Welcome to our summary of the biopharmaceutical market in 2022. A recent article published in Nature Biotechnology provided a comprehensive overview of the biopharmaceutical benchmarks in 2022, including information on approved products, clinical pipelines, and key players in the industry.

Production platforms

The biopharmaceutical industry has continued to grow over the past few years, with a total of 578 biopharmaceuticals gaining approval in the European Union (EU) and United States since 2018. These products are used to treat a range of diseases, including cancer, autoimmune conditions, and inflammatory disorders. Most biopharmaceuticals are produced using mammalian cell culture systems, with Chinese hamster ovary (CHO) cells being the most commonly used. Other systems include NS0 mouse myeloma cells and baby hamster kidney (BHK) cells. Non-mammalian production platforms include Escherichia coli (E. coli), P. pastoris, S. cerevisiae, P. fluorescens, and H. polymorpha.

Product administration

Most biopharmaceuticals are administered parenterally, meaning they are injected into the bloodstream, but some are administered directly to the site of action via non-parenteral means, such as orally or intravenously. One example is Rybelsus (semaglutide), which is administered orally in tablet form for the treatment of type 2 diabetes. Another example is Aduhelm (aducanumab), an intravenous infusion for the treatment of Alzheimer’s disease that has been approved by the Food and Drug Administration (FDA) in the United States, but not by the European Medicines Agency (EMA) due to safety concerns.

Impact of COVID-19

The COVID-19 pandemic has had a significant impact on the biopharmaceutical industry, with the development and approval of several biopharmaceuticals for the treatment and prevention of the disease. To date, six COVID-19 vaccines have been approved for use in the EU and United States, all of which use messenger RNA (mRNA) technology. In addition, several antiviral treatments for COVID-19 have been developed, including remdesivir and monoclonal antibodies (mAbs) such as bamlanivimab and casirivimab/imdevimab.

Biosimilars

Biosimilars, or generic versions of biologics, have gained increasing approval in recent years. A total of 94 biosimilars have gained approval in the EU and United States since 2006, with 83 being approved in the EU and 37 in the United States. The majority of these are antibody- or antibody-fusion-based products, with others including human growth hormone (hGH), erythropoietins (EPOs), granulocyte colony-stimulating factors (G-CSFs), follicle-stimulating hormone (FSH), engineered insulins, and parathyroid hormone (PTH).

While the number of biosimilars approved has increased, their overall revenues and savings to patients and healthcare systems remain relatively modest. In the EU, the biosimilars market is estimated to have reached €8.8 billion in 2021, representing savings of €5.7 billion. In the United States, the market for biosimilars is estimated to have reached $4.7 billion in 2020, representing savings of $4.6 billion.

Despite this, the use of biosimilars is expected to continue to increase in the coming years as more biologics come off patent. This will provide more treatment options for patients and may help to reduce healthcare costs. However, the uptake of biosimilars may be limited by factors such as regulatory barriers, intellectual property disputes, and issues surrounding interchangeability with the originator products.

Traditional biotech products

A total of 37 traditional biotech products, or products produced naturally or via nonrecombinant means, were approved for marketing in the EU and United States during the current survey period. These include blood-derived products, natural extracts, traditional (non-recombinant) vaccines, and un-engineered cells. The profile of approvals largely mirrors product types approved in previous surveys, and many of these products are used to treat a wide range of conditions, including blood disorders, immune deficiencies, and infections.

Future directions

Data from PhRMA indicates that there are currently more than 7,800 biopharmaceutical products in clinical development globally, of which over 1,000 have reached phase 3 trials. Cancer remains the most common indication for these products, followed by genetic disorders, cardiovascular disease, and neurological, eye, and blood disorders. Almost a third of the products in clinical development (2,533) are monoclonal antibody (mAb) based. There are also smaller but still notable numbers of gene-modified cell therapies (348) and nucleic acid and gene-based therapies (546) being assessed in clinical trials.

The biopharmaceutical industry has a strong experimental product pipeline, and total global biotech product sales continue to steadily increase as a percentage of overall global pharmaceutical sales. This trend is expected to continue, with the market for biopharmaceuticals estimated to reach $450 billion by 2024.

There are more than 100 mAb-based products in late-stage clinical development that are not related to COVID-19. These products are likely to resemble the profile of the current cohort of experimental mAbs, with 60 targeting cancer and the rest targeting a range of conditions such as autoimmune disorders and infectious diseases. A third of the experimental mAbs are bispecific, and one-fifth are antibody conjugates.

Earlier stages in the mAb development pipeline show a greater diversity of formats, including antibody-drug conjugates (ADCs), bispecific antibodies, and fragments. Many of these products are targeting solid tumors, which are the leading cause of cancer deaths globally, including lung, colon and rectal, liver, stomach, and breast cancer.

Nucleic acid and engineered cell-based therapies continue to be a promising area of research and development. The success of mRNA vaccines in the COVID-19 pandemic has provided a boost to the field, and advances in CAR-T cell therapies are expected to drive the development of these products, particularly for the treatment of cancer. The use of data analytics in biopharmaceutical development and manufacturing is also expected to increase, with the aim of improving efficiency and reducing costs.

Despite the many successes in the biopharmaceutical industry, there are still challenges to be faced. Patent expiration, competition from biosimilars, and increasing regulatory scrutiny are all issues that need to be addressed. However, with the advances in technology and the increasing understanding of the underlying mechanisms of disease, the biopharmaceutical industry is well positioned to continue making significant contributions to improving global health.