Companion Diagnostics Market by Technology, Indication, End-user

List of Tables

[194 Pages Report] The Companion Diagnostics Market size was estimated at USD 6.64 billion in 2023 and expected to reach USD 7.30 billion in 2024, at a CAGR 10.65% to reach USD 13.49 billion by 2030.

Companion diagnostics are specialized tests designed to help healthcare professionals determine whether a particular medical treatment is effective for a patient or to identify the best dosage of medication for that individual. These tests are an integral part of personalized medicine, a medical approach that tailors treatment to the individual characteristics of each patient, such as their lifestyle, genetic makeup, and environment. Companion diagnostics are particularly prevalent in the management of certain cancers, where the effectiveness of the treatment can depend significantly on the genetic alterations present within the tumor. The push towards personalized medicine, where treatments are optimized for individual patient profiles, significantly drives the demand for companion diagnostics. Moreover, the development of targeted therapies, especially in oncology, necessitates companion diagnostics to identify patients who would most benefit from these treatments. However, the development and implementation of companion diagnostics can be costly, with inadequate reimbursement posing a significant barrier. Furthermore, technologies, including next-generation sequencing and digital PCR, are expanding the capabilities of companion diagnostics, allowing for more comprehensive genetic profiling poses significant opportunities for market growth.

KEY MARKET STATISTICS
Base Year [2023]	USD 6.64 billion
Estimated Year [2024]	USD 7.30 billion
Forecast Year [2030]	USD 13.49 billion
CAGR (%)	10.65%

Technology: Increasing preference of next-generation sequencing in precision medicine

Immunohistochemistry (IHC) is a technique used to diagnose diseases by detecting proteins in tissue section cells. It is widely employed in cancer diagnostics to identify specific markers that help in determining the type of cancer and its potential responsiveness to treatments. IHC is preferred when the diagnostic focus is on the localization and qualitative assessment of protein expressions in tissue samples. Situ Hybridization (ISH) permits the detection and localization of specific DNA or RNA sequences in tissue sections or cell samples, providing insights into gene expression and chromosomal abnormalities. This technology is particularly valuable in detecting specific gene rearrangements or amplifications associated with certain cancers. Next-generation sequencing (NGS) offers comprehensive insights into the genetic makeup by allowing the sequencing of entire genomes or targeted regions of interest at an unprecedented speed and scale. NGS is the technology of choice for applications requiring a broad understanding of genetic variations, including small mutations, copy number variations, and others that may be relevant for selecting targeted therapies across various diseases. Polymerase Chain Reaction (PCR) is a technique utilized to strengthen small segments of DNA or RNA, making it easier to conduct further analyses. It stands as one of the most widely used technologies due to its simplicity, sensitivity, and specificity. PCR is highly favored for its rapid turnaround times, making it ideal for diseases requiring quick decision-making for therapy selection.

End-user: Expansion of pharmaceutical and biopharmaceutical sector driving the significance of companion diagnostics

Pharmaceutical and biopharmaceutical companies engaged primarily in the discovery, development, and commercialization of therapeutics. The integration of companion diagnostics is crucial in the drug development process, especially for targeted therapies, including those used in cancer treatment. These companies need companion diagnostics to monitor responses to therapy and adjust treatment plans as necessary. Reference laboratories are specialized facilities that perform complex and advanced diagnostic testing, often not available in standard hospital labs. They play a critical role in the implementation of companion diagnostics by providing high-complexity tests that help in the identification of biomarkers associated with specific diseases and treatment responses.

Regional Insights

In the Americas, the demand for companion diagnostics is driven by a robust healthcare infrastructure, heightened awareness about personalized medicine, and significant research and development activities. The U.S. Food and Drug Administration (FDA) has been proactive in approving companion diagnostics, especially for cancer treatments, which underscores the importance of these tools in therapeutic decisions. Investments and initiatives in this region are primarily focused on oncology, cardiovascular diseases, and neurology, reflecting a broader trend toward personalized healthcare solutions. EU countries exhibit a high demand for companion diagnostics, supported by a strong regulatory framework that promotes innovation while ensuring patient safety. The European Medicines Agency (EMA) plays an vital role in the approval of companion diagnostics across Europe. Consumer needs in the EU are sophisticated, with a high expectation for personalized healthcare services. Middle Eastern countries, such as the United Arab Emirates and Saudi Arabia, are witnessing a growing interest in personalized medicine, which is supported by government initiatives and investments in healthcare infrastructure. Africa, however, faces significant hurdles due to limited healthcare infrastructure and access. In APAC, the market for companion diagnostics is expanding swiftly, fueled by government initiatives aimed at improving healthcare standards and embracing personalized medicine. The government has launched several initiatives to promote precision medicine, including significant investments in genetic research. This focus is gradually translating into increased demand for companion diagnostics, particularly in urban areas with better healthcare facilities.

FPNV Positioning Matrix

The FPNV Positioning Matrix is pivotal in evaluating the Companion Diagnostics Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

Market Share Analysis

The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Companion Diagnostics Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

Key Company Profiles

The report delves into recent significant developments in the Companion Diagnostics Market, highlighting leading vendors and their innovative profiles. These include Abbott Laboratories, Abnova Corporation, Agendia, Inc., Agilent Technologies, Inc., Almac Group, Amoy Diagnostics Co., Ltd., ARUP Laboratories, Bio-Techne Corporation, Biogenex Laboratories, Inc, bioMerieux SA, Danaher Corporation, Eli Lilly and Company, F. Hoffmann-La Roche AG, Guardant Health, Inc, ICON PLC, Illumina, Inc., Invivoscribe Technologies, Inc., Myriad Genetics, Inc., NG biotech, QIAGEN N.V., R-Biopharm AG, Siemens AG, Sysmex Corporation, and Thermo Fisher Scientific Inc..

Market Segmentation & Coverage

This research report categorizes the Companion Diagnostics Market to forecast the revenues and analyze trends in each of the following sub-markets:

Technology
- Immunohistochemistry
- In Situ Hybridization
- Next-Generation Sequencing
- Polymerase Chain Reaction

Indication
- Cancer
  - Blood Cancer
  - Breast Cancer
  - Colorectal Cancer
  - Lung Cancer

Cardiovascular Diseases
Infectious Diseases
Neurological Disorders

End-user
- Pharmaceutical & Biopharmaceutical Companies
- Reference Laboratories

Region
- Americas
  - Argentina
  - Brazil
  - Canada
  - Mexico
  - United States
    - California
    - Florida
    - Illinois
    - New York
    - Ohio
    - Pennsylvania
    - Texas
- Asia-Pacific
  - Australia
  - China
  - India
  - Indonesia
  - Japan
  - Malaysia
  - Philippines
  - Singapore
  - South Korea
  - Taiwan
  - Thailand
  - Vietnam

Europe, Middle East & Africa
- Denmark
- Egypt
- Finland
- France
- Germany
- Israel
- Italy
- Netherlands
- Nigeria
- Norway
- Poland
- Qatar
- Russia
- Saudi Arabia
- South Africa
- Spain
- Sweden
- Switzerland
- Turkey
- United Arab Emirates
- United Kingdom

The report offers valuable insights on the following aspects:

1. Market Penetration: It presents comprehensive information on the market provided by key players.

2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.

3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.

4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.

5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.

The report addresses key questions such as:

1. What is the market size and forecast of the Companion Diagnostics Market?

2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Companion Diagnostics Market?

3. What are the technology trends and regulatory frameworks in the Companion Diagnostics Market?

4. What is the market share of the leading vendors in the Companion Diagnostics Market?

5. Which modes and strategic moves are suitable for entering the Companion Diagnostics Market?

Product Code: MRR-433AB1DC2871

1. Preface

1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders

2. Research Methodology

2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

5.1. Market Dynamics
- 5.1.1. Drivers
  - 5.1.1.1. Growing significance of companion diagnostics in drug development
  - 5.1.1.2. Increasing demand for personalized medicines and targeted therapy
  - 5.1.1.3. Rise in research and development for innovation in next generation sequencing
- 5.1.2. Restraints
  - 5.1.2.1. High costs associated with development and implementation of companion diagnostics
- 5.1.3. Opportunities
  - 5.1.3.1. Ongoing technological advancements in diagnostic techniques
  - 5.1.3.2. Favorable regulatory policies encouraging the development and approval of companion diagnostics
- 5.1.4. Challenges
  - 5.1.4.1. Reimbursement issues associated with companion diagnostic tests
5.2. Market Segmentation Analysis
- 5.2.1. Technology: Increasing preference of next-generation sequencing in precision medicine
- 5.2.2. End-user: Expansion of pharmaceutical and biopharmaceutical sector driving the significance of companion diagnostics
5.3. Market Disruption Analysis
5.4. Porter's Five Forces Analysis
- 5.4.1. Threat of New Entrants
- 5.4.2. Threat of Substitutes
- 5.4.3. Bargaining Power of Customers
- 5.4.4. Bargaining Power of Suppliers
- 5.4.5. Industry Rivalry
5.5. Value Chain & Critical Path Analysis
5.6. Pricing Analysis
5.7. Technology Analysis
5.8. Patent Analysis
5.9. Trade Analysis
5.10. Regulatory Framework Analysis

6. Companion Diagnostics Market, by Technology

6.1. Introduction
6.2. Immunohistochemistry
6.3. In Situ Hybridization
6.4. Next-Generation Sequencing
6.5. Polymerase Chain Reaction

7. Companion Diagnostics Market, by Indication

7.1. Introduction
7.2. Cancer
7.3. Cardiovascular Diseases
7.4. Infectious Diseases
7.5. Neurological Disorders

8. Companion Diagnostics Market, by End-user

8.1. Introduction
8.2. Pharmaceutical & Biopharmaceutical Companies
8.3. Reference Laboratories

9. Americas Companion Diagnostics Market

9.1. Introduction
9.2. Argentina
9.3. Brazil
9.4. Canada
9.5. Mexico
9.6. United States

10. Asia-Pacific Companion Diagnostics Market

10.1. Introduction
10.2. Australia
10.3. China
10.4. India
10.5. Indonesia
10.6. Japan
10.7. Malaysia
10.8. Philippines
10.9. Singapore
10.10. South Korea
10.11. Taiwan
10.12. Thailand
10.13. Vietnam

11. Europe, Middle East & Africa Companion Diagnostics Market

11.1. Introduction
11.2. Denmark
11.3. Egypt
11.4. Finland
11.5. France
11.6. Germany
11.7. Israel
11.8. Italy
11.9. Netherlands
11.10. Nigeria
11.11. Norway
11.12. Poland
11.13. Qatar
11.14. Russia
11.15. Saudi Arabia
11.16. South Africa
11.17. Spain
11.18. Sweden
11.19. Switzerland
11.20. Turkey
11.21. United Arab Emirates
11.22. United Kingdom

12. Competitive Landscape

12.1. Market Share Analysis, 2023
12.2. FPNV Positioning Matrix, 2023
12.3. Competitive Scenario Analysis
- 12.3.1. Innovative Partnership Between Thermo Fisher Scientific and Bayer Sets New Standard in Precision Cancer Care
- 12.3.2. Strategic Partnership between Agilent and Incyte Elevates Companion Diagnostic Development
- 12.3.3. Unlocking New Treatment Horizons: FDA Approves Capivasertib & Fulvestrant Combo for Advanced Breast Cancer, Backed by FoundationOne(R) CDx Diagnostic Advances
12.4. Strategy Analysis & Recommendation

13. Competitive Portfolio

13.1. Key Company Profiles
13.2. Key Product Portfolio