China Takes A Bigger Role In The World Pharma Stage
COVID-19’s Impact On R&D And Novel Drug Launches Wanes
Executive Summary
2021 saw a record number of novel drug launches and the size of the pipeline topped 20,000 candidates for the first time, new analysis shows, while China came of age as a pharma player.
The pharma world’s tectonic plates shifted towards China in 2021, as the record number of 97 novel drug launches included 19 in that market, and the proportion of Chinese-based biopharma firms rose to more than 12% of the total active in R&D.
Overall, the pharma R&D pipeline expanded by more than 8% in 2021 to reach 20,109 drugs at the start of January, new research shows.
The expansion rate of the pharma pipeline during 2021 was nearly twice that seen in the previous 12 months (4.76%), although it was lower than 2020’s 9.62%. Even so, the growth rate compared well with the 2019 and 2018 figures of 5.99% and 2.66%, respectively, putting 2021 at the upper reaches of the figures seen over the past five years, and well above the five-year average of 6.25%. It also took the pipeline size beyond the 20,000-mark for the first time.
The biopharma industry launched 97 novel active substances in their first markets in 2021, smashing the previous year’s record new product tally of 83. Novel product launches for COVID-19 continued to make an impact, with 17 new products against the coronavirus making their market debuts during the year, but the industry’s response to the pandemic did not fully account for the acceleration seen in this strict measure of R&D productivity.
The data come from Pharmaprojects’ Pharma R&D Annual Review 2022, published by Citeline (part of Informa Intelligence) and based on a snapshot of the database taken on 4 January. Now in its 30th year, the analysis also includes a complementary analysis of novel drug launches, Pharma R&D Annual Review 2022 Supplement: New Active Substances Launched During 2021, and allows for comparisons to be made across the years and decades.
In the analysis, ‘pipeline’ refers specifically to all drugs in development by pharmaceutical and biotech companies, from those at the preclinical stage, through the various stages of clinical testing and regulatory approval, and up to and including launch. Launched drugs are still counted, but only if they are still in development for additional indications or markets. Drugs for which development has stopped, or is complete, are not included.
The report reveals that, overall, there were 1,527 more drugs in development than at the same time point last year, when the uplift was only of 845 drugs over the year before. COVID-related treatments did not have as great an impact on the figure as they did in 2020 when 800 novel vaccines and treatments for SARS-CoV-2 swelled the pipeline. (Also see "COVID-19 Accounts For Most Of 2020’s Pharma Pipeline Growth" - Scrip, 5 Apr, 2021.)
This year’s chart of the top 25 companies by the size of their R&D pipelines (Table 1) shows no change in the make-up of the top 15 companies, and very little change in their relative positions.Novartis AG remains at the top for the sixth year running, although its pipeline did contract slightly from 232 to 213 drugs over the year. Compatriot Roche Holding AG was runner-up again but posted a bigger fall in its pipeline size. The remainder of the top five – Takeda Pharmaceutical Co. Ltd., Bristol Myers Squibb Company and Pfizer Inc. – each also reported a reduction in their pipelines. The biggest climber within the top ten was AstraZeneca PLC, up three places, although this was on the back of just four more drugs, despite its acquisition of Alexion Pharmaceuticals Inc.
Meanwhile, pharma’s center of gravity is shifting eastwards. While the US continues its dominance, accounting for 53.4% of all drug R&D development activities globally, China came in second with 20.8%.
Overall, the pharma company world expanded once again in 2021, with 5,416 firms being involved in R&D as of January 2021, an increase of 317 (6.2%). As with the numbers of drugs, the growth rate seen was less than that in the previous year: the 2021 data added 283 companies (up by 5.9% vs 11.4% growth the previous year). The number of newly identified companies in the past year was 1,042, slightly down on the previous year’s record-breaking 1,055.
China In The Ascent
China may be a relative latecomer to the global pharma R&D scene, but some of the fastest pipeline growth is now coming out of the country, which for the first time also has several home-grown firms ranking among the world’s top 25 pharma companies by pipeline size.
Jiangsu Hengrui Medicine Co., Ltd. soared from 37th place the previous year to rank at 16th, fueled by a colossal 71.2% increase in its R&D portfolio size. And Shanghai Fosun Pharmaceutical (Group) Co., Ltd., made an even steeper ascent, surging up 43 places with a pipeline expanded by 127% during the year. Unlike Hengrui, Fosun has relied mainly on licensing in assets from partners, including BioNTech SE for its mRNA COVID-19 vaccine.
“It’s certainly fair to say that after a number of years of building a presence at a quite extraordinary rate, novel pharma R&D from China is finally on the map.”
The Chinese major BeiGene, Ltd., perhaps best known known for its multi-billion dollar alliances with Amgen, Inc. and with Novartis for the PD-1-targeting antibody tislelizumab, ranked among the world's top 20 pharma companies in terms of rare disease drug pipeline and was 26th in terms of pipeline size overall.
These developments represent "something of a landmark moment for Chinese pharma R&D," said the report’s author Ian Lloyd, senior director at Pharmaprojects.
Although the figures for each individual Chinese company may look good, it is the developing ecosystem in China that is helping sustain the strong growth. The US has long been a hub for medical innovation, sustained by clusters of emerging start-ups and R&D centers, and something similar is emerging in China. The proportion of biopharma firms with active pipelines based in China jumped from 9% to 12%, while those headquartered in the US fell by 2%, with the number of Chinese pharma companies rising by an "astounding" 43.3%, from 522 to 792. This was a “very significant expansion for a single year," noted Lloyd. “There is truly a boom in R&D going on there.”
He concluded: “It’s certainly fair to say that after a number of years of building a presence at a quite extraordinary rate, novel pharma R&D from China is finally on the map.”
Pipeline Data
Figure 3 breaks down the 20,109 drugs in the pipeline by their current global status – the most advanced stage of development each drug has reached in any country, for any disease, and by any company.
It shows the lion’s share of pipeline expansion occurred in drugs that are still at the preclinical stage, with a growth rate here is an impressive 11.0%. “This is a considerable uptick on the rate of expansion in the preclinical pipeline witnessed in 2020, which was only 6.0%,” noted Lloyd. An additional 1,128 drugs are in preclinical development compared with the same time point last year, he added, noting that it is at the preclinical phase that a lot of churn takes place, “so there are not just more overall, but many more different ones this year compared to last.”
NAS Launches
The 97 NASs that made their market debuts in 2021 are contained in 95 new products (two launches were of combination products with two NASs apiece) and, together with 2020’s previous record tally, reinforce a strong upward trend in new launches over the past five years. See Figure 4.
Of the new product launches, 38.8% were for cancer indications, with neurologicals coming in second at 14.7%, while anti-infectives, including most of the COVID-related products, were in third place with 12.0% of the new drugs. 17.5% of new drugs are focused on one or more rare disease.
AstraZeneca, which launched its COVID-19 vaccines in early 2021, topped the list for the company with the most novel launches (with five) pushing out Pfizer and Gilead which led the charge in 2020. Cancer therapies regained their position as the most popular therapy area for novel products, having lost their crown to anti-infectives in 2020 when five new products for Ebola added to the tally of COVID-19 therapies introduced that year.
Thirteen companies introduced two novel products apiece. These include six companies outside of the top 25 by pipeline size, four of which are Chinese, with Guangzhou Pharmaceuticals being the company with the biggest NAS launch to pipeline size ratio.
They were joined by Hong Kong’s HUTCHMED (China) Limited and BridgeBio Pharma, Inc. in the US. A further seven of the dual drug deliverers are top 25 companies by pipeline size, including one of the first Chinese-headquartered firms to enter that list, Jiangsu Hengrui.