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A Detailed Analysis of the Molecular Diagnostics Market Based on Increasing Prevalence of Infectious Diseases, and Rising Demand for Personalized Medicine Solutions
The global molecular diagnostics market is forecast to expand at a CAGR of 6.2% and thereby increase from a value of US$23.2 Bn in 2024, to US$35.6 Bn by the end of 2031.
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Attributes |
Key Insights |
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Molecular Diagnostics Market Size (2024) |
US$23.2 Bn |
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Projected Market Value (2031F) |
US$35.6 Bn |
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Global Market Growth Rate (CAGR 2024 to 2031) |
6.2% |
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Historical Market Growth Rate (CAGR 2019 to 2023) |
4.9% |
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Revenue Share of Top Four Countries (2023A) |
56.7% |
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Molecular diagnostics involves the analysis of biological markers at the molecular level to detect specific genetic sequences or mutations associated with various diseases. This field has witnessed significant advancements, and the market has grown steadily due to the increasing prevalence of infectious diseases, genetic disorders, and cancer.
The growth prospects of the Molecular Diagnostic industry can vary depending on factors such as economic development, infrastructure projects, urbanization rates, and construction activity. Form strategic partnerships and collaborations with research institutions, healthcare providers, and technology firms to access expertise, resources, and novel technologies.
Moreover, according to the Nature Reviews Microbiology Journal, as molecular technologies are nimble, rapid, and versatile, they are an effective answer for infectious disease diagnostics in situations with limited resources and a large range of probable aetiologies. Healthcare systems that use molecular diagnostics regularly will gain economies of scale, maximize limited expertise, and respond quickly to new threats.
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A subset of molecular diagnostics is called companion diagnostics. Companion diagnostics and molecular diagnostics are intertwined, and comprehension of molecular diagnostics facilitates comprehension of companion diagnostics.
The increased use of targeted medications in oncology and other areas has increased the need for companion diagnostic testing. Using a multi-analyte approach, next-generation sequencing (NGS) provides comprehensive biomarker information, making it an ideal means of integrating precision medicine into everyday clinical practice.
The FDA and other regulatory agencies support the creation and application of companion diagnostics. To guarantee safe and efficient use, the approval of companion diagnostics may be required for the prescription medications in question.
Companion diagnostics are not limited to cancer treatments. They're extending to other therapeutic areas like infectious diseases, cardiovascular conditions, and neurological disorders, broadening the potential market for related diagnostic tools.
High Cost of Both Equipment and Reagents
Modern molecular diagnostic tools and supplies can be costly; thus, it might be difficult for labs to make the most technological investments without going over budget. Large molecular diagnostic equipment purchases can be expensive up front, which discourages smaller labs or establishments with tighter finances from acquiring this technology. The establishment expenses of specialist facilities and infrastructure also contribute to the financial strain.
Molecular diagnostics reagents, including enzymes, PCR kits, and DNA probes, can be expensive. It is expensive for laboratories to regularly restock these consumables since it adds to continuing operating costs, particularly in environments with limited resources.
The equipment requires additional costs for upkeep and servicing after the initial purchase. Upgrades, maintenance, and calibration raise the total cost of ownership even more.
Skilful Workforce Training
Operating molecular diagnostic equipment frequently involves specific knowledge and abilities in molecular biology, genetics, biochemistry, and related subjects. Qualified workers may be required to operate and maintain these advanced instruments effectively.
Training people to use molecular diagnostic equipment and interpret results necessitates the purchase of training programs, workshops, and educational resources. High training expenses might be prohibitively expensive, especially for smaller healthcare organizations or laboratories with restricted finances.
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Increasing Government Support, and Favorable Regulations
In the past, real-time PCR (RT PCR) was thought to be a largely specialized technology used by a small number of labs nationwide. COVID-19 placed pressure on the diagnostics industry to rapidly grow to the point where over 3000 testing laboratories in India alone perform molecular testing. The prevalence of RT PCR, viral amplification, and genome sequencing is about to revolutionize the field of molecular diagnosis.
The legislative stances of the US, and the EU regarding laboratory-developed tests (LDTs) and in-house tests differ, offering molecular diagnostic companies a rare chance to take advantage of this difference and drive innovation in both markets. The secret is to carefully craft molecular diagnostic products so that they comply with local laws and regulations.
Businesses can highlight FDA-compliant testing for the US market to demonstrate their compliance with strict regulations. In the EU, they can also present themselves as collaborators that support improved internal testing capacities by providing additional and creative molecular diagnostic solutions. By using this tactical strategy, businesses may take advantage of the different regulatory frameworks in each area, maximizing their market share and product offers.
Which Product Types are Expected to be at the Forefront of Adoption?
Reagents likely to be the Primary Product Category as Demand for Diagnostic Testing Soars
Reagents are the primary components utilized in molecular diagnostic testing methods. These include extraction of DNA and RNA, amplification, tagging, purification, and detection. Reagents such as DNA polymerases, primers, nucleotides, and buffers, for example, are required for DNA amplification in Polymerase Chain Reaction (PCR) testing.
Reagents of high quality are critical for assuring the precision and accuracy of molecular diagnostic procedures. They add to the reliability of test results by reducing false positives and negatives.
Which Category is Most Focused in Molecular Diagnostics by Disease Area?
Infectious Diseases Account for the Largest Market Share Owing to Point-of-Care Testing
The focus on disease areas in molecular diagnostics can evolve based on scientific advancements, emerging health threats, and the availability of new technologies. The rapid and precise identification of infectious agents, including bacteria, viruses, fungi, and parasites, is made possible by molecular diagnostics.
In contrast to conventional culture-based procedures, techniques such as PCR (Polymerase Chain Reaction), and nucleic acid amplification tests (NAATs) enable the detection of specific genetic material of diseases, aiding faster diagnosis. By identifying genetic markers linked to drug resistance in infectious organisms, molecular diagnostics aids in the monitoring of antimicrobial resistance. This helps medical professionals prescribe suitable and efficient therapies, which help fight antibiotic resistance.
Which is the Leading End User Segment?
Hospitals Continue to Take the Lead on the Back of Advanced Treatment Facilities, and Specialized Expertise
Molecular diagnostics is widely used in hospitals and clinics for illness monitoring, screening, and detection. To find genetic mutations, infectious agents, and biomarkers linked to a range of illnesses, including cancer, infectious diseases, genetic abnormalities, and more, these institutions rely on molecular testing.
Molecular diagnostics provide comprehensive genetic information on a patient's diseases, which helps with tailored medicine. This increases the effectiveness of treatments and lowers side effects by enabling doctors to customize treatment regimens based on each patient's unique genetic profile.
North America Continues to Leverage the Early Mover’s Advantage
The accuracy, efficiency, and speed of molecular diagnostic tests have been improved by ongoing advancements in technologies like digital PCR, microarrays, polymerase chain reaction (PGR), and next-generation sequencing (NGS). North America, a center of technical innovation, adopts these developments quickly.
Accurate and early diagnostic methods are becoming more and more necessary in North America due to the rising occurrence of chronic diseases such as cancer, cardiovascular disorders, diabetes, and genetic abnormalities. Precise illness detection made possible by molecular diagnostics allows for early intervention and individualized treatment plans.
Asia Pacific's Mounting Healthcare Needs Complement Market Expansion
The Asia Pacific area is home to a sizable and diverse population, and several of its nations have high rates of chronic illnesses like diabetes and cancer as well as infectious diseases like hepatitis and tuberculosis. Because of this, there is a need for sophisticated molecular diagnostics for the early diagnosis, observation, and treatment of many illnesses.
In the Asia-Pacific region, there is a growing need for point-of-care molecular diagnostics, particularly in isolated or underdeveloped locations. Producers that can offer lightweight, easily navigable diagnostic instruments would be able to meet the wide range of healthcare requirements in the area.
The COVID-19 pandemic, along with other infectious disease outbreaks, has underscored the crucial role played by molecular diagnostics in the early and precise diagnosis of illnesses. This heightened awareness of the significance of molecular diagnostics has resulted in a substantial expansion of the market. Molecular diagnostics, originally associated primarily with clinical diagnostics, has broadened its scope to include applications in genomics, pharmacogenomics, and biomarker discovery.
Moreover, molecular diagnostics has contributed substantially to biomarker discovery, identifying specific molecules indicative of various diseases. This has implications for early disease detection, monitoring treatment efficacy, and predicting patient outcomes. The report suggests that the increased recognition of the benefits of molecular diagnostics has led to its wider integration into healthcare systems. Hospitals, clinics, and laboratories are increasingly incorporating molecular diagnostic technologies into routine patient care, further driving market demand.
Supply-side Dynamics
As a result of continuous research, technology developments, and the potential to improve patient outcomes, allow early interventions, and increase diagnostic accuracy, there is an increasing trend toward the development and refinement of liquid biopsy procedures. As these methods advance, they have the potential to completely change the way that illness management is thought of and solidify molecular diagnostics as a mainstay of contemporary healthcare.
Liquid biopsy is important because it can give dynamic, real-time information regarding the molecular changes and genetic composition of the tumor. This makes it possible to track the progression or recurrence of disease, identify possible medication resistance, assess therapy response, and spot malignancies early. When it is difficult or impracticable to acquire tissue biopsies, liquid biopsy procedures are especially helpful.
Research on liquid biopsy is also significant in the treatment of glioblastoma (GB), a tumor of the central nervous system that is particularly aggressive and has a dismal prognosis. O6-methylguanine-DNA methyltransferase (MGMT) methylation (mMGMT), which is linked to a better response to treatment and a longer survival time, is the only validated predictive and prognostic biomarker for GB. However thus far, the methods of mMGMT status monitoring that have been used have not been sufficient. Via liquid biopsy, small extracellular vesicles, or sEVs, have the power to revolutionize clinical diagnosis.
Prominent organizations, including Roche Diagnostics, Abbott Laboratories, Siemens Healthineers, Thermo Fisher Scientific, and bioMérieux are at the vanguard of this sector, each having a significant market presence due to their diverse product portfolios and established brand recognition.
In the rapidly evolving field of molecular diagnostics, competitive intelligence is integral to shaping effective business strategies. Understanding the market landscape, including competitor offerings, technological advancements, and regulatory dynamics, is crucial for companies operating in this space. Businesses need to continuously assess the competitive environment to identify emerging trends and potential disruptions, ensuring they stay ahead of market shifts.
A comprehensive analysis of competitor strengths and weaknesses, coupled with insights into customer needs, allows companies to refine their product development and marketing strategies. Strategic collaborations and partnerships with key players in the industry can provide access to complementary technologies and expanded market reach.
Partnership
July 2023, llumina Inc. and Pillar Biosciences Inc., the pioneers of Decision Medicine™, announced a strategic partnership to make Pillar's suite of oncology assays commercially available globally as part of the Illumina portfolio of oncology products.
FDA Approval
October 2023, Roche announced the US Food and Drug Administration (FDA) approved the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody to identify metastatic breast cancer patients with low HER2 expression.
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Details |
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Forecast Period |
2024 to 2031 |
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Historical Data Available for |
2019 to 2023 |
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Market Analysis |
US$ Million for Value |
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Key Regions Covered |
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Key Countries Covered |
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Key Market Segments Covered |
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Key Companies Profiled |
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Report Coverage |
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Customization & Pricing |
Available upon request |
By Product Type:
By Disease Area:
By End-use:
By Region:
The market is anticipated to grow at a CAGR of 6.2% during the projected period.
The global molecular diagnostics market size was around US$23.2 billion in 2023.
The US held the largest market share in 2023.
Some of the prominent players in the market are F. Hoffmann la Roche, Thermo Fisher Scientific Inc., Abbott Laboratories, and Siemens Healthineers.
The reagents segment is expected to grow at the fastest CAGR during the forecast period.
