Rahul Pathak, Divyata Manvati, Vidya Raina and Julia Duncan contributed to this article.

For decades, biopharma leaders operated with a shared understanding: if you invested in innovation, generated the right evidence and followed regulatory guidance, you would ultimately be rewarded with regulatory approval, reimbursement and a fair chance to realize value at launch. That unspoken understanding is now under strain. Recent developments—such as most favored nation (MFN) pricing and pharma tariff threats—are challenging typical global launch strategies. At the same time, regulators’ evidence requirements are increasingly diverging, as seen in recent Food and Drug Administration (FDA) and European Medicines Agency (EMA) rejections of rare disease therapies.

Such events have spotlighted launch as the most consequential and risky point in the biopharma enterprise. Not because the fundamentals of launch excellence have changed, but because the predictability that once underpinned launch investment has eroded. Regulatory outcomes, pricing mechanics, global launch sequencing and even the basic economics of commercialization are increasingly uncertain, just as the industry is entering a period with more launches than ever.

Over the next four years, the top 15 pharma manufacturers are poised to launch more than 120 assets and will spend on average $350M per launch per year. This means top manufacturers are set to invest nearly $3B each on launch in the coming years against the backdrop of an unpredictable healthcare landscape.

Leaders now need to redesign launch as an agile system that operationalizes uncertainty, investing earlier in reusable infrastructure, later in asset-specific spend and using AI to keep options open.

An uncertain landscape and the “new normal” for pharma product launch

Recent events have created substantial risk to pharma manufacturers planning launches:

Regulatory uncertainties:

• FDA evidence requirements or late-stage rejections: The FDA has signaled shifting evidence requirements, such as proposing oncology manufacturers use overall survival as a primary endpoint and publishing guidance that drug and biologic approvals will require a single, robust pivotal study, instead of two trials. They have also rejected or delayed several rare disease drugs in recent months.
• Global regulatory divergence: Core global regulators like FDA, EMA, the National Medical Products Administration (NMPA) in China and the Pharmaceuticals and Medical Devices Agency in Japan have diverged in their evidence requirements (e.g., EMA applying greater scrutiny on cell and gene therapy, NMPA expectation of “localized” data), challenging pharma’s typical approach to evidence generation for approval.
• U.S. approval timing: The increased (and increasingly political) use of FDA Priority Review Vouchers have introduced uncertainty around U.S. launch timing, as regulatory approval may come faster than anticipated, leaving manufacturers on their back foot if they are not ready.

Evolving global pricing dynamics:

• MFN models and tariffs: MFN pricing models and tariff threats have flipped the typical “launch everywhere” strategy and forced manufacturers to reconsider when, where and how to launch. Historically, pharma has used country launch sequencing to minimize reference pricing exposure. But MFN has shifted the question from “in what order?” to the much starker “can we launch at all?” because typical ex-U.S. prices can create material exposure to U.S. revenues.
• U.S. net pricing evolution: The recent FTC/Express Scripts settlement and launch of TrumpRx stand to substantially reshape the net pricing landscape in the U.S., bringing transparency to a system that loses significant value to middlemen. Against the backdrop of MFN, global pricing is more under pressure, interconnected and uncertain than ever before.

How should pharma companies prepare for a successful launch against a backdrop of uncertainty?

For pharma leaders, launch performance is a credibility issue as much as an execution issue. Leaders need to ensure the launch can deliver what was promised to analysts and investors. They should also pressure-test their leadership on whether the organization is truly set up to win under uncertainty.

The time to prepare is now, as biopharma approaches a wave of launches over the next several years, reflecting sustained R&D investment, maturation of late-stage pipelines and breakthroughs across novel modalities like cell and gene therapy. This will demand substantial resourcing from pharma, particularly for bigger manufacturers who may be executing two or more launches per year.

The conventional wisdom is to begin heavy launch investment following a positive phase 3 readout, meaning substantial launch preparation must happen in the 12 months before launch. This time crunch is a key reason many launches underperform: ZS analysis shows launches fail not because assets lack promise, but rather because companies invest too little, too late and fail to demonstrate sufficient commitment to customers.

This poses a paradox: launches demand more manufacturer commitment to succeed, but early investment has never carried more risk. In this new normal, launch success will no longer be defined by flawless execution of a fixed plan, but rather how leaders build launch organizations to meet the moment.

The new launch blueprint for success in the next 3-5 years

Pharma leaders who want to win in this uncertain environment need to ask themselves two key questions that will change how they make investments around launch:

• How can I shrink the time from investment to launch certainty without sacrificing launch quality?
• How can I build durable capabilities that can be applied across multiple launches more effectively?

Shrinking the time from investment to launch certainty

In uncertain times, companies must build tools and establish processes that allow for speed, as there may be reasons to delay certain investments—like hiring HQ or field teams or locking strategic go-to-market decisions—until there is more clarity. Delaying doesn’t mean sacrificing peak revenue down the line if companies can quickly stand up their launch operations. To move quickly at launch, leading organizations will build practical accelerators that enable efficiency gains. Opportunities include:

• Operationalizing large investments in less time: Take the commercial field force, traditionally the largest prelaunch investment, where a hypothetical 300-person sales force in the U.S. will cost a company $100M per year. Instead of hiring this team six to nine months before launch and assuming the ~$75M in carrying costs, the leading pharma companies of the future will develop the tools, processes and enablers to hire, onboard and productively deploy a field team in three to four months, halving their “at-risk” investment without sacrificing on customer impact.
• Traditional HR processes of recruiting, hiring and onboarding are time and resource intensive. Already today, AI tools exist to speed up end-to-end hiring workflow and onboarding. Instead of spending weeks in synchronous—and sometimes in-person—classroom-style training, field team members can learn through AI trainers. These tools accelerate education, enable simulation and reinforcement and can be used on the job, dramatically compressing the time from hiring to impact.
• Accelerating resource-intensive processes: Pharma companies create enormous volumes of customer-facing materials for launch (provider detail aids, patient education, office staff tools, payer value stories, websites, etc.). All of these materials must go through medical, legal and regulatory (MLR) review—a process that can become a major bottleneck in launch preparation. Today, individual assets may require several iterations of MLR and take a month or longer to be approved, diverting focus and resources from other launch-critical activities.
  
  The leading pharma companies of the future will use AI to accelerate manual processes like MLR and drive efficiency in the launch period. By compressing MLR timelines from weeks to days, companies can dramatically accelerate launch readiness while preserving compliance rigor.

Building durable capabilities across launches

Rethink launch playbooks (and don’t recreate the wheel for each launch): Many organizations maintain extensive playbooks and build “bottom up” for every launch. The problem isn’t the frameworks, which generally serve as a useful checklist. The problem is that too few of the items in the playbook are built and applied in a durable way that can be used for speed across launches.

By 2030, the launch organizations that thrive will resemble agile operating systems rather than static teams. They’ll invest earlier in infrastructure and later in asset-specific spend, preserve options longer and treat volatility as a design constraint to build around. Some ways to do this:

• Build an always-on launch control tower: Develop a hub that consolidates key launch performance metrics (e.g., customer sentiment, access dynamics, demand signals, sales and revenue), drives real-time insights and prompts for rapid course correction. Consolidating and structuring this information removes the need to develop endless Excel trackers and dashboards bespoke for each launch.
• Create a launch “SWAT team”: Companies and business units typically establish a brand team for launch and the team follows the asset throughout the life cycle. Instead, companies can cultivate a small, high-performing team (headquarters or field) of “launch experts” who rotate from launch to launch. These experts can drive best practices from the early days (e.g., T-12 months) and provide surge capacity where needed. This approach speeds up early launch planning, minimizes risk from hiring new FTEs and gives flexibility to redeploy the team if needed.

Leaders who answer these questions and build ways to shorten the time from investment to certainty while applying durable launch capabilities will reduce risk and turn launch into a competitive advantage.