Day one of a new drug launch is one of the most anticipated moments for a pharmaceutical company. After more than a decade of research and billions of dollars in investment, FDA approval marks a major milestone. Yet for many organizations, the celebration is short-lived: a significant percentage of new drug launches fail to meet expectations, with half falling short of peak sales and missing targeted goals.
Why do so many launches struggle to gain momentum, and what can be done to ensure success? While each launch is unique, five barriers consistently hinder market performance. Addressing these challenges early and strategically can mean the difference between strong adoption and missed opportunity.
Barrier 1: Taking a One-Size-Fits-All Approach
Every drug launch requires a tailored strategy based on therapeutic area, patient population, competitive landscape, and market access dynamics. Generic approaches often fail to capture critical nuances. Successful launches start by defining the product’s differentiators: Is it first-to-market or filling an unmet need? Does it offer improved safety or novel administration? Will patients face fewer barriers to access or lower costs?
CMK Select approach: We leverage cross-functional expertise and market insights to craft launch strategies that align with each product’s value proposition, competitive environment, and patient needs.
Barrier 2: Start Planning Too Late
Many companies underestimate the time and resources needed for a successful launch. Planning should begin 18–24 months before anticipated approval to allow for research, stakeholder mapping, access strategy development, and cross-functional alignment. Delayed timelines often result in misaligned teams, incomplete plans, and missed market opportunities.
CMK Select approach: We implement structured launch-readiness frameworks with clear milestones, timelines, and risk mitigation strategies ensuring every workstream is ready for Day One and beyond.
Barrier 3: Limited Launch Knowledge
Even experienced brand leaders may lack operational expertise for seamless execution. Launches involve hundreds of interdependent activities, requiring dedicated leadership to anticipate risks, align teams, and translate strategy into action.
CMK Select approach: Acting as the “chief of staff” for the launch, our consultants provide program and project leadership that accelerates decision-making, smooths collaboration, and drives measurable results.
Barrier 4: Working in Silos or With the Wrong Teams
Successful launches demand alignment across Market Access, Pricing, Manufacturing, Trade, Medical Affairs, Regulatory, Patient Advocacy, Commercial Operations, and Communications. Siloed teams risk misaligned timelines, supply chain gaps, and inconsistent messaging.
CMK Select approach: We create structured launch environments that foster cross-functional communication, align priorities, and proactively address risks ensuring the entire launch ecosystem operates efficiently and cohesively.
Barrier 5: Not Utilizing Metrics or Learnings
The first six months post-approval often determine a product’s trajectory. Without robust metrics, companies cannot course-correct or capture insights for future launches. Key performance indicators should include sales force effectiveness, message resonance, time-to-patient access, inventory readiness, payer coverage, and competitive response.
CMK Select approach: We implement launch dashboards and KPI frameworks that provide real-time visibility. Post-launch reviews capture best practices and lessons learned, building institutional knowledge for continuous improvement.
Driving Launch Excellence with CMK Select
Overcoming these barriers requires structured planning, operational expertise, cross-functional collaboration, and real-time performance monitoring. CMK Select serves as the central hub for launch strategy, execution, and optimization so every milestone is achieved and every opportunity leveraged.
Launch Smarter. Faster. Better.
CMK Select equips your teams with strategy, leadership, and operational rigor to maximize launch performance.
Start your transformation today – give CMK Select a call 973 244-6060.