Contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs) are projecting the second-highest growth of any bioprocessing segment measured, with a 13.8% average growth rate in 2024. This, according to BioPlan Associates’ “21st Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production,”¹ is an indication of the return to the long-term stable growth the CDMO segment has seen over the past two decades. While we are not quite back to pre-COVID growth, the trend is in the right direction.

CDMO services for large molecules have shown considerable fluctuation over recent years, reflecting the dramatic shifts in demand due to COVID, but the underlying growth has been tied to the industry’s long-evolving need for outsourced manufacturing.

In our survey, we examine the growth in sales of suppliers by segment over the years—from 2007 to 2024. This longitudinal analysis provides insights into how different segments have per-formed historically and helps in forecasting future demands in the biopharmaceutical industry.  Use of consumables such as cell culture media, and single-use system (SUS) device can be a barometer of the industry’s health. 

The Raw Materials and Consumables segment experienced some of the most dramatic fluctuations during COVID. Suppliers saw double-digit growth in volume, followed by similarly rapid drops in following years. In 2023, BioPlan’s research on SUS devices, for example showed an average 18% drop in volumes among SUS suppliers. But in follow-up research this year, we found the same group is projecting a 28% increase in volumes through June 2025.² This growth can be an indicator of the industry’s underlying growth which mirrors the large molecule contract manufacturing space as well. 

Long-term trends

Over the last twenty years, the biomanufacturing sector has shown exceptional resilience, successfully managing recessions and supply chain disruptions. This stability is driven by robust innovation pipelines, advancements in novel therapies, and the increase entrance of biosimilars in emerging markets. Each of which increasingly require external CMO services.  

Improved technologies such as process intensification, have been adopted by CMOs at a great-er rate than with biologics innovators. This is because CMOs tend to focus on technologies and platforms that can improve efficiencies and tend to scout for next-generation manufacturing strategies and processes to further optimize production. 

The leading strategies for bioprocess improvements by CDMOs

The industry is returning its focus toward process efficiency. To improve manufacturing efficiency facilities are leveraging advanced and emerging technologies to streamline processes and reduce costs.

In 2024, we identified the main areas where CDMOs are targeting adoption of innovations and compared these to biomanufacturers’ adoption (Figure 1).


CMOs are interested in developing a unique capability to handle a wide variety of products and minimizing costs for their clients. This puts them in a position where CMOs are frequently leading in evaluating and adopting new technologies. Further, CMOs can sometimes be the only choice for clients facing complex bioprocessing challenges because the CMO may have greater experience with innovative technologies and have seen and solved more project problems in the past.

We can see this in Figure 1 where CMOs are clearly willing to evaluate innovations such as continuous bioprocessing, automation, and various downstream purification options.
Automation, for example, is being evaluated by 43% of CMOs, compared to only 29% of biologics developers. Automation can offer significant advantages in terms of consistency, precision, and reduced human error. During COVID hiring operations and scientific staff had become very challenging, according to the “21st Annual Report.” This enhanced the industry’s interest in automation as a way to address future staffing challenges. Automation technologies, including advanced robotics and process control systems, enable continuous monitoring and optimization of bioprocesses, leading to higher yields and improved product quality. Automation also supports the integration of data analytics and real-time decision-making, further driving efficiency and in-novation. CDMOs primarily aim to enhance their efficiency, and scalability as a way to maintain a competitive edge.

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Bioprocess intensification is any activity that enhances the efficiency and productivity of bioprocesses by optimizing variables such as temperature and pH. These activities usually involve integrating advanced technologies such as continuous processing and automation to improve scalability and reduce costs. For example, an innovative bioreactor design or a streamlined integration of upstream and downstream processes can achieve higher yields, better product quality, and reduced costs, all while minimizing environmental impact.

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SUS adoption higher among CMOs vs biologics innovators

Understanding the most used SUS across various stages of biopharmaceutical manufacturing helps us pinpoint where SUS are most advantageously applied in the industry.³ CMOs frequently handle a varied product portfolio, that needs more SUS. Thus, CMOs tend to adopt more SUS than traditional biomanufacturers. This trend has been seen across the years but in 2024 CMOs are using more SUS types compared to general biomanufacturers.

Tangential flow filtration devices (TFF), disposable chromatography devices, and membrane absorbers are some of the SUS types that show a significant usage difference between CMOs and general biomanufacturers (Figure 2). TFF devices are used for separating and purifying biomolecules. In a non-SUS TFF system, extensive cleaning and sterilization are required between batches to prevent contamination.


Disposable chromatography can allow CMOs to switch between different processes quickly and efficiently, speeding their process time, and ultimately increasing productivity. These are used by 80% of CMOs vs 64% of biologics innovators.

In traditional systems, membrane absorbers need to be cleaned and validated between uses, which can be labor-intensive and prone to human error. SUS membrane absorbers, however, can be quickly replaced, ensuring consistent performance and reducing the risk of cross-contamination. Again, these are used more by CMOs than biologics innovators (80% vs 64% respectively).

The overall trend toward higher SUS usage by CMOs, highlights their greater need for flexible systems that can be quickly adapted, whereas biomanufacturers tend to focus on optimizing a single or few existing systems.

Outsourcing as a strategic necessity

Biopharmaceutical developers increasingly depend on CMOs, particularly in advanced fields like cell and gene therapy, where specialized manufacturing expertise is often beyond the reach of innovator companies. This growing reliance on outsourcing is driven by the recognition of its strategic and operational benefits. Consequently, they now expect more from these partnerships, demanding greater flexibility, efficiency, and expertise from their CMO collaborators.

Based on the Report’s 21 years of analysis, outsourcing has clearly become a cornerstone strategy in the biopharmaceutical industry. Outsourcing allows companies to concentrate on their core strengths by delegating other tasks to external specialists. By leveraging CMOs for manufacturing and CROs for testing, clinical trials, and regulatory submissions, biopharmaceutical companies can significantly cut down on the need to hire, train, and maintain specialized staff. Outsourcing is not just a temporary fix for capacity shortages; it is a strategic approach to cost management and operational efficiency. Tasks that were traditionally kept in-house are now being outsourced.

CMOs are continuously enhancing their services, focusing not only on providing technical expertise but also on implementing productivity improvements to lower overall costs for their clients while ensuring a stable supply of, and access to, capacity that meets demand. For smaller companies, outsourcing the manufacturing of biologics may be the only feasible way to advance from clinical phases and eventually reach the market. These strategic benefits are especially crucial when specialized expertise, equipment, or infrastructure is required. According to data from the past 15 years, outsourcing to CMOs has doubled for microbial and mammalian systems (Figure 3).


Mammalian cell culture systems are a cornerstone of biopharmaceutical manufacturing. In Figure 3, we see that facilities outsourcing a majority (50% or more) of their production has nearly doubled from 29% in 2009, to 57% this year.

Microbial systems on the other hand include the production of various biologics, including recombinant proteins, enzymes, and vaccines has grown even more substantially from 24% to 62.5% between 2009 and this year.

Outsourcing these two systems can be due to:

• Insufficient staff to perform specialized operations.
• Need to control costs and minimize internal resources.
• Temporary capacity constraints do not justify investment in internal expansion.
• Requirement to rapidly market a product, often due to investor expectations.
• Accelerated regulatory approval demanding quick and guaranteed access to production facilities.

These data underscore the critical role that CMOs now play in the biopharmaceutical industry. This growth also reflects the increasing reliance on outsourcing as companies seek to optimize their manufacturing capabilities and remain competitive in a rapidly evolving market.

Growth in offshoring continues, post-COVID

In our study, we found 60% of non-US innovators report interest in outsourcing to the U.S., although CMOs in Asia are increasingly relevant. Asia is becoming an increasingly attractive destination for outsourcing manufacturing activities, with China emerging as a key player. Nearly 50% are looking towards China. This highlights the increasing significance of Asian countries in contract manufacturing. We note that these data were collected early in 2024, prior to the introduction of the U.S. Biosecure Act. This disruptive legislation may change the percentage of companies considering China as an outsource destination in the future.

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The U.S. Biosecure Act has the potential to become law and may significantly impact biotechnology companies and supply chains, particularly if they are doing business with the U.S. Government. If enacted (most of the act would not go into effect until 2032), it would prohibit U.S. Governmental agencies from engaging with “biotechnology companies of concern.” The bill specifies several large Chinese companies, including Wuxi Biologics, one of the world’s largest CMOs. The list could expand to include other biotechnology companies that pose a national security concern. The Act has the potential to disrupt a significant number of U.S. and EU supply chains that could be difficult to reconstruct.

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India’s potential as an outsourcing destination has significantly increased, surpassing the levels of Singapore, France, and Germany in 2019. Meanwhile, traditional outsourcing leaders in Europe, such as Ireland, Denmark, and Belgium, have experienced a flattening in their attractive-ness as outsourcing destinations.

Asian countries have a growing pool of highly skilled professionals in STEM fields, ensuring the availability of necessary talent for biopharmaceutical production. As these regional CMOs expand and demonstrate GMP quality manufacturing, their attractiveness will likely increase in coming years.

Cities like Shanghai, Beijing, and Shenzhen have become innovation hubs, hosting biotech companies, research institutions, and incubators. This ecosystem attracts global biopharmaceutical outsourcing, and our study shows this, with 39.8% of U.S. respondents indicating a “Strong Likelihood” or “Likelihood” of outsourcing production to China.

CMOs optimistic over financial outlook for 2024

Following the disruptions caused by COVID-19, and the dramatic swings in revenues and profitability among CDMOs, it has been challenging to accurately assess the overall state of the industry. However, data in our Annual Report indicates a strong belief among CDMOs that the slow-growth period is being left behind. Price changes for CMO services, which had jumped dramatically in 2019 actually showed reductions in 2023, before showing a modest 2.3% in-crease this year.

In 2024, vendors to the biopharma industry, on average, showed much more optimism about their financial outlook, with many expecting better or much better performance. For instance, in 2024, 13.0% of vendors anticipate a “Much better” financial performance, up from only 8.1% in 2023. This suggests stronger confidence in their strategies and market conditions.

In the “Better” category, 26.6% of vendors expect an improvement this year, another increase from the previous year reported at 15.0% (Figure 4).

Key takeaways from current CDMO trends

Successful CDMOs understand that their future depends on offering top-tier customer support and nurturing long-term relationships. High customer satisfaction is crucial for securing long-term clients and ensuring substantial financial returns. Companies that outsource a large portion of their manufacturing typically rely on their CDMO’s technical expertise and equipment. To maintain competitiveness, CDMOs must continually focus on technologies that enhance their unique skills and services so they can meet their clients’ needs.

CDMOs have increasingly become strategic players leveraging their ability to manage challenging products and implement innovative solutions. CDMOs are not just keeping up with industry changes—they are leading change. Their approach to integrating new technologies ensures they can meet the growing demands of biomanufacturing, in a competitive market.

An example of this interdependency is with cell and gene therapy products. Innovators in these segments have significantly benefited from the rapid advancements and growth of these niche CDMOs. Our Top1000bio.com database⁴ profiles 191 global Cell Therapy-competent CDMOs, and 124 gene therapy CDMOs. The number of CDMOs providing services in these advanced therapy areas has grown dramatically over the past 5 years, and there is likely to be considerable consolidation as the segments mature.

For example, CDMOs like Lonza, WuXi Biologics, and scores of others have led innovation in cell and gene therapy manufacturing, providing end-to-end solutions from process development to clinical and commercial manufacturing.

Successful CDMOs continue to demonstrate their commitment to excellence even through global disruption. Their resilience meeting the stressful demands with the necessary expertise and infrastructure while managing costs and timelines demonstrated competence through adversity. As a result, we are returning to the pre-COVID, stable growth patterns we have seen for the past 21 years. 

Note: All figures and charts sourced from: 21st Annual Report and Survey of Biopharmaceutical Manufacturing Capacity, 2024, BioPlan Associates, Inc. Rockville, MD.

References

1. Langer, E.S., et al., 21st Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, BioPlan Associates, Rockville, MD, July 2024, 506 pages.
2. Source: BioPlan Associates, Inc. Poll of SUS Suppliers July 23 2024
3. Covid-19 Impact on Bioprocessing, BioPlan Associates, 16 pages (White Paper), https://bioplanassociates.com/reports-studies/covid-19-impact-on-bioprocessing-white-paper-bioplan-20200605/
4. Cell and Gene Therapy CDMO data from BioPlan’s www.top1000bio.com database accessed August 7, 2024; BioPlan Associates, Inc, Rockville, MD www.bioplanassociates.com

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Ioanna Deni is an experienced Quantitative Market Research Analyst, completing her Ph.D. in Biomedical Sciences and demonstrating extensive experience in biopharmaceutical life science research. Her research background includes quantitative and qualitative market research expertise as an AI and healthcare specialist. For more information: info@bioplanassociates.com; +1 (301) 921-5979.