Molecular Diagnostics Market (By Test Location: OTC, PoC; By Application; By End Use: Decentralized Labs, Hospitals; By Application; By Technology) - Global Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook 20212030

The global Molecular Diagnostics market size is expected to be worth around US$ 59.3 billion by 2030, according to a new report by Vision Research Reports.

The global Molecular Diagnostics market size was valued at US$ 46.2 billion in 2020 and is anticipated to grow at a CAGR of 4.9% during forecast period 2021 to 2030.

Growth Factors

This growth is owing to factors such as an increasing geriatric population, the outbreak of COVID-19, and the growing demand for point-of-care facilities.

Molecular diagnostics play an important role in infectious disease testing as they can yield effective and fast results. Hence, the increasing prevalence of hospital-acquired infections and infectious diseases is projected to drive the market over the forecast period. Increasing incidence of cardiovascular, neurological, and genetic disorders is further anticipated to accelerate market growth.

Companies expanding their regional presence owing to approval of COVID-19 IVD tests are expected to boost the market growth. For instance, Vela Diagnostics received the CE-IVD mark for ViroKey SARS-CoV-2 RT-PCR Test. It is a probe-based RT-PCR test used on Applied Biosystems 7500 Fast Dx instrument to detect SARS-CoV-2. The CE-IVD mark has enabled Vela diagnostics to expand its COVID-19 test in Europe.

Key players are enhancing their range of testing options for real-time PCR instruments by increasing R&D activities for the development of kits that target emerging diseases, or by entering into agreements with other kit manufacturing companies. These include the introduction of Cobas HPV test assay in Cobas 4800 by Roche Diagnostics. The introduction of tuberculosis testing Xpert assay on GeneXpert platform by Cepheid is an example of such advancement. Such advances are anticipated to drive the market. 

Report Highlights

The reagents segment accounted for the largest revenue share of 65.6% in 2020. It is anticipated to grow at a significant rate in upcoming years owing to its wide adoption in research and clinical settings. Standard reagents help achieve efficient and accurate results. Standardized results, improved efficiency, and cost-effectiveness are anticipated to support market growth.

Furthermore, the growing use of instruments to detect coronavirus, which were earlier developed for other infectious diseases, is anticipated to boost the growth of the market for molecular diagnostics. For instance, in March 2020, Abbott received Emergency Use Authorization (EUA) for RealTime SARS-CoV-2 EUA tests to be used on the m2000 RealTime System.

Increasing adoption of molecular diagnostics with analyzer software at diagnostic centers is anticipated to fuel the market growth. For instance, in July 2019, Mobidiag Ltd. entered into an agreement with Pro Med Diagnostics for Novodiag solution and Amplidiag solution distribution in African countries. Amplidiag solution consists of Amplidiag Analyzer software that automates the complete process of detection of Helicobacter pylori infection, C. difficile infection, and other infectious diseases.

The central laboratories segment dominated the market for molecular diagnostics and accounted for the largest revenue share of 85.7% in 2020. This growth is attributable to high market penetration and procedure volumes. An increase in the number of initiatives undertaken by the government to provide various services, such as reimbursement for diagnostic tests, is another major factor anticipated to drive the market. Many healthcare institutions are working with laboratories to integrate different tests, such as microbiology testing.

There is an increasing interest in the development of molecular diagnostic platforms that can also be used in PoC settings. Therefore, various companies are designing assays and molecular diagnostic platforms for POC or near-patient testing. In addition, the growing development of new assays that offer quick PoC results is anticipated to boost the market growth. For instance, in October 2018, the U.S. FDA cleared Abbott’s Influenza A & B2 and Strep A2 assay for PoC testing, which can be used on the ID NOW platform.

PoC is gaining popularity in the molecular diagnostics space. PoC includes tests that provide rapid results and are portable. Molecular tests that identify the genetic material of an infectious agent are one of the fastest-growing PoC test types. Since many tests are fast, portable, and inexpensive, they are being adopted in as well as away from hospital settings. Companies such as Alere, Roche Diagnostics, and Cepheid have already marked their presence in this space.

The infectious disease segment dominated the market for molecular diagnostics and accounted for the largest revenue share of 86.3% in 2020, owing to molecular diagnostics forming the basis of medical diagnosis for COVID-19. The drawbacks of traditional testing, such as long turnaround time, difficulty in growing organisms in manually prepared culture media, poor in vitro kinetic development, and the lack of sensitivity have been offset with technological advancements, such as PCR and ISH.

Molecular diagnostics find applications in neurological disorders, such as neurodegenerative diseases, brain tumors, chronic depression, and more due to rapid and precise diagnosis. With the growing incidence of diseases of the nervous system, such as chronic depression and neuroblastoma, this application segment is expected to witness moderate growth during the forecast period.

The application of molecular diagnostic techniques in the field of pharmacogenomics involves high throughput testing of NCE that are viable for novel drug development specific to a certain genetic profile. Analysis of individual drug responses helps gain insights into the correlation between nucleotide polymorphism and drug metabolism. This enables the formulation of medication specific to a population subset suffering from a particular disease, which paves way for the development of personalized medicine.

Oncology research and cancer drug discovery have significant advantages in performing molecular diagnosis using specific biomarkers with regard to major cancer-causing genes and their manifestations. Early identification of predictive biomarkers in molecular diagnosis provides opportunities for early diagnosis of cancer-affected patients, which helps develop specifically tailored medication for treatment. As a result, the application of molecular diagnostics in oncology holds high growth potential; thus, the segment is expected to witness the highest CAGR during the forecast period.

The Polymerase Chain Reaction (PCR) segment dominated the market for molecular diagnostics and accounted for the largest revenue share of 83.3% in 2020. This is attributed to its use in the detection of infectious microorganisms such as viruses and bacteria. The significant share held by the PCR segment is due to the associated benefits and varied applications of multiplex PCR over conventional PCR methodologies. Increasing use of high-throughput PCR technology to detect coronavirus is expected to drive the market. For instance, in April 2020, Mobidiag Ltd. received EUA for Amplidiag COVID-19 for use in clinical laboratories in Finland.

Sequencing technologies for the molecular diagnostics market include DNA sequencing processes and emerging NGS technologies, such as sequencing platforms and RNA sequencing. DNA sequencing technologies are integrally linked to drug discovery, novel drug development, and personalized medicine. It is expected that the sequencing technology segment will witness the highest growth throughout the forecast period owing to an increase in the number of genome profiling initiatives & R&D for novel drugs and a decrease in prices and sizes of DNA sequencers.

The sequence specificity of the technique is the major application that helps in understanding pathogenic processes and performing molecular testing for diagnosis, monitoring, and treatment of cancer. Key applications of ISH technology include identifying and investigating mRNA expression in preserved tissue samples, using probes that are complementary to the concerned sequence, and molecular diagnosis of chromosomal integrity using Fluorescence ISH (FISH). Owing to the increasing use of the ISH technology for the detection of cancer and a rise in the aging population that is more prone to cancer, this technology segment is expected to witness significant growth over the forecast period.

North America dominated the market for molecular diagnostics and accounted for the largest revenue share of 36.2% in 2020. This growth is attributed to rising consumer awareness, technological advancements, the growing prevalence of diseases, and better healthcare infrastructure. Europe accounted for a significant revenue share of 27.5% in 2020 and is expected to grow at a lucrative rate over the forecast period. This is attributed to the rising epidemiology of infectious as well as chronic diseases, thus encouraging the R&D activities, thereby boosting the market growth. High standard of living and consumer awareness about the early diagnosis, as well as the well-established healthcare system, acts as key drivers for growth.

In Asia Pacific, the market for molecular diagnostics is anticipated to exhibit the fastest CAGR of 5.7% during the forecast period, owing to increased market penetration and high unmet needs of the market, which are collectively driving the growth in this region. Constantly expanding patient pool, early prevention & diagnosis, and more targeted therapies are expected to boost the market in the region.

Key Players

• BD

• bioMérieux SA

• Bio-Rad Laboratories, Inc.

• Abbott

• Agilent Technologies, Inc.

• Danaher

• Hologic Inc. (Gen-Probe)

• Illumina, Inc.

• Johnson & Johnson Services, Inc.

• Grifols, S.A.

• QIAGEN

• F. Hoffmann-La Roche, Ltd.

• Siemens Healthineers AG

• Sysmex Corporation

Market Segmentation

• Product Outlook

• Instruments

  • Reagents

  • Others

• Test Location Outlook

  • Point-of-Care

  • Self-test or Over the Counter

  • Central Laboratories

• Technology Outlook

  • Polymerase Chain Reaction (PCR)

    • PCR, by Type

      • Multiplex PCR

      • Other PCR

    • PCR, by Product

      • Instruments

      • Reagents

      • Others

    • PCR, by Procedure

      • Nucleic Acid Extraction & Purification

      • Others

  • In Situ Hybridization (ISH)

    • Instruments

    • Reagents

    • Others

  • Isothermal Nucleic Acid Amplification Technology (INAAT)

    • Instruments

    • Reagents

    • Others

  • Chips and Microarrays

    • Instruments

    • Reagents

    • Others

  • Mass Spectrometry

    • Instruments

    • Reagents

    • Others

  • Sequencing

    • Instruments

    • Reagents

    • Others

  • Transcription Mediated Amplification (TMA)

    • Instruments

    • Reagents

    • Others

  • Others

    • Instruments

    • Reagents

    • Others

• Application Outlook

  • Oncology

    • Breast Cancer

    • Prostate Cancer

    • Colorectal Cancer

    • Cervical Cancer

    • Kidney Cancer

    • Liver Cancer

    • Blood Cancer

    • Lung Cancer

    • Other Cancer

  • Pharmacogenomics

  • Infectious Diseases

    • Methicillin-resistant Staphylococcus Aureus (MRSA)

    • Clostridium Difficile

    • Vancomycin-resistant Enterococci (VRE)

    • Carbapenem-resistant Bacteria

    • Flu

    • Respiratory Syncytial Virus (RSV)

    • Candida

    • Tuberculosis and Drug-resistant TB

    • Meningitis

    • Gastrointestinal Panel Testing

    • Chlamydia

    • Gonorrhea

    • HIV

    • Hepatitis C

    • Hepatitis B

    • Other Infectious Disease

  • Genetic Testing

    • Newborn Screening

    • Predictive and Presymptomatic Testing

    • Other Genetic Testing

  • Neurological Disease

  • Cardiovascular Disease

  • Microbiology

  • Others

• Regional Outlook

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Belgium

    • Switzerland

    • Netherlands

    • Poland

    • Austria

    • Greece

    • Sweden

    • Turkey

    • Finland

  • Asia Pacific

    • Japan

    • China

    • India

    • Sri Lanka

    • Malaysia

    • Australia

    • New Zealand

    • Thailand

    • Vietnam

    • Singapore

  • Latin America

    • Brazil

    • Mexico

    • Chile

    • Peru

    • Colombia

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • Jordan

    • UAE

    • Qatar

    • Nigeria

    • Egypt

The Molecular Diagnostics 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 Molecular Diagnostics market for the base year 2020 and the forecast between 2021 and 2030. 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 Molecular Diagnostics market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Molecular Diagnostics market development in United States, Europe and China.

It is pertinent to consider that in a volatile global economy, we haven’t just conducted Molecular Diagnostics 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 Molecular Diagnostics 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 Molecular Diagnostics 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 Molecular Diagnostics market. These figures have been provided in terms of both revenue and volume for the period 2017 to 2030. 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 Molecular Diagnostics market companies.

Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of Molecular Diagnostics 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 Molecular Diagnostics 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 Molecular Diagnostics 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 Molecular Diagnostics 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 Molecular Diagnostics 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 Molecular Diagnostics market. These factors have benefited the growth of the global market for Molecular Diagnostics. 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 Molecular Diagnostics. 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 Molecular Diagnostics are as follows:

• Historic Year: 2017-2020
• Base Year: 2021
• Forecast Year 2021 to 2030

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 (2021-2030);
• 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.