Market Access 2026: Global Expansion in a Fragmented World

When evaluating newly approved therapies, consider where pivotal trials were conducted. Drugs with China-initiated Phase I/II programs may reach US approval 12-18 months faster than EU-originated assets due to accelerated trial timelines and lower development costs.

This creates a counterintuitive reality: a therapy developed in Shanghai may become available to your patients before one developed in Basel, despite geographic proximity. Monitor FDA approval announcements for foreign-originated trials—these increasingly represent first-line treatment options.

Engagement Question:

Have you noticed differences in approval timelines based on where clinical trials were conducted? How does trial location influence your perception of evidence quality?

The characterization of Chinese pharmaceutical innovation as derivative has become obsolete. In 2019, Chinese companies launched 11 innovative drugs; by 2024, that number reached 46. More striking, China now leads development in bispecific antibodies, antibody-drug conjugates, CAR-T therapies, and GLP-1 receptor agonists.

This transformation stems from three converging forces: regulatory reform accelerating NMPA approvals, returned Chinese scientists establishing biotechs with Western training, and strategic government investment designating pharmaceuticals as critical infrastructure. Thirty-five percent of pharmaceutical licensing deals in 2025 originated in China, representing a fundamental rebalancing of global innovation sourcing.

The Geopolitical Complexity

Nearly 80% of surveyed US biotech companies now rely on Chinese manufacturing, creating supply chain vulnerabilities that extend beyond active ingredients to upstream innovation itself. The BIOSECURE Act, though not yet law, has prompted manufacturers to evaluate China+1 strategies—maintaining Chinese innovation partnerships while diversifying manufacturing.

Clinical Implications

Engagement Question:

How comfortable are you prescribing therapies where early-stage development occurred primarily in China? Does trial location influence your evidence assessment?

The European Health Data Space (EHDS) Regulation, entering force in 2027, creates the world's largest cross-border health data infrastructure. For pharmaceutical companies, the EHDS opens access to real-world health data under a clear legal regime, accelerating research and AI-based drug development.

For prescribers, this means:

1. Enhanced real-world evidence: Post-approval studies will leverage larger, more diverse patient populations.
2. Faster comparative effectiveness data: Multi-country registries will generate treatment comparison data more rapidly.
3. Improved clinical trial feasibility: Patient identification for trials becomes more efficient across borders.

The Compliance Trade-Off

Health data holders must submit dataset descriptions to national authorities by March 2029, with annual verification requirements. Companies face balancing transparency obligations with intellectual property protection—a tension particularly acute for clinical trial data.

Industry concerns center on how commercial access will be regulated and priced, with pricing models still unclear. This uncertainty may delay some manufacturers' European data-sharing commitments, potentially impacting the pace of post-marketing surveillance and real-world evidence generation.

Practical Considerations

1. Evidence timing: European real-world data may become available faster than US registry data due to EHDS infrastructure.
2. Patient opt-out rights: Some countries allow patients to opt out of secondary data use, potentially skewing evidence.
3. Cross-border consistency: National implementation variations may create data quality heterogeneity.

Engagement Question:

Would you value real-world evidence from European Health Data Space analyses when making treatment decisions? How does data source geography influence your confidence in evidence?

The Middle East and Africa pharmaceutical market is projected to expand from $85.27 billion in 2026 to $141.3 billion by 2034, with a CAGR of 6.52%—outpacing traditional Western markets. This growth reflects more than demographic expansion; it represents structural transformation through manufacturing localization and regulatory modernization.

Saudi Arabia's Biopharmaceutical Ambitions

Saudi Arabia established the Biopharma Valley project near Riyadh, a $2.5 billion initiative creating a biopharmaceutical cluster. The Saudi Food and Drug Authority has introduced fast-track biosimilar approval pathways aligned with EMA and FDA standards, signaling serious regulatory maturity.

Clinical Trial Expansion

Roche initiated multi-center clinical trials in Saudi Arabia and the UAE in November 2024 to evaluate next-generation cancer therapies, indicating major manufacturers view MENA not just as a market but as a viable trial location. This has direct implications for treatment availability—therapies tested in Middle Eastern populations may receive regional approval before Western authorization.

Late-Stage MENA-Relevant Assets

1. Hikma Pharmaceuticals: Preparing generic semaglutide launch as patents expire, targeting Middle Eastern obesity epidemic.
2. Eva Pharma: Manufacturing Eli Lilly's Olumiant for rheumatoid arthritis, distributing across 49 African countries from 2026.
3. Julphar: Expanding biosimilar insulin production in UAE, targeting regional diabetes burden.

Access Implications

For prescribers treating Middle Eastern or African patient populations, monitor regional approval pathways separately from FDA/EMA. Some therapies may receive MENA authorization first, particularly for diseases with high regional prevalence like diabetes and cardiovascular conditions.

Engagement Question:

Do you consider regional drug approvals outside US/EU when recommending treatments to patients from those regions? How do you assess evidence from MENA clinical trials?

— Analysis synthesized from Evaluate, Nikkei Asia, and IQVIA reports

What This Means:

This represents a fundamental shift in where novel mechanisms originate. In 2023 alone, 20 licensing transactions between China and the West exceeded $500 million each, with oncology, immunology, and cardiometabolic deals leading. Major pharmaceutical companies increasingly source early-stage innovation from Chinese biotechs rather than developing internally—a reversal of historical patterns where China in-licensed Western innovations.

The clinical consequence: patients gain faster access to novel mechanisms through accelerated Chinese development timelines, but prescribers face evaluating safety and efficacy data generated under different regulatory frameworks and patient populations.

A: FDA approval standards remain identical regardless of where early development occurred. A China-originated drug must complete US Phase III trials under FDA oversight to receive approval. The distinction lies in speed—Chinese Phase I/II programs often progress faster due to lower costs and streamlined NMPA processes, meaning US Phase III enrollment can begin 12-18 months earlier than comparable Western assets.

The evidence quality question centers on early-stage data. Some prescribers express concern about Phase I/II data generated under different regulatory oversight. However, FDA independently verifies this data during IND review before allowing US trials to proceed.

A: Potentially yes. Rare disease research particularly benefits from cross-border data pooling, as patient populations are too small within single countries for robust studies. The EHDS enables researchers to identify and aggregate rare disease patients across 27 EU member states, dramatically improving statistical power for real-world effectiveness studies.

The challenge: implementation timelines mean meaningful rare disease evidence won't emerge until 2029-2030 at earliest, as data infrastructure must be built first.

A: From a clinical standpoint, manufacturing location shouldn't influence initial prescribing decisions—quality standards apply globally. However, for chronic medications where supply continuity is critical, awareness of manufacturing concentration helps anticipate potential disruptions. China controls near-monopoly positions on certain active pharmaceutical ingredients, with some antibiotic APIs seeing 99% US import dependence.

Consider having contingency conversations with patients on chronic therapies: "Your medication is effective and we'll continue it, but I'm aware manufacturing is concentrated in a single region, so we'll monitor supply closely and have backup options identified."

https://www.evaluate.com/thought-leadership/chinas-biopharma-innovation-strategic-playbook/

This comprehensive analysis examines China's transformation from generic manufacturing to global innovation leadership, with specific focus on bispecific antibodies, ADCs, CAR-T therapies, and GLP-1 development. Particularly valuable for understanding deal structure trends and identifying which therapeutic areas show genuine first-in-class potential versus incremental improvement.

Additional Recommended Resources:

1. European Health Data Space Official Hub: Technical implementation guidance for healthcare providers (https://european-health-data-space.com/)
2. PwC's Pharma Deals Outlook 2026: Detailed analysis of cross-border licensing structures and valuation trends.
3. BioPharma Dive's China Licensing Deal Tracker: Real-time updates on China-West pharmaceutical partnerships.

Engagement Question:

What resources do you use to stay current on international pharmaceutical developments? How do you evaluate evidence from trials conducted outside traditional US/EU frameworks?