AIM presents guide for biopharma expansion into the GCC region

For biopharma companies looking to grow, international expansion is key. A new white paper from boutique supply chain consultancy AIM lays out the critical supply chain and distribution considerations for expansion into the Gulf Cooperation Council (GCC) countries, an increasingly strategic region for biopharma.

The GCC countries (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the UAE) have in recent years invested heavily in diversifying their economies, with healthcare and pharmaceuticals emerging as priority sectors. Their growing focus on biopharma is creating new opportunities for collaboration, innovation, and market access in the region.

The GCC presents a unique mix of harmonized regional frameworks and country-specific complexities that make it both attractive and operationally challenging. Some of the appealing aspects to the GCC include favorable demographic trends, improved access to innovative therapies, and regulatory structure that encourage innovation.

“In the increasingly competitive and innovation-driven biopharma industry, growth is not only a strategic objective for companies, it’s also a necessity,” said Ronald van Zitteren, principal at AIM.

“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.”

For a GCC market entry strategy to be successful, there are several components that biopharma companies need to cover, according to AIM.

Mapping physical, financial, and information flows
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 includes input from various departments of an organization.

Some of the questions addressed through this process include:

• 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?

Developing a regulatory and operational roadmap

Once the foundational planning is complete, a detailed project roadmap should follow. It must factor national regulatory approval timelines, time needed for manufacturing, regional licensing, and partner contracting.

While the GCC countries share many similarities and the region is relatively well integrated, these countries each have their own import and documentation requirements. Subject matter expertise is essential to help interpret the requirements correctly and avoid any costly missteps.

Identifying and qualifying regional distribution partners

A successful market entry strategy will require a company to choose partners wisely. Identifying and qualifying regional distributors, logistics providers, and local representatives is a time-consuming process. It requires due diligence, contracting, and onboarding, among other steps.

Given the potential for delays in regulatory approvals or commercial urgency, it’s important to prevent supply chain readiness from becoming the critical path bottleneck. For that reason, AIM recommends that companies begin this process early, well before any commercial launch is scheduled.

Establishing launch workstreams

A launch team can help to manage all the decisions and parallel tasks at hand. AIM recommends organizing a launch team across four key workstreams: supply planning, production readiness, logistics management, and distribution partnership.

“These workstreams help surface and resolve tactical questions early,” said Corné van Raak, Principal at AIM. “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?”

The bottom line is that biopharma companies looking to expand into the GCC should start planning early and plan holistically. They should also stay agile because timelines shift and flexibility is key. Working with local expertise can be greatly beneficial and choosing the right partners can spell the difference between success and failure.