The 2024 Pharmaceutical R&D Trends Annual Review White Paper (hereinafter referred to as the White Paper) recently released by Citeline, a well-known international consulting firm, shows that in 2023, 5,428 new drugs were added to the global R&D pipeline. Anti-tumor drugs still accounted for the largest proportion, with neurological drugs ranking second. Rare diseases have also received significant attention. As of January this year, the number of rare disease drugs under global development reached 7,191, increasing by 7.6% year-on-year.
In the ranking of the number of R&D pipelines, Hengrui Pharma, Sino Biopharm, Fosun Pharmaceutical, CSPC, and Regeneron, five Chinese pharmaceutical companies, made it into the TOP25.
Over 5,400 New Drug Developments Globally in 2023
Citeline's Pharmaprojects Global Drug R&D Database has been tracking global pharmaceutical R&D trends since 1980. According to the white paper data, in 2023, the scale of the global pipeline in the Pharmaprojects database reached a new high, with an accelerated growth rate. As of January 2, 2024, there are 22,825 drugs under development globally, representing a year-on-year increase of 7.2%, close to the average growth rate over the past five years. Additionally, the growth in the pipeline is accompanied by a new round of eliminations: in 2023, 5,428 new R&D drugs were added globally, while 3,895 candidate drugs exited the pipeline, indicating a relatively high attrition rate for pipeline drugs during the year.
In terms of the new additions to companies' pipelines, Pfizer added 32 new candidate drugs this year, surpassing Hengrui Pharma to rank first, while Hengrui Pharma added 30 new drugs, ranking second. Regarding the development locations of newly added pipeline drugs in 2023, the United States remains the most prominent region this year with 1,856 new candidate drugs. China is closing the gap, adding 1,627 new drugs, up from 1,457 in 2023.
From the Perspective of Clinical Stages, Global Preclinical Pipeline Scale Increased Significantly by 650 Drugs in January This Year. The number of drugs in Phase I clinical trials reached 3,703, with the highest growth rate of 13.5%. The Phase II clinical trial stage also showed a positive trend, with 3,374 drugs and an increase of 7.8%. There are 1,248 drugs in Phase III clinical trials, only 19 more than last year. Historical data shows that during 2017-2021, the number of drugs in Phase III clinical trials was inversely related to the growth trends in Phase I and Phase II, indicating a worsening dropout rate. From 2022 to 2023, the number of drugs in Phase III clinical trials resumed a growth trend. Data from industry analysis institutions such as Deloitte show that drug development costs are increasing year by year, while return on investment continues to decline.
Moreover, in 2023, Pharmaprojects reported 88 mergers and acquisitions, a slight increase from the 81 recorded in 2022. After experiencing the storm of large-scale mergers and acquisitions by pharmaceutical giants from the late 1990s to the early 2000s, the market has remained calm for a long period.
Three Chinese Companies Advance into the Global TOP25 in R&D Pipeline Count
In terms of the scale of companies' R&D pipelines (as of January 2024), the white paper shows that among the global TOP25, Roche (218), Pfizer (205), AstraZeneca (166), Eli Lilly (159), and Bristol-Myers Squibb (158) rank in the top five. Among them, Pfizer, AstraZeneca, and Eli Lilly achieved growth in the number of drugs in their R&D pipelines after completing new acquisition projects. Novartis fell from first place last year to sixth this year due to a significant reduction in its pipeline. In addition, the scale of R&D pipelines of Bristol-Myers Squibb, Johnson & Johnson, Merck & Co., Sanofi, and Takeda also shrank.
Among Chinese companies, Hengrui Pharma (147 products), Sino Biopharm (103 products), Fosun Pharmaceutical (90 products), CSPC (73 products), and Regeneron (71 products) also entered the TOP25, ranking 8th, 15th, 17th, 24th, and 25th respectively. Hengrui Pharma became the first Chinese pharmaceutical company to enter the TOP10 based on pipeline size, with a recorded pipeline growth of 38.7% year-over-year. In terms of the number of original drugs in 2023, Hengrui Pharma ranked first with 138 products, surpassing Roche (125 products), Pfizer (127 products), and AstraZeneca (103 products). Hengrui Pharma has the highest proportion of original drugs, with nearly 94% of its R&D pipeline being independently developed. Sino Biopharm also saw a significant increase of 72% in its pipeline size this year. Two decades ago, China had almost no domestically developed original compounds.
Regionally, although the United States still dominates, its advantage is declining. Of all drugs in the pipeline, 49.1% are being developed in the U.S., down from last year's 51.1%, and falling below the 50% benchmark for the first time. China has become the second-largest country in new drug development, with its R&D pipeline scale increasing to 26.7% of the global total. Since 2019, China’s pharmaceutical development has entered a golden age over the past five years, with an increase of 200.9%, partly due to a sharp rise in government investment in the pharmaceutical sector. Meanwhile, South Korea, another Asian country, rose to third place, while the UK dropped to fourth.
The Number of Drugs in Development for Rare Diseases is Increasing Year by Year
In terms of therapeutic areas, oncology drugs accounted for the largest proportion of the pipeline entering 2023, representing 38% of all new drug candidates in 2023, a slight decrease from 2022. Neurological drugs ranked second, accounting for 12.7%, also down from 13.5% last year.
Among the top 10 companies in pipeline scale, Eli Lilly is the only one that does not focus on anti-cancer drugs, instead specializing in digestive/metabolic drugs. Nearly 50% of Bristol-Myers Squibb's drugs are concentrated in the field of oncology. Sanofi's portfolio of anticancer drugs is roughly equivalent in size to its anti-infective drugs, while Pfizer and Merck also have a significant presence in the field of cancer treatment.
The field of rare diseases is also an area of focus for major pharmaceutical giants. The number of rare diseases targeted for drug development has increased from 389 in 2013 to 761 in 2023, showing a year-by-year growth trend. In addition to the urgent clinical needs, the substantial profits brought by the successful development of orphan indications have also become one of the important reasons for pharmaceutical companies to invest in rare disease drug research and development.
In terms of the number of orphan drug developments, at the beginning of 2024, the number of orphan drugs in development reached 7,191, increasing by 7.6% from 6,682 last year, accounting for 31.5% of the total pipeline drugs, slightly higher than in 2023. However, most orphan drug developments are still in the preclinical stage, with considerable clinical activity ongoing. The number of clinical trials initiated for orphan drugs in 2023 was 2,430, an increase of 95 compared to 2022.
White Paper Shows Novartis Replaces Pfizer at the Top of the List of Companies with the Most Rare Disease Drugs in the R&D Pipeline. Among the top 20 companies with the most rare disease drugs, Novartis, Pfizer, Bristol-Myers Squibb, and Roche rank in the top four, each with over 100 rare disease drugs. Of these, Novartis and Bristol-Myers Squibb have more than 50% of their total R&D pipeline dedicated to rare disease drugs, accounting for 53.6% and 50.9%, respectively. Although Biogen has only 36 rare disease drugs, its pipeline proportion reaches 53.7%. Hengrui Pharma and Sino Biopharm have 37 and 36 rare disease drugs, respectively, also making it into the top 20 list for the number of rare disease drugs. The proportions of rare disease drugs in their R&D pipelines are 24.8% and 34.3%, respectively.
Reporter Wang Kala from The Beijing News
Proofread by Baoqing Liu