Downstream Bio-processing Controllers Market by Procedure (Chromatography, TFF), Product (Chromatography Controller System, TFF Controller System, Disposable Flow Path], Application (Commercial, Research), and End User - Global Forecasts to 2025

The Downstream Bio-processing Controllers Market is expected to grow at a CAGR of 17.3% from 2019 to reach $1.92 billion by 2025. Downstream bio-processing is a process in biopharmaceutical manufacturing to recover the pure protein from contaminant proteins. The growth in this market is majorly driven by growing demand for biopharmaceuticals, rising adoption of single-use technology (single use bio-processing equipment and consumables), and capacity expansion by biopharmaceutical manufacturers. Further, rising demand form emerging Asia-Pacific and Latin American markets, expected surge in biosimilar production in the U.S., growing demand for personalized medicine, and increase in the support from governments for biopharmaceutical research offer significant growth opportunities for the players operating in the downstream bio-processing controllers market.

Growing demand for biopharmaceuticals is propelling the growth of downstream bio-processing controllers market           

With the increasing prevalence of chronic illness across the globe, the biopharmaceuticals have exhibited substantial growth in the overall pharmaceutical market. According to American Pharmaceutical Review - one of the leading journals in the pharmaceutical industry - the percentage of antibody-based products currently under the biologic license application (BLA) or equivalent stage of regulatory submission - accounts for ~67% of all biopharmaceuticals. Also, according to the journal, antibody-based products contribute ~82% of products in phase 3 development and ~90% of products in phase 1 and 2 development. In addition, with the increasing demand, the approval of biopharmaceutical products has increased in recent years. For instance, according to Creative Biolabs, Inc. (a life science company), the number of antibody approval has increased in numbers since past 3-4 years. In 2017, 10 new monoclonal antibodies were approved for commercialization around the world as compared to 3 in 2014. Therefore, with growing demand for bio-pharmaceuticals, the overall production capacity is expected to grow over the coming years, thereby driving the growth of the bioprocessing equipment market including downstream bio-processing controllers.

Significant opportunities from emerging Asia-Pacific and Latin America support the market growth

Growing investments in infrastructure and capacity development, low labor cost, growing adoption of single-use technology, improving adherence to the global manufacturing standards, and increasing regulatory oversight in developing economies are the major reasons for increase in biopharmaceutical production in the emerging Asia-Pacific and Latin American markets. For instance, in November 2015, JHL Biotech (Taiwan) used modular single-use technology – KUBio, prefabricated factory on wheels – offered by GE Healthcare Life Sciences - for construction of its biopharmaceutical facility in Wuhan, China. Further, the increasing approvals of biological entities in emerging economies have attracted the players to invest in bio-manufacturing research and production activities. For instance, in July 2017, Chugai Pharmaceutical Co., Ltd. (Japan) signed a joint research agreement with the National Cancer Center (Japan) - for the “MASTER KEY Project” to promote research and development in the field of rare cancers and genomic medicines. Therefore, owing to aforementioned reasons, the bio-production and related research & development is increasing in emerging economies, thereby driving the demand for downstream bio-processing controllers.

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Key findings in the global downstream bio-processing controllers study:

Tangential flow filtration procedures to witness the fastest demand through 2025

Tangential Flow Filtration (TFF) procedure segment is estimated to account for the largest share of the overall downstream bio-processing controllers market in 2019, mainly due to higher adoption of TFF procedures for protein purification and contaminant removal.

TFF products (TFF controllersystem, TFF disposable flow path) contributed largest share of the overall market and generated large proportion of revenue as compared to chromatography products. The major share is mainly attributed to their higher adoption for the removal of bioburden, biofilm, and endotoxin reduction from biopharmaceutical fluids without affecting the product quality. On the other hand, due to growing number of biopharmaceutical start-ups with small and medium scale production capabilities and increasing penetration of single-use technology in research and development, the chromatography products (chromatography controller system and chromatography disposable flow path) are slated to grow at the fastest CAGR during the forecast period.

Commercial bioprocessing to register the fastest growth in the downstream bio-processing controllers market, by 2025

Commercial bioprocessing is one of the major application areas of downstream bio-processing controllers due to increasing antibody approvals, growing production of therapeutic protein products, and approval of large number of protein products in the recent past. For instance, according to Cell and Gene Therapy Catapult (U.K.), in the U.K. in 2017, 62 cell and gene therapy clinical trials were recorded as compared to 35 trials in 2013. Therefore, increasing protein product approvals and entry of most of the products in clinical trial pipeline is driving the growth of the downstream bio-processing controllers market.

Pharmaceutical & biotechnology companies to dominate the global downstream bio-processing controllers market

Pharmaceutical & biotechnology companies segment is estimated to account for the largest share of the overall downstream bio-processing controllers market in 2019. Rising number of biotechnology companies, increasing government investments for the improvement of pharmaceutical industry, and increasing capacity expansions of pharmaceutical & biotechnology companies are the major factors contributing to the largest share of pharmaceutical & biotechnology companies in the downstream bio-processing controllers market.

Asia-Pacific: The fastest growing regional market

North America commanded the largest share of the overall downstream bio-processing controllers market, followed by Europe, Asia-Pacific, Latin America, and Middle East & Africa. However, Asia-Pacific region will be the fastest growing regional market due to increasing outsourcing of biopharmaceuticals contract manufacturing in the region. In addition, favorable regulatory reforms and continuous investment & focus of pharmaceutical giants towards expanding their research and manufacturing operations in the region also supports the growth of the downstream bio-processing controllers market in the APAC region.

Key Players

The report includes competitive landscape based on extensive assessment of the key strategic developments adopted by the leading market participants in the industry over the past 4 years (2016-2019). The key players profiled in the global downstream bio-processing controllers market report are Merck Group, Danaher Corporation, GE Healthcare, ARTeSYN Biosolutions Ireland Ltd, Sepragen Corporation, Parker-Hannifin Corporation, 3M Company, VERDOT Ips², Repligen Corporation, and Sartorius AG.

Scope of the Report:

Market by Procedure

• Tangential Flow Filtration
• Chromatography

Market by Product

• Tangential Flow Filtration
  • TFF Controller System
  • Disposable Flow Paths
• Chromatography
  • Chromatography Controller System
  • Disposable Flow Paths

Market by Application

• Commercial Bioprocessing
  • Monoclonal Antibody Production
  • Therapeutic Protein Production
  • Vaccine Production
  • Cell and Gene Therapy
• Research Bioprocessing

Market by End user

• Pharmaceutical & Biotechnology Companies
• Contract Manufacturing Organizations
• Academic & Research Institutes

Market by Geography

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • Italy
  • France
  • U.K.
  • Spain
  • Rest of Europe (RoE)
• Asia-Pacific (APAC)
  • Japan
  • China
  • India
  • Rest of APAC (RoAPAC)
• Latin America
• Middle East & Africa

Key questions answered in the report:

Pharmaceutical and biotechnology companies are driving the adoption of downstream bio-processing controllers

• How does the penetration of downstream bio-processing controllers differ among various end users?
• Which are the high growth market segments in terms of procedure, product, application, end-user, and regions/countries?

Monoclonal antibody production is the fastest growing application segment of the downstream bio-processing controllers market

• What factors are propelling the growth of downstream bio-processing controllers market in commercial bioproduction?
• What factors contribute to the growth of downstream bio-processing controllers in research bioproduction?

The North American region has the largest bioproduction capacity and includes various global and local players competing in multiple segments

• Who are the top competitors in this market and what strategies do they employ to gain shares?
• Which product and procedure segments of the downstream bio-processing controllers market is expected to offer lucrative growth duringthe forecast period and why?
• What strategies should the new companies focus to enter this market in order sustain and compete with the established players?
• What are the major drivers, restraints, opportunities, challenges, and trends in the global downstream bio-processing controllers market?
• What are the geographic trends and high growth regions/countries?

Recent new product launches, partnerships, agreement, expansions, acquisitions that have taken place in the downstream bio-processing controllers market space

• What companies have recently merged/acquired and how will these unions affect the competitive landscape of the downstream bio-processing controllers market space?
• What companies have created partnerships and how will these partnerships promote a competitive advantage?
• Who are the major players operating in the global downstream bio-processing controllers market and what share of the market do they hold?
• Who are the local emerging players in the global downstream bio-processing controllers market and how do they compete with the global players?