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From Patent Cliff to AI Gaps: Six Commercialization Challenges Shaping Pharma in 2026

Authors

Caroline Crowson
Caroline Crowson

Partner, Commercial Strategy

Mary Fletcher-Louis
Mary Fletcher-Louis

Managing Director,
Value, Access, and Pricing

Additional Contributors:

Trinity recently convened its leadership team to examine the scale of the industry’s current commercialization challenges and stress test the solutions we are bringing to clients. Our senior leadership articulated the six most material issues facing biopharma today and created space for leaders to share how they are responding in active engagements. The perspectives below reflect those themes:

1. Patent cliff and growth replacement

Companies are being forced to do more with less as they seek to fill gaps from blockbuster products with new indications/assets.

Trinity’s perspective

Redesign growth around risk-balanced diversification. Combine high-conviction white space or scale deals with a systematic set of “small space” moves, such as new indications, devices, and geographies, to avoid dependence on a single replacement blockbuster.

  • Hardwire evidence-based portfolio discipline. Use clear clinical and commercial stage gates, risk-adjusted value, and strategic fit to rank assets, increase shots on goal, and cull weaker programs early through a repeatable portfolio planning process.
  • Treat loss of exclusivity (LoE) as a managed transition, not a sudden cliff. Start years ahead to reshape the curve with lifecycle extensions, differentiated value, and price strategies, and locally led market tactics.

2. Pricing and access pressure

Policy evolution is making pricing a permanent structural constraint, tightening global pricing governance to manage spillover from ex-U.S. decisions onto the U.S., and leading to GTN complexity.

Trinity’s perspective

The game is no longer won in standalone negotiations; it is won upstream by designing assets and evidence packages that are “reimbursable by design” and then executing to pull through the optimized opportunity.

  • Move from “pricing strategy at launch” to “value architecture at TPP.” Building payer needs into target product profiles, trial design, and endpoints from day one, and then using scenarios to optimize the achievable value position.
  • Treat global pricing as a network problem, not a country-by-country process; model and optimize spillover as deliberately as you model demand, based on the commercial ambition.
  • Ensure that your US and global colleagues stay (or become) connected and work hard to communicate their distinct needs. Involving US and global colleagues in the governance structure will be key so that the US team can communicate the pricing risks they see, while the global and regional teams can communicate the value of their markets.

3. Increased challenges in peak sale attainment

Access hurdles and price/volume trade-offs are challenging time to peak sales, requiring commercial teams to deliver sharper targeting, more robust evidence, and better customer engagement

Trinity’s perspective

The binding constraint is no longer sales capacity. It is attention, orchestration, and timing. Peak sales increasingly go to teams that subtract low yield activity, deploy the right mix of field roles, and sequence investment as uncertainty resolves.

  • Move beyond blanket “coverage and frequency” to an integrated field engagement model; design customer engagement holistically across Sales, Field Access, Medical, and other roles, aligning each role to specific customer needs, patient journeys, trigger events, and decision points where influence matters. Take other field touchpoints into account alongside the sales team’s engagement.
  • Replace activity accumulation with decision oriented focus; hold every launch activity to a simple test: does this materially change a decision for a clearly defined target segment? If not, it is noise, regardless of execution quality.
  • Monitor field performance and effectiveness post launch; the real risk window is 12–18 months after launch. Winning teams continuously refresh target lists, recalibrate levels and types of engagement by role, and reallocate effort based on ROI to keep field engagement effective and momentum strong as access dynamics and customer behavior evolve.
  • Use phased field deployment when forecast or market access uncertainty is high; stage field investments and start with a focused core footprint. Pressure test access, demand signals, and customer responsiveness, then scale roles, geographies, and cadence as uncertainty clears and confidence increases.

4. Personalized treatment, crowded pipelines, and increased marketing complexity

These dynamics present commercialization challenges. The advantage shifts to organizations that can operationalize insights at speed.

Trinity’s perspective

An always-learning insights engine that pulls in information from across the organization allows for the integration and democratization of insights across the organization. Hypersegments and real-time resource allocation through agentic methods and platforms allow for more personalized differentiation without significant capital expenditure, while improving each function’s ROI.

  • Go beyond the expected by weaving traditional primary market research, real-world analytics, and internal data sources such as manufacturing capacity, shipment ordering, account prioritization, and sales rep CRM systems
  • Use AI agents to connect datasets and reduce duplication
  • Build digital twins for on-the-fly synthetic responses that can learn over time and improve with continual feedback

5. Fragmented customer engagement and channel fatigue

Harder-to-reach HCPs, declining access, and channel fatigue across digital and in-person channels make targeting and resource allocation more difficult. There is a lack of precision in finding high-value patients, accounts, and prescribers.

Trinity’s perspective

Fragmented HCP engagement is fundamentally a precision challenge, not just an access issue. As reach declines and channel fatigue increases, broad orchestration falls short, making it critical to focus on high-value HCPs, accounts, and patients where impact is measurable. This requires both sharper targeting and disciplined, outcome-driven measurement anchored in clear KPIs.

  • Integrate diverse data sources to map HCPs and patients within the treatment funnel and prioritize high-impact segments.
  • Define KPIs upfront tied to business outcomes such as patient starts, prescriptions, and adherence, avoiding reliance on proxy engagement metrics.
  • Focus measurement on a small set of leading indicators for near-term optimization and lagging indicators for long-term impact.

6. Data paralysis & AI adoption gaps

These risks are driven by fragmented, siloed sources with variable quality and standards, which require reconciliation and governance to ensure agile decision-making and technology adoption.

Trinity’s perspective

The biggest AI risk for pharma is not missing the latest model; it is scaling flawed decisions built on unreliable and/or siloed data. Data readiness is what turns AI from experimentation into impact; without harmonized, high-quality, and governed data, even advanced models produce inconsistent or misleading outputs.

Equally critical is the AI context layer, the business logic that connects raw data to real decisions. This includes standardized definitions, clinical and commercial rules, and decision frameworks that make outputs interpretable and actionable. Without this layer, AI generates insights without direction, which limits trust and adoption.

  • Shift from “AI-first” to “decision-first.” Anchor on three to five high-value decisions and align data and AI accordingly.
  • Build the data layer as a strategic asset with clear ownership and governance.
  • Invest in a context layer that translates data into decision-grade intelligence.

These six commercialization challenges do not sit in silos; they interact across the full lifecycle, from asset selection and evidence generation to launch planning, omnichannel execution, and in-line optimization. The companies that win in 2026 and beyond will be those that treat portfolio, pricing, engagement, and data decisions as part of a single strategy, supported by clear governance and a disciplined approach to what they will start, scale, and stop.

Trinity partners with pharma, biotech, and medtech teams to tackle these issues in an integrated way, combining advisory expertise, deep therapeutic insights, and advanced analytics to support better, faster decisions. If these themes resonate with what you are seeing in your portfolio or upcoming launches, connect with Trinity to pressure-test your current plans and identify specific moves you can make in the next 6 to 12 months to protect revenue, unlock growth, and build a more resilient commercialization model.

Questions?

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