Scaling Globally: What Life Sciences Executives Need to Know Before Entering New Markets

For life sciences companies, scaling into new geographies isn’t just about chasing market size - it’s about navigating complex regulatory environments, cultural and talent challenges, supply chain fragility, and doing so in a way that sustains innovation. CEOs, COOs, and Chief Commercial Officers must lead with a blend of strategic ambition and operational discipline. Below are key levers to pull (and caution flags to watch) on the road to successful global expansion.

 

Assessing Market Viability & Regulatory Hurdles

Before opening a new market, rigorous due diligence is non - negotiable.

·         Regulatory alignment: Understand how your product or service maps against different regulatory authorities - FDA in the U.S., EMA in Europe, PMDA in Japan, etc. Requirements around clinical trials, safety data, GMP (Good Manufacturing Practices) standards, labelling, and post - market surveillance can differ significantly. Misalignment here can lead to costly delays or outright rejection.

·         Regulatory harmonisation and divergence: Sometimes what’s accepted under EMA does not satisfy FDA, and vice versa. For example, differences in requirements for orphan drug designations, accelerated approval pathways, or data exclusivity may make or break the economics of market entry. Life sciences firms should build a regulatory roadmap that anticipates these differences (or even mismatches) and builds in lead time for bridging data or certifications.

·         Market size vs. market accessibility: Even if demand is large, access barriers (customs, import restrictions, pricing & reimbursement, intellectual property protection) can erode viability. Two markets might look similar on paper, but one may impose heavy tariffs or require expensive registration procedures, or may have weak IP enforcement.

·         Reimbursement and health systems: Gaining regulatory approval is only half the battle. Getting paid is equally challenging. Understanding local health systems, pricing regulation, reimbursement pathways and payor expectations is essential. What works in a private healthcare - oriented market might not translate to countries with socialised medicine.

 

Building Cross - Border Teams & Partnerships

Scaling globally is not just about entering new geographies - it’s about building capability in them.

·         Local expertise: Hire or partner with people who know the region - regulatory consultants, clinical trial experts, market access specialists. Local regulatory agencies often respect submissions that involve locally - knowledgeable teams. Cultural understanding helps in tailoring messaging, navigating relationships, and avoiding missteps.

·         Strategic partnerships: In many instances, collaboration with local manufacturers, CROs (contract research organisations), distributors or even local biotech firms is critical. These partnerships help bridge regulatory, logistical, and cultural gaps. For example, using a local distributor who knows how to navigate import regulations and relationships with regional health authorities can fast - track market entry.

·         Hybrid operating models: Many globalising life sciences firms maintain a mix of centralised R&D and regulatory strategy, combined with decentralised commercial operations. The COOs often spearhead building regional hubs that are empowered (but aligned) with central oversight for quality, brand, compliance, etc.

 

Managing Supply Chain Resilience in a Post - COVID World

The pandemic exposed how fragile global supply chains can be; life sciences companies are especially vulnerable due to the need for raw materials, cold - chain logistics, cross - border shipping, and specialised manufacturing.

·         Diversified sourcing: Don’t rely on a single source of raw materials, APIs, or components. Seek alternative suppliers across regions or consider dual/backup suppliers even if they’re more expensive, to ensure continuity.

·         Regulatory compliance for manufacturing/supply nodes: If your global expansion requires local manufacturing or packaging, be sure those facilities meet the regulatory standards of all your target markets (e.g., achieving FDA, EMA inspections). It’s often more complex (and more expensive) than anticipated.

·         Logistics & cold chain robustness: Especially for biologics, vaccines, or temperature - sensitive products, shipping, storage, and handling standards need to be maintained end - to - end. Delays or lapses can ruin product efficacy or lead to regulatory non - compliance.

·         Risk modelling & contingency planning: Include geopolitical risk, trade policy changes, border closures, customs delays, etc., in your expansion plan. Many companies now run “stress tests” or scenario planning for disruptions - e.g., how would operations be affected if a key shipping route is blocked, or raw material suppliers in a region are shut down due to regulatory or natural disaster reasons.

 

Case Studies: Biotech & Medtech That Scaled Successfully

Real examples help ground theory in practice:

·         Dr. Reddy’s Laboratories (India): Initially focused on supply of active pharmaceutical ingredients (APIs) and generic drugs to less regulated markets, Dr. Reddy’s progressively built manufacturing plants that satisfy stringent regulatory regimes (e.g., FDA inspections) enabling export to the U.S. and Europe.

·         Catalent: A service provider spanning drug delivery, biologics, gene therapy & more, Catalent established facilities across continents, aligning manufacturing and quality systems in all sites so that they meet multiple regulatory regimes, enabling both speed and regulatory compliance in multiple markets.

·         Novartis: As a global pharma giant, Novartis demonstrates how careful planning across regulatory, commercial, and manufacturing domains allows it to enter emerging markets with localised hubs, along with strategic M&A to fill capability gaps (for example, acquiring or partnering to access local manufacturing or regulatory strength).

These examples show that successful scaling often involves incremental steps - first establishing regulatory compliant factories or partnerships, then moving into full commercial launch with local teams and supply chains.

 

A Decision - Making Framework for C - Suite Strategy

To bring all this together, executives can follow a phased decision - making process when considering new market entry. It begins with market selection, evaluating which geographies offer a balance of strong demand, favourable regulatory regimes, intellectual property protection, and viable reimbursement potential. Next comes regulatory and compliance planning, where leaders must map out which authorities - such as the FDA, EMA, or local agencies - govern approvals and what certifications, inspections, or trials will be needed. From there, operational and supply chain setup becomes critical, including assessing whether to source or manufacture locally, choosing reliable suppliers, and meeting global quality standards.

The next stage focuses on commercial and cultural adaptation - hiring local talent, tailoring branding and market access strategies, and understanding local cultural nuances. Alongside this, executives must build risk and contingency plans to anticipate disruptions like political instability, trade policy changes, or logistics challenges. Finally, throughout execution, leaders should establish a feedback loop with clear KPIs to monitor time - to - approval, launch costs, and sales metrics, adjusting as needed to ensure long - term success.

 

Scaling Means Strategy

For life sciences executives, scaling globally is a strategic imperative - particularly in a world where access to international markets, global trials, wider patient populations, and diversified revenue streams can greatly amplify value. But ambition alone won’t deliver. It requires carefully charted regulatory paths, resilient supply chains, local relationships, and operational flexibility. When done well, global expansion doesn’t just multiply reach - it strengthens a company’s ability to innovate, absorb shocks, and sustain growth in changing global environments.