PROTEINASE K MARKET ANALYSIS

The Global Proteinase K Market is estimated to be valued at US$ 27.5 million in 2023 and is expected to exhibit a CAGR of 6.2% during the forecast period (2023-2030).

Analysts’ Views on Global Proteinase K Market:

Increase in exploring newer methods of cell separation by diagnostic labs and research laboratories is one of the key factors contributing to the growth of the market within the forecast period. For instance, on April 8, 2022, Researchers from Cornell University, U.S., launched a startup called Inso Biosciences to commercialize nucleic acid extraction and sample preparation technology.  Its first application is based on targeting DNA extraction and sample preparation for long-read sequencing. This technology can complete sample processing in 30 to 40 minutes, instead of four to six hours for DNA pieces 40 kb to 50 kb in length or as long as 100 kb. Moreover, the firm's method keeps DNA in solution, which results in less damage than chemical binding-based methods. As Proteinase K plays a major role in DNA purification, such techniques can increase the demand of global proteinase K market.

Figure 1. Global Proteinase K Market Share (%), by Application, 2023

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Global Proteinase K Market – Driver

Collaborations by key market players to expand product portfolio

In order to carry out the research in an efficient way, key market players are focused on collaborating with other clinical research organizations to expand their product portfolio. For instance, on April 19, 2022, Thermo Fisher Scientific Inc., a U.S.-based reagent supplier, and Matrix Clinical Trials, a U.S.-based clinical service organization, announced a collaboration to bring clinical trials to patients with an innovative decentralized clinical trial (DCT) solution. Thermo Fisher Scientific is deploying state-of-the-art Matrix mobile research sites and expert clinical staff across the U.S. to help identify, recruit, and retain trial participants while ensuring a positive patient experience. This increase in clinical trials can help in increasing the growth of the global proteinase K market for diagnosis purposes.

Newer research and development activities in field of proteinase K

Proteinase K is commonly used in extraction and purification of DNA and RNA. Apart from that alternative uses of it are also under study. This can fuel the growth of global proteinase K market. For instance, according to article published by Journal of Functional Polymers on June, 2022, Proteinase K can be used along with antimicrobials to enhance penetration of antimicrobials across the biofilm. It was found that proteinase K has ability to disperse over the mature biofilm of methicillin resistant staphylococcus aureus and increase entry of antimicrobial agent.

Figure 2. Global Proteinase K Market Value (US$ Million), by Region, 2023

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Global Proteinase K Market - Regional Analysis

Among regions, North America is estimated to hold a dominant position in global proteinase K market over the forecast period. The growing prevalence of infectious diseases and genetic disorders directly impacts the increased demand for the global proteinase K market. For instance, as per the report from the World Health Organization in 2021, there was an increase in tuberculosis cases by 4.5% in 2021. The number of cases was 10.1 million which rose to 10.6 million, reversing many years of slow decline. Similarly, the tuberculosis incidence rate (new cases per 100, 000 population per year) is estimated to have increased by 3.6% between 2020 and 2021. Thus, the rise in infectious cases like tuberculosis, human immunodeficiency viruses, influenza, and hepatitis is anticipated to increase market growth over the forecast period. Globally, 38.4 million [33.9–43.8 million] people were living with human immunodeficiency viruses at the end of 2021. An estimated 0.7% [0.6-0.8%] of adults aged 15–49 years worldwide are living with HIV, although the burden of the epidemic continues to vary considerably between countries and regions.

Global Proteinase K Market – Impact of Coronavirus (COVID-19) Pandemic

Since the COVID-19 virus outbreak in December 2019, the disease spread to over 100 countries across the globe, and the World Health Organization declared it a public health emergency on January 30, 2020.

COVID-19 affected the economy in three main ways: by directly affecting the production and demand of drugs, by creating disruptions in distribution channels, and through its financial impact on firms and financial markets. Due to nationwide lockdowns, several countries such as China, India, Saudi Arabia, the U.A.E., Egypt, and others are facing problems with the transportation of drugs from one place to another.

However, the COVID-19 pandemic had a positive impact on the global Proteinase K market. This is because Proteinase K was widely used in test kits designed for the detection of COVID-19 infection. For instance, on August 17, 2021, Thermo Fisher Scientific, U.S. based medical instruments and reagents-based company received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for two of its next-generation COVID-19 assays. The two assays are the TaqPath COVID-19 Fast PCR Combo Kit 2.0 and TaqPath COVID-19 RNase P Combo Kit 2.0. Both kits are designed with increased target redundancy to address current and emerging SARS-CoV-2 variants. These kits are based on the use of the Proteinase K enzyme.

Global Proteinase K Market Segmentation:

The Global Proteinase K Market report is segmented into by form, by application, by end-user, and by Region.

By Form, the market is segmented into lyophilized powder form and liquid form. Out of which, the lyophilized powder form segment is expected to hold a dominant position in the global Proteinase K market during the forecast period and this is attributed to the advantages imparted due to lyophilization techniques. The powder after lyophilization have high stability, long shelf life and inexpensive shipping. Lyophiliziation also does not reduce the activity of proteinase K.

By Application, the market is segmented into Purification of DNA & RNA, In situ Hybridization, Mitochondria Isolation, and Enzyme Removal. Out of which, the purification of RNA & DNA segment is expected to hold a dominant position in the global proteinase K market during the forecast period and this is attributed to the increasing number of infectious diseases worldwide. This increases the demand for techniques used in diagnosis of infectious diseases like hepatitis, influenza, human immunodeficiency virus.

By End user, the market is segmented into Contract Research Organization, Academic Institutes, Biotechnology Companies, and Diagnostic Laboratories. Out of which, the contract research organization segment is expected to dominate the market over the forecast period and this is attributed to the increasing research activities in Clinical Research Organizations.

Among all the segmentations, the application segment has the highest potential due to continuous newer technological advancements in the purification of DNA & RNA using proteinase K. For instance, as per an article published in Frontier Journal in Cellular and Infection Microbiology, on November 3, 2021, few scientists from Institute of medical sciences, Banaras Hindu University, India studied vitality of Proteinase K in rRTPCR detection of SARS-CoV2 bypassing RNA Extraction. The study was conducted by comparing the proteinase K heat treatment method with a standard method of using Qiagen, a Germany-based molecular diagnostic company’s column-based QIAamp Nucleic Acid kit for the detection of SARS-CoV2. Results showed that PK exposure and heat treatment is an effective method and can be employed in situations where gold-standard reagents are not available to carry out molecular detection of the SARS-CoV2 viral component.

Global Proteinase K Market Cross Sectional Analysis:

Rising numbers of clinical research organizations due to increasing research activities in emerging economies are also expected to boost demand for Proteinase K in North America region, which results in the introduction of newer technologies in the market. For instance, on March 23, 2023, PerkinElmer Inc., a U.S.-based diagnostic company received U.S. Food and Drug Administration approval for New Coronavirus Nucleic Acid Detection Kit. It is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in oropharyngeal, nasopharyngeal, and anterior nasal swabs taken from individuals suspected of having COVID-19. This test is also for use with saliva samples collected using the Saliva Secure Saliva Collection Kit, either by healthcare personnel or self-collected under the supervision of healthcare personnel in a healthcare setting from individuals suspected of COVID-19. It has better sensitivity than other commercially available kits.

Global Proteinase K Market: Key Developments

Due to increasing applications of sequencing technology, various government initiatives are being taken to promote genomics research and precision medicine. One of the ways is to by funding the research projects by analyzing the type of research needed to be done. This is expected to drive growth of Proteinase K market. For instance, on April 7, 2021, 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 will increase the research and development activities in healthcare and are expected to increase the applications of proteinase K during the forecast period in the region.

Key players in the market are adopting various strategies such as partnerships, mergers and acquisitions, joint ventures, and strategic collaborations to expand their market presence. For instance, on February 23, 2022, Merck KGaA, a Germany-based pharmaceutical company acquired Exelead, a U.S.-based pharmaceutical company, and announced plans to invest approximately US$ 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 June 24, 2020, according to article published in Microbial Cell Factories , a neutral, heat sensitive serine protease originating from fungus Onygena Corvina was described which is alkaline serine protease of substilisin type S8 family. It has enzymatic activity at neutral pH. Compared to proteinase K it has two- fold higher specific activity. It can also be used for protein sequencing. Protein coverage is also higher in comparison to proteinase K.

In December 6, 2021, according to data published in Journal of Forensic Sciences, a study was conducted to check impact of using reduced concentration of phosphate buffer saline and proteinase k on interpretation of forensic DNA signal.It was found that with modest modification to proteinase K does not significantly impact on single cell electrophoretogram. It was concluded that a lower than recommended proteinase K concentration coupled with a lower than recommended Phosphate-buffered saline (PBS)  concentration result in enhanced single cell electrophoretogram (scEPGs) within the semi-automated single-cell pipeline. 

Global Proteinase K Market: Key Trends

Funding for research and development in the biotechnology field

Market players are focused on granting funding to increase research and funding in biotechnology industry, the global proteinase K market is expected to experience considerable expansion in the North American region. For instance, in January 2021, Pfizer Inc., a multinational biotechnology company, announced that as part of its Pfizer Breakthrough Growth Initiative (PBGI), it has invested a total of US$ 120 million in four clinical-stage biotechnology firms. Pfizer is investing up to US$ 500 million in biotechnology firms through PBGI, offering capital and access to Pfizer's scientific expertise to support the continuation of promising clinical development programs that Pfizer may find strategically valuable in the future.

Global Proteinase K Market: Restraint

New alternative technologies for protein purification

Proteinase K takes time for giving results while there are newer technologies and instruments introduced that can give results within a few minutes. Such kits are also easily available and have everything required to isolate pure DNA genome effectively. For instance, on April 4, 2022, MolGen, U.S. based biotechnology company launches high-quality DNA/RNA extraction kits for efficient high throughput testing. Due to strong magnetic beads present in this DGX kit, fast magnetic separation can be formed which gives high yield of purified RNA can be obtained.

Alternative products that are available at less prices are also gaining popularity. For instance, according to an article published on September 10, 2020, by Biocatalysts Ltd, a U.K. based biotechnology company, its novel product Proteocut K, is a broad-spectrum serine that meets the requirements needed for use in molecular biology applications. These tests prove Proteocut K is a high-quality, cost-effective alternative to Proteinase K.

To counterbalance these restrain, the newer research and development activities in the field of proteinase K are needed to be done which can overcome existing shortcomings of proteinase K. This can boost the growth of global proteinase K market.

Global Proteinase K Market - Key Players

Major players operating in the Global Proteinase K Market include Thermo Fisher Scientific Inc., Merck KGaA, Qiagen N.V., F. Hoffmann-La Roche Ltd., New England Biolabs, Worthington Biochemical Corporation, Norgen Biotek Corp., BIORON GmbH, Sisco Research Laboratories Pvt. Ltd., Bioline (Meridian Biosciences Inc.), Promega Corporation.

*Definition: Proteinase K is a serine protease produced by the fungus Tritirachium album Limber. It is used as an enzyme or reagent in different chemical reactions. It digests the unwanted nuclease in protein purification and produces a pure sample of high molecular weight DNA & RNA. Proteinase K has various applications such as isolation and purification of nucleic acid, mitochondria isolation, enzyme removal, and PCR purification.