Brief
한눈에 보기
- Biopharma companies have typically assumed molecules can be marketed globally. While biology remains borderless, other factors are fragmenting the global model.
- Shifts in policy, regulation, clinical assessments, pricing, and supply chains are pressuring companies to “unbundle” from the global market and align with regional or political peers.
- Leaders must revisit go-to-market assumptions and make challenging trade-off decisions about how to operate in a multipolar market.
The “one world, one molecule” strategy for pharma is evolving. Multiple factors are driving this shift, including:
- International referencing and recognition. Policies like international reference pricing are linking markets and creating tension for biopharma companies that historically managed product life cycles independently in each country.
- Supply chain realignment. Pharmaceutical supply and localization have become policy focuses to support domestic industry, biosecurity, and resilience. For example, Europe’s Critical Medicines Act favors EU-based production, and the US government has pushed for domestic manufacturing in most-favored-nation negotiations.
- Approval and access requirements. While efforts like the EU Health Technology Assessment Regulation aim to harmonize clinical assessments across member states, they may drive further differentiation between countries operating within or outside their jurisdiction.
- China’s development. China has emerged as a significant innovation hub in both discovery and development (see Figure 1). It also demonstrates a clear preference for domestic products on the National Reimbursement Drug List. Together, China’s innovation ecosystem and commercial markets have the potential to become a distinct biopharma market with different dynamics and products than the rest of the world.
Biopharma is facing a multipolar world where different markets require substantially different approaches. This gives rise to challenging questions: which markets to pursue, how to balance economics and patient access, and how to make effective decisions across multiple markets.
Reorganizing for multipolarity
Biopharma companies are evolving their traditional, globally focused strategies to address these shifts. As global markets rebalance, organizational structures must evolve to match. Biopharma companies could pursue:
- Geographic autonomy. Major markets operate independently, with separate pipelines, development programs, and commercial models tailored to specific economic and regulatory standards.
- Global integration with explicit governance. Organizations continue to compete globally by adopting rigorous governance structures to arbitrate complex trade-offs, such as whether to prioritize a region’s economics or access.
- Differentiated market entry. Instead of managing regional variations reactively, companies pursue trial designs, molecules, or commercial processes that match each market’s competitive or clinical profile from the start. For example, a firm might develop a specific version of an asset to meet a certain market’s pricing boundaries or clinical standards.
Building strengths around multipolarity
Navigating new regional alignments requires more than an updated org chart; it requires building new organizational muscles—from decision-making frameworks and data foundations to localized China strategies and global innovation sourcing.
Decision-making frameworks
Firms need new decision-making frameworks to assess explicit, asset-by-asset trade-offs. This involves calibrating every stage of development—from trial design to commercialization—against local regulations, data submission requirements, and access pathways. This requires a fundamentally new framework—not something that can be layered onto existing US-focused processes.
Data foundations
Resilience requires stronger data and artificial intelligence (AI) foundations than most firms possess today. Companies must be able to generate, integrate, and act on market-specific evidence that satisfies multiple national regulatory submissions and reimbursement dossiers simultaneously. In addition, data collection and trial design must reflect the patient populations who will depend on these therapies from the start.
China strategies
For multinational corporations and established biopharma firms, a meaningful presence in China represents a significant and growing opportunity—both commercially and in reaching a large, underserved patient population. Success here requires end-to-end design, not a regionalized commercial strategy. Trials must integrate in-country populations from the start, and commercialization capabilities need to function independently of Western operations.
Innovation sourcing
Finally, as R&D returns compress, firms must find new ways to innovate. One solution is to broaden innovation sourcing into regions like Japan, South Korea, India, and Singapore. By accelerating AI adoption and establishing research hubs in emerging markets, companies could compress delivery timelines and improve development economics.
Multipolarity is forcing a strategic moment
The status quo is being replaced by a more complex reality, and further market fragmentation may be ahead. Biopharma leaders are adjusting their portfolios and operating models now—but because the pace of change is accelerating, how rapidly they adapt will be the defining capability of the future.
The authors would like to acknowledge and thank the broader team that contributed to this point of view, including Brittany Rodriguez, Kristin Moneyron, Kusha Korla, Vipresha Jain, Anirudh Mishra, and Anusha Prasad.