Pharmaceutical major, Zydus Cadila is fast emerging as one of the leading players in the vaccine landscape. Building up on its existing expertise, the company is scaling up efforts to develop novel vaccine platforms. To tap the hot COVID-19 market, Zydus has identified five novel programs that target 3 different stages of virus, a mix of new chemical entities (NCEs) and new biological entities (NBEs).

Zydus has developed a novel approach for its DNA based COVID-19 vaccine development with favourable vaccine characteristics. Expected to be in the market by September 2021, the ZyCoV-D vaccine has demonstrated a good safety profile during one of the largest Phase I/II studies in India among 1,048 subjects. As per company, the vaccine is very safe and well tolerated with no Grade 3/4 Adverse Event/Serious Adverse Event and has demonstrated high neutralizing antibody and cellular response. The vaccine is currently undergoing a robust Phase III clinical evaluation among around 30,000 volunteers.

For its another vaccine candidate, Zydus has opted for the ‘cocktail’ monoclonal antibody (Mab) approach and is set to hit the market by September 2021. Eyeing a market potential of over $6 billion, the company is confident that its quick development timelines and manufacturing capabilities ensure the drug will be available to all without compromising any safety and efficacy parameters.

The company is expected to deliver 100-150 Million doses of vaccine by the end of 2021. The POC studies and cell line development were initiated during July 2020 while the preclinical efficacy and toxicity studies were done in November 2020. As per tentative deadline, the filing with regulators is expected to be initiated in September 2021.

In the COVID-19 portfolio, the company's single dose therapy of PEGIHEP showed greater viral load reduction, in mild to moderate COVID-19 patients. PEGIFN treated patients showed statistically significant viral reduction by RT-PCR on day 14. One injection (single dose) prevents disease severity and promotes recovery in mild to moderate patients (affordable). Company has already initiated phase III trials in India that will get completed by February 2021. It plans to file the IND application in the United States as well. The company is also developing a measles vectored base vaccine for COVID-19 which is currently in preclinical development.

Robust pipeline of vaccines to tap $3.9 billion opportunity

Setting a high target to supply affordable vaccines to global markets, Zydus aims to get 2-3 vaccines WHO pre-qualified by the year 2023. Company is among few WHO prequalified players in rabies vaccine. Globally, Zydus is the 2nd player to launch a typhoid conjugate vaccine. Company’s approved Measles Rubella vaccine has highest demand in GAVI 73 nations. From year 2023 onwards, the company anticipates major progress in the prequalified vaccine portfolio.

Between 2024-2028, the vaccines portfolio presents a cumulative opportunity of nearly $2.6 billion. With aim to get two to three more vaccines prequalified by 2024, these prequalified vaccines present a total opportunity of around $1.3 billion from 2024 -2028.

Zydus’ prequalified vaccine will not only cater demand from GAVI/UNICEF but will also cater demand of various emerging markets, these vaccines will be one of the key drivers for vaccines’ business growth in this decade.