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  • Published In : Jun 2024
  • Code : CMI7061
  • Pages :167
  • Formats :
      Excel and PDF
  • Industry : Biotechnology

Market Size and Trends

The Global Downstream Processing Market is estimated to be valued at USD 26.11 Bn in 2024 and is expected to reach USD 77.10 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 16.7% from 2024 to 2031.

Downstream Processing Market Key Factors

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The downstream processing market is expected to witness rapid growth owing to increasing demand for biopharmaceutical products such as monoclonal antibodies, vaccines, and recombinant proteins. The need for developing large-scale manufacturing capacities and lowering the costs involved in production while maintaining quality standards will further aid the revenue generation in the downstream processing industry. The rising demand for biotherapeutics along with an increasing amount of funds being invested in research and development are some of the key factors driving the market growth. Additionally, the rapid uptake of single-use technologies to improve process flexibility and productivity is expected to support the market growth during the forecast period.

Rising government funding and investment in biopharmaceutical industries

Increasing government funding and investments in biopharmaceutical industries have significantly boosted the global downstream processing market growth in recent years. As governments across the world look to strengthen healthcare infrastructures and increase universal access to critical medicines, there has been a coordinated push to bolster domestic production of vaccines and biologics. Advanced economies like the US, UK, Germany have announced massive funding packages, while emerging markets like India, China have provided lucrative production-linked incentives. This surge in public support for indigenous drug manufacturing has cascaded into increased demand for downstream processing equipment, consumables and services. Bioprocessing facilities catering to government-backed projects require sophisticated downstream processing setups to meet stringent quality standards for large-scale production. For instance, in July 2021, the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) was granted a total of USD 153 million from the National Institute of Standards and Technology (NIST) under the United States Department of Commerce. Additionally, as a component of the American Rescue Plan, NIIMBL received USD 83 million over three years from the National Institute of Standards and Technology (NIST) to support research and development endeavors aimed at preventing, preparing for, and addressing coronavirus outbreaks.

Market Concentration and Competitive Landscape

Downstream Processing Market Concentration By Players

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Advancing Bioprocessing Technologies

With the biopharmaceutical industry continually expanding, so too are the demands on downstream processing. As therapeutic monoclonal antibody and recombinant protein production increases in scale and complexity, manufacturers require more sophisticated methods for recovery, purification and formulation. New technologies that improve yields, throughput and product quality are high priorities. Continuous manufacturing platforms allow for real-time monitoring and control across separation, filtration and chromatography steps. This brings increased process understanding and flexibility compared to traditional batch operations. Membrane adsorbers are gaining favor for their ability to consolidate multiple unit operations into single-use cassettes. Their effectiveness at capturing targets from crude feedstocks while allowing rapid, scalable elution assists in meeting tight timelines. Looking further ahead, integrated modular systems incorporating multiple separation technologies promise to automate downstream workflows from start to finish. If successful in demonstrating reliable performance at commercial biomanufacturing scales, such integrated solutions could help facilities boost productivity and reduce unit costs by streamlining changeovers between campaigns. 

Key Takeaways from Analyst:

Key growth drivers such as the rapid expansion of the biopharmaceutical industry and growing demand for monoclonal antibodies and recombinant proteins will boost the downstream processing market revenues. Increased R&D investments by biotech companies in downstream purification technologies is another factor that will propel the market growth.

However, high costs associated with downstream processing equipment and concerns regarding the disposal of hazardous waste are some challenges restraining the market's potential. Complex regulatory processes also delay product approvals.

North America currently dominates the downstream processing market and is expected to continue its leadership during the forecast period. Growing biosimilar approvals and rising cell and gene therapy research in the U.S. and Canada support the regional market. Asia Pacific is emerging as the fastest growing regional market, fueled by improving healthcare infrastructure, rising contract manufacturing, and increasing government funding for biologics research in China, India, and South Korea.

On the technology front, chromatography systems account for the largest segment of the downstream market. However, filters are gaining rapid acceptance as they allow for easier scale-up during manufacturing. Membrane adsorbers are another technology expected to witness significant adoption in the coming years as they provide improved productivity and integrated capture/purification capabilities.

Market Challenges: High cost of Downstream Processing

Strict regulatory guidelines around downstream processing are indeed posing challenges for the market growth. Downstream processing deals with purification and recovery of biosimilars, biologics, and pharmaceutical products from fermentation broth or other reaction mixtures. It is a complex process that involves several critical steps like separation, purification, formulation and fill-finish. Regulatory agencies across the world have established stringent norms and quality standards that need to be followed at each step of downstream processing to ensure safety, purity and efficacy of end products. Compliance to these regulations involves significant cost and time investments from manufacturers. For instance, the U.S. FDA expects downstream processors to have detailed documentation for their facilities, equipment, processes and personnel right from lab development to commercial-scale manufacturing. Any change made to an established downstream process requires extensive validation as per FDA guidelines. Similarly, the EMA in the EU has published several Annexes under Good Manufacturing Practice regulations covering critical aspects of downstream processing like virus removal/inactivation procedures, characterization of cell lines etc. Adhering to these guidelines involves high capital expenditure, specialized staff training and maintenance of paper trails. This regulatory burden adds significantly to the production costs for companies.

Market Opportunities: Consolidation activities by market leaders

Consolidation activities by big players in the downstream processing market present a major opportunity for growth. As leading companies look to expand their capabilities and offerings, acquisitions of smaller specialized firms allow them to vertically integrate across the process development lifecycle. This type of consolidation allows larger players to provide customers with end-to-end solutions under one roof by combining complementary technologies and expertise. For example, in 2020, Thermo Fisher Scientific acquired PPD to enhance its clinical research services and better support customers in Phase I-IV trials. By offering customized solutions through different stages of a product's development and commercialization, consolidated firms improve their stickiness with clients. Further consolidation is likely in the coming years as well. The competitive pressure to continuously enhance efficiency and productivity will drive more mergers and alliances. Mid-sized firms seeking to scale up may become prime acquisition targets. Successful integrations will help strengthened companies realize synergies across their combined resources.

Downstream Processing Market By Technique

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Insights By Technique- Purification methods enable process optimization and product quality

By Technique, the Purification Techniques segment is estimated to hold the highest share of 40.12% in 2024, owing to its ability to deliver highly pure products and enable optimization of downstream processes. Purification allows separation of biomolecules from raw materials or intermediate products through various methods such as chromatography, precipitation, centrifugation etc. This results in removal of contaminants and helps obtain purified products of desired quality and specification. Given stringent regulatory requirements for purity and quality of biologics, purification is a critical and mandatory step for various biotherapeutic applications. Furthermore, purification techniques facilitate optimized processing conditions by improving clarity and removing impurities that may otherwise interfere with downstream operations. Continuous technological advancements have also expanded purification capabilities, allowing for higher product yields and efficiencies. Growing demand for biotherapeutics will thus continue augmenting adoption of purification techniques in the downstream processing market.

Insights By Product - Chromatography dominates product portfolio due to versatility and high-resolution separation

By Product, the Chromatography Columns and Resins segment is estimated to hold the highest share of 40.21% in 2024 owing to its versatility across multiple purification applications and ability to enable high resolution separations. Chromatography utilizes column chromatography technology for targeted separation of biomolecules. It offers selective and highly efficient purification through interaction of sample components with resin/media inside the column. Chromatography columns and resins also facilitate scalable purification from development to commercial production. Techniques such as affinity chromatography leverage unique molecular interactions to specifically isolate targets. Moreover, chromatography equipment and resins are continuously optimized to improve selectivity, binding capacity, flow rates and automation. Their wide compatibility and customization with varied biomolecules further augment popularity and utilization in downstream processes. Together, these advantages have cemented chromatography's dominance in the downstream product portfolio.

Insights By Application- Antibodies Production leads application demand driven by biologics commercialization

By Application, the Antibodies Production segment is estimated to hold the highest share of 30.22% in 2024 owing to extensive antibody therapeutic development and rising commercialization of biologics. Antibodies have emerged as the largest and fastest growing class of biotherapeutics due to their high specificity and efficacy against several diseases. Their downstream production involves critical purification and processing steps to deliver pure, consistent and safe antibody drugs. Several major blockbuster antibody drugs are also driving continued large-scale manufacture of these biologics. Meanwhile, robust pipeline and ongoing clinical trials indicate a steady influx of novel antibody modalities such as bispecifics, antibody-drug conjugates and others. Expanding clinical success is thus translating to growing commercial demand, compelling pharmaceutical companies to boost manufacturing infrastructure and capacities for antibody production. This is having a profound strengthening effect on the demand for various downstream processing solutions within this application segment.

Regional Insights

Downstream Processing Market Regional Insights

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North America has dominated the downstream processing market for many years owing to strong presence of leading biopharmaceutical companies in the region and is estimated to account for a high share of 39.3 % in 2024. The U.S. accounts for majority of the market share in North America. Strong focus on innovation along with growing biologics sector has propelled the growth. Presence of well-established CMOs who offer wide range of downstream services has further boosted the regional market growth.

Many biopharma companies in the region have been focusing on the development of complex biologics which involves extensive downstream processing. This provides impetus to CMOs to invest in state-of-the-art technologies for large-scale purification and manufacturing of such products. Growing interest of small companies in outsourcing downstream activities to well-equipped CMOs supplements the regional market size.

Asia Pacific region has emerged as the fastest growing market for downstream processing in recent years. Rapid expansion of biopharmaceutical industry across major APAC countries including China, India, South Korea and others drives significant growth opportunities. Governments across APAC are partnering with global players to set up manufacturing facilities which will augment regional market.

Market Report Scope

Downstream Processing Market Report Coverage

Report Coverage Details
Base Year: 2023 Market Size in 2024: US$ 26.11 Bn
Historical Data for: 2019 To 2023 Forecast Period: 2024 To 2031
Forecast Period 2024 to 2031 CAGR: 16.7% 2031 Value Projection: US$ 77.10 Bn
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East & Africa: GCC Countries, South Africa, and Rest of Middle East & Africa
Segments covered:
  • By Technique: Purification Techniques, Solid-Liquid Separation, and Clarification/Concentration
  • By Product: Chromatography Columns and Resins, Filters, Evaporators, Centrifuges, and Other Products
  • By Application: Antibodies Production, Vaccines Production, Insulin Production, and Other Applications
  • By End User: Biopharmaceutical Companies, CMOs/CDMOs , Research Institutes, CROs, and Others 
Companies covered:

Merck KGaA, Thermo Fisher Scientific Inc., GE Healthcare, Sartorius Stedim Biotech S.A., Repligen Corporation, Pall Corporation, M Company, Eppendorf AG, Agilent Technologies, Inc., Waters Corporation, Shimadzu Corporation, Bio-Rad Laboratories, Inc., Avantor Performance Materials, LLC, Tosoh Corporation, Column Technology Inc., Purolite, W.R. Grace & Co., Asahi Kasei Corporation, Novasep Holding S.A.S, and Boehringer Ingelheim

Growth Drivers:
  • Rising government funding and investment in biopharmaceutical industries
  • Advancing bioprocessing technologies
Restraints & Challenges:
  • High cost of downstream processing
  • Stringent regulatory guidelines

Key Developments

  • In June 2022, Merck, a multinational pharmaceutical company, partnered with Agilent Technologies, a life sciences company, to bridge the industry gap in process analytical technologies (PAT) for downstream processing. Through this collaboration, Merck's bioprocess portfolio is combined with Agilent Technologies' advanced analytical products to enhance real-time monitoring and automated process control of critical process parameters (CPPs) and critical quality attributes (CQAs) in downstream processing (DSP).
  • In February 2022, Sartorius Stedim Biotech, a biopharmaceutical industry, completed the acquisition of the chromatography division of Novasep. This division encompasses chromatography systems primarily designed for smaller biomolecules such as oligonucleotides, peptides, and insulin, as well as innovative systems for the continuous manufacturing of biologics.
  • In April 2022, Thermo Fisher Scientific, a biotechnology company, inaugurated a bioprocessing manufacturing facility in Ogden, Utah, dedicated to the advancement of biologics and vaccines.
  • In June 2022, Bio-Rad Laboratories, Inc., a U.S.-based developer and manufacturer of specialized technological products for the life science, launched the CHT prepacked Foresight Pro Columns to cater to downstream process-scale chromatography needs across all phases of biological drug research and production.

*Definition: The downstream processing market refers to the collection of steps employed to extract and purify a biological or chemical product from a reaction mixture after intellectual production. This includes filtration, purification, formulation and storage of products in the biopharmaceutical industry. Downstream processing helps reduce contaminants and isolate the target product from other process-related impurities, residues or contaminants. It allows for the concentration or drying of products and ensures their safety, purity and potency before final packaging.

Market Segmentation

  • Technique Insights (Revenue, USD Bn, 2019 - 2031)
    • Purification Techniques
    • Solid-Liquid Separation
    • Clarification/Concentration
  •  Product Insights (Revenue, USD Bn, 2019 - 2031)
    • Chromatography Columns and Resins
    • Filters
    • Evaporators
    • Centrifuges
    • Other Products
  •  Application Insights (Revenue, USD Bn, 2019 - 2031)
    • Antibodies Production
    • Vaccines Production
    • Insulin Production
    • Other Applications
  •  End User Insights (Revenue, USD Bn, 2019 - 2031)
    • Biopharmaceutical Companies
    • CMOs/CDMOs
    • Research Institutes
    • CROs
    • Others
  • Regional Insights (Revenue, USD Bn, 2019 - 2031)
    • North America
      • U.S.
      • Canada
    • Latin America
      • Brazil
      • Argentina
      • Mexico
      • Rest of Latin America
    • Europe
      • Germany
      • U.K.
      • Spain
      • France
      • Italy
      • Russia
      • Rest of Europe
    • Asia Pacific
      • China
      • India
      • Japan
      • Australia
      • South Korea
      • ASEAN
      • Rest of Asia Pacific
    • Middle East
      • GCC Countries
      • Israel
      • Rest of Middle East
    • Africa
      • South Africa
      • North Africa
      • Central Africa
  • Key Players Insights
    • Merck KGaA
    • Thermo Fisher Scientific Inc.
    • GE Healthcare
    • Sartorius Stedim Biotech S.A.
    • Repligen Corporation
    • Pall Corporation
    • M Company
    • Eppendorf AG
    • Agilent Technologies, Inc.
    • Waters Corporation
    • Shimadzu Corporation
    • Bio-Rad Laboratories, Inc.
    • Avantor Performance Materials, LLC
    • Tosoh Corporation
    • Column Technology Inc.
    • Purolite
    • W.R. Grace & Co.
    • Asahi Kasei Corporation
    • Novasep Holding S.A.S
    • Boehringer Ingelheim

Frequently Asked Questions

The CAGR of the global downstream processing market is projected to be 16.7% from 2024 to 2031.

Rising government funding and investment in biopharmaceutical industries and advancing bioprocessing technologies are the major factors driving the growth of the global downstream processing market.

High cost of downstream processing and stringent regulatory guidelines are the major factors hampering the growth of the global downstream processing market.

In terms of Technique, Purification Techniques is estimated to dominate the market revenue share in 2024.

Merck KGaA, Thermo Fisher Scientific Inc., GE Healthcare, Sartorius Stedim Biotech S.A., Repligen Corporation, Pall Corporation, M Company, Eppendorf AG, Agilent Technologies, Inc., Waters Corporation, Shimadzu Corporation, Bio-Rad Laboratories, Inc., Avantor Performance Materials, LLC, Tosoh Corporation, Column Technology Inc., Purolite, W.R. Grace & Co., Asahi Kasei Corporation, Novasep Holding S.A.S, and Boehringer Ingelheim are the major players.

North America is expected to lead the global downstream processing market.

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