Drug companies are increasingly focused on biologic-based drugs, with top 10 best-sellers. Discover the trends and innovations shaping the future of medicine.
Biologic-based drugs have increasingly dominated the pharmaceutical market, playing a key role in the portfolios of leading bio/pharma companies. This trend reflects the industry’s shift toward more specialized, targeted treatments, many of which leverage biotechnology innovations. Among the top 10 selling drugs in 2023, biologics are strongly represented, shaping the future of pharmaceutical innovation.
Biologic-Based Products on the Rise
Biologic-based products continue to gain traction, with seven of the top 10 best-selling drugs in 2023 falling into this category. These include major players such as:
- Keytruda (pembrolizumab) – Merck & Co.
- Humira (adalimumab) – AbbVie
- Comirnaty (COVID-19 vaccine mRNA) – Pfizer/BioNTech
- Eylea (aflibercept) – Bayer/Regeneron Pharmaceuticals
- Dupixent (dupilumab) – Sanofi/Regeneron Pharmaceuticals
- Stelara (ustekinumab) – Johnson & Johnson
- Opdivo (nivolumab) – Bristol-Myers Squibb/Ono Pharmaceuticals
These biologics have become foundational in treating various conditions, from cancer to immunological diseases. Notably, their market impact has grown significantly, with biologic-based drugs now accounting for a major portion of the revenue for pharmaceutical companies.
Biologics Continue to Lead in New Approvals
While small-molecule drugs continue to dominate new drug approvals, biologics are rapidly catching up. The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 17 biologic-based drugs in 2023, representing 31% of all new drug approvals. This marks a high point in the rise of biologics, following a steady increase over the past few years.
In 2022, biologics represented 41% of FDA new drug approvals, an increase from the 26% average seen between 2018 and 2021. This trend is expected to continue, as biologics become more important in addressing unmet medical needs, particularly for complex diseases.
Biologics with Blockbuster Potential
Several biologic-based drugs have blockbuster potential, meaning they are expected to generate over $1 billion in annual revenue by 2029. According to Clarivate’s 2024 “Drugs to Watch” report, 10 out of 13 potential blockbuster drugs are biologics. These include new vaccines, gene therapies, and advanced monoclonal antibodies, all of which promise to reshape the treatment landscape.
Here are some of the standout biologic drugs poised to become blockbuster successes:
High-Dose Eylea (aflibercept) – Bayer & Regeneron Pharmaceuticals
Already a successful treatment for eye diseases, the high-dose version of Eylea offers less-frequent administration, providing a significant advantage in patient compliance. This new version aims to stave off competition from biosimilars and other late-phase contenders, like Roche’s Vabysmo and Oculis’ OCS-01.
Datopotamab Deruxtecan – AstraZeneca & Daiichi Sankyo
This antibody-drug conjugate (ADC) targets cancer cells by linking a monoclonal antibody with a topoisomerase inhibitor. Its potential to treat breast cancer and non-small cell lung cancer (NSCLC) places it among the next-generation cancer therapies.
Altuviiio (efanesoctocog alfa) – Sanofi & Sobi
Altuviiio is the first once-weekly factor VIII replacement therapy for hemophilia, reducing the burden of frequent injections. Its convenience and efficacy make it an attractive option for patients who prefer not to use gene therapies or monoclonal antibodies.
Gene Therapies Enter the Spotlight
Gene therapies are rapidly emerging as a revolutionary approach to treating previously untreatable genetic conditions. Two key therapies expected to achieve blockbuster status include:
- Casgevy (exagamglogene autotemcel) – Vertex Pharmaceuticals & CRISPR Therapeutics: The first FDA-approved treatment using CRISPR genome-editing technology, targeting sickle-cell disease.
- Lyfgenia (lovotibeglogene autotemcel) – bluebird bio: A gene therapy for sickle-cell disease, using a lentiviral vector for genetic modification.
Both therapies represent groundbreaking advancements for patients suffering from blood disorders like sickle cell disease and beta-thalassemia.
Vaccines Make an Impact
The race to develop new vaccines continues, especially in the context of respiratory viruses. Two vaccines for respiratory syncytial virus (RSV) stand out:
- Arexvy (RSV vaccine) – GlaxoSmithKline: Approved for older adults, this vaccine is expected to reduce hospitalizations caused by RSV.
- Abrysvo (RSV vaccine) – Pfizer: Targets both infants and older adults, making it a key player in the global fight against respiratory infections.
Oncology and Rare Disease Innovations
Innovative biologics are also making their mark in oncology and rare disease treatments:
- Talvey (talquetamab) – Johnson & Johnson: This first-in-class bispecific antibody treats multiple myeloma and is set to expand into new indications.
- Zolbetuximab – Astellas Pharma: A first-in-class claudin 18.2 inhibitor for HER2-negative gastric cancer, addressing an unmet need in oncology.
Despite some regulatory setbacks, such as a Complete Response Letter from the FDA for zolbetuximab, these biologics are expected to be game-changers in their respective fields.
Biologic-based drugs are driving much of the innovation in today’s pharmaceutical landscape. As these therapies continue to evolve and expand into new indications, their market presence will only grow. With biologics making up a significant portion of the top-selling drugs and leading the charge in new drug approvals, the future of medicine is increasingly biologic.
Drug Companies
Drug Companies
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