EY study Corona is changing the pharmaceutical industry

Status: June 21, 2021 3:53 p.m.

The corona pandemic did not give the pharmaceutical industry a boost in 2020, it actually slowed it down. According to an EY study, only cancer medicine and ophthalmology are booming.

by Notker Blechner, tagesschau.de

Is “Big Pharma” but not a beneficiary of the corona pandemic? The management consultants from EY (formerly Ernst & Young) are convinced: “The corona crisis was not a growth driver in the past year, on the contrary, it led to higher spending on research and development”, says Klaus Ort, head of EY’s Life Sciences & Healthcare market segment in German-speaking countries. “The pharmaceutical industry wasn’t a big winner from the pandemic.” In fact, sales of the world’s 21 largest pharmaceutical companies rose by just 4.4 percent in 2020. In the year before the pandemic, the increase was almost 13 percent. However, this was also due to a billion-dollar takeover in the industry.

Corona slowed growth

According to Ort, Corona led to delays in various treatments. Among other things, the fact that fewer operations were carried out in hospitals had a negative effect. This slowed down sales of the corresponding drugs and therapies. In the case of funds for heart and circulatory diseases, for example, revenues stagnated after having increased significantly in 2019. Sales of therapeutics for respiratory diseases even fell. Place refers to the wearing of face and nose masks as the reason, which also prevented infectious diseases such as flu.

Corona surge will not come until 2021

With sales of 26.4 billion euros, vaccines only made up a good five percent of total sales last year “Big Pharma” out. That should change in 2021. The US pharmaceutical giant Pfizer has already announced that the corona vaccine Comirnaty will flush a good 15 billion dollars into the coffers. That’s a good quarter of Pfizer’s total sales. “At Pfizer, Corona will only have an impact on sales in 2021″says EY expert Ort.

Pfizer partner BioNTech also expects an enormous growth spurt in new, unimagined dimensions this year. The Mainz corona vaccine pioneer expects sales of 9.8 billion euros for 2021 and should thus become the third largest German pharmaceutical manufacturer – behind Bayer and Boehringer.

766 Covid vaccines and therapeutics pending

EY was unable to quantify how high the market volume for combating corona is. However, the management consultants see huge potential. They refer to 260 vaccine candidates who are currently in studies. So far, only four vaccines have been approved. “The four big players dominate the market and will continue to do so”, predicts Alexander Nuyken, co-author of the study and head of life sciences transaction consulting at EY. Because of the increasing number of mutations, the hurdle for approval will become higher and higher in future.

EY has found out that 506 therapeutics are in the pipeline for drugs against Covid-19. However, no means of this have yet managed to obtain approval. “Despite all the vaccination euphoria, one should not lose sight of this fact”, warns EY expert Nuyken. People are still dying of Covid-19 due to a lack of medication. After all, the number of drug candidates has doubled since the end of 2020. And: 162 therapeutics are in the clinical phase III study. The most promising means is considered the cortisone drug dexamethasone . According to a large-scale study by Oxford University, it lowers the death rate of seriously ill Covid patients by at least 25 percent. In the initial phase of the corona disease, Remdesivir, which was the first Covid drug approved in Europe, also works – albeit only under certain conditions.

Price drop for corona tests

The EY experts see the market for corona tests as completely oversaturated. There are currently 1,021 diagnostic tests on the market, more than half of which are so-called immunassays (including rapid antigen tests). “We see a drop in prices here”says EY expert Nuyken. Individual drugstore and supermarket chains are now offering self-tests for 80 cents.

Thanks to Corona, the vaccine business has experienced a renaissance, emphasize the EY experts. The biotech sector in particular benefits. Due to new trends such as digitization as well as gene and cell therapies, it is on the threshold of further growth. According to EY, the German biotechs received more capital in 2020 than ever before.

Cancer medicine is the major growth driver

The main market for “Big Pharma” but oncology remains. In the fight against cancer, the industry has a turnover of over 200 billion euros, which is more than a third of the entire pharmaceutical business. In 2020, the world’s 21 largest pharmaceutical companies increased their sales in oncology by 14.6 percent. Experts are also predicting growth rates of ten percent for the coming years. Only ophthalmology promises similarly strong growth. Because of the trend towards home office in the pandemic, myopia increased in many people, especially children.

Biotech companies could provide a new boost in the cancer market. Amgen recently made a breakthrough in cancer therapy with Lumakras. For the first time, an active ingredient was approved that is directed against mutations in the KRAS gene. The KRAS mutations are one of the most common causes of pancreatic, colon and lung cancers. The mRNA technology that BioNTech and Moderna are successfully using in the fight against Corona also promises huge potential for cancer research.

Hope in the fight against Alzheimer’s

Biotech could also bring progress in the fight against Alzheimer’s. In early June, Biogen received “green light” for the active ingredient aducanumab . It is the first Alzheimer’s drug to receive FDA approval since 2003.

According to the study by EY, the Swiss Roche Group has maintained its top position in the ranking of the world’s largest pharmaceutical companies with 43.4 billion euros. AbbVie climbed to second place – just ahead of Johnson & Johnson and Merck & Co. Pfizer slipped to sixth place in the rankings. Due to the corona surge, the US pharmaceutical giant should regain the top spot in 2021

From Notker Blechner, tagesschau.de So far it has seemed that children are largely spared from Corona. Many who were infected with Covid-19 had asymptomatic or mild disease. Serious illnesses were rare. “I haven’t had a bad case so far,” says pediatrician Axel Gerschlauer from Bonn, regional spokesman for the professional association of paediatricians. But there have also been deaths in children in connection with a corona infection. Long-term effects are even more common. More than 250 cases of the PIMS syndrome (“Pediatric Inflammatory Multisystem Syndrome”) have already been counted. This is an immune reaction that occurs a few weeks after infection, especially in children, and can be life-threatening.

Some children suffer from long-term effects

Surveys from abroad are also alarming, according to which numerous children and adolescents suffer from “long covid”, i.e. post-viral symptoms weeks or months after the infection. According to recently published data from Great Britain, 15 percent of adolescents between the ages of eleven and 16 complained of persistent headaches, sudden learning disorders or a drop in performance in sports five weeks after the corona illness. In a study by a clinic in Rome, it was even found that almost half (43 percent) of the children infected with Corona had at least one symptom that was affecting them four months later. “Children are not the drivers of the pandemic,” said Jörg Dötsch, President of the German Society for Child and Adolescent Medicine. However, since February the incidence among the youngest has also increased significantly in Germany. On the one hand, this may be due to the numerous tests that were carried out in schools. On the other hand, the proportion of people over the age of 70 in cases of illness has fallen significantly, as they have largely been vaccinated. Pediatricians consider it important to vaccinate children and adolescents as quickly as possible – especially in view of the mutated South African, British and Brazilian corona viruses. This is the only way to achieve herd immunity. Experts now believe that 80 to 90 percent of the population should be vaccinated to ensure collective protection. Because the more contagious the virus, the higher the vaccination rate must be. “If vaccination is not carried out across all population groups, extensive immunity cannot arise in the general population,” says Thomas Fischbach, President of the Association of Pediatricians. Heinz Hilgers, President of the Child Protection Association, also says: “We will not get out of this pandemic without vaccinations for children.”

Schoolchildren in Israel already vaccinated

Vaccine manufacturers understand the importance of children and teenagers. “Younger children, who make up a large part of the world’s population, play a crucial role in our fight against Covid-19,” said BioNTech and Pfizer recently. The German-American company duo wants to accelerate the development of vaccines for children and adolescents. BioNTech boss Ugur Sahin spoke of promising studies at the analysts’ balance sheet conference. A phase III study in 12 to 15 year olds was particularly successful. The vaccine has been shown to be safe and effective in this age group. None of the vaccinated 2260 participants in the study was sick with Covid-19, it said. “The first results of the study in adolescents indicate that children are particularly protected by the vaccination,” said CEO Sahin. BioNTech-Pfizer plans to apply for emergency approval in the USA and the European Medicines Agency (EMA) in the coming weeks. Pfizer boss Albert Bourla is confident that the first young Americans will be vaccinated in the US before the start of the next school year. So far, the drug has been approved for people aged 16 and over in countries such as the USA and Israel. In Israel, the first pupils under the age of 18 were vaccinated.

The very little ones still have to wait

Now there should also be clinical tests for vaccines in children between six months and eleven years. If the study is positive, the vaccine could be used in the youngest from the beginning of 2022. The US company Moderna and the British-Swedish pharmaceutical company AstraZeneca were faster. They had started testing their corona vaccines on younger children even before BioNTech-Pfizer. The results of the Moderna study for the vaccine in 12 to 17 year olds are expected in the middle of the year. The US FDA has approved Moderna tests on children aged six months to twelve years. AstraZeneca began a study of its vaccine in 6 to 17 year olds in the UK in February. Johnson & Johnson is also planning its own pediatric studies. The European Medicines Agency has obliged the four major suppliers to also test their vaccines for children.

BioNTech and Pfizer clearly ahead

But so far BioNTech-Pfizer has been ahead in the race for children’s vaccines. Analysts like Daniel Wendorff from Commerzbank are convinced of this. The Mainz vaccine is so far the only one that has been proven to be effective in 12 to 15 year olds. BioNTech and Pfizer would have such great market power anyway that the two companies could quickly increase production. When it comes to absolute vaccination doses and the availability of data, BioNTech-Pfizer is a leader, says Wendorff. The EU is increasingly relying on BioNTech-Pfizer. Brussels is about to finalize a huge order for 1.8 billion cans, the majority of which are for children and young people. The rest are booster vaccinations that are likely to be required in the years to come.

First approval in late summer?

Thomas Mertens, the chairman of the Standing Vaccination Commission (Stiko), has shown confidence that in Germany Corona vaccine available for children at the end of the year will be. Association president Dötsch even hopes that “we will get a vaccine for 12 to 15 year olds in late summer or autumn at the latest, for smaller children it will probably take longer”. However, other experts warn against being too optimistic. “Children are not little adults,” says pediatrician Gerschlauer. You can’t give them half the dose just because they’re half the size of adults. The immune system of the little ones is completely different. In addition, there is the problem that it is more difficult to find children as test subjects for studies. Smarter would like to see a vaccine approved for the youngest of our society as soon as possible. Because children in particular are the biggest losers in the corona pandemic. In his practice he currently counts more young patients with mental disorders than ever before. “Many have eating and sleeping disorders or even depression.” This is confirmed by Jörg Dötsch, President of the German Society for Child and Adolescent Medicine: “70 to 90 percent of children are under severe psychological stress from the pandemic,” he estimates. “We’re really worried about the little ones.”

From Peter Allgaier, BR A high fence, barbed wire and a lot of forest – from the road you can see very little of R-Pharm in Illertissen. But the Bavarian state government has high hopes for the company in the Neu-Ulm district. 2.5 million doses of the Sputnik V vaccine is to be supplied by the company with which a preliminary contract has already been concluded, emphasized Bavaria’s Prime Minister Markus Söder last week . He wants to alleviate the vaccine shortage in vaccination centers and doctors’ offices. But when and whether R-Pharm can deliver the promised quantity is open.

It is currently unclear whether R-Pharm can deliver the promised quantities. Image: REUTERS On the one hand, this is due to the vaccine’s approval for Europe. The location in Illertissen provided a corresponding one in February Application to the European Medicines Agency (EMA) in Amsterdam. Their employees traveled to Russia last Monday to visit production sites there. They also toured two clinics where patients were cared for during clinical trials.

Doubt despite study too high effectiveness

The medical journal “The Lancet” Sputnik V certifies a high level of effectiveness , similar to that of the vaccines from BioNTech / Pfizer or Moderna. But there are also doubts. According to the Slovak Medicines Agency the vaccine that was supplied is different from the one that “The Lancet” rated. However, R-Pharm is struggling with other problems in Illertissen. There are no permits from the Neu-Ulm district for the planned expansion of the company. A construction freeze on the site was the result.

The process in Illertissen is to be accelerated

“We can only approve a fire protection concept or an application under immission control law if they are on the table,” says Franz-Clemens Brechtel, the deputy district administrator. In immission control, for example, it is checked what effects a system has on the flora and fauna, but also on air and water quality. A specially established task force and a project manager are now supposed to ensure that the procedures are accelerated and run more smoothly. Illertissen has a long tradition in the manufacture of chemical products. In 1860 Heinrich Mack bought an oil mill and made bath tablets there. In the 1930s, the physician Karl August Forster then built one of the largest beekeeping farms in Europe with more than 100 million animals on the site. A rheumatoid drug called “Forapin” was made from their poison. The bee culture is still visible in the city today, in a specially set up museum in the city’s castle.

R-Pharm took over the location in 2014

The US company Pfizer then took over the site in the 1970s. The company had drugs packaged, but also drugs made with highly effective substances. The company was particularly at the forefront of what is known as “containment”, a process in which employees do not come into contact with the active ingredient. But that could not prevent the loss of jobs. Around 350 people are currently still employed by the company, which was finally taken over by R-Pharm in 2014.

The municipality has great hopes for production

“The vaccine production would be like winning the lottery,” says Jürgen Eisen. He is mayor of Illertissen, a town with around 17,000 inhabitants, many of whom share his opinion. They hope for good jobs and more income for the place. R-Pharm is currently advertising vacancies: Among other things, specialists in biotechnology are being sought. More than 30 million euros are to be invested in the expansion, according to the Russian company in a press release. In addition to Sputnik V, the manufacturer could also produce AstraZeneca in the future. Corresponding plans have been circulating for six months. But much is still in the balance.

Possible start of production unclear

R-Pharm can currently only produce on the so-called pilot plant scale, that is, try out the individual steps in a small test arrangement and, for example, produce samples for customers. It is unclear when the correct production can start. The government of Upper Bavaria announced that R-Pharm has not yet submitted an application to be allowed to manufacture the vaccine. The authority sees the urgency in the face of the pandemic, but emphasizes – like the district office – the rule of law. The basis is that all necessary documents are available and the requirements are met.

Time is running out

R-Pharm in Illertissen, however, is running out of time. There are still too few vaccine doses nationwide. However, the situation could change in just a few months. Because established manufacturers are expanding their production, others such as the US company Novavax or the French manufacturer Sanofi are trying to get approval. In the end, it could be similar to FFP2 masks. At first there was far too little, but now the copies are piling up at the dealers. The vaccine is likely to be needed in many other, especially poorer countries, also because the vaccine is comparatively cheap.

From Anja Martini, tagesschau.de “There will not be one miracle pill against Covid-19” – with these words Federal Research Minister Anja Karliczek dampened the prospect of rapid scientific success. The Federal Ministry of Research intends to spend 50 million euros on drug research. A panel of experts has made recommendations for several projects. Sandra Ciesek, director of the Institute for Medical Virology in Frankfurt am Main, and Christoph Spinner, senior physician for infectiology and pandemic officer at the Rechts der Isar Clinic in Munich, were involved as experts. He says patients need different therapies depending on the severity or stage of the disease. Remdesivir, hydroxychloroquine or antibody cocktails: they have all attracted attention. But how far is research on drugs against Covid-19 actually?

An asthma spray as a “game changer”?

The active ingredient budesonide is currently the focus of research. It is an active ingredient in an asthma spray, also known colloquially as cortisone spray, which is said to be able to prevent severe courses of Covid-19. This is the conclusion reached by researchers at Oxford University in a study that was published in the journal “The Lancet”. The British scientists had randomly divided 146 adult corona patients with mild symptoms into two groups. 73 of them were treated with budesonide twice a day at an early stage of the disease, 73 received standard therapy such as paracetamol for the fever. Subjects who inhaled the active ingredient budesonide had to go to hospital less often and recovered more quickly than those who received standard therapy. According to senior physician Spinner, that sounds good at first – but the study is still based on a hypothesis. A placebo-controlled study must follow in which the second group is treated with a dummy drug. In addition, the number of subjects was very small. The results would have to be checked in larger studies.

Anti-inflammatory drugs slow the immune response

The anti-inflammatory dexamethasone is mainly used in patients who are admitted to the clinic. It is recommended in the national guideline for the treatment of Covid-19 patients. The drug, which belongs to the corticoids, is supposed to slow down an excessive immune reaction, which often occurs with Covid.

Antibody drugs attack the virus

These active ingredients were made public when the former US President Donald Trump became infected with the corona virus in October. Among other things, he received an antibody cocktail that Regeneron had developed and that is produced by the pharmaceutical manufacturer Roche outside of America. At that time, the drug was not yet approved in the United States. After his relatively quick recovery, Trump described the cocktail as a “miracle” and a “cure”. The drug now has emergency approval in the USA. For Europe, the tests are being carried out by the European Medicines Agency (EMA). At the beginning of the week Roche presented the first results of the clinical phase 3 study. According to this, the administration of an antibody combination from the agents casirivimab and imdevimab could reduce the risk of symptomatic corona infections by about 81 percent. Unexpected serious side effects did not occur. Antibody drugs such as Bamlanivimab and REGN-COV2 may be used in clinics in Germany under certain conditions. However, they are only to be used at a very early stage of the infection, according to medical experts Spinner.

New development of the TU Braunschweig to “paralyze” the virus

It is different with an antibody drug that was developed in Braunschweig. The Paul Ehrlich Institute has just approved it for the first clinical studies. It is called COR 101 and is intended to be used for the treatment of hospitalized patients. These are patients with a moderate course of Covid-19 who have to be hospitalized, but not yet in the intensive care unit. Stefan Dübel laid the foundation for this drug. He is a biologist and heads the biotechnology department at the Technical University of Braunschweig. The antibody, according to Dübel, binds to the outside of the virus – in a way that prevents the virus from docking on cells. The pathogen is, so to speak, tied up by the antibody and can no longer move; In addition, the virus can no longer penetrate the cells, so that infection can no longer take place. The company CORAT Therapeutics has been running the clinical work since summer 2020. André Frenzel, clinical director, hopes for results for a possible approval soon.

Convalescent plasma: use of naturally formed antibodies

Research into so-called convalescent plasma is also being continued in Germany. Antibodies against SARS-CoV-2 are obtained from the blood plasma of recovered Covid-19 patients. The antibodies work in a similar way to synthetically produced ones. Nationwide, clinics have asked those who have recovered from corona for blood plasma donations in order to obtain naturally formed antibodies. But the statements on the effectiveness are not clear, says the Munich infectiologist Spinner.

Remdesivir, chloroquine & Co .: drugs are “misappropriated”

A glimmer of hope was initially the drug Remdesivir – originally an Ebola drug. In October 2020, however, the World Health Organization (WHO) reported that the agent used as a corona drug had little or no benefit, and a short time later spoke out against hospital treatment. In recent months, the malaria drug chloroquine has also been tested worldwide for its effectiveness against SARS-CoV-2. Ex-US President Trump had touted it as a miracle weapon and “gift from God” at the beginning of the pandemic. The US FDA granted the drug emergency approval – and withdrew it after a few weeks. In June 2020, the WHO finally stopped clinical studies on the effectiveness of the related drug hydroxychloroquine in the fight against the coronavirus.