### **Overview** **Vivo Bio Tech Limited** is one of India’s most prominent and fully integrated **preclinical Contract Research Organizations (CROs)**, headquartered in Hyderabad, Telangana. Since its inception in 2009–2010, the company has evolved from a niche animal breeding provider into a **globally compliant, end-to-end preclinical research partner** for pharmaceutical, biotechnology, agrochemical, medical device, and FMCG firms. With a strong emphasis on regulatory compliance, scientific excellence, and scalable infrastructure, Vivo Bio Tech is strategically positioned to capture high-value outsourcing demand from both Indian and multinational innovators. --- ### **Core Business & Services** Vivo Bio Tech operates as a **full-service CRO**, offering a comprehensive suite of preclinical research services including: - **In-vitro & In-vivo Toxicology**: Safety assessment, genotoxicity, reproductive toxicity, inhalation toxicity, ecotoxicity. - **Pharmacology & Safety Pharmacology**: Efficacy testing, disease modeling (especially oncology), and system-specific safety evaluations. - **ADME / DMPK Studies**: Pharmacokinetics (PK), toxicokinetics (TK), absorption, distribution, metabolism, and excretion profiling — now expanding into **large animal models**. - **Analytical & Bioanalytical Services**: Including LC-MS/MS platforms, immunoassays (ADA/NAb), cytokine profiling, qPCR/ddPCR for biologics and nucleic acid therapeutics. - **Medical Device Testing**: Biocompatibility (ISO 10993), implant safety, long-term toxicity, and regulatory support under **US FDA, EU MDR, CDSCO**. - **IND-Enabling Studies**: Integrated packages for Investigational New Drug (IND) submissions to FDA, EMA, PMDA, and CDSCO, covering toxicology, PK/PD, safety pharmacology, and pathology. - **Specialized Capabilities**: Organ-on-chip platforms, 3D cell cultures, AI-assisted pathology, surgical models, and chronic disease studies. - **Late-Stage Drug Discovery**: Formulation development, disease modeling, imaging, and efficacy testing. - **Clinical Trial Support**: Partnerships enable Phase I–III clinical trials and Phase IV pharmacovigilance. The company is actively transitioning from a **"study vendor" to a "program-level IND-enabling partner"**, integrating toxicology, bioanalysis, regulatory writing, and pathology into unified drug development programs. --- ### **Key Strategic Advantages** #### 1. **World-Class Infrastructure** - Operates a **150,000 sq. ft. GLP-compliant preclinical research facility** on a **53-acre campus** in Pragnapur, Siddipet District — **the largest dedicated preclinical CRO facility in India**. - Houses **biosecure vivariums**, **surgical suites**, **pathology labs**, and advanced analytical instrumentation. - Owns land and facilities that allow **long-term scalability**, distinguishing it from space-constrained competitors. #### 2. **Regulatory Compliance & Accreditations** - Holds multiple global certifications: - **OECD GLP** - **AAALAC International Accreditation** (since 2011) - **CPCSEA Registration** - **ISO 9001, ISO 17025** - Compliance with **US FDA, EMA, CDSCO, OECD** standards. - This ensures **global regulatory acceptance** of its study data and builds **client trust and stickiness**. #### 3. **Species Capability & Animal Models** - **Small Animals**: Rats, mice, rabbits, hamsters, guinea pigs. - **Large Animals**: Dogs, sheep, goats, mini-pigs, pigs — operational since **January 2025**. - **Future Expansion**: **Non-Human Primate (NHP) studies** under development — a high-barrier, high-margin segment critical for biologics, gene/cell therapies, and complex vaccines. - **SPF Rodent Breeding**: India’s **only commercial supplier** and **largest breeder/distributor** of Specific Pathogen-Free (SPF) rodents. - Proprietary **Knockout Repository** with >4,000 genetically modified lines. - Partners with **Taconic Biosciences (USA)** and **Cyagen Biosciences** for advanced models. - Distributor for **Special Diets Services (UK)** and **SAFE Diets (France)**, ensuring premium nutrition. #### 4. **Strategic Global Partnerships** - **Taconic Biosciences**: Authorized Indian distributor for SPF rodent models. - **Cyagen Biosciences**: Provides Indian researchers access to custom transgenic and genome-edited models; distributor since 2016. - **Elm Hill Labs (USA)**: Source for SPF guinea pig breeders — first commercial distributor in India. - These alliances position Vivo Bio Tech as a **gateway for global research tools in India**. #### 5. **Diversified Client Base & Revenue Streams** - Serves **200+ clients** across pharma, biotech, agrochemical, medical devices, FMCG, and diagnostics. - Revenue sources include: - **Fee-for-service**, **milestone-based**, and **project-based** contracts. - Long-term outsourcing agreements with **U.S. and European multinationals**. - **Revenue diversification** across sectors reduces cyclicality and enhances stability. #### 6. **Cost Advantage with Global Quality** - Leverages **India’s skilled workforce** and **lower operational costs** to deliver high-quality studies at **30–50% lower cost** than U.S./EU CROs. - Ideal destination for **outsourced IND-enabling studies** and high-complexity research. --- ### **Financial & Operational Highlights** - **Workforce**: Over **140–300 scientific professionals**, including toxicologists, veterinary pathologists, molecular biologists, and lab technicians. Team includes experts certified by the **American Board of Toxicology**. - **Leadership**: - **Chairman**: Mr. Sunder Kanaparthy - **Dr. Alangudi Sankaranarayanan**: Veteran with 35+ years in pharma R&D, >30 patents, 70+ publications. - **CFO**: Mr. Sri Kalyan Kompella — expertise in healthcare infrastructure and quality systems. - **Funding & Investment**: - Raised **₹18.17 Crores from Canara Bank (Aug 2021)** for an end-to-end drug discovery platform. - Invested in large animal facility via internal accruals and debt; now operational. - **Revenue Drivers**: - First agrochemical data contract worth **₹10.5 Crores (Sep 2025)** — a strategic breakthrough. - Major **medical device testing contracts** secured with global players. - **U.S.-driven project growth** at **~20% CAGR**. --- ### **Market Opportunity & Competitive Position** - **Global CRO Market**: Valued at **$28 billion by 2026** (6% CAGR); rising R&D costs ($2.18B per drug) and low pharma R&D returns (<2%) are driving **outsourcing growth**. - **India’s Role**: Emerging as a **cost-competitive, OECD-GLP-compliant hub** for preclinical research. - **Competitive Moats**: - **High barriers to entry** due to capital, time, regulatory approvals (2-year track record requirement for GLP). - **Unique infrastructure ownership** (land, facilities). - **Client stickiness** from regulatory continuity and data confidentiality. Vivo Bio Tech is **one of the few Indian CROs** capable of end-to-end IND-enabling services. With expansion into large animals, NHP, and bioanalytics, it is positioned to become **India’s leading fully integrated preclinical CRO**.