August 24, 2026, Shanghai — Hipro Biotechnology Co., Ltd. (“Hipro Biotech”) and SPH KDL (Shanghai) Pharmaceutical Co., Ltd. (“SPH KDL”) officially signed an Exclusive Strategic Cooperation Agreement in Shanghai. The two parties will focus on the global wellness sector and launch exclusive strategic collaboration for Hipro’s wellness‑oriented product portfolio, jointly exploring market opportunities across Europe, Southeast Asia and other overseas regions.
Under the agreement, SPH KDL, the import‑and‑export platform of Shanghai Pharmaceutical Holdings, will act as Hipro’s exclusive strategic partner for designated overseas territories. Leveraging its mature pharmaceutical supply‑chain capabilities, end‑consumer‑oriented channel resources and proven commercialization expertise, SPH KDL will deliver end‑to‑end support covering market access, customer development and business partnership engagement, enabling Hipro’s innovative diagnostic solutions to gain traction in global wellness markets.
Hao Shushun, Chairman of Hipro, and Xu Keda, General Manager of SPH KDL, attended the signing ceremony.
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The global in‑vitro diagnostic (IVD) industry for at‑home testing is at an inflection point with reshaping market dynamics. According to Kalorama Information, the global at‑home IVD market reached USD 28.1 billion in 2025 and is projected to hit USD 39.3 billion by 2030, representing a compound annual growth rate (CAGR) of 6.9%.
The COVID‑19 pandemic has significantly raised public awareness of self‑health management. Mass‑scale home‑based testing helped break down adoption barriers for household diagnostic products. As industry analyses note: “Pandemic‑era testing has demonstrated that diagnostic products can be reliably developed, regulated and delivered directly to consumers for safe at‑home use.”
Technological advances are transforming at‑home IVD from mere testing tools into wellness companions and entry points for digital health management. Innovations including minimally‑invasive and non‑invasive sampling, miniaturized devices, smartphone‑connected test results and AI‑powered result interpretation have become increasingly mature. Shifting consumer mindsets encourage a move from reactive medical treatment toward proactive health monitoring. Combined with digital health integration, supportive regulatory reimbursement policies worldwide, plus rising chronic‑disease burdens and aging populations, these factors collectively fuel robust growth for home‑use diagnostic markets.
Founded in 2006, Hipro has focused on the IVD sector for two decades with a commitment to original in‑house R&D. As a national‑level “Specialized, Refined, Differential and Innovative” enterprise, Hipro holds nearly 300 granted patents. Its core technological achievements include a globally‑original integrated sampling device, multi‑method fully‑automated immunoassay systems, triple‑quality‑control mechanisms and AI‑driven big‑data quality‑control platforms.
The company has obtained 76 EU CE certifications, 22 US FDA clearances and more than 100 NMPA registrations in China. Notably, its glycated hemoglobin assay received the first‑ever FDA 510(k) clearance for this product category among Chinese IVD manufacturers. Hipro’s business footprint covers all 34 provincial‑level administrative regions across China, with exports to over 120 countries and regions, serving more than 30 000 end‑user institutions worldwide.
Building on core competencies in microfluidics, artificial intelligence and precision sensors, Hipro has expanded into consumer wellness. Re‑engineered for household scenarios, its home‑focused products meet higher standards for sensitivity, stability and ease‑of‑use compared with professional‑grade clinical instruments. The company has built an integrated, user‑friendly digital precision‑testing portfolio, including fluorescence immunoassay analyzers, the ZOAN™ Home Test System and a digital wellness management platform. Its solutions address a wide range of home‑based testing needs covering cardiovascular health, diabetic‑kidney conditions, digestive health, infectious diseases, reproductive health and thyroid function.
SPH KDL is a comprehensive pharmaceutical supply‑chain service provider covering pharmaceuticals, medical devices and medical aesthetics products. It offers integrated import‑export, warehousing and logistics capabilities. Backed by Shanghai Pharmaceutical Group’s complete industrial ecosystem, nationwide distribution network, refined operational models and international compliance standards, SPH KDL delivers high‑quality business models, supply‑chain resources and full‑stack commercialization services for Hipro Biotech.
This strategic partnership brings complementary strengths: Hipro contributes innovative product R&D, smart manufacturing and global technical expertise; SPH KDL provides import‑export agency services, warehousing‑logistics infrastructure and localized channel networks. The collaboration will first roll out in Hong Kong and Macao SARs of China, delivering accessible, standardized and reliable IVD products and health services to local medical institutions, B‑to‑B clients and consumers.
“While continuing to serve professional IVD markets, Hipro is investing heavily in out‑of‑hospital monitoring, home‑use testing and chronic‑disease management for consumer wellness. Home‑based testing demands even higher product accuracy than clinical settings. Going global means far more than product exports — we aim to export complete companion‑diagnostic solutions worldwide,” commented Hao Shushun, Chairman of Hipro Biotech. “SPH KDL boasts extensive overseas medical‑device distribution networks and deep practical experience in consumer‑health cross‑border operations. Through this partnership, we intend to unlock new opportunities such as overseas home‑health monitoring and insurance‑linked wellness services, bringing simpler, more stable and accurate end‑to‑end health‑management solutions to global users.”
“China’s IVD industry is advancing toward high‑quality development. Hipro’s innovative track record exemplifies the vision and inventive spirit of leading domestic enterprises,” said Xu Keda, General Manager of SPH KDL. “We look forward to deepening our collaboration, exploring international pathways for integrated health‑management solutions, and bringing Chinese‑made diagnostic innovations to patients across the globe.”
Both parties have aligned detailed business plans covering corporate capabilities, product portfolios, market access, channel development, supply‑chain delivery and scenario‑driven business models. Hong Kong and Macao will serve as priority launch markets, Southeast Asia as a key growth region, while market entry into Europe and other territories will be pursued in parallel.
Hong Kong hosts more than 15 000 registered physicians, among whom approximately 8 300 primary‑care general practitioners represent core target customers for POCT solutions. Hipro’s handheld assay platform fits well for primary‑care clinics and pre‑hospital emergency scenarios to support rapid diagnosis and patient triage. Macao offers strong brand‑validation value: the partners plan to deploy Hipro’s “Good Morning” series of home‑test products through local pharmacy retail channels, validating commercial models for pharmacy sales and household health management.
Southeast Asia will be a key priority market. Cooperation will kick‑start via local agents with government‑level connections and robust end‑market access. The region demonstrates high receptivity toward CE‑marked medical products and solutions endorsed by leading Chinese pharmaceutical distributors, supporting the development of long‑term sustainable partner networks.
For Europe, market activities will be rolled out in phases according to regional regulatory requirements, channel landscapes and product fit, progressing through registration, pilot sales and scaled‑up commercialization.
The worldwide IVD sector is undergoing profound technological and business‑model transformation. Testing scenarios are extending beyond hospitals and laboratories into communities, pharmacies and private households, turning diagnostic tools into everyday wellness enablers.
Future industry success hinges on digital transformation, robust clinical value realization, resilient global supply chains and adaptive business models for consumer‑oriented testing. The strategic alliance between Hipro and SPH KDL represents a major step in response to these industry shifts. Together, the two partners will bring Chinese‑origin innovative IVD technologies to global markets and empower home‑based health management for people around the world.
