Wockhardt's novel antibiotic Zaynich eyes $9 billion global market

Company to launch Zaynich in India this fiscal; sees $7 bn market in US and EU and ₹17,000 crore in India; USFDA, EU filings underway for FY26

Mumbai-based pharma major Wockhardt, which is all set to launch its new class of antibiotic Zaynich targeted at treating complicated gram-negative infections in India this year, estimates that the drug would have an addressable market of $7 billion in the United States (US) and Europe, besides a ₹17,000 crore opportunity in India, taking the total opportunity to $9 bn.

 

The company’s stock went up 2.4 per cent on BSE on Thursday after its investor presentation outlined its growth plans over the next three to five years.

 

Zaynich or WCK5222 is the blockbuster research candidate in Wockhardt’s kitty, which has completed global phase-3 clinical trials achieving 20 per cent higher (statistically superior) composite cure over conventional antibiotic Meropenem (which is considered the gold standard). Wockhardt claims that it is a new class of antibiotic in over 30 years that will treat gram-negative bacteria infections like urinary tract infections, hospital-acquired and ventilator-associated bacterial pneumonia, bloodstream infection and complicated intra-abdominal infections. The drug has saved 51 lives so far in compassionate usage, including three in the US. These patients had failed all available therapies.

 

 

The company is expecting to get a nod from the Drugs Controller General of India (DCGI) soon. It hopes for a launch in the second half of this financial year.

 

In an investor presentation, Wockhardt said that it had completed the pre-ANDA meeting with the US Food and Drug Administration (USFDA) in May and is filing with the regulator in Q2FY26, expecting a potential launch in the financial year 2026-27 (FY27). It aims to file for approval in the European Union (EU) and emerging markets in H2FY26.

 

Around 1.1 million patients in India are estimated to be addressable by Zaynich, while 371,000 carbapenem-resistant cases in the US and Europe can take Zaynich. In all, there are 4.3 million hospitalised cases for key gram-negative pathogens in the US and EU. Wockhardt said that overall it sees an addressable market of 2 million patients in India, US, Europe and China.

 

Apart from Zaynich, Wockhardt is pinning its hopes on other drugs in its antibiotic portfolio (like Miqnaf or Nafithromycin), and its biotechnology portfolio including insulins. Miqnaf has already been launched in India and is used to treat Community Acquired Bacterial Pneumonia (CABP) & Upper Respiratory tract infections (RTI). The drug has been granted Qualified Infectious Disease Product (QIDP) status granted by USFDA indicating significant unmet need and also Breakthrough Medicinal Product (BMP) designation granted in Saudi Arabia.

 

Miqnaf is targeting a ₹10,800 crore market opportunity in India with over 96 million potential prescriptions.

 

Besides antibiotics, the company is bullish on its biotech capabilities where it focuses on diabetes management and sees a significant opportunity opening up in India and emerging markets after Danish major Novo Nordisk is phasing out human insulin cartridges. In India, it provides an opportunity of ₹450 crore or so, and in the emerging markets, the opportunity size is around $157 million. Wockhardt noted in its investor presentation that with only three players operating in this space in India, it sees significant benefit.