This piece outlines the power of a multi-capability partnership, diving into Clarkston’s work with a pharma client pursuing U.S. market entry following a series of targeted acquisitions.  

The global pharmaceutical M&A environment has shifted meaningfully over the past several years. Amid heightened pricing pressure, evolving regulatory expectations, and increased scrutiny on capital allocation, scale and geographic reach have become strategic imperatives,no longer  optional advantages. For many European pharmaceutical companies, establishing a durable presence in the United States has emerged as a critical lever for long-term growth, resilience, and global relevance. 

Against this backdrop, Clarkston Consulting partnered with a private equity owned UK-based pharmaceutical company pursuing U.S. market entry through a series of targeted acquisitions. While the client possessed strong scientific capabilities and a successful European commercial model, leadership recognized that entering the U.S., the world’s largest and most complex pharmaceutical market, would require far more than simply acquiring assets. It demanded a deep understanding of U.S. healthcare dynamics and a disciplined, holistic approach to due diligence. 

Why the U.S. Market Is Critical 

The U.S. pharmaceutical market represents nearly half of global pharma revenues and continues to be the primary engine for innovation returns. Beyond sheer scale, the market offers access to sophisticated provider networks, advanced specialty distribution channels, and a reimbursement environment that, while complex, is still more conducive to funding innovation than many global counterparts. 

However, these advantages come with trade-offs. Companies must navigate a fragmented payer landscape, increasingly rigorous FDA expectations, heightened quality and compliance standards, and operational models that differ materially from those in Europe. For European firms, these structural differences can materially impact deal value if not fully understood during diligence. 

A Multi-Lens Due Diligence Approach 

To support the client’s acquisition strategy, Clarkston led a series of commercial, operational, quality, and regulatory due diligence engagements across multiple targets,each designed to assess not only deal viability, but long-term scalability in the U.S. market. 

• Commercial diligence focused on U.S. market attractiveness, competitive positioning, pricing and reimbursement dynamics, go-to-market models, and the sustainability of forecasted revenue under U.S. payer scrutiny. 
• Operational diligence assessed manufacturing and supply chain readiness, scalability of production for U.S. demand, integration complexity, and alignment with U.S. distribution and logistics expectations. 
• Quality diligence evaluated quality management systems, inspection readiness, data integrity, and the ability to meet FDA and U.S. GMP standards, often a key risk area for non-U.S. operators. 

Importantly, these workstreams were not conducted in isolation. Insights from one diligence area consistently informed others, creating a more holistic view of risk, value, and integration readiness. 

Educating on U.S. Healthcare Realities 

A defining element of the engagement was not just diligence execution, but education. Clarkston helped the client’s leadership team understand how U.S. healthcare economics, regulatory enforcement, and operational expectations differ fundamentally from European norms. Topics such as FDA inspection cadence, payer influence on commercial strategy, and the operational implications of U.S. distribution models were critical to shaping informed investment decisions. 

This knowledge transfer proved essential not only in evaluating targets, but in building internal confidence to operate successfully post-close. 

The Power of a Multi-Capability Partner 

Running multiple diligence workstreams through a single partner created both efficiency and strategic clarity. A unified team reduced redundancy, ensured consistent assumptions across workstreams, and allowed risks and opportunities to be evaluated in context rather than in silos. For leadership, this meant faster decision-making and greater confidence in outcomes. 

The Outcome 

Today, the client has an established U.S. operating platform that serves as both a commercial foothold and a launchpad for future growth. With U.S. infrastructure in place, the company is now positioned to introduce its own therapies to the market, unlocking exponential growth opportunities well beyond the initial acquisitions. 

In an environment where cross-border pharma expansion is increasingly complex, comprehensive due diligence is no longer just best practice but a prerequisite for success. 

Clarkston would love to partner with your organization on accelerating its corporate vision. Our M&A consulting team leverage our industry expertise in the consumer products, life sciences, and retail industries to help our clients maximize their profitability and increase the likelihood of deal success.