The Companion Diagnostics Market was estimated at USD 8.68 billion in 2023 and is poised to reach at 20.6 billion in 2031 anticipated to expand at a compound annual growth rate approx. CAGR of 11.40% for the forecast period of 2024-2031.
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In the field of personalised medicine, where therapies are customised for individual patients based on their unique traits, such as their genetic make-up or molecular profile, companion diagnostics play a critical role. Companion Diagnostics helps to optimise the use of costly medications, enhance treatment results, and prevent unneeded side effects by identifying patients who are more likely to respond to a certain therapy. By locating particular biomarkers or genetic variants linked to the illness or therapy response, companion diagnostics can be created. These biomarkers may be genes, proteins, or other quantifiable signs that offer important details about the patient's illness condition or propensity to respond to a certain medication. Health regulatory agencies like the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) are in charge of monitoring the development and approval of companion diagnostics. To ensure Companion Diagnostics' dependability and clinical value, regulatory bodies assess its safety, efficacy, and analytical validity. Pharmaceutical and diagnostic businesses frequently work together on the development and commercialization of Companion Diagnostics. The treatment drugs are supplied by pharmaceutical firms, while the companion diagnostic tests are developed and validated by diagnostic businesses. By working together, the medicine and diagnostic test are exploited to their fullest potential for patient benefit. Numerous medical specialities, such as cancer, infectious diseases, cardiovascular disorders, neurology, and others, employ companion diagnostics. Companion Diagnostics, for instance, can find certain mutations or biomarkers in oncology that show a patient's receptivity to various cancer therapy.
DRIVERS
Individualized Medicine The prevalence of complex diseases is rising.
Regulatory Assistance.
By enabling tailored therapy, companion diagnostics are essential in the age of personalized medicine. The introduction of companion diagnostics is being driven by the rising desire for individualized treatment plans. Accurate diagnostic tools are required due to the growth in complicated illnesses including cancer, genetic abnormalities, and infectious infections. Companion diagnostics provide accurate illness characterization and diagnosis, enabling more individualized therapy choices. Companion diagnostics are valuable, and regulatory organizations like the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have established rules for their creation and approval. Positive regulatory backing promotes market expansion.
RESTRAIN
High development costs, difficulties with reimbursement, and a lack of companion diagnostic biomarkers.
Companion diagnostic development requires extensive research, development, and validation procedures. Companion diagnostic tests may not be as accessible or affordable due to these high expenses. varied healthcare systems and geographical areas have varied companion diagnostics reimbursement and coverage regulations. Market expansion may be hampered by the absence of standardized reimbursement mechanisms and reimbursement uncertainty. It might be difficult to find and validate appropriate biomarkers for companion diagnostics. The creation and use of companion diagnostics are directly impacted by the availability of validated biomarkers.
OPPORTUNITY
Emerging Technologies.
Technology Advances Growing Collaborations.
Beyond cancer, additional treatment fields including cardiovascular disease, infectious illnesses, and neurological disorders are now using companion diagnostics. This diversity offers fresh chances to grow the industry. Technology developments like liquid biopsy, digital pathology, and next-generation sequencing (NGS) are improving the efficiency and precision of companion diagnostics. These developments pave the way for increased clinical usefulness and diagnostic precision. The development of companion diagnostics is being promoted by increased cooperation between pharmaceutical firms, diagnostic manufacturers, and research organizations. The acceptance and marketing of companion diagnostic items can be sped up by collaborative initiatives.
CHALLENGES
Market Access Barriers Complex Regulatory Environment.
Adoption and Education of Doctors.
Companion diagnostics' regulatory environment might be complicated and dynamic. Developers and manufacturers face difficulties adhering to regulatory criteria, including clinical validation and securing required approvals. Due to varied payment practices, intellectual property rights, and market competitiveness, companion diagnostics confront challenges to market availability. Strategic market entry strategy is required to overcome these obstacles. Companion diagnostics' successful incorporation into clinical practice depends heavily on physician knowledge, comprehension, and uptake. To make healthcare personnel aware of the advantages and practicality of companion diagnostics, education programmers are required.
Regulatory agencies and systems may experience disruptions or adjustments during times of conflict. This may have an effect on Companion Diagnostics' clearance and approval, as well as the application of pertinent rules and regulations. The market entry of novel diagnostic tests might be slowed down by regulatory delays or revisions.
Priorities in healthcare frequently shift towards emergency treatment and essential healthcare services during times of conflict and humanitarian catastrophes. Companion Diagnostics, which are often employed in personalised medicine and targeted therapeutics, could attract less money and attention than urgent medical need.
IMPACT OF ONGOING RECESSION
It's important to keep in mind that a recession's impact on the market for companion diagnostics may change based on the length and severity of the economic downturn in various geographic regions. Furthermore, during a downturn, changes in healthcare technology, lower healthcare prices, a delay in integrating new technology, a reduction in access to healthcare, the impact of the pharmaceutical sector on the structure of the healthcare system, and governmental restrictions can all have an impact on market dynamics. The market for companion diagnostics is expanding at an accelerated rate due to factors such as the growing use of personalised medications, a rise in adverse drug reactions (ADRs), and an increase in the number of unmet requirements for cancer treatment. The business is seeing favourable expansion thanks to rising healthcare costs worldwide and improvements in diagnostic technology.
By Technology Type
Frequency Immunohistochemistry
Polymerase Chain Reaction (PCR)
In Situ Hybridization
Others
By Indication
Oncology
Neurology
Others
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North America
USA
Canada
Mexico
Europe
Germany
UK
France
Italy
Spain
The Netherlands
Rest of Europe
Asia-Pacific
Japan
South Korea
China
India
Australia
Rest of Asia-Pacific
The Middle East & Africa
Israel
UAE
South Africa
Rest of the Middle East & Africa
Latin America
Brazil
Argentina
Rest of Latin American
North America:
In 2021, North America brought in USD 2.35 billion. The domination of the region is ascribed to a greater frequency of cancer and other chronic diseases as well as a rise in the use of sophisticated CDx tests in the area.
Europe:
On the other hand, it is expected that in terms of revenue, Europe would rank second internationally in 2021. The expansion of cooperation between local pharmaceutical firms and companion diagnostic manufacturers is credited with the region's success.
The major key players are Agilent Technologies, Inc., Illumina, Inc., QIAGEN N.V., Thermo Fisher Scientific, Inc., F. Hoffmann-La Roche Ltd., ARUP Laboratories, Abbott, Myriad Genetics, Inc., bioMérieux SA, Invivoscribe, Inc., and others.
F. Hoffmann-La Roche Ltd;
In October 2022, Roche announced they have received approval from the FDA for the first companion diagnostic to identify patients with HER2-low metastatic breast cancer
Illumina, Inc:
In May 2022, Illumina, Inc. announced the addition of a companion diagnostic (CDx) indication to its CE-marked in vitro diagnostic TruSight Oncology (TSO) Comprehensive (EU) test.
| Report Attributes | Details |
| Market Size in 2023 | US$ 8.68 Bn |
| Market Size by 2031 | US$ 20.6 Bn |
| CAGR | CAGR of 11.40% From 2024 to 2031 |
| Base Year | 2023 |
| Forecast Period | 2024-2031 |
| Historical Data | 2020-2022 |
| Report Scope & Coverage | Market Size, Segments Analysis, Competitive Landscape, Regional Analysis, DROC & SWOT Analysis, Forecast Outlook |
| Key Segments | • By Technology Type (Frequency Immunohistochemistry, Polymerase Chain Reaction (PCR), Next Generation Sequencing (NGS), In Situ Hybridization, Others) • By Indication (Oncology, Neurology, Others) |
| Regional Analysis/Coverage | North America (USA, Canada, Mexico), Europe (Germany, UK, France, Italy, Spain, Netherlands, Rest of Europe), Asia-Pacific (Japan, South Korea, China, India, Australia, Rest of Asia-Pacific), The Middle East & Africa (Israel, UAE, South Africa, Rest of Middle East & Africa), Latin America (Brazil, Argentina, Rest of Latin America) |
| Company Profiles | Agilent Technologies, Inc., Illumina, Inc., QIAGEN N.V., Thermo Fisher Scientific, Inc., F. Hoffmann-La Roche Ltd., ARUP Laboratories, Abbott, Myriad Genetics, Inc., bioMérieux SA, Invivoscribe, Inc., and others |
| Key Drivers | • Individualized Medicine The prevalence of complex diseases is rising. • Regulatory Assistance. |
| Market Opportunities | • Emerging Technologies. • Technology Advances Growing Collaborations. |
Ans: The CAGR Growth rate of Companion Diagnostics Market is approx. CAGR 11.2% for the forecast period of 2023-2030.
Ans: The projected market size of Companion Diagnostics USD 7.8 billion in 2022 and is poised to reach at 18.2 billion in 2030.
Ans: The major key players are Agilent Technologies, Inc., Illumina, Inc., QIAGEN N.V., Thermo Fisher Scientific, Inc., F. Hoffmann-La Roche Ltd., ARUP Laboratories, Abbott, Myriad Genetics, Inc., bioMérieux SA, Invivoscribe, Inc., and others.
Ans: The market will expand due to the rising incidence of cancer globally.
Ans: During the projected period, the polymerase chain reaction sector is anticipated to be in the lead.
Table of Contents
1. Introduction
1.1 Market Definition
1.2 Scope
1.3 Research Assumptions
2. Research Methodology
3. Market Dynamics
3.1 Drivers
3.2 Restraints
3.3 Opportunities
3.4 Challenges
4. Impact Analysis
4.1 Impact of ongoing Recession
4.1.1 Introduction
4.1.2 Impact on major economies
4.1.2.1 US
4.1.2.2 Canada
4.1.2.3 Germany
4.1.2.4 France
4.1.2.5 United Kingdom
4.1.2.6 China
4.1.2.7 Japan
4.1.2.8 South Korea
4.1.2.9 Rest of the World
5. Value Chain Analysis
6. Porter’s 5 forces model
7. PEST Analysis
8. Companion Diagnostics Market, By Technology Type
8.1 Frequency Immunohistochemistry
8.2 Polymerase Chain Reaction (PCR)
8.3 Next Generation Sequencing (NGS)
8.4 In Situ Hybridization
8.5 Others
9. Companion Diagnostics Market, By Indication
9.1 Oncology
9.2 Neurology
9.3 Others
10. Regional Analysis
10.1 Introduction
10.2 North America
10.2.1 North America Companion Diagnostics Market, by country
10.2.2North America Companion Diagnostics Market by Technology Type
10.2.3 North America Companion Diagnostics Market by Indication
10.2.4 USA
10.2.4.1 USA Companion Diagnostics Market by Technology Type
10.2.4.2 USA Companion Diagnostics Market by Indication
10.2.7 Canada
10.2.7.1 Canada Companion Diagnostics Market by Technology Type
10.2.7.2 Canada Companion Diagnostics Market by Indication
10.2.8 Mexico
10.2.8.1 Mexico Companion Diagnostics Market by Technology Type
10.2.8.2 Mexico Companion Diagnostics Market by Indication
10.3 Europe
10.3.1 Europe Companion Diagnostics Market by country
1.3.3.2 Europe Companion Diagnostics Market by Technology Type
10.3.3 Europe Companion Diagnostics Market by Indication
10.3.6 Germany
10.3.6.1 Germany Companion Diagnostics Market by Technology Type
10.3.6.2 Germany Companion Diagnostics Market by Indication
10.3.7 UK
10.3.7.1 UK Companion Diagnostics Market by Technology Type
10.3.7.2 UK Companion Diagnostics Market by Indication
10.3.8 France
10.3.8.1 France Companion Diagnostics Market by Technology Type
10.3.8.2 France Companion Diagnostics Market by Indication
10.3.9 Italy
10.3.9.1 Italy Companion Diagnostics Market by Technology Type
10.3.9.2 Italy Companion Diagnostics Market by Indication
10.3.10 Spain
10.3.10.1 Spain Companion Diagnostics Market by Technology Type
10.3.10.2 Spain Companion Diagnostics Market by Indication
10.3.11 The Netherlands
10.3.11.1 Netherlands Companion Diagnostics Market by Technology Type
10.3.11.2 Netherlands Companion Diagnostics Market by Indication
10.3.12 Rest of Europe
10.3.12.1 Rest of Europe Companion Diagnostics Market by Technology Type
10.3.12.2 Rest of Europe Companion Diagnostics Market by Indication
10.4 Asia-Pacific
10.4.1 Asia Pacific Companion Diagnostics Market by country
10.4.2 Asia Pacific Companion Diagnostics Market by Technology Type
10.4.3 Asia Pacific Companion Diagnostics Market by Indication
10.4.6 Japan
10.4.6.1 Japan Companion Diagnostics Market by Technology Type
10.4.6.2 Japan Companion Diagnostics Market by Indication
10.4.7 South Korea
10.4.7.1 South Korea Companion Diagnostics Market by Technology Type
10.4.7.2 South Korea Companion Diagnostics Market by Indication
10.4.8 China
10.4.8.1 China Companion Diagnostics Market by Technology Type
10.4.8.2 China Companion Diagnostics Market by Indication
10.4.9 India
10.4.9.1 India Companion Diagnostics Market by Technology Type
10.4.9.2 India Companion Diagnostics Market by Indication
10.4.10 Australia
10.4.10.1 Australia Companion Diagnostics Market by Technology Type
10.4.10.2 Australia Companion Diagnostics Market by Indication
10.4.11 Rest of Asia-Pacific
10.4.11.1 APAC Companion Diagnostics Market by Technology Type
10.4.11.2 APAC Companion Diagnostics Market by Indication
10.5 The Middle East & Africa
10.5.1 The Middle East & Africa Companion Diagnostics Market by country
10.5.2 The Middle East & Africa Companion Diagnostics Market by Technology Type
10.5.3 The Middle East & Africa Companion Diagnostics Market by Indication
10.5.6 Israel
10.5.6.1 Israel Companion Diagnostics Market by Technology Type
10.5.6.2 Israel Companion Diagnostics Market by Indication
10.5.7 UAE
10.5.7.1 UAE Companion Diagnostics Market by Technology Type
10.5.7.2 UAE Companion Diagnostics Market by Indication
10.5.8 South Africa
10.5.8.1 South Africa Companion Diagnostics Market by Technology Type
10.5.8.2 South Africa Companion Diagnostics Market by Indication
10.5.9 Rest of Middle East & Africa
10.5.9.1 Rest of Middle East & Asia Companion Diagnostics Market by Technology Type
10.5.9.2 Rest of Middle East & Asia Companion Diagnostics Market by Indication
10.6 Latin America
10.6.1 Latin America Companion Diagnostics Market by country
10.6.2 Latin America Companion Diagnostics Market by Technology Type
10.6.3 Latin America Companion Diagnostics Market by Indication
10.6.6 Brazil
10.6.6.1 Brazil Companion Diagnostics Market by Technology Type
10.6.6.2 Brazil Africa Companion Diagnostics Market by Indication
10.6.7 Argentina
10.6.7.1 Argentina Companion Diagnostics Market by Technology Type
10.6.7.2 Argentina Companion Diagnostics Market by Indication
10.6.8 Rest of Latin America
10.6.8.1 Rest of Latin America Companion Diagnostics Market by Technology Type
10.6.8.2 Rest of Latin America Companion Diagnostics Market by Indication
11. Company profile
11.1 Agilent Technologies, Inc.
11.1.1 Market Overview
11.1.2 Financials
11.1.3 Treatment/Services/Offerings
11.1.4 SWOT Analysis
11.1.5 The SNS View
11.2 Illumina, Inc.
11.2.1 Market Overview
11.2.2 Financials
11.2.3 Treatment/Services/Offerings
11.2.4 SWOT Analysis
11.2.5 The SNS View
11.3 QIAGEN N.V.
11.3.1 Market Overview
11.3.2 Financials
11.3.3 Treatment/Services/Offerings
11.3.4 SWOT Analysis
11.3.5 The SNS View
11.4 Thermos Fisher Scientific, Inc.
11.4.1 Market Overview
11.4.2 Financials
11.4.3 Treatment/Services/Offerings
11.4.4 SWOT Analysis
11.4.5 The SNS View
11.5 F. Hoffmann-La Roche Ltd.
11.5.1 Market Overview
11.5.2 Financials
11.5.3 Treatment/Services/Offerings
11.5.4 SWOT Analysis
11.5.5 The SNS View
11.6 ARUP Laboratories.
11.6.1 Market Overview
11.6.2 Financials
11.6.3 Treatment/Services/Offerings
11.6.4 SWOT Analysis
11.6.5 The SNS View
11.7 Abbott.
11.7.1 Market Overview
11.7.2 Financials
11.7.3 Treatment/Services/Offerings
11.7.4 SWOT Analysis
11.7.5 The SNS View
11.8 Myriad Genetics, Inc.
11.8.1 Market Overview
11.8.2 Financials
11.8.3 Treatment/Services/Offerings
11.8.4 SWOT Analysis
11.8.5 The SNS View
11.9 Bio Meraux SA.
11.9.1 Market Overview
11.9.2 Financials
11.9.3 Treatment/Services/Offerings
11.9.4 SWOT Analysis
11.9.5 The SNS View
11.10 MiniScribe, Inc.
11.10.1 Market Overview
11.10.2 Financials
11.10.3 Treatment/Services/Offerings
11.10.4 SWOT Analysis
11.10.5 The SNS View
12. Competitive Landscape
12.1 Competitive Benchmarking
12.2 Market Share analysis
12.3 Recent Developments
13. Use Case and Best Practices
14. Conclusion
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