Drug developers need staying power.

Only a small fraction of the research efforts lead to success - i.e. to a drug that actually finds its way to the patient.

Many remedies fall through the cracks in clinical studies beforehand, in which they have to prove their effectiveness and tolerability.

The Association of Research-Based Pharmaceutical Companies (VFA) has now published a forecast of how many new medicines are likely to actually come onto the market in Europe in the coming year: it is likely to be more than 45.

According to the information, this results from EU approvals for medicines that have been applied for or have recently been granted.

Thiemo Heeg

Editor in Business.

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Cancer drugs are at the forefront.

2023 is no exception in this respect.

The fight against tumors has dominated corporate efforts for many years.

According to the VFA, this also has to do with the fact that there are many different types of cancer that need to be treated differently.

Anti-cancer drugs likely to be on the horizon in the coming year could include people with breast or prostate cancer, esophageal, pancreatic, hepatocellular or bile duct cancer, non-small cell lung cancer, melanoma, multiple myeloma, or any of many forms of leukemia or benefit lymphoma.

A third are cancer drugs

According to the experts, around a third of the 45 or so new drugs that are likely to be launched in EU countries will be in the field of tumours.

They belong to different drug classes.

These include kinase inhibitors, which stop cancer cells from multiplying by targeting them at specific sites, which also helps patients with advanced disease to improve and often survive longer.

There are also several bifunctional antibodies.

Experts know that they intervene in the disease processes at two different points and, for example, involve immune cells in the fight against cancer.

In addition to cancer therapeutics, new drugs to combat inflammatory and metabolic diseases have played an important factor in the new range.

In the coming year, infectious diseases are likely to play a dominant role.

They are likely to account for a fifth of the expected new launches.

Gene therapies for hereditary diseases

The industry association VFA believes that this could make it possible for the first time to offer all small children and older people protection against RSV infections.

So far, this has only been available for premature babies and children with certain diseases.

New vaccines could also be used against influenza and dengue fever.

For the first time, a drug could be used for HIV patients that only has to be used every six months.

The repertoire for Covid-19 therapy and prevention could also be expanded, it is said - even if everything is no longer about Corona.

2023 should also be a good year for patients suffering from inherited genetic defects.

Despite progress since the turn of the millennium, most of the diseases that are based on it are still not causally treatable, explained the pharmaceutical association.

In the new year, the first drugs that will work against some of them will probably be around the corner, including a drug for the very rare disease "fibrodysplasia ossificans progressiva".

In those affected, cartilage and other types of connective tissue gradually transform into bone.

A drug could also become available for people with CDKL5-associated epileptic encephalopathy.

Great progress - and also worries

Gene therapies are said to make several hereditary diseases treatable, including hemophilia B, a particularly rare form of a blood clotting disorder.

Pharmaceutical companies are also developing drugs to alleviate hereditary diseases that have to be used regularly throughout life;

such drugs could become available for patients with Fabry disease or Pompe disease in 2023.

There is also hope for patients with amyotrophic lateral sclerosis (ALS), which leads to progressive paralysis.

So far, the process can only be delayed to a small extent with medication.

In recent years, however, intensive work has been done on new drugs;

one or two of these could hit the market in 2023.

"For many other patients, drugs for market launch are likely to be considered in 2023," explains the VFA, listing: type 2 diabetes, autoimmune diseases such as lupus nephritis or psoriasis, osteoporosis, migraines and anemia.

"Drug development is making great progress," summarizes the manufacturers' association.

The assessment is justified if one looks at the sometimes much meager numbers of the past.

In the pre-corona year 2019, pharmaceutical companies only launched 25 new drugs.

However, the lobby association is worried about this year.

More than in previous years, it is unclear which of them will also be permanently available to the population in Germany.

"So far, almost all new medications have been able to be included in German care promptly and permanently every year and thus made available to those affected," says association president Han Steutel.

The GKV Financial Stabilization Act, which came into force in January, with its far-reaching discount requirements and price specifications, is now making this more difficult: "It is unclear which drugs will actually be introduced and will remain available as therapy options even after the price negotiations."