Biotechs step up clinical trials

Biotechs are developing more and more treatments and drugs without the support of the big pharmaceutical companies, whose number of clinical trials has been declining over the past 10 years. The RNA vaccines against the SARS-Cov-2 virus, developed by biotechs Moderna and BioNTech, illustrate this worldwide dynamism in biomedicine.

3,300 clinical trials launched by biotechs in 2021

Biotechs are increasingly going it alone, away from the big pharma companies whose clinical trials have fallen by a third over the last 10 years, according to a recent global overview by research institute IQVIA.

What these innovative companies have in common is that they are young, have annual sales of less than $500 million and specialize in the development of biomedicines.

Unlike conventional medicines, which are still the most widespread on the market and whose active ingredient is obtained through chemical synthesis, biomedicines contain an active substance derived from a biological source (plasma, cells, tissues, bacteria, plants, etc.).

Biotechs, whose new product development has doubled since 2016, are multiplying clinical trials: by 2021, they have launched 3,300, a figure that has almost doubled in 5 years.

Currently, no fewer than 4,000 drugs and treatments are being developed by biotechs, representing 65% of the pipeline of new molecules under evaluation. In 2001, biotechs accounted for just 34% of the total, rising to 50% in 2016.

Disparities by region

Worldwide, 2,624 biotechs had at least one biomedical product in clinical trials by 2021. However, this apparent dynamism masks major disparities by geographic region.

The share of biotech in the pipeline is 22% in Japan, 47% in Europe and 62% in the United States. This figure rises to 83% in China, where the pharmaceutical industry is still in the early stages of growth.

The majority of biotechs are based in the USA, where they benefit from high stock market valuations and a highly profitable market. Those headquartered in Europe account for 20% of the global biotech drug pipeline, compared with 46% for those headquartered in the USA.

Up until now, big pharma has been accustomed to buying up biotech companies as soon as their biomedical products reached phase 3 of clinical trials.

An increasing number of biotechs now prefer to join forces with other biotechs to bring their products to market. Such alliances now account for 62% of all transactions, compared with just 49% in 2016.

Ten years ago, the share of new products submitted to US health authorities by biotechs was just 11%; it has now risen to 42%.

The selling price of drugs is a decisive factor for biotechs. The U.S. market owes its profitability to the free price of drugs, while in Europe, biotechs have to contend with lower prices and lack the financial resources to market their products themselves.