Molecular Diagnostics Market Size, Share, Industry, Forecast and outlook (2024-2031)

Global Molecular Diagnostics Market is segmented By Product Type (Reagents, Instruments, Software & Services), By Application (Oncology, Cardiovascular Diseases, Infectious Diseases, and Others), By End-User (Research Laboratories, Hospitals, Medical Academics), By Technology (PCR, Hybridization, INAAT, and Others), and By Region (North America, Latin America, Europe, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2024-2031

Molecular Diagnostics Market Size

The Global Molecular Diagnostics Market reached USD 22.8  billion in 2022 and is projected to witness lucrative growth by reaching up to USD 35.7 billion by 2031. The global molecular diagnostics market is expected to exhibit a CAGR of 5.9% during the forecast period 2024-2031.

The Molecular Diagnostics Market trends show rising demand for these owing to the rising prevalence of cancerous diseases and increasing research and development.

Furthermore, the numerous bacterial or viral epidemics and rising demand for diagnostics at the point of care are driving up the molecular diagnostics market size. Due to the expansion of research in these fields, the market is seeing an increase in demand from North American regions. With significant competitors like F Hoffmann-la Roche Ltd, Hologic, Inc., Abbott, and others actively operating in the market, the competitive struggle is escalating the molecular diagnostics market growth.   

Molecular Diagnostics Market Summary

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Molecular Diagnostics Market Trends

Large Outbreaks of Bacterial And Viral Epidemics in the World drive the growth of the molecular diagnostics market.

The rising prevalence of numerous bacterial or viral epidemics, together with rising demand for diagnostics at the point of care, recent developments in pharmacogenomics and novel product launch, are likely to fuel global molecular diagnostic market size expansion throughout the course of the forecast period.

Additionally, on March 15, 2023, a quick, point-of-care molecular diagnostic tool that pinpoints a subset of people who will most likely benefit from hypnotherapy interventions for pain treatment was developed by researchers. 

They also discovered that a subpopulation of highly hypnotizable people might be more prone to have intense postoperative pain, according to their study published in The Journal of Molecular Diagnostics, an Elsevier publication.

Furthermore, to find the best combination of COMT SNPs in patient DNA samples, the researchers created an SNP genotyping assay on a massive magneto-resistive (GMR) biosensor array. GMR biosensor arrays may be quickly and readily installed at point-of-care settings utilizing saliva or blood samples, and they are dependable, affordable, and sensitive.

Rising Technological Advancements by Key Companies create lucrative opportunities for manufacturers. 

There is a growing molecular diagnostics market opportunity owing to rising technological advancements and novel product launch proficiencies by key players. The rising prevalence of various infectious or cardiovascular disorders is also a molecular diagnostics market trend driving the market. 

In March 2023, the ultrafast PCR technology was created, according to the Korea Institute of Science and Technology (KIST). The ultrafast PCR reduces the test time by ten times as compared to the time required for the existing test by employing photothermal nanomaterials. The new test method can be finished in 5 minutes and has diagnostic performance on par with the old test method.

The KIST research group has created a polymer composite that can physically hold and stabilize photothermal nanoparticles. They have made a portable PCR machine without a heat plate by connecting it to a PCR setup. They also used a multiplex diagnostic method, which simultaneously detects numerous genes and can discriminate between various COVID-19 variant types in a single result.

The High Cost of Molecular Diagnostics will hamper the growth of the market. 

Although immensely useful, molecular diagnostics do have some restrictions and drawbacks. Molecular diagnostics typically cost more than more established conventional methods. The cost of equipment and supplies may be prohibitive for some labs. 

The expenses might go down when molecular techniques become more widespread. Currently, labs that find the cost prohibitive would rather send molecular specimens to an external reference lab. These elements limit market expansion during the anticipated term.

Molecular Diagnostics Market Segment Analysis

The Global Molecular Diagnostics Market is segmented based on product type, technology, application, end-user and region.

The PCR (Polymerase Chain Reaction) technology segment accounted for approximately 39.4% of the molecular diagnostics market share in 2022 due to the high demand.

Based on technology, the market is divided into PCR (polymerase chain reaction), fluorescence in situ hybridization, next-generation sequencing and isothermal nucleic acid amplification technology (INAAT). Due to the rise in demand for infectious and cardiovascular diseases, molecular diagnostics is the most rapidly expanding industry. Due to the increasing demand for better diagnostic approaches for the rising number of infectious disorders, the PCR (Polymerase Chain Reaction) segment held the greatest market share in the Global Molecular Diagnostics Market. 

A given DNA segment can be quickly multiplied (amplified) into millions or billions of copies using the PCR, allowing for more in-depth analysis. In PCR, a section of the genome to be replicated is chosen using short segments of synthetic DNA called primers. Several cycles of DNA synthesis are then used to replicate that segment. Additionally, the market is predicted to have future growth prospects thanks to the expanding pipeline, product approvals, and clinical trials.

The variety of organisms, infections, or illnesses that might be diagnosed with PCR increased as its application spread to various fields of study and disease regions. To provide a better picture of a patient's condition, many targets can be recognized simultaneously from a single sample using multiplex testing.

Global Molecular Diagnostics Market Geographical Share

North America accounted for approximately 37.1% of the market share in 2022, owing to the strong presence of major players and increasing healthcare infrastructure investment.

The need for molecular diagnostics in North America is increasing, providing manufacturers with the opportunity to expand their operations. The region has many producers and suppliers, and economic growth has driven demand. Factors contributing to market growth include higher healthcare spending, greater awareness, and advancements in diagnosis and treatment technologies.

The primary healthcare organizations and businesses' joint research endeavors and new product development that continuously aims to enhance available diagnostics and treatment options are also expected to contribute to the rising demand. Individuals are becoming more aware of various technologies being studied for the treatment leading to the expansion of the market in this region. The factors mentioned above further prove North America's dominance on a global scale.

Molecular Diagnostics Market Key Players

The major global players in the molecular diagnostics market include F Hoffmann-la Roche Ltd, Illumina, Inc., Abbott, BD, Bio-Rad Laboratories, Inc., Hologic, Inc., Agilent Technologies Inc., Myriad Genetics, Inc., Thermo Fisher Scientific Inc. and Danaher among others. 

Russia Ukraine Conflict Analysis

The Russia-Ukraine conflict is estimated to have a moderate impact on the global molecular diagnostics market, owing to the low prevalence and absence of key market players in this region. However, the impact of the import and export of raw materials is expected to have little influence over the global molecular diagnostics market growth over the forecast period.

Key Developments

• On May 19, 2023, The Panther Fusion Flu A/B/SARS-CoV-2/RSV assay from Hologic Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This assay is a molecular diagnostic test that distinguishes between the four most common respiratory viruses, including the respiratory syncytial virus (RSV), influenza A, influenza B, and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
• On April 13, 2023, The Agilent SureSelect Cancer CGP Assay, created for somatic variant profiling for various solid tumor types, was made available, according to an announcement from Agilent Technologies Inc. 

The NGS panel of 679 genes used in the pan-cancer assay was carefully chosen from the best cancer datasets in the world in consultation with significant clinical cancer researchers.  Thanks to the assay workflow's effectiveness, automatability, and flexibility, tumor molecular profiling is now more widely available to the clinical research community.

• On May 12, 2022, A renowned provider of medical technology, BD (Becton, Dickinson & Company), recently announced the debut of their brand-new, high-throughput, fully computerized, infectious illness molecular diagnostics platform in the United States. For large, high-throughput labs, the BD COR MX/PX System unifies and automates the whole molecular laboratory processes, from the processing of samples to diagnostic test result.  

Why Purchase the Report?

• To visualize the Global Molecular Diagnostics Market segmentation based on product type, technology, application, end-user and region, and understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development. 
• Excel data sheet with numerous molecular diagnostics market-level data points with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping available as Excel consisting of key products of all the major players.

The Global Molecular Diagnostics Market Report Would Provide Approximately 53 Tables, 54 Figures And 195 Pages.

Target Audience 2024

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies