Proteinase K Market Size, Share & Trends Analysis Report By Form (Powder, Liquid), By Therapeutic Area (Infectious Diseases, Neurology, Oncology), By Application, By End Use, By Region, And Segment Forecasts, 2022 - 2030

Report Overview

The global proteinase K market size was valued at USD 3.62 billion in 2021 and is expected to expand at a compound annual growth rate (CAGR) of 8.84% from 2022 to 2030. Increasing implementation of cell separation techniques by cell banks, diagnostic labs, and research laboratories and institutions is one of the key factors likely to contribute to the growth of the market in the forecast period. For instance, academic institutions are actively seeking innovation in cell separation and sequencing samples. For instance, in April 2022, researchers from Cornell University established a startup Inso Biosciences to market patented nucleic acid extraction and sample preparation technology. The new technology can complete sample processing in 30 to 40 minutes instead of 6 hours for DNA pieces from 40 kb to 50 Kb in length.

Moreover, the rising demand for proteinase K in POC diagnostics applications is likely to fuel market growth. Numerous smartphone-based POC devices and related tools have developed as next-generation POC diagnostics or testing devices, thus enhancing the growth of the market. For instance, ACMC platform-based smartphone application integrates with the autonomous capillary microfluidic chip for cardiac troponin I in myocardial infarction testing. This platform can be easily used in developing economies, where resources are scarce. Thus, innovative technological advancements in POC devices are anticipated to further drive the market.

The market is driven by the broad applications of molecular diagnostic techniques and their associated enzymes for IVD. Recombinant proteinase K from tritirachium is used for nonspecific digestion in diagnostics and NGS-grade applications, which need limited residual DNA content. Proteinase K can be used as a supplement in molecular diagnostic applications, such as NGS and PCR. NGS is expected to witness the increasing adoption of personalized medicines and other clinically developed therapies. Targeted panels and gene expression profiling via qPCR remain the two most common uses for NGS sequencers in a pathology lab. In addition, the decline in the cost of sequencing has broadened the use of NGS technologies. Therefore, increasing demand for NGS diagnostic techniques is anticipated to increase the uptake of proteinase K in the coming years.

Furthermore, the COVID-19 pandemic boosted the demand for proteinase K, exponentially propelling the growth of the market. Proteinase K is widely employed in extraction protocols of genetic material. It is important since it can absorb proteins that eliminate cross-contamination from nucleic acids. According to a study published on PLOS in March 2021, proteinase K treatment, followed by thermal shock for RNA extraction of COVID-19, is faster and relatively cost-effective. In addition, companies are considering the use of proteinase K in developing kits for COVID-19 diagnostics. For instance, the U.S. FDA granted EUA to Coronavirus Nucleic Acid Detection Kit by PerkinElmer, which is an RT-PCR that uses saliva samples to assess patient conditions. Such progress in the development of COVID-19 diagnostic kits and associated enzymes is expected to positively impact market growth.

Form Insights

The powder segment accounted for the largest share of over 50.0% in 2021 owing to the benefits offered by the technique. The powder form of proteinase K is ready to use and has numerous advantages such as long shelf-life, inexpensive shipment, and high stability. In addition, powder form does not reduce the activity of proteinase K and is stable to transport through the ship with no prerequisite in terms of temperature conditions, thus cutting down the extra cost for ice-pack shipment. Thus, the advantages of powder form are increasing its applications, thereby contributing to the market growth.

The liquid segment is expected to grow at the fastest rate over the forecast period. Under various circumstances, the liquid form of proteinase K is preferred over the powdered form. The liquid form is relatively more convenient to boil down. In addition, it is a time saver as the solution is ready to use and thus no time is required for solubilizing. Importantly, there is a lower risk of contaminating proteinase K, which would harm the RNA or DNA samples. Therefore, such advantages of liquid form aid in the large batch production, which is expected to fuel the market growth during the forecast period.

Therapeutic Area Insights

The infectious diseases segment captured the largest share of over 30.0% in 2021. The increasing incidence of infectious diseases such as HIV, tuberculosis, and malaria in low- to mid-income countries is anticipated to encourage players to develop products that are easy to operate in a low-resource setting. For instance, QIAGEN offers QIAGEN Proteinase K, which is isolated from the saprophytic fungus Tritirachium album, and it is a subtilisin-type protease. The product is used in the isolation of DNA and RNA from the samples during the diagnosis of viral and bacterial infection. Hence, the presence of proteinase K in rapid molecule testing is expected to accelerate market growth.

The neurology segment is predicted to expand at an exponential CAGR of 9.53% during the forecast period. Various therapies for neurology are under development such as small molecule therapies, enzyme replacement, gene editing, splicing, and gene-replacement therapies with adeno-associated vectors. In addition, gene expression profiling is considered to be an important tool for identifying diagnostic and therapeutic targets in neurological diseases. Proteinase K is used during the extraction process as it enhances the RNA yield and makes the majority of samples eligible for array analysis. Innovation in therapies is one of the key drivers for the market.

End-use Insights

The biotechnology companies segment accounted for the largest share of over 35.0% in 2021. This is due to an increase in the application of in situ hybridization (ISH) techniques to support clinical and preclinical studies for biotechnology companies is expected to drive the segment. ISH staining, tissue sectioning, high-resolution full-slide scanning, scoring, and image analysis are ISH protocols implemented by these entities. Implementation of ISH protocols fuels the usage of a proteinase K enzyme that is used for the digestion of tissue samples during ISH.

The academic institutes' segment is expected to witness the fastest growth during the forecast period. Academic laboratories offer integrated services for every stage of IVD clinical research, ranging from its development to commercialization. In addition, several collaborations for the development of new technologies with other academic and industrial agencies for the development of clinical trial procedures, such as expert review of biopsy histopathology or cytology. Such reviewing of histology assays by academic laboratories involves the usage of proteinase K enzyme for the digestion of tissue samples, thereby driving its usage rate in academic laboratories.

Application Insights

The isolation and purification of genomic DNA and RNA segments held the largest share of over 55.0% in 2021. Proteinase K is used at multi-stages in the process of genomic DNA and RNA purification. Before initiating the process, it is stored at -20°C. Under the stage of sample lysis, it is used for cultured cells, mammalian whole blood (non-nucleated), animal tissue, and nucleated whole blood. The isolation and purification of genomic DNA and RNA have become a routine process in CROs and biotechnology companies. With the emerging need for personalized treatment in cancer and rare diseases, the demand for DNA or RNA isolation is anticipated to witness upward trends and similar trends will be reflected in the market.

The in situ hybridization segment is expected to expand at a lucrative CAGR during the forecast period. The increasing adoption can be attributed to associated benefits such as high-volume testing and the presence of automated devices equipped to facilitate tests with greater speed and accuracy. The increasing incidence of diseases associated with chromosomal aberrations such as genetic abnormalities and cancer, coupled with unmet diagnostic and clinical needs, is expected to be a high growth-rendering factor for this segment.

Regional Insights

North America captured the largest share of over 45.0% in 2021 owing to the high demand for proteinase K and the increasing prevalence of infectious disorders in the region. To combat the COVID-19 pandemic, the FDA issued Emergency Use Authorizations (EUA) for in vitro COVID-19 laboratory-developed tests. In addition, most of these EUAs have been for enzyme-linked immunosorbent assay and reverse transcription polymerase chain reaction (RT-PCR)-based tests for the detection of SARS-CoV-2. Owing to the high applications of enzymes during RT-PCR, the development of such tests is expected to help generate revenue in the North American market.

Asia Pacific is expected to grow at the fastest rate of 11.42% from 2022 to 2030 owing to increasing applications of sequencing technology, coupled with various government initiatives to promote genomics research and precision medicine. For instance, in 2020, the government of Singapore launched the National Precision Medicine (NPM) Strategy to better analyze how phenotypic, genomic, clinical factors and lifestyle factors affect the health of Singapore citizens. Such government initiatives are expected to increase the applications of proteinase K during the forecast period in the region.

Key Companies & Market Share Insights

Key players in the market are adopting various organic and inorganic strategies such as partnerships, mergers and acquisitions, joint ventures, and strategic collaborations to expand their market presence. For instance, in February 2022, Merck KGaA completed the acquisition of Exelead and announced plans to invest approximately USD 542 million for scaling up its technology. The initiative is expected to broaden the company’s portfolio of offerings and can positively affect its growth. In addition, in April 2022, Thermo Fisher Scientific, Inc. collaborated with Matrix Clinical Trials for enhancing its clinical research solutions and boosting its market prospects for decentralized trial solutions and associated products. Some prominent players in the global proteinase K market include:

• Merck KGaA

• Qiagen

• Thermo Fisher Scientific, Inc.

• F. Hoffmann-la Roche Ltd.

• Abcam Plc

• Agilent Technologies, Inc.

• Biocatalysts Ltd.

• Minerva Biolabs GMBH

• Promega Corporation

• Takara Bio, Inc.

• New England Biolabs

• MP Biomedicals

Proteinase K Market Report Scope

Global Proteinase K Market Segmentation

This report forecasts revenue growth at the global, regional, and country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2018 to 2030. For the purpose of this report, Grand View Research has segmented the global proteinase K market report on the basis of form, therapeutic area, application, end-use, and region:

• Form Outlook (Revenue, USD Million, 2018 - 2030)

  • Powder

  • Liquid

• Therapeutic Area Outlook (Revenue, USD Million, 2018 - 2030)

  • Infectious Diseases

  • Diabetes

  • Oncology

  • Cardiology

  • Nephrology

  • Autoimmune Diseases

  • Neurology

  • Others

• Application Outlook (Revenue, USD Million, 2018 - 2030)

  • Isolation and Purification of Genomic DNA & RNA

  • In Situ Hybridization

  • Mitochondria Isolation

• End-use Outlook (Revenue, USD Million, 2018 - 2030)

  • Contract Research Organization

  • Academic Institutes

  • Biotechnology Companies

  • Diagnostic Laboratories

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • Singapore

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE