Astellas Pharma has been evolving its approach to innovation. Rather than organizing its pipeline primarily around disease states—such as oncology, immunology, or diabetes—the company, under president and CEO Naoki Okamura, aims to maximize patient outcomes through a “focus area” innovation model that prioritizes scientific rationale over the traditional therapeutic area approach. This approach was laid out in the company’s corporate strategic plan 2026, a five-year growth strategy announced in May 2026. What follows is an edited version of Okamura’s conversation with McKinsey senior partners Michele Raviscioni and Shail Thaker.
McKinsey: Can you describe Astellas’ focus area approach to R&D, and how that structural pivot has shaped your pipeline?
Naoki Okamura: Most pharmaceutical companies define themselves based on therapeutic areas or technology platforms. But in our case, we integrate three elements: biology, modality, and disease. We start with biology that has a strong linkage to disease. Then we think about what the best modality is to address that biology, and from there we identify the patient population that could benefit from that combination. We do not begin with a predefined therapeutic area, and we do not necessarily end in one.
In the past, we may have thought of ourselves as a urology or immunology company. The focus-area approach is about exploring where we can make the greatest impact for patients. If you look at our current product portfolio, those products are not the result of this approach. But what you see now in our pipeline is increasingly coming from our primary focuses, defined by biology, modality, and disease.
McKinsey: When one of these elements in that “innovation triangle” breaks down, how does the focus-area approach enable you to redeploy insight and progress elsewhere?
Naoki Okamura: It depends on which element of the triangle fails. If the biology and modality remain valid, and there is a strong rationale for another indication, we may redeploy that combination to a different disease area. However, if the biology itself proves invalid, we typically discontinue it as a candidate for a primary focus. The decision ultimately comes down to scientific rationality. If we understand why something failed and have a credible alternative approach, we may continue. If not, we move on.
The key principle is that we do not remain attached to a failed configuration. Instead, we treat failure as a source of learning and shift quickly to the next opportunity. That ability to reconfigure and redeploy is central to how the model sustains momentum.
McKinsey: Given the number of possible combinations across biology, modality, and disease, how does Astellas manage resource allocation without diluting focus?
Naoki Okamura: At early stages, we deliberately take a broad view, investing across multiple potential areas of innovation. However, prioritization becomes much sharper once a program reaches clinical proof of concept (PoC). When a flagship program within a primary focus achieves clinical PoC, we significantly increase resource allocation to that program. At the same time, that success often generates multiple follow-on programs from the same triangle, or the primary focus.
As a result, resource allocation shifts from a wide set of exploratory efforts to a more concentrated investment in primary focuses that have demonstrated clinical validation. This allows us to balance breadth in early discovery with depth in later-stage development.
McKinsey: A persistent challenge in Japan’s biotech sector is translating early science into clinical outcomes. How has Astellas reconfigured its operating model so innovations don’t stall?
Naoki Okamura: Historically, Astellas operated along functional lines. In April 2025, we shifted our primary management axis from functions to patients. In practical terms, this means eliminating functional silos and empowering cross-functional teams with end-to-end accountability, from discovery through the product lifecycle. These teams are responsible for decision-making and execution across the entire program.
We call these asset-maximization teams. They are co-led by representatives from different functions, depending on the stage of development. For example, in early stages, research and clinical leaders’ co-lead; later, clinical and medical leaders take on that role.
McKinsey: Does focus-area specialization risk narrowing agility? How does Astellas preserve the ability to move into adjacent or emerging areas?
Naoki Okamura: It depends on how the organization is structured. We have integrated research and development under a single chief research and development officer within what we call the “VALUE creation organization.” Within that structure, one group of researchers advances existing primary focuses, while another group explores new candidates for future primary focuses. This allows us to maintain focus while continuously renewing the pipeline.
In addition, partnerships are critical. We collaborate extensively with academia and startups, even at early stages of discovery. Business development spans the entire lifecycle, ensuring that we can access external innovation alongside our internal capabilities.
McKinsey: Alongside your focus-area approach, Astellas has positioned “patient axis” as a strategic pillar. How does that emphasis influence decision-making and resource allocation?
Naoki Okamura: Our vision is to turn innovative science into VALUE for patients. Science alone is not the goal; it must translate into outcomes that benefit patients and create VALUE for the healthcare system. That is why we have moved away from a functional axis. Functions exist to support VALUE creation and delivery, not as ends in themselves. Regardless of function, every employee should see their role as contributing to the progression of a program that delivers patient VALUE. This mindset aligns the entire organization around patient outcomes.
McKinsey: Astellas recently received one of the first FDA Advanced Manufacturing Technology designations1 for its Maholo humanoid robot cell culture system. How will Maholo, and automation more broadly, change the speed and nature of in-house innovation?
Naoki Okamura: Cell culture is one of the most delicate processes in manufacturing cell therapies. Robots can replicate expert techniques and operate continuously. But that is not the primary objective.
The real value lies in data. By automating these processes, we generate large volumes of high-quality data, which enables continuous improvement. Another advantage is reproducibility. A process developed in one location can be replicated exactly elsewhere without traditional technology transfer hurdles. This significantly accelerates the scaling of innovation across geographies.
McKinsey: How does Astellas decide what to build internally versus access through partnerships or acquisitions? How has that played out in practice—for example, when pursuing “undruggable” targets such as the KRAS G12D oncogenic mutation within your targeted protein degradation primary focus?
Naoki Okamura: Astellas has a strong heritage in small-molecule medicinal chemistry, which makes targeted protein degradation a natural area to develop internally. It represents an evolution of that capability, combining two binding elements into a single compound.
We leverage our internal expertise in this area, but we do not operate in isolation. We remain open to external partnerships and are willing to access superior technologies or assets when appropriate. Our approach is to combine internal strengths with external innovation, rather than choosing one over the other.
McKinsey: Your prostate cancer drug XTANDI is approaching its patent cliff. How is Astellas managing the transition to sustain its growth?
Naoki Okamura: XTANDI has been a significant success, benefiting more than 1.5 million patients globally. However, every pharmaceutical product has a lifecycle, and we have long anticipated this transition.
Our strategy is to build a portfolio of multiple high-potential products rather than relying on a single blockbuster. We currently have five strategic brands, each with blockbuster potential. With these, we can compensate for the impact of XTANDI’s loss of exclusivity.
From FY2029, our pipeline assets emerging from our focus area approach will drive our growth. We are particularly encouraged by progress in targeted protein degradation, immuno-oncology, and blindness and regeneration, all of which have achieved clinical proof of concept. In genetic regulation, our flagship program, AT845, is currently undergoing clinical proof of concept evaluation.
McKinsey: Astellas’ emphasis on organic innovation could be seen as somewhat contrarian to broader industry norms. How do you lead the company to sustain alignment, momentum, and focus within that model?
Naoki Okamura: I would not necessarily say our approach is contrarian. Of course, we continue to do internal research. Innovation often emerges from the combination of different ideas, so we encourage openness and collaboration, including external partnerships with academia and startups. Internally, I delegate responsibility to my senior leadership team of experienced executives while maintaining accountability for outcomes. We also emphasize a flat organizational culture and direct communication, including two-way forums where employees can engage directly with leadership. Ultimately, leadership is about building an organization that puts patients at the center of everything we do—one that is flexible, adaptable, and resilient in the face of uncertainty.
McKinsey: Innovation is often generated locally but must be developed and delivered at global scale. How does Astellas reconcile those dynamics?
Naoki Okamura: Innovation can originate anywhere. It may come from Tsukuba [Japan], Cambridge [Massachusetts], or elsewhere. However, transforming innovation into a pharmaceutical product requires global capabilities. While discovery can be local, development and delivery must be coordinated globally.
McKinsey: What has been one of the most difficult decisions Astellas has made in pursuing its innovation strategy?
Naoki Okamura: Our continued commitment to cell and gene therapy is one of the most significant decisions. While some companies are stepping back from this area, we have chosen to remain invested. We believe these approaches have the potential to deliver truly transformative treatments by addressing disease at its root. Although the challenges are substantial, we see this as part of our mission.
This is both a strategic decision and a personal conviction. Advancing transformative therapies requires long-term commitment, particularly where significant unmet medical needs remain, and we are prepared to make that investment.
McKinsey: Looking ahead, what do you see as Astellas’ greatest strengths—and how are you building on them to support innovation over the long term?
Naoki Okamura: Innovation is our lifeline. Our priority is to build an organization that is bold, agile, and creative, with the ability to sustain innovation over the long term. We are reinforcing this through structural changes, cultural transformation, and simplification of our operating model. Moving away from functional silos toward an end-to-end, patient-centric model is central to this effort. My role is to trust and empower our teams to make bold decisions, while ensuring that patients remain at the center of every choice we make.
