Companion Diagnostics Market Size, Share, and Trends

Companion Diagnostics Market (By Indication: Cancer, Neurological Disorders, Cardiovascular Diseases, Infectious Diseases, Other Indications; By Product & Service: Assays, Kits & Reagents, Software & Services; By Technology: Polymerase Chain Reaction, Next-Generation Sequencing, In Situ Hybridization, Immunohistochemistry, Other; By Indication: Oncology, Neurology, Infectious Diseases, Others; By End-User) - Global Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2023-2032

  • Last Updated : January 2024
  • Report Code : 2457
  • Category : Healthcare

The global companion diagnostics market size was exhibited at USD 6.88 billion in 2022 and is projected to hit around USD 22.03 billion by 2032, growing at a CAGR of 12.4% during the forecast period 2023 to 2032.

Companion Diagnostics Market Size 2023 To 2032

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Growth Factors

With signs of progress in hereditary sequencing and genomics, it is currently generally accepted that medications can show shifting results in various people. A superior comprehension of the hereditary attributes or biomarkers of an individual can advance the act of overseeing 'the right medication, with impeccable timing, at the right portion, for the perfect individual'. Drug and biopharmaceutical organizations are ceaselessly endeavoring to execute patient-choice analytic systems in the previous phases of medication improvement to give designated treatments to the right competitor. These further backings the development of the companion diagnostics market.

NGS-based friend symptomatic tests intend to open atomic data from every patient's growth genome to direct therapy choices for disease treatments. Cutting-edge sequencing recognizes numerous biomarkers for various medication treatments in a more limited time when contrasted with other sequencing procedures. The utilization of NGS boards for biomarker estimation in one test can help in the therapy of a wide range of kinds of diseases. The different innovative headways in NGS likewise give market players a quick upper hand over players giving different advancements like PCR, ICH, and ISH. Subsequently, significant market players are zeroing in on creating companion demonstrative items in light of NGS.

Companion Diagnostics Market Scope

Report Coverage Details
Market Size in 2023 USD 7.69 Billion
Market Size by 2032 USD 22.03 Billion
Growth Rate from 2023 to 2032 CAGR of 12.4%
Base Year 2022
Forecast Period 2023 to 2032
Segments Covered
  • By Indication
  • By Product & Service
  • By Technology
  • By Indication
  • By End-User
Regions Covered
  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East & Africa


Companion Diagnostics Market Dynamics

Drivers: Advancements in the latest technologies

The next-generation sequencing based companion indicative tests mean to open nuclear information from each persistent development genome to coordinate treatment decisions for illness medicines. Forefront sequencing perceives various biomarkers for different medicines in a more restricted time when stood out from other sequencing strategies. The use of NGS sheets for biomarker assessment in one test might perhaps help in the treatment of a wide scope of sorts of illnesses. The different creative degrees of progress in NGS moreover give market players a speedy advantage over players giving various headways like PCR, ICH, and ISH. Thusly, critical market players are focusing on making amigo illustrative things considering NGS.  

Restraints: Lack of awareness and high cost of companion diagnostics techniques

While immunotherapy has shown a critical guarantee in malignant growth treatment, its significant expense has restricted generally persistent access. Doctors could rather find it best to join treatments; this, thusly, could broaden the length of the treatment from five months to the north of three years. For this situation, the more extended the term, the more prominent the cost. Also, the expense of customized immunotherapies is high. The expense of disease immunotherapies can far surpass the expense expected for other treatment choices, like chemotherapy or radiation treatment. In this way, the significant expense of immuno-oncology treatments is supposed to hamper the development of the companion diagnostics market. 

Opportunities: Growing advancements in biologics

The companion diagnostics market is exceptionally solidified. The top players are F. Hoffmann-La Roche Ltd. (Switzerland), Agilent Technologies, Inc. (the US), Qiagen N.V. (Germany), Thermo Fisher Scientific, Inc. (the US), Abbott Laboratories, Inc. (the US) - in the companion diagnostics market represented a joined larger part portion of the overall industry in 2020. There is a serious level of rivalry among the market players. Just significant organizations can bear the cost of high-capital ventures as well as the significant expense of R&D and production. This will keep new contestants from entering this market. 

Challenges: Lack of resources in underdeveloped nations

It is essential to assemble mindfulness among patients, clinicians, and the general population concerning the significance of clinical preliminaries. To further develop mindfulness among clinicians, giving extraordinary admittance to legitimate, proof put together most recent data concerning these new malignant growth medications can be useful. To work on open mindfulness, expanding admittance to a typical and believed wellspring of truth is vital. A few distributing houses and industry players give month-to-month diaries and data handouts. Partners have likewise centered around mindfulness drives to guarantee patients and suppliers can get to and figure out the advantages of friend diagnostics.

Indication Insights

The companion diagnostics market is portioned into malignant growth, cardiovascular illnesses (CVDs), neurological sicknesses, irresistible infections, and different signs (provocative and acquired infections, among others). In 2022, the malignant growth section represented the biggest portion of the companion diagnostics market. Factors like developing job of friend diagnostics in the customized medication therapy for malignant growth, and expanding the utility of biomarkers in the analysis of disease.

End-User Insights

The drug and biotechnology organizations and reference research facilities fragment represented the biggest offer on the lookout, by the end client. The companion diagnostics market is fragmented into drug and biotechnology organizations, reference labs, CROs, and opposite-end clients (counting doctor and clinic labs, and scholastic clinical focuses). In 2022, drug and biotechnology organizations represented a bigger portion of the companion diagnostics market. The developing utilization of companion diagnostics is inferable from their rising conspicuousness in drug improvement and the rising significance of companion analytic biomarkers.

Regional Insights

North America represented the biggest portion of the friend diagnostics market. The North American friend diagnostics market development can be ascribed to the presence of many driving companion diagnostics sellers and public clinical research centers, the simple availability of innovatively progressed gadgets and instruments, and the profoundly evolved medical services framework in the US and Canada.

The utilization of companion diagnostics is viewed as a significant treatment choice device for different oncology drugs, which is likewise reflected in how the FDA orders these examinations concerning risk.

Companion Diagnostics Market Share, By Region, 2022 (%)

The companion diagnostics clinical preliminaries have come to the cutting edge in the drug business, regardless of the COVID-19 flare-up, as it helps support the possibilities of clinical achievement. The testing unit has been seeing popularity for distinguishing those contaminated with SARS-CoV-2. The novel Covid stayed the primary concentration for symptomatic test producers regarding innovative work.

The rising weight of disease in the United States is additionally expected to drive market development. As indicated by the information distributed by American Cancer Society Inc., in January 2020, in the United States, there were around 1.8 million new disease cases analyzed and 606,520 malignant growth passings.

Moreover, the great repayment situation for bosom disease symptomatic arrangements in the United States is expected to work with their reception. For example, in January 2020, the Centers for Medicare and Medicaid Services (CMS) extended its inclusion of cutting-edge sequencing as an asymptomatic device for patients with germline (acquired) bosom malignant growth.

Additionally, in October 2021, the United States Food and Drug Administration endorsed Agilent's Ki-67 IHC MIB-1 pharmDx (Dako Omnis) that guides in recognizing patients with early bosom malignant growth (EBC) at high gamble of infection repeat. This will additionally prompt drive the market development over the conjecture period around here.

Inferable from the above factors, the North American portion is supposed to hold a significant offer in the worldwide companion diagnostics market.

Asia-Pacific presents rewarding open doors for the central members working in the companion diagnostics market, attributable to high populace base, development in mindfulness about companion diagnostics, improvement in medical care foundation, and expansion popular for advanced treatments. organizations are zeroing in on consolidations and acquisitions to reinforce the improvement in indicative methods, as would be considered normal to drive the market development around here. Nonetheless, greater expenses caused in R&D to create friend diagnostics can hamper the companion diagnostics market development in Asia-Pacific.

Key Market Developments

  • In May 2021, Qiagen N.V. (Germany) extended the Thera screen KRAS Kit.
  • In April 2019, Roche Diagnostics (Switzerland) obtained TIB Molbiol Group (Germany). This securing will improve Roche's expansive arrangement of sub-atomic diagnostics arrangements with a wide scope of examines for irresistible infections, for example, distinguishing SARS-CoV-2 variations.

Companion Diagnostics Market Companies

  • F. Hoffmann-La Roche Ltd. (Switzerland)
  • Agilent Technologies, Inc. (US)
  • Qiagen N.V. (Germany)
  • Thermo Fisher Scientific, Inc. (US)
  • Abbott Laboratories, Inc. (US)

Segments Covered in the Report

By Indication

  • Cancer
    • Lung Cancer
    • Breast Cancer
    • Blood Cancer
    • Colorectal Cancer
    • Other Cancer Types
  • Neurological Disorders
  • Cardiovascular Diseases
  • Infectious Diseases
  • Other Indications

By Product & Service

  • Assays, Kits & Reagents
  • Software & Services

By Technology

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

By Indication

  • Oncology
  • Neurology
  • Infectious Diseases
  • Others 

By End-User

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

By Geography

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East & Africa (MEA)

Frequently Asked Questions

The global companion diagnostics market size was accounted at USD 6.88 billion in 2022 and it is expected to reach around USD 22.03 billion by 2032.

The global companion diagnostics market is poised to grow at a CAGR of 12.4% from 2023 to 2032.

The major players operating in the companion diagnostics market are F. Hoffmann-La Roche Ltd. (Switzerland), Agilent Technologies, Inc. (US), Qiagen N.V. (Germany), Thermo Fisher Scientific, Inc. (US), Abbott Laboratories, Inc. (US) and Others.

The advancements in the latest technologies is the primary driving factors of the companion diagnostics market.

North America region will lead the global companion diagnostics market during the forecast period 2023 to 2032.

Chapter 1. Introduction

1.1. Research Objective

1.2. Scope of the Study

1.3. Definition

Chapter 2. Research Methodology

2.1. Research Approach

2.2. Data Sources

2.3. Assumptions & Limitations

Chapter 3. Executive Summary

3.1. Market Snapshot

Chapter 4. Market Variables and Scope 

4.1. Introduction

4.2. Market Classification and Scope

4.3. Industry Value Chain Analysis

4.3.1. Raw Material Procurement Analysis 

4.3.2. Sales and Distribution Channel Analysis

4.3.3. Downstream Buyer Analysis

Chapter 5. COVID 19 Impact on Companion Diagnostics Market 

5.1. COVID-19 Landscape: Companion Diagnostics Industry Impact

5.2. COVID 19 - Impact Assessment for the Industry

5.3. COVID 19 Impact: Global Major Government Policy

5.4. Market Trends and Opportunities in the COVID-19 Landscape

Chapter 6. Market Dynamics Analysis and Trends

6.1. Market Dynamics

6.1.1. Market Drivers

6.1.2. Market Restraints

6.1.3. Market Opportunities

6.2. Porter’s Five Forces Analysis

6.2.1. Bargaining power of suppliers

6.2.2. Bargaining power of buyers

6.2.3. Threat of substitute

6.2.4. Threat of new entrants

6.2.5. Degree of competition

Chapter 7. Competitive Landscape

7.1.1. Company Market Share/Positioning Analysis

7.1.2. Key Strategies Adopted by Players

7.1.3. Vendor Landscape

7.1.3.1. List of Suppliers

7.1.3.2. List of Buyers

Chapter 8. Global Companion Diagnostics Market, By Indication

8.1. Companion Diagnostics Market, by Indication, 2023-2032

8.1.1. Cancer

8.1.1.1. Market Revenue and Forecast (2021-2032)

8.1.2. Neurological Disorders

8.1.2.1. Market Revenue and Forecast (2021-2032)

8.1.3. Cardiovascular Diseases

8.1.3.1. Market Revenue and Forecast (2021-2032)

8.1.4. Infectious Diseases

8.1.4.1. Market Revenue and Forecast (2021-2032)

8.1.5. Other Indications

8.1.5.1. Market Revenue and Forecast (2021-2032)

Chapter 9. Global Companion Diagnostics Market, By Product & Service

9.1. Companion Diagnostics Market, by Product & Service, 2023-2032

9.1.1. Assays, Kits & Reagents

9.1.1.1. Market Revenue and Forecast (2021-2032)

9.1.2. Software & Services

9.1.2.1. Market Revenue and Forecast (2021-2032)

Chapter 10. Global Companion Diagnostics Market, By Technology 

10.1. Companion Diagnostics Market, by Technology, 2023-2032

10.1.1. Polymerase Chain Reaction

10.1.1.1. Market Revenue and Forecast (2021-2032)

10.1.2. Next-generation Sequencing

10.1.2.1. Market Revenue and Forecast (2021-2032)

10.1.3. In Situ Hybridization

10.1.3.1. Market Revenue and Forecast (2021-2032)

10.1.4. Immunohistochemistry

10.1.4.1. Market Revenue and Forecast (2021-2032)

10.1.5. Other

10.1.5.1. Market Revenue and Forecast (2021-2032)

Chapter 11. Global Companion Diagnostics Market, By Indication

11.1. Companion Diagnostics Market, by Indication, 2023-2032

11.1.1. Oncology

11.1.1.1. Market Revenue and Forecast (2021-2032)

11.1.2. Neurology

11.1.2.1. Market Revenue and Forecast (2021-2032)

11.1.3. Infectious Diseases

11.1.3.1. Market Revenue and Forecast (2021-2032)

11.1.4. Others

11.1.4.1. Market Revenue and Forecast (2021-2032)

11.1.5. Others

11.1.5.1. Market Revenue and Forecast (2021-2032)

Chapter 12. Global Companion Diagnostics Market, By End-User

12.1. Companion Diagnostics Market, by End-User, 2023-2032

12.1.1. Pharmaceutical & Biopharmaceutical Companies

12.1.1.1. Market Revenue and Forecast (2021-2032)

12.1.2. Reference Laboratories

12.1.2.1. Market Revenue and Forecast (2021-2032)

12.1.3. Contract Research Organizations

12.1.3.1. Market Revenue and Forecast (2021-2032)

12.1.4. Other End Users

12.1.4.1. Market Revenue and Forecast (2021-2032)

Chapter 13. Global Companion Diagnostics Market, Regional Estimates and Trend Forecast

13.1. North America

13.1.1. Market Revenue and Forecast, by Indication (2021-2032)

13.1.2. Market Revenue and Forecast, by Product & Service (2021-2032)

13.1.3. Market Revenue and Forecast, by Technology (2021-2032)

13.1.4. Market Revenue and Forecast, by Indication (2021-2032)

13.1.5. Market Revenue and Forecast, by End-User (2021-2032)

13.1.6. U.S.

13.1.6.1. Market Revenue and Forecast, by Indication (2021-2032)

13.1.6.2. Market Revenue and Forecast, by Product & Service (2021-2032)

13.1.6.3. Market Revenue and Forecast, by Technology (2021-2032)

13.1.6.4. Market Revenue and Forecast, by Indication (2021-2032)

13.1.6.5. Market Revenue and Forecast, by End-User (2021-2032) 

13.1.7. Rest of North America

13.1.7.1. Market Revenue and Forecast, by Indication (2021-2032)

13.1.7.2. Market Revenue and Forecast, by Product & Service (2021-2032)

13.1.7.3. Market Revenue and Forecast, by Technology (2021-2032)

13.1.7.4. Market Revenue and Forecast, by Indication (2021-2032)

13.1.7.5. Market Revenue and Forecast, by End-User (2021-2032)

13.2. Europe

13.2.1. Market Revenue and Forecast, by Indication (2021-2032)

13.2.2. Market Revenue and Forecast, by Product & Service (2021-2032)

13.2.3. Market Revenue and Forecast, by Technology (2021-2032)

13.2.4. Market Revenue and Forecast, by Indication (2021-2032) 

13.2.5. Market Revenue and Forecast, by End-User (2021-2032) 

13.2.6. UK

13.2.6.1. Market Revenue and Forecast, by Indication (2021-2032)

13.2.6.2. Market Revenue and Forecast, by Product & Service (2021-2032)

13.2.6.3. Market Revenue and Forecast, by Technology (2021-2032)

13.2.7. Market Revenue and Forecast, by Indication (2021-2032) 

13.2.8. Market Revenue and Forecast, by End-User (2021-2032) 

13.2.9. Germany

13.2.9.1. Market Revenue and Forecast, by Indication (2021-2032)

13.2.9.2. Market Revenue and Forecast, by Product & Service (2021-2032)

13.2.9.3. Market Revenue and Forecast, by Technology (2021-2032)

13.2.10. Market Revenue and Forecast, by Indication (2021-2032)

13.2.11. Market Revenue and Forecast, by End-User (2021-2032)

13.2.12. France

13.2.12.1. Market Revenue and Forecast, by Indication (2021-2032)

13.2.12.2. Market Revenue and Forecast, by Product & Service (2021-2032)

13.2.12.3. Market Revenue and Forecast, by Technology (2021-2032)

13.2.12.4. Market Revenue and Forecast, by Indication (2021-2032)

13.2.13. Market Revenue and Forecast, by End-User (2021-2032)

13.2.14. Rest of Europe

13.2.14.1. Market Revenue and Forecast, by Indication (2021-2032)

13.2.14.2. Market Revenue and Forecast, by Product & Service (2021-2032)

13.2.14.3. Market Revenue and Forecast, by Technology (2021-2032)

13.2.14.4. Market Revenue and Forecast, by Indication (2021-2032)

13.2.15. Market Revenue and Forecast, by End-User (2021-2032)

13.3. APAC

13.3.1. Market Revenue and Forecast, by Indication (2021-2032)

13.3.2. Market Revenue and Forecast, by Product & Service (2021-2032)

13.3.3. Market Revenue and Forecast, by Technology (2021-2032)

13.3.4. Market Revenue and Forecast, by Indication (2021-2032)

13.3.5. Market Revenue and Forecast, by End-User (2021-2032)

13.3.6. India

13.3.6.1. Market Revenue and Forecast, by Indication (2021-2032)

13.3.6.2. Market Revenue and Forecast, by Product & Service (2021-2032)

13.3.6.3. Market Revenue and Forecast, by Technology (2021-2032)

13.3.6.4. Market Revenue and Forecast, by Indication (2021-2032)

13.3.7. Market Revenue and Forecast, by End-User (2021-2032)

13.3.8. China

13.3.8.1. Market Revenue and Forecast, by Indication (2021-2032)

13.3.8.2. Market Revenue and Forecast, by Product & Service (2021-2032)

13.3.8.3. Market Revenue and Forecast, by Technology (2021-2032)

13.3.8.4. Market Revenue and Forecast, by Indication (2021-2032)

13.3.9. Market Revenue and Forecast, by End-User (2021-2032)

13.3.10. Japan

13.3.10.1. Market Revenue and Forecast, by Indication (2021-2032)

13.3.10.2. Market Revenue and Forecast, by Product & Service (2021-2032)

13.3.10.3. Market Revenue and Forecast, by Technology (2021-2032)

13.3.10.4. Market Revenue and Forecast, by Indication (2021-2032)

13.3.10.5. Market Revenue and Forecast, by End-User (2021-2032)

13.3.11. Rest of APAC

13.3.11.1. Market Revenue and Forecast, by Indication (2021-2032)

13.3.11.2. Market Revenue and Forecast, by Product & Service (2021-2032)

13.3.11.3. Market Revenue and Forecast, by Technology (2021-2032)

13.3.11.4. Market Revenue and Forecast, by Indication (2021-2032)

13.3.11.5. Market Revenue and Forecast, by End-User (2021-2032)

13.4. MEA

13.4.1. Market Revenue and Forecast, by Indication (2021-2032)

13.4.2. Market Revenue and Forecast, by Product & Service (2021-2032)

13.4.3. Market Revenue and Forecast, by Technology (2021-2032)

13.4.4. Market Revenue and Forecast, by Indication (2021-2032)

13.4.5. Market Revenue and Forecast, by End-User (2021-2032)

13.4.6. GCC

13.4.6.1. Market Revenue and Forecast, by Indication (2021-2032)

13.4.6.2. Market Revenue and Forecast, by Product & Service (2021-2032)

13.4.6.3. Market Revenue and Forecast, by Technology (2021-2032)

13.4.6.4. Market Revenue and Forecast, by Indication (2021-2032)

13.4.7. Market Revenue and Forecast, by End-User (2021-2032)

13.4.8. North Africa

13.4.8.1. Market Revenue and Forecast, by Indication (2021-2032)

13.4.8.2. Market Revenue and Forecast, by Product & Service (2021-2032)

13.4.8.3. Market Revenue and Forecast, by Technology (2021-2032)

13.4.8.4. Market Revenue and Forecast, by Indication (2021-2032)

13.4.9. Market Revenue and Forecast, by End-User (2021-2032)

13.4.10. South Africa

13.4.10.1. Market Revenue and Forecast, by Indication (2021-2032)

13.4.10.2. Market Revenue and Forecast, by Product & Service (2021-2032)

13.4.10.3. Market Revenue and Forecast, by Technology (2021-2032)

13.4.10.4. Market Revenue and Forecast, by Indication (2021-2032)

13.4.10.5. Market Revenue and Forecast, by End-User (2021-2032)

13.4.11. Rest of MEA

13.4.11.1. Market Revenue and Forecast, by Indication (2021-2032)

13.4.11.2. Market Revenue and Forecast, by Product & Service (2021-2032)

13.4.11.3. Market Revenue and Forecast, by Technology (2021-2032)

13.4.11.4. Market Revenue and Forecast, by Indication (2021-2032)

13.4.11.5. Market Revenue and Forecast, by End-User (2021-2032)

13.5. Latin America

13.5.1. Market Revenue and Forecast, by Indication (2021-2032)

13.5.2. Market Revenue and Forecast, by Product & Service (2021-2032)

13.5.3. Market Revenue and Forecast, by Technology (2021-2032)

13.5.4. Market Revenue and Forecast, by Indication (2021-2032)

13.5.5. Market Revenue and Forecast, by End-User (2021-2032)

13.5.6. Brazil

13.5.6.1. Market Revenue and Forecast, by Indication (2021-2032)

13.5.6.2. Market Revenue and Forecast, by Product & Service (2021-2032)

13.5.6.3. Market Revenue and Forecast, by Technology (2021-2032)

13.5.6.4. Market Revenue and Forecast, by Indication (2021-2032)

13.5.7. Market Revenue and Forecast, by End-User (2021-2032)

13.5.8. Rest of LATAM

13.5.8.1. Market Revenue and Forecast, by Indication (2021-2032)

13.5.8.2. Market Revenue and Forecast, by Product & Service (2021-2032)

13.5.8.3. Market Revenue and Forecast, by Technology (2021-2032)

13.5.8.4. Market Revenue and Forecast, by Indication (2021-2032)

13.5.8.5. Market Revenue and Forecast, by End-User (2021-2032)

Chapter 14. Company Profiles

14.1. F. Hoffmann-La Roche Ltd. (Switzerland)

14.1.1. Company Overview

14.1.2. Product Offerings

14.1.3. Financial Performance

14.1.4. Recent Initiatives

14.2. Agilent Technologies, Inc. (US)

14.2.1. Company Overview

14.2.2. Product Offerings

14.2.3. Financial Performance

14.2.4. Recent Initiatives

14.3. Qiagen N.V. (Germany)

14.3.1. Company Overview

14.3.2. Product Offerings

14.3.3. Financial Performance

14.3.4. Recent Initiatives

14.4. Thermo Fisher Scientific, Inc. (US)

14.4.1. Company Overview

14.4.2. Product Offerings

14.4.3. Financial Performance

14.4.4. Recent Initiatives

14.5. Abbott Laboratories, Inc. (US)

14.5.1. Company Overview

14.5.2. Product Offerings

14.5.3. Financial Performance

14.5.4. Recent Initiatives

Chapter 15. Research Methodology

15.1. Primary Research

15.2. Secondary Research

15.3. Assumptions

Chapter 16. Appendix

16.1. About Us

16.2. Glossary of Terms

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