The proteinase K market size is estimated to be USD 3,825.4 million in 2022 and is expected to witness a CAGR of 8.97% during the forecast period 2023-2033. Growing demand for NGS diagnostic techniques and increase in prevalence of chronic diseases are some of the factors contributing to the market growth. Additionally, technological developments in POC devices and rising adoption of cell separation techniques by diagnostic labs, cell banks, and research organizations are other factors supporting the market growth. However, availability of alternatives for proteinase K is expected to hinder the growth.

Technological developments in POC devices are expected to propel the market growth during the forecast period. As next-generation POC diagnostics or testing devices, various smartphone-based POC devices and associated tools have emerged, boosting the market’s expansion. For instance, the autonomous capillary microfluidic chip and the ACMC platform-based smartphone application can be used together to test for cardiac troponin I in myocardial infarction. This platform is simple to use in resource-constrained emerging economies. Thus, it is projected that the market would continue to be driven by innovative technological developments in POC devices.

Rising adoption of cell separation techniques by diagnostic labs, cell banks, and research organizations is predicted to fuel the market growth. For instance, academic institutions are actively searching for innovation in sample sequencing and cell separation. For instance, Cornell University researchers founded the start-up Inso Biosciences in April 2022 to market their patented nucleic acid extraction and sample preparation method. For DNA fragments between 40 and 50 kb in length, the new method can process samples in 30 to 40 minutes as compared to 6 hours.

Segmentation

By Form

The market is categorized into liquid and powder. In the global market, the powder segment accounted for the largest revenue share in 2022 owing to the advantages the technique offered. Proteinase K is available in powder form, which offers many benefits including high stability, low cost of shipping, and a long shelf life. Additionally, the powder form reduces the need for special temperature requirements while shipping and does not affect proteinase K’s action, saving on the additional expense associated with ice-pack shipment. As a result, the advantages of powder form are expanding its applications and fueling market expansion. The liquid segment is anticipated to expand at the fastest rate over the projected period. The liquid form of proteinase K is preferable over the powdered form in a variety of situations. The liquid form is easier to boil down than the stable state. When boiling down, the liquid form is more convenient.

By Therapeutic Area

The market is divided into infectious diseases, autoimmune diseases, oncology, nephrology, neurology, cardiology, diabetes, and others. In 2022, the infectious diseases segment accounted for the highest revenue share due to rising frequency of infectious diseases including HIV, TB, and malaria in low- to middle-income nations. For instance, QIAGEN provides QIAGEN Proteinase K, a subtilisin-type protease that was isolated from the saprophytic fungus Tritirachium album. The product is used to isolate DNA and RNA from samples in order to diagnose viral and bacterial disease. Therefore, it is anticipated that the inclusion of proteinase K in rapid molecular testing will accelerate market expansion. The neurology market is expected to grow rapidly over the course of the projected period. Small molecule therapies, enzyme replacement, gene editing, splicing, and gene replacement therapies using adeno-associated vectors are just a few of the medicines for neurology that are currently being developed. Additionally, it is anticipated that gene expression profiling is a crucial approach for locating diagnostic and therapeutic targets in neurological diseases.

By Application

The market is segregated into mitochondria isolation, isolation and purification of genomic DNA & RNA, and in situ hybridization. In the global market, the isolation and purification of genomic DNA & RNA segment accounted for the largest revenue share in 2022 owing to the fact several stages of the purification process for genomic DNA and RNA involve the use of proteinase K. In CROs and biotechnology companies, the isolation and purification of genomic DNA and RNA are standard procedures. The need for DNA or RNA isolation is projected to see increasing trends, and these trends will be reflected in the market, with the growing need for personalised therapy in cancer and rare diseases. The in-situ hybridization market is anticipated to grow at a lucrative CAGR during the forecast period. The benefits of high-volume testing and the availability of automated instruments that enable tests to be conducted more quickly and accurately should be attributed for the growing use. This market is anticipated to have substantial growth due to the rising prevalence of chromosomal aberration-related disorders including genetic abnormalities and cancer, and unmet diagnostic and clinical needs.

By End Use

The market is segmented into academic institutes, contract research organization, diagnostic laboratories, and biotechnology companies. In 2022, the biotechnology companies segment accounted for the largest revenue share owing to increasing use of in situ hybridization (ISH) techniques to assist clinical and preclinical research for biotechnology companies. These organizations have implemented ISH staining, tissue sectioning, high-resolution full-slide scanning, scoring, and image analysis methods. The usage of the proteinase K enzyme, which is used to break down tissue samples during ISH, is fueled by the implementation of ISH techniques. The segment for academic institutes is anticipated to increase at the fastest rate during the projected period. Academic laboratories provide integrated services for IVD clinical research at every level, from inception to commercialization. The use of proteinase K enzyme in academic laboratories is increasing as a result of the examination of histology assays by these laboratories, which uses the enzyme to digest tissue samples.

Regional Markets

In 2022, North America region accounted for the highest revenue in the proteinase K market and is expected to maintain its dominance during the forecast period. This is attributed to strong demand for proteinase K and rising incidence of infectious diseases in the region. The FDA granted Emergency Use Authorizations (EUA) for in vitro COVID-19 laboratory-developed tests to help fight the COVID-19 pandemic. Additionally, the majority of these EUAs have been for RT-PCR and enzyme-linked immunosorbent assay (ELISA) tests for the detection of SARS-CoV-2. Asia Pacific is predicted to expand at the fastest rate due to growing applications of sequencing technology, and several government programmes to support genomics research and precision medicine. For instance, the National Precision Medicine (NPM) Strategy was introduced by the Singaporean government in 2020 to better understand how phenotypic, genetic, clinical, and lifestyle factors affect the health of Singaporeans. During the forecast period in the region, several government measures are anticipated to enhance proteinase K applications.

Competitor Insights

Some of the key players operating in the proteinase K market are Abcam Plc, Biocatalysts Ltd., Promega Corporation, New England Biolabs, Qiagen, Minerva Biolabs GMBH, Thermo Fisher Scientific, Inc., Merck KGaA, F. Hoffmann-la Roche Ltd., Agilent Technologies, Inc., Takara Bio, Inc., and MP Biomedicals.

To achieve a competitive edge, these companies are implementing a variety of growth strategies. Strategic partnerships, alliances, and agreements with different businesses and research institutions are seen to be the main strategies used by companies in this sector.

• For instance, Merck KGaA announced plans to invest about USD 542 million in scaling up Exelead’s technology in February 2022 after completing the acquisition of the company. The effort can help the company grow by expanding its variety of products and services. Additionally, in April 2022, Thermo Fisher Scientific, Inc. partnered with Matrix Clinical Trials to improve its clinical research solutions and increase the market potential for its associated products and decentralized trial solutions.

This comprehensive research report focuses on the global and regional market size and forecasts of diverse segments including form, therapeutic area, application, end use from 2023 to 2033.

Report Scope:

Segmentation: Proteinase K Market Report 2022 – 2033

Form (Revenue, USD Million), 2022 – 2033

• Liquid
• Powder

Therapeutic Area (Revenue, USD Million), 2022 – 2033

• Infectious Diseases
• Autoimmune Diseases
• Oncology
• Nephrology
• Neurology
• Cardiology
• Diabetes
• Others

Application (Revenue, USD Million), 2022 – 2033

• Mitochondria Isolation
• Isolation and Purification of Genomic DNA & RNA
• In Situ Hybridization

End Use (Revenue, USD Million), 2022 – 2033

• Academic Institutes
• Contract Research Organization
• Diagnostic Laboratories
• Biotechnology Companies

By Region (Revenue, USD Million), 2022 – 2033

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • France
  • UK
  • Spain
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • South Korea
  • Rest of APAC
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of LATAM
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • Rest of MEA