Personalised Medicine and Companion Diagnostics: Market Opportunity
What Are Companion Diagnostics?
A companion diagnostic (CDx) is an in vitro diagnostic device used as a condition of approval for a specific drug or biologic — the test identifies patients who will benefit from (or be harmed by) the targeted therapy. The canonical example: KRAS mutation testing to identify colorectal cancer patients who will not respond to EGFR inhibitors (cetuximab, panitumumab).
CDx are unique in that they are co-developed and co-approved with their paired drug — the FDA, EMA, and other regulatory authorities approve the diagnostic and the drug simultaneously. This creates a mandatory demand driver: every patient who receives the drug must first be tested with the approved CDx or equivalent validated assay.
Part 02The Global CDx Market — Size and Growth Drivers
| Metric | Value (2025) |
|---|---|
| Global CDx market size | USD ~7.8 billion |
| Projected market size (2030) | USD ~18.5 billion |
| CAGR (2025–2030) | ~16.2% |
| Oncology share of CDx market | >85% |
| FDA-approved CDx (cumulative) | Over 60 (as of 2025) |
| Fastest-growing CDx technology | Next-Generation Sequencing (NGS) panels |
| Key therapeutic areas | Lung cancer (NSCLC), breast cancer (HER2), colorectal cancer (KRAS/NRAS/BRAF), haematology (BCR-ABL) |
Key CDx Technology Categories
- IHC (Immunohistochemistry): PD-L1 expression testing for immune checkpoint inhibitors (pembrolizumab, nivolumab) — the highest-volume CDx globally
- FISH/CISH: HER2 gene amplification in breast and gastric cancer
- PCR-based mutation assays: EGFR, KRAS, BRAF, BRCA mutation testing — largely automated now on platforms like cobas (Roche) and therascreen (Qiagen)
- NGS tumour profiling panels: FoundationOne CDx (Foundation Medicine/Roche), MSK-IMPACT, Tempus — 300+ gene panels detecting all mutation types simultaneously
- Liquid biopsy (ctDNA): Circulating tumour DNA from blood samples — non-invasive, enables treatment monitoring and resistance detection
- Pharmacogenomics (PGx): Germline variants predicting drug metabolism — CYP2D6, CYP2C19 for psychiatry and cardiology drug dosing
Regulatory Pathway for CDx
CDx face a more demanding regulatory pathway than standard IVDs because they are linked to drug approval:
- EU — IVDR Class C or D: CDx are classified as Class C or D under IVDR — the most stringent IVD categories requiring Notified Body review of the full technical dossier and clinical evidence. IVDR Class C Notified Body submission deadline: May 2027.
- FDA — PMA or 510(k) for CDx: Most CDx require PMA (Premarket Approval) alongside the drug BLA/NDA — or 510(k) when a predicate CDx exists for the same drug-target combination
- Co-development: Regulatory agencies strongly prefer that CDx are developed in parallel with the drug, using clinical samples from Phase III trials. Retrospective CDx development is possible but more complex.
Opportunities for Turkish IVD Manufacturers
Turkish IVD manufacturers are well-positioned to participate in the CDx ecosystem at several levels:
- Open-system NGS reagent kits: Many emerging market oncology laboratories use open NGS systems (Illumina, Thermo Fisher platforms) with third-party library preparation kits. Turkish manufacturers capable of producing CE-IVD marked NGS library preparation reagents can supply this growing market.
- IHC antibody-based kits: PD-L1, HER2, and hormone receptor IHC kits are high-volume products used in pathology laboratories across emerging markets. Turkish manufacturers with IHC kit capability and IVDR-compliant technical files are well-positioned.
- PCR-based mutation assays: For markets where NGS is not yet standard (many African and Middle Eastern markets), PCR-based EGFR, KRAS, and BRAF mutation assays remain the standard of care and represent an accessible product category for Turkish IVD manufacturers.
- Distribution: Turkish distributors in GCC, North Africa, and the Balkans can build CDx-specialist portfolios partnering with established CDx platforms (Roche, Qiagen, Abbott) as authorised regional distributors.
Pharmacogenomics — The Next CDx Wave
While oncology CDx dominates today's market, pharmacogenomics (PGx) — testing for genetic variants that affect drug metabolism — is the next major growth wave. PGx applications in psychiatry (antidepressant dosing based on CYP2D6/CYP2C19 status), cardiology (clopidogrel effectiveness based on CYP2C19), and pain management are entering mainstream clinical practice.
PGx testing is performed once per patient lifetime (germline testing) but has high unit value (USD 200–500 per panel). The key technology is SNP genotyping or targeted NGS of pharmacogene panels. Turkish clinical chemistry and molecular diagnostics manufacturers should consider PGx as a product diversification avenue given growing reimbursement support in EU and GCC markets.