The global biologicals market surged to an impressive US$419.07 billion in 2023. Blood and blood products led the market, commanding a dominant 66% share. Oncology stood out as the leading application segment, accounting for 36% of the market. North America held the largest revenue share, at 46%, while the Asia-Pacific region emerged as a rising star, poised to be the fastest-growing region over the next decade.
In 2023, significant patent expirations [1], the emergence of weight loss drugs, and other new market dynamics shaped the landscape. Of the top 20 drugs by global sales, nine were biological drugs, collectively generating US$105.08 billion. Table 1 provides further details on these nine biologicals.
By disease category, immunology dominated the market share at 44.60%, followed by oncology at 33.30%, see Table 1. Biologicals, including monoclonal antibodies, and immunotherapies, have revolutionized cancer treatment, significantly improved survival rates and reducing side effects.
| Table 1: Top nine biologicals by worldwide sales in 2023
|
| No.
|
Brand name
|
INN
|
Company
|
US$ billion
|
Disease category
|
| 1
|
Keytruda
|
pembrolizumab
|
Merck & Co
|
25
|
Oncology
|
| 2
|
Humira
|
adalimumab
|
AbbVie
|
14.4
|
Immunology
|
| 3
|
Dupixent
|
dupilumab
|
Regeneron and Sanofi
|
11.6
|
Immunology
|
| 4
|
Stelara
|
ustekinumab
|
Johnson & Johnson
|
10.9
|
Immunology
|
| 5
|
Opdivo
|
nivolumab
|
Bristol Myers Squibb and Ono
|
10
|
Oncology
|
| 6
|
Darzalex/
Darzalex Faspro
|
daratumumab and hyaluronidase-fihj
|
Johnson & Johnson
|
9.7
|
Haematology
|
| 7
|
Eylea/Eylea HD
|
aflibercept
|
Regeneron and Bayer
|
9.4
|
Ophthalmology
|
| 8
|
Skyrizi
|
Risankizumab
|
AbbVie
|
7.7
|
Immunology
|
| 9
|
Ocrevus
|
ocrelizumab
|
Roche
|
6.38
|
Autoimmune
|
|
|
Total
|
105.08
|
|
| INN: International Nonproprietary Names.
|
The American Cancer Society estimates that in the US, there were 1.92 million new cancer cases and 609,360 deaths in 2022, contributing to a global toll of 9.6 million lives lost in 2022. The World Health Organization's most recent projections suggest a staggering 77% increase in new cancer cases globally by 2050, compared to approximately 20 million recorded in 2022 [2]. In 2023, the European prescription sales for oncology reached €307 billion, with biologicals accounting for 30%.
Among the top nine biologicals in global sales in 2023, three — adalimumab, ustekinumab, and aflibercept — have multiple biosimilars approved worldwide.
Beyond the top nine biologicals, two complex drugs also achieved substantial sales in 2023. Novo Nordisk's Ozempic (semaglutide) and Eli Lilly's Trulicity (dulaglutide), both used to treat type 2 diabetes, generated sales of US$14 billion and US$7.2 billion, respectively.
Additionally, several companies are actively developing biosimilars for pembrolizumab [3, 4], ocrelizumab [5], nivolumab [6], and daratumumab [7].
Related article
Ten best-selling biosimilars in Brazil in 2023
|
LATIN AMERICAN FORUM
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References
1. Derbyshire M. Patent expiry dates for biologicals: 2018 update. Generics and Biosimilars Initiative Journal (GaBI Journal). 2019;8(1):24-31. doi:10.5639/gabij.2019.0801.003
2. GaBI Online - Generics and Biosimilars Initiative. Role of biologicals and biosimilars in cancer treatment amidst rising cases [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 29]. Available from: www.gabionline.net/reports/role-of-biologicals-and-biosimilars-in-cancer-treatment-amidst-rising-cases
3. GaBI Online - Generics and Biosimilars Initiative. Tocilizumab and pembrolizumab biosimilar advances for Korean firms [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 29]. Available from: www.gabionline.net/biosimilars/research/tocilizumab-and-pembrolizumab-biosimilar-advances-for-korean-firms
4. GaBI Online - Generics and Biosimilars Initiative. Forwards for Formycon’s Keytruda and backwards for Prestige’s Herceptin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 29]. Available from: www.gabionline.net/biosimilars/news/forwards-for-formycon-s-keytruda-and-backwards-for-prestige-s-herceptin
5. GaBI Online - Generics and Biosimilars Initiative. Phase III trial results of CinnaGen’s ocrelizumab similar biotherapeutic product [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 29]. Available from: www.gabionline.net/pharma-news/phase-iii-trial-results-of-cinnagen-s-ocrelizumab-similar-biotherapeutic-product
6. GaBI Online - Generics and Biosimilars Initiative. STADA and Xbrane strengthen biosimilars collaboration [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 29]. Available from: www.gabionline.net/pharma-news/STADA-and-Xbrane-strengthen-biosimilars-collaboration
7. GaBI Online - Generics and Biosimilars Initiative. China accepts IND application for daratumumab copy biological HLX15 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 29]. Available from: www.gabionline.net/biosimilars/news/China-accepts-IND-application-for-daratumumab-copy-biological-HLX15
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