The global companion diagnostic market size was estimated to be USD 7.42 billion in 2023 and is expected to reach at USD 27.67 billion by 2034 with a CAGR of 12.71% during the forecast period 2024-2034. Increasing research & development activities on targeted therapies, growing demand for personalized medicine, rising prevalence of chronic diseases, surge in technological advancements, increasing focus on development of novel tests, growing utilization of biomarkers in cancer diagnosis, and rising approval of companion diagnostic test are some of the key factors boosting the market growth.
Rising approval of companion diagnostic test is predicted to boost the market growth during the forecast period. An in vitro medical device known as a companion diagnostic is used in conjunction with a matching medication or biological product to provide vital information required for the safe and successful use of that product. This diagnostic test aids healthcare professionals in assessing whether a specific therapeutic product can provide benefits to patients that outweigh any potential serious side effects or risks. Hence, due to rising prevalence of chronic disorders, market players are focusing on development of novel test products. For instance, in August 2022, The U.S. Food and Drug Administration (FDA) has granted approval to Thermo Fisher Scientific Inc.'s Oncomine Dx Target Test as a companion diagnostic (CDx). This test is designed to detect HER2 (ERBB2) activating mutations, including single nucleotide variants (SNVs) and Exon 20 Insertions, in non-small cell lung cancer.
By product, assays, kits & reagents was the highest revenue-grossing segment in the global companion diagnostic market in 2023 owing to the rising approvals by regulatory bodies. Assays, kits, and reagents are necessary for creating numerous DNA molecules using primers and for preparing libraries from the newly synthesized DNA molecules. For instance, in August 2023, QIAGEN has revealed that the U.S. Food and Drug Administration (FDA) has granted approval to its therascreen PDGFRA RGQ PCR kit, also known as the therascreen PDGFRA kit. Additionally, software &services is predicted to grow at fastest CAGR during the forecast period owing to the increasing technological developments and surge in launch of innovative platforms.
By technology, polymerase chain reaction was the highest revenue-grossing segment in the global companion diagnostic market in 2023 owing to the cost-effectiveness, ease of use, high sensitivity & specificity, rising utilization for straightforward automation, increasing adoption to determine the genetic sequences associated with the unknown causes of various diseases, and growing regulatory authority approvals. For instance, in October 2023, The FDA has approved the use of the CRCdx RAS Mutation Detection Kit as a companion diagnostic for panitumumab in patients with metastatic colorectal cancer (mCRC). Additionally, next generation sequencing is predicted to grow at fastest CAGR during the forecast period owing to its heightened sensitivity for identifying low-frequency variants, quicker processing times for large sample quantities, & the capacity to sequence hundreds to thousands of genes or gene regions simultaneously, among other advantages.
By indication, cancer was the highest revenue-grossing segment in the global companion diagnostic market in 2023 owing to the growing prevalence of cancer, increasing research & development activities for cancer, surge in the number of companion diagnostics that have received approval from the FDA, rising awareness regarding personalized medicine among the patients, growing utilization of biomarkers in cancer diagnosis. Additionally, neurological disorders is predicted to grow at fastest CAGR during the forecast period owing to the increasing prevalence of central nervous system (CNS) diseases such as Alzheimer’s, Schizophrenia, & Parkinson’s and surge in launch of innovative tests. For instance, in March 2022, H.U. Group Holdings Inc. and its wholly-owned subsidiary, Fujirebio, have unveiled the Lumipulse G β-Amyloid 1-42 Plasma and Lumipulse G β-Amyloid 1-40 Plasma assays, which are designed for use with the fully automated LUMIPULSE G immunoassay systems. These assays, based on CLEIA (chemiluminescent enzyme immunoassay) technology, enable the quantitative measurement of β-amyloid 1-42 and β-amyloid 1-40 in human plasma, with results available in just 35 minutes.
By end-user, pharmaceutical & biotechnology companies was the highest revenue-grossing segment in the global companion diagnostic market in 2023 owing to the growing use of companion diagnostics owing to their increasing prominence in drug development, increasing importance of companion diagnostic biomarkers, and surge in regulatory approvals. For instance, in June 2023, ARUP Laboratories has announced that the U.S. Food and Drug Administration (FDA) has granted approval to AAV5 DetectCDx as a companion diagnostic. This diagnostic tool is intended to assist in the selection of adult patients eligible for treatment with ROCTAVIAN™ (valoctocogene roxaparvovec-rvox), a gene therapy developed by BioMarin Pharmaceutical Inc. ROCTAVIAN™ has also received FDA approval and is used for the treatment of adults with severe hemophilia A (congenital factor VIII [FVIII] deficiency with FVIII activity < 1 IU/dL) who do not have antibodies to adeno-associated virus serotype 5 (AAV5), as detected by an FDA-approved test. Additionally, contract research organizations is predicted to grow at fastest CAGR during the forecast period owing to the increasing number of clinical trial procedures, growing prevalence of chronic diseases, and surge in research & development activities.
North America region is anticipated for the highest revenue share during the forecast period owing to the growing adoption of advanced CDx assays, surge in prevalence of cancer, and increasing collaborations within market players to launch advanced technologies. For instance, in June 2022, Laboratory Corporation of America Holdings has partnered with OmniSeq Corporation to introduce OmniSeq INSIGHTsm, a comprehensive genomic and immune profiling tissue-based test that utilizes next-generation sequencing (NGS) technology. This test is specifically designed to advance precision oncology and enhance patient outcomes. Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the rising awareness regarding companion diagnostics, growing healthcare infrastructure, surge in demand for advance therapies, and increasing approvals by regulatory authorities. For instance, in September 2023, Guardant Health, Inc. has revealed that the Japanese Ministry of Health, Labour, and Welfare (MHLW) has given its approval for the Guardant360 CDx liquid biopsy test to serve as a companion diagnostic. It is used for the selection of patients with unresectable (inoperable) advanced or recurrent non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) mutations and have progressed after chemotherapy. These patients can now be treated with ENHERTU® (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate engineered by Daiichi Sankyo.
Rising approval of companion diagnostic test is predicted to boost the market growth during the forecast period. An in vitro medical device known as a companion diagnostic is used in conjunction with a matching medication or biological product to provide vital information required for the safe and successful use of that product. This diagnostic test aids healthcare professionals in assessing whether a specific therapeutic product can provide benefits to patients that outweigh any potential serious side effects or risks. Hence, due to rising prevalence of chronic disorders, market players are focusing on development of novel test products. For instance, in August 2022, The U.S. Food and Drug Administration (FDA) has granted approval to Thermo Fisher Scientific Inc.'s Oncomine Dx Target Test as a companion diagnostic (CDx). This test is designed to detect HER2 (ERBB2) activating mutations, including single nucleotide variants (SNVs) and Exon 20 Insertions, in non-small cell lung cancer.
By product, assays, kits & reagents was the highest revenue-grossing segment in the global companion diagnostic market in 2023 owing to the rising approvals by regulatory bodies. Assays, kits, and reagents are necessary for creating numerous DNA molecules using primers and for preparing libraries from the newly synthesized DNA molecules. For instance, in August 2023, QIAGEN has revealed that the U.S. Food and Drug Administration (FDA) has granted approval to its therascreen PDGFRA RGQ PCR kit, also known as the therascreen PDGFRA kit. Additionally, software &services is predicted to grow at fastest CAGR during the forecast period owing to the increasing technological developments and surge in launch of innovative platforms.
By technology, polymerase chain reaction was the highest revenue-grossing segment in the global companion diagnostic market in 2023 owing to the cost-effectiveness, ease of use, high sensitivity & specificity, rising utilization for straightforward automation, increasing adoption to determine the genetic sequences associated with the unknown causes of various diseases, and growing regulatory authority approvals. For instance, in October 2023, The FDA has approved the use of the CRCdx RAS Mutation Detection Kit as a companion diagnostic for panitumumab in patients with metastatic colorectal cancer (mCRC). Additionally, next generation sequencing is predicted to grow at fastest CAGR during the forecast period owing to its heightened sensitivity for identifying low-frequency variants, quicker processing times for large sample quantities, & the capacity to sequence hundreds to thousands of genes or gene regions simultaneously, among other advantages.
By indication, cancer was the highest revenue-grossing segment in the global companion diagnostic market in 2023 owing to the growing prevalence of cancer, increasing research & development activities for cancer, surge in the number of companion diagnostics that have received approval from the FDA, rising awareness regarding personalized medicine among the patients, growing utilization of biomarkers in cancer diagnosis. Additionally, neurological disorders is predicted to grow at fastest CAGR during the forecast period owing to the increasing prevalence of central nervous system (CNS) diseases such as Alzheimer’s, Schizophrenia, & Parkinson’s and surge in launch of innovative tests. For instance, in March 2022, H.U. Group Holdings Inc. and its wholly-owned subsidiary, Fujirebio, have unveiled the Lumipulse G β-Amyloid 1-42 Plasma and Lumipulse G β-Amyloid 1-40 Plasma assays, which are designed for use with the fully automated LUMIPULSE G immunoassay systems. These assays, based on CLEIA (chemiluminescent enzyme immunoassay) technology, enable the quantitative measurement of β-amyloid 1-42 and β-amyloid 1-40 in human plasma, with results available in just 35 minutes.
By end-user, pharmaceutical & biotechnology companies was the highest revenue-grossing segment in the global companion diagnostic market in 2023 owing to the growing use of companion diagnostics owing to their increasing prominence in drug development, increasing importance of companion diagnostic biomarkers, and surge in regulatory approvals. For instance, in June 2023, ARUP Laboratories has announced that the U.S. Food and Drug Administration (FDA) has granted approval to AAV5 DetectCDx as a companion diagnostic. This diagnostic tool is intended to assist in the selection of adult patients eligible for treatment with ROCTAVIAN™ (valoctocogene roxaparvovec-rvox), a gene therapy developed by BioMarin Pharmaceutical Inc. ROCTAVIAN™ has also received FDA approval and is used for the treatment of adults with severe hemophilia A (congenital factor VIII [FVIII] deficiency with FVIII activity < 1 IU/dL) who do not have antibodies to adeno-associated virus serotype 5 (AAV5), as detected by an FDA-approved test. Additionally, contract research organizations is predicted to grow at fastest CAGR during the forecast period owing to the increasing number of clinical trial procedures, growing prevalence of chronic diseases, and surge in research & development activities.
North America region is anticipated for the highest revenue share during the forecast period owing to the growing adoption of advanced CDx assays, surge in prevalence of cancer, and increasing collaborations within market players to launch advanced technologies. For instance, in June 2022, Laboratory Corporation of America Holdings has partnered with OmniSeq Corporation to introduce OmniSeq INSIGHTsm, a comprehensive genomic and immune profiling tissue-based test that utilizes next-generation sequencing (NGS) technology. This test is specifically designed to advance precision oncology and enhance patient outcomes. Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the rising awareness regarding companion diagnostics, growing healthcare infrastructure, surge in demand for advance therapies, and increasing approvals by regulatory authorities. For instance, in September 2023, Guardant Health, Inc. has revealed that the Japanese Ministry of Health, Labour, and Welfare (MHLW) has given its approval for the Guardant360 CDx liquid biopsy test to serve as a companion diagnostic. It is used for the selection of patients with unresectable (inoperable) advanced or recurrent non-small cell lung cancer (NSCLC) who have HER2 (ERBB2) mutations and have progressed after chemotherapy. These patients can now be treated with ENHERTU® (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate engineered by Daiichi Sankyo.
Segmentation: Companion Diagnostic Market Report 2023 - 2034
Companion Diagnostic Market Analysis & Forecast by Product 2023 - 2034 (Revenue USD Bn)
- Software & Services
- Assays, Kits & Reagents
Companion Diagnostic Market Analysis & Forecast by Technology 2023 - 2034 (Revenue USD Bn)
- Next-Generation Sequencing
- Polymerase Chain Reaction
- Immunohistochemistry
- In Situ Hybridization
- Others
Companion Diagnostic Market Analysis & Forecast by Indication 2023 - 2034 (Revenue USD Bn)
- Neurological Disorders
- Cardiovascular Diseases
- Cancer
- Infectious Diseases
- Others
Companion Diagnostic Market Analysis & Forecast by End-user 2023 - 2034 (Revenue USD Bn)
- Contract Research Organizations
- Pharmaceutical & Biotechnology Companies
- Reference Laboratories
- Others
Companion Diagnostic Market Analysis & Forecast by Region 2023 - 2034 (Revenue USD Bn)
- North America
- U.S.
- Canada
- Europe
- Germany
- France
- UK
- Spain
- Italy
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- Australia
- South Korea
- Rest of APAC
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of LATAM
- Middle East & Africa
- South Africa
- GCC
- Rest of MEA
Table of Contents
1. Research Methodology
2. Introduction
4. Market Environment Analysis
5. Market Dynamics
7. Companion Diagnostic Market: Product Estimates & Trend Analysis
8. Companion Diagnostic Market: Technology Estimates & Trend Analysis
9. Companion Diagnostic Market: Indication Estimates & Trend Analysis
10. Companion Diagnostic Market: End-user Estimates & Trend Analysis
11. Regional Market Analysis
12. North America Companion Diagnostic Market
13. Europe Global Companion Diagnostic Market
14. Asia Pacific Global Companion Diagnostic Market
15. Latin America Global Companion Diagnostic Market
16. MEA Global Companion Diagnostic Market
17. Competitor Analysis
18. Company Profiles
Companies Mentioned
- Abbott Laboratories Molecular Inc.
- ARUP Laboratories Inc.
- BioMerieux
- Thermo Fisher Scientific
- Roche
- Foundation Medicine Inc.
- Agilent
- QIAGEN N.V.
- Danaher Corporation
- Myriad Genetics Inc.
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 200 |
| Published | January 2024 |
| Forecast Period | 2023 - 2034 |
| Estimated Market Value ( USD | $ 7.42 Billion |
| Forecasted Market Value ( USD | $ 27.67 Billion |
| Compound Annual Growth Rate | 12.7% |
| Regions Covered | Global |
| No. of Companies Mentioned | 10 |
