Companion Diagnostics Market by Technology (Immunohistochemistry, In Situ Hybridization, Next-Generation Sequencing), Indication (Cancer, Cardiovascular Diseases, Infectious Diseases), End-user - Global Forecast 2024-2030

Companion Diagnostics Market by Technology (Immunohistochemistry, In Situ Hybridization, Next-Generation Sequencing), Indication (Cancer, Cardiovascular Diseases, Infectious Diseases), End-user - Global Forecast 2024-2030

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.

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.

Market Insights

Market Dynamics

The market dynamics represent an ever-changing landscape of the Companion Diagnostics Market by providing actionable insights into factors, including supply and demand levels. Accounting for these factors helps design strategies, make investments, and formulate developments to capitalize on future opportunities. In addition, these factors assist in avoiding potential pitfalls related to political, geographical, technical, social, and economic conditions, highlighting consumer behaviors and influencing manufacturing costs and purchasing decisions.

Market Drivers

Growing significance of companion diagnostics in drug development
Increasing demand for personalized medicines and targeted therapy
Rise in research and development for innovation in next generation sequencing

Market Restraints

High costs associated with development and implementation of companion diagnostics

Market Opportunities

Ongoing technological advancements in diagnostic techniques
Favorable regulatory policies encouraging the development and approval of companion diagnostics

Market Challenges

Reimbursement issues associated with companion diagnostic tests

Market Segmentation Analysis

Technology: Increasing preference of next-generation sequencing in precision medicine
End-user: Expansion of pharmaceutical and biopharmaceutical sector driving the significance of companion diagnostics

Market Disruption Analysis

Porter’s Five Forces Analysis
Value Chain & Critical Path Analysis
Pricing Analysis
Technology Analysis
Patent Analysis
Trade Analysis
Regulatory Framework Analysis

FPNV Positioning Matrix

The FPNV positioning matrix is essential in evaluating the market positioning of the vendors in the Companion Diagnostics Market. This matrix offers a comprehensive assessment of vendors, examining critical metrics related to business strategy and product satisfaction. This in-depth assessment 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, namely 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 assessment of the current state of vendors in the Companion Diagnostics Market. By meticulously comparing and analyzing vendor contributions, companies are offered a greater understanding of their performance and the challenges they face when competing for market share. These contributions include overall revenue, customer base, and other vital metrics. 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 these illustrative details, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

Recent Developments

Innovative Partnership Between Thermo Fisher Scientific and Bayer Sets New Standard in Precision Cancer Care

Thermo Fisher Scientific has announced a groundbreaking collaboration with Bayer aimed at advancing precision oncology treatments through the development of companion diagnostic assays. Utilizing Thermo Fisher's cutting-edge Ion Torrent Genexus Dx System, this partnership is poised to revolutionize cancer care by enabling the rapid analysis of both liquid and tissue samples within 24 hours, thus facilitating quicker access to targeted therapies for patients.

Strategic Partnership between Agilent and Incyte Elevates Companion Diagnostic Development

Agilent Technologies has announced a strategic collaboration with pharmaceutical company Incyte to advance the development of companion diagnostics. This partnership aims to create diagnostic tests that accurately identify patients who can benefit from targeted treatments, particularly within Incyte’s hematology and oncology portfolio. This collaboration signifies a proactive step towards innovative patient care and a strengthened position in the diagnostics market.

Unlocking New Treatment Horizons: FDA Approves Capivasertib & Fulvestrant Combo for Advanced Breast Cancer, Backed by FoundationOne® CDx Diagnostic Advances

In a significant move towards enhancing treatment options for individuals with advanced hormone receptor-positive, HER2-negative breast cancer, the FDA greenlit the use of capivasertib in conjunction with fulvestrant. This approval targets patients battling locally advanced & metastatic cancer that exhibits specific genetic alterations (PIK3CA, AKT1, or PTEN), post at least one failed endocrine-based regimen, and recurrence within a year post adjuvant therapy.

Strategy Analysis & Recommendation

The strategic analysis is essential for organizations seeking a solid foothold in the global marketplace. Companies are better positioned to make informed decisions that align with their long-term aspirations by thoroughly evaluating their current standing in the Companion Diagnostics Market. This critical assessment involves a thorough analysis of the organization’s resources, capabilities, and overall performance to identify its core strengths and areas for improvement.

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, bioMérieux 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

Please Note: PDF & Excel + Online Access - 1 Year