The market for Companion Diagnostics Development Services is valued at over USD 800 million; Roots Analysis projects growth at an annualized rate of ~5% through 2030.
A record number of personalized therapeutic products have been approved in the US in recent years, creating an urgent need for companion diagnostics and prompting many drug developers to actively seek external support and expertise. It is estimated that around 80% of innovative companies rely on external companion diagnostics developers, mainly due to the lack of required in-house expertise.
On the other hand, numerous contract service providers are offering a broad portfolio of diagnostic test/assay development services. Such companies are known for having extensive technical knowledge and experience in working with cutting-edge analytical tools and technologies.
The report offers a comprehensive study of the current market landscape and offers an informed opinion on the likely adoption of diagnostic development services over the next decade. It includes an in-depth analysis that highlights the capabilities of the different players in this field. It includes transcripts of interviews conducted with the following senior representatives from the participating companies:
- Anton Iliuk (President, CTO Tymora Analytical Operations)
- Paul Kortschak (Senior Vice President, Novodiax)
- Pablo Ortiz (Managing Director, OWL Metabolomics)
- Lawrence M. Weiss (Scientific Director, NeoGenomics Laboratories)
KEY MARKET INSIGHTS
- Currently, more than 180 companies from different regions of the world offer services for the development of complementary diagnostic tests.
- A variety of services are now available across the diagnostic development supply chain, including assays based on a wide range of analytical techniques, particularly in developed regions.
- Many pharmaceutical players are actively seeking partnerships with providers of complementary diagnostic services to benefit from their expertise in this field.
- The increasing interest in this area is reflected in the number of partnerships that have been established in the recent past, involving both international and indigenous stakeholders and focusing on a variety of end goals.
- To gain an advantage over today's competition, companies operating in this space are increasingly focusing on integrating advanced service offerings into their respective portfolios.
- The value chain includes drug and diagnostic developers, service providers, and other key stakeholders, each with their priorities and needs.
- Given the growing demand for precision medicine, the market for complementary diagnostic services is expected to grow at double-digit rates; The opportunity will likely be spread across different regions and techniques.
- In the long term, the growth of the market is expected to be driven by clinical trials based on novel tumor markers identified as promising biological targets for companion diagnostic development.
- A detailed analysis of several relevant parameters (i.e., number of developer-sponsored clinical trials and time to market of proprietary personalized medical devices) is likely to be associated with providers of complementary diagnostic services in the future.
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OTHER KEY MARKET INSIGHTS -
A detailed assessment of the current market landscape of companies providing complementary diagnostic services, including information on the type of services offered, the type of analytical technique used, and regulatory certifications/accreditations, as well as other company-specific details (e.g., year of incorporation, company size, and geographic location).
Tabular profiles of providers of complementary diagnostic services (preselected based on the number of services offered) with a general description of the company, their financial information (if available), and details of the portfolio of services related to complementary diagnostics. Additionally, each profile comes with a list of potential strategies that these players can employ to help future growth.
A comparative analysis of the needs of the different stakeholders (drug developers, diagnostic developers, testing laboratories, clinicians, payers, and patients) involved in this field.
A discussion of the various steps of design operations, namely research and development, clinical product evaluation, manufacturing and assembly, payer negotiations and marketing/sales activities, supporting diagnostics, and the cost requirements at each of the stated phases.
An analysis of completed, ongoing, and planned clinical trials using disease-specific biomarkers. The analysis highlights important trends related to these clinical trials across various parameters such as study start year, study status, development phase, key indications, type of therapy, evaluated biomarkers, included patient population, and the regional distribution of the studies.
The report answers a wide range of questions, some of the top-rated questions answered are as follows:
- Who are the key players providing complementary diagnosis development services?
- What kind of partnership models are commonly adopted by stakeholders in this area?
- What different initiatives are being taken by the big pharmaceutical companies in this area?
- What are the cost requirements at each stage of companion diagnostic test development?
- Which development companies are likely to work with service providers in the foreseeable future?
- What are the current and long-term needs of the different actors in this field?
- How are the current and future market opportunities likely to be distributed among the key market segments?
The report includes the following companies that we have identified as key players in this space:
1. Almac Diagnostic Services
2. Asuragen
3. BARD1 Life Sciences
4. BioMarCare Technologies
5. Covance
6. gene curie
7. genius
8. Leica Biosystems
9. macro genre
10. MD Biosciences
11. R-Biopharm
12. researched
13. Tepnel Pharmaceutical Services
