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Wockhardt eyes $9 bn market opportunity for novel antibiotic Zaynich

Mumbai-based pharmaceutical major Wockhardt, which is set to launch a new class of antibiotic, Zaynich, in India this year, estimates a total addressable market opportunity of $9 billion. This includes a $7-billion market in the US and Europe, and a ₹17,000-crore opportunity in India. The company's stock rose 2.4 per cent on the BSE on Thursday following an investor presentation outlining its growth plans for the next three to five years. Zaynich (or WCK 5222) is a key research candidate in Wockhardt's pipeline. It has completed global Phase 3 clinical trials, demonstrating a 20 per cent higher (statistically superior) composite cure rate compared to Meropenem, the current gold standard in antibiotics. Wockhardt claims Zaynich is the first new class of antibiotic in over 30 years to treat gram-negative infections. The drug has already saved 51 lives under compassionate use, including three in the US, where patients had failed all existing therapies. Zaynich is indicated for complicated urinary tract infections (UTIs), hospital-acquired and ventilator-associated bacterial pneumonia, bloodstream infections, and complicated intra-abdominal infections. The company expects approval from the Drugs Controller General of India (DCGI) shortly and plans to launch the drug in the second half of this financial year. Wockhardt has completed a pre-NDA (New Drug Application) meeting with the US Food and Drug Administration (USFDA) in May and plans to file in Q2FY26, targeting a potential launch in FY27. Regulatory filings in the EU and emerging markets are scheduled for the second half of FY26. Wockhardt estimates that around 1.1 million patients in India may benefit from Zaynich, while 371,000 carbapenem-resistant cases in the US and Europe are potential candidates. Overall, there are 4.3 million hospitalised cases involving key gram-negative pathogens in the US and EU. The firm sees a combined addressable patient pool of 2 million across India, the US, Europe, and China. Apart from Zaynich, Wockhardt is also betting on other antibiotics in its portfolio, such as Miqnaf (Nafithromycin), and its biotechnology portfolio, including insulin products. Miqnaf, already launched in India, treats community-acquired bacterial pneumonia (CABP) and upper respiratory tract infections. It has received Qualified Infectious Disease Product (QIDP) status from the USFDA, signifying unmet medical need, and Breakthrough Medicinal Product (BMP) designation in Saudi Arabia. Miqnaf targets a ₹10,800-crore market in India, with over 96 million potential prescriptions. In the biosimilars segment, Wockhardt is focusing on diabetes care and sees significant opportunity arising as Danish major Novo Nordisk phases out human insulin cartridges. This creates a ₹450-crore opportunity in India and a $157-million market across emerging economies. With only three major players in India, including itself, Wockhardt expects to benefit substantially. The company is doubling its diabetes biosimilars capacity over the next three years to meet growing demand, targeting business growth of 20–25 per cent.