers will need to design trials that satisfy not only regulatory safety/efficacy standards but also the comparative effectiveness data required by the JCA, effectively harmonizing evidence expectations across the continent.
