Healthcare and life sciences trends 2026

Few developments in recent memory rival the scale and consequence of most favored nation (MFN) pricing. After decades of political debate on high drug prices in the US, MFN has moved from a theoretical threat to a regulatory reality and represents the single biggest pricing disruption the global pharmaceutical industry has ever faced. Its ripple effects will reshape global pricing, market access, launch sequencing, investment strategy, and biopharma dealmaking for years to come.

MFN brings international reference pricing (IRP) into the US for the very first time, linking US drug prices to the lowest prices observed in a basket of developed OECD markets. Given that US prices for innovative drugs nowadays are three to four times higher than those in other developed nations, the potential compression is enormous. If fully implemented, MFN could materially reduce industry revenues, pressure profitability, and weaken incentives for R&D, with downstream effects on innovation and patient access worldwide.

The policy accelerated sharply in 2025. On May 12, 2025, President Trump signed an executive order instructing federal agencies to benchmark drug prices against the lowest levels in qualifying OECD countries. Two months later, 17 major pharmaceutical companies received letters from the administration giving them 60 days to take action. The demands, ranging from extending MFN pricing to Medicaid, to offering MFN prices through a direct-to-consumer platform, to expanding US manufacturing, signaled unprecedented pressure.

The industry’s response was significant. Collectively, manufacturers meanwhile committed to more than $500 billion in US investments over the next decade. Several companies entered voluntary agreements with the administration, each with its own mix of commitments around MFN pricing, DTC availability, US manufacturing, and alignment of global pricing with US R&D benefits. These voluntary deals are expected to set a precedent, with more announcements likely.

The policy landscape escalated again on November 6, 2025, when CMS introduced the GENERoUS model (Generating Cost Reductions for US Medicaid). This framework adds another layer of international referencing by tying Medicaid outpatient drug prices to the second-lowest net price across eight major countries. Prices should include all rebates and discounts and are adjusted for purchasing power parity, with benchmarks recalculated annually and supplemental rebates updated quarterly. The model runs for five years and applies on a voluntary, product-by-product basis, yet the operational lift for manufacturers is considerable.

What’s certain today is that MFN and GENERoUS are focused on in-market products, and that manufacturers face near-term deadlines: submitting access-condition requests for all Medicaid products by March 2026, and signing participation agreements with CMS by June 2026. What remains uncertain is whether MFN logic will spill into Medicare via the proposed GLOBE or GUARD models, or to commercial markets, or how it will influence pricing strategies for new product launches.

For new medicines approved between 2018–2023, roughly two-thirds (~67%) of global sales occurred in the US/ North America, underlining how critical this market remains for global pharma value. The new rules could lead companies to delay launches in low-price markets, prioritize earlier launches in non-reference geographies, or even forgo launches in certain countries altogether to avoid damaging the US reference price. To justify higher ex-US prices, companies may increasingly pursue narrower labels, more restricted reimbursement, or alternative contracting pathways. The consequences for patient access, especially in countries historically paying far less than the US, could be severe.

What pharma leaders must do now

In the near term, companies must engage in scenario planning, model MFN’s impact on their in-market portfolio, re-evaluate international launch sequences, and reassess global pricing strategies, particularly in Europe, Japan, and Canada, where pricing will directly influence US benchmarks. They also need to prepare for the significant operational burden of CMS reporting and negotiations under GENERoUS.

Longer term, manufacturers will need to strengthen the value of their evidence packages, focus on clinically meaningful differentiation, and refine label strategies to manage international price corridors. They will also need to revisit licensing structures, especially for ex-US rights, and explore innovative contracting models such as outcomes-based agreements or alternative funding pathways. Companies that adapt quickly, with disciplined pricing governance and robust evidence strategies, will be best positioned in this new global pricing order.

Commercial due diligence will also evolve. Historically, valuation models relied heavily on the US opportunity, with ex-US sales often estimated as a percentage of U.S. value based on analogs. That approach is no longer viable. Deal teams must now conduct country-level assessment of pricing potential and MFN risk, understand whether ex-US partners could jeopardize US pricing through their governance, and carefully structure territorial splits to mitigate reference pricing exposure. In categories with large US-to-ex-US price deltas, such as immunology, MFN risk may materially lower the value of ex-US rights.

Read more:
Medicare’s ‘Black Friday’ drug discounts arrive, but MFN-level pricing still on the horizon

The EU Joint Clinical Assessment (EU JCA, years in the making, is now transforming how pharmaceutical and biotech companies generate evidence and prepare for market access across Europe. As of January 12, 2025, JCA requirements apply to oncology medicines and ATMPs, with orphan drugs joining in 2028 and all centrally authorized medicines by 2030. This rollout marks a fundamental transformation in how Europe evaluates clinical benefit.

The purpose of EU JCA is not to centralize pricing or reimbursement. Member states still retain full authority over local access decisions. Instead, it centralizes the clinical evidence assessment, consolidating what used to be up to 30 separate dossier evaluations into a single EU-level evaluation. The goal is greater consistency, faster access, and reduced duplication. Ideally, JCAs will be available within 30 days of EMA approval, enabling countries to begin P&MA processes immediately rather than waiting for lengthy national reviews.

This shift introduces both opportunities and risks. On one hand, companies will no longer need to build tailored clinical dossiers for all countries, reducing administrative burden and potentially accelerating time to market. On the other hand, they will need to build one unified clinical narrative strong enough to withstand scrutiny across all EU markets. A single weakness identified in the JCA, whether relevant to all countries or not, becomes visible everywhere. A gap that one country would have overlooked may suddenly be referenced in every negotiation across Europe. The shared clinical foundation creates an unprecedented degree of transparency and may compress pricing corridors across the EU as payers anchor to a single interpretation of the data.

What pharma leaders must do now

To succeed under this new framework, companies must rethink how they plan and generate evidence. EU JCA assessments are structured around the PICO framework (population, intervention, comparator, outcomes), making early “PICO prediction” a critical capability. Companies must start planning for EU JCA requirements at the earliest stages of clinical development, aligning trial design, comparator selection, endpoint strategy, and evidence generation with a pan-European view of value. This requires deep cross-functional alignment among regulatory, clinical development, medical, market access, pricing, and affiliate teams. Early engagement with regulators and HTA bodies during the scoping phase, when PICOs are defined, will be decisive in shaping outcomes.

Executing effectively under EU JCA also demands new internal structures. Companies need dedicated EU JCA leads, ideally supported by a centralized Centers of Excellence to coordinate activities across global, regional and local teams. Large organizations will require task forces that bring together global market access, pricing & access, HEOR, medical affairs, regulatory affairs, legal, and affiliates in key markets. Even companies not directly affected by the early oncology and ATMP waves cannot afford to wait. EU JCA readiness must be built well before 2030.

Yet readiness remains low. According to our research conducted in late 2024, only one-third of companies feel well prepared for EU JCA. Companies with near-term oncology or ATMP launches tend to be further ahead, while others are taking a “watch and wait” approach. But with EU JCA processes for 10 products already underway and first results expected in early 2026, the window is closing quickly.

EU JCA is more than a new process. It represents a mindset shift. It challenges companies to think beyond national requirements and instead build a single, compelling, and data-driven European value story. The winners will be those who engage early, invest in evidence, coordinate cross-functionally, and build robust internal capabilities. Those that delay will face costly catch-up as EU JCA becomes the new foundation of European access.

The next few years will determine how smoothly this transition unfolds, and whether EU JCA delivers on its promise of faster, more consistent access for patients across Europe. For the industry, the work has only just begun.

Read more:
https://www.simon-kucher.com/en/insights/eu-hta

Low- and middle-income countries (LMICs) represent 80% of the world’s population and are becoming essential markets for innovative therapies, specialty medicines, and advanced treatments. One of the clearest signals of change is occurring in clinical development. Leading companies now consider LMICs during phase II and phase III, shaping decisions about trial design, footprint, registration pathways, and even tech-transfer models.

Historically, LMIC prioritization relied heavily on GDP, often leading to oversimplification. The next wave of access strategy goes far deeper. Companies now evaluate health system readiness, policy trajectory, unmet need, inequality levels, and the growth of insurance coverage and household spending power. Instead of scattering resources across many markets, companies are selecting 8–10 priority LMICs as regional anchor markets, using them as launchpads for broader clusters.

Investor behavior reflects this shift. On earnings calls, analysts increasingly ask companies to articulate their LMIC strategies and quantify how these markets contribute to growth. What used to be a side initiative is now a core expectation from shareholders, governments, and global health stakeholders.

What pharma leaders must do now

Winning in LMICs requires companies to meet markets where they are. That means investing beyond the pill: diagnostics, HCP education, referral pathways, supply-chain strengthening, digital tools, and systems that enable continuity of care, especially in rural or underserved areas. These “adjacent” investments were once seen as outside pharma’s role. Today, they are essential both to unlock access and to build the infrastructure needed for future portfolio growth.

We’re already seeing concrete examples of public-private partnerships in LMICs, from oncology to rare disease collaborations, and from capacity-building programs in Indonesia to real-world-evidence ecosystems emerging in Vietnam. Crucially, companies are no longer treating these as one-off projects; they are designing long-term, multi-asset strategies aligned for markets which experience rising GDPs, growing middle classes, and expanding insurance penetration.

Pricing remains the toughest balancing act. LMIC prices cannot approach high-income levels, but low LMIC prices risk spilling over through indirect reference chains into major markets. There is no perfect solution, but companies are increasingly relying on smart sequencing strategies, tiered pricing, second-brand or “clone” strategies, confidential discounts, and outcomes-based models to protect global price corridors. Many LMIC deals now incorporate creative contracting to avoid publishing low net prices that could reverberate globally.

Meanwhile, a critical and often overlooked part of the equitable-access discussion is the growing vulnerability within high-income countries. In the US, recent policy changes could result in 10–15 million people losing Medicaid coverage. Affordability gaps are widening. In Europe, payer budgets are tightening, time to access is lengthening, and patient cost burden is increasing, sometimes pushing therapies out of reach even where they are technically reimbursed by national social security systems. In this sense, equitable access is no longer a “Global South” issue; it’s a global issue. Lessons from LMIC models, such as community engagement, targeted contracting, and alternative funding pathways, may also become increasingly relevant in mature markets.

Read more:
https://www.simon-kucher.com/en/insights/new-model-equitable-access-lmics-initiative-integrated-ecosystems

Large language models have become credible and dependable enough to be used in complex domain spaces, including commercial, pricing, and access. This is precisely where the risks are highest. Pricing & market access sit at the intersection of clinical nuance, policy detail, precedent, and negotiation. Small misinterpretations of data, comparators, or value arguments can have outsized consequences, and the heterogeneity of payer systems and markets makes it easy for generic AI to overgeneralize and get things wrong.

This is why the idea of a “push-button pricing strategy” is a non-starter. You get one shot at launch pricing and access positioning for a new pharmaceutical product; no responsible team will hand that over to a black box. At the same time, it would be equally wrong to dismiss AI altogether. Many organizations are already using AI in second- and third-level use cases: discovering analogs, scanning competitive landscapes, drafting or reviewing value stories and HTA dossiers, or summarizing large bodies of precedent. These tools are already improving operational efficiency, research speed, and decision confidence.

The frontier now is the next level of sophistication, where AI becomes not just an efficiency engine, but a growth accelerator. This includes use cases like smarter evidence-generation planning, early HTA outcome prediction, PICO simulators linked to EU JCA planning, dynamic international reference pricing and launch sequence scenario testing, and AI-powered negotiation trainers that simulate payer interactions for field and access teams.

The common thread across all of these advanced use cases is a human-in-the-loop design. Rather than pushing a button and accepting whatever comes out, business owners stay at the center of the process, with multiple checkpoints for review, adjustment, and override. The system documents every step, creating an audit trail that improves explainability and trust. The result is a powerful balance: more speed, more consistency, more insight, without sacrificing judgment, accountability, or quality.

By 2026, we can expect to see two things happening in parallel. First, basic integrations (chatbots over internal pricing databases, rapid analog searches, automated dossier drafting support) will become standard tools rather than pilots. Second, the industry will start to scale more advanced, human-in-the-loop AI use cases in pricing and access, particularly in companies that have already invested in clean data and strong governance.

What pharma leaders must do now

The real story of AI in pricing and market access is not about replacing people. It’s about equipping teams to see more, test more, and decide better than they ever could alone. The organizations that invest in AI literacy, guardrails, and collaborative design between business owners and data teams will be the ones that turn AI from a buzzword into a competitive advantage. It looks very much like 2026 will be the year pricing and access functions move from “experimenting with AI” to competing with it.

China has long played a role in the global biopharma ecosystem, but 2026 marks a turning point: China has rapidly become one of the most important sources of frontier scientific innovation; and one of the fastest-moving engines of clinical proof-of-concept anywhere in the world.

Over the last decade, Chinese biotechs built formidable expertise in monoclonal antibodies and antibody–drug conjugates, catching up to global leaders with remarkable speed. But the real story now is how far beyond those modalities China has gone. A growing number of Chinese companies are innovating in next-generation therapeutic modalities, from RNA therapeutics (including mRNA, saRNA, and siRNA), to T-cell receptor therapies, bispecific and multispecific antibodies, and even targeted protein degraders such as PROTACs.

This has fundamentally changed global licensing dynamics. US and European companies are increasingly looking to China when sourcing the next wave of innovation. Before the pandemic, only a handful of Western investors, five to ten per year, were doing cross-border licensing or acquisition deals for Chinese assets. Today, that number has ballooned to 75–80 deals annually, reflecting a massive shift in where global R&D leaders believe the next breakthroughs will come from.

One reason the interest is so strong is the advantage of “China speed.” Executives use the term to describe rapid patient recruitment, large numbers of treatment-naïve individuals, broad site networks, lower trial costs, and increasingly predictable regulatory timelines. These factors can dramatically accelerate clinical proof-of-concept. The story of Belgium-based ESO Biotech illustrates this perfectly: facing capital constraints, the company supported a small investigator-initiated CAR-T trial in China. They dosed the first patient in January 2025, generated first evidence by Q2, and were acquired by AstraZeneca shortly thereafter. An almost impossible timeline in most Western markets.

What pharma leaders must do now

China’s biotech boom comes with important caveats. The ecosystem remains fragmented, with no single reliable source of visibility into emerging assets. High-potential companies may sit deep inside provincial incubators, university spinouts, or local venture networks. Successful sourcing requires boots on the ground, local partnerships, and ongoing relationship-building. Without presence, you won’t find the deals, because the deals don’t come to you.

However, while China is delivering rapid proof-of-concept, China-only datasets rarely meet the standard required for Western regulatory pathways. Companies licensing Chinese innovation must expect to run bridging studies, expand cohorts, and generate additional evidence tailored to FDA and EMA expectations. China may deliver the spark, but Western regulators still require a much more comprehensive clinical evidence package before accelerating approvals.

Even with these caveats, the trajectory is unmistakable. China has become a strategic engine of global innovation, especially for business development and licensing teams. The combination of scientific ambition, modality diversity, clinical speed, and growing regulatory maturity makes China one of the most important geographies for anyone scouting the future of biotech.

Read more: https://www.simon-kucher.com/en/insights/fueling-global-pharma-pipelines-rise-chinas-innovations

The year 2026 will test the industry’s agility, discipline, and ability to adapt at speed. From MFN pricing to EU-wide joint clinical assessments, from AI-enabled decision making to equitable access models for LMICs and China’s accelerating innovation engine, the forces shaping life sciences are more global, interconnected, and  higher stakes than ever.

At Simon-Kucher, our healthcare & life sciences experts help organizations navigate this complexity, optimizing pricing, market access, evidence, and commercial strategy to unlock sustainable growth.

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