Biopharmaceutical CMO Downstream Processing Market Size, Share & Industry Analysis, By Technique (Purification, Concentration, and Others), By Source (Mammalian and Non-mammalian), By Product (Biologics and Biosimilars), and Regional Forecast, 2025-2032

The global biopharmaceutical CMO downstream processing market size was valued at USD 3.83 billion in 2024. The market is projected to grow from USD 4.18 billion in 2025 to USD 13.65 billion by 2032, exhibiting a CAGR of 16.1% during the forecast period.

Downstream processing in biopharmaceutical manufacturing refers to the series of operations followed by the fermentation or cell culture stage that are aimed at the purification and formulation of the biologic product. These processes include cell separation, extraction, purification, and polishing, ensuring that the final product is of high purity and meets regulatory standards.

The market growth is attributed to the rising demand for biologics and biosimilars, expansion in contract manufacturing services, and innovation in purification technologies. Moreover, rising approvals of biosimilars and regulatory pressure for efficient manufacturing practices are compelling companies to adopt advanced downstream technologies.

Some of the major players in the biopharmaceutical CMO downstream processing industry are Lonza, Catalent Inc., Thermo Fisher Scientific, and Samsung Biologics. These players are focusing on massive investments, expansion of production capabilities, and technological advancements with an aim to maintain a substantial market share. In addition, emphasis on strategic partnerships and robust research & development activities is projected to accelerate market expansion during the forecast period.

MARKET DYNAMICS

Market Drivers

Robust Pipeline and Rising Demand for Biologics to Boost Market Growth

The demand for biologics is increasing for the treatment of chronic conditions due to their efficacy and specificity. As pharmaceutical companies invest heavily in biologic drug development pipelines, the need for efficient downstream processing has increased. These products typically require highly specialized purification and formulation steps to ensure safety, potency, and regulatory compliance. Furthermore, the complexity and sensitivity of biologics necessitate advanced purification methods that minimize product loss while maximizing yield and purity.

Additionally, the significantly increasing number of biologics pipelines and the number of approved products are also major factors driving the global biopharmaceutical CMO downstream processing market growth. The complexity inherent in the development of biopharmaceutical drugs and their mass production for commercial purposes results in the growing demand for contract manufacturing by manufacturers. This boosts the demand for outsourcing services for the manufacturing of these products.

• According to data published by the U.S. FDA in January 2024, the regulatory body approved 55 new drug products in 2023, which comprises 18 biologics products.

Market Restraints

High Cost of Equipment and Operations Deter Market Growth

The high cost associated with equipment procurement, maintenance, and operational complexities is one of the prominent restraining factors impacting the market growth. The cost challenge is further exacerbated by the need for stringent validation, compliance with regulatory standards, and periodic calibration of instruments to maintain product quality. Operational inefficiencies, material losses during purification, and batch failures due to contamination or inconsistency can further escalate production costs.

Additionally, the skilled workforce required to operate and manage complex downstream systems is limited and demands higher salaries, contributing to rising labor costs. As manufacturers strive to balance high purity requirements with affordability, the economic burden of downstream processing remains a key concern. This financial barrier may deter new entrants and delay product development cycles, ultimately impacting the scalability and accessibility of biologics in the global biopharmaceutical CMO downstream processing industry. Further, the deployment of stainless steel manufacturing facilities for producing biopharmaceutical drugs at a large scale leads to higher costs of manufacturing, decreasing the affordability of the final product to the general patient population.

• For instance, for a study published in May 2023 in the Drug Discovery Today Journal for the annual production of a 3,400 kg final product using stainless-steel fed batch processing, the total capital expenses were around USD 540 million. This cost is significantly higher than the disposable fed batch processing.

Market Opportunities

Growth of Biosimilars in Emerging Markets Offer Substantial Opportunity for Market Growth

The global expansion of biosimilars represents a major opportunity for downstream processing solution providers, particularly in emerging markets where affordability and access to biologic therapies are key priorities. As patents for blockbuster biologics continue to expire, biosimilar manufacturers are aggressively pursuing market entry with cost-effective alternatives. Countries across Asia, Latin America, and the Middle East are witnessing a surge in the demand for biosimilars due to supportive regulatory frameworks, increasing healthcare coverage, and a growing burden of chronic diseases. In addition, an increasing number of partnerships is estimated to offer lucrative opportunities for biopharmaceutical CMO downstream processing. 

• For instance, in August 2021, Kemwell Biopharma and Cipla signed a joint venture agreement for the development, manufacturing, and commercialization of biosimilars for the global market.

Moreover, biopharmaceutical CMO downstream processing manufacturers in these regions are adopting modular and scalable downstream systems to meet diverse product demand while maintaining regulatory compliance. International collaborations, technology transfers, and government incentives are further catalyzing the development of localized biopharmaceutical ecosystems.

• For instance, in October 2024, Samsung Biologics introduced a new high-concentration formulation platform named S-HiCon. This platform is aimed at supporting the development and manufacturing of high-dose biopharmaceuticals.

Market Challenges

Product Degradation During Downstream Process Challenges Market Growth

One of the critical challenges in biopharmaceutical CMO downstream processing is significant product degradation that can occur during purification stages. Biologics, especially monoclonal antibodies and recombinant proteins are often produced in low concentrations and require multiple purification steps to achieve the necessary purity levels for clinical and commercial use. Each step, whether centrifugation, filtration, or chromatography, presents a risk of product loss due to adsorption, degradation, or inefficiencies in separation.

In addition, biologics are sensitive to pH, temperature, and shear stress, which increases the risk of denaturation or aggregation during handling. Process optimization is further complicated by batch variability and the biological nature of source materials.

BIOPHARMACEUTICAL CMO DOWNSTREAM PROCESSING MARKET TRENDS

Shift toward Single-Use Technologies Boost Efficiency of Downstream Processing

The biopharmaceutical CMO downstream processing market is witnessing a rise in the adoption of single-use technologies across biopharmaceutical manufacturing facilities. These disposable systems, including single-use filters, chromatography columns, and bioreactors, are increasingly replacing traditional stainless-steel setups due to their operational flexibility and cost-efficiency.

Furthermore, these technologies require lower capital investment and facility infrastructure, making them attractive to both emerging biotech firms and established pharmaceutical players looking to expand capacity. As innovation continues, with enhanced material durability and sensor integration, single-use technologies are poised to transform downstream processing by enabling faster development timelines, lower operational costs, and improved process consistency, thereby contributing significantly to the evolving demand for biopharma production.

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Impact of COVID-19

Market Recorded Expansion as High Number of Manufacturing Contracts were Signed during the Pandemic

As a result of the COVID-19 pandemic, the global biopharmaceutical CMO downstream processing industry experienced a positive impact on growth as compared to 2019. The major market players, such as Lonza, Wuxi Biologics, and other players operating in the market, reported a positive growth in their biopharmaceutical CMO segment revenues during this period.

This sudden growth was mainly due to the high number of manufacturing contracts signed between biopharmaceutical manufacturers and contract manufacturing service providers for the manufacturing of COVID-19 vaccines. Several vaccine manufacturers partnered with CMOs for the effective and timely manufacturing of vaccines to fulfill the market demand.

• For instance, in June 2020, AstraZeneca signed a manufacturing contract with Emergent BioSolutions Inc., for the manufacturing of AstraZeneca’s vaccine candidate for COVID-19, AZD1222. The latter company provided contract development and manufacturing services for the large-scale manufacturing of the vaccine candidate.

SEGMENTATION ANALYSIS

By Technique

Major Emphasis on Product Purification to Boost Segment Growth

Based on technique, the market is segmented into purification, concentration, and others.

The purification segment is expected to hold the highest share of the biopharmaceutical manufacturing market, driven by its critical role in ensuring product safety, efficacy, and regulatory compliance. The purification phase is indispensable in removing impurities, host cell proteins, DNA fragments, and aggregates from biologic drug products. Techniques such as chromatography, ultrafiltration, and diafiltration are widely used and continuously evolving to support high-throughput and high-yield processes.

The concentration segment is projected to hold the second-highest share of the biopharmaceutical manufacturing market, owing to its essential function in increasing the strength of active pharmaceutical ingredients post-cultivation or purification. Concentration processes such as tangential flow filtration (TFF), vacuum evaporation, and centrifugation are widely employed to condense product volumes for downstream processing or final formulation.

By Source

Major Focus on Manufacturing through Mammalian Source to Accelerate Segment Growth

Based on source, the market is categorized into non-mammalian and mammalian.

The mammalian segment held a significant global biopharmaceutical CMO downstream processing market share in 2024. This is mainly due to the rising number of mammalian systems-based regulatory-approved products, coupled with the high usage of these systems in research and development of new biopharmaceutical products.

• For instance, as per data published by BioProcess International in August 2022, out of the total marketed biopharmaceutical products recorded till June 2022, 68% were based on mammalian systems.

The non-mammalian segment is expected to grow considerably during the forecast period. The non-mammalian-based sources are increasingly being used in the drug discovery pipeline. This is due to the various factors such as their speed, lower cost, and scale.

By Product

High Production of Biologics to Dominate the Market During the Forecast Period

Based on product, the market is fragmented into biosimilars and biologics.

The biologics segment held a dominant share of the market in 2024. Some of the factors contributing to the dominance of the segment include the strong focus of biopharmaceutical manufacturers on the development and manufacturing of biologics such as monoclonal antibodies, vaccines, and others, coupled with a supportive regulatory environment leading to an increasing number of product approvals among others.

The biosimilars segment is poised to witness strong growth over the coming years due to cost-effectiveness of biosimilars, growing demand, and other factors.

• For instance, according to data provided by the Center for Biosimilars, until January 2024, 45 biosimilar products were approved in the U.S.

BIOPHARMACEUTICAL CMO DOWNSTREAM PROCESSING MARKET REGIONAL OUTLOOK

By geography, the market is categorized into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

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North America

North America dominated the global market in 2024 with a market size of USD 1.63 billion. The dominance of North America in the global market is attributed to the increasing number of contract manufacturing companies in the region. Similarly, the surging initiatives by key market players for expanding their production capabilities are expected to propel regional growth.

In the U.S., massive investments by contract manufacturing companies coupled with a focus on strategic collaborations and technological advancements is set to boost the market growth during the forecast period.

• For instance, in October 2024, Lonza collaborated with a major global biopharmaceutical partner for the commercial-scale manufacture of ADCs.

Europe

The market in Europe held a significant share in 2024. The strong focus on innovation, coupled with the emphasis of biopharma companies to outsource their manufacturing process, is likely to have a positive impact on market growth.

• For instance, in November 2024, Lonza expanded bio conjugation capabilities in Visp with the addition of two multipurpose 1,200 L manufacturing suites and manufacturing-related infrastructure.

Asia Pacific

Asia Pacific is expected to witness the highest CAGR during the forecast period. The market growth is attributed to increasing investments by leading companies in the region, expanding healthcare infrastructure, and rising research and development activities.

• For instance, in August 2022, Yaohaibio, an emerging CDMO in Japan, introduced a research-grade sample preparation service platform for microbial expression systems in Japan.

Latin America and the Middle East & Africa

The growth of the Latin America market is attributed to the increasing number of biopharmaceutical manufacturing facilities and the rising emphasis of leading players to enter this market due to lower costs. On the other hand, the Middle East & Africa market is expected to witness lucrative growth due to the surging number of strategic initiatives.

• For instance, in June 2023, the Public Investment Fund (PIF) introduced a commercial-scale CDMO named Lifera to boost Saudi Arabia’s biopharmaceutical manufacturing sector. This strengthened the country’s manufacturing capabilities for biopharmaceuticals.

COMPETITIVE LANDSCAPE

Key Industry Players

Strategic Partnerships and Introduction of Advanced Products Drive Revenue Growth for Key Players

The market is highly fragmented, given the operation of a considerable number of players. The players, such as Lonza, Catalent Inc., and Thermo Fisher Scientific, are some of the players actively operating in the market with comparatively considerable market share.

Other major players, including Samsung Biologics, FUJIFILM Corporation, and others, are focusing on the expansion of their service portfolio and strengthening market share. These market players have also increased their emphasis on partnerships and mergers with other players for expanding their service offerings.

KEY BIOPHARMACEUTICAL CMO DOWNSTREAM PROCESSING COMPANIES PROFILED:

• Samsung Biologics (Republic of Korea)
• Lonza (Switzerland)
• Recipharm AB (Sweden)
• WuXi Biologics (China)
• FUJIFILM (FUJIFILM Diosynth Biotechnologies) (Japan)
• Siegfried Holding AG (Switzerland)
• Cambrex Corporation (U.S.)
• Catalent, Inc. (U.S.)
• Thermo Fisher Scientific Inc. (Patheon) (U.S.)

KEY INDUSTRY DEVELOPMENTS:

• October 2024: LenioBio and Recipharm collaborated to boost vaccine production.
• October 2024: Recipharm AB partnered with Exela Pharma Sciences to enhance sterile manufacturing capabilities in the U.S.
• June 2024: Wuxi Biologics announced that the company installed three sets of 5,000L single-use bioreactors at its Hangzhou (China) manufacturing facility. With this, the total capacity of the facility is increased from 8,000L to 23,000L.
• October 2023: Samsung Biologics and Kurma Partners entered a partnership for the development and manufacturing of biologics for Kurma Partners’ portfolio companies.
• October 2023: Thermo Fisher expanded its manufacturing capacity in St. Louis with an aim to support complex biologic therapies for diseases.

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Report Scope & Segmentation