2026从准入到蓬勃发展：体外诊断产品出海如何创领全球健康洞察报告 (英文版)

A CREATInG Initiative Insights Report The CREATInGinitiative Commissioned by the Gates FoundationCoRE and Duke-Kunshan collaborative project toEnableAccessToIn-vitro diagnostics forGlobal health needs The CREATInG Initiative was commissioned by the Gates Foundation to bridge innovation,regulation and access, aiming to accelerate the time to market for in-vitro diagnostics (IivD) tomeet critical global health needs in infectious diseases and maternal and foetal health. Thisproject is co-led by the Duke-National University of Singapore (NUS) Medical School Centre ofRegulatory Excellence (CoRE) and Duke Kunshan University (DKU) Global Health Program The project: . Facilitates regulatory dialogue among IvD manufacturers and regulators in Asia to acceleratemarket access of essential IVD for Low and Middle-Income Countries (LMIC). • Develops executive strategic leadership skills and deepens regulatory knowledge fordiagnostics manufacturers in China to align and comply with global regulatory requirementsandstandards.. Supports the Gates Foundation EDGE* Team's core strategic pillar to develop manufacturingcapability of affordable diagnostics.(* Enterics, Diagnostics, Genomics& Epidemiology) Additional details: Contents StrategicOverview1 Global Health as the Next Frontier2 Horizon Scanning: Trends and Insights (2026-2030)4 Opportunities5 Opportunities from Emerging Markets for Innovative IVD Solutions5Policy Support as a Key Enabler of Product Innovation in China6Facilitated Regulatory Pathways into Key International Markets6 Challenges in Pursuing a Global Expansion Strategy RegulatoryChallenges9Access Challenges and Strategies to Overcome Them9 Southeast Asia as a Regional Bright Spot11Potential Global Target Markets11 BlueprintforAccesstoGlobal Markets13 Major Southeast Asian Markets13OtherGlobal Markets14 Sustaining Growth After Market Entry16 Acknowledgements20 Strategic Overview New global realities and a changingregulatory landscape are challenging theconventional models to enter internationalmarkets,prompting companies to seekalternate pathways for global businessexpansion.This Reportaimstoprovidesenior business leaders of China-basedin-vitro diagnostics (IVD) companies withinsights to access international markets,with a focus on addressing the global healthneeds in infectious diseases and maternaland child health. Challenges in Pursuing a GlobalExpansion Strategy Regulatory considerations are thepredominant challenge for global marketpenetration by diagnostic manufacturers.Capacitybuildingofregulatoryknowledgeand skills can help bridge regulatory gaps,particularly in areas such as market entryand quality production. Incorporatingastute regulatory strategies into theoverall business strategy allows efficientmanagement of regulatory complexitiesand timelines and improve the chances ofsuccess in market access. The Insights Report will discuss:1.Horizon Scanning: Trends and Insights(2026-2030)2.Opportunities in the Global IVD market3.Challenges in Pursuing a Global ExpansionStrategy4.Blueprint for Access to Global Markets Sustaining Business Growth To sustain growth, IVD solutions willhavetoprovidevaluetolocalhealthcaresystems. Innovative, bespoke and locallyintegrated IVD solutions informed by adeep understanding of the needs of thetarget market will be crucial for continuedbusiness relevance. Horizon Scanning: Trends and Insights Affordable and innovative point of carediagnostics are changing the delivery ofpublic health programmes and clinical carein emerging markets. These innovative IVDsolutions are adaptable for decentralisedtesting and are likely to be automated,molecular based and digitally integrated. Blueprint to Access Global Markets Southeast Asia is a bright spot with growthopportunities despite global economicuncertainties. This presents an opportunityto use the region as a launchpad into otherglobal markets including the Global South.Facilitated regulatory pathways includingthose that leverage approvals by StringentRegulatory Authorities (SRA) from Australia,Canada, European Union, Japan, Singaporeand the United States of America couldaccelerate access into emerging markets. Opportunities Demand from emerging markets couldbe the next major growth engine for IVDcompanies, as these markets seek cost-effectiveandinnovativeIvDsolutionstosupport national public health programmes.In addition, Chinese government initiativessuch as the 15th Five-Year Plan for Economicand Social Development (2026-30) andBelt and Road Initiative provide strategicguidance to advance trade and two-wayinvestment withforeigncountries.Theseinitiatives deepen South-South cooperationand create favorable policy conditions forChina-based IVD companies to expand tooverseas markets. Furthermore, regulatoryreforms to align with internationalstandards and participation in regulatorycooperative mechanisms are creatingnew pathways for market entry into keyinternational markets. Looking ahead, new busin