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Top 50 Biopharma Products Drive Growth in Contract Manufacturing

Monoclonal antibodies driving contract manufacturing’s growth in 2023.

The biopharmaceutical manufacturing segment has demonstrated remarkably consistent growth over the past 20+ years. Even during the current post-COVID economic environment where investment in biologics R&D has been reducing, the overall long-term outlook remains strong for global bioproduction. This has moved the production and even the innovation of these critical products beyond the borders of the current established markets in the U.S. and Europe. 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 21st Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production published by BioPlan Associates,1 CDMO services during COVID increased dramatically, growing from $7 billion in 2018 to $18 billion in 2023. This is more than 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 approximately 10% in 2023 was the fact that CDMO services are simply in higher demand. Though growth had weakened a bit as compared to previous years, owing to the post COVID recovery, overall, the segment is growing steadily.

Data from BioPlan’s 21st Annual Report1 also suggests 73.1% of biologics developers plan some level of outsourcing in 2024 for mammalian cell culture. This marks a decrease in in-house production to 26.9% from previous years, continuing a trend of increasing reliance on external manufacturing services to enhance flexibility and capability.

Similarly, for microbial fermentation, 30.2% of respondents intend to keep all production in-house, showing a gradual decrease from previous years. For the advanced modalities like cell or gene therapies, outsourcing trends fluctuate more distinctly in this category, with only 30.4% of production remaining completely in-house. The spread of outsourcing percentages across various levels (from 1% to over 50%) reflects the specialized nature of these therapies and the strategic use of CDMOs to handle high-value, complex productions.1

On top of 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, few CDMOs were involved in the production of large amounts of mRNA. Now in 2024, 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 lend themselves to become acquisition targets for established CDMOs needing to complement existing capabilities. Examples include the acquisitions of Seagen by Pfizer and Immunogen by AbbVie. Another significant acquisition in the CDMO industry is Novo Nordisk’s acquisition of Catalent.

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

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.

The Top 50 Biologics made up $251 billion in sales in 2023, compared to $273 billion in 2022. Table 1 provides an overview of the Top 50 biopharmaceutical products, by sales, in 2023. As noted, the change in blockbuster drugs resulted from the declining need for COVID-related vaccines. The largest product in 2022 was Comirnaty (BNT162b2), Pfizer’s COVID vaccine, with a total of $37.8 billion in sales, which moved to the second position with a revenue of $15.3 billion in 2023, with more than a 50% decline in the revenue. Similarly, Moderna’s COVID drug Spikevax did not make it to the Top 10 list in 2023.

The largest selling biopharma drug in 2023 was Keytruda by Merck & Co. with $25 billion in sales. This year, AbbVie’s Humira’s sales also declined from $21.2 billion in 2022 to $14.4 billion in 2023, though Humira was in third position with a 5.7% share of the Top 50 Biopharma revenue.

Gilead’s Yescarta, a personalized cell therapy, entered the Top 50 this year. In coming years, these drugs could take a center stage and could augment a growth in the market. There was a significant decline in the total revenue of the Top 50 Biopharma drugs attributed to the decline in sales of COVID-19 related drugs. The total share of Top 50 Biopharma drugs dipped from 62.1% in 2022 to 47.5% in 2023.

From a revenue perspective, Merck’s Keytruda has emerged as the world’s top-selling drug in 2023, with sales reaching $25 billion, surpassing Pfizer and BioNTech’s Comirnaty, which led the previous two years. Keytruda’s success marks a momentous milestone, outpacing long-time leading drugs like AbbVie’s Humira. The Merck’s Keytruda has been consistent since its launch, with substantial sales increases each year, though Keytruda now faces potential competition from Novo Nordisk’s semaglutide-based therapies, which are rapidly gaining market share.

Pfizer/BioNTech’s Comirnaty enjoyed the top position in 2022, but slipped to second position in 2023, and revenue is further expected to decline in 2024. In August 2024, the drug received FDA approval (the supplemental Biologics License Application) for emergency use authorization for individuals 6 months through 11 years of age for companies’ Omicron KP.2-adapted 2024-2025 Formula COVID-19 vaccine. The company is steering towards a new era for their vaccines by developing new versions of the drug with broader and longer-lasting immunity against the virus. Similarly, in June 2023, Moderna disclosed 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 from Pfizer in the COVID-19 vaccine development race.

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 autoimmune drug which has enjoyed the top position for various years. Humira came off-patent after generating more than $200bn in sales over two decades. Nevertheless, Humira is facing competition from European and U.S. biosimilars rivals of adalimumab. In addition, AbbVie delivered Y/Y growth in the second quarter despite Humira’s decline, with Skyrizi and Rinvoq as key growth drivers, achieving 45% and 56% Y/Y growth, respectively. Skyrizi held the 10th with $7.7 billion in sales.

Regeneron Pharmaceuticals, Eylea (aflibercept) moved to fourth position in 2024, but it is worth noting the drug is reporting declining sales in 2024. Johnson & Johnson’s Stelara slipped to sixth position on the list in 2023 with reported revenue of $10.9 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 include Johnson & Johnson’s Darzalex with $9.7 billion, and Bristol Myers Squibb and Ono Pharmaceutical’s Opdivo with $9 billion. Merck’s Gardasil was at ninth position with $8.9 billion.



Table 1. Global Market for Top 50 Biopharma Products in (2022-2023, $USD Million)
Source: 21st Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, BioPlan Associates.

Top 50 biopharmaceuticals take center stage

According to the 21st Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production published by BioPlan Associates,¹ the total worldwide human biopharmaceuticals market was estimated to be approximately $530 billion in 2023 and the world market for recombinant protein therapeutics and monoclonal antibodies is now more than $220 billion and more than $210 billion respectively, 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 47.4% or a total revenue of $251.4 billion, this year.

Overall, this data indicates 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 47.4% of the industry (Figure 1). It is also interesting to note that the total bioprocess cost of goods represents only a small proportion of around 10% of the total market value (Table 2).


Figure 1.
Source: 21st Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, BioPlan Associates


Table 2. Bioprocess Related Industry Expendtures on Manufacture of Biotherapeutics (estimated $USD, billions)
Source: BioPlan estimates

Contract services a major expenditure in global biomanufacturing

As calculated in the 21st Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production by BioPlan Associates in 2024,1 the total bioprocess related industry expenditure was an estimated $54.5 billion in 2023. This data highlights certain cost-of-goods related to biopharmaceutical production and does not include fixed costs, R&D or other expenditures.

Conclusions

The biopharmaceutical segment remains active, innovative, and profitable. The recent downturn in sales of bioprocess consumables used for manufacturing has been due to multiple causes including over purchasing during COVID resulting in draw-down of warehoused materials, returns to normal industry discounting, and economic conservatism post COVID. Despite these challenges, the pharmaceutical industry and, especially, the biopharmaceutical subset remain profitable and growing and have experienced a transformative landscape post COVID-19.

In terms of biotherapeutic sales, industry witnessed a sluggish market in 2023 owing to declining COVID-19 related sales. In spite of this, the biologics industry is still growing at a smooth pace.

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.

BioPlan’s 21st Annual Report,1 reveals significant trends regarding the U.S. as a favored destination for biomanufacturing outsourcing or expansion, highlighting the growing appeal of the U.S. for bioprocessing capacity expansion. Partly due to the impact of the pandemic, biopharmaceutical manufacturing capacity outside of the usual major market countries is also 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.

Overall, we observe that four out of the top ten destinations are in Asia, with China, India, Korea, and Singapore representing significant outsourcing opportunities due to their growing biopharmaceutical industries and favorable regulatory environments. 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 evident by the recent very large capacity expansions, involving building large fixed stainless-steel bioreactor-based facilities for commercial product manufacture, such as Samsung and Celltrion in S. Korea. Along with the end of a pandemic market, increased capacity and enhanced outsourcing can be expected in the coming year. 

References
  1. 21st Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, BioPlan Associates, Rockville, MD, April 2024, 500 pages https://www.bioplanassociates.com/21st/
  2. Top 1000 Global Biopharmaceutical Facilities Index, BioPlan Associates, Inc. (www.top1000bio.com).

Dr. Smita Khanna is technical director of 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. For more information visit: www.bioplanassociates.com

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