The companion diagnostics market is seeing a large influx of newly approved products. A lot of tests are being adopted as a result of the growing number of approved new products, which is boosting market growth. Important producers also concentrate on creating new tests that drive the expansion of the companion diagnostics market. For example, in May 2022, Illumina’s TruSight oncology (TSO) complete test was approved by the CE. This test analyzes several tumor indicators to pinpoint a cancer patient’s unique molecular profile. Additionally, Agilent Technologies Inc. was granted approval in May 2022 for their qualitative immunohistochemistry assay, PD-L1 IHC 22C3 pharmDx. This test is used to identify patients with cervical cancer, for whom KEYTRUDA (anti-PD-1 therapy) would be a suitable course of treatment.
The lack of a uniform procedure to determine the reimbursement amount for a companion diagnostic test persists despite growing acceptance. Compensation is determined case-by-case.
For example, in June 2022, an article from Germany’s Taylor Wessing LLP states that inpatient and outpatient reimbursement will differ. Diagnostic-related groups are primarily responsible for covering diagnostics for the inpatient care system. Reimbursement for outpatient therapy is determined by the particular list of services that are eligible for reimbursement.
Research Methodology:
After secondary research provided a fundamental understanding of the worldwide Companion Diagnostics Market Market scenario, extensive primary research was carried out. A number of primary interviews were carried out with industry experts from the supply and demand sides, including C- and D-level executives, product managers, and marketing and sales managers of major manufacturers, distributors, and channel partners from tier 1 and tier 2 companies offering Companion Diagnostics Market Market details, as well as personnel from academia, research, and CROs. These interviews were conducted across five major regions: North America, Europe, Asia Pacific, and the Rest of the World (Latin America & the Middle East & Africa). Participants from the supply-side and demand-side participated in about 70% and 30% of the primary interviews, respectively. Through the use of questionnaires, emails, online surveys, in-person interviews, and phone interviews, this main data was gathered.
Companion Diagnostics Market based on Connectivity Technology:
Companion Diagnostics Market based on Indication:
- Cancer
- Neurological Diseases
- Infectious Diseases
- Others
Companion Diagnostics Market based on End-user:
- Pharmaceutical & Biopharmaceutical Companies
- Reference Laboratories
- Contract Research Organizations (CROs)
Companion Diagnostics Market based on Geography:
- North America
- Europe
- Germany
- UK
- France
- Italy
- Spain
- Rest of Europe (RoE)
- Asia Pacific (APAC)
- China
- Japan
- India
- Australia
- South Korea
- Rest of Asia Pacific (RoAPAC)
- Latin America (LATAM)
- Brazil
- Argentina
- Rest of South America
- Middle East and Africa (MEA)
- UAE
- Turkey
- Saudi Arabia
- South Africa
- Rest of Middle East & Africa
Due to the release of new PCR kits by major players including QIAGEN N.V. and Thermo Fisher Scientific Inc., polymerase chain reaction technique held a dominant market position in the worldwide companion diagnostics market in 2023. QIAGEN N.V. announced the release of the therascreen KRAS RGQ PCR Kit in May 2021. This test kit helps determine which individuals with non-small cell lung cancer (NSCLC) are eligible to receive LUMAKRAS, a novel medication created by Amgen Inc.
Thermo Fisher Scientific Inc. announced in March 2021 the introduction of the QuantStudio 5 Dx Real-Time PCR System, which will improve and accurately report laboratory procedures while supporting the upkeep of molecular diagnostic workflows. Thus, the segment’s supremacy was brought about by the introduction of new products and regulatory approval.
Because of the rising incidence of cancer and the attention that major players are paying to cutting-edge technology to provide sophisticated testing for cancer medications, it is projected that the cancer segment will have a significant market share for companion diagnostics. Additionally, there are more and more biomarker assays being employed for targeted cancer medications.
Due to the advancement of diseases affecting the central nervous system (CNS), such as schizophrenia, Parkinson’s disease, and Alzheimer’s disease, the neurology segment is predicted to expand at the fastest rate of compound annual growth (CAGR). This presents an opportunity to leverage precision medicine and companion diagnostic devices to improve diagnostic tools.
Companies in the pharmaceutical and biopharmaceutical industries brought in the most money in the market in 2023. This segment’s supremacy is the result of partnerships with makers of companion diagnostics.
Furthermore, because of new product launches and worldwide technical breakthroughs, the pharmaceutical and biopharmaceutical firms category is predicted to increase at the greatest CAGR throughout the projection period. These businesses are consistently working on creating companion diagnostic tests for various indications.
In 2023, North America brought in USD 2.94 billion in income. Higher rates of cancer and other chronic illnesses, as well as a growing use of sophisticated CDx assays, are the reasons for the region’s supremacy.
Conversely, it is projected that Europe would rank second internationally in terms of revenue in 2023. The expansion in this field is a result of a growing partnership between local companion diagnostic makers and pharmaceutical corporations.
Over the course of the projection period, Asia Pacific is expected to develop at the greatest CAGR. This is explained by the increasing number of medical device businesses creating diagnostic tools for treatment, the expanding healthcare infrastructure, and the rising incidence of cancers.
- This report illustrates the most vital attributes of the Companion Diagnostics Market, which are driving and providing opportunities.
- This research gives an in-depth analysis of the Companion Diagnostics Market growth on the basis of several segments in the market.
- This report presents the predictions of the past and present trends of the Companion Diagnostics Market.
- This study also presents the competitive analysis, such as key strategies and capabilities of major players of the Companion Diagnostics Market.
List of Tables
TABLE 1. COMPANION DIAGNOSTICS MARKET VALUE, BY TECHNOLOGY, 2021-2030 (USD BILLION)
TABLE 2. COMPANION DIAGNOSTICS MARKET VALUE FOR POLYMERASE CHAIN REACTION, BY GEOGRAPHY, 2021-2030 (USD BILLION)
TABLE 3. COMPANION DIAGNOSTICS MARKET VALUE FOR IMMUNOHISTOCHEMISTRY, BY GEOGRAPHY, 2021-2030 (USD BILLION)
TABLE 4. COMPANION DIAGNOSTICS MARKET VALUE FOR IN-SITU HYBRIDIZATION, BY GEOGRAPHY, 2021-2030 (USD BILLION)
TABLE 5. COMPANION DIAGNOSTICS MARKET VALUE FOR NEXT GENERATION GENE SEQUENCING, BY GEOGRAPHY, 2021-2030 (USD BILLION)
TABLE 6. COMPANION DIAGNOSTICS MARKET VALUE, BY INDICATION, 2021-2030 (USD BILLION)
TABLE 7. COMPANION DIAGNOSTICS MARKET VALUE FOR CANCER, BY GEOGRAPHY, 2021-2030 (USD BILLION)
TABLE 8. COMPANION DIAGNOSTICS MARKET VALUE FOR NEUROLOGICAL DISEASES, BY GEOGRAPHY, 2021-2030 (USD BILLION)
TABLE 9. COMPANION DIAGNOSTICS MARKET VALUE FOR OTHERS, BY GEOGRAPHY, 2021-2030 (USD BILLION)
TABLE 10. COMPANION DIAGNOSTICS MARKET VALUE FOR INFECTIOUS DISEASES, BY GEOGRAPHY, 2021-2030 (USD BILLION)
TABLE 11. COMPANION DIAGNOSTICS MARKET VALUE, BY END-USER, 2021-2030 (USD BILLION)
TABLE 12. COMPANION DIAGNOSTICS MARKET VALUE FOR PHARMACEUTICAL & BIOPHARMACEUTICAL COMPANIES, 2021-2030 (USD BILLION)
TABLE 13. COMPANION DIAGNOSTICS MARKET VALUE FOR REFERENCE LABORATORIES, BY GEOGRAPHY, 2021-2030 (USD BILLION)
TABLE 14. COMPANION DIAGNOSTICS MARKET VALUE FOR CONTRACT RESEARCH ORGANIZATIONS (CROS), 2021-2030 (USD BILLION)
TABLE 15. NORTH AMERICA COMPANION DIAGNOSTICS MARKET VALUE, BY COUNTRY, 2021-2030 (USD BILLION)
TABLE 16. NORTH AMERICA COMPANION DIAGNOSTICS MARKET VALUE, BY TECHNOLOGY, 2021-2030 (USD BILLION)
TABLE 17. NORTH AMERICA COMPANION DIAGNOSTICS MARKET VALUE, BY INDICATION, 2021-2030 (USD BILLION)
TABLE 18. NORTH AMERICA COMPANION DIAGNOSTICS MARKET VALUE, BY END-USER, 2021-2030 (USD BILLION)
TABLE 19. U.S COMPANION DIAGNOSTICS MARKET VALUE, BY TECHNOLOGY, 2021-2030 (USD BILLION)
TABLE 20. U.S COMPANION DIAGNOSTICS MARKET VALUE, BY INDICATION, 2021-2030 (USD BILLION)
TABLE 21. U.S COMPANION DIAGNOSTICS MARKET VALUE, BY END-USER, 2021-2030 (USD BILLION)
TABLE 22. CANADA COMPANION DIAGNOSTICS MARKET VALUE, BY TECHNOLOGY, 2021-2030 (USD BILLION)
TABLE 23. CANADA COMPANION DIAGNOSTICS MARKET VALUE, BY INDICATION, 2021-2030 (USD BILLION)
TABLE 24. CANADA COMPANION DIAGNOSTICS MARKET VALUE, BY END-USER, 2021-2030 (USD BILLION)
TABLE 25. MEXICO COMPANION DIAGNOSTICS MARKET VALUE, BY TECHNOLOGY, 2021-2030 (USD BILLION)
TABLE 26. MEXICO COMPANION DIAGNOSTICS MARKET VALUE, BY INDICATION, 2021-2030 (USD BILLION)
TABLE 27. MEXICO COMPANION DIAGNOSTICS MARKET VALUE, BY END-USER, 2021-2030 (USD BILLION)
TABLE 28. EUROPE COMPANION DIAGNOSTICS MARKET VALUE, BY COUNTRY, 2021-2030 (USD BILLION)
TABLE 29. EUROPE COMPANION DIAGNOSTICS MARKET VALUE, BY TECHNOLOGY, 2021-2030 (USD BILLION)
TABLE 30. EUROPE COMPANION DIAGNOSTICS MARKET VALUE, BY INDICATION, 2021-2030 (USD BILLION)
TABLE 31. EUROPE COMPANION DIAGNOSTICS MARKET VALUE, END USE INDUSTRIES, 2021-2030 (USD BILLION)
TABLE 32. GERMANY COMPANION DIAGNOSTICS MARKET VALUE, BY TECHNOLOGY, 2021-2030 (USD BILLION)
TABLE 33. GERMANY COMPANION DIAGNOSTICS MARKET VALUE, BY INDICATION, 2021-2030 (USD BILLION)
TABLE 34. GERMANY COMPANION DIAGNOSTICS MARKET VALUE, BY END-USER, 2021-2030 (USD BILLION)
TABLE 35. U.K COMPANION DIAGNOSTICS MARKET VALUE, BY TECHNOLOGY, 2021-2030 (USD BILLION)
TABLE 36. U.K COMPANION DIAGNOSTICS MARKET VALUE, BY INDICATION, 2021-2030 (USD BILLION)
TABLE 37. U.K COMPANION DIAGNOSTICS MARKET VALUE, BY END-USER, 2021-2030 (USD BILLION)
TABLE 38. FRANCE COMPANION DIAGNOSTICS MARKET VALUE, BY TECHNOLOGY, 2021-2030 (USD BILLION)
TABLE 39. FRANCE COMPANION DIAGNOSTICS MARKET VALUE, BY INDICATION, 2021-2030 (USD BILLION)
TABLE 40. FRANCE COMPANION DIAGNOSTICS MARKET VALUE, BY END-USER, 2021-2030 (USD BILLION)
TABLE 41. ITALY COMPANION DIAGNOSTICS MARKET VALUE, BY TECHNOLOGY, 2021-2030 (USD BILLION)
TABLE 42. ITALY COMPANION DIAGNOSTICS MARKET VALUE, BY INDICATION, 2021-2030 (USD BILLION)
TABLE 43. ITALY COMPANION DIAGNOSTICS MARKET VALUE, BY END-USER, 2021-2030 (USD BILLION)
TABLE 44. SPAIN COMPANION DIAGNOSTICS MARKET VALUE, BY TECHNOLOGY, 2021-2030 (USD BILLION)
TABLE 45. SPAIN COMPANION DIAGNOSTICS MARKET VALUE, BY INDICATION, 2021-2030 (USD BILLION)
TABLE 46. SPAIN COMPANION DIAGNOSTICS MARKET VALUE, BY END-USER, 2021-2030 (USD BILLION)
TABLE 47. ROE COMPANION DIAGNOSTICS MARKET VALUE, BY TECHNOLOGY, 2021-2030 (USD BILLION)
TABLE 48. ROE COMPANION DIAGNOSTICS MARKET VALUE, BY INDICATION, 2021-2030 (USD BILLION)
TABLE 49. ROE COMPANION DIAGNOSTICS MARKET VALUE, BY END-USER, 2021-2030 (USD BILLION)
TABLE 50. ASIA PACIFIC COMPANION DIAGNOSTICS MARKET VALUE, BY COUNTRY, 2021-2030 (USD BILLION)
TABLE 51. ASIA PACIFIC COMPANION DIAGNOSTICS MARKET VALUE, BY TECHNOLOGY, 2021-2030 (USD BILLION)
TABLE 52. ASIA PACIFIC COMPANION DIAGNOSTICS MARKET VALUE, BY INDICATION, 2021-2030 (USD BILLION)
TABLE 53. ASIA PACIFIC COMPANION DIAGNOSTICS MARKET VALUE, BY END-USER, 2021-2030 (USD BILLION)
TABLE 54. CHINA COMPANION DIAGNOSTICS MARKET VALUE, BY TECHNOLOGY, 2021-2030 (USD BILLION)
TABLE 55. CHINA COMPANION DIAGNOSTICS MARKET VALUE, BY INDICATION, 2021-2030 (USD BILLION)
TABLE 56. CHINA COMPANION DIAGNOSTICS MARKET VALUE, BY END-USER, 2021-2030 (USD BILLION)
TABLE 57. INDIA COMPANION DIAGNOSTICS MARKET VALUE, BY TECHNOLOGY, 2021-2030 (USD BILLION)
TABLE 58. INDIA COMPANION DIAGNOSTICS MARKET VALUE, BY INDICATION, 2021-2030 (USD BILLION)
TABLE 59. INDIA COMPANION DIAGNOSTICS MARKET VALUE, BY END-USER, 2021-2030 (USD BILLION)
TABLE 60. JAPAN COMPANION DIAGNOSTICS MARKET VALUE, BY TECHNOLOGY, 2021-2030 (USD BILLION)
TABLE 61. JAPAN COMPANION DIAGNOSTICS MARKET VALUE, BY INDICATION, 2021-2030 (USD BILLION)
TABLE 62. JAPAN COMPANION DIAGNOSTICS MARKET VALUE, BY END-USER, 2021-2030 (USD BILLION)
TABLE 63. REST OF APAC COMPANION DIAGNOSTICS MARKET VALUE, BY TECHNOLOGY, 2021-2030 (USD BILLION)
TABLE 64. REST OF APAC COMPANION DIAGNOSTICS MARKET VALUE, BY INDICATION, 2021-2030 (USD BILLION)
TABLE 65. REST OF APAC COMPANION DIAGNOSTICS MARKET VALUE, BY END-USER, 2021-2030 (USD BILLION)
TABLE 66. LATIN AMERICA COMPANION DIAGNOSTICS MARKET VALUE, BY TECHNOLOGY, 2021-2030 (USD BILLION)
TABLE 67. LATIN AMERICA COMPANION DIAGNOSTICS MARKET VALUE, BY INDICATION, 2021-2030 (USD BILLION)
TABLE 68. LATIN AMERICA COMPANION DIAGNOSTICS MARKET VALUE, BY END-USER, 2021-2030 (USD BILLION)
TABLE 69. BRAZIL COMPANION DIAGNOSTICS MARKET VALUE, BY TECHNOLOGY, 2021-2030 (USD BILLION)
TABLE 70. BRAZIL COMPANION DIAGNOSTICS MARKET VALUE, BY INDICATION, 2021-2030 (USD BILLION)
TABLE 71. BRAZIL COMPANION DIAGNOSTICS MARKET VALUE, BY END-USER, 2021-2030 (USD BILLION)
TABLE 72. ARGENTINA COMPANION DIAGNOSTICS MARKET VALUE, BY TECHNOLOGY, 2021-2030 (USD BILLION)
TABLE 73. ARGENTINA COMPANION DIAGNOSTICS MARKET VALUE, BY INDICATION, 2021-2030 (USD BILLION)
TABLE 74. ARGENTINA COMPANION DIAGNOSTICS MARKET VALUE, BY END-USER, 2021-2030 (USD BILLION)
TABLE 75. MIDDLE EAST AND AFRICA COMPANION DIAGNOSTICS MARKET VALUE, BY TECHNOLOGY, 2021-2030 (USD BILLION)
TABLE 76. MIDDLE EAST AND AFRICA COMPANION DIAGNOSTICS MARKET VALUE, BY INDICATION, 2021-2030 (USD BILLION)
TABLE 77. MIDDLE EAST AND AFRICA COMPANION DIAGNOSTICS MARKET VALUE, BY END-USER, 2021-2030 (USD BILLION)
TABLE 78. SAUDI ARABIA COMPANION DIAGNOSTICS MARKET VALUE, BY TECHNOLOGY, 2021-2030 (USD BILLION)
TABLE 79. SAUDI ARABIA COMPANION DIAGNOSTICS MARKET VALUE, BY INDICATION, 2021-2030 (USD BILLION)
TABLE 80. SAUDI ARABIA COMPANION DIAGNOSTICS MARKET VALUE, BY END-USER, 2021-2030 (USD BILLION)
TABLE 81. UAE COMPANION DIAGNOSTICS MARKET VALUE, BY TECHNOLOGY, 2021-2030 (USD BILLION)
TABLE 82. UAE COMPANION DIAGNOSTICS MARKET VALUE, BY INDICATION, 2021-2030 (USD BILLION)
TABLE 83. UAE COMPANION DIAGNOSTICS MARKET VALUE, BY END-USER, 2021-2030 (USD BILLION)
TABLE 84. REST OF MIDDLE EAST AND AFRICA COMPANION DIAGNOSTICS MARKET VALUE, BY TECHNOLOGY, 2021-2030 (USD BILLION)
TABLE 85. REST OF MIDDLE EAST AND AFRICA COMPANION DIAGNOSTICS MARKET VALUE, BY INDICATION, 2021-2030 (USD BILLION)
TABLE 86. REST OF MIDDLE EAST AND AFRICA COMPANION DIAGNOSTICS MARKET VALUE, BY END-USER, 2021-2030 (USD BILLION)
TABLE 87. ARUP LABORATORIES: FINANCIALS
TABLE 88. ARUP LABORATORIES: PRODUCTS & SERVICES
TABLE 89. ARUP LABORATORIES: RECENT DEVELOPMENTS
TABLE 90. ROCHE MOLECULAR SYSTEMS INC.: FINANCIALS
TABLE 91. ROCHE MOLECULAR SYSTEMS INC.: PRODUCTS & SERVICES
TABLE 92. ROCHE MOLECULAR SYSTEMS INC.: RECENT DEVELOPMENTS
TABLE 93. DAKO INC.: FINANCIALS
TABLE 94. DAKO INC.: PRODUCTS & SERVICES
TABLE 95. DAKO INC.: RECENT DEVELOPMENTS
TABLE 96. QIAGEN LTD.: FINANCIALS
TABLE 97. QIAGEN LTD.: PRODUCTS & SERVICES
TABLE 98. QIAGEN LTD.: RECENT DEVELOPMENTS
TABLE 99. BIOMÉRIEUX INC.: FINANCIALS
TABLE 100. BIOMÉRIEUX INC.: PRODUCTS & SERVICES
TABLE 101. BIOMÉRIEUX INC.: RECENT DEVELOPMENTS
TABLE 102. VENTANA MEDICAL SYSTEMS INC.: FINANCIALS
TABLE 103. VENTANA MEDICAL SYSTEMS INC.: PRODUCTS & SERVICES
TABLE 104. VENTANA MEDICAL SYSTEMS INC.: RECENT DEVELOPMENTS
TABLE 105. ABBOTT MOLECULAR INC.: FINANCIALS
TABLE 106. ABBOTT MOLECULAR INC.: PRODUCTS & SERVICES
TABLE 107. ABBOTT MOLECULAR INC.: DEVELOPMENTS
TABLE 108. MYRIAD GENETICS INC.: FINANCIALS
TABLE 109. MYRIAD GENETICS INC.: PRODUCTS & SERVICES
TABLE 110. MYRIAD GENETICS INC.: RECENT DEVELOPMENTS
TABLE 111. BIOGENEX LABORATORIES, INC.: FINANCIALS
TABLE 112. BIOGENEX LABORATORIES, INC.: PRODUCTS & SERVICES
TABLE 113. BIOGENEX LABORATORIES, INC.: RECENT DEVELOPMENTS
TABLE 114. THERMO FISHER SCIENTIFIC INC.: FINANCIALS
TABLE 115. THERMO FISHER SCIENTIFIC INC.: PRODUCTS & SERVICES
TABLE 116. THERMO FISHER SCIENTIFIC INC.: RECENT DEVELOPMENTS