In February 2023, Thermo Fisher Scientific Inc. (US) acquired Binding Site Group (UK), a global leader in specialty diagnostics, to expand Thermo Fisher's existing specialty diagnostics portfolio with the addition of pioneering innovation in diagnostics and monitoring for multiple myeloma.

Northbrook, IL 60062 -- (SBWire) -- 08/01/2023 --Molecular Diagnostics Market in terms of revenue was estimated to be worth $16.6 billion in 2023 and is poised to reach $28.6 billion by 2028, growing at a CAGR of 11.4% from 2023 to 2028 according to a new report by MarketsandMarkets™. Due to the high prevalence of such infectious diseases, the demand for molecular diagnostic products and services is expected to increase in the coming years, which, in turn, will drive market growth. Also, globally, the prevalence of cancer has increased significantly over the last few years. The growing prevalence of cancer globally will increase the number of specimens tested, thus creating a demand for new diagnostic procedures, including molecular diagnostics.

The molecular diagnostics industry is poised to undergo significant advancements in the near future, fueled by rapid technological innovation and increasing demand for personalized healthcare. With the advent of next-generation sequencing (NGS) technologies, the field of molecular diagnostics is witnessing a revolution in terms of accuracy, speed, and cost-effectiveness. These advancements enable the identification and characterization of disease-causing genetic mutations with unprecedented precision, facilitating early and accurate diagnosis of various diseases, including cancer, infectious diseases, and genetic disorders. Furthermore, the integration of artificial intelligence (AI) and machine learning algorithms in data analysis and interpretation enhances the predictive capabilities of molecular diagnostics, enabling clinicians to make more informed decisions regarding patient treatment and prognosis. Additionally, the miniaturization of diagnostic devices and the emergence of point-of-care testing platforms allow for rapid and decentralized testing, improving access to molecular diagnostics in resource-limited settings. As a result, the molecular diagnostics industry is anticipated to transform healthcare delivery by providing personalized, precise, and timely diagnostic information, ultimately leading to improved patient outcomes and more efficient healthcare systems.

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Browse in-depth TOC on "Molecular Diagnostics Market"

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In 2022, the infectious disease diagnostics segment held the largest share of the molecular diagnostics market, by application segment

The molecular diagnostics market is segmented into infectious disease diagnostics, oncology testing, genetic testing, and other applications based on applications. The infectious disease diagnostics segment accounted for the largest share the global molecular diagnostics market in 2022. The large share of this segment can be attributed to the development of advanced assays for the diagnosis of different diseases & conditions, the increasing prevalence of infectious diseases, and rising awareness of the effective use of molecular diagnostic technologies/products to control the spread of infectious diseases. Infectious diseases pose a significant public health challenge, with outbreaks and epidemics occurring worldwide. The need for timely and accurate identification of infectious agents is paramount for implementing appropriate treatment strategies, infection control measures, and preventive interventions.

Diagnostic laboratories segment held the largest share of the molecular diagnostics market, by end user segment in 2022

The molecular diagnostics market is differentiated into diagnostic laboratories, hospitals & clinics, and other end users. In 2022, diagnostic laboratories dominated the molecular diagnostics market. Diagnostics laboratories play a crucial role in performing molecular diagnostic tests. These laboratories are equipped with specialized infrastructure, including advanced molecular testing platforms, equipment, and trained personnel. They are designed to handle complex molecular diagnostic procedures efficiently. The continuous advancements in molecular diagnostic technologies have expanded the capabilities of diagnostics laboratories. New platforms, such as next-generation sequencing (NGS), digital PCR, and microarrays, offer enhanced sensitivity, accuracy, and efficiency, enabling diagnostics laboratories to provide more comprehensive and precise testing services.
North America is the largest regional market for molecular diagnostics market

The molecular diagnostics market has been segmented into five major regions namely, North America, Europe, the Asia Pacific, Latin America, and the Middle East & Africa. In 2022, North America accounted for the largest share of the molecular diagnostics market. The large share of North America in this market can be attributed to the increasing prevalence of infectious diseases and cancer, rising healthcare spending, and the growing healthcare system that is highly developed in the US and Canada.

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Molecular Diagnostics Market Dynamics:

Drivers:

1. Increasing prevalence of infectious diseases and cancer globally
2. Rising focus on R&D and growing funding in molecular diagnostics by healthcare-based companies
3. Growing awareness regarding early disease diagnosis in developing countries
4. Rising technological advancements in molecular diagnostics in recent years
5. Increasing use of PoC diagnostic tests in homecare settings and hospitals

Restraints:

1. Unfavorable reimbursement scenario for diagnostic companies
2. High cost of molecular diagnostic instruments

Opportunities:

1. Growing significance of companion diagnostics in drug development process
2. Increasing growth opportunities for molecular diagnostics companies in emerging economies

Challenges:

1. Changing regulatory landscape for IVD and molecular diagnostics in US and European Union
2. Operational barriers and shortage of skills across major markets
3. Introduction of alternative technologies for disease detection and diagnosis

Key Market Players:

The major players operating in this market are F. Hoffmann-La Roche Ltd. (Switzerland), Hologic, Inc. (US), Thermo Fisher Scientific Inc. (US), Abbott Laboratories (US), bioMérieux (France), QIAGEN (Netherlands), PerkinElmer Inc. (US), Myriad Genetics, Inc. (US), Siemens Healthineers AG (Germany), Danaher (US), Illumina, Inc. (US), Becton, Dickinson and Company (US), Grifols, S.A. (Spain), QuidelOrtho Corporation (US), Agilent Technologies, Inc. (US), DiaSorin S.p.A. (Italy), Exact Sciences Corporation (US), Genetic Signatures (Australia), MDx Health (Belgium), Biocartis (Belgium), TBG Diagnostics Limited (Australia), HTG Molecular Diagnostics, Inc. (US), Vela Diagnostics (Singapore), Amoy Diagnostics Co., Ltd. (China), ELITechGroup (France), Molbio Diagnostics Pvt. Ltd. (India), Savyon Diagnostics (Israel), Abacus Diagnostica Oy (Finland), and geneOmbio Technologies Pvt. Ltd. (India)

Recent Developments:

- In February 2023, Thermo Fisher Scientific Inc. (US) acquired Binding Site Group (UK), a global leader in specialty diagnostics, to expand Thermo Fisher's existing specialty diagnostics portfolio with the addition of pioneering innovation in diagnostics and monitoring for multiple myeloma.

- In October 2022, F. Hoffmann-La Roche Ltd. (Switzerland) received 510(k) clearance from the US FDA for the cobas SARS-CoV-2 Qualitative PCR test for use on the fully automated cobas 6800 and cobas 8800 Systems.
- In May 2022, F. Hoffmann-La Roche Ltd. (Switzerland) partnered with Global Fund to support low- and middle-income countries in strengthening critical diagnostics infrastructure.

- In December 2021, Hologic, Inc. (US) launched Panther Trax for high-volume molecular testing.

- In March 2021, Abbott Laboratories (US) received Emergency Use Authorization (EUA) from the FDA for a laboratory PCR assay, Alinity m Resp-4-Plex molecular assay, that detects and differentiates between SARS-COV-2, flu A, flu B, and RSV in one test.

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Molecular Diagnostics Market Advantages:

- Accuracy and Precision: Molecular diagnostics provide highly accurate and precise results, enabling early detection, diagnosis, and monitoring of diseases. This accuracy allows for timely intervention and treatment planning, leading to improved patient outcomes and reduced healthcare costs.

- Personalized Medicine: Molecular diagnostics offer a personalized approach to healthcare by analyzing an individual's genetic profile. This enables tailored treatment plans based on specific genetic markers and mutations, maximizing therapeutic efficacy while minimizing adverse effects.

- Infectious Disease Management: Molecular diagnostics play a crucial role in infectious disease management by enabling rapid and sensitive detection of pathogens. This facilitates early identification, containment, and prevention of outbreaks, leading to improved public health outcomes.

- Cancer Diagnosis and Monitoring: Molecular diagnostics are instrumental in cancer diagnosis and monitoring. They enable the identification of specific genetic mutations, guiding targeted therapies and improving patient outcomes.

- Automation and User-Friendly Platforms: Advancements in technology have led to the development of user-friendly, automated platforms for molecular diagnostics. This allows for faster and easier testing, reducing the reliance on specialized laboratory personnel and increasing accessibility.

- Integration with Technology: Molecular diagnostics can be integrated with other healthcare technologies such as artificial intelligence and big data analytics. This integration enhances data interpretation, predictive modeling, and facilitates the implementation of precision medicine approaches.

- Potential for Advancing Healthcare Systems: The advantages of molecular diagnostics have the potential to significantly improve patient care, optimize treatment outcomes, and advance healthcare systems by providing more accurate and personalized diagnostic information.

Molecular Diagnostics Market – Report Highlights:

- More Refined Presentation of the Competitive Landscape and Recent Market Developments: We have added market shares for top players. Recent developments are helpful to know the market trends and growth strategies adopted by players in the market. The report provides updated developments in product launches, collaboration, acquisitions, and partnerships.

- Additional Information: The current edition of the report covers recession impact analysis. Also, a new segment, sample type, has been added.

- More Refined Presentation of the Company Profiles Segment: Company profiles give a glimpse of the key players in the market with respect to business overviews, financials, product offerings, and recent developments. The new edition of the report provides an updated product portfolio of the companies profiled in the report. A total of 29 companies have been profiled. These companies have emerged as key market players in recent years due to the products they offer, and various strategic investments undertaken in the molecular diagnostics market space.

- Newer and Improved Representation of Financial Information: The new edition of the report provides updated financial information in the context of the molecular diagnostics market until 2022 (depending on availability) for each listed company. This will help analyze the present status of the profiled companies in terms of their financial strength, profitability, key revenue-generating country/region, business segment focus in terms of the highest revenue-generating segments, and investments in research and development activities.

- Recent Market Developments: Recent developments are important to understand the market trends and growth strategies adopted by players operating in the global molecular diagnostics market. The current edition of this report provides updated developments of profiled players from January 2020 to May 2023, indicating a continuation of the previous version. Product launches and acquisitions are the principal growth strategies adopted by market players in this period.