Last month, Citeline unveiled its Pharma R&D Annual Review for 2023, weaving a captivating literary tapestry of the pharmaceutical industry's journey. The annual analysis, facilitated by senior director of Pharmaprojects at Citeline Ian Lloyd, offers an in-depth look at industry trends through the lens of pharma pipelines.
The review revealed a steady growth in the drug pipelines, with diverse therapeutic areas and an increased focus on rare disease. The landscape has stayed relatively stable, with top companies experiencing minimal changes in their pipeline sizes, setting the stage for a potential resurgence of mergers and acquisitions in the near future.
Challenges such as increasing costs and prolonged clinical trials persist, but so too has the industry's unwavering commitment to delivering treatments and addressing unmet medical needs. With smaller companies assuming prominent roles and major players expanding their interests, the ever-evolving pharma landscape has become fertile ground for innovation, fostering a plot that paves the way for remarkable advancements in health care.
Ample pipeline content
This year, pharma's R&D narrative features substantial pipeline content, with 21,292 drugs in development (preclinical to launch). With a growth rate of 5.89%, slightly behind the previous year's 8.22% surge but surpassing 2021's 4.76%, pharma’s tale speaks of a steadfast and sustainable rise, hinting at the industry's potential resurgence from recent tribulations — ahem, a global pandemic.
Amidst this saga, a prominent protagonist emerges in the form of Jiangsu Hengrui Pharmaceutical, a Chinese powerhouse, leading the charge with the most significant increase in pipeline size. Founded in 1970 and headquartered in China's Jiangsu Province, Hengrui focuses on both innovative and generic medications in areas like oncology, cardiovascular diseases, anesthesia and neurology.
In terms of sheer number of drugs in the pipeline, established titans Roche and Novartis are still in the lead, with 194 and 191 drugs, respectively. The U.S. has retained its developmental dominion with 1,840 candidates, while China, inching closer, boasts an impressive 1,457 candidates.
All told, there are 1,183 more drugs in development than there were at this time last year.
This year, several characters are fighting to become protagonists. Looking at the top 25 pharmaceutical companies, Roche and Novartis have swapped positions this year, with Roche surpassing Novartis in terms of pipeline numbers. Overall, pipeline sizes remained relatively stable from 2022, with minimal changes observed among the top players. Of the top ten companies, only Bristol Myers Squibb and Pfizer showed an increase in pipeline size compared to the previous year.
Not only has the number of pharmaceutical companies involved in R&D grown significantly, reaching 5,529 — indicating a considerable expansion within the industry — but smaller companies with one or two drugs in their pipeline have seen an increase in their contributions, accounting for a larger share (17.5%) compared to major companies. This is up slightly from a 16.91% contribution last year.
Setting the scene
Pharma's R&D story is mainly being told in the cancer space, with oncology owning over 40% of new drug candidates in the 2023 pipeline. In fact, Eli Lilly is the only company in the top 10 whose largest therapeutic area for R&D is not anticancer, with the drugmaker more focused on metabolic drugs.
Cancer is followed by 13.5% of pipeline drugs focused on neurological conditions. There is a surge in the pursuit of remedies for rare disease, with 19.5% of the fresh additions focused on one or more orphan indications — a significant leap compared to the previous year.
Breast cancer, non-small cell lung cancer and Alzheimer's disease are fastly emerging as pivotal areas of research, echoing the urgent demand for advancements in these domains.
Challenging plot lines
Within the vast expanse of industry's ambitious pipeline, an uncomfortable truth emerges — most of these drugs are still in the prelaunch phase, symbolizing costs and risks rather than revenue-generating treatments. Recently, 2021 witnessed a record-breaking 97 New Active Substances (NAS) successfully making their market debut, surpassing the previous milestone of 82 set in 2020. It remains to be seen if 2022 can match this output, but so far, approximately 60 NAS have debuted.
Yet, amidst potential and promise, concerns loom large, as mounting drug development costs and prolonged clinical trial phases cast shadows over the industry. A report from the Deloitte Centre for Health Solutions found that cycle times for clinical trials have grown from 6.9 to 7.09 years, and a substantial rise in the average cost of drug development, soaring from $1,986 million to $2,284 million.
The overriding theme of Citeline's pipeline review was positive one: Despite everything that has been thrown at the industry in recent times, pharma R&D continues to grow.