Global In-vitro Diagnostics Enzymes Market by Enzyme Type (Proteases, Polymerase & Transcriptase) and Region (North America, Latin America, Europe, Asia Pacific and Middle East & Africa), Forecast To 2028

Summary of the Report

In-vitro diagnostic enzymes market was worth USD 706.97 millions in 2019. It is projected to grow at an 8.97% compound annual growth rate (CAGR), between 2020 and 2027. Enzymes are used in diagnosing various metabolic disorders due to their extraordinary catalytic capabilities. Numerous research studies have shown the clinical use of enzymes such as acid phosphatase and creatine kinase as well as acid phosphatase and aspartate transaminase. These enzymes are the preferred biomarkers for many diseases, such as myocardial injury, liver disease and schizophrenia, rheumatoidarthritis, and cancer.

Many molecular biology techniques have been gaining popularity, including IVM (IVD), which can be used to detect and prevent many diseases. The PCR (polymerase chain reaction) has had the greatest impact on molecular biology practices. PCR uses a thermostable polymerase that produces multiple copies of a particular nucleic acid region quickly and exponentially. PCR amplification cycles are dominated by the use of three enzymes: Taq polymerase (reverse transcriptase enzyme) and thermostable DNA Polymerase (thermostable DNA polymerase).

Market growth has been fueled by the utility of enzymes in the diagnosis of COVID-19. There are many commercial COVID-19 test options available. Some of the tests either detect the SARS-CoV-2 viral RNA using the nucleic acid hybridization-related strategies or PCR technique while others are serological and immunological assays that detect the antibodies produced in response to the virus.

For testing the presence of SARS-CoV-2 viruses, the PCR method is widely accepted. This method employs a DNA-copying enzyme called Taq DNA polymerase that remains active at high temperatures. Reverse transcriptase can also be used to copy the virus' RNA in the DNA. This allows for further amplifications. BioVendor and Creative Enzymes are two key companies that provide enzymes to diagnose COVID-19.

Enzyme Type Insights

In 2019, polymerase and transcriptase represented 29.5% of the total revenue and will see the most growth in the forecast period. Their wide use in molecular diagnostic tests is why this is so. Segment growth will be aided by the large number of enzyme-providers.

Over the forecast period, significant growth is expected in the proteases segment. Common molecular biology procedures will see the use of proteases. To digest heat-stable molecular biology enzymes such as PvuII or Taq Polymerase using heat-labile protease, the enzymes are further activated by mild heat treatment.

This is a major advantage of protease when further chemical reactions can take place without the need for an intermediate purification step. It also reduces product loss and saves you time. This makes protease an important enzyme for IVD procedures.

Proteases in oncology will see significant growth due to rising cancer cases worldwide and the expansion IVD techniques such as Next-Generation Sequencing and In Situ Hybridization (ISH).

Disease Type Insights

The largest revenue share, 27.3%, was attributed to infectious disease in 2019. Because PCR technology is widely applicable in infectious disease diagnosis, it has allowed for early diagnosis and treatment. The ability to identify complex organisms with greater precision and sensitivity has allowed them to be diagnosed earlier. PCR is used to diagnose infectious diseases such as tuberculosis and streptococcal pharyngitis.

The Thermus thermophilus DNA polymerase gene is expressed in Escherichiacoli and allows for an efficient reverse transcriptase activity to detect cellular mRNA expression within a single step. An IgM antibody capture ELISA is (MAC-ELISA), a well-proven technology that can diagnose dengue during the late acute or early convalescent phase. Among the enzyme-based diagnostic kits for infectious diseases are Panbio Dengue Duo IgG, Panbio Dengue Duo Rapid Cassette and Platelia Dengue NS1 ELISA kits.

The fastest growing segment in oncology is expected to grow during the forecast period. The oncology segment is driven by large-scale adoptions of ISH methods and the development of high throughput technologies such as comparative genomic hybridization and next-generation DNA sequence for diagnosis of human tumours.

Technology Type Insights

The market leader in IVD enzymes in 2019 was histology assays with a 44.9% revenue share. This is due to the benefits of the technique for the analysis of tissues for diagnostic purposes. Histopathology is fast and safe for patients and clinicians. It also helps them understand the internal structure of cells and tissues.

For the diagnosis of infectious diseases, molecular diagnostics is preferable to serology. This technique is extremely sensitive and can detect disease-causing agents early. Over the forecast period, molecular diagnostics will experience the most rapid growth. Enzymes are essential for multiple steps in molecular diagnostics assays such as sample preparation and NGS library. They can be used to speed up difficult or slow reactions, as well as for repair, modification and amplification nucleic acid for many applications.

Because of their specificity and speed, enzymes are an integral part of clinical chemistry diagnostic assays. The enzyme specificity can be used to measure a substrate or remove interferents from another reaction. It is also possible to measure cofactors, activators, and inhibitors using enzymes. Enzymes are also ideal for labeling immunoassay methods because of their catalytic activity. BBI Solutions is a key player that offers a broad range of enzymes to clinical chemistry.

End-use Insights

With a market share of 39.8%, hospitals and diagnostic labs dominated the market in 2019. In hospitals, IVD has been used more frequently in recent years. Many doctors are now switching from traditional testing methods to molecular and histopathology in hospitals and clinics. Histopathology-based tests are more popular than conventional methods due to their long turnaround time. They also help reduce the timelines.

From 2020 to 2027, the academic labs sector is expected to grow at the fastest rate of CAGR. The adoption of diagnostic enzymes during IVD procedures in these settings is driven by an increase in NGS andPCR technology use in academic and institutional projects.

Researchers at the UNC Medical Center Microbiology and Molecular Microbiology Laboratories explored NGS technology to accurately diagnose COVID-19 in March 2020. This technology allowed scientists to identify the mutations and gain insight into the genetic code of COVID-19, the virus that causes it. NGS allows for the use of enzymes that are used in library preparation such as DNA polymerase and reverse transcriptase.

Regional Insights

North America held the largest share at 41.76% in 2019, due to its high demand for IVD enzymes, and increasing number of infectious diseases in the region. The FDA issued emergency authorizations for COVID-19 laboratory-developed tests to combat the COVID-19 pandemic.

These emergency use authorizations include Enzyme-Linked immunosorbent Assays (ELISA) as well as Reverse Transcription Polymerase Chain Reactions (RT-PCR), which are tests that detect SARS-CoV-2. Due to the high useability of enzymes during RTPCR, such tests are expected to generate revenue for the North American market.

Asia Pacific will be the fastest growing region market during the forecast period. This is due to improvements in healthcare infrastructure and the introduction of insurance policies that allow for favorable reimbursements. Also, there has been an increase in the prevalence of HIV/AIDS and cancer, which has led to an increased demand for diagnostic testing. China is the dominant market in Asia Pacific due to its many suppliers of enzymes.

Market Share Insights & Key Companies

Companies are continuously working to meet the growing demand for enzymes used in diagnostic procedures for clinical disorders, particularly COVID-19. Richcore Lifesciences, an Indian firm, produced and optimized Reverse Transcriptase and Taq Polymerase in May 2020. These are two essential enzymes for RT-PCR diagnostics.

These enzyme samples are currently being offered by the company to test kit manufacturers in order to verify their stability and consistency. The company will be able mass-produce these enzymes to meet the needs of millions of Indian certified testing kits. These companies take such initiatives to produce large quantities of enzymes in order to meet the urgent demand for COVID-19 testing kits. The following are some of the major players in the global market for in-vitro diagnostic enzymes:

• 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

Up Market Research published a new report titled “In-vitro Diagnostics Enzymes Market research report which is segmented by Enzyme Type (Proteases, Polymerase & Transcriptase), By Players/Companies Codexis Inc, American Laboratories, F Hoffmann-La Roche Ltd, Advanced Enzymes Technologies Ltd, Dyadic International, Biocatalysts Ltd, Amano Enzyme Inc, Amicogen, Affymetrix, BBI Solutions, Merck KGaA”. As per the study the market is expected to grow at a CAGR of XX% in the forecast period.

Report Scope

The report covers comprehensive data on emerging trends, market drivers, growth opportunities, and restraints that can change the market dynamics of the industry. It provides an in-depth analysis of the market segments which include products, applications, and competitor analysis.

Global In-vitro Diagnostics Enzymes Market Report Segments:

The market is segmented by Enzyme Type (Proteases, Polymerase & Transcriptase).

In-vitro Diagnostics Enzymes Market research report delivers a close watch on leading competitors with strategic analysis, micro and macro market trend and scenarios, pricing analysis and a holistic overview of the market situations in the forecast period. It is a professional and a detailed report focusing on primary and secondary drivers, market share, leading segments and geographical analysis. Further, key players, major collaborations, merger & acquisitions along with trending innovation and business policies are reviewed in the report.

Key Benefits for Industry Participants & Stakeholders:

• Industry drivers, restraints, and opportunities covered in the study
• Neutral perspective on the market performance
• Recent industry trends and developments
• Competitive landscape & strategies of key players
• Potential & niche segments and regions exhibiting promising growth covered
• Historical, current, and projected market size, in terms of value
• In-depth analysis of the In-vitro Diagnostics Enzymes Market

Overview of the regional outlook of the In-vitro Diagnostics Enzymes Market:

Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa (MEA). North America region is further bifurcated into countries such as U.S., and Canada. The Europe region is further categorized into U.K., France, Germany, Italy, Spain, Russia, and Rest of Europe. Asia Pacific is further segmented into China, Japan, South Korea, India, Australia, South East Asia, and Rest of Asia Pacific. Latin America region is further segmented into Brazil, Mexico, and Rest of Latin America, and the MEA region is further divided into GCC, Turkey, South Africa, and Rest of MEA.

Highlights of The In-vitro Diagnostics Enzymes Market Report:

1. The market structure and projections for the coming years.
2. Drivers, restraints, opportunities, and current trends of In-vitro Diagnostics Enzymes Market.
3. Historical data and forecast.
4. Estimations for the forecast period 2028.
5. Developments and trends in the market.

                1. Proteases

                2. Polymerase & Transcriptase

7. Market scenario by region, sub-region, and country.
8. Market share of the market players, company profiles, product specifications, SWOT analysis, and competitive landscape.
9. Analysis regarding upstream raw materials, downstream demand, and current market dynamics.
10. Government Policies, Macro & Micro economic factors are also included in the report.

We have studied the In-vitro Diagnostics Enzymes Market in 360 degrees via. both primary & secondary research methodologies. This helped us in building an understanding of the current market dynamics, supply-demand gap, pricing trends, product preferences, consumer patterns & so on. The findings were further validated through primary research with industry experts & opinion leaders across countries. The data is further compiled & validated through various market estimation & data validation methodologies. Further, we also have our in-house data forecasting model to predict market growth up to 2028.

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Reasons to Purchase the In-vitro Diagnostics Enzymes Market Report:

• The report includes a plethora of information such as market dynamics scenario and opportunities during the forecast period
• Segments and sub-segments include quantitative, qualitative, value (USD Million,) and volume (Units Million) data.
• Regional, sub-regional, and country level data includes the demand and supply forces along with their influence on the market.
• The competitive landscape comprises share of key players, new developments, and strategies in the last three years.
• Comprehensive companies offering products, relevant financial information, recent developments, SWOT analysis, and strategies by these players.