### **Overview** AstraZeneca Pharma India Ltd. is a science-led biopharmaceutical company headquartered in Bengaluru, with over 45 years of presence in India. Established in 1979, the company employs more than 620 people and operates as a single business segment focused on discovering, developing, and commercializing innovative prescription medicines across key therapeutic areas: **Oncology, Biopharmaceuticals (CVRM and Respiratory), and Rare Diseases**. It also provides clinical trial coordination and marketing support services to its global parent. The company follows a **“Growth Through Innovation”** strategy, positioning itself as a market shaper by advancing transformative therapies and pioneering science-driven solutions. In FY 2024–25, AstraZeneca generated **₹1,700 crore (USD 200 million)** in revenue from operations, with product sales up **33.4% YoY**, rising from ₹1,205 crore in FY 2023–24. This robust growth propelled it from rank #44 to **#40 in the Indian Pharmaceutical Market**, making it one of the **fastest-growing MNCs by revenue**. --- ### **Therapeutic Business Segments** #### **1. Oncology – The Core Growth Engine (69.5% of Total Sales)** - AstraZeneca's oncology business accounted for **69.5% of total sales** in FY 2024–25 and grew **49% YoY**, making it one of the **fastest-growing oncology companies in India by value**. - It ranks among the **top five oncology pharmaceutical companies** in India (IPSOS MAT data). - Key commercial strategy pillars: - Launching transformative medicines - Strengthening expertise in priority tumor types - Driving superior patient outcomes - Therapeutic focus: **Lung, Breast, Gastrointestinal (GI), Genitourinary (GU), and Gynecological cancers**. **Key Oncology Brands & Developments:** | Product | Indication & Updates | |--------|----------------------| | **Tagrisso (Osimertinib)** | Standard of care for **EGFR-mutated NSCLC** (advanced and early-stage resectable). Largest oncology brand by sales; ranks among **top 5 oncology brands in India**. | | **Imfinzi (Durvalumab)** | Key brand in **NSCLC and SCLC**, with strong growth. Expanding into **Hepatocellular Carcinoma (HCC)** via HIMALAYA regimen and **Biliary Tract Cancer (BTC)** via TOPAZ-1. Among India’s top 5 oncology brands. | | **Enhertu (Trastuzumab Deruxtecan)** | Launched January 2024 for HER2+ metastatic breast cancer; became a **Top 10 oncology brand within a year**. Also approved for **HER2-low breast cancer (DB-04 trial)** and **HER2+ gastric cancer**. Approved in March 2024 with Breakthrough Therapy Designation by US FDA. | | **Lynparza (Olaparib)** | Market-leading brand in **ovarian cancer**. Lost patent exclusivity in India (March 2024), resulting in **generic competition and expected market share erosion**. Continued focus on utilization in **earlier-line settings and diagnostic alignment**. | | **Zoladex, Koselugo, Imjudo (Tremelimumab)** | Part of pipeline for GU/Gynae cancers and combo regimens (e.g., HIMALAYA). | - **Recent Oncology Approvals & Pipeline:** - **ADRIATIC (SCLC)** and **AEGEAN (NSCLC)** – New indications for early-stage lung cancer. - 11 regulatory approvals secured since 2023 across oncology and other areas. - Active pipeline includes next-generation therapies and modalities targeting multiple stages of GI, liver, and endometrial cancers. --- #### **2. Biopharmaceuticals – Driving Innovation in Chronic Diseases** This vertical covers **Cardiovascular, Renal, Metabolic (CVRM), Respiratory & Immunology**, and infectious disease prevention. It contributes significantly to revenue and has shown resilience despite generic competition. **Cardiovascular, Renal & Metabolic (CVRM):** - Focus on **disease modification, early intervention, and remission** in interrelated conditions. - **Brilinta (Ticagrelor)**: Despite losing market exclusivity in 2019 and facing over 40 generic competitors, Brilinta remains the **market-leading oral antiplatelet drug**, growing at **double-digit rates** in FY 2024–25. - Sustained growth due to physician education, cath lab penetration, and emphasis on potent antiplatelet therapy. - **Forxiga (Dapagliflozin)**: Leading brand in SGLT2 inhibitor class, maintains **#1 value share** despite over 350 generic versions. - Approved for **Type 2 Diabetes, Heart Failure (HFrEF & HFpEF)**, and **Chronic Kidney Disease (CKD)** — making it a multi-indication asset. - Growing 13% in private segment (5/10mg); focus on **use beyond diabetes**. - India was among the first countries to approve Forxiga for HF and CKD, reinforcing the company’s leadership in science-led label expansions. - **CVRM Strategy:** Leverage shared pathophysiology to halt progression and aim for remission. - **Project HeartBeat**: AI-powered ECG initiative using InstaECG devices. Screens patients across 37 hubs and 150+ remote centers. To date, **189,000+ patients screened**, **13,000+ critical MI cases identified and treated**. - Digital campaigns: #BeyondSugar, #HeartMitra reached **12 million users**. **Respiratory & Immunology:** - Portfolio: **Asthma, COPD, Severe Eosinophilic Asthma (SEA)**. - **Fasenra (Benralizumab)**: Top-selling **respiratory biologic in India** by value. Used in SEA, reduces reliance on oral corticosteroids. - Over 400 patients enrolled; high HCP acceptance. - Being evaluated for new indications. - **Breztri Aerosphere**: Fixed-dose triple-combo inhaler for **COPD maintenance**. - Launched January 2025 with proprietary **Aerosphere™ pMDI technology** (~50% lung deposition efficiency). - Clinically proven to **reduce mortality and exacerbations**. - Rapid uptake: **>1,500 patients initiated in Q1 2025**. - **Symbicort (Budesonide/Formoterol)**: - Fast-growing ICS/LABA inhaler. - Growth accelerated to **48% via exclusive distribution partnership with Mankind Pharma**, which brings pan-India reach. - Strategic goal: Shift from **symptom control to disease modification and remission**. --- #### **3. Rare Diseases – Strategic Expansion into Underserved Areas** - AstraZeneca entered the rare disease space in FY 2023–24, responding to high unmet needs and aligning with global capabilities post-**Alexion acquisition (2021)**. - India was among the **first Asian markets** to launch Alexion portfolio therapies. **Current & Upcoming Launches:** | Product | Indication | |--------|-----------| | **Koselugo (Selumetinib)** | Approved in 2023; **only treatment for pediatric NF1 with inoperable plexiform neurofibromas**. Launched to support highly debilitating rare condition. | | **Soliris (Eculizumab)** | Planned launch for two rare diseases: **Paroxysmal Nocturnal Hemoglobinuria (PNH)** and **atypical Hemolytic Uremic Syndrome (aHUS)**. First **anti-complement therapy** approved in India. | **Access & Advocacy Initiatives:** - Partnered with **aHUS India Foundation, PNH India Alliance** to build patient communities. - Conducted **>825 medical interactions**, 15+ awareness programs, and 7 scientific events to improve **TMA diagnosis and early identification of aHUS**. - Collaborating with **industry associations and government** to expand **Centers of Excellence (COEs)** under India’s **National Policy for Rare Diseases**. - Advocating for improved diagnostics, policy support, and access in underserved regions. --- ### **Commercial & Strategic Highlights** #### **Innovation & Growth Drivers** - **11 product approvals since 2023** across oncology, CVRM, respiratory, and rare diseases. - **“Beyond the Pill” Digital Solutions**: - **PHARMASTEER**: Postgraduate medical student training program in Medical Affairs with Seth GS Medical College and KEM Hospital (Mumbai). - **Project HeartBeat & AI ECG triage** – life-saving, scalable model. - **AI-powered lung cancer screening** with **Qure.ai** – deployed in 31+ hospitals, screening **>325,000 patients**. - Digital tools: Alveo.Fit (asthma), EMR, telemedicine, iPharmacy (6,400+ pharmacists trained), Skill For Scale (5,000 nurses in NCD management). - **Augmented/Virtual Reality**: Used to enhance HCP engagement and value communication. #### **Key Collaborations & Partnerships** - **Mankind Pharma**: Exclusive distributor for **Symbicort and Turbuhaler**, enabling widespread access. - **Government of Karnataka & Goa**: AI-powered chest X-ray screening for **early lung cancer detection**; comprehensive lung cancer strategy (Goa). - **Rajiv Gandhi Cancer Institute**: Center of Excellence for **NGS testing in lung cancer**. - **Roche Diagnostics**: Streamlining **HER2 testing** for better breast cancer diagnosis. - **Qure.ai & Predible Health**: AI for radiological screening of lung nodules. - **Tricog**: Instant ECG and remote interpretation platform. --- ### **Market Position & Financial Performance (FY 2024–25)** | Metric | Value | |-------|-------| | **Total Revenue from Operations** | ₹1,700 crore (~USD 200 million) | | **Product Sales** | ₹1,608 crore (+33.4% YoY) | | **Service Income (Clinical Trials & Marketing Support)** | ₹105 crore | | **Oncology Contribution to Sales** | 69.5% | | **Biopharmaceuticals Growth** | +8% YoY | | | (Despite intense generic competition) | | **Rare Disease Business** | Active post-2023 launch | | **Market Rank (India Pharma)** | #40 (up from #44; fastest-growing among top MNCs) |