The global downstream processing market size was estimated at USD 18.61 billion in 2019, estimated to witness a CAGR of 13.1% over the analysis period. A steady increase in the demand for recombinant products or drug quality has driven the adoption of downstream processing. The rise in the penetration of the biologics and large molecules is anticipated to drive the adoption of downstream methodologies.
The products are finished to obtain their appropriate and highly purified form with final formulation and packaging. Drug production of a requisite efficacy, purity, and a reasonable cost per unit is the overall goal of this process. Downstream technology is increasingly being used in both laboratory and industrial-scale applications owing to a growing demand for biologics, which is expected to boost the growth of the market for downstream processing.
Key developments made in the field of downstream processing include membrane affinity chromatography, high throughput process development, single-use systems, perfusion chromatography, and new uses of data analytics. Merck’s range of membrane affinity chromatography resins are designed for high throughput, cost-effective purification of engineered, polyclonal, and monoclonal antibodies and are specifically used for large-scale purification of advanced higher titer therapeutic antibodies.
Benefits pertaining to the usage of Single-Use Technology (SUT), such as a significant reduction in capital cost and facility construction time, are expected to boost the implementation of downstream processing. Other advantages include increased scalability, improved mobility, high productivity, eliminated risk of cross-contamination, and reduced demand for cleaning and sterilization. These advantages result cost-saving by 60%than the cost savings with the use of traditional stainless-steel bioprocessing equipment.
The industry players are undertaking several R&D activities in order to cut down the overall production costs and thereby, minimize the product retail costs. This has surged the biotech research investments, which has widened the scope of throughput and has shortened the processing time. Major pharmaceutical companies are shifting towards R&D activities owing to high profits associated with the sales of biopharmaceuticals.
The chromatography segment dominated the overall downstream processing market in 2019. The key players provide integrated and safe solutions that work efficiently during the vital steps of process development to production scale. Technological advancements have derived the development of single-use chromatography, which is considered a vital innovation in the field of bio pharmacy and is anticipated to witness positive growth over the forecast timeframe.
The filters segment is expected to exhibit the fastest CAGR in the market for downstream processing over the forecast period. Filtration has eliminated the need for alternative separation and purification methods and is particularly essential in viral safety as a virus can have a considerable impact on the entire process. In addition, technological advancements in single-use filtration technology are expected to enhance the segment growth.
For instance, MaxiCaps MR-a pre-sterilized, pre-assembled, and ready to use single-use filtration system by Sartorius AG-has eliminated the scale-up limitations associated with single-use filtration. The system is the first single-use alternative to multi-round, large-scale stainless-steel filters. The product combines the advantages offered by conventional as well as single-use solutions with minimal changes in user risk for scale-up, installation, and time for filtration.
Antibiotic production accounted for the largest revenue share in 2019. Antibiotics are used in the treatment of a number of conditions from cancers to infectious diseases. β-lactam antibiotics, especially cephalosporin and penicillin, are one of the most commonly commercialized antibiotics classes worldwide. Natural cephalosporin and penicillin are manufactured at an industrial scale through bioprocessing techniques and are harvested through downstream processing.
Although some of the specific antibiotics have been proven to be effective against the treatment of certain diseases, they are not available commercially owing to the difficulty in the filtration and purification process and low productivity of the bioprocess. This also increases the total cost of the product. These difficulties can be overcome to a certain extent by using mathematical modeling in bioprocess and optimizing production and bio-product recovery processes.
Antibodies production segment is expected to witness the fastest CAGR in the market for downstream processing throughout the forecast period. This is due to the evolution of robust platforms for the manufacture of high titers for monoclonal antibodies (MABs) in mammalian cultures. In addition, the development of novel methods such as non-chromatographic separation and alternative expression systems for the bio-production of antibodies has led to the evolution of process platform approaches.
Purification by chromatography dominated the overall market for downstream processing in 2019 and the solid-liquid separation segment is expected to witness the fastest CAGR in the coming years. Chromatography by separation is used during the separation and purification of the most high value products. This is a vital step technique that can be employed at any phase of downstream processing until the final step of purification.
Although chromatography is an essential step in purification, it can be expensive and difficult to scale-up. Pressure drop in chromatography columns is the most common concern observed during the scale-up of chromatography as drop increases with an increase in column height. This problem can be addressed to some extent using rigid media and short chromatography columns with a larger diameter, thereby reducing the impact of the restraint on segment growth.
Solid-liquid separation is increasingly adopted owing to a rise in the advancement of the filtration technique. However, clogging and fouling of filter is a common hurdle during scale-up. Therefore, tangential flow filtration and dead-end filtration methods have been developed to overcome such issues during the filtration of products. A noteworthy innovation in this field is the development of vortex flow filtration technology. Vortex flow filtration technique has a longer clogging time than tangential flow filtration and is useful in the separation of viscous materials.
North America region dominated the market for downstream processing with the largest revenue share in 2019 owing to government support for the promotion of bioprocess technologies, a significant rise in medical expenditure, and the presence of robust healthcare infrastructure. The region has also witnessed major collaborative activities and the dominance of some of the healthcare giants who are extensively making investments in the research and development of biopharmaceuticals and vaccines.
Continuous technological advancements in the biotechnology industry of U.S. have led to a significant increase in the sale of recombinant products. It is expected that there would be a 10-fold increase in sales in the coming decade. Therefore, continuous innovation in the biotechnology and bioprocessing sector is expected to provide growth avenues to the U.S. market for downstream processing.
Asia Pacific is expected to register the fastest growth rate in the market for downstream processing due to the rising investments by developers and consumers in the field of biotechnology. The presence of a large population base has driven the need for advanced medical facilities and the players are keen on implementing rapid analytical methods that can support the assessment of process design and the establishment of supply chains, and vendors.
Some of the dominant players in the market for downstream processing include GE Healthcare; Merck KGaA; Sartorius Stedim Biotech S.A.; Thermo Fisher Scientific Inc.; and Danaher Corporation. This is because of the large bioprocessing portfolio offered by these companies to their customers with the help of a broadglobal distribution network.
Other prominent market players for downstream processing include Repligen, 3M Company, Eppendorf AG, Boehringer Ingelheim International GmbH, Corning Corporation, Lonza Group Ltd, Dover Corporation, Ferner PLC, and Ashai Kasei. These players are involved in strategic collaborations, partnerships, and merger agreements with other players to maintain a competitive edge in the market for downstream processing.
For instance, in March 2019, Sartorius Stedim Biotech collaborated with Novasep to develop novel systems for single-use bioprocessing and membrane chromatography. Such initiatives are expected to enhance the availability of advanced products for chromatography and downstream processing, which in turn, is expected to aid the growth of the market for downstream processing.
Base year for estimation
Actual estimates/Historical data
2016 - 2018
2020 - 2027
Revenue in USD Million & CAGR from 2020to 2027
North America, Europe, Asia Pacific, Latin America, MEA
U.S., Canada, Germany, U.K., Japan, China, India, Brazil, Mexico, South Africa, UAE
Revenue forecast, competitive landscape, growth factors and trends
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This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2016 to 2027. For the purpose of this study, Grand View Research has segmented the global downstream processing market report on the basis of product, technique, application, and region:
Product Outlook (Revenue, USD Million, 2016 - 2027)
Technique Outlook (Revenue, USD Million, 2016 - 2027)
Purification by Chromatography
Application Outlook (Revenue, USD Million, 2016 - 2027)
Regional Outlook (Revenue, USD Million, 2016 - 2027)
Middle East and Africa (MEA)
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Biopharmaceutical innovators are at the forefront of the human response to the coronavirus pandemic. A significant number of major biotech firms are in the midst of a race to investigate the Sars-Cov-2 genome and prepare a viable vaccine for the same. As compared to the speed of response to SARS/MERs etc, the biotech entities are investigating SARs-Cov-2 at an unprecedented rate and a considerable amount of funds are being put into the R&D. With multiple candidates in trial, the public and private sectors are anticipated to work in unison for the foreseeable period, until a vaccine is developed for Covid-19. The report will account for Covid19 as a key market contributor.