The molecular diagnostics market is valued at an estimated USD 16.6 billion in 2023 and is projected to reach USD 28.6 billion by 2028 at a CAGR of 11.4% during the forecast period. Diseases such as tuberculosis, HIV/AIDS, hepatitis, sexually transmitted infections, and respiratory infections require an accurate and timely diagnosis for effective treatment and control. Molecular diagnostics play a crucial role in the detection and monitoring of these infectious diseases, driving the growth of the market in this area.

Apart from infectious disease diagnostics, molecular diagnostic techniques are increasingly being used to enhance patient management, particularly in the field of cancer. The growing prevalence of cancer globally will increase the number of specimens tested, thus creating a demand for new diagnostic procedures, including molecular diagnostics.

“Blood, serum, and plasma segment accounted for the highest growth rate in the molecular diagnostics market, by sample type, during the forecast period”
The molecular diagnostics market is bifurcated into blood, serum, and plasma, urine, and other sample types on the basis of sample type. The blood, serum, and plasma segment in molecular diagnostics is experiencing substantial growth, largely driven by the increased demand for infectious disease testing. Infectious diseases pose significant global health challenges, and the accurate and timely diagnosis of these conditions is crucial for effective disease management and public health measures.

Plasma and serum samples provide several advantages for infectious disease testing. Plasma and serum samples have wide-ranging diagnostic applications in infectious diseases, including viral, bacterial, fungal, and parasitic infections. They aid in early diagnosis, appropriate treatment selection, and the assessment of treatment response. Moreover, Blood-based molecular diagnostics have demonstrated clinical utility across a broad range of applications, including genetic testing, infectious disease diagnosis, cancer diagnostics, and monitoring disease progression.

“Oncology testing segment accounted for the highest growth rate in the molecular diagnostics market, by application, during the forecast period”
The global molecular diagnostics market is bifurcated into infectious disease diagnostics, oncology testing, genetic testing, and other applications. Oncology testing segment is currently witnessing the highest growth rate within the molecular diagnostics market, reflecting the increasing importance of precision medicine and personalized approaches in cancer care. The surge in demand for oncology testing is fueled by various factors that are transforming the landscape of cancer diagnostics and treatment. Molecular diagnostic tests enable physicians to study the predisposition of genetic materials to diseases and diagnose diseases, such as cancer, at an early stage.

Through various strategic developments, pharmaceutical companies and molecular diagnostic manufacturers have increasingly focused on integrating their synergies to develop personalized medicine and companion diagnostic assays that can support the monitoring of a patient’s response to a given drug therapy. This is a major factor boosting the growth of the oncology testing segment. The growth of this segment is also driven by technological advancements and the increasing incidence of cancer.

“Asia Pacific: The fastest-growing region molecular diagnostics market”
The global molecular diagnostics market is segmented into North America, Europe, the Asia Pacific, Latin America, and the Middle East & Africa. The Asia Pacific region is projected to register the highest CAGR during the forecast period. Emerging countries in this region have witnessed growth in their GDPs and a significant rise in disposable income levels. This has led to increased healthcare spending by a larger population base, healthcare infrastructure modernization, and the rising penetration of cutting-edge clinical laboratory technologies in the Asia Pacific countries. These factors are expected to provide significant growth opportunities for molecular diagnostic companies operating in this region.

The Asia Pacific, which has become a medical tourism hub, is considered one of the fastest-growing markets for medical procedures and devices. Low infrastructure and treatment costs and the availability of highly educated physicians have driven medical tourists to these countries, which is a major factor driving the growth of the molecular diagnostics market in this region.

The break-up of the profile of primary participants in the molecular diagnostics market:

  • By Company Type: Tier 1 - 40%, Tier 2 - 30%, and Tier 3 – 30%
  • By Designation: C-level - 27%, D-level - 18%, and Others - 55%
  • By Region: North America - 51%, Europe - 21%, Asia Pacific - 18%, Latin America – 6%, and Middle East & Africa- 4%

The key players in this market are F. Hoffmann-La Roche Ltd. (Switzerland), Hologic, Inc. (US), Thermo Fisher Scientific Inc. (US), Abbott Laboratories (US), bioM?rieux (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).

Research Coverage:
This research report categorizes the molecular diagnostics market by product & service (reagents & kits, instruments, and services & software), test type (lab tests and PoC tests), sample type (blood, serum, and plasma, urine, and other sample types), application (infectious disease diagnostics (hepatitis, HIV, CT/NG, HAI, HPV, tuberculosis, influenza, and other infectious diseases), oncology testing (breast cancer, colorectal cancer, lung cancer, prostate cancer, and other cancer testing), genetic testing, and other applications, technology (polymerase chain reaction, isothermal nucleic acid amplification technology, DNA sequencing & next-generation sequencing, in situ hybridization, DNA microarrays, and other technologies), end user (diagnostic laboratories, hospitals & clinics, and other end users), and region (North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa). The scope of the report covers detailed information regarding the major factors, such as drivers, restraints, challenges, and opportunities, influencing the growth of the molecular diagnostics market. A detailed analysis of the key industry players has been done to provide insights into their business overview, solutions, and services; key strategies; acquisitions, agreements. new product & service launches, and recent developments associated with the molecular diagnostics market. Competitive analysis of upcoming startups in the molecular diagnostics market ecosystem is covered in this report.

Reasons To buy this report:
The report will help the market leaders/new entrants in this market with information on the closest approximations of the revenue numbers for the overall molecular diagnostics market and the subsegments. This report will help stakeholders understand the competitive landscape and gain more insights to position their businesses better and to plan suitable go-to-market strategies. The report also helps stakeholders understand the pulse of the market and provides them with information on key market drivers, restraints, challenges, and opportunities.

The report provides insights on the following pointers:

  • Analysis of key drivers (increasing prevalence of infectious diseases and cancer globally, rising focus on R&D and growing funding in molecular diagnostics by healthcare-based companies, growing awareness of early disease diagnosis in developing countries, rising technological advancements in molecular diagnostics in recent years, and increasing use of PoC diagnostic tests in homecare settings and hospitals), restraints (unfavorable reimbursement scenario for diagnostic companies and high cost of molecular diagnostic instruments), opportunities (growing significance of companion diagnostics in drug development process and growth opportunities for molecular diagnostic companies in emerging economies), and challenges (changing regulatory landscape for IVD and molecular diagnostics in US and European Union, operational barriers and shortage of skills across major markets, and introduction of alternative technologies for disease detection and diagnosis) influencing the growth of the molecular diagnostics market
  • Product Development/Innovation: Detailed insights on upcoming technologies, research & development activities, and new product launches in the molecular diagnostics market.
  • Market Development: Comprehensive information about lucrative markets – the report analyses the molecular diagnostics market across varied regions.
  • Market Diversification: Exhaustive information about new products & services, untapped geographies, recent developments, and investments in the molecular diagnostics market
  • Competitive Assessment: In-depth assessment of market shares, growth strategies and service offerings of leading players like F. Hoffmann-La Roche Ltd. (Switzerland), Hologic, Inc. (US), Thermo Fisher Scientific Inc. (US), Abbott Laboratories (US), and bioM?rieux (France), among others in the molecular diagnostics market strategies.