Over the past two years the list of the best-selling biopharmaceuticals has been the direct result of the COVID-19 pandemic. Since the start of the pandemic the use of contract development and manufacturing organizations (CDMOs) and the use of single use bioprocessing equipment (SUS) has grown. According to the 20th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production published by BioPlan Associates in April 2023,¹ CDMO revenues for biologics and vaccines alone hit $16.9 billion in 2022.

This is nearly double the revenue pre-pandemic. However, the segment’s underlying growth, which had been running in the 9-12% range, would have doubled nearly every five years regardless.

What pushed the revenue growth rate to 17% in 2022 was the fact that CDMOs are simply in higher demand. For example, the percent of biologics developers doing their entire production in-house has trended down steadily since 2006, dropping from 57.6% in 2006 to only 29.7% in 2023.¹ 

On top if this fundamental growth, when COVID hit, the segment quickly responded to new market demands and was able to extend its capacity, scope of modalities, and manufacturing. For instance, in 2019, before COVID, hardly any CDMO was involved in the production of large amounts of mRNA. Now in 2023, only a few years later, a wide range of companies have adopted this novel molecule class and established new capabilities. 

The expansion towards new and more sophisticated modalities, mRNA, cell and gene therapies or antibody drug conjugates (ADCs) leads to the formation of specialized companies that themselves become acquisition targets for established CDMOs that need to complement existing capabilities. Good examples are the takeovers of Brammer Bio by Thermo Fisher Scientific and MolMed by AGC Biologics.

Consumables suppliers such as Thermo Fisher Scientific, Sartorius and others have successfully entered the CDMO market space by acquiring smaller contract manufacturers. These newly integrated CDMOs will benefit from early access to new technologies or reduced consumable costs and a more secure material supply chain.

We have also seen examples of more established companies searching for partners to get their products outsourced to free up internal capacity for new, upcoming pipeline products.

Top 10 best-selling biopharmaceuticals and their anticipated growth

CDMOs are now integrated into most areas of bioprocessing including some of the largest expansions of blockbuster biologics. Measuring the overall growth of the biopharma products also allows insights into the growth of their manufacturing, and the growth of the CDMO segment.

AbbVie’s immunology drug Humira has long held the position of the number one top ranked drug based on revenue, but due to the demand during the pandemic, Pfizer’s COVID-19 vaccine, Comirnaty, dethroned Humira in 2021. As the pandemic wound down, Comirnaty (BNT162b2) maintained its position as the best-selling pharmaceutical of 2022, but it experienced single digit growth. Table 1 provides an overview of the top 50 biopharmaceutical products, by sales, in 2022. Last year Comirnaty provided Pfizer $37.8 billion in revenue and represented over 8% of the entire biopharmaceutical market in 2022. The second largest product by sales was Humira by AbbVie and Eisai, with $21.2 billion in 2022. While the third largest product was Keytruda by Merck & Co. at $20.1 billion. Moderna’s Spikevax reached $20.9 billion. These four products alone total $100 billion.


From a revenue perspective, Pfizer and BioNTech’s Comirnaty had the highest revenue for any pharma product in history. In 2022, total demand in the U.S. (includes use of existing government supply) was 92 million doses, but in 2023, this is estimated to decline due to lower contracted deliveries (including the U.S. government contracts) and less demand in international markets. The company is developing new versions of the vaccines. In June 2023, Pfizer and BioNTech submitted regulatory applications to the FDA and EMA for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine for the 2023-2024 fall and winter season.  Another COVID-19 blockbuster at the top of the list is Spikevax by Moderna, the second largest vaccine product and fourth in the overall list. It realized $17.7 billion in 2022.

In June 2023, Moderna disclosed that their preliminary clinical testing has demonstrated that mRNA-1273.815 is effective in generating an immune response against the current XBB variants and the company has completed submission of a regulatory application to the FDA for its updated COVID-19 vaccine. The company is poised to take the front seat with Pfizer in the COVID-19 vaccine development race. The two segment leaders are steering towards a new era for their vaccines by developing new versions of the drug with broader and longer-lasting immunity against the virus.

As the COVID pandemic wanes, drugs for cancer, autoimmune diseases, and cardiovascular diseases are returning to top positions on the list. Humira is one such an autoimmune drug which has enjoyed the top position for various years. Though, it slipped to second position in 2021, since its approval in 2002, Humira has accounted for a major revenue share of AbbVie. Humira is expected to encounter competition from the European and U.S. biosimilars rivals of adalimumab. Eight of the nine FDA-approved Humira biosimilars will launch in 2023. In first-quarter earnings statements of 2023, AbbVie reported $2.9 billion in revenue in the U.S. from Humira—a 26% drop from the first quarter of 2022. Under this expected pressure, AbbVie is turning to its next generation immunology drugs—Skyrizi and Rinvoq—to help address the biosimilars competition. Rinvoq (upadacitinib) and Skyrizi (risankizumab) saw U.S. sales increase 44.4% and 45.9%, respectively, in the first quarter of this year relative to 2022.

Another major biopharmaceutical product is Merck & Co.’s Keytruda, the world’s best-selling cancer drug; in 2022 this drug held third place in the list. Keytruda is a cancer immunotherapy medication and is doing much better compared to its closest rival, Bristol Myers Squibb’s Opdivo, which holds seventh position with $9.4 billion in sales. In 2022, Keytruda sales jumped 22% year over year to $20.9 billion, while Opdivo sales climbed 10%.

Johnson & Johnson’s Stelara moved one step up to fifth position on the list in 2022 with reported revenue of $9.7 billion during the year. Launched in 2009, Stelara was the first biologic treatment to selectively inhibit the IL-12 and IL-23 pathways. Other significant contributors in the market are Novo Nordisk’s Ozempic and Johnson & Johnson’s Darzalex made it to ninth and tenth positions with $8.7 billion and $7.9 billion respectively. Ozempic took a big leap from the past year, and it seems positioned to do well in the coming years.

Originally granted approval in the U.S. in 2017, Ozempic has also been approved for three distinct dosages to treat type 2 diabetes. Novo Nordisk’s leading drug Ozempic is anticipated to augment a sales growth of 23% in 2023. Ozempic’s forecast 2023 sales are $12.5 billion and is expected to sustain its sales growth over the next five years, with an expected annual sales figure of $17 billion in 2029. This would mark a significant 83% increase in sales from 2022–2029.

Top 50 biopharmaceuticals take center stage in the industry

According to BioPlan’s report,¹ the total worldwide human biopharmaceuticals market was an estimated approximately $470 billion in 2022 and the world market for recombinant protein therapeutics is now more than $250 billion, with non-recombinant vaccines, blood/plasma and cellular products comprising nearly all the remainder of the market. The top 50 biopharmaceutical products represented an estimated 62.1% or a total revenue of $291 billion, this year.

Overall, this data indicates that there is a concentration of market share around the top 50 products of the biopharmaceutical industry, with the revenue of these products alone making up 62.1% of the industry (Figure 1). It is also interesting to note that the total bioprocess cost of goods represents only a small proportion (9.6%) of the total market value (Table 2).

 

Contract services: major expenditure in global biomanufacturing

As calculated in BioPlan’s report,¹ the total bioprocess related industry expenditure was an estimated $45.2 billion, in 2022. This data highlights certain cost-of-goods related to biopharmaceutical production. It does not include fixed costs, R&D or other expenditures.

Conclusions

The biopharmaceutical segment remains active, innovative, and profitable. It continues to grow, including having generally recovered from worldwide economic problems and is now returning to its fundamental growth. Although revenues to CDMOs for production of COVID-19 pandemic vaccines and therapeutics made a significant impact on the segment’s growth, the historical growth seen over the past 20 years continues.

The changes in bioprocessing and supply chain security measures resulting from the COVID-19 pandemic are focused on regionalization, more geographic distribution, and more bioprocessing facilities.² In the future, these regional foreign collaborations may involve greater outsourcing of R&D, the licensing of manufacturing rights to organizations in developing countries, or establishment of local clinical research and manufacturing operations.

Partly due to the impact of the pandemic, biopharmaceutical manufacturing capacity outside of the usual major market countries is increasing, as indicated by BioPlan’s Top 1000 Global Biopharmaceutical Facilities Index,² which ranks facilities worldwide in terms of cumulative bioreactor capacity, along with staffing, number of products, and other factors. Much new and increased capacity is being added worldwide, with biopharmaceutical markets in many developing countries rapidly growing and domestic/regional companies increasingly serving these markets. Along with the shift from a pandemic market, increased capacity and enhanced outsourcing can be expected in the coming year.

References
1. 20th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, BioPlan Associates, Rockville, MD, April 2023, 490 pages; www.bioplanassociates.com/20th.
2. Top 1000 Global Biopharmaceutical Facilities Index, BioPlan Associates, Inc; www.top1000bio.com.

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Arvind Deol, MSc, is senior director of strategic research at Bioplan Associates. He has a comprehensive background in marketing and analytics within the biotechnology industry and brings demonstrated expertise in strategy development, market research, competitive analysis, and business intelligence. Having worked in both the US and the UK, he provides a unique approach with an international perspective that is further supported by his experience working for global scientific thought leader organizations, such as Springer Nature. He has an MSc in biotechnology, bioprocessing and business management from University of Warwick, UK, and a degree in microbiology from the University of Georgia.

Smita Khanna, PhD, is director of technical research at BioPlan Associates, and is a biopharma and healthcare market researcher/analyst. With a PhD in biotechnology, she has extensive experience working in several key industry segments and has experience at the Council of Scientific & Industrial Research – Indian Institute of Toxicology Research (CSIR-IITR), India. Her expertise includes primary and secondary research, and market analysis of healthcare and biopharma segments. She contributes to international publications and journals, and research for in-depth reports.

For more information about BioPlan Associates: +1 301-921-5979; www.bioplanassociates.com