Molecular Diagnostics Market Analysis

Global Molecular Diagnostics Market Overview

The Molecular Diagnostics Market Valued at USD 17.1 billion in 2023, projected to grow from USD 17.9 billion in 2024 to USD 28.89 billion by 2032, at a CAGR of 4.40% during the forecast period (2024 - 2032). The rising worldwide geriatric population and the prevalence of various diseases are the key market drivers enhancing market growth. The market is expanding because of illnesses like cancer, cardiovascular diseases, neurological disorders, diabetes, and obesity that the growing elderly population may bring on. The incidence of infectious diseases is predicted to rise, driving market expansion.

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

In March 2023, Cepheid, a global pioneer in molecular diagnostics, established a manufacturing facility in Bengaluru, India. Cepheid has achieved a significant accomplishment by inaugurating their new production facility in India, showcasing their commitment to providing cost-effective and top-notch molecular diagnostic solutions to healthcare professionals and patients in India. In 2018, the process of setting up an Indian manufacturing plant for Cepheid commenced in order to cater to the growing demands of the Indian market. The local production of components will increase the availability of Cepheid's MTB kits, aligning with the Indian government's "Make in India" initiative and enhancing India's overall molecular diagnostics production capabilities.

In July 2023, Thermo Fisher Scientific introduced the Scalable Diomni Enterprise Software for Molecular Diagnostics Laboratories and Test Developers. The program was developed with the objective of standardizing and expediting the turnaround time for obtaining findings from fundamental diagnostic testing. By integrating process phases inside a consistent user interface, it enhances a laboratory's capacity to effectively adjust to quickly changing testing environments. The new tool simplifies the implementation of quantitative polymerase chain reaction (qPCR) in various diagnostic facilities. Furthermore, it expedites the creation of novel testing solutions by developers. In addition, it enables laboratories to automate their interface with their existing laboratory information systems, hence improving traceability. Diomni Enterprise provides flexible testing processes to enable tests and equipment that are specifically designed for use in vitro or in laboratory settings.

In March 2023, AstraGene LLC became the first Molecular Diagnostics Manufacturing company in the United Arab Emirates. During the same month, Mylab Discovery Solutions, a leading Indian biotech firm, entered into an exclusive strategic agreement with AstraGene to develop automated molecular diagnostics specifically for the UAE and Kuwait markets. Mylab and AstraGene have entered into a collaborative agreement to jointly develop molecular diagnostic solutions, including reagents, kits, and automated devices. This partnership is Mylab's latest venture into international markets and aligns with the company's strategic objective of expanding access to top-notch diagnostic solutions in emerging economies.

A molecular residual disease liquid biopsy test was developed by Illumina and Janssen in January 2024 that involved their collaboration. A cost-effective whole-genome sequencing multi-cancer test to detect ctDNA is being developed by the company.

For example, documents were submitted for review of the Co-Dx PCR COVID-19 test on Co-Dx PCR Pro instrument at the U.S. FDA for emergency use authorization in December 2023.

As an example, F. Hoffmann-La Roche Ltd launched LightCycler PRO System in November 2023 to make it possible to use its molecular PCR tests more frequently in translational research and in vitro diagnostic applications.

For instance, QIAGEN and Myriad Genetics partnered in October 2023 to develop companion diagnostic tests based on PCR, dPCR, and NGS technology for cancer.

Indian companies CrisprBits and MolBio Diagnostics made an alliance towards changing POC diagnostics through the integration of CRISPR technology into POC tests capable of detecting pathogens as well as genetic markers during August 2023.

In addition, QIAGEN got approval from the United States Food and Drug Administration (USFDA) on a therascreen PDGFRA RGQ PCR kit, which helps physicians identify patients with Gastrointestinal Stromal Tumors (GIST).

Sansure Biotech exhibited iPonatic III portable molecular workstation, among other IVD products, during EuroMedLab Rome 2023 in May 2023.

In April 2023, Quest Diagnostics Incorporated acquired the MRD Platform of Haystack Oncology for early detection of cancer and personalized medicine based on circulating tumor DNA technology. This is to increase their expertise and extend their reach to new areas in the rapidly growing market.

In April 2023, Oxford Nanopore, together with bioMérieux, entered into a strategic partnership that will see them employ nanopore technology to develop new treatment methods for infectious diseases.

Molecular Diagnostics Market Trends

• Rising prevalence of infectious diseases is driving the market growth

Market CAGR for molecular diagnostics is driven by the rising cases of infectious diseases. At the moment, managing microbial outbreaks and diseases around the world is a major concern for all countries. A significant amount of resource engagement is boosting the market for molecular diagnostics in terms of technology, experience, financial services, and a favorable environment for imitating research initiatives, particularly for infectious diseases. Additionally, it is anticipated that increased awareness campaigns for infectious diseases launched by international organizations like World Health Organisation, World Bank, and others will inspire the talent pool to increase the use of such diagnostic tools.

The molecular diagnostics industry has growth prospects thanks to government programs, funding efforts, and other initiatives that support and promote research and development. For instance, in August 2020, NIH launched its Rapid Acceleration of Diagnostics (RADx) initiative, which has $200 million in funding. The objective of this project was to hasten the creation, adoption, and commercialization of technology for COVID-19 testing.  Additionally, the Collaborative Influenza Vaccine Innovation Centres (CIVICs) program was introduced by the National Institute of Allergy and Infectious Diseases (NIAID), a division of US National Institutes of Health, in 2019 to support a wide range of influenza research activities, including the diagnostics, development of vaccines, and therapeutics against seasonal and pandemic influenza. NIAID announced 51 million USD in funding for CIVICs.  Such government programs and funding examples are anticipated to expand the market. Thus, driving the molecular diagnostics market revenue.

Molecular Diagnostics Market Segment Insights

Molecular Diagnostics Products Insights

The Molecular Diagnostics Market Segments based on products, includes reagents & kits, instruments, and services & software.  The reagents & kits segment dominated the market, accounting for 49.2% of market revenue (9.1 Billion).  Due to its widespread use in research and clinical settings, it is anticipated to maintain its supremacy in the next years. Standard reagents aid in obtaining reliable and timely results. It is envisaged that standardized outcomes, increased effectiveness, and cost-effectiveness will support market expansion. Furthermore, in 2022, the instruments segment experienced the fastest growth rate. The sector growth is also predicted to be boosted by the expanding usage of coronavirus detection tools created for other infectious disorders.

Figure 1: Molecular Diagnostics Market, by Product, 2023 & 2032 (USD Billion)

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Molecular Diagnostics Technique Insights

The Molecular Diagnostics Market segmentation, based on technique, includes polymerase chain reaction (PCR), isothermal amplification, hybridization, sequencing, microarray, and others. In 2022, the polymerase chain reaction (PCR) segment's revenue share was the highest. Its usage in the detection of COVID-19 and other infectious diseases explains this. The increased use of high-throughput PCR technology to detect viral and genetic disorders will boost market expansion.

January 2022 Seegene Inc., South Korea's premier molecular diagnostics business, announced today the impending release of the AllplexTM SARS-CoV-2 Fast PCR Assay, which may provide PCR results in as little as 60 minutes. According to the business, this assay is predicted to lower total turnaround time by one-third and increase testing capacity by up to thrice for hospitals and laboratories without additional instruments or sacrificing accuracy.

Additionally, in 2022, the sequencing sector witnessed the fastest growth rate. Sequencing procedures and newly developed NGS technologies, such as sequencing platforms and RNA sequencing, are examples of sequencing technologies for the market of molecular diagnostics. Drug discovery, the development of innovative drugs, and personalized treatment are all closely related to DNA sequencing technologies.

Molecular Diagnostics Application Insights

The Molecular Diagnostics Market segmentation based on application, includes infectious diseases, oncology, genetic tests, and others. The infectious disease segment had the greatest revenue share in the molecular diagnostics market. The primary factor driving this market's domination is the rising prevalence of molecular diagnostics, particularly PCR tests, for the diagnosis of COVID-19.  The causes related to the huge market share of this category include the rising prevalence of infectious diseases, the rising funding for infectious disease diagnostic research activities, and the rapid advent of a pandemic. However, the oncology segment saw considerable growth in 2022. WHO estimates 19.3 million new cancer diagnoses will be worldwide in 2020 and 10.0 million cancer-related deaths. Additionally, the British In Vitro Diagnostics Association made an effort in January 2021 by requesting that NHS England create a commissioning framework for molecular diagnostics in oncology.

Molecular Diagnostics End-User Insights

The Market segmentation of Molecular Diagnostics, based on end-user, includes hospitals & clinics, diagnostic laboratories, and others. The molecular diagnostics segment is expected to be dominated by the hospitals and clinics industry. The share of hospital admissions for this demographic segment is influenced by several variables, including the aging population growth and the high prevalence of healthcare-associated illnesses (HAIs). Due to the large procedure volumes for COVID testing in these laboratories, the diagnostic laboratory section is anticipated to expand in the future. The increasing number of actions the government takes to provide various services, such as paying for these diagnostic tests, is another driver fueling the growth of this market.

Molecular Diagnostics Regional Insights

By region, the study provides market insights into North America, Europe, Asia-Pacific and Rest of the World. The North American molecular diagnostics market area will dominate this market. In United States, the expansion of the healthcare system and a rise in the incidence of infectious diseases and cancer have led to a shift away from traditional diagnostic methods and towards molecular diagnostics. For example, the ACS "Cancer Facts & Figures 2022" predicts that there will be roughly 1,918,030 new cases of cancer and 609,360 deaths from cancer in the United States in that year.

Further, the major countries studied in the market report are US, Canada, France, German, Italy, UK, Spain, Japan, China, Australia, India, South Korea, and Brazil.

Figure 2: MOLECULAR DIAGNOSTICS MARKET SHARE BY REGION 2023 (USD Billion)

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

Asia-Pacific molecular diagnostics market accounts for the second-largest market share due to the sector's high unmet needs and rising market penetration. Due to the region's consistently expanding patient population, early identification, targeted therapy, and early prevention, the Asia Pacific market is expected to expand. In India, the use of molecular diagnostics has significantly increased in recent years. Numerous causes, like the rising use of Next-Generation Sequencing (NGS) and an increase in the testing of infectious diseases like cancer, can be used to explain this expansion. Moreover, China’s market of molecular diagnostics held the largest market share, and the Indian  molecular diagnostics market was the rapidly-growing market in the Asia-Pacific region.

Europe’s Molecular Diagnostics Market is estimated to expand at a rapid rate from 2024 -2032. This is related to the increased prevalence of infectious and chronic diseases, which has sparked R&D efforts and boosted market expansion. Key factors influencing expansion include a high standard of living, consumer awareness of early diagnosis, and an established healthcare system. Further, the German market of molecular diagnostics held the largest market share, and the UK market of molecular diagnostics was the rapidly-growing market in the European region.

Molecular Diagnostics Competitive Insights & Key Market Players

Leading market players are largely investing in research and development to expand their product lines, which will help the market of molecular diagnostics, grow even more. The launch of new products, larger-scale mergers and acquisitions, contractual agreements, and collaboration with other organizations are significant market developments in which market participants engage to increase their global presence. The molecular diagnostics industry must provide affordable products to expand and thrive in a more competitive and challenging market environment.

One of the major business strategies manufacturers use in the global molecular diagnostics industry to increase market sector and benefit customers is local manufacturing to lower operational costs. In recent years, the molecular diagnostics industry has stipulated some of the most important medicinal benefits. Major players in the molecular diagnostics market, including Agilent Technologies, Thermo Fisher Scientific, Becton Dickinson and Company, Abbott Laboratories, Hoffman La Roche Ltd, and others, are funding operations for research and development to boost market demand.

Illumina, Inc. creates, manufactures, and sells integrated solutions for large-scale investigation of genetic variation and biological function. Over 90% of the company's income comes from sequencing tools, consumables, and services. The high-throughput technology of Illumina permits whole-genome sequencing in humans and other big species. In March 2023, llumina Inc. and GenoScreen, a cutting-edge genomics firm, launched a package combining Illumina products with the GenoScreen Deeplex Myc-TB assay, a targeted next-generation sequencing (NGS)-based test for the rapid and comprehensive detection of anti-TB medication resistance. This will contribute to the World Health Organization's (WHO) aim to end global tuberculosis (TB) epidemic by 2035.

Roche is a biopharmaceutical and diagnostic firm based in Switzerland. The company's best-selling pharmaceutical products include a range of oncology medicines from acquired partner Genentech, and the 2008 acquisition of Ventana strengthened its diagnostics division. Oncology goods account for half of all pharmaceutical sales, with centralized and point-of-care diagnostics accounting for more than half of all diagnostic-related sales. In November 2021, Roche announced the availability of the Cobas 5800 System, a new molecular laboratory instrument, in countries where the CE mark is accepted. Testing is one of the most important lines of defense in guaranteeing a patient's general well-being, and it is crucial in guiding their therapy as soon as possible.

Key Companies in the market of molecular diagnostics include

• Hoffman La Roche Ltd


• Hologic Inc.


• Becton Dickinson and Company


• Abbott Laboratories


• Cepheid


• Siemens


• QIAGEN


• Thermo Fisher Scientific


• Agilent Technologies

Molecular Diagnostics Industry Developments

February 2024: Hologic Unveils FDA-Certified GeniusTM Digital Diagnostics System. The unique technique will enhance cervical cancer screening by improving operational and screening efficiency, promoting innovation in the cytology field, and providing a more accurate disease diagnosis than manual and image-guided cytology review

November 2023: F. Hoffmann-La Roche AG introduced the LightCycler PRO device, a next-generation qPCR device. By providing agility and flexibility for translational research and diagnostics, the new system will promote personalized healthcare and support preparedness for outbreaks

November 2023: QIAGEN launched QIAcuity digital PCR kits and software in an attempt to grow its user base among food safety and biopharma clients.  Three new QIAcuity kits that ensure accurate quantification, better sensitivity, and cost-effectiveness enhance digital PCR applications in biopharma research and food safety

October 2023: QIAGEN (Germany) and Myriad Genetics (US) collaborate to progress the development of cancer companion diagnostics. The Partnership included companion diagnostic test development in the lab and kit distribution

July 2023: Siemens Healthineers launches Atellica CI Analyzer, a portable testing instrument intended to alleviate lab issues.  The aim of the Atellica CI Analyzer for immunoassay and clinical chemistry testing is to increase revenue growth and address labor scarcity issues by fostering agility that goes beyond standardization and clinical equivalency

Molecular Diagnostics Market Segmentation

Molecular Diagnostics Products Outlook

• Reagents & Kits


• Instruments


• Services & Software

Molecular Diagnostics Technique Outlook

• Polymerase Chain Reaction (PCR)


• Isothermal Amplification


• Hybridization


• Sequencing


• Microarray


• Others

Molecular Diagnostics Application Outlook

• Infectious Diseases


• Oncology


• Genetic Tests


• Others

Molecular Diagnostics End-User Outlook

• Hospitals & Clinics


• Diagnostic Laboratories


• Others

Molecular Diagnostics Regional Outlook

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  North America

  
  
  
  
  • US
  
  
  • Canada
  
  
  
  


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  Europe

  
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  


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  Asia-Pacific

  
  
  
  
  • China
  
  
  • Japan
  
  
  • India
  
  
  • Australia
  
  
  • South Korea
  
  
  • Australia
  
  
  • Rest of Asia-Pacific
  
  
  
  


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  Rest of the World

  
  
  
  
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    Middle East

    
    
  
  
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    Africa

    
    
  
  
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    Latin America