Companion Diagnostic (CDx) Development: Enhancing Personalized Treatment
Roots Analysis
Market research & consulting services in the pharma / biopharma, medical devices & contract manufacturing domains
The USFDA has provided guidelines to streamline the co-development of CDx and therapeutic products, aiming to expedite access to innovative treatments for patients suffering from serious and life-threatening illnesses. It is worth highlighting that CDx-guided drug development can lead to a reduction in clinical trial costs by nearly 60%. Till date, close to 170 companion diagnostics have been approved by the USFDA.
For detailed information:
Email: [email protected]
Competitive Landscape of Companion Diagnostics (CDx) Development Market
According to Roots Analysis, the current market landscape features the presence of over 155 contract service providers offering a wide range of services related to companion diagnostics (CDx) development. These services encompass biomarker identification and discovery, biomarker selection and development, assay development, analytical validation, clinical validation, regulatory assistance, manufacturing, and commercialization. Notably, more than 90% of these service providers hold regulatory accreditations and certifications like ISO, CLIA, CAP, GLP, and GCP.
Within the companion diagnostic (CDx) development industry, majority of the service providers are headquartered in North America (~60%) followed by Europe and Asia-Pacific. Further, the companion diagnostic (CDx) development market features the presence of small, mid-sized and large companies having the required expertise to offer contract manufacturing services across the globe. These companies are actively engaging in strategic initiatives such as forming partnerships, expanding capabilities, and increasing capacities to meet the rising demand for companion diagnostics.
Companion Diagnostics (CDx) Development Market Trends: Increasing Partnerships and Collaborations with and Amongst the Service Providers to Foster Progress and Innovation
The companion diagnostics (CDx) development market is experiencing significant market growth, driven by the increasing number of partnerships and collaborations between diagnostic service providers and other stakeholders. Majority of these partnerships are mergers and acquisitions, and product development and commercialization agreements, as companies strive to advance their service offerings for various applications and therapeutic areas within the global market. For instance, Agilent Technologies partnered with Incyte in January 2024 to develop CDx for hematological and oncological disorders, while Exact Sciences acquired Resolution Bioscience in September 2023 to enhance its NGS-based CDx capabilities. These strategic alliances are expected to contribute to the market's growth during the forecast period.
领英推荐
Companion Diagnostics (CDx) Development Market Size
The global market opportunity for companion diagnostics (CDx) development is estimated to be $0.57 billion in 2024. In terms of the type of services offered, the market size for feasibility studies is anticipated to grow at a relatively higher CAGR of 12% during the forecast period, till 2035. The market growth is primarily fueled by the increasing need for identification and development of the correct biomarker as it determines the success of all the subsequent steps, namely assay development, analytical validation, clinical validation and manufacturing in the companion diagnostic development process.
Regional Analysis: North America Holds the Largest Companion Diagnostics (CDx) Development Market Share
North America currently dominates the companion diagnostics (CDx) development market, accounting for 65% of the market value due to stringent regulatory guidelines and strategic partnerships between stakeholders. However, the Asia-Pacific region is projected to exhibit a higher compound annual growth rate (CAGR) of 11.3% during the forecast period. This growth is driven by an increasing demand for early cancer diagnosis and the implementation of supportive research initiatives in countries like China, Japan and India. China, with its fast-growing population and increasing demand for personalized medical care, is forecasted to be the fastest-growing regional market in the Asia-Pacific region. In Japan, the growing elderly population and rising cancer incidence are expected to contribute to the market's expansion. Meanwhile, in India, the government's support for in-vitro diagnostics (IVD) systems and public-private partnerships are anticipated to propel the market's demand.
All your Questions Related to Companion Diagnostic (CDx) Development Market Answered in this Report
The Companion Diagnostic (CDx) Development Market (3rd Edition), till 2035 report features extensive research of the current market landscape, market size, market forecast and future opportunities for the companies involved in the companion diagnostic (CDx) development industry. The report answers many key questions related to this market. Click on the below link to know more about this emerging area of research.
About Roots Analysis
Roots Analysis is a global leader in the pharma / biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists and strategic investors for more than a decade, we offer a highly analytical / data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights.