Addressing the 58% Launch Failure Rate: Accelerating Market Access Through Intelligent Decision-Making

The Gambler’s Fallacy holds that, if you’ve called heads five times in a row and called wrong each time, the next toss is sure to be heads. Stay the course and your luck will change. Statisticians, of course, know this to be false. One of the main reasons ‘the house always wins’ is that gamblers often dupe themselves. Currently, more pharma launches miss expectations (58%) than meet or surpass them (42%), and yet pharma launch teams keep tossing the same coin in the hopes it will land on heads next time. Successful pharma companies aren’t in the business of gambling away millions in development dollars and countless hours of market research and planning, but even so, too much is left to chance. 

Let’s examine some of the structural and strategic causes behind that eye-catching 58% failure rate, and discuss how to improve launch outcomes with an evidence-based roadmap to launch excellence. 

Understanding the 58%: Why launches fail

As we know, pharmaceutical markets are experiencing radical change. Over the past decade, the industry has faced technological disruption, mounting regulatory complexity, and increasingly aggressive competition. What’s more, growing pricing pressures brought about by the Inflation Reduction Act (among others) have reduced drug development timelines and shrunk profitability margins. Exclusivity windows are likewise shrinking, with more than 190 products forecast to lose exclusivity between 2022 and 2030, jeopardizing an estimated $300 billion in sales before 2028.

These factors (among others) have created a perfect storm of market forces. Pharmaceutical markets are more complex and competitive than ever. They move swiftly and don’t forgive mistakes. Pharma companies, for their part, have largely failed to keep pace with these market changes. Organizational structures and launch methodologies have remained unchanged while market realities have transformed around them, rendering those processes obsolete. 

Launch teams are no better or worse at ‘playing the game’ than they’ve ever been, but the game itself has changed beyond recognition. 

Pinpointing the root causes

One of the key contributors to that 58% failure rate is that pharma companies have struggled to gain a complete understanding of complex, fast-moving markets. This is further intensified by the industry’s move toward rare disease, oncology, and other specialty markets, with specialty therapies comprising 75% of the current pipeline.

Historically, gaining an understanding of these markets was a challenging and time-consuming process. Deloitte’s new Rethinking Market Access report highlights how a lack of adequate market understanding is currently hindering launch success, with more than half (57%) of drug launch failures attributed to limited market access, 47% ascribed to inadequate understanding of market and customer needs, and 41% to poor product differentiation.

Even when an organization has developed a good idea of what the market wants and needs, it’s not always possible to act on that knowledge. Misalignment between medical and commercial teams interrupts the flow of insights through an organization, and prevents teams from acting on market signals in a timely fashion. It’s a top-down issue – a lack of any overarching launch strategy means individual teams don’t have a ‘north star’ to aim for, and so end up working toward their own departmental targets and priorities. Siloed data ultimately leads to disjointed thinking and a lack of collaborative effort, leaving launch teams without the organizational agility to respond proactively to reimbursement hurdles or unforeseen market forces.

Strategic decisions that should be made confidently and informed by market signals become coin flips.

Market access as an early strategic pillar

In The need to consider market access for pharmaceutical investment decisions: a primer, SV Ramagopalan et al argue that “treating market access as an essential strategic capability” will help pharma companies better attract investment and ultimately achieve successful drug commercialization. Organizations that incorporate market access planning early will be those best-positioned for success. Teams should aim to begin market shaping as early as pre-Phase 2, integrating diverse payer and stakeholder perspectives to inform strategic planning in the early pre-launch phases. Preapproval information exchange should also begin sooner than later. Starting these conversations with payers, and using continuous integration of real-world data sources such as claims data, electronic health records, field engagements, and more can help teams to adapt and strengthen their messaging in order to define a strong value proposition. 

Imagine a scenario where patients with comorbid mental health conditions experience delays in receiving GI diagnoses. By bringing together insights from congress monitoring and field observations, a team could identify an overlooked HCP population and adapt educational strategies to address unmet needs. This kind of coordinated approach can lead to faster diagnosis, stronger patient engagement, and better access to care.

Bridging the AI trust gap

Artificial intelligence has the ability to skew the odds in launch teams’ favor. Per McKinsey, commercial applications of artificial intelligence offer the greatest opportunity for value creation in the pharmaceutical industry, and are expected to generate 18-30 billion dollars of value annually. AI can reduce the launch failure rate by delivering accurate, actionable market signals in real time, enabling confident, informed decision-making.

However, the pharmaceutical industry has been understandably slow to adopt AI tools. Ongoing concerns around data privacy and security, ethical governance, bias, and accuracy persist. Along with complex regulatory hurdles and internal policies that must be navigated. It’s important to make a distinction between open-source LLMs such as ChatGPT, Copilot, and launch AI solutions that are specifically built and tailored for the pharmaceutical industry. 

Purpose-built pharma AI will: 

• Have compliance built in, and should explicitly state that sensitive customer data is never used to ‘train’ AI systems 
• Conform to the highest ethical standards, and use strict guardrails to limit hallucinations 
• Address bias at the training stage, with sentiment models built to reflect a diverse range of perspectives – not a single definition of what’s fair or accurate 
• Put the launch team back in the loop as a final safeguard to assess the accuracy and relevance of AI output 

Imagine the power to act faster, more decisively, and with greater confidence in your decisions than your competitors. Your pharma team will no longer leave anything to chance, but will accelerate market access through intelligent decision-making. Drug launches shouldn’t feel like coin flips. And with a purpose-built launch AI, they aren’t.

Photo: akindo, Getty Images

Lance Hill is the Founder and CEO of Within3, a global leader in Launch Intelligence technology for life sciences. Under his leadership, the world’s top pharma and medtech companies rely on Within3 to break down communication barriers across the healthcare ecosystem. A former VP at webMethods and technologist at IBM, Lance brings a deep background in digital transformation. He’s passionate about democratizing drug development and leveraging technology to elevate diverse voices and improve global health outcomes.

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