The lung cancer PCR panel market size is projected to reach USD 599.41 million in 2025. The market is expected to grow at a CAGR of 8.0% during the forecast period between 2025 and 2035. By 2035, the market will acquire a total valuation of USD 1.29 billion.
In 2024, the industry for lung cancer PCR panels saw significant developments and strategic moves that boosted its growth. One of the major developments was Pfizer's united effort to advance BRAF mutation testing in patients with lung cancer.
In September 2024, Pfizer announced three-year follow-up Phase 2 trial data showing patients with BRAF V600E-mutant metastatic NSCLC receiving Braftovi and Mektovi had a median progression-free survival of over two and a half years.
The industry also experienced an increase in the use of liquid biopsy tests, which screen for circulating tumor DNA (ctDNA) in blood. PCR panels were a central component of these tests since they were used to identify certain mutations and variations in ctDNA, enabling early detection and targeted treatment options.
The industry for lung cancer PCR panels is anticipated to grow steadily during the projection period between 2025 and 2035. This expansion is fueled by the rising incidence of lung cancer, increased awareness of early detection, and advances in diagnostic technology.
Technologies like liquid biopsies, next-generation sequencing (NGS), and artificial intelligence-based imaging devices are improving diagnostic precision and allowing non-invasive testing.
| Metrics | Values |
|---|---|
| Industry Size (2025E) | USD 599.41 million |
| Industry Value (2035F) | USD 1.29 billion |
| CAGR | 8.0% |
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The lung cancer PCR panel industry is growing strongly, led by an increase in global lung cancer incidence and rising acceptance of precision diagnostics. The driving force is the need for early, mutation-specific detection to facilitate targeted therapies, complemented by advances such as liquid biopsy and integration with NGS.
Diagnostic firms and pharma companies with precision oncology platforms to offer will gain, but those that are tardy in responding to molecular test trends risk obsolescence.
Increase Molecular Testing Capabilities
Invest in PCR-based and complementary diagnostic platforms (e.g., NGS, liquid biopsy) to increase mutation detection accuracy and expand the clinical utility of lung cancer panels.
Align with Precision Medicine Trends
Form strategic partnerships with pharmaceutical firms developing targeted therapies to align diagnostic panels with new biomarkers and treatment approaches.
Enhance Global Access and Distribution
Seek collaborations with local labs, health systems, and distributors to enter underserved industries, while investigating M&A possibilities to expand R&D and manufacturing capabilities.
| Risk | Assessment (Probability - Impact) |
|---|---|
| Regulatory Delays in Approving New PCR Panels | Medium - High |
| Limited Reimbursement for Advanced Molecular Diagnostics | High - High |
| Technological Obsolescence Due to Rapid Innovation (e.g., AI/NGS) | Medium - Medium |
| Priority | Immediate Action |
|---|---|
| Expand Liquid Biopsy Integration | Run feasibility on integrating ctDNA-based liquid biopsy into PCR panels. |
| Strengthen Pharma-Diagnostic Collaboration | Initiate feedback loop with OEMs on emerging biomarker demands. |
| Accelerate Global Industry Penetration | Launch channel partner incentive pilot in APAC and LATAM regions |
In order to remain competitive in the fast-changing lung cancer PCR panel industry, the company needs to concentrate on speeding up its R&D spending in precision diagnostics, especially in high unmet-need areas such as China and Japan.
Through strategic collaborations with local healthcare players and obtaining appropriate certifications, the company can rapidly expand its offerings and establish a strong presence in these strategic industries. Moreover, the development of partnerships with cancer research centers and riding the wave of new trends in molecular targeted therapies will further its competitive advantage.
(Surveyed Q4 2024, n=500 stakeholder participants evenly distributed across diagnostic manufacturers, lab directors, oncologists, and procurement leads in the USA, Western Europe, Japan, and South Korea)
Regional Variance:
High Variance:
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Regional Breakdown:
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Global Alignment:
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Global Consensus:
Speed, accuracy, mutation breadth, and reimbursement remain central to PCR panel success.
Key Regional Contrasts:
Strategic Insight:
Success in the lung cancer PCR panel industry hinges on regional customization. A modular platform strategy - combining high-performance core capabilities with region-specific pricing, mutation targets, and support systems - will unlock industry share across developed and price-sensitive regions alike.
| Countries | Regulatory Impact and Mandatory Certifications |
|---|---|
| United States | The USA Food and Drug Administration (FDA) oversees the approval of in vitro diagnostic (IVD) devices, including lung cancer PCR panels. Manufacturers must obtain FDA clearance or approval, demonstrating safety and effectiveness through rigorous clinical evaluations. Companion diagnostics require specific FDA approval in conjunction with the associated therapeutic. |
| European Union | IVD devices in the EU must comply with the In Vitro Diagnostic Regulation (IVDR), which replaced the In Vitro Diagnostic Directive (IVDD) in May 2022. Manufacturers need to obtain CE marking by demonstrating conformity with the regulation, involving assessment by a Notified Body for higher-risk devices. The IVDR emphasizes increased scrutiny of clinical evidence and post-industry surveillance. |
| Japan | The Ministry of Health, Labour and Welfare (MHLW) regulates medical devices, including IVDs. Approval requires compliance with the Pharmaceutical and Medical Device Act (PMDA). The AmoyDx® Pan Lung Cancer PCR Panel, for instance, received MHLW approval as a companion diagnostic for specific therapies, reflecting Japan's stringent regulatory process for companion diagnostics. |
| China | The National Medical Products Administration (NMPA) oversees IVD regulation. IVD reagents are classified into three classes based on risk, with Class II and III requiring registration. Clinical trials may be necessary unless exempted. The NMPA has established numerous guidelines and standards for IVD products, and overseas clinical trial data can be considered if they meet specific criteria. |
| India | The Central Drugs Standard Control Organization (CDSCO) regulates IVD devices under the Medical Device Rules, 2017. IVDs are categorized based on risk, with higher-risk categories requiring prior approval. Manufacturers must obtain Import Licenses for foreign-made devices and ensure compliance with Indian standards and quality systems. |
| Australia | The Therapeutic Goods Administration (TGA) regulates IVDs, requiring inclusion in the Australian Register of Therapeutic Goods (ARTG). Devices are classified by risk, and higher-risk devices necessitate conformity assessment by the TGA or recognized bodies. Compliance with the Australian Regulatory Guidelines for Medical Devices (ARGMD) is mandatory. |
| South Korea | The Ministry of Food and Drug Safety (MFDS) oversees IVD regulation. Devices are classified into four classes based on risk. Higher-class devices require more stringent review, including clinical data submission. Compliance with Korean Good Manufacturing Practice (KGMP) is also required for manufacturers. |
The USA lung cancer PCR panel industry is driven by the growing adoption of precision diagnostics and positive reimbursement dynamics. The prevalence of lung cancer, in particular among older populations, continues to fuel demand for fast, mutation-specific PCR assays.
The incorporation of PCR panels in NCCN guidelines and the increasing trend of liquid biopsy-compatible PCR kits are bolstering clinical adoption. Pharmaceutical company and diagnostics company collaborations are also driving companion diagnostic development.
Although reimbursement coverage is enhanced, clinician training and access gaps create moderate challenges. The USA continues to be a worldwide innovation center for oncology diagnostics, with hospital laboratories and reference laboratories giving high priority to PCR panel upgrades.
FMI opines that the United States lung cancer PCR panel sales are likely to grow at a CAGR of 9.06% from 2025 to 2035.
The United Kingdom PCR panel industry for lung cancer will grow steadily from 2025 to 2035 through NHS-led initiatives for precision medicine and cancer diagnosis networks cantered under the NHS.
The expansion of genomics hubs under the Genomic Medicine Service is generating opportunities for PCR-based biomarker analysis, especially among early-stage as well as metastatic NSCLC cases. The use of multiplex PCR assays is gaining pace with clinical pathways placing greater emphasis on targeted therapies.
Procurement delays, differing trust-level adoption rates, and pre-analytical sample handling standardization are among the challenges, though. The UK is determined to increase access to biomarker-driven diagnostics despite stringent budget restrictions and is therefore a primary growth region in Western Europe.
FMI opines that the United Kingdom's lung cancer PCR panel sales are likely to grow at a CAGR of 7.92% from 2025 to 2035.
France's PCR panel industry for lung cancer is estimated to grow and is driven by robust public healthcare infrastructure and investments by the country in molecular oncology. The nation has set up regional cancer genomics platforms (PLGAs), making PCR tests widely accessible in hospitals. EGFR and KRAS testing through real-time PCR are the norm in the majority of public oncology departments.
Nonetheless, fragmented regional financing and lower-than-anticipated adoption by the private sector create growth constraints. Clinical consciousness of early detection is rising, supported by government-sponsored screening pilots. Reimbursement parity for PCR-based and NGS-based testing is also a priority in France. With an expanding diagnostics ecosystem and strong clinical research in oncology, France continues to be a significant industry for PCR panel developers.
FMI opines that the France lung cancer PCR panel sales are likely to grow at a CAGR of 7.55% from 2025 to 2035.
Germany is likely to witness robust growth in the industry for lung cancer PCR panels by 2035, as a result of its well-developed diagnostics network and liberal reimbursement setup. Molecular testing is now part of the diagnostic process in lung cancer, particularly in DKG-certified oncology centers.
High usage of CE-marked PCR panels and good reimbursement by statutory health insurance is driving growth. Short-turnaround-time PCR platforms are becoming more popular than wide sequencing for standard mutation detection.
Germany also has a thriving clinical trials environment, with companion diagnostics being tested in parallel with new therapies. Regulatory certainty and laboratory automation are enhancing efficiency, although regional differences in lab capacities continue to be a limitation.
FMI opines that German lung cancer PCR panel sales are likely to grow at a CAGR of 8.30% from 2025 to 2035.
Italy's PCR panel industry for lung cancer is expected to expand with growth being more concentrated in the northern and central regions where hospital laboratories are more equipped. Adoption of PCR-based molecular diagnostics is increasing, especially for mutations in EGFR and ALK, but access continues to be unequal across regions. National cancer care networks are driving the implementation of uniform diagnostic standards, which will increase adoption in underpenetrated regions.
The PCR industry is being helped by EU recovery fund investments in health system digitization and diagnostic modernization. Nevertheless, prolonged public procurement timelines and uneven local reimbursement processes continue to hinder wider industry growth.
FMI opines that the Italy lung cancer PCR panel sales are likely to grow at a CAGR of 7.17% from 2025 to 2035.
Italy's PCR panel industry for lung cancer is expected to expand with growth being more concentrated in the northern and central regions where hospital laboratories are more equipped. Adoption of PCR-based molecular diagnostics is increasing, especially for mutations in EGFR and ALK, but access continues to be unequal across regions. National cancer care networks are driving the implementation of uniform diagnostic standards, which will increase adoption in underpenetrated regions.
FMI opines that South Korea's lung cancer PCR panel sales are likely to grow at a CAGR of 7.55% from 2025 to 2035.
Japan's lung cancer PCR panel industry is expected to surge during the forecast period. This growth will be driven by Japan's advanced healthcare infrastructure, high prevalence of lung cancer, and a strong focus on precision medicine. Government support for new-age diagnostic technologies and the availability of prominent pharmaceutical companies further drive the growth of the industry.
FMI believes that the Japanese lung cancer PCR panel industry is poised to register a growth rate of CAGR 6.2% during the forecast period from 2025 to 2035.
China's lung cancer PCR panel industry is anticipated to achieve significant growth. The country's vast population, growing smoking population, and escalating air pollution levels lead to a high prevalence of lung cancer. High investments in healthcare infrastructure and a rising emphasis on sophisticated diagnostic solutions are major drivers of industry growth.
FMI concludes that the industry of Chinese lung cancer PCR panels is anticipated to expand at a CAGR of 6.4% from 2025 to 2035.
The Australia and New Zealand combined lung cancer PCR panel industry is anticipated to register constant growth by 2035. Australia and New Zealand both possess robust healthcare infrastructures and a high level of healthcare spending, enabling the uptake of sophisticated diagnostic technologies. However, their smaller size means that there is a smaller total industry size as compared with larger nations.
FMI believes that the Australian and New Zealand lung cancer PCR panel industry will expand at a CAGR of 5.0% during 2025 to 2035.
Between 2025 and 2035, Adenocarcinoma will be the most profitable application segment for the lung cancer PCR panel industry. This is because it is highly prevalent in non-small cell lung cancer (NSCLC) subtypes and is increasingly pertinent in genomic testing and biomarker testing. PCR panels are highly efficient in detecting driver mutations like EGFR, ALK, ROS1, and BRAF that are predominantly found in adenocarcinoma.
The increasing focus on personalized medicine and early mutation detection has driven adoption in both diagnostic and monitoring applications. Moreover, growing awareness among clinicians and enhancements in reimbursement policies are also facilitating PCR-based adenocarcinoma testing. Therefore, the adenocarcinoma segment is expected to expand at a CAGR of around 9.2% during the period 2025 to 2035, ahead of the overall industry.
Between 2025 and 2035, Hospitals are also expected to be the highest-revenue-generating end-user segment for lung cancer PCR panels. This is fueled by the pivotal position of hospitals in diagnostic pipelines, especially in complex and metastatic cancer treatment environments. Hospitals tend to be the initial point of treatment for patients showing symptoms and have the appropriate infrastructure for molecular diagnostics and PCR testing. In addition, hospital labs increasingly interact with oncology departments to adopt precision medicine protocols.
Such centers also enjoy government funding access, patient volumes, and healthcare delivery models that incorporate integrated care to ensure continuity. Due to these structural advantages, the hospital segment is projected to grow at a CAGR of around 8.6% during the forecast period, ahead of research institutes and specialty clinics.
The industry is partially consolidated, with dominance by a few major players (Thermo Fisher, Roche, Qiagen) and increasing threats from niche and regional players. Competition is being fueled by innovation, regulatory clearances, and strategic alliances.
Leaders compete on:
It detects genetic mutations in lung cancer to guide diagnosis and treatment decisions.
Adenocarcinoma, due to its high mutation rate and responsiveness to targeted therapies.
Hospitals and cancer research institutes are the main users.
Yes, they can identify actionable mutations even in early-stage lung cancer.
Yes, driven by rising cancer cases and expanding diagnostic infrastructure.
Adenocarcinoma, Squamous Cell Carcinoma (SCC), Large Cell Carcinoma
Hospitals, Cancer Research Institutes, Specialty Clinics, Research & Educational Institutes
North America, Latin America, Europe, East Asia, South Asia, Oceania, Middle East & Africa
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Lung Cancer PCR Panel Market
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