Introduction

For pharmaceutical companies today, the challenge isn’t just whether to launch in multiple markets—it’s how to do so effectively amid rising complexity. Evidence shows the stakes are real: more than 35% of new cancer drugs were launched in only one country, and just 43% reached more than five markets by the end of 2022.

“The common message is clear: global launches demand local insight, regulatory alignment, and partnerships that go beyond transactions.”

From approval timelines to reimbursement and distribution, each region demands a different pharma launch strategy, making “global” distribution far from simple. What works seamlessly in the United States often needs a complete rethink in Europe, Asia-Pacific, Latin America, or the Middle East.

The pressure is intensifying as the patent cliff approaches. Several high-value brands are set to lose exclusivity in the next few years, opening the door for a wave of generic pharmaceutical drugs. For companies competing in this space, the opportunity is significant — but so is the risk of delays, missteps, or misaligned strategies.

Here, we bring together perspectives from Strides’ business development leaders across five regions. Their experiences highlight what it takes to synchronise regulatory, manufacturing, and commercial steps for a successful multi-country launch pharma strategy.

Regulatory Launch Alignment: Navigating Fragmented Pathways

If there is one constant in global launches, it is regulatory complexity. Every geography has its own interpretation of compliance, making regulatory launch alignment the first and often the hardest step in a pharma product launch strategy.

In Europe, the challenge lies in navigating a patchwork of national authorities. “Europe has various local dynamics. Each regulator acts like its own little kingdom,” notes Oren Weininger, Head of Europe | CEO, Strides Pharma International, Switzerland. Even with a dossier aligned to EMA standards, local variations in pricing rules, packaging requirements, and language filings can create bottlenecks. Companies increasingly rely on hybrid models — leveraging in-house regulatory teams supported by local consultants — to meet the expectations of both regulators and customers.

Asia Pacific presents a different picture: diverse levels of maturity and evolving regulatory pathways. “Some countries in APAC allow fast-track filings if you already hold EMA or FDA approval, while others insist on local manufacturing,” explains Swati Head, APAC Business Development & P&L.

This means designing flexible filing strategies for global launch planning that balance first-to-market opportunities with long-term scalability.

Manufacturing & Supply Chain Synchronization: Building Reliability Across Borders

Getting a product approved is only half the battle. The real test comes in ensuring it moves smoothly from manufacturing sites to pharmacies or hospitals across continents. Each geography adds its own operational twist to this equation.

In Europe, credibility often comes from being seen as “locally released.” “We import the product, test it in European labs, and handle the regulatory release here. For customers, it feels like a made-in-Europe product,” explains Oren Weininger. This step not only satisfies regulators but also reassures buyers who are increasingly cautious about supply chains stretched across continents.

Latin America places different demands on synchronization. In Mexico, procurement rules change frequently, forcing companies to adjust at speed. “To capture opportunities, you have to be extremely fast and complete in your response. Delays mean losing access to large government tenders,” says Ashok Yadav Sr. Director, Sales + BD (Canada & LATAM). In practice, this means supply chain planning and regulatory agility are inseparable.

The United States, despite being a single-regulator market, poses a different set of challenges: intense scrutiny for OTC and e-commerce generics, plus price erosion combined with customer service expectations. “What keeps us competitive is not just pricing, but how quickly we can supply and how flexible we are with warehousing,” notes Kush Choksi, Director Business, Development (USA), at Strides Pharma By storing stock in its own facilities and releasing smaller lots on demand, Strides has turned logistics into a differentiator in the crowded OTC space.

Commercial & Licensing Models: Choosing the Right Playbook

If supply chains are about execution, commercial models are about positioning. The same generic drug can succeed or fail depending on whether it is launched as a commodity tender, a branded generic, or part of a larger licensing play.

In the Middle East, scale is the lever. “With generics, a single product license rarely creates impact. Basket deals — 20 or more products at once — give both sides enough volume to make it worthwhile,” says Milan Doshi, SVP Business Development & Regional BD Lead (GCC, CIS, Russia). “For local partners, this shortcut builds a portfolio that might otherwise take years to assemble.”

Asia Pacific shows that differentiation matters more than volume. “Instead of focusing on commodity generics where margins collapse, we focus on differentiated or branded products that can be localised,” explains Swati. In markets like Indonesia, this often combines with co-branding through local partners, creating a product identity that resonates with prescribers and patients.”

Licensing also plays a role in bringing complex products to market faster. “If time-to-market is critical or development costs are prohibitive, in-licensing becomes the smarter path,” Milan adds.

Drug Patents & Generics: The Global Opportunity Landscape

Industry analysts estimate that by 2026, drugs worth tens of billions of dollars in annual sales will go off patent, creating an unprecedented opening for pharmaceutical generic medicines and biosimilars. For companies with the right pharma product launch strategy, this “patent cliff” represents both a growth opportunity and a test of execution.

Therapeutic categories at the centre of this shift include diabetes, oncology, cardiovascular disease, women’s health, and nephrology.

Milan points out that “when we focus on therapeutic areas like women’s health or nephrology, in-licensing allows us to complement our own R&D and move faster into these segments”.

By aligning portfolio bets with upcoming expiries, companies can prepare launches that meet real demand as soon as exclusivity lapses.

The Big Picture

Together, these threads show why multi-country launch pharma strategies cannot be run from headquarters alone.

What emerges across regions is not a single formula but a playbook: scale where it matters, differentiate where it counts, and license where it saves time or cost.

The most successful companies embed regulatory launch alignment, manufacturing synchronization, portfolio management, and tailored commercial models into their planning, but they also allow local teams the flexibility to adapt to nuance. Without that, the best portfolio may still stall at the border.

It is this spirit of complementary teamwork across continents — India, Europe, the Americas, APAC, and MENA — that brings the vision of “One Strides” to life.

Source: https://www.iqvia.com/blogs/2025/02/launch-excellence-five-foundational-success-factors?

Key Takeaways:

• Regulatory complexity is the first barrier in multi-country pharma launches; success depends on embedding regulatory alignment early in the launch plan.

• Manufacturing and supply chain synchronisation are no longer just about efficiency but about building credibility through local release, agile procurement responses, and warehousing flexibility.

• Commercial success relies on choosing the right model — whether basket licensing in MENA, branded generics in APAC, or private-label agility in the U.S.

• The upcoming patent cliff opens major opportunities in therapeutic areas such as diabetes, oncology, and women’s health, but only companies with proactive portfolio planning will capture value.

• Strides’ approach shows that global pharma launches succeed when complementary teams across continents work toward One Strides — combining regulatory foresight, manufacturing reliability, and locally attuned commercial strategies.

References