Downstream Processing Market Size, Share & Trends Analysis Report By Application (Antibodies, Antibiotic Production), By Product (Filters, Evaporators), By Technique, And Segment Forecasts, 2018 - 2025

Industry Insights

The global downstream processing market size was valued at USD 14.39 billion in 2017. It is anticipated to expand at a CAGR of 13.4% during the forecast period. Downstream processing is an important aspect of drug manufacturing, especially for vaccines, monoclonal antibodies, hormones, antibiotics, enzymes, and antibodies. The process involves recovery and purification of pharmaceuticals from animal, plant, or any other natural source.

Rapid growth of the biotechnology sector is one of the key trends fueling the demand for downstream processing. This is majorly due to high adoption of biotech processes in the pharmaceutical, agricultural, and bio-services industries. In addition, developments in the field of gene therapy and genetic engineering are estimated to propel the market during the forecast period.

Efforts are being taken by major players to streamline the process and cut-down the overall procedure cost, which will subsequently reduce the overall price of the product. This is leading to increase in investments in biotech R&D and evolution of new downstream processing technologies that allow high throughput and have short processing time.

Some of the promising downstream processing techniques are membrane affinity chromatography, perfusion chromatography, single use systems, and employment of high throughput process development. Moreover, product quality constraints, regulatory directives, and increased titers are further encouraging advancements in downstream processing.

Growing investments in the development of bioprocess and fermentation technologies to support large scale production of biologics and biosimilar are expected to spur the growth of the market. Scope for the usage of downstream processing technique for commercial production of biosimilars has been expanding owing to rising demand for biosimilars.

Biopharmaceuticals are emerging as new paradigms for blockbuster medications and their sales are spiraling, despite their high costs. Therefore, due to high capital profits offered by biopharmaceuticals, major pharma manufacturers are increasingly shifting their R&D activities to biopharma.

Contract manufacturing organizations (CMOs) are playing a significant role in the growth of the market. A new biopharma plant, which is to be equipped with large stainless-steel bioreactors to produce high-volume biopharmaceuticals, requires nearly more than $250 million and a minimum lead time of four years. Therefore, new market entrants, start-ups, and some large pharma companies expanding their pipeline to biopharma switch to CMOs rather than building up their own production capacity.

Moreover, a strong pipeline of biologics including viral vectors, multispecific monoclonal antibodies, peptides, and oligonucleotides requires transformation of biopharma plants into multi-modality and multi-platform units. However, most of these plants are still in mono-platform and mono-modality setup. Thus, in this situation, contract manufacturing becomes an optimal choice for commercial production of biologics without increasing manufacturing costs.

Increasing adoption of integrated solutions, wherein a single company offers each individual component of the downstream system such as instrument, consumables, technical support, validation, and training services, is a significant trend observed in this marketspace. This helps in a better product recovery and avoids any loss due to several steps in conventional production. Some of the major providers of integrated solutions are Merck KGaA (Merck Millipore) and General Electric Company (Amersham Biosciences).

Products Insights

Major market players offer safe and integrated chromatography solutions that work efficiently during all steps of a bioprocess. In recent years, key players have developed technologically efficient systems that address developing needs of the industry to perform state-of-the-art chromatography steps during manufacturing of bio-therapeutics. For instance, single-use chromatography is one of the most significant inventions of the biopharmaceutical industry.

Single-use chromatography eliminates the need for large-scale chromatography columns, column packing, resin storage, and storage of packed columns. The technology has also led to reduction in water and chemicals for buffer to as much as 80.0%. This ensures increased productivity and efficiency of bioprocess in less time and with reduced labor.

Filter manufacturers have been developing advanced filters with high performance owing to surging demand for viral clearance. Viruses can severely damage an entire process stream. There are several micro and ultra-filters commercially available in the market. A few examples of the same include Planova virus removal filters from Asahi-Kasei, Virosart brand from Sartorius Stedim Biotech, and Viresolve filters from Merck Millipore.

In addition to virus clearance, sterile filtration is also used for removal of certain antibiotic resistant bacterial species such as Mycoplasma. Filters used for this purpose include Millipore Express from Merck, Fluorodyne from Pall Corporation (Danaher), and Nalgene PES filters.

Technique Insights

Cell disruption technologies are undergoing constant advancements to increase the efficacy of the method. In this regard, a novel method for cell disruption using laser is being studied quantitatively and qualitatively in continuous and batch systems, respectively. This method can be a rapid, clean, and convenient alternative to other conventional disruption techniques.

Filtration is one of the most commonly used techniques for separation of culture filtrate and biomass. However, fouling and clogging of filter is a notable problem during scaling up of filtration technologies. Therefore, dead-end and tangential flow filtration systems have been designed to overcome this problem.

Application Insights

Antibodies are one of the most predominant modalities offered by the biopharmaceutical industry today. This success can be attributed to establishment of robust manufacturing platforms that produce high titers for monoclonal antibodies in mammalian cell cultures.

In addition, evolution of certain new methods in bioprocessing of antibodies have further augmented the market. These new methods include continuous bio manufacturing, alternative expression systems, and non‐chromatographic separation formats.

Moreover, as antibiotic resistance is on rise, there is an increase in demand for development of antibodies that act against resistant strains. This, in turn, is increasing the demand for downstream processing for antibody production at industrial scale.

Regional Insights

North America dominated the global downstream processing market in 2017. The growth of the region can be attributed to increased focus of government bodies on the development of the biotechnology industry, rising healthcare expenditure, and presence of adequate infrastructure for growth and development of bioprocessing industries.

Owing to recent advancements, there is a substantial rise in sales of biotechnology products in the region. Therefore, continual innovations in the biotechnology sector are likely to provide ample growth opportunities to the regional market during the forecast period.

Asia Pacific is poised to witness the fastest growth during the same period owing to constant efforts undertaken to strengthen the biotechnology infrastructure and genomic landscape in countries such as India and China. In recent times, the region has witnessed advent of rapid analytical methods that provide in-process control and support evaluation of process design. Besides this, establishment of vendors and supply chains for bioprocessing consumables and equipment that are at par with the highest international standards, across major developing countries, is projected to contribute to the growth of the region.

Downstream Processing Market Share Insights

The market is dominated by Thermo Fisher Scientific Inc.; General Electric Company (GE Healthcare); Sartorius Stedim Biotech S.A.; Merck KGaA (Merck Millipore); and Danaher Corporation. These players have a competitive edge in the market owing to strong bioprocessing product offerings and their wide distribution network throughout the globe.

Other prominent players operating in this market are 3M Company, Repligen, Boehringer Ingelheim International GmbH, Eppendorf AG, Lonza Group Ltd, Corning Corporation, Ashai Kasei, Dover Corporation (CPC (Colder Products Co.)), and Ferner PLC.

Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the industry trends in each of the sub-segments from 2014 to 2025. 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, 2014 - 2025)

  • Chromatography Systems

  • Filters

  • Evaporators

  • Centrifuges

  • Dryers

  • Others

• Technique Outlook (Revenue, USD Million, 2014 - 2025)

  • Cell Disruption

  • Solid-liquid separation

    • Filtration

    • Centrifugation

  • Concentration

    • Evaporation

    • Membrane filtration

  • Purification by Chromatography

  • Formulation

• Application Outlook (Revenue, USD Million, 2014 - 2025)

  • Antibiotic Production

  • Hormone Production

  • Antibodies Production

  • Enzyme Production

  • Vaccine Production

• Regional Outlook (Revenue, USD Million, 2014 - 2025)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

  • Asia Pacific

    • Japan

    • China

    • India

  • Latin America

    • Brazil

    • Mexico

  • Middle East and Africa (MEA)

    • South Africa

    • U.A.E