By: John Ward and Paul Hamill

INTRODUCTION

Developing a new biopharmaceutical can take more than a decade of research and costs billions of dollars in development and clinical trials.¹ Because patent protection is typically sought at the point of discovery, this prolonged development cycle significantly compresses the commercial window available to recoup these investments. By the time a drug is approved, loss of exclusivity timelines are already fast approaching.

Between 2025 and 2030, over $300 billion in prescription drug revenues are expected to lose exclusivity.² To optimize returns within this compressed timeframe, some sponsors prioritize earlier multi-market launch planning as part of their commercialization strategy. Consequently, launch readiness matters just as much as development progress. For many programs, global expansion is therefore shifting from a long-term ambition to a near-term priority.

This article examines this trend, and also explores how globally integrated contract development and manufacturing organizations (CDMOs) are reducing market-entry risk through redundant capacity and agile downstream execution.

MARKET TRENDS CONSTRAINING MULTI-MARKET LAUNCHES

Achieving an earlier multi-market launch is increasingly difficult due to a convergence of industry trends. Sponsors encounter significant friction caused by constrained manufacturing capacity, complex regional logistics and a tendency to underestimate the final stages of product assembly.

High-volume demand is altering what capacity gets prioritized

The pharmaceutical industry overwhelmingly prioritizes sustained, high-volume manufacturing runs, with large CDMOs building their facilities to minimize equipment downtime. Setting up a production line requires significant time – up to four weeks – and resources, making it commercially unviable to execute frequent equipment changeovers for a run that might only last a few minutes. That bias has become more pronounced for high-demand therapies, such as glucagon-like peptide-1 (GLP-1) medications, and many CDMOs are placing greater emphasis on these large, continuous campaigns.^3,4

The impact of this high-volume demand shows up in the middle of the market. Small and mid-volume programs find it harder to secure dependable downstream partners that support a faster speed to market, even when they have a clear regulatory path and a realistic forecast. That “underserved” band spans roughly 10,000 to 5 million units, which is substantial in operational terms but remains deprioritized relative to continuous blockbuster campaigns with runs of tens or hundreds of millions of units.

Working in the European market introduces logistical hurdles

Market requirements can multiply downstream complexity and impact launch timelines, even when demand forecasts are stable. The European Union has 24 official languages before local market preferences are even considered.⁵ This language variation, combined with national regulations, leads to stock-keeping unit (SKU) proliferation. Commercial packaging volumes then need to be split into multiple smaller, localized variants to meet the sponsor’s specific rollout strategy. This fragmentation transforms what might be a straightforward production run into a complex web of small batches, making manufacturing flexibility an operational advantage.

The last stretch is where timelines quietly slip

Final assembly and secondary packaging are often scheduled after upstream manufacturing, so delays at this stage can quickly affect the launch timeline. The physical production run is not always the primary bottleneck. Timelines are often dictated by documentation alignment, regulatory requirements and artwork approvals, which can extend timelines by three to six months and, if not integrated into the plan early, force teams into a reactive cycle.

Drug product and device components move across regions before they ever reach final assembly and packaging. Each handoff triggers a new round of regulatory documentation and release coordination, creating an administrative lead time that can delay the entire timeline. Because these steps occur immediately before market entry, there is no buffer for error. Any administrative bottleneck directly delays patient access and halts the start of revenue.

INTEGRATED SOLUTIONS FOR GLOBAL MARKET ENTRY

To overcome these late-stage bottlenecks and successfully execute earlier global launches, sponsors require a proactive approach to their supply chain architecture. Moving away from disjointed, single-node models toward globally integrated CDMOs provides the necessary foundation for success. This approach relies on three core operational solutions.

1) Redundant capacity supports recovery planning and faster regional expansion

One practical way to reduce late-stage launch risk is to treat capacity as part of business recovery planning rather than a simple scheduling problem. Redundant capacity works best when it is built on aligned execution. Operating identical assembly equipment and tooling across North America, Europe and Asia, along with consistent test methods and comparable GMP manufacturing cleanroom environments (such as Grade C and D), reduces the rework required when a program expands from one region into another. The sponsor still completes the work required for each market, but the baseline is stable enough that teams avoid rebuilding the process from the ground up.

This regional alignment supports a credible first or second source strategy. If one region faces a disruption, the sponsor can shift production to another without a full-scale revalidation. With aligned capacity available across regions, sponsors can protect continuity without requiring every change to be a full-scale revalidation project.

2) A unified quality system can reduce audit burden

A global footprint will not help much if each site behaves like a separate supplier. Fragmented quality governance stretches oversight resources and increases the audit burden. This raises the likelihood that small changes will create delays.

A unified quality and regulatory (QA/RA) framework across global sites reduces management costs and friction. Sponsors can qualify a CDMO based on a single audit or system, then manage local differences as controlled exceptions. That approach does not eliminate market-specific requirements, but it limits how often sponsors have to repeat governance work to achieve the same outcome.

A shared framework makes timelines more predictable and reduces handoff friction, preventing quality alignment from becoming a recurring bottleneck during expansion.

3) Localized downstream operations reduce trade and tax friction

Short physical distances still introduce avoidable transaction hurdles. Shipping products across nearby borders for final assembly and then back into the target market instantly triggers multiple taxable events and documentation cycles that add cost and uncertainty.

Locating final assembly and secondary packaging in-region reduces those loops. It also shortens the feedback cycle when market requirements change because the work is closer to the teams managing artwork and release expectations. In practical terms, that localization is one of the clearer levers sponsors can use to reduce exposure to documentation delays without compromising compliance.

EXECUTING A DESIGNED OPERATING STRATEGY

While physical assets and quality frameworks are the foundation of global expansion, true manufacturing agility requires a deliberately designed operating strategy. To successfully navigate the unpredictable nature of global launches, this agility depends on having operational flexibility structurally embedded into the production model.

Although flexibility is sometimes framed as a willingness to adapt, true flexibility stems from intentional capacity design. Running standard operations on a predictable weekly cadence while protecting headroom for variability frees up capacity. For example, operating on a five-day, two-shift basis and capping baseline equipment utilization at 80% leaves nearly 40% in flexible capacity. This creates room to absorb changes through weekend time and additional shifts when delivery dates move or packaging variants change. That headroom matters most for small and mid-volume programs because these products consistently face more SKU variation and less schedule priority than the largest campaigns. The operating choices above tend to show their value most clearly in programs where timing pressure meets right-sized capacity.

CASE STUDIES IN MID-MARKET EXECUTION

The value of an agile and flexible operating strategy is most evident in the compressed launch timelines of biosimilars and the low-volume requirements of orphan drugs.

Biosimilars

For biosimilars, operational readiness is the primary commercial differentiator. While the market opportunity is vast, the biosimilar void is widening; IQVIA reports that 90% of the 118 biologics losing exclusivity over the next decade currently have no biosimilar candidates in development.⁶

Because competition is sparse, but the patent window is short, the first mover often captures the majority of market share. In this environment, execution speed determines who wins the race to the start line. A CDMO that can skip the months of administrative setup and documentation alignment through pre-validated, redundant capacity provides a decisive advantage in capturing that first wave of revenue.

Orphan drugs

Orphan drugs illustrate the need for high-mix agility within an underserved market. These programs face a mismatch between supply and demand: they require the same high regulatory standards as blockbusters but only produce around 30,000 units per year.

Most large-scale manufacturers prioritize equipment uptime and enforce prohibitive minimum runs, making these niche treatments commercially unviable to produce in a traditional environment. To reach vulnerable patient populations, sponsors need a partner that treats small, 5,000-unit batches – spread across the calendar – as standard operations rather than disruptive interruptions. By designing quality governance and release protocols specifically for frequent changeovers, a flexible CDMO removes the operational barrier to patient access.

THE FUTURE OF GLOBAL LAUNCH READINESS

As the patent cliff approaches in 2030, the traditional, siloed approach to drug launches is becoming an unsustainable risk. As a result, the next decade of biopharmaceutical success will be defined by the precision of the downstream supply chain.

For sponsors in the underserved middle market, survival requires shifting from reactive logistics to intentional network design. The shift toward globally integrated CDMOs is a strategic necessity to reclaim the commercial time lost during development.

By prioritizing redundant capacity, unified quality frameworks and localized assembly, sponsors ensure they are not just ready for launch but also resilient against the inevitable disruptions of a global market. The window to recoup billions in R&D is shrinking, meaning the speed and reliability of the final mile will be the decider of patient access and commercial longevity.

REFERENCES

1. Kim, E., Yang, J., Park, S., & Shin, K. (2023). Factors Affecting Success of New Drug Clinical Trials. Therapeutic Innovation & Regulatory Science, 1. https://doi.org/10.1007/s43441-023-00509-1.
2. Evaluate, “Portfolio tactics to scale the $300bn patent cliff” https://www.evaluate.com/thought-leadership/portfolio-tactics-to-scale-the-300bn-patent-cliff/ (October 13, 2025).
3. Lindahl, S. B., Babi, D. K., Gernaey, K. V., & Sin, G. (2023). Integrated capacity and production planning in the pharmaceutical supply chain: Framework and models. Computers & Chemical Engineering, 171, 108163 https://doi.org/10.1016/j.compchemeng.2023.108163.
4. Altabas, V., Orlović, Z., & Baretić, M. (2025). Addressing the Shortage of GLP-1 RA and Dual GIP/GLP-1 RA-Based Therapies—A Systematic Review. Diabetology, 6(6), 52, https://doi.org/10.3390/diabetology6060052.
5. European Union, “Languages, multilingualism, language rules” (accessed February 27, 2026), https://european-union.europa.eu/principles-countries-history/languages_en.
6. IQVIA Institute, “Assessing the Biosimilar Void in the U.S.” (February 5, 2025), https://www.iqvia.com/Insights/The-IQVIA-Institute/Reports-and-Publications/Reports/Assessing-the-Biosimilar-Void-in-the-US.