Gene Panel Market - Growth Drivers and Challenges
Growth Drivers
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Government spending and reimbursement policies: There has been an increase in approvals from the government organization, which is further accelerating the adoption. For instance, the Medicare spending on gene panels reached USD 1.21 billion in 2023, fueled by widespread coverage for the testing of hereditary cancer. Additionally, in Germany, G-BA is now reimbursing 81% of the cancer panels based on NGS is further increasing patient access. Companies are aligning with the value-based reimbursement models to secure coverage. Also, the recognition of blood biomarker tests is increasing, resulting in higher investment.
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Rising disease prevalence and patient pool expansion: The cases of genetic disorders are mushrooming across the world. For instance, in Germany, the rare disease patient pool reached 4.1 million at the beginning of 2025. The National Health Service in the UK is planning to sequence 500,100 genomes by 2025, promoting the adoption. Also, there has been an increased newborn screening program, and prenatal testing cases are increasing the adoption of gene panels for early diagnosis. Precision medicine initiatives, such as oncology panels for targeted therapy selection for rendering personalized care, are propelling the clinical adoption.
- Technological innovations and integration: The advancements in the multi-cancer screening through cell-free DNA and AI-enabled analytics are in high demand. The next-generation sequencing is considered to be the backbone of the modern gene panels for enabling high throughput. Also, the amalgamation of AI and ML is revolutionizing the interpretation of the variants and reducing the turnaround time. The adoption of the liquid biopsy-based gene panels is allowing cancer detection through blood samples. These factors are bolstering the market growth during the forecasted period.
Historical Gene Panel Patient Growth (2010–2020)
|
Country |
2010 Patients (Millions) |
2020 Patients (Millions) |
Growth (%) |
|
USA |
1.1 |
5.8 |
384% |
|
Germany |
0.61 |
2.9 |
382% |
|
France |
0.42 |
2.1 |
424% |
|
Spain |
0.32 |
1.4 |
366% |
|
Australia |
0.21 |
1.1 |
451% |
|
Japan |
0.7 |
3.6 |
352% |
|
India |
0.51 |
3.8 |
661% |
|
China |
1.01 |
7.5 |
652% |
Revenue Feasibility Models for Gene Panel Market
|
Country |
Feasibility Model |
Revenue Growth (%) |
Time Period |
|
India |
Public-private partnership with diagnostic labs and insurance schemes (e.g., Ayushman Bharat) |
12% |
2022–2024 |
|
USA |
CMS-approved reimbursement pathways for oncology and rare disease gene panels |
15% |
2020–2023 |
|
France |
National Genomic Medicine Plan using decentralized lab networks and digital health registries |
18% |
2021–2024 |
|
China |
Volume-based procurement (VBP) plus regional government co-funding for genetic screening |
16% |
2021–2023 |
|
South Korea |
AI-enabled genomic panels integrated into public hospitals under the K-genome project |
13% |
2022–2024 |
|
Germany |
Digital health application (DiGA) registry with fast-track approvals for precision diagnostics |
11% |
2021–2023 |
Challenges
- Pricing restraints and reimbursement barriers: Payers and governments impose stringent price caps to limit the profitability and access to the market. For instance, Medicaid in the U.S. covers only 35.2% of the eligible patients for the hereditary cancer panels owing to the exorbitant costs of the treatment. Similarly, in Germany, price negotiation via G-BA forces Illumina to lower the panel costs by almost 21% in 2023.
- Regulatory delays and complex approvals: The complex approval methods slow down the entry into the market. For instance, in Japan, the Pharmaceuticals and Medical Devices Agency took 8 months to approve in 2022 to approve Foundation Medicine’s pan-cancer panel.
Gene Panel Market: Key Insights
|
Base Year |
2024 |
|
Forecast Year |
2025-2037 |
|
CAGR |
17.7% |
|
Base Year Market Size (2024) |
USD 3.76 billion |
|
Forecast Year Market Size (2037) |
USD 31.3 billion |
|
Regional Scope |
|