In the increasingly competitive and innovation-driven biopharma industry, growth is not only a strategic objective for companies, it’s also a necessity. While expanding market share, launching new products and technologies, and acquiring assets through mergers and acquisitions remain key drivers, international expansion offers a powerful route to sustainable long-term growth. Success in new geographies hinges not only on regulatory acceptance and commercial readiness, but also on the effective design and execution of robust supply chain and distribution strategies.

Understandably, the complexities of global expansion demand more than just ambition – they require a tailored blueprint. How can companies ensure their supply chains are not only scalable but also resilient and responsive to the nuances of each new market?

This article explores the critical supply chain and distribution considerations that underpin international expansion, with a particular focus on the Gulf Cooperation Council (GCC) countries.  The member nations include Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates.  Collectively, they represent an increasingly strategic region for biopharma investments.

Prioritizing the Right Markets for Expansion

Although the industry strives to serve “every patient, every time,” companies must also ensure commercial viability and profitability. Consequently, initial product launches are often prioritized in what the IMF calls the Advanced Economies – such as the US, Canada, Europe, Japan, South Korea, Australia and New Zealand. These markets offer mature and predictable regulatory frameworks (controlled by agencies like the FDA and EMA), market access, established pricing and reimbursement models, and high-return potential.  These factors help make them natural launch paths for new products.

Figure 1:  Global Country Classification by Economic Development (as defined by UNICEF, IMF and UN)

Once launches are secured in mature, high-value Advanced Economy countries, companies often begin evaluating opportunities across emerging and developing economies. According to United Nations classifications there are roughly 130-140 Emerging and Developing Countries and 46 countries have been designated as Least Developed Countries. Given the broad and diverse list of emerging and developing countries to consider, a structured approach to prioritization is necessary. This is guided by factors like regulatory feasibility, market readiness, healthcare infrastructure, receptiveness for innovative therapies and return on investment.

The BRICS nations (Brazil, Russia, India, China, and South Africa) are often assumed to be the natural next step due to their scale and economic influence, though each presents unique challenges. These include complex and evolving regulatory landscapes, lengthy and sometimes unpredictable approval timelines, and challenging reimbursement mechanisms, all of which can delay access and dilute commercial viability. 

As a result, many biopharma companies are turning toward more navigable and strategically aligned regions, such as the GCC region, North Africa, and Eastern Europe. These regions not only offer improving regulatory pathways and investment in healthcare infrastructure that mirrors Western standards, but there is also rising patient demand for innovation and participation in clinical studies, all of which are key indicators of market readiness. Additionally, proximity to European regional company infrastructure (European commercial and operational headquarters) allows for integrated management of day-to-day operations in those regions.

While the decision of where to expand is often led by commercial and regulatory teams, the question of how to serve those markets and the task of executing effectively lie primarily with the supply chain and operations teams. Making market entry feasible hinges on the design of distribution frameworks that are flexible, compliant, and scalable. 

A common approach, particularly for companies with one or two initial products, is to leverage a good distribution)partner. This allows biopharma companies to rapidly reach their markets of choice. However, how easy is it to decide between using a distributor, wholesaler, international pharmacy, or even establishing an entity? The simple answer is: “it depends.” Factors such as a company’s maturity, risk tolerance, and growth outlook can all affect a company’s approach. Even when working with a partner, launch preparation and operational supply chain management remain highly hands-on functions that require foresight and cross-functional coordination.

Gulf Cooperation Council (GCC) Insights

In the remainder of this document, we turn our focus to the GCC region to share a compelling and illustrative example of how supply chain design can enable international growth for biopharma companies. The GCC presents a unique mix of harmonized regional frameworks and country-specific complexities that make it both attractive and operationally challenging.

Recently, the AIM team presented a client case study at the LogiPharma 2025 conference at Lyon, France, where we presented key learnings from our collaboration with Agios Pharmaceuticals. This real-world example highlighted many of the critical success factors required to effectively navigate supply chain execution in the region.

A map of the united arab emirates AI-generated content may be incorrect.

Figure 2: Gulf Cooperation Council (GCC) member countries and size (population)

While the GCC offers strong commercial potential, its attractiveness extends beyond profitability. This region has a growing unmet medical need, favorable demographic trends, and improved access to innovative therapies. Regulatory structures are also evolving in a direction that supports innovation: for instance, Saudi Arabia allows patient access to new therapies in certain situations even before FDA or EMA approval is granted. Additionally, the Gulf Health Council plays a central role in harmonizing drug registration and procurement across the region, and streamlined access is possible through unified procurement platforms and initiatives like the Gulf Central Drug Registration Program. On a more practical level, there is a shared language (Arabic) across the GCC countries and a widespread use of English. These cultural and linguistic commonalities can accelerate rollout.  

Before diving into execution, it is essential to break down the key components that form a successful market entry strategy. In the sections that follow, we walk through the core steps that biopharma companies should cover:

  1. Mapping physical, financial, and Information flows
  2. Developing a regulatory and operational roadmap
  3. Identifying and qualifying regional distribution partners
  4. Establishing launch work streams

Each of these steps plays a critical role in translating a market opportunity into a successful market launch.

1. Mapping Physical, Financial, and Information Flows

From our experience, successful expansion begins with laying the groundwork through a structured and cross-functional effort to map out the desired physical, financial, and information flows. This planning process must include input from across the organization including Regulatory Affairs, CMC/Technical Operations, Finance and Tax, Commercial, and Quality among others, ensuring alignment from the outset. The resulting alignment document acts as a good starting point for the supply chain setup. Key questions that must be addressed early:

  • Where is the product manufactured and where will it be stored?
  • How will the product flow through the region?
  • Who will be the first economic customer in each market?
  • What licensing, customs, and compliance steps are required based on each route?

For example, for a launch in the GCC region, whether the product is manufactured in the US, UK, Switzerland, or Europe, and then shipped into a hub in Dubai or to a local distributor in Bahrain, will trigger a variety of requirements and actions. These decisions have far-reaching implications, from trade compliance and pharmaceutical licensing to optimal Incoterms 2020 selection. Each route-to-market configuration requires analysis, especially given the implications for service, cost, speed, risk and regulatory burden.

2. Developing a Regulatory and Operational Roadmap

Once foundational planning is complete, a detailed project roadmap, or overall timeline, should follow. This roadmap must factor in: 

  • National regulatory approval timelines and strategic sequencing
  • Time needed for manufacturing readiness
  • Regional licensing requirements 
  • Partner contracting and onboarding 

This is often where projects become complex. Even with a seemingly harmonized region like the GCC, each country has its own import requirements, regulatory pacing, and documentation requirements. Subject matter expertise is essential – not only to interpret requirements correctly but to avoid costly missteps. 

For US-origin biopharma companies without a local footprint, the challenge can be magnified. Many are hesitant to commit to local infrastructure or “boots on the ground” too early in their commercial journey. In such cases, choosing capable and compliant partners becomes even more critical.

3. Identifying and Qualifying Regional Distribution Partners

Partner selection is one of the most time-sensitive aspects of a successful market entry. Identifying and qualifying regional distributors, logistics providers, or local representatives takes time. From long-listing and short-listing to due diligence, contracting, qualification, and onboarding, the process requires many resources. 

We strongly recommend initiating partner search efforts early, well before commercial launch is on the horizon. Given the potential for delays in regulatory approvals or commercial and financial urgency, it’s vital to prevent supply chain readiness from becoming the critical path bottleneck. In many cases, compressing timelines becomes unavoidable, making early preparation essential to avoid high-risk or last-minute workarounds as initial buffers are exhausted.

4. Establishing Launch Workstreams

To manage the breadth of decisions and parallel tasks, we recommend organizing a launch team across four key workstreams:

  1. Supply Planning: Manage API sharing, manufacturing lead times, shelf-life requirements, and the establishment of a Sales and Operations Planning (S&OP) process.
  2. Production Readiness: Define SKUs and artwork specifications, meet local serialization and labeling requirements, and plan for production challenges.
  3. Logistics Management: Address product flows, licensing requirements, incoterms and supply risk and complexity.
  4. Distribution Partnership: Finalize partner selection, establish onboarding and ongoing management, and ensure commercial visibility.

These workstreams help surface and resolve tactical questions early. For instance, will a dedicated Saudi Arabia pack be created, or will a shared GCC pack be used with bilingual (English and Arabic) labeling? What are the country-specific shelf-life and stability requirements? Which temperature controls or packaging formats are required? Other important questions can be around the mode of transport (road, ocean, air) and applying / negotiating the right Incoterms 2020 – which may not always be obvious. Even small details can become critical bottlenecks. For example, expiry date formats differ by region – some cases may require month names (e.g. “MAR 2026”), other cases allow numeric-only formats. Ensuring your production line can accommodate both requirements is an essential consideration. 

Despite regional collaboration through the Gulf Health Council, country-specific requirements must be considered. These may include

  • Participation in local or national tender systems, often with specific branding
  • Shelf-life or serialization rules
  • Seasonality of demand
  • Requirements for local presence or packaging
  • Regulations around in-country testing or labeling

These issues require insight and flexible operations. Overlooking them can result in costly delays or rejected shipments. This is where local expertise, either in-house or through partners, makes a material difference.

Maturing Regulatory Landscape in Developing Countries

Luckily, developing countries are indeed developing, and regulators across the globe regularly collaborate and learn from one another. An example of a positive development across the GCC is the rise of serialization (or track-and-trace) capabilities. What was largely absent in 2010 is now a key regulatory requirement in many regions like the US, EU, Turkey, China, Korea, India, Brazil, and Argentina. In the GCC this is not any different. Serialization is seen as a cornerstone of supply chain security and is rapidly advancing in the region. While centralized guidelines established by the Gulf Health Council around serialization provide a harmonized framework, each member state retains unique requirements.

  • Saudi Arabia: The Saudi Food and Drug Authority (SFDA) leads the regional serialization effort and since 2018, mandates serialization across the full supply chain – including manufacturers, distributors, pharmacies, and hospitals.
  • United Arab Emirates: The Tatmeen track-and-trace platform enables national-level pharmaceutical safety, integrity, and reporting.
  • Bahrain: The National Health Regulatory Authority (NHRA) has adopted a phased approach to serialization and enforces the use of GS1 Data Matrix barcodes.
  • Kuwait: The Ministry of Health mandates full Data Matrix barcoding with GTIN, batch number, expiry date, and serial number. 
  • Oman and Qatar: These nations are progressing toward full implementation, though they are still in the early stages.

Even though the GCC acts as one region, the information above demonstrates that different regulations can be in place. Efforts by The Gulf Health Council (GHC) to unify requirements across the GCC – such as unified barcoding (as of September 2023) and the rollout of electronic patient information leaflets (e-PIL), reflect a broader drive toward regulatory alignment, increasing patient safety and digitalization. However, execution currently remains country-specific, and serialization strategies must be tailored accordingly. 

Summary: Practical Insights for Biopharma Leaders

Drawing on our direct experience supporting clients in GCC market entry, we conclude with several key recommendations:

  • Start Early and Plan Holistically: Incorporate supply chain into strategic market entry planning, not just post-approval execution.
  • Treat Each Market Individually: Despite regional collaboration, the GCC is not a single market. Each country requires a localized approach.
  • Build in Agility: Timelines shift, approvals get delayed, and local regulations evolve. Anticipating change and building flexibility in your approach will help you stay agile. 
  • Engage with Local Expertise: Don’t underestimate the value of local knowledge.  Interpretation is important to understand local and regional requirements.
  • Choose the Right Partners: invest time in partner evaluation. A mutual understanding is needed to make the partnership work effectively and can spell the difference between success and failure.

At AIM, we specialize in helping growing and emerging biopharma companies design supply chains that are fit-for-purpose from day one. Our cross-functional expertise, combined with hands-on experience in markets like the GCC, allows us to support companies in navigating unfamiliar geographies with confidence. To discuss the contents of this article, or to inquire about how AIM can help you plan for launch or expansion in a new market, please contact us. 

AIM publishes information and resources related to supply chains for a wide range of biopharma products. Please follow our LinkedIn page or visit our Insights page to stay up to date. 

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