The global proteinase K market size was valued at USD 66.52 million in 2020 and is projected to expand at a considerable CAGR during the forecast period, 2021 – 2028. The growth of the market is attributed to the wide use of enzymes rampant in DNA and RNA extraction and rising demand for in-vitro diagnostics.
Proteinase K is extensively used in in-vitro diagnostics (IVD) to remove endotoxins that attach to ribonuclease A, lysozyme, and other cationic proteins, and isolate mitochondria from hepatic cells. This helps to analyze the localization of enzymes on membranes, which allows to treat paraffin-embedded tissue parts during antibody labelling and digest protein from clinical tissue samples. The enzyme is also further used in the purification of PCR products for a variety of IVD applications.
The outbreak of the COVID-19 pandemic offers lucrative opportunities for the market growth as the pretreatment capacity of proteinase K is considered to be effective for the COVID-19 detection. The use of RT-qPCR to detect the COVID-19 virus has gained a lot of attention in the battle to stop the COVID-19 pandemic from spreading. Furthermore, for the diagnosis of COVID-19 infected individuals, PCR is considered to be the gold standard testing process. As the demand for diagnostic kits are in surge worldwide, the healthcare professionals and key players are working together to produce more testing devices. These professionals are also investigating the potential of updated protocols with direct-to-test enhancements, which can greatly improve the quality of test results besides assisting in the expansion of COVID-19 testing capability.
In May 2020, a study was conducted in Brazil by using proteinase K in the pre-treatment of samples. In the experiment, it developed a protocol that was eventually able to detect COVID-19 infection in samples taken without the need for RNA extraction. The researchers concluded that, using this enzyme as a method of diagnosing people infected with COVID-19, the test method is a time-saving alternative to using time-consuming standard protocols to purify and remove RNA. Furthermore, more than 90% of the samples in this analysis were matched to the findings of samples processed according to standard protocols.
Market Trends, Drivers, Restraints, and Opportunities
- Wide prevalence of chronic illness and infectious diseases across the globe is a major driver boosting the market.
- Increasing adoption of enzymes process for DNA and RNA extraction and rapid development of advance in-vitro diagnostics are expected to fuel the market development.
- Rising spending on R&D activities from key players and implementation of favorable government bodies to develop innovative technology and devices for DNA and RNA testing are key factors driving the market growth.
- Factors such as time-consuming and expensive in respect to the COVID-19 PCR protocol's RNA extraction process associated with proteinase K treatment are key limitations that can restrict the scaling up of COVID-19 experiments.
- Lack of qualified staff handling various testing procedures and limited resource with constrained environments pose major challenges that can hamper the market growth.
Scope of the Report
The report on the global proteinase K market includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.
Proteinase K Market - Global Industry Analysis, Growth, Share, Size, Trends, and Forecast
Therapeutic Areas (Neurology, Oncology, Infectious Diseases, Diabetes, Cardiology, Nephrology, Autoimmune diseases, and Others) and Forms (Powder and Liquid)
Asia Pacific, North America, Latin America, Europe, and Middle East & Africa
Company Share, Market Analysis and Size, Competitive Landscape, Growth Factors, and Trends, and Revenue Forecast
Key Players Covered in the Report
Merck KGaA; Codexis, Inc.; F. Hoffmann-La Roche Ltd.; Amano Enzyme Inc.; Advanced Enzymes Technologies Ltd.; Biocatalysts Ltd.; Amicogen; Dyadic International; BBI Solutions; Affymetrix; and American Laboratories
Proteinase K Market Segment Insights
Neurology segment is expected to represent a key share
Based on therapeutic areas, the global proteinase K market is divided into neurology, oncology, infectious diseases, diabetes, cardiology, nephrology, autoimmune diseases, and others. The neurology segment is anticipated to expand at a rapid pace during the forecast period owing to its wide applications. Using EDTA and proteinase K to treat Plasmodium DNA eliminates the need for DNA purification and isolation during PCR. This leads to minimize sample preparation time for malaria molecular diagnostics, which could improve the utility of proteinase K for malaria diagnosis. Moreover, the neurology segment is widely used for proteinase K in prion disease diagnosis. For cross-linking research, this enzyme is increasingly being used instead of trypsin and the mass distribution of cross-linked peptides is generated by digestion with the enzyme, making the sample suitable for MALDI-MS analysis. The enzyme has also been used to treat samples during the detection of prions using the Enzyme-linked Immunospot (Elispot) cell infection assay.
Powder segment is expected to hold a dominant share
On the basis of forms, the market is bifurcated into powder and liquid. With a revenue of around USD 33.94 million in 2020, the powder segment is expected to hold a dominant share in the coming years. As opposed to the liquid form of proteinase K, the powdered form is high preferable due to easy stock solutions and effectively applied according to the protocol's requirements. Enzymes are extremely vulnerable to autolytic degradation, denaturation, and oxidation processes, which are often promoted by water softening manufacturers. This enzyme can also catalyze the lytic degradation of other ingredients in a solution. The physical separation of the enzymes in different particles in a powdered formulation overcomes these obstacles. Powdered enzymes are also predicted to have a longer shelf life than other enzyme formulations. Physical separation of enzymes in liquid formulation is difficult and the presence of a solvent such as acid, amplifies the enzymes' negative effects while also speeding up undesirable reactions. Companies, on the other hand, are working hard to solve the difficulties associated with liquid formulation. A mixture of calcium chloride and carboxylic acid salts, for example, are used to protect enzymes from degradation.
Asia Pacific is a fast-growing market
In terms of regions, the market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. In 2020, North America dominated the proteinase K segment, accounting for around 42.06 percent of the total global sales. As the incidence of cancer rises in the region, so does the use of next-generation sequencing (NGS) and polymerase chain reaction (PCR). Proteinase K and other enzymes along with reagents are used in NGS and PCR techniques, which result in high demand for the components in the region.
Due to increase in the prevalence of several health disorders and chronic diseases combined with a large consumer base in Asian countries, the market in Asia Pacific is expected to expand at a fast pace during the forecast period. By the end of 2020, around 4.51 million cancer cases and 3.04 million cancer deaths were reported in China. Furthermore, Asia Pacific excluding Oceania accounted for more than 30% of all COVID-19 cases worldwide as of September 2020. Proteinase K is increasingly used for the analysis of COVID-19 and cancer biopsy specimens in various clinical labs, thereby, is expected to boost the regional market development.
Segments Covered in the Report
The global proteinase k market has been segmented on the basis of
- Infectious Diseases
- Autoimmune Diseases
- Asia Pacific
- North America
- Latin America
- Middle East & Africa
- Merck KGaA
- Codexis, Inc.
- F. Hoffmann-La Roche Ltd.
- Amano Enzyme Inc.
- Advanced Enzymes Technologies Ltd.
- Biocatalysts Ltd.
- Dyadic International
- BBI Solutions
- American Laboratories
Some of the key players operating in the market are Merck KGaA; Codexis, Inc.; F. Hoffmann-La Roche Ltd.; Amano Enzyme Inc.; Advanced Enzymes Technologies Ltd.; Biocatalysts Ltd.; Amicogen; Dyadic International; BBI Solutions; Affymetrix; and American Laboratories. Several kits involving the use of proteinase K that can be applied for a wide range of applications are increasingly being produced by key players. For example, Leica Biosystems' Novocastra Enzyme Proteinase K (IHC) RE7160-K is used to enzymatically pre-treat paraffin-embedded or formalin-fixed tissue before incubation with an antibody during Immunohistochemical (IHC) analysis of tissue samples.
Some of the latest development can be the adoption of molecular biology techniques that use proteinase K in the area. Implementation of several initiatives and research programs such as the National Human Genome Research Institute's Newborn Sequencing in Genomic Medicine and Public Health (NSIGHT) program, which screens infants for genetic diseases is a key example of the latest development. BLIRT S.A.'s NGS grade proteinase K is used to extract nucleic acids from a variety of starting materials, detoxify target materials from contaminated proteins, and eliminate RNases and DNases during nucleic acid isolation.