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  • Published In : Mar 2024
  • Code : CMI6749
  • Pages :166
  • Formats :
      Excel and PDF
  • Industry : Medical Devices

Market Size and Trends

The precision diagnostics market is estimated to be valued at USD 84.54 Bn in 2024 and is expected to reach USD 196.45 Bn by 2031, growing at a compound annual growth rate (CAGR) of 12.8% from 2024 to 2031.

Precision Diagnostics Market Key Factors

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The precision diagnostics market is expected to witness significant growth over the forecast period. Key factors, such as rising focus on personalized medicine, growing applications of companion diagnostics, and technological advancements in molecular diagnostics, are expected to drive the demand for precision diagnostics tools. With the adoption of advanced technologies like next-generation sequencing (NGS), the pipeline for companion diagnostics is expected to strengthen over the coming years. Several market players are making investments to develop innovative diagnostic tests, which is further expected to support the market expansion. The development of rapid diagnostic tests for infectious diseases and the increasing adoption of point-of-care testing are likely to create new opportunities for precision diagnostics manufacturers during the forecast period.

Technological advancement

The precision diagnostics market is being driven significantly by the rapid advancements happening in technologies being used for diagnostics. New and innovative diagnostic tools that leverage cutting edge technologies are allowing for much more accurate diagnosis of diseases. Technologies, such as next generation sequencing, laboratory automation, machine learning, and artificial intelligence, are enabling precision diagnostics to reach new levels. Next generation sequencing has revolutionized genetic testing and enabled the diagnosis of various inherited disorders, cancers, and infections that were not possible to detect earlier with traditional methods. For instance, in May 2020, Paragon Genomics, a precision medicine company based in the U.S., announced a partnership with Saphetor, a Switzerland-based precision medicine company. Paragon Genomics' ready-to-use and custom NGS panel solutions have enabled several lab-developed tests (LDTs) in infectious illnesses, oncology, reproductive health, cardiology, and genetic diseases across the globe.

Market Concentration and Competitive Landscape

Precision Diagnostics Market Concentration By Players

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Development of companion diagnostics

Another major factor bolstering growth in the precision diagnostics market is the increasing integration of companion diagnostics with targeted therapies. Companion diagnostics are in vitro diagnostic tests or imaging tools that provide critical information for the safe and effective use of corresponding therapies or drugs. They help identify patients that are most likely (or not likely) to benefit from specific treatments. This allows for more precise selection of treatment options for patients and prevents potential adverse reactions. Regulatory agencies now mandate the development and approval of companion diagnostics along with several new targeted therapies. This is driving significant R&D investments from pharmaceutical companies into precision diagnostics. For instance, most new oncology drugs are now launched along with a corresponding DNA or protein-based companion diagnostic test to identify patients with specific genomic alterations or biomarkers.

Precision Diagnostics Market Key Takeaways From Lead Analyst

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Market Challenges – Stringent government regulations:

The precision diagnostics market faces several challenges. Regulatory hurdles can delay the approval of new tests. The cost of developing and validating advanced diagnostic technologies is very high. There are also data management and analysis challenges involved in handling the huge volumes of data generated from techniques like genomic sequencing. Reimbursement policies sometimes do not adequately cover the cost of new precision diagnostic tests, reducing their uptake. Physician adoption can also be slow as they need extensive education on new technologies and tests.

Market Opportunities – Demand for personalized healthcare:

The growing need for personalized healthcare tailored to individual patient genotypes and disease subtypes is driving demand for precision diagnostics kits. Genomic sequencing and other advanced techniques are enabling new diagnosis and treatment strategies. Demand for non-invasive liquid biopsies using blood or other bodily fluids is increasing rapidly, thus creating lucrative growth opportunities for market growth over the forecasted period.

Precision Diagnostics Market By Product

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Insights, By Product: Technological Advancements are Fueling the Growth of Kits & Assays

The product segment includes kits & assays and consumables, out of which the kits & assays segment is anticipated to register 56.9% of the market share in 2024 owning to ongoing technological advancements in diagnostic kits and assay development. The development of more sensitive and specific kits and assays that can accurately detect diseases at an early stage is a major factor driving their popularity among end users. Technological upgrades enabling the integration of multiple diagnostic assays into a single test kit is also boosting demand. This contributes to higher testing efficiency and diagnostic accuracy while reducing costs. Additionally, ongoing R&D efforts to develop kits and assays for new disease indications are expanding the market coverage of these products. Scientists are constantly working on assays tailored for specific disease biomarkers, population segments, and therapeutic areas which is supporting the market growth.

Insights, By Technology: Growing PCR Applications are Driving the Adoption of Technology

The technology segment includes next-generation sequencing, polymerase chain reaction, mass spectrometry, and others, out of which the polymerase chain reaction is expected to have the highest share, i.e., 33.8% of the market share in 2024. Owing to its diverse applications across specialties, Polymerase chain reaction has become an indispensable technique in research and clinical diagnostics due to its ability to amplify minute quantities of DNA or RNA into detectable levels. PCR plays a vital role in the detection of infectious diseases by identifying pathogens. It is the gold standard technique for the detection of bacterial and viral infections such as HIV, Hepatitis, HPV, SARS-CoV-2, etc. Additionally, PCR finds widespread application in oncology for cancer screening, prognosis, and detection of relapse. For instance, in July 2023, Anbio Biotechnology, a leading developer of novel diagnostic solutions, announced the launch of a full RT-PCR solution for both pharmacogenomics and non-pharmacogenomics applications. Anbio Biotechnology's molecular diagnostic test menu covers a wide range of clinical applications including healthcare-associated infections, critical infectious disease, sexual health, virology, pharmacogenomics, and cancer.

Insights, By Application: Early Detection is Driving the Adoption of Precision Diagnostics

The application segment comprises of accurate diagnosis, personalized treatment, early detection and intervention, and others, out of which the early detection and intervention is projected to have 29.6% of the market share in 2024 owing to benefits of early disease identification. Precision diagnostics aids in early tumor detection by identifying cancer-associated genetic mutations and gene expressions variations, even before structural changes manifest. Early detection enables timely treatment initiation before the disease progresses to later stages, improving clinical outcomes. Furthermore, precision diagnostics plays a critical role in early-stage diagnosis of infectious diseases. It facilitates early pathogen identification which is vital for initiating prompt treatment and controlling disease spread. Companion diagnostics find increased use in early detection of treatment resistance as it helps identify biomarkers for non-responsiveness to drugs.

Regional Insights

Precision Diagnostics Market Regional Insights

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North America remains the dominant region in the global precision diagnostics market. The region is anticipated to account for 43.8% of the market share in 2024 due to a strong presence of leading diagnostics companies and advanced healthcare infrastructure. Major diagnostics players based in the U.S. have established widespread distribution network and sales channels within the country as well as globally. Furthermore, higher healthcare spending and adoption of advanced diagnostics tests are driving the market growth. For instance, in May 2023, HALO Precision Diagnostics, the pioneer in early disease diagnosis using precision diagnostics, announced a partnership with Agamon Health, the leader in Generative AI/NLP-powered automated patient workflow management solutions. HALO Precision Diagnostics is dedicated to saving and improving people's lives through early detection of the primary causes of mortality using precision diagnostics.

Meanwhile, the Asia Pacific region is identified as the fastest growing regional market for precision diagnostics. Rapid economic development, growing medical tourism industry, and rising healthcare expenditure are some key factors propelling the regional market growth. Countries like China, India, Japan, and South Korea have emerged as major importers of diagnostic products owing to their large population base and increasing access to advanced diagnostics services.

Growing incidences of lifestyle diseases and focus on early detection are prompting governments in Asia Pacific to invest more in the preventive healthcare infrastructure. This has led to the establishment of super-specialty hospitals as well as independent diagnostic centers that offer a comprehensive portfolio of precision diagnostics tests. Domestic diagnostics industries have also emerged in several APAC countries including India through the transfer of foreign technologies. They are engaged in manufacturing test kits and reagents at competitive prices.

Market Report Scope

Precision Diagnostics Market Report Coverage

Report Coverage Details
Base Year: 2023 Market Size in 2024: US$ 84.54 Bn
Historical Data for: 2019 To 2023 Forecast Period: 2024 To 2031
Forecast Period 2024 to 2031 CAGR: 12.8% 2031 Value Projection: US$ 196.45 Bn
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East: GCC Countries, Israel, and Rest of Middle East
  • Africa: South Africa, North Africa, and Central Africa
Segments covered:
  • By Product: Kits & Assays and Consumables 
  • By Technology: Next-Generation Sequencing, Polymerase Chain Reaction, Mass Spectrometry, and Others 
  • By Application: Accurate Diagnosis, Personalized Treatment, Early Detection and Intervention, and Others 
  • By Indication: Oncology, Cardiovascular, Immunology, Neurology, Infectious Diseases, and Others
Companies covered:

SomaLogic, Ezra, Egnite, PrecisionLife, HALO Precision Diagnostics, Danaher Corporation, QuidelOrtho Corporation, Precision Diagnostics, Koninklijke Philips N.V., , Swiss Precision Diagnostics GmbH, Precision Diagnostic Laboratory, Abbott, Cepheid, Hologic, Inc. , Precision Medicine Group, LLC. , Thermo Fisher Scientific, and Illumina, Inc. 

Growth Drivers:
  • Technological advancement
  • Development of companion diagnostics 
Restraints & Challenges:
  • Stringent government regulations
  • High cost of developing and validating advanced diagnostic technologies 

Key Developments

  • In November 2023, Roche announced the launch of the LightCycler PRO System, based on the established gold standard technology of previous LightCycler Systems. This innovative technology improves performance and usability while closing the gap between translational research and in vitro diagnostics. The LightCycler PRO System expands Roche's molecular PCR testing portfolio, which includes solutions for a wide range of healthcare professionals, including those conducting research and those testing patients for cancer, infectious diseases, and other public health issues.
  • In June 2023, Diatech Pharmacogenetics, a provider of molecular diagnostic tools, signed a collaborative agreement with Janssen Pharmaceutica NV, a pharmaceutical business, to improve access to precision medicine for patients with bladder cancer. Diatech Pharmacogenetics, one of Europe's leading precision medicine firms, develops and manufactures In Vitro Diagnostic (IVD) oncology tests for a variety of solid tumours and blood cancers.
  • In March 2023, QIAGEN N.V., a multinational provider of sample and assay technologies, announced a strategic partnership with Servier, a global pharmaceutical group, to develop a companion diagnostic test for TIBSOVO, an isocitrate dehydrogenase-1 (IDH1) inhibitor used to treat acute myeloid leukemia (AML). Under the master collaboration agreement, QIAGEN N.V. will create and validate a real-time in vitro PCR test for detecting IDH1 gene alterations in AML patients' whole blood and bone marrow aspirates.
  • In March 2021, Konica Minolta Precision Medicine, Inc. (KMPM), a Konica Minolta Group company, announced a five-year collaboration with Amazon Web Services, Inc. (AWS). As the Preferred Cloud Provider for KMPM, AWS will help the company scale out its LATTICE project globally. LATTICE is a ground-breaking integrated diagnostic data platform that combines genomes, pathology, and radiology data with other important information to identify novel, clinically relevant biomarkers and develop the next generation of diagnostic tests.
  • *Definition:The precision diagnostics market involves diagnostic tests, technologies, and tools that can accurately detect specific medical conditions and provide information to guide more effective, targeted treatments. This emerging market features technologies like next-generation sequencing, companion diagnostics, liquid biopsy tests, and other advanced molecular diagnostic tests that can analyze biomarkers and genomic profiles to precisely diagnose diseases, determine patient prognosis, and customize treatment approaches based on an individual's unique medical profile and genetics. The goal is to transform healthcare by enabling truly personalized, precision medicine approaches.

Market Segmentation

  •  Product Insights (Revenue, USD Bn, 2019 - 2031)
    • Kits & Assays
    • Consumables
  •  Technology Insights (Revenue, USD Bn, 2019 - 2031)
    • Next-Generation Sequencing
    • Polymerase Chain Reaction
    • Mass Spectrometry
    • Others
  •  Application Insights (Revenue, USD Bn, 2019 - 2031)
    • Accurate Diagnosis
    • Personalized Treatment
    • Early Detection and Intervention
    • Others
  •  Indication Insights (Revenue, USD Bn, 2019 - 2031)
    • Oncology
    • Cardiovascular
    • Immunology
    • Neurology
    • Infectious Diseases
    • Others
  • Regional Insights (Revenue, USD Bn, 2019 - 2031)
    • North America
      • U.S.
      • Canada
    • Latin America
      • Brazil
      • Argentina
      • Mexico
      • Rest of Latin America
    • Europe
      • Germany
      • U.K.
      • Spain
      • France
      • Italy
      • Russia
      • Rest of Europe
    • Asia Pacific
      • China
      • India
      • Japan
      • Australia
      • South Korea
      • ASEAN
      • Rest of Asia Pacific
    • Middle East
      • GCC Countries
      • Israel
      • Rest of Middle East
    • Africa
      • South Africa
      • North Africa
      • Central Africa
  • Key Players Insights
    • SomaLogic 
    • Ezra 
    • Egnite 
    • PrecisionLife
    • HALO Precision Diagnostics
    • Danaher Corporation
    • QuidelOrtho Corporation
    • Precision Diagnostics
    • Koninklijke Philips N.V., 
    • Swiss Precision Diagnostics GmbH
    • Precision Diagnostic Laboratory
    • Abbott
    • Cepheid
    • Hologic, Inc. 
    • Precision Medicine Group, LLC. 
    • Thermo Fisher Scientific
    • Illumina, Inc. 

Frequently Asked Questions

The CAGR of the precision diagnostics market is projected to be 12.8% from 2024 to 2031.

Technological advancements and development of companion diagnostics are the major factors driving the growth of the precision diagnostics market.

Stringent government regulations and high cost of developing and validating advanced diagnostic technologies are the major factor hampering the growth of the precision diagnostics market.

In terms of product, kits & assays is estimated to dominate the market revenue share in 2024.

SomaLogic, Ezra, Egnite, PrecisionLife, HALO Precision Diagnostics, Danaher Corporation, QuidelOrtho Corporation, Precision Diagnostics, Koninklijke Philips N.V., , Swiss Precision Diagnostics GmbH, Precision Diagnostic Laboratory, Abbott, Cepheid, Hologic, Inc. , Precision Medicine Group, LLC. , Thermo Fisher Scientific, and Illumina, Inc. are the major players operating in the market.

North America is expected to lead the precision diagnostics market.

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