Pfizer Inc. is projected to dominate a $ 20 billion market for Covid pills next year as richer nations scramble to buy supplies, while less wealthy countries will have to wait until early 2023 for the ones to come. Generic drug companies produce large quantities, analysis shows.
Pfizer, which is already making huge profits from its Covid vaccine, is expected to make about $ 17 billion from the sales of its experimental therapy, Paxlovid, in 2022. According to Airfinity Merck & Co., molnupiravir will fetch about $ 2.5 billion in revenue next year. said the London-based data company.
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Demand for the drugs is poised to outstrip supply as Covid spreads across the world and scientists wonder how well vaccines and antibody treatments against omicron and other variants that could emerge will hold up. Purchases by rich countries have fueled concerns that, after struggling to obtain vaccines, the less wealthy could be left behind once again, despite licensing agreements to expand the availability of the drugs.
“The question of inequity in access to Covid medicines is definitely staring us in the face,” said John Amuasi, specialist in global health and infectious diseases at the Kumasi Center for Collaborative Research in Tropical Medicine in Ghana. “There is no reason to think that it will not be a problem. It is clear that it will be. The sooner noise is made about this, the better. ”
Pfizer and Merck have agreed to allow generic manufacturers to make inexpensive versions of their pills for low- and middle-income countries. The deals could mean supplies begin pouring into those nations in a few months, Charles Gore, executive director of the United Nations-backed Drug Patent Fund, said last month.
Drug makers have signaled a number of steps they have taken to expand access to their treatments globally.
Merck expects its therapy to be available in high-, middle- and low-income countries almost simultaneously, it wrote in an email. The company said it booked at least 3 million courses from its own offering for low- and middle-income countries by the first half of 2022 and expects another 3 million generic courses to be produced through licensing agreements in the same period.
More than 100 applications have been filed for each drug, according to the patent group, and it is unclear how many generic producers will be licensed, according to the patent group. Once the companies have permission, they must manufacture the pill, conduct studies to show that it works as well as the original, and apply for regulatory approval.
“We expect this to happen quickly, but it will be a long time before the products are available,” said Gelise McCullough, representative of the Geneva-based patent group. “We will try where we can move as quickly as possible.”
Concerns persist about how long it will take for supplies to reach many countries. Health advocates have called for more measures to expand access, including increased testing in low-income countries to detect cases in the first days of infection, when the drugs could be most effective.
Pfizer’s goal is to deliver its oral antiviral therapy to patients in greatest need as soon as possible and at an affordable price, subject to the country’s regulatory clearance, spokeswoman Sharon Castillo said in an email. Merck did not immediately respond to a request for comment.
Some generic drug makers indicated they could produce up to 10 million cycles of Covid pills a month, but regulatory hurdles and other challenges must be resolved, Trevor Mundel, president of the global health division of the Bill & Melinda Gates Foundation. he said in an interview in October.
The pills from Pfizer and Merck are expected to replace the more expensive antibody cocktails from Regeneron Pharmaceuticals Inc. and Eli Lilly & Co. for the early treatment of high-risk patients. The antibodies target specific characteristics of the coronavirus spike protein that may change as mutants evolve, and Regeneron said Thursday that his drug loses potency against omicron.
Pfizer’s pill is likely to become a standard treatment for Covid patients at risk of developing serious illness. Studies showed that it was very effective in keeping patients out of the hospital, but less adept at erasing the milder symptoms that are often associated with breakthrough infections.
Paxlovid is poised to extend a successful Covid run for Pfizer, whose shares are up about 65% this year. The U.S. drugmaker’s vaccine, developed with partner BioNTech SE, is the best-selling pharmaceutical product of all time in any given year and is expected to generate more than $ 36 billion in sales in 2021 and beyond. minus another $ 29 billion in 2022.
During the pandemic, Pfizer has said it plans to use tiered prices so that richer countries pay more than poorer countries. The company also said it would invest up to $ 1 billion to support manufacturing and distribution.
Merck shares plunged last month after data showed that its pill, developed with Ridgeback Biotherapeutics LP, was less effective than previously reported and US regulators raised concerns about safety and security. long-term effectiveness. The staff also mentioned the risk of drug resistance, which occurs when viruses and bacteria evolve to mitigate or defeat a drug’s attack mechanism.
The US is projected to be the biggest buyer of the two pills, accounting for more than half of revenue in 2022, while European countries and the UK will likely spend nearly $ 5 billion, Airfinity estimates. Sales generated in more than 50 other nations are forecast to reach $ 3.7 billion, excluding more than 100 countries covered in patent reservation agreements.
Faced with the omicron variant, some countries are moving fast. The UK, the first country in the world to approve the Merck pill, is beginning to provide supplies to its population through a national study of some 10,000 people.
High-income countries have bought more pills than they are likely to need amid the risks posed by the variants and questions about the effectiveness of vaccines, according to Airfinity.
Pfizer has said that laboratory tests indicate that Paxlovid will maintain activity against omicron. The drug targets an internal protein, called a protease, which is believed to change little as the virus evolves. The vaccines target the spike protein, which is highly mutated in omicron and could undergo further changes in future variants.
“Antiviral pills will be easier to produce and distribute, and will face less hesitation than vaccines,” said Airfinity analyst Arsalan Azad. “We are likely to see another race to secure a limited supply in 2022.”
© 2021 Bloomberg