Molecular Diagnostics Market Analysis Asia, Europe, North America, Rest of World (ROW) - China, US, Germany, Japan, France - Size and Forecast 2024-2028

Molecular Diagnostics Market Size 2024-2028 

The molecular diagnostics market size is forecast to increase by USD 7.92 billion, at a CAGR of 5.84% between 2023 and 2028. The growth of the industry relies on factors such as the increasing prevalence of age-related diseases, global acceptance of innovative treatment options, and high demand from emerging markets. This field involves examining DNA, RNA, and other molecules to identify disorders, infectious diseases, and cancer. Moreover, molecular diagnostics play a role in identifying, assessing, and monitoring conditions like age-related illnesses and cancer by providing personalized insights into an individual's genetic predispositions, symptoms, disease progression, and response to treatment methods. Molecular diagnostics and synthetic biology are increasingly intersecting, as advances in synthetic biology enhance the precision and efficiency of molecular diagnostics techniques, leading to more accurate disease detection and personalized treatment options. The market has experienced expansion due to advancements and the rising interest, in personalized healthcare. This market research and growth report also includes a review of the drivers, trends, and challenges influencing the industry landscape.

What will be the Size of the Market During the Forecast Period?

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Market Dynamics and Customer Landscape

The market is growing exponentially, driven by the technical advancements in precision pathology testing and the field of laboratory technology. This area is concerned with genetic analysis, allowing clinicians and researchers to identify various diseases with accuracy. Molecular diagnostics technique uses DNA and RNA samples for biomarker identification, sequencing, or clinical testing to match the disease. The market's growth is fuelled by the constant innovation that the genomics and new molecular technique sectors face. They are an essential part of modern healthcare, as they provide a greater level of accuracy and disease mechanism insight. As the need for accurate diagnostic spreads, the industry will continue to be at the forefront of medical innovation and diagnosis practices.

Key Market Driver

The increased prevalence of age-related diseases is the key driver for the testing market. The increasing elderly population has had a notable influence on demand. Conditions associated with aging, such as cardiovascular diseases, cancer, neurodegenerative disorders, and chronic ailments like diabetes, are perceived to be more prevalent among older individuals.

Moreover, molecular diagnostics play a vital role in the timely detection, diagnosis, and monitoring of diseases. By offering personalized insights into an individual's genetic makeup, symptoms, disease progression, and treatment response, they enhance precision in healthcare. As the population continues to rise, the importance of disease prevention and early intervention grows. Molecular diagnostics enable the identification of genetic predispositions to specific conditions, facilitating targeted screening and preventive actions. These factors contribute to the expected growth of the market during the forecast period, as they address the increasing demand for advanced testing, analysis, and clinical management in healthcare settings.

Significant Market Trends

The primary trend driving global market growth is the adoption of next-generation sequencing (NGS) technologies. These innovations have transformed molecular diagnostics by enabling in-depth analysis of genetic data. NGS facilitates comprehensive genetic profiling, allowing for the analysis of multiple genes or entire genomes, aiding in disease diagnosis, symptom understanding, and treatment selection. It has become an indispensable tool in genomics research and drug development, empowering healthcare facilities and researchers to make informed decisions. Companies like Grifols are leveraging NGS advancements to strengthen their foothold in the diagnostics market through strategic pricing, product development, and launches. The rise in NGS adoption is fueled by its flexibility, advances in mass spectrometry, and the commercialization of diagnostic solutions.

Moreover, NGS is used to study the genetic basis of diseases, such as identify potential therapeutic targets, and discover novel biomarkers. The integration of NGS in these areas has shown a rise in the demand for molecular diagnostics. NGS technology has enlarged the test menu, improved diagnostic accuracy, facilitated personalized medicine, supported research and drug development, and reduced costs. These factors have collectively contributed to the increased demand in clinical practice and research settings, which in turn will propel the growth of the global market in focus during the forecast period.

Major Market Challenge

Insufficient medical reimbursements pose a significant challenge to global market growth. Given the high cost of modern diagnostic products, adequate reimbursement is essential. Limited reimbursements adversely affect the utilization of these advanced devices. For example, in the United States, the Centers for Medicare and Medicaid Services only provide reimbursements for select diagnostic test kit products. This scenario impacts end users across various regions, including Spain, Italy, and Latin America, where cases of diseases like prostate cancer, lung cancer, and genetic disorders necessitate advanced genetic testing and diagnostic solutions. Despite developments in molecular diagnostics and the incidence of pathogens, inadequate reimbursements continue to dominate the healthcare landscape, hindering optimal utilization of diagnostic technologies.

Moreover, many private and government centers provide reimbursement facilities in the US and a few parts of Europe. for secure reimbursements process and funding for diagnostic tests, is difficult owing to the process since stakeholders must recognize the knowledge necessary by payers and purchasers through research. Factors such as high healthcare costs and increased demand for treatment care are affecting the reimbursement structures in the US and European countries. The lack of reimbursements for expensive diagnostic procedures and molecular diagnostic methods, this aspect may limit the market's expansion during the forecast period.

Exclusive Customer Landscape

The market forecasting report includes the adoption lifecycle of the market, covering from the innovator's stage to the laggard's stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth analysis strategies.

 Customer Landscape

Key Companies & Market Insights

Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market.

Abbott Laboratories: The company provides molecular diagnostics tests tailored for COVID-19, featuring automated, high-throughput systems designed to accommodate various laboratory requirements.

The market research and growth report also includes detailed analyses of the competitive landscape of the market and information about key companies, including:

• Agilent Technologies Inc.
• Becton Dickinson and Co.
• Bio Rad Laboratories Inc.
• Biocartis NV
• BioMerieux SA
• Danaher Corp.
• ELITechGroup SAS
• F. Hoffmann La Roche Ltd.
• Genome Diagnostics Pvt. Ltd.
• Hologic Inc.
• Illumina Inc.
• QIAGEN NV
• Siemens Healthineers AG
• Solone Life Sciences India Pvt. Ltd.
• Spectrum Diagnostics and Health Care
• Sysmex Corp.
• Thermo Fisher Scientific Inc.
• U Gen Biotechnology Inc.
• Xiamen Zeesan Biotech Co. Ltd.

Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.

Market Segmentation

By Product

During the projected period, the instruments segment is expected to witness significant global market share growth. Over the last five years, molecular diagnostic instruments have experienced notable advancements. These improvements encompass the enhancement of nucleic acid amplification techniques, such as polymerase chain reaction (PCR) and isothermal amplification methods, facilitating faster and more accurate testing in laboratory settings. Moreover, the introduction of next-generation sequencing (NGS) platforms has brought about a transformative shift in genomic analysis within the healthcare industry.

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The instruments segment showed a gradual increase in the market share of USD 14.84  billion in 2018. The rising demand for molecular diagnostic instruments is fulfilled by the continuous improvement and accessibility of these technologies. Moreover, molecular diagnostic instruments are essential in research and development efforts across various fields, including genomics, pharmaceuticals, and biotechnology. These innovations play a crucial role in precision diagnosis and research by enabling the detection of genetic biomarkers, sequencing DNA and RNA samples, and facilitating clinical pathology studies. This innovation-driven growth is indicative of the dynamic evolution within the molecular diagnostics market, positioning it as a key player in the healthcare industry's ongoing pursuit of improved diagnostic capabilities and patient care. The demand for molecular diagnostic instruments is driven by ongoing research and development activities which will positively impact the growth of the global market during the forecast period.

By Region

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Asia is estimated to contribute 38% to the growth of the global market during the forecast period. Technavio's analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period. These innovations play a crucial role in precision diagnosis and research by enabling the detection of genetic biomarkers, sequencing DNA and RNA samples, and facilitating clinical pathology studies. This innovation-driven growth is indicative of the dynamic evolution within the molecular diagnostics market, positioning it as a key player in the healthcare industry's ongoing pursuit of improved diagnostic capabilities and patient care.

Segment Overview

The market research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD Billion " for the period 2024-2028, as well as historical data from 2018 - 2022 for the following segments.

• Product Outlook
  • Instruments
  • Reagents
  • Kits

• Application Outlook
  • Infectious disease
  • Oncology
  • Blood screening
  • Microbiology
  • Others

• Region Outlook
  • North America
    • The U.S.
    • Canada
  • Europe
    • U.K.
    • Germany
    • France
    • Rest of Europe
  • Asia
    • China
    • India
  • Rest of World (ROW)
    • Australia
    • Argentina
    • Brazil

Market Analyst Overview

The market is experiencing strong growth, increased by technological advancements in Polymerase Chain Reaction (PCR), DNA sequencing, and Microarray technologies. These innovations are instrumental in early diagnosis and monitoring of prevalent diseases such as cancer, cardiovascular diseases, and diabetes. Biological markers, including genetic and protein markers, are increasingly used for accurate disease detection and personalized treatment. The infectious diseases segment has garnered significant attention, with initiatives targeting conditions like Coronavirus, Sexually Transmitted Infections (STIs), and vaccinations receiving substantial funding. As the geriatric population grows, along with the prevalence of chronic diseases and obesity, there's a rising demand for diagnostic kits and alternative methods that offer cost-effective solutions. Funding in research and development activities, supported by organizations like the National Institutes of Health, is driving further advancements. From resource-limited settings to well-established healthcare infrastructures, the adoption of molecular diagnostics is gaining traction, enhancing patient management, treatment outcomes, and overall healthcare quality.

Further, the industry is experiencing significant growth driven by advancements in the diagnostics industry and increasing awareness among patients. With innovation in molecular testing and assays, hospitals and healthcare facilities are adopting point-of-care (POC) solutions for faster results. Product development and commercialization efforts by diagnostics companies like Grifols are expanding the molecular diagnostics markets globally. In regions like Spain, Italy, and Latin America, the incidence of diseases like prostate cancer, lung cancer, and obesity is driving the demand for genetic testing and pathogens detection. Mass spectrometry and emergency use authorization for assays are further fuelling market growth.

Moreover, in the field of molecular biology and medical testing, genome and proteome serve as crucial biological markers for understanding diseases and assessing risks. Techniques such as DNA sequencing and fluorescence in situ hybridization allow personalized medicine customized to individual patients. Oncology heavily relies on these markers to diagnose cancers like breast cancer, lung cancer, and melanoma. Advanced technologies like next-generation sequencing and high-throughput protein arrays have transformed clinical diagnostics, pinpointing genetic variations and driver mutations. Bigger players in molecular diagnostic lead in cancer research with tests such as BRCA1/2 and Qiagen therascreen. Prenatal genetic tests can identify conditions like thalassemia in fetuses, guiding treatments. In agricultural biosecurity, molecular diagnotic methods detect crop and livestock diseases, while clinical labs use cutting-edge equipment for accurate analyses. Innovations in pharmacogenomics and RNA expression levels promise more targeted therapies.

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What are the Key Data Covered in this Market Report?

• CAGR of the market during the forecast period
• Detailed information on factors that will drive the market growth and forecasting between 2024 and 2028
• Precise estimation of the size of the market  and its contribution of the market in focus to the parent market
• Accurate predictions about upcoming market growth and trends and changes in consumer behavior
• Growth of the market across Asia, Europe, North America, and Rest of World (ROW)
• Thorough analysis of the market's competitive landscape and detailed information about companies
• Comprehensive analysis of factors that will challenge the growth of market companies