Proteinase K Market Size, Share & Trends Analysis Report By Therapeutic Area (Neurology, Oncology, Infectious Diseases), By Form (Powder, Liquid), By Region, And Segment Forecasts, 2020 - 2027

Report Overview

The global proteinase K market size was valued at USD 61.44 million in 2019 and is expected to expand at a compound annual growth rate (CAGR) of 7.6% from 2020 to 2027. Broad application of the enzyme in the DNA and RNA extraction for in-vitro diagnostics is anticipated to drive market growth. Proteinase K finds application in in-vitro diagnostics for the removal of endotoxins that bind to ribonuclease A, lysozyme, and other cationic proteins; isolation of mitochondria from hepatic cells; analysis of the localization of enzymes on membranes; treatment of paraffin-embedded sections of tissues during antibody labeling; and protein digestion from clinical tissue samples. The enzyme is also used during PCR purification for a wide range of IVD applications.

The potential of proteinase K pretreatment for efficient detection of COVID-19 is anticipated to provide growth avenues to the market. Detection of the COVID-19 virus via the employment of RT-qPCR has gained significant traction to contain the spread of the COVID-19 pandemic. Additionally, PCR is considered to be the gold standard technology for the diagnosis of COVID-19 infected individuals. However, the RNA extraction step of the COVID-19 PCR protocol is labor-intensive and is associated with high costs.

This has led to certain limitations for scaling up of COVID-19 tests across resource-limited settings, wherein laboratories face a lack of trained personnel along with sufficient funding. Thus, healthcare professionals are exploring the potential of modified protocols with direct-to-test additions, which can enhance the accuracy of test results significantly apart from assisting in expanding the capacity of COVID-19 testing.

A study performed on these lines in May 2020, in Brazil, designed a protocol that can potentially detect COVID-19 infection in samples collected without the need for RNA extraction step, via the use of proteinase K in the pre-treatment of samples. The study concluded that the use of this enzyme serves as an efficient technique of diagnosing individuals affected with the COVID-19, eliminating the need of performing time-consuming standard protocols to purify and extract the RNA. Additionally, in this study, more than 90% of the samples matched the results to that of samples processed under standard protocols.

Proteinase K Market Trends

Recombinant proteinase K from tritirachium is used for nonspecific digestion in diagnostics and in NGS-grade applications which need limited residual DNA content. The enzyme can also be used as a supplement in molecular diagnostic applications, such as NGS and PCR. Therefore, increasing demand for NGS diagnostic techniques is anticipated to boost the market for proteinase K enzyme.

Furthermore, wide range of applications of PCR for in vitro diagnostics and the launch of novel PCR products is anticipated to further boost the market growth. PCR has become a standard technique in laboratory biology, gaining popularity primarily due to the COVID-19 pandemic. Use of the technique has been accelerated by the launch of portable & affordable RT-PCR home testing kits. For instance, in April 2022, Laboratory Corporation of America received U.S. FDA’s approval for Pixel, an RT-PCR-based COVID-19 home collection kit. The utility of proteinase K in these molecular biology tests contributes to the growth of the market.

Growing concern about infectious diseases, and precautionary measures undertaken in this regard, have led to a high demand for rapid diagnostic test products. For instance, in April 2022, Quidel Corporation recorded a highly positive revenue performance at USD 1.70 billion. The company believed that point-of-care (POC) testing has the potential to grow further, and therefore the company acquired Ortho Clinical Diagnostics to provide an end-to-end diagnostic solution, including POC solutions. In addition, the growing prevalence of infections caused by multidrug-resistant bacteria has led to an increase in the demand for rapid diagnostics, which is likely to positively affect the market growth.

Furthermore, increasing adoption of cell separation techniques in numerous segments is one of the key factors which is likely to contribute to the growth of the proteinase K market in the near future. Techniques such as Aptamer Technology use RNA or DNA to bind to targeted cells depending on specific biomarkers. Hence, the growing use of cell separation among research laboratories & institutions, cell banks, hospitals labs, and diagnostics labs is anticipated to fuel the demand for proteinase K.

Over the past few years, diagnostic testing was a source of profit for several clinical laboratories. However, current reimbursement rates may not cover the entire cost of performing such tests. This, in turn, imposes a significant effect on patients. In some cases, the burden of the entire cost is imposed on the patients. Such challenges in the reimbursement structure can limit the market growth.

Test manufacturers are designing and publishing studies to prove the clinical utility of molecular tests that now require positive coverage determination for reimbursement. However, these clinical studies are costly, and for molecular tests affecting small populations, it can be challenging to gather sufficient patients to determine meaningful clinical data from these tests. These factors can hinder the growth of the market.

Therapeutic Area Insights

Infectious diseases accounted for the largest revenue share of 30.3% in 2019. The wide applicability of proteinase K in the diagnosis of several infectious diseases is a key factor that drives revenue generation in this segment. Studies have shown that the incubation of DNA from the Hepatitis B virus (HBV) with proteinase K results in efficient DNA isolation and higher yields. This is because the use of proteinase K results in the separation of the HBV genome from protein, which in turn facilitates efficient isolation of DNA from the aqueous phase.

Studies suggest that DNA yield from this method increased by five times when compared to the standard protocol that does not include treatment with proteinase K. Treatment of Plasmodium DNA with EDTA and proteinase K eliminates the DNA purification and isolation steps during PCR. This reduces the sample preparation time during molecular diagnostics of malaria, which in turn is expected to increase the utility of proteinase K for malaria diagnosis.

The neurology segment is expected to grow with the fastest CAGR from 2020 to 2027 owing to the utility of proteinase K in prion disease diagnosis. This enzyme is increasingly used as an alternative to trypsin for cross-linking studies. Digestion with the enzyme leads to the mass distribution of cross-linked peptides and makes the sample ideal for analysis with MALDI-MS. The enzyme has also been used for sample treatment during the Enzyme-linked Immunospot (Elispot) cell infection assay during the detection of prions.

Form Insights

The powdered form of proteinase K dominated the form segment with a revenue of USD 33.79 million in 2019. The powdered formulation of proteinase K is advantageous as compared to the liquid one. As the powdered form allows the preparation of stock solutions based on the requirements of the protocol. Enzymes are highly susceptible to autolytic degradation, denaturation, and oxidation processes that are often encouraged by the water‐softening builders. This enzyme sometimes catalyzes the lytic degradation of other components present in the formulation. Powdered formulation overcomes such challenges by allowing the physical isolation of the enzymes in separate particles. Moreover, powdered enzymes are expected to have a longer shelf-life as compared to other formulation.

The physical isolation of enzymes in liquid formulations is difficult and the presence of a solvent, such as water, surges the detrimental effect of the enzymes, as well as increases the rate of undesirable reactions. Conversely, companies are making considerable efforts to overcome the challenges associated with the liquid formulation. For instance, a combination of calcium chloride and carboxylic acid salts is expected to protect against enzyme degradation.

Regional Insights

North America dominated the market with the largest revenue share of about 45.78% in 2021. The region is witnessing increasing applications of Next-Generation Sequencing (NGS) and Polymerase Chain Reaction (PCR) fueled by the rising prevalence of cancer in the region. As a result, demand for proteinase K and other enzymes & reagents associated with NGS and PCR techniques is also expected to rise over the forecast period.

The U.S. accounted for the major revenue share of the North America market in 2021. Increasing application of NGS technology, developments in PCR tools, adoption of technologically advanced products, and strategic initiatives from key players are contributing to market growth. For instance, in May 2021, U.S.-based New England Biolabs, Inc. acquired a lyophilization R&D service company, Fluorogenics Limited for increasing its offerings in the reagents market. Such initiatives are expected to boost the market prospects for proteinase K products.

Germany is witnessing significant growth in its biotechnology industry due to an increasing medical or healthcare sector, which makes use of advanced biotechnology research for development of diagnostic products. The expanding biotechnology industry is anticipated to boost the market for proteinase K in the country. In addition, the local presence of key manufacturers and biotechnology companies, such as QIAGEN, Merck KGaA, Rentschler Biotechnologie GmbH, and Miltenyi Biotech GmbH, is contributing to the market revenue in the country.

Key Players & Market Share Insights

Key players have developed kits that involve the use of proteinase K for a wide range of applications. For instance, the Novocastra Enzyme Proteinase K (IHC) RE7160-K, offered by Leica Biosystems, is used for the enzymatic pretreatment of paraffin-embedded or formalin-fixed tissue before incubation with an antibody during Immunohistochemical (IHC) analysis of tissue samples. Some of the prominent players operating in the global proteinase K Market include:

• Merck KGaA

• Codexis, Inc.

• F. Hoffmann-La Roche Ltd.

• Amano Enzyme Inc.

• Advanced Enzymes Technologies Ltd.

• Biocatalysts Ltd.

• Amicogen

• Dyadic International

• BBI Solutions

• Affymetrix

• American Laboratories

Proteinase K Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional & country levels and provides an analysis of the industry trends in each of the sub-segments from 2016 to 2027. For this study, Grand View Research has segmented the global proteinase K market report based on therapeutic area, form, and region:

• Therapeutic Area Outlook (Revenue, USD Million, 2016 - 2027)

  • Infectious Diseases

  • Diabetes

  • Oncology

  • Cardiology

  • Nephrology

  • Autoimmune Diseases

  • Neurology

  • Others

• Form Outlook (Revenue, USD Million, 2016 - 2027)

  • Powder

  • Liquid

• Regional Outlook (Revenue, USD Million, 2016 - 2027)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • France

    • U.K.

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

  • Latin America

    • Brazil

    • Mexico

  • Middle East and Africa (MEA)

    • South Africa