### **Overview** 3B Blackbio DX Ltd (formerly Kilpest India Limited) is a leading Indian biotechnology company that has strategically transitioned from an agrochemicals focus to become a prominent player in the global molecular diagnostics sector. The company specializes in the design, development, manufacturing, and commercialization of high-quality in vitro diagnostic (IVD) products under its primary brands: **TRUPCR®** (qPCR), **TRUNGS®** (Next-Generation Sequencing), and **TRURAPID®** (lateral flow assays). With a strong R&D foundation and ISO 13485:2016 certification from BSI (UK), the company delivers innovative diagnostic solutions for infectious diseases, oncology, genetic disorders, and antimicrobial resistance (AMR). --- ### **Strategic Business Model & Innovations (Nov 2025)** - **Reagent Rental Model**: The company has introduced an **automated DNA/RNA extraction system** offered under a **reagent rental model**, requiring long-term contracts and exclusive use of 3B Blackbio’s proprietary reagents and consumables. This model ensures: - Reduced upfront costs for customers - Predictable operating expenses - Enhanced customer retention via guaranteed reagent supply - End-to-end support including installation, application training, and after-sales service This model contributes **20%–25% of total revenue** and includes over **15 active contracts**, providing a stable, recurring revenue stream. - **Sales Mix in India**: - **5%–7%**: Government/Institutional Tender Sales - **20%–25%**: Reagent Rental Model - **65%–70%**: Direct Product Supply to Labs & Hospitals The company maintains a **liberal credit policy** to retain customers but plans to gradually reduce debtor levels. --- ### **Global Expansion & Presence** - **International Footprint**: Products supplied in **over 70 countries**, serving more than **200 global customers**. - **Export Growth**: Projected at **20–25%** for FY 2025–26, driven by: - High-quality, regulatory-compliant product portfolio - Fast delivery to European markets - Responsive technical support - **Export Distribution**: - **45%** Europe - **25%** Middle East - **25%** APAC - **5%** Rest of World (With expected shifts due to new market entries) - **Registration & Market Access**: New regulatory approvals in Africa; average 10–15 month timelines for market entry across geographies. --- ### **Subsidiaries & International Operations** - **TRUPCR® Europe Limited (TPE), Manchester, UK**: - Key strategic subsidiary supporting "Made in UK" branding - Fully integrated facility with sales, marketing, technical support, and R&D - Achieved over **90% YoY revenue growth in FY 2024–25**, with **20–25% growth projected in FY 2025–26** - Sales rose from GBP 133K (Q3 FY24) to **GBP 417K (Q3 FY25)** - ISO 13485 certified, ensuring regulatory alignment with EU markets - **Acquisition of Coris Bioconcept SRL (Belgium)**: - Acquired 100% stake in August 2025 for **£2.765 million** (upfront £2.15m + earn-out) - Formerly a 30-year-old IVD manufacturer specializing in **rapid lateral flow tests**, including: - **HAT Sero K-SeT** (global monopoly for detecting African sleeping sickness) - Antibiotic resistance markers (AMR), respiratory and gastroenteric pathogens - Expected to become **EBITDA positive by FY2026–27** - Strengthened 3B Blackbio’s position in AMR diagnostics and enables: - Cross-selling of PCR kits via Coris' distributor network - Integration of rapid diagnostics with molecular testing - Expansion into the U.S., Canada via FDA approval pathway - Management forecasts **€7–8 million in annual revenue within 2–3 years** with 10%–15% EBITDA margins. --- ### **R&D & Innovation Strength** - **R&D Team**: Highly experienced scientists including Ph.D.s and M.Sc.s in: - Assay design - Molecular diagnostics - Bioinformatics - 8–10 years of tenure, enabling rapid development (e.g., completed Monkeypox test in 30 days) - **Technology Platforms**: - **qPCR**: Over **120 commercially available CE-IVD & Indian IVD PCR assays** – the largest such portfolio in India - **NGS (TRUNGS®)**: - *TRUNGS® Solid Tumor Panel*: Detects lung, colorectal, breast, liver, ovarian cancers - *PAN-MYELOID Panel* (65 genes) - *BRCA Plus Kit*, *Endometrial Cancer Panel* - Focus on niche, regulated cancer testing; gradual revenue build due to early-stage market - **Digital PCR (dPCR)**: - Under development; launches expected in **Q2–Q3 FY2025–26** - Enables absolute nucleic acid quantification for precision diagnostics - **Lateral Flow (TRURAPID®)**: - Fully operational manufacturing with **CDSCO approval** - New AMR rapid tests under development (e.g., RESIST-5 OKNVI for carbapenem resistance) - Addresses global AMR crisis (~5 million deaths in 2019; $100T economic threat by 2050) - **Flexible R&D Framework**: - Enables rapid response to emerging threats (pandemics, AMR) - Real-world data used to refine assay sensitivity, specificity, and workflow efficiency - In-house enzyme production enhances self-reliance; only **5.5% raw materials imported** --- ### **Market Position & Financial Highlights** - **Indian Molecular Diagnostics Market**: - Estimated **TAM: ₹350–450 crore** - **Company’s Market Share: 12%–15%** (among top leaders) - Industry CAGR: **8%–10%**; company targets **15%–20% growth (FY25–26)** - Growth drivers: Aging population, lifestyle diseases, government healthcare projects - **Revenue & Growth**: - FY 2023–24 Revenue: **₹7,412.47 lakh** - FY 2024–25 Revenue: **₹9,646.86 lakh** - MDx Division grew **~18% Q1 FY25 YoY** - **Non-COVID exports** up **97%** (excluding pandemic sales) - **Manufacturing & Capacity**: - Fastest large-scale production capacity in India - Average capacity utilization: **~65%** (spikes during seasonal outbreaks) - **Quality & Compliance**: - ISO 13485 certified in **India, UK, and Belgium** - GMP-compliant and CDSCO-licensed - First Indian company to receive **US FDA EUA for a COVID-19 test (June 2020)** --- ### **Unique Competitive Advantages** - **Only global molecular diagnostics company integrating**: - **Rapid diagnostics (lateral flow)** - **qPCR platforms** - **NGS-based solutions** - **End-to-end innovation**: All assays in-house developed (0% royalties or imported kits) - **"Made in India" and "Made in UK" dual manufacturing strategy** enhances regulatory credibility and global appeal - **Strong brand recognition**: National MSME Award (2018), in Forbes India DGEMS 2023 (Top 200 global potential companies) --- ### **Strategic Priorities (2025–26)** 1. **Increase market penetration**: Expand product portfolios within existing customer base 2. **Geographic expansion**: Appoint new channel partners in LATAM, Africa, APAC, Europe 3. **Product development**: Launch new panels in oncology, syndromic testing, and AMR 4. **Inorganic growth**: Actively pursuing M&As in EU and USA; funds also allocated to Manchester JV 5. **Participation in key global trade events**: - **MEDICA 2025** (Düsseldorf): To showcase EU-compliant products and strengthen European partnerships - **HAEMATOCON 2025**, **MICROCON**, **MEDLAB Middle East**: Enhance brand visibility and clinician engagement 6. **Global tenders & annual rate contracts**: Secured in Middle East, Southeast Asia, Europe --- ### **Risk Management & Challenges** - **Geopolitical Risks**: Exposures in Middle East and Ukraine; mitigated by diversified market presence - **Market Competition**: Rising pressure from new entrants and "sample-to-answer" automation systems - Countermeasures: Higher-value applications (viral load, pharmacogenomics), fast QC support, reagent contracts - **Supply Chain**: Managed via safety stocks and stringent supplier agreements - **Regulatory Hurdles**: Ongoing product registrations across emerging markets