Key takeaways

• Growth in oncology will increasingly come from earlier-stage intervention and high-unmet-need patient segments, not deeper competition in late-stage, crowded disease areas. Companies that don’t pivot risk being trapped in a shrinking value pool.
• AI and data-driven care models are becoming the primary way oncology companies identify unmet need, improve diagnosis and reduce friction across the patient journey. They are no longer just analytical add-ons.
• Resilient oncology portfolios will be built through disciplined bets on new modalities, earlier action at launch and proactive loss-of-exclusivity planning.
• Companies that integrate health systems, regions and affiliates earlier in strategy development will be better positioned to convert innovation into outcomes and long-term value.

Oncology will keep growing at a rate of 5%-9%, per In Vivo, but a growing share of that headline growth will come from places most pipelines are currently not pointed: earlier-stage disease, underserved tumors and the underlying operational layer between the drug and patient. Companies optimizing for the late-stage U.S. market they grew up in will discover, gradually and then suddenly, that they are competing for a shrinking pool.

The oncology industry is at an inflection point, with the next decade of growth expected to look different. Growth will increasingly be driven by earlier-stage interventions, smarter portfolio construction that prioritizes incidence and survival rather than crowded markets, greater focus on gaps in care and deeper healthcare ecosystem integration, all enabled by AI and data-driven care models.

ASCO 2026 reinforced our view on where oncology growth is headed

ASCO 2026 was quietly a referendum on where the next decade of growth will come from. PROTEUS and LIBRETTO-432 told early-stage stories that the market did not reward a few years ago. RASolute 302 showed that disciplined bets on hard targets and biology, such as KRAS in pancreatic cancer, are now table stakes.

Data on Artera’s multimodal AI digital pathology platform in localized prostate and early breast cancers also made clear that AI and data-driven models are rapidly becoming embedded in diagnosis, treatment selection and workflow optimization. ASCO’s collaboration with Ryght AI on global trial site selection for a CDK4/6 inhibitor study further demonstrated how integrating data across research sites and health systems can accelerate activation, broaden patient access and improve outcomes.

The implications for global oncology business unit leaders

Global oncology business unit leaders face a different strategic mandate than their U.S. counterparts. While U.S. leaders must solve for launch execution, care-delivery friction and policy-driven commercial pressure in a single complex market, global leaders must decide where oncology growth should come from across markets and how to build portfolios, evidence strategies and affiliate capabilities that can travel. That means making clearer choices about disease-area prioritization, portfolio construction and the role regions and affiliates play in adapting strategy to market realities.

Where global oncology growth lives in 2026—and where it doesn’t

Global leaders should refocus strategy around unmet need, early detection and earlier-stage disease, even if this challenges traditional ROI models. Companies that fail to do so risk optimizing within a shrinking late-stage value pool.

AI will be a catalyst for winning the early-stage shift in oncology, particularly in screening for early-stage cancers, identifying treatment initiation opportunities via minimal residual disease and identifying patients with actionable biomarkers.

To redirect growth toward higher-value opportunities, global leaders should focus on three priorities:

• Consider the interplay of cancer incidence, growth and survival. Shape oncology disease area strategy and more precisely prioritize tumor types and subtypes along these dimensions. The next wave of value creation in oncology will not come from competing harder in well-served tumors but rather in cancers where burden is accelerating fast and outcomes have failed to keep up with the pace.
• Aim to improve rates of early diagnosis. Many solid tumors continue to be diagnosed at advanced stages, where marginal survival gains require exponentially higher expenditure. Without earlier detection and intervention, the ceiling on impact and value remains low.
• Increase focus on early-stage disease. Late-stage disease has delivered impact, but it can no longer be the primary growth engine. Early-stage disease is the next frontier of both outcomes and growth, though this will require collaboration with country health technology assessments to align expectations for evidence with clinical development timelines that will benefit patients.

How can global leaders build resilient oncology portfolios?

Global oncology business unit leaders should embed proactive planning; a platform mindset; and predictive, AI-driven analytics across portfolio construction, external innovation sourcing and clinical development.

Here are five actions they can take to build a resilient portfolio:

• Expand derisked targets into underpenetrated modalities. Oncology R&D has increasingly clustered around derisked targets, creating intense competition and reducing differentiation. While this has improved the probability of technical success, it has also reduced the potential for differentiated patient outcomes and commercial success.
• Bet on novel modalities, but with a stopwatch. Novel modalities carry promising platform potential that must be balanced against technical risk. The portfolios that lose the next decade will not be the ones that chose the wrong modalities but the ones that took three years to admit the modality wasn’t working. The “fail fast” philosophy with clear criteria has to become a capability.
• Plan development of potential blockbusters proactively to mitigate the impact of loss of exclusivity events. Oncology blockbusters don’t often achieve blockbuster status “overnight”; a judicious acceleration of clinical development is needed to soften patent cliffs with new blockbuster revenue.
• Prioritize platform-centric external innovation from emerging pharma. While there are exceptions, such as addressing a near-term revenue gap, early-phase platform licensing or acquisition is a high-ROI-external-innovation approach. Emerging pharma in the U.S. and, increasingly, in China is an accessible source of this innovation.
• Make clinical trial operations a strategic priority. Oncology clinical trials face challenges with enrollment, procedure and data overload, and lengthening timelines. The industry needs patient-oriented and analytical solutions to address these challenges and prevent clinical development from becoming a rate-limiting step to innovation reaching patients. Further, in silico trials may provide a blueprint for the future to optimize trials before they even start recruiting patients.

How can global oncology companies enable success for regions and affiliates?

Winning globally will require incorporating regional- and affiliate-level differentiation into global strategy, as well as giving regions and affiliates an earlier “seat at the table” to define strategy. Companies that take this approach will set their regions and affiliates up for success more so than companies that “hand off” a fully baked, one-size-fits-all strategy.

Here’s how leaders can set themselves up to win in a global marketplace:

• Factor variation in global cancer burden into launch sequencing and strategy. Cancer incidence, diagnosis patterns, infrastructure readiness and regulatory dynamics vary dramatically by region. Improvements in survival are uneven across regions and tumor types. These factors must shape where and how innovation is introduced.
• Shift pricing strategy earlier in clinical development and bring affiliates together to consider pricing strategy interplay. While the impact of the U.S. Most Favored Nation pricing policy on global oncology thus far is limited, future implications are potentially broad-reaching, requiring global and affiliate pricing entities to work together proactively to optimize global pricing strategy.
• Ensure that regulatory has strong input to launch priority and sequencing. Changing regulatory pathways and expectations around evidence are at times increasing and decreasing the speed to approval for different markets. Regulatory must work with global and affiliates to optimize launch sequence and timing based on the latest regulatory policy.

The implications for U.S. oncology business unit leaders

In the U.S., oncology leaders are managing a market where the path from innovation to growth is becoming harder to control. Clinical differentiation still matters, but it is no longer enough on its own; performance increasingly depends on whether companies can anticipate access constraints, support provider workflows and make disciplined investment choices across launches, inline brands and assets approaching loss of exclusivity. In the U.S., the central challenge is turning strong science into sustained market impact in an environment where access, care delivery, policy and competition increasingly shape uptake, outcomes and value.

How can U.S. oncology leaders better prepare for launches?

A single launch playbook is no longer sufficient in the U.S. With the volume and complexity of launches in oncology, organizations must customize their approach and resource allocation from launch to launch. Launches should go beyond mere commercial events; they should intervene at the system level at AI-identified patient journey leverage points.

The U.S. launch question is no longer “Is the data good enough?” but “Does my brand make the practice’s workflow easier?” Brands that help oncology practices function better will outperform those that merely show clinical benefit.

To function better, they need to:

• Understand their launch archetype and resource accordingly. Launches will vary by product characteristics (like novelty) and indication characteristics (like unmet need), falling into different archetypes. Organizations can tailor launch resourcing intensity and orientation (commercial versus medical-led) according to these archetypes to launch more efficiently.
• Understand the factors that contribute to launch under- and overperformance compared to forecast and tailor their launch strategy accordingly. ZS analysis has associated product characteristics, access environment, indication characteristics and commercial investment with launch under- or overperformance. Organizations can use these characteristics to understand where to lean into potential advantages and mitigate potential disadvantages.
• Commit to the healthcare ecosystem beyond the medicine. ZS analysis has also shown that manufacturer commitment in the form of ecosystem partnership beyond the medicine itself plays an outsized role in launch success.

How can U.S. oncology leaders drive growth with inline brands amid structural headwinds?

Similar to launch success, inline brand growth will increasingly come from reducing friction in the patient journey at AI-identified leverage points. U.S. leaders must think like health system partners, not just brand stewards. At the same time, U.S. leaders must tailor this investment to revenue windows potentially compressed by Inflation Reduction Act (IRA) impact.

Here’s how to drive inline growth:

• Identify the impact of structural barriers on your brands. Many barriers to improved oncology outcomes and commercial success are inherent to care delivery in the U.S. Oncology spend is increasing without commensurate gains in outcomes—patients face rising financial toxicity, health system capacity is strained and oncologist burnout is increasing. Improvements in outcomes are hindered by regional, racial and socioeconomic disparities.
• Lead the coalitions to address structural barriers. No one company can completely solve structural problems. Be the first company to convene pan-industry solutions that combine industry, academia and government.
• Use AI to uncover care gaps and unaddressed opportunity throughout the patient journey. AI solutions around direct-to-patient engagement, treatment decision support, workflow optimization and patient monitoring can help improve patient and commercial outcomes.
• Account for the IRA as a structural headwind compressing inline brand economics. Medicare price negotiation timelines and the small molecule “pill penalty” are eroding peak revenue potential for inline brands. U.S. leaders must quantify brand-level IRA exposure, adapt commercial investment and access strategy to compressed revenue windows, and ensure U.S.-specific IRA dynamics are reflected in global life cycle and sequencing decisions.

How can U.S. companies protect value as brands approach loss of exclusivity (LOE)?

In oncology, the most effective LOE mitigation strategies are those that advance care delivery while extending value, not those that try to preserve revenue in isolation. Strategies misaligned with patient outcomes carry reputational risk, particularly in oncology.

Here’s how to mitigate LOE:

• Evaluate the value proposition of reformulation of the originator molecule. Reformulation, such as moving from IV to SubQ or from a standard oral therapy to extended-release oral therapy, can offer real value to patients and pharma if it capably addresses real unmet need. Without a compelling, patient- and provider-relevant value proposition, such moves risk being perceived as defensive rather than beneficial.
• Evaluate (with healthy skepticism) the value of novel coformulations. This strategy has the potential to protect valuable originator molecules with best-in-class combinations, but thus far has shown limited technical and regulatory success (Phesgo, Opdualag and Vyxeos are the primary successes so far).
• Explore contracting as a way to improve value compared to generic or biosimilar competition. This strategy tends to be stronger when generic or biosimilar net price gaps are smaller compared to originator molecules.
• Generate real-world data showing the value of originator molecules beyond what generics or biosimilars can claim. This strategy is often aimed at developing a body of evidence around quality of life or safety in the real world that generic or biosimilar equivalence studies may not be able to replicate.

Driving growth in 2026

Companies that treat oncology as a system challenge rather than merely a commercial challenge will shape the future of oncology. Sustainable growth requires a strategic pivot aided by AI and predictive analytics toward earlier-stage disease, platform-driven portfolio construction and empowering affiliates as ecosystem orchestrators.

New launches require a tailored strategy and committed health system partnership, and inline brand growth will come from reducing care delivery friction (balanced against commercial budgets potentially affected by the IRA). LOE mitigation strategies must advance patient outcomes to protect both value and corporate reputation.

The honest test for any oncology leadership reading this is uncomfortable. If you removed your top three late-stage assets from your plan, would there be a strategy left? The oncology companies that can answer “yes” are the ones that will define the industry’s next decade because they have already moved earlier in disease and connected global portfolio choices to local execution realities.

Two questions oncology leadership teams should be asking right now are:

• Where on your portfolio map are you optimizing inside a shrinking late-stage pool?
• Which one structural barrier could your company credibly lead the industry on by 2027?

Our full global and U.S. oncology reports, which will publish soon, go deep into both of these questions. If you want to pressure-test your 2027 plan against either question now, please reach out to ZS Oncology Team.