Aurobindo Pharma, Cadila Healthcare and Serum Institute are readying their vaccine candidates.
Illustration: Uttam Ghosh/Rediff.com
The duopoly of pneumonia vaccines in India is in for some shake-up soon, as homegrown players like Aurobindo Pharma, Cadila Healthcare (Zydus Cadila), and Serum Institute are readying their vaccine candidates.
The Indian market is at present dominated by GlaxoSmithKline Pharma and Pfizer.
India has the highest burden globally for pneumonia-related child deaths.
In 2016, the number of pneumonia deaths among children under five was 158,176 in India, according to the Pneumonia and Diarrhoea Progress Report released in 2018-end by International Vaccine Access Centre (IVAC) at the Johns Hopkins Bloomberg School of Public Health.
Over two-thirds of the global burden of pneumonia and diarrhoea mortality occurs in just 15 countries and nearly half a million pneumonia and diarrhea deaths still occurred in two countries - India and Nigeria.
Lupin co-markets a pneumonia vaccine with another multinational player MSD.
The lion’s share of the market, however, lies with GSK and Pfizer - shows data from market research firm AIOCD AWACS.
GSK’s Synflorix has a 56.74 per cent share of the Rs 458 crore market while Pfizer's Prevnar 13 has 27.3 per cent share and Prevnar 7 has a 12.85 per cent share.
“By all means, this is a duopoly between the MNCs who dominate around 97 per cent of the market.
"Entry of new players will definitely challenge the market shares; however, this will take time.
"Initially, the new entrants are likely to target the government-tendered market to gain the volumes,” said a Mumbai-based analyst.
Hyderabad-based US focussed drug maker Aurobindo Pharma is all set to complete the phase one clinical trials for the pneumococcal conjugate vaccine (PCV) that will protect against 15 types of bacteria causing pneumonia.
Pfizer’s Prevnar13 protects against 13 types of bacteria-causing pneumonia and Prevnar7 protects against seven types, while GSK’s Synflorix provides protection against 10 types of bacteria.
Aurobindo aims to finish the phase-two trials this year and submit results to the Drug Controller General of India (DCGI) by mid 2020 and sources indicate it aims to participate in the government’s tender process to procure the vaccine in 2021.
Cadila Healthcare’s PCV is also in phase II of development, informed a source.
The Serum Institute of India is collaborating with a non-profit healthcare agency PATH for the development of a 10-valent PCV, focusing on the serotypes prevalent in 70.4 per cent of the affected population (Asia, Africa, Latin America, India).
“At present, the Indian government is procuring PCV from Pfizer that imports it.
"Gavi, the Vaccine Alliance provides support to India’s immunisation programme.
"However, this is till 2021. After that, the government will have to procure it with its own funds and is thus looking for cheaper variants of the same vaccine.
"Entry of Indian players opens up the market,” said a person in the know.
Aurobindo will try to supply to Gavi markets, but for that it would need three years of track record in the domestic immunisation programme.
The addressable market size for the vaccine globally is estimated to be over $6.2 billion and Aurobindo plans to start filings from 2021 onwards.
Prevnar 13 was introduced in India’s public immunisation programme in 2017 and is aimed to protect over 20 mn children in the first phase.
Himachal Pradesh, Bihar, Uttar Pradesh, Rajasthan and Madhya Pradesh were the first set of states to sign up.
Prevnar13 also enjoys a patent in India.
"Each dose of PCV 13 requires two and a half years to manufacture with 400 different raw materials, 580 manufacturing steps and 678 quality tests.
"We are pleased that after a thorough examination by competent authorities, including a study of all pre grant oppositions, the validity of the Prevenar 13 patent has been recognized by the Indian Patent Office," the Pfizer spokespserson said adding that the company welcomes innovation in the PCV space by all stakeholders as it will help address continuing public health needs and protect more children against this disease.
Speaking about the entry of new players in the scene that is expected to lower prices, a Pfizer India spokesperson said, “Launched in India in 2006, Pfizer’s pneumococcal conjugate vaccine has been administered over 8 million times to help protect over 2.5 million child lives in the country.
"Even though in the past decade, the vaccine was upgraded to include 13 serotypes that cover 78.4 per cent of serotypes of pneumococcal disease found in India, the price of PCV 13 has been kept the same as what it was for PCV7 in 2006 – a decade old price.”
Aurobindo has partnered with Tergene Biotech, a company where it has picked up a significant stake, to develop a potent vaccine candidate for pneumonia.
Tergene has developed the product and Aurobindo is funding the clinical trials, production and marketing costs.
"The company does not have a presence in the domestic market and thus it is natural for it to aim for the government tender process," said an industry source.
GSK, on the other hand, does not participate in the Indian government tender. It operates in the private market here.
The national immunisation programme offers a volume game, about 25 mn birth cohorts as opposed to one million birth cohorts in the private market.
“As more states add the PCV to their immunisation list, the private market is expected to shrink further,” said an industry source.
Data also ratifies the same. AIOCD AWACS data showed that from a moving annual turnover (MAT) value of Rs 485 crore in March 2018, the PCV market had shrunk to Rs 458 crore in March 2019.
Pfizer's Prevnar13 has clocked a decent 5-year CAGR of around 44 per cent, while its Prevnar7 has clocked an eight 8 per cent CAGR.
In comparison, GSK’s Synflorix has clocked a 14 per cent value CAGR.