As we start the new year, we look back at a year of innovations in the life sciences sector.
The Clarivate Drugs to Watch 2025 report detailed the therapeutic drugs that are expected to achieve blockbuster status ($1bn annual sales) or transform treatment standards within the next five years. Eleven therapeutics were identified, spanning treatment areas such as diabetes, obesity, oncology and rare diseases, which we have summarised in the table below.
| Drug to watch |
Disease or disorder |
Relevance |
| AWIQLI® (insulin icodec) |
Long-acting basal insulin analog |
Type 1 and 2 diabetes |
First once weekly subcutaneous administered insulin; can be used in conjunction with a mobile app for individually optimised dosing |
| CagriSema (cagrilintide + semaglutide) |
Combination of a GLP1R agonist + a long-acting amylin analog |
Obesity and type 2 diabetes |
Combines the known advantages of GLP-1s (enhanced insulin secretion and slowed gastric emptying) with the activity of amylin (slowed glucose absorption and hepatic release) for greater efficacy |
| COBENFYTM (KarXT; xanomeline-trospium) |
Muscarinic acetylcholine receptor agonist |
Schizophrenia and psychosis related to Alzheimer’s disease |
Selectively targets M1 and M4 receptors, rather than the traditional dopamine pathways, making it the first drug approved with a novel mechanism of action for schizophrenia in more than 30 years |
| EBGLYSSTM (lebrikizumab) |
IL-13 monoclonal antibody |
Atopic dermatitis |
Less frequent dosing and more selective inhibition of IL-13 than competitor products |
| Fitusiran |
Antithrombin-targeting siRNA |
Haemophilia A and B |
First antithrombin-lowering therapy based on a double-stranded RNA molecule |
| GSK-3536819 |
Pentavalent vaccine targeting the five groups of the bacteria Neisseria meningitidis |
Meningococcal disease |
5-in-1 vaccine reduces the number of injections required to achieve protection |
| IMDELLTRATM (tarlatamab) |
DLL3 × CD3-targeting BiTE® molecule |
Small-cell lung cancer |
Uses T-cells to recognise and lyse tumor cells; DLL3 is expressed on the surface of SCLC cells in more than 85% of patients but is minimally expressed on healthy cells, making it an attractive target |
| mRESVIA (mRNA-1345) |
mRNA-based vaccine |
Lower respiratory tract diseases caused by respiratory syncytial virus (RSV) |
Only RSV vaccine available in a single dose pre-filled syringe; RSV vaccines address a significant need for infectious disease control and decreased hospital burden, especially during the “tripledemic” of RSV, flu and COVID-19 |
| SEL-212 |
Co-administration of pegylated uricase + ImmTOR™ (nanoparticles
encapsulating sirolimus) |
Gout |
Combination designed to improve efficacy of uricase by reducing the formation of anti-drug antibodies |
| Vepdegestrant (ARV-471) |
Oestrogen receptor PROTAC degrader |
Breast cancer |
First PROTAC therapy to reach Phase 3 |
| Zanzalintinib (XL092) |
Tyrosine kinase inhibitor (TKI) targeting VEGF receptors, MET and the TAM kinases (TYRO3, AXL, MER) |
Colorectal cancer; renal cell carcinoma; squamous cell carcinoma of head and neck |
Potential to treat a broad patient population including nccRCC, which is a heterogenous group of rare, histologic subtypes with a poor prognosis and
limited treatment options |
The report also explores broader trends within the life sciences sector, highlighting the diversity in the types of therapy that are coming onto the market and the utility of artificial intelligence (AI) and machine learning (ML) within therapeutic innovation. This includes the use of such tools in identifying molecules, repurposing existing drugs, diagnosing rare diseases, and maximising the efficiency of clinical trials. AI and ML may also be helpful in improving manufacturing processes to ensure the demands for drugs can be met and for cost efficiency purposes.
These developments in the life sciences space give rise to several considerations in relation to patent protection, in particular with regard to filing strategies and the subject matter that can be protected.
As the industry shifts towards new modalities such as mRNA platforms, gene editing and cell therapies, patent portfolios are likely to become more intricate, with companies seeking to cover the delivery systems, manufacturing processes and digital companion technologies associated with such therapies. In addition, most of the drugs to watch identified in the report have core patents expiring between the late 2020s and 2030s, despite the drugs only receiving regulatory approval recently. This reinforces the importance of strategic filing considerations, for example through secondary patents, formulation improvements or new indications. It is notable, however, that the shorter development time for mRNA therapeutics in particular appears to afford pharmaceutical companies longer periods of market exclusivity. For example, the core patents for the approved therapy mRESVIA® are estimated to expire as late as 2038.
Interestingly, the Clarivate report specifically highlights the radiopharmaceuticals market as a potential game changer in cancer treatments. They predict that the radiopharmaceutical market could grow by 10% over the next 10 years. The modern radiotherapeutic era is partly being driven by “theranostics”, a concept which combines diagnostic imaging and therapeutic radiopharmaceuticals to provide a “see it and treat it” approach. Although there is promising activity within the radiopharmaceutical market, the report highlights the challenges for further development in this area, including the management of radioactive waste material, the reliability of supplies of medical isotopes and regulatory challenges. There are also additional patent considerations for “theranostics” that requires navigating exclusions for diagnostic methods practiced on the human body.
The Biotechnology team at Boult have experience of working on a broad range of technologies. Please do not hesitate to get in touch with the team if you would like to discuss any of the above.
