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Part of: Companion Diagnostics Market (Global)

The Australia Companion Diagnostics Market was valued at $79.6 Million in 2026 and projected to reach to $116.7 Million by 2031, representing a compound annual growth rate of 13.2%. Australia's companion diagnostics market is poised for sustained growth through 2031, driven by increasing healthcare expenditure, rising prevalence of chronic diseases, and growing adoption of precision medicine approaches.

Australia Companion Diagnostics Market (2026-2031) : Size and Share
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Market Size in USD 26.32 MN
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Australia Companion Diagnostics Market Trends and Insights

  • This 13.2% compound annual growth rate reflects Australia's advancing healthcare infrastructure and increasing adoption of precision medicine across the region.
  • Australia is positioning itself as a key market within Asia Pacific, driven by rising demand for targeted therapies and personalized treatment approaches. The expansion of Australia's companion diagnostics sector is underpinned by growing investment in genomic testing capabilities and strengthened regulatory frameworks supporting diagnostic innovation.
  • Australia's healthcare system increasingly recognizes the clinical and economic value of companion diagnostics in optimizing patient outcomes and reducing treatment costs.
  • Between 2026 and 2031, Australia is expected to see accelerated market penetration as pharmaceutical companies expand their diagnostic partnerships and healthcare providers integrate companion testing into standard care protocols. Australia's market dynamics reflect broader Asia Pacific trends while maintaining distinct regulatory and reimbursement characteristics.
  • The country's commitment to evidence-based medicine and strong pharmaceutical sector presence position Australia as an attractive market for companion diagnostic developers and manufacturers seeking regional expansion opportunities..

Key Market Statistics

  • CAGR (2026-2031) 13.2% CAGR
  • Market Size, 2026 ~USD 79.6 Million
  • Forecast, 2031 ~USD 116.7 Million
  • Country Australia

Australia Companion Diagnostics Market Overview

Market Valuation Growth :

Australia's companion diagnostics market is valued at $79.6 million in 2026 and is projected to reach $116.7 million by 2031, representing a robust 13.2% CAGR that outpaces the global average of 12.9%.

Precision Medicine Adoption :

Australian healthcare providers are increasingly integrating companion diagnostics into clinical practice, driven by growing demand for personalized treatment approaches and improved patient outcomes across oncology and other therapeutic areas.

Healthcare Infrastructure Advancement :

Australia's well-developed healthcare system, strong regulatory framework, and investment in diagnostic technologies create a favorable environment for companion diagnostics market expansion and innovation.

Asia Pacific Leadership Position :

Australia is establishing itself as a key market leader within the Asia Pacific region, leveraging its advanced healthcare capabilities and serving as a hub for precision medicine adoption across the broader region.

Australia Companion Diagnostics Market Dynamics

  • The market's 13.2% CAGR reflects strong demand from hospitals, diagnostic laboratories, and oncology centers seeking to implement targeted treatment strategies. Key growth drivers include expanding pharmaceutical partnerships, regulatory support for companion diagnostic development, and heightened awareness among healthcare professionals and patients about personalized medicine benefits.
  • Australia's mature healthcare infrastructure and strong reimbursement landscape position the country as an attractive market for diagnostic innovators and pharmaceutical companies seeking to commercialize companion diagnostic solutions..

Related Ecosystem

In Vitro Diagnostics

Top Technologies
  • Polymerase Chain Reaction (PCR)
  • Enzyme-Linked Immunosorbent Assay (ELISA)
  • Dna Microarrays
  • Assay Kits
  • Microarrays
Top Companies
  • ROCHE HOLDINGS AG
  • Thermo Fisher Scientific Inc.
  • Danaher Corporation
  • Abbott Laboratories
  • Biomerieux s.a.

    Medical Devices

    Top Technologies
    • Polymerase Chain Reaction (PCR)
    • Magnetic Resonance Imaging (MRI)
    • Disposable Autoinjectors
    • Pulse Oximeters
    • Blood Pressure Monitors
    Top Companies
    • Medtronic plc
    • Abbott Laboratories
    • Stryker Corporation
    • Becton, Dickinson and Company
    • JOHNSON & JOHNSON

      Key Takeaways

      • Australia's companion diagnostics market is valued at $79.6 million in 2026 and is forecast to reach $116.7 million by 2031, representing a 13.2% CAGR.
      • Australia's healthcare system is increasingly integrating precision medicine and genomic testing into standard clinical practice, driving companion diagnostic adoption.
      • Strong regulatory frameworks and reimbursement policies in Australia support the commercialization and uptake of companion diagnostic solutions.
      • Australia represents a strategic growth opportunity within Asia Pacific for diagnostic developers seeking to expand their regional market presence.

      Companion Diagnostics Market Report Scope

      Report Metric Details
      Base Year 2026
      Fastest Growing Segment NEXT-GENERATION SEQUENCING (Technology)
      Forecast Period 2026–2031
      Growth Rate CAGR of 12.9% from 2026 to 2031
      Largest Segment CANCER (Indication)
      Market Size Base Year (Billions) ~USD 6.31 (2026)
      Revenue Forecast (Billions) ~USD 11.57 (2031)
      Segments Covered Product & Service, Technology, Indication, Type, Sample Type, End User

      Australia Companion Diagnostics Market Report Segmentation

      6 segment dimensions are covered across the global market.

      By Product & Service

      • Assays, Kits, And Reagents
      • Instruments & Systems
      • Software & Services

      By Technology

      • Immunohistochemistry
      • In Situ Hybridization
      • Next-Generation Sequencing
      • Other Technologies
      • Polymerase Chain Reaction

      By Indication

      • Cancer
      • Cardiovascular Diseases
      • Infectious Diseases
      • Neurological Diseases
      • Other Indications

      By Type

      • Blood Cancer
      • Breast Cancer
      • Colorectal Cancer
      • Lung Cancer
      • Other Cancer Types
      • Other Cancers

      By Sample Type

      • Blood Samples
      • Other Sample Types
      • Tissue Samples

      By End User

      • Contract Research Organizations
      • Other End Users
      • Pharmaceutical & Biopharmaceutical Companies
      • Pharmaceutical & Biotechnology Companies
      • Reference Laboratories

      Target Audience

      • Pharmaceutical Companies : Develop companion diagnostic strategies aligned with drug development pipelines and identify Australian market opportunities for co-commercialization with diagnostic partners.
      • Diagnostic Test Manufacturers : Understand Australian market demand, regulatory requirements, and reimbursement pathways to guide product development, launch strategies, and market expansion decisions.
      • Healthcare Providers & Pathology Labs : Evaluate market trends, emerging diagnostic technologies, and clinical adoption patterns to optimize service offerings and investment in companion diagnostic capabilities.
      • Investment & Private Equity Firms : Assess market growth potential, competitive dynamics, and investment opportunities in Australia's high-growth companion diagnostics sector for portfolio companies and acquisitions.
      • Healthcare Consultants & Advisors : Access Australia-specific market data and insights to support client strategy development, market entry planning, and competitive positioning in the companion diagnostics space.

      Key Companies in the Australia Companion Diagnostics Market

      CompanyHQOwnershipStrongest segments
      CLARITY PHARMACEUTICALSAustraliaPublic CompanySAR-bisPSMA theranostic platform,SAR-Bombesin pan-cancer theranostics,SARTATE (SSTR2-targeted theranostics),
      FOUNDATION MEDICINEUnited StatesPrivate CompanyFoundationOne CDx (tissue-based solid tumor CGP),FoundationOne Liquid CDx (blood-based solid tumor CGP),Hematologic malignancy / sarcoma / other LDTs,
      GEUnited StatesPublic CompanyCommercial Engines & Services,Defense & Propulsion Technologies,
      GENOMIC HEALTH INCUnited StatesPrivate CompanyOncotype DX Breast Recurrence Score and related breast assays,Oncotype DX Colon and prostate cancer assays,Other genomic and emerging epigenomic decision-support services,
      MEDICAL & BIOLOGICAL LABORATORIES CO.JapanPrivate CompanyAllergy in vitro diagnostics,Autoimmune and skin disease diagnostics,COVID-19 and respiratory diagnostics,
      ROSETTA GENOMICSIsraelPublic CompanymicroRNA-based oncology tests (RosettaGX Cancer Origin, mi-KIDNEY, RosettaGX Reveal, mi-LUNG),FISH-based assays (UroVysion, ERG/PTEN, ALK/ROS1),PCR gene mutation analysis (bladder, lung, colon, melanoma),
      TOSOH CORPORATIONJapanPublic CompanyBasic chemicals and chlor-alkali (caustic soda, sodium bicarbonate, related),Vinyls and petrochemicals (VCM, ethylene, propylene, aromatics, EDC),Polymers and synthetic rubbers (EVA, PE, functional polymers, PVC pastes),
      DIASORINItalyPublic CompanyImmunodiagnostics (LIAISON XL / LIAISON XS),Molecular diagnostics (Simplexa, LIAISON PLEX assays),xMAP technology and other IVD solutions,
      GE HEALTHCAREUnited StatesPublic CompanyImaging,Advanced Visualization Solutions (AVS),Patient Care Solutions (PCS),
      AGILENT TECHNOLOGIES, INC.United StatesPublic CompanyLife Sciences and Diagnostics Markets,Agilent CrossLab,Applied Markets,
      QIAGENNetherlandsPublic CompanySample technology consumables and instruments,Immune response and infectious disease diagnostics,Oncology and sexual & reproductive health assays,
      THERMO FISHER SCIENTIFIC INC.United StatesPublic CompanyLife Sciences Solutions,Analytical Instruments,Specialty Diagnostics,
      ABBOTTUnited StatesPublic CompanyDiagnostic Products (lab, transfusion, molecular, point-of-care, rapid tests),Medical Devices (cardiovascular, diabetes care, neuromodulation, vascular, structural heart),Nutritional Products (pediatric, adult, infant formula),
      DANAHERUnited StatesPublic CompanyBiotechnology (Bioprocessing & Single-Use),Life Sciences Tools & Genomics,Diagnostics,
      GUARDANT HEALTHUnited StatesPublic CompanyGuardant360 portfolio (CDx, Liquid, Tissue),Shield colorectal cancer screening,Minimal residual disease and recurrence (Guardant Reveal),
      ILLUMINA, INC.United StatesPublic CompanySequencing instruments,Sequencing consumables (reagents, flow cells, library prep),Array-based instruments and consumables,
      BIOMéRIEUXFrancePublic CompanyBIOFIRE & SPOTFIRE multiplex/lowplex PCR,VITEK (2, MS, REVEAL) ID/AST systems,BACT/ALERT VIRTUO & blood culture,
      ICON PLCIrelandPublic CompanyFull-service clinical development (Phase I–IV, peri/post-approval),Functional service partnerships & contract staffing,Laboratory, bioanalytical, biomarker, and vaccine testing,
      MYRIAD GENETICS, INC.United StatesPublic CompanyHereditary and oncology diagnostics (MyRisk, BRACAnalysis CDx, MyChoice CDx, Prolaris, EndoPredict, Precise Tumor),Women’s health and reproductive genetics (Prequel, Foresight, SneakPeek, FirstGene),Pharmacogenomics and mental health (GeneSight Psychotropic),
      SYSMEX CORPORATIONJapanPublic CompanyHematology analyzers and reagents (XN-Series, XN-V, ProCyte Dx and related),Coagulation diagnostics,Blood gas, electrolyte, and urinalysis systems,
      ABNOVA CORPORATIONTaiwanPublic CompanyAntibodies (mono/polyclonal, recombinant, circulating rare cell),Proteins/Peptides, Lysates/Slides, Beads/Dyes, Ab Arrays,Medical Diagnostic Instruments, Systems, and Automation,

      CLARITY PHARMACEUTICALS

      Clarity Pharmaceuticals is an Australian public company founded in 2010 that employs 88 people. The company operates in the pharmaceutical sector.

      FOUNDATION MEDICINE

      Foundation Medicine is a United States-based private company established in 2009 with 662 employees. The company operates in the pharmaceutical and biotechnology industry.

      GE

      GE is a United States public company founded in 1892 with 57,000 employees. The company is a diversified conglomerate operating across multiple industrial sectors.

      GENOMIC HEALTH INC

      Genomic Health Inc. is a United States-based private company founded in 2000 with 829 employees. The company operates in the genomics and biotechnology sector.

      MEDICAL & BIOLOGICAL LABORATORIES CO.

      Medical & Biological Laboratories Co. is a Japan-based private company founded in 1969 with 408 employees. The company operates in the medical and biological laboratory sector.

      ROSETTA GENOMICS

      Rosetta Genomics is an Israel-based public company established in 2000 with 86 employees. The company operates in the genomics and molecular diagnostics sector.

      TOSOH CORPORATION

      Tosoh Corporation is a Japan-based public company founded in 1935 with 14,850 employees. The company operates across multiple sectors including chemicals, pharmaceuticals, and diagnostics.

      DIASORIN

      DiaSorin is an Italy-based public company founded in 1968 with 3,242 employees. The company operates in the in vitro diagnostics sector.

      GE HEALTHCARE

      GE Healthcare is a United States-based public company founded in 2022 with 54,000 employees. The company operates in the healthcare technology and diagnostics industry.

      AGILENT TECHNOLOGIES, INC.

      Agilent Technologies, Inc. is a United States-based public company founded in 1999 with 18,000 employees. The company operates in life sciences, diagnostics, and applied chemical markets.

      QIAGEN

      QIAGEN is a Netherlands-based public company founded in 1984 with 5,500 employees. The company operates in molecular diagnostics and life sciences research.

      THERMO FISHER SCIENTIFIC INC.

      Thermo Fisher Scientific Inc. is a United States-based public company founded in 1956 with 125,000 employees. The company is a global leader in serving science with laboratory equipment, reagents, and software.

      ABBOTT

      Abbott is a United States-based public company founded in 1888 with 115,000 employees. The company operates in diagnostics, medical devices, pharmaceuticals, and nutrition.

      DANAHER

      Danaher is a United States-based public company founded in 1969 with 59,000 employees. The company operates across life sciences, diagnostics, environmental, and applied solutions sectors.

      GUARDANT HEALTH

      Guardant Health is a United States-based public company founded in 2011 with 2,498 employees. The company operates in precision oncology and liquid biopsy diagnostics.

      ILLUMINA, INC.

      Illumina, Inc. is a United States-based public company founded in 1998 with 8,625 employees. The company is a leader in DNA sequencing and genetic analysis technologies.

      BIOMéRIEUX

      bioMérieux is a France-based public company founded in 1963 with 14,894 employees. The company operates in in vitro diagnostics and microbiology testing.

      ICON PLC

      ICON PLC is an Ireland-based public company founded in 1989 with 40,350 employees. The company provides clinical research and development services to the pharmaceutical and biotechnology industries.

      MYRIAD GENETICS, INC.

      Myriad Genetics, Inc. is a United States-based public company founded in 1991 with 2,700 employees. The company operates in molecular diagnostics and personalized medicine.

      SYSMEX CORPORATION

      Sysmex Corporation is a Japan-based public company founded in 1968 with 10,861 employees. The company operates in clinical laboratory diagnostics and life sciences.

      ABNOVA CORPORATION

      Abnova Corporation is a Taiwan-based public company founded in 2002. The company operates in the biotechnology and life sciences research sector.

      Reasons to Buy this Report

      • Market-Specific Growth Projections : Access detailed forecasts showing Australia's companion diagnostics market expanding from $79.6M to $116.7M by 2031, enabling accurate business planning and investment decisions tailored to the Australian market.
      • Competitive Landscape Analysis : Understand key players, market share distribution, and competitive strategies specific to Australia's companion diagnostics sector, helping identify partnership and acquisition opportunities.
      • Regulatory and Reimbursement Insights : Gain comprehensive understanding of Australia's regulatory environment, TGA approval pathways, and Medicare reimbursement policies that directly impact market entry and commercialization strategies.
      • End-User Demand Patterns : Identify specific adoption rates among Australian hospitals, pathology labs, and oncology centers, revealing which diagnostic applications and therapeutic areas show strongest growth potential.
      • Strategic Market Positioning : Leverage Australia-specific insights to develop targeted go-to-market strategies, establish local partnerships, and capitalize on the country's position as Asia Pacific's precision medicine leader.

      Frequently asked questions

      What is the current size of Australia's companion diagnostics market?

      Australia's companion diagnostics market is valued at $79.6 million in 2026 and is expected to grow to $116.7 million by 2031.

      What is the projected growth rate for Australia's companion diagnostics market?

      Australia's companion diagnostics market is projected to grow at a compound annual growth rate (CAGR) of 13.2% from 2026 to 2031.

      What factors are driving growth in Australia's companion diagnostics market?

      Growth in Australia's companion diagnostics market is driven by increasing adoption of precision medicine, expanding genomic testing capabilities, supportive regulatory frameworks, and rising demand for personalized treatment approaches.

      How does Australia's companion diagnostics market compare to the broader Asia Pacific region?

      Australia represents a significant and strategically important market within Asia Pacific, characterized by advanced healthcare infrastructure, strong regulatory standards, and high adoption rates of innovative diagnostic technologies.

      What is the forecast market size for Australia's companion diagnostics market in 2031?

      Australia's companion diagnostics market is forecast to reach $116.7 million by 2031, up from $79.6 million in 2026.

      RESEARCH METHODOLOGY

      This study involved four major activities in estimating the current size of the companion diagnostics market. Exhaustive secondary research was conducted to gather information on the market, its peer markets, and its parent market. These findings, assumptions, and sizing were then validated with industry experts across the value chain through primary research. Both top-down and bottom-up approaches were employed to estimate the complete market size. Following this, the data triangulation procedure was used to estimate the market size of segments and subsegments.

      Secondary Research

      Secondary research was primarily used to identify and gather information for the extensive, technical, market-oriented, and commercial study. The secondary sources referred for this research study include publications from government sources, such as the National Center for Biotechnology Information (NCBI), National Institutes of Health (NIH), World Health Organization (WHO), Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceutical Research and Manufacturers of America (PhRMA), Global Cancer Observatory (GLOBOCAN), Centers for Disease Control and Prevention (CDC), and European Federation of Biotechnology,. Secondary sources also included corporate and regulatory filings (such as annual reports, SEC filings, investor presentations, and financial statements); business magazines and research journals; press releases; and trade, business, and professional associations. These sources were also used to obtain key information on major players, global product revenues, market classification, and segmentation by industry trends, regional/country-level markets, market developments, and technology perspectives. Secondary data were collected and analyzed to determine the overall size of the global companion diagnostics market, and the findings were validated through primary research.

      Primary Research

      In-depth interviews were conducted with primary respondents, including key industry participants, subject-matter experts, C-level executives of key market players, and industry consultants, among others, to obtain and verify critical qualitative and quantitative information and assess market prospects. Various primary sources from both the supply and demand sides of the market were interviewed to obtain qualitative and quantitative information. The following is a breakdown of the primary respondents:

      Companion Diagnostics Market Size, and Share

      To know about the assumptions considered for the study, download the pdf brochure

      Market Size Estimation

      The global size of the companion diagnostics market was estimated through multiple approaches. A detailed market estimation approach was used to estimate and validate the market value and other dependent submarkets. These methods were also used extensively to estimate the size of various subsegments in the market. The research methodology used to estimate the market size includes the following:

      Companion Diagnostics Market Top Down and Bottom Up Approach

      Data Triangulation

      After estimating the overall market size from the market size estimation process, the total market was split into several segments. To complete the overall market engineering process and arrive at the exact statistics for all segments, the data triangulation procedure was employed; it involved studying various factors and trends from both the demand and supply sides.

      Market Definition

      A companion diagnostic (CDx) is an in vitro diagnostic (IVD) device that is used to make biomarker assessments to identify whether a patient with certain chronic diseases, such as cancer, infectious diseases, and cardiovascular diseases, could benefit from a particular drug provides information essential for the safe and effective use of a specific therapeutic product, particularly targeted therapies and biologics. These tests help identify patients who are most likely to benefit from a treatment, may experience adverse reactions, or require therapy selection based on biomarker or molecular profiling. The market includes assay kits, reagents, instruments, software, and laboratory testing services across technologies such as polymerase chain reaction, next-generation sequencing, immunohistochemistry, and in situ hybridization, among others.

      Key Stakeholders

      • Manufacturers and Distributors of Companion Diagnostics Products
      • In Vitro Diagnostic (IVD) Companies
      • Hospital Laboratories
      • Diagnostic Laboratories
      • Diagnostics Suppliers
      • Pharmaceutical Companies
      • Research Laboratories and Academic Institutes
      • Clinical Research Organizations (CROs)
      • Research & Development (R&D) Companies
      • Academic Medical Centers/Government Research Organizations
      • Companion Diagnostics Service Providers
      • Government Associations
      • Market Research & Consulting Firms
      • Venture Capitalists & Investors

      Report Objectives

      • To define, describe, segment, and forecast the global companion diagnostics market, by product & service, technology, Indication, Sample type, Drug Class Associated with CDX, Application, end user, and region
      • To provide detailed information regarding the major factors influencing market growth (such as drivers, restraints, opportunities, and challenges)
      • To analyze micromarkets with respect to individual growth trends, prospects, and contributions to the overall companion diagnostics market
      • To analyze market opportunities for stakeholders and provide details of the competitive landscape for key players
      • To forecast the size of the market segments with respect to six regions: North America(US and Canada), Europe (Germany, France, the UK, Switzerland Italy, Spain, and the Rest of Europe), Asia Pacific (China, Japan, India, South Korea, Australia, and the Rest of Asia Pacific), Latin America (Brazil, Mexico, Argentina, and the Rest of Latin America), the Middle East [GCC and the Rest of Middle East], and Africa
      • To profile the key players and comprehensively analyze their product portfolios, market positions, and core competencies
      • To track and analyze company developments such as product launches & approvals, partnerships, acquisitions, agreements, collaborations, expansions, and other developments
      • To benchmark players within the market using the proprietary “Company Evaluation Matrix” framework, which analyzes market players on various parameters within the broad categories of business and product excellence strategy

      Available customizations:

      With the given market data, MarketsandMarkets offers customizations per the company’s specific needs. The following customization options are available for the report:

      Geographical Analysis

      • Further breakdown of the Rest of Europe companion diagnostics market, by country
      • Further breakdown of the Rest of Asia Pacific companion diagnostics market, by country

      Company Information

      • Detailed analysis and profiling of additional market players (up to five)

      Segment Analysis

      • Cross-segment analysis

       

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      Full forecast, segment splits, and company analysis for all Companion Diagnostics Market.

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