In-vitro Diagnostics Enzymes Market Size, Share, Trends, Growth, Production, Consumption, Revenue, Company Analysis and Forecast 2021-2028

Published Date : Dec 2020 | No. of Pages : 250 Pages | Category : Healthcare

The global In-vitro Diagnostics Enzymes market size is expected to be worth around US$ 1.44 billion by 2028, according to a new report by Vision Research Reports.

The global In-vitro Diagnostics Enzymes market size was valued at US$ 706.98 million in 2020 and is anticipated to grow at a CAGR of 8.99% during forecast period 2021 to 2028.

Growth Factors

The development of enzyme biosensors has increased the enzyme utility in clinical diagnostics. Despite the necessity in clinical diagnosis, the commercialization and translation of biosensors from research to clinics are still low. However, with an increase in R&D efforts, lactate, cholesterol, and glucose biosensors have been commercialized for diagnostic use.

Proteases are important signaling proteins that are critical to a few pathological processes, including cancer, neurological, inflammatory, and cardiovascular disorders. Polymerase and transcriptase enzymes are expected to exhibit the fastest CAGR over the forecast period. In addition, the presence of a substantial number of players that offer these enzymes is expected to enhance the growth. Key players such as Kaneka Eurogentec S.A.; Toyobo Co., Ltd.; and Sekisui Diagnostics, LLC manufacture and distribute a wide range of polymerases, including KOD DNA Polymerase, Taq DNA Polymerase, Tth DNA Polymerase, and TTx DNA Polymerase.

The infectious disease segment dominated the market in 2019. An exponential rise in the COVID-19 cases globally drives the adoption rate of diagnostic enzymes for COVID-19 diagnosis. An increase in the availability of qualitative and quantitative molecular assays based on real-time PCR, Loop-mediated Isothermal Amplification- PCR (LAMP-PCR), multiplex PCR, and digital PCR technologies for the diagnosis of infectious diseases drives the demand for enzymes in this segment.

Enzymatic immunohistochemistry (IHC) is preferred for histology owing to a better contrast ratio and the method’s compatibility for use with multiple stains for the detection of target components. IVD enzymes are employed in different end-use settings for the analysis of tissue specimens and bodily fluids. A wide range of end users including large laboratories that conduct multiple analyses in a day and smaller clinics that conduct a few tests use enzymes for in-vitro diagnostics (IVD).

Report Highlights

Polymerase and transcriptase accounted for the largest revenue share of 29.8% in 2020 and are anticipated to witness the fastest growth during the forecast period. This is attributed to their wide applications in molecular diagnostic assays. In addition, the presence of a substantial number of players that offer these enzymes is expected to enhance the segment growth.

The proteases segment is expected to witness significant growth over the forecast period. Proteases are expected to gain traction in the common molecular biology procedures. The application of heat-labile protease is used to digest the heat-stable molecular biology enzymes, such as PvuII and Taq Polymerase, which further inactivates due to a mild heat treatment.

This indicates the major benefit of protease in instances where further chemical reactions can be completed without the requirement of an intermediate purification stage; therefore, it reduces product loss and saves time. This benefit of protease makes it an important diagnostic enzyme to be used in IVD procedures

Infectious disease accounted for the largest revenue share of 27.5% in 2020 . The wide applicability of PCR technology in infectious disease diagnosis has led to early diagnosis and treatment. Organisms that are difficult to be detected can now be identified with better precision and sensitivity. The application of PCR in infectious disease diagnosis includes detection of tuberculosis, streptococcal pharyngitis, atypical pneumonia, ulcerative urogenital infections, and several persistent infections.

The Thermus thermophilus DNA polymerase gene expressed in Escherichia coli allows an efficient reverse transcriptase activity for the detection of cellular mRNA expression in a single step. Moreover, an IgM antibody capture ELISA (MAC-ELISA) is a proven technology for dengue diagnosis during the early convalescent or late acute phase of the infection. Platelia Dengue NS1 antigen-capture ELISA kits and Panbio Dengue Duo IgG and IgM Rapid Cassette test kits are some of the enzyme-based kits for the diagnosis of infectious diseases.

The oncology segment is expected to expand at the fastest CAGR throughout the forecast period. Large-scale adoption of ISH methods as well as the development of high-throughput technologies, such as next-generation DNA sequencing and comparative genomic hybridization, for the diagnosis of human tumors drive the usage of diagnostic enzymes in the oncology segment.

Histology assays dominated the IVD enzymes market with a revenue share of 44.11% in 2020 to the advantages offered by the technique in the analysis of tissue samples for diagnostic purposes. Moreover, histopathology is quick, with little or no risk to patients, and helps clinicians analyze the internal architecture of tissues and cells.

Molecular diagnostics is preferred over serology for the diagnosis of infectious diseases as this technique is highly sensitive and offers detection of disease-causing agents, allowing early detection of several disorders. The molecular diagnostics segment is expected to witness the fastest growth over the forecast period. Moreover, enzymes are crucial to multiple steps in molecular diagnostic assays, such as NGS library and sample preparation. They provide shortcuts for difficult or slow reactions and enable repair, modification, and amplification of nucleic acids for a wide range of applications.

Enzymes form an essential component of the clinical chemistry diagnostic assays owing to the specificity and speed offered by enzymes. Enzyme specificity is used either for the removal of interferents in another reaction or for the measurement of a substrate in an assay. Enzymes are also used to measure activators, inhibitors, or cofactors. In addition, the catalytic activity of enzymes makes them ideal for use as labels in immunoassay techniques. Thus, key players, such as BBI Solutions, offer a wide range of enzymes for clinical chemistry use.

The hospitals and diagnostic laboratories segment dominated the market with a share of 39.10% in 2020. The usage of IVD assays in hospitals has increased over the years. In several hospitals and clinics, the physicians are switching to histopathology and molecular diagnostics from conventional testing procedures. The long turnover time associated with the conventional processes is boosting the adoption rate of histopathology-based tests as these aid in reducing the timelines.

The academic labs segment is expected to expand at the fastest CAGR from 2020 to 2027. An increase in the application of NGS and PCR technologies in academic and institutional projects drives the adoption rate of diagnostic enzymes used during the IVD procedures conducted in these settings.

For instance, researchers at the UNC Medical Center Microbiology and Molecular Microbiology Laboratories, the U.S., explored the usage of NGS technology for accurate COVID-19 diagnosis in March 2020. The use of this technology helped scientists in the identification of the mutations and gain insights related to the genomic code of COVID-19 causing virus. This application of NGS drives the utilization of enzymes used in library preparation, such as T4 polynucleotide kinas, ligase, DNA polymerase, and reverse transcriptase.

North America occupied the largest share of 41.78% in 2020 owing to the high demand for IVD enzymes and the increasing prevalence of infectious disorders in the region. To combat the ongoing COVID-19 pandemic, the FDA has issued emergency use authorizations for in-vitro COVID-19 laboratory-developed tests.

Asia Pacific is anticipated to be the fastest-growing regional market over the forecast period due to the improvements in healthcare infrastructure, the introduction of insurance policies allowing favorable reimbursements, and increasing prevalence of cancer and HIV/AIDS, leading to increased demand for diagnostic tests. China holds a significant position in the Asia Pacific market due to the presence of several suppliers of enzymes.

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

Market Segmentation

  • Enzyme Type Outlook 

    • Proteases

      • By Disease Type

        • Infectious disease

        • Diabetes

        • Oncology

        • Cardiology

        • Nephrology

        • Autoimmune diseases

        • Others

      • By Technology Use

        • Histology Assays

        • Molecular Diagnostics

        • PCR Assays

        • NGS Assays

        • Others

        • Clinical Chemistry

      • By Physical Form

        • Powder

        • Liquid

        • By Type

        • Natural

        • Recombinant

      • By End-use

        • Pharma & Biotech

        • Hospital & Diagnostic Labs

        • CROs

        • Academic Labs

    • Polymerase & Transcriptase

    • Ribonuclease

    • Others

  • Disease Type Outlook 

    • Infectious disease

      • COVID-19 Testing

      • Hepatitis

      • HIV

      • Others

    • Diabetes

    • Oncology

    • Cardiology

    • Nephrology

    • Autoimmune diseases

    • Others

  • Technology Type Outlook 

    • Histology Assays

    • Molecular Diagnostics

      • PCR Assays

      • NGS Assays

      • Others

    • Clinical Chemistry

  • End-use Outlook 

    • Pharma & Biotech

    • Hospital & Diagnostic Labs

    • Contract Research Organizations (CROs)

    • Academic Labs

  • Regional Outlook 

    • North America

      • U.S.

      • Canada

    • Europe

      • Germany

      • France

      • U.K.

      • Italy

      • Spain

    • Asia Pacific

      • Japan

      • China

      • India

    • Latin America

      • Brazil

      • Mexico

    • Middle East and Africa (MEA)

      • South Africa

The In-vitro Diagnostics Enzymes market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.

The report provides size (in terms of volume and value) of In-vitro Diagnostics Enzymes market for the base year 2020 and the forecast between 2021 and 2028. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.

This report focuses on the global In-vitro Diagnostics Enzymes market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the In-vitro Diagnostics Enzymes market development in United States, Europe and China.

It is pertinent to consider that in a volatile global economy, we haven’t just conducted In-vitro Diagnostics Enzymes market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.

In terms of production side, this report researches the In-vitro Diagnostics Enzymes capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.

In terms of consumption side, this report focuses on the consumption of In-vitro Diagnostics Enzymes by regions (countries) and application.

Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global In-vitro Diagnostics Enzymes market. These figures have been provided in terms of both revenue and volume for the period 2017 to 2028. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.

With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major In-vitro Diagnostics Enzymes market companies.

Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of In-vitro Diagnostics Enzymes market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.

The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.

Overall, this is an in-depth research report specifically for the In-vitro Diagnostics Enzymes industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.

The In-vitro Diagnostics Enzymes market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to In-vitro Diagnostics Enzymes market.

Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of In-vitro Diagnostics Enzymes market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.

Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new In-vitro Diagnostics Enzymes market. These factors have benefited the growth of the global market for In-vitro Diagnostics Enzymes. Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.

New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for In-vitro Diagnostics Enzymes. The global market is segmented on the basis of region, application, en-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).

In this study, the years considered to estimate the market size of In-vitro Diagnostics Enzymes are as follows:

  • Historic Year: 2017-2020
  • Base Year: 2020
  • Forecast Year 2021 to 2028

Reasons to Purchase this Report:

- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
- Market value USD Million and volume Units Million data for each segment and sub-segment
- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players

Research Methodology:

In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.

This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.

Market Size Estimation

Top-down and bottom-up approaches are used to estimate and validate the global market size for company, regional division, product type and application (end users).

The market estimations in this report are based on the selling price (excluding any discounts provided by the manufacturer, distributor, wholesaler or traders). Market share analysis, assigned to each of the segments and regions are achieved through product utilization rate and average selling price.

Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.

All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or others factors are accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from Vision Research Reports and presented in this report.

Market Breakdown and Data Triangulation

After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation. Extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub-segments listed in this report.

Secondary Sources

Secondary Sources occupies approximately 25% of data sources, such as press releases, annual reports, Non-Profit organizations, industry associations, governmental agencies and customs data, and so on. This research study includes secondary sources; directories; databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), TRADING ECONOMICS, and avention; Investing News Network; statista; Federal Reserve Economic Data; annual reports; investor presentations; and SEC filings of companies.

Primary Sources

 In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers, etc.

The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end users (product buyers), and related key executives from various key companies and organizations operating in the global market.

The study objectives of this report are:

  • To analyze and study the global market capacity, production, value, consumption, status (2017-2020) and forecast (2021-2028);
  • Focuses on the key manufacturers, to study the capacity, production, value, market share and development plans in future.
  • Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
  • To define, describe and forecast the market by type, application and region.
  • To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.
  • To identify significant trends and factors driving or inhibiting the market growth.
  • To analyze the opportunities in the market for stakeholders by identifying the high growth segments.
  • To strategically analyze each submarket with respect to individual growth trend and their contribution to the market
  • To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market
  • To strategically profile the key players and comprehensively analyze their growth strategies.

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