In-vitro Diagnostics Enzymes Market

The global in-vitro diagnostics enzymes market size was valued at USD 914.79 Million in 2022 and is projected to reach USD 1.98 Billion by 2031, expanding at a CAGR of 8.97% during the forecast period, 2023-2031.

The growth of the market is attributed to the increase demand for testing for various healthcare applications and rising development of new diagnostic devices in vitro diagnostic systems for laboratories and hospitals. Moreover, increasing number of COVID-19 cases presents a key aspect for the lucrative growth of the market.

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The diagnosis of various metabolic disorders is carried out by the adoption of enzymes owing to their outstanding catalytic properties. Various research studies stated that the clinical application of enzymes include alanine transaminase, acid phosphatase, aspartate transaminase, lactate dehydrogenase, gelatinase-B, and creatine kinase.

These enzymes are widely adopted biomarkers in various disease conditions, such as myocardial infarction, liver disease, renal disease, rheumatoid arthritis, cancer, and schizophrenia. Several molecular biology techniques are continuously gaining traction as in-vitro diagnostics (IVD) to detect and prevent several diseases.

The Polymerase Chain Reaction (PCR) technique has a greater adoption among others owing to the practices involved in the field of molecular biology. The PCR tool implements a thermostable polymerase in order to generate multiple copies of a specific nucleic acid region exponentially. The PCR amplification cycles uses enzymes such as taq polymerase, reverse transcriptase enzyme, and thermostable DNA polymerase.

These enzymes are used in the diagnosis of COVID-19 virus and extensive range of commercial COVID-19 tests are available in the market due to the rising cases of COVID-19 patients. The tests either detect the SARS-CoV-2 viral RNA by the use of nucleic acid hybridization-related strategies or PCR techniques. While some of the other tests are carried out by serological and immunological assays that detect the antibodies produced in response to the virus.

The PCR method is extensively used for the testing of SARS-CoV-2 virus. This method is carried out by using a DNA-copying enzyme as well as Taq DNA polymerase, which remain active at high temperatures. Additionally, reverse transcriptase is utilized to copy the RNA of the virus in the DNA for further amplifications. Creative Enzymes and BioVendor are the leading companies, offering enzymes for the diagnosis of COVID-19.

In-vitro Diagnostics Enzymes Market Drivers, Restraints, Trends, and Opportunities

• Growing demand for diagnostic enzymes process due to rising cases of of COVID-19 across the globe is driving the growth of the in-vitro diagnostic enzymes market.
• Increasing number of the geriatric population across the globe is expected to increase the prevalence of age-related diseases. This is expected to boost the demand for diagnostic method during the forecast period.
• Recent technological developments in genomics, proteomics, and molecular pathology lead to the introduction of new biomarkers with potential clinical value. The availability of biomolecular tools and the integration of biomarkers are expected to spur the IVD market.
• The outbreak of COVID-19 pandemic has positively impacted the market growth since the increasing demand for new COVID-19 test kits are creating various growth opportunities for the key players in the IVD market.
• Insufficient reimbursement policy especially in developing countries is expected to restrain the growth of the IVD market during the forecast period.
• Strict regulatory to restrict the transfer of technology and raw material supply for the manufacturing of diagnostic devices are key challenges expected to hinder the market growth.

Scope of In-vitro Diagnostics Enzymes Market Report

The report on the global in-vitro diagnostics enzymes market includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have also been included in the report.

In-Vitro Diagnostics Enzymes Market Segment Insights

Enzyme Types Segment Analysis

On the basis of enzyme types, the market is bifurcated into polymerase & transcriptase and proteases. The polymerase & transcriptase segmented is projected to represent a key market share during the forecast period owing to its wide range of applications in molecular diagnostic assays.  Additionally, the presence of large number of players offering these enzymes is projected to spur the segment growth.

The protease segment, on the other hand, is projected to expand at an impressive CAGR during the forecast period. Proteases is gaining significant traction in the common molecular biology procedures. Heat-labile protease is applied to digest the heat-stable molecular biology enzymes such as PvuII and Taq Polymerase, which inactivate due to a mild heat treatment.

Protease reduces product loss and saves time as the chemical reaction can be further completed without the requirement of an intermediate purification stage. Additionally, protease is used in the oncology disease type. The rising number of cancer cases across the globe and the expansion of IVD techniques such as In Situ Hybridization (ISH) and Next-Generation Sequencing (NGS), in the oncology field, is expected to further boost the segment growth during the forecast period.

Disease Types Segment Analysis

Based on disease types, the market is divided into infectious disease, diabetes, oncology, cardiology, nephrology, autoimmune diseases, and others. The infectious disease segment is anticipated to constitute a large market share during the forecast period owing to the rising application of PCR technology in the infectious disease diagnosis to early diagnosis and treatment of diseases.

PCR has a wide range of applications in infectious disease diagnosis including detection of tuberculosis, streptococcal pharyngitis, ulcerative urogenital infections, atypical pneumonia, and several persistent infections. Platelia Dengue NS1 antigen-capture ELISA kits along with Panbio Dengue Duo IgG and IgM Rapid Cassette test kits are the few enzyme-based kits for the diagnosis of infectious diseases.

On the other hand, the oncology segment is expected to expand at a high CAGR during the forecast period due to rapid development of high-throughput technologies such as next-generation DNA sequencing and comparative genomic hybridization. The rising demand for diagnosis of human tumors is driving the market of diagnostic enzymes in the oncology segment.

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Technology Types Segment Analysis

In terms of technology types, the market is classified as histology assays, molecular diagnostics, clinical chemistry, and others. The molecular diagnostics segment is further divided into PCR assays and NGS assays. The histology assays segment is expected to account for a significant market share during the forecast period owing to the advantages offered by the technique in the analysis of tissue samples for diagnostic purposes.

Additionally, histopathology poses little or no risk to patients and helps clinicians to analyze the internal architecture of tissues and cells.The molecular diagnostics segment, however, is anticipated to expand at a healthy CAGR during the forecast period. The molecular diagnostics technique is highly sensitive in nature and enables detection of disease-causing agents, thereby allowing the early detection of several disorders.

Furthermore, enzymes are crucial to steps in molecular diagnostic assays such as NGS library and sample preparation. They offer shortcuts for slow reactions and allow modification, repair and amplification of nucleic acids for an extensive range of applications.

End-Users Segment Analysis

On the basis of end-users, the market is segmented into pharma & biotech, hospital & diagnostic labs, contract research organizations (CROs), and academic labs. The extensive use of IVD assays in hospitals is driving the hospital & diagnostic labs segment growth. In the recent years, the physicians have taken a significant shift to histopathology and molecular diagnostics from conventional testing procedures.

Conventional process requires more time as compared to histopathology-based tests. Thus, the increasing adoption rate of histopathology-based tests is owing to the reduced timelines. However, the academic labs segment is projected to expand at a high CAGR during the forecast period owing to growing application of NGS and PCR technologies in academic and institutional projects.

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Regional Analysis

In terms of regions, the market is classified as Asia Pacific, North America, Latin America, Europe, and Middle East & Africa. North America is projected to represent a large market share during the forecast period owing to the high demand for IVD enzymes and the growing prevalence of infectious disorders in the region.

The US FDA has issued emergency use authorizations for in-vitro COVID-19 laboratory-developed tests to cope with the ongoing COVID-19 pandemic. Additionally, most of the emergency use authorizations are Enzyme-Linked Immunosorbent Assay (ELISA) and Reverse Transcription Polymerase Chain Reaction (RT-PCR)-based tests for the detection of SARS-CoV-2.

The market in Asia Pacific, however, is anticipated to expand at a substantial CAGR during the forecast period due to the increasing development of healthcare infrastructure and introduction of insurance policies allowing favorable reimbursements. The wide prevalence of cancer and HIV/AIDS in the region is further boosting the demand for diagnostic tests. China holds a significant position in the regional market in terms of revenue share.

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Segments

The global in-vitro diagnostic enzymes market has been segmented on the basis of

Enzyme Types

• Polymerase & Transcriptase
• Proteases

Disease Types

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

Technology Types

• Histology Assays
• Molecular Diagnostics
  • PCR Assays
  • NGS Assays
• Clinical Chemistry
• Others

End-users

• Pharma & Biotech
• Hospital & Diagnostic Labs
• Contract Research Organizations (CROs)
• Academic Labs

Regions

• Asia Pacific
• North America
• Latin America
• Europe
• Middle East & Africa

Key Players

• 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

Competitive Landscape

Some of the key market players in the global in-vitro diagnostic enzymes 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, and American Laboratories. The companies are focusing on catering the increasing demand for enzymes used during diagnostics procedures for clinical disorders, specifically COVID-19.For instance,

• In May 2020, an India-based company, Richcore Lifesciences and the Indian Institute of Science Education & Research at Pune and Chandigarh along with the Indian Institute of Science, Bengaluru, has produced and optimized Reverse Transcriptase and Taq Polymerase, two key enzymes, for the RT-PCR diagnostic kits.