PARP Inhibitor Biomarkers Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (Kits, Assays), By Services (BRCA 1 & 2 Testing, HRD Testing, HRR Testing, Others), By Application (Breast Cancer, Ovarian Cancer, Others), By Region & Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 942.14 Million
CAGR (2026-2031)	8.81%
Fastest Growing Segment	Kits
Largest Market	North America
Market Size (2031)	USD 1563.61 Million

Market Overview

The Global PARP Inhibitor Biomarkers Market will grow from USD 942.14 Million in 2025 to USD 1563.61 Million by 2031 at a 8.81% CAGR. PARP inhibitor biomarkers are specific molecular indicators, such as BRCA mutations and homologous recombination deficiency status, utilized to identify cancer patients likely to respond to poly (ADP-ribose) polymerase inhibitor therapies. The market is primarily driven by the expanding paradigm of precision medicine and the increasing regulatory approval of companion diagnostics for ovarian, breast, and prostate cancers. This demand is further supported by the rising prevalence of these malignancies which necessitates robust diagnostic screening for effective treatment planning. According to the American Cancer Society, in 2025, approximately 313,780 new cases of prostate cancer are expected to be diagnosed in the United States, highlighting the substantial patient pool requiring accurate biomarker assessment for optimal therapeutic management.

Despite the strong growth trajectory, the market faces a significant challenge regarding the high cost and reimbursement complexities associated with comprehensive genomic profiling. Inconsistent insurance coverage policies and varying regulatory requirements across different global healthcare systems can restrict patient access to necessary companion diagnostics. These economic and administrative barriers may impede the broader clinical adoption of biomarker testing and limit the overall expansion of the sector in price sensitive markets.

Key Market Drivers

The rising global prevalence of BRCA-associated cancers acts as a fundamental driver for the biomarker market, necessitating robust diagnostic screening to identify eligible patients for PARP inhibitor therapy. As the incidence of malignancies such as breast, ovarian, and pancreatic cancers continues to climb, the clinical urgency to detect germline and somatic mutations has intensified. This increasing patient volume directly correlates with the utilization of companion diagnostics, as identifying BRCA1/2 mutations is often a regulatory prerequisite for prescribing targeted therapies. According to the American Cancer Society, January 2024, in the 'Cancer Facts & Figures 2024' report, an estimated 310,720 new cases of invasive breast cancer were projected to be diagnosed in women in the United States, creating a substantial baseline of patients requiring genomic evaluation for effective treatment planning.

Simultaneously, the growing clinical demand for Homologous Recombination Deficiency (HRD) stratification and comprehensive genomic profiling is accelerating market expansion. Clinicians are increasingly moving beyond single-gene testing to broader panels that capture a wider array of genomic instability markers, supported by advancements in Next-Generation Sequencing (NGS) technologies. This shift towards more extensive molecular characterization is evidenced by the rapid uptake of diagnostic services across the precision oncology sector. According to Myriad Genetics, February 2024, in the 'Fourth Quarter and Full-Year 2023 Financial Results', the company reported that its full-year testing volume grew 35% year-over-year, highlighting the surge in diagnostic adoption. This strong demand trajectory is further illustrated by broader market data; according to Guardant Health, February 2024, the company reported 172,900 tests provided to clinical customers in 2023, representing a 39% increase compared to the prior year.

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Key Market Challenges

The high cost and reimbursement complexities associated with comprehensive genomic profiling constitute a formidable barrier hampering the growth of the Global PARP Inhibitor Biomarkers Market. These financial hurdles directly impede the widespread adoption of companion diagnostics, which are strictly required to prescribe PARP inhibitor therapies. When insurance policies deny coverage or impose substantial out-of-pocket expenses, the clinical uptake of these critical tests stagnates. Consequently, the eligible patient pool for targeted therapies remains under-identified, effectively capping the revenue potential for both diagnostic developers and pharmaceutical companies.

Furthermore, administrative inconsistencies across healthcare systems exacerbate this challenge, preventing the sector from reaching its full potential in price-sensitive regions. This creates a disconnect between regulatory approval and actual patient access, as economic friction discourages providers from ordering necessary screens. According to the American Society of Clinical Oncology, in 2025, a study revealed that the molecular testing rate for advanced cancers remained at a suboptimal 35%, underscoring the persistent gap between clinical guidelines and actual utilization due to access barriers. Without consistent reimbursement pathways, the market struggles to convert the rising prevalence of malignancies into sustained economic expansion.

Key Market Trends

The market is experiencing a significant shift towards liquid biopsy for non-invasive biomarker profiling and longitudinal monitoring. Clinicians are increasingly adopting circulating tumor DNA (ctDNA) analysis to overcome the limitations of tissue-based sampling, such as tumor heterogeneity and the invasiveness of repeat biopsies. This method allows for real-time tracking of Minimal Residual Disease (MRD) and the early detection of resistance mechanisms, which is critical for optimizing PARP inhibitor regimens. The rapid uptake of these blood-based diagnostics is evident in industrial performance metrics. According to Natera, February 2025, in the 'Fourth Quarter and Full Year 2024 Financial Results', the company processed approximately 528,200 oncology tests in 2024, representing a substantial 54.9% increase compared to the prior year, underscoring the surging demand for non-invasive molecular monitoring.

Concurrently, the integration of artificial intelligence is revolutionizing genomic variant interpretation to manage the complexity of large-scale sequencing data. As diagnostic panels expand to include comprehensive homologous recombination repair (HRR) genes, laboratories face a bottleneck in classifying Variants of Uncertain Significance (VUS). AI-driven platforms are being deployed to automate variant curation, improve classification accuracy, and accelerate turnaround times for critical treatment decisions. This digital transformation is enabling decentralized testing networks to scale their precision medicine capabilities efficiently. According to SOPHiA GENETICS, March 2025, in the 'Fourth Quarter and Full Year 2024 Results', the company performed a record 352,000 analyses globally on its data-driven medicine platform in 2024, reflecting an 11% year-over-year volume growth driven by the adoption of these advanced analytical tools.

Segmental Insights

The Kits segment currently represents the fastest-growing category in the Global PARP Inhibitor Biomarkers Market, driven by a significant industry shift toward decentralized diagnostic testing. Laboratories and hospitals increasingly prioritize in-house analysis to achieve faster turnaround times for patient evaluations compared to outsourced services. This expansion is strongly supported by regulatory actions from the United States Food and Drug Administration, which continues to authorize specific companion diagnostic kits essential for identifying patients eligible for PARP inhibitor therapies. Consequently, the rising adoption of standardized commercial kits enables healthcare providers to implement personalized treatment strategies more efficiently.

Regional Insights

North America holds a dominant position in the Global PARP Inhibitor Biomarkers Market, driven primarily by the high prevalence of target indications such as ovarian, breast, and prostate cancers. This leadership is reinforced by a robust regulatory framework, where the U.S. Food and Drug Administration (FDA) actively approves companion diagnostics essential for identifying eligible patients. Furthermore, the region benefits from a well-established healthcare infrastructure and the strong presence of major diagnostic companies, facilitating the widespread adoption of precision medicine. Favorable reimbursement policies for genetic testing further support the integration of these biomarkers into standard clinical practice.

Recent Developments

• In May 2025, the Oncologic Drugs Advisory Committee of the U.S. FDA concluded that the label for the PARP inhibitor talazoparib should not be expanded to include metastatic castration-resistant prostate cancer patients without homologous recombination repair (HRR) gene mutations. The committee voted unanimously that the drug's benefit-risk profile was unfavorable in the unselected population, emphasizing that efficacy was primarily driven by the biomarker-positive subgroup. This regulatory outcome reaffirmed the essential role of HRR biomarker testing in the market, ensuring that PARP inhibitor prescriptions remain targeted toward patients with specific genetic alterations who are proven to respond to the therapy.
• In December 2024, AstraZeneca presented updated long-term results from the Phase III OlympiA trial, highlighting the prognostic value of biomarkers in early-stage breast cancer. The data, shared at a major medical symposium, demonstrated that the company's PARP inhibitor, olaparib, significantly improved overall survival in patients with germline BRCA-mutated, HER2-negative high-risk early breast cancer compared to placebo. These findings underscored the clinical necessity of early germline BRCA testing to identify patients who could achieve sustained survival benefits from adjuvant biomarker-directed therapy, further solidifying the role of genetic testing in the standard of care for this patient population.
• In September 2024, Foundation Medicine received approval from the U.S. Food and Drug Administration for two of its comprehensive genomic profiling tests to serve as companion diagnostics for a specific PARP inhibitor. The regulatory decision authorized the use of the company's tissue-based and liquid biopsy assays to identify patients with metastatic castration-resistant prostate cancer harboring deleterious BRCA mutations. This approval allowed for the precise selection of individuals eligible for treatment with a combination of olaparib and abiraterone, reinforcing the growing importance of genomic biomarkers in guiding first-line therapeutic strategies for aggressive prostate cancer subtypes.
• In June 2024, Myriad Genetics entered into a strategic collaboration with a major pharmaceutical company to expand patient access to homologous recombination deficiency (HRD) testing in the oncology market. This partnership focused on making the company's specialized HRD companion diagnostic tests available to women with high-grade serous ovarian cancer in nine additional countries, including Brazil, Singapore, and the Netherlands. The initiative aimed to address the critical need for precise biomarker identification, enabling clinicians to determine which patients were most likely to derive clinical benefit from targeted maintenance therapy with PARP inhibitors based on their tumor's genomic instability profile.

Key Market Players

• Myriad Genetics, Inc.
• Ambry Genetics
• Thermo Fisher Scientific, Inc.
• Illumina, Inc.
• CENTOGENE N.V.
• Amoy Diagnostics Co., Ltd.
• Invitae Corporation
• NeoGenomics Laboratories
• QIAGEN N.V.
• Agilent Technologies, Inc.

By Product	By Services	By Application	By Region
Kits Assays	BRCA 1 & 2 Testing HRD Testing HRR Testing Others	Breast Cancer Ovarian Cancer Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global PARP Inhibitor Biomarkers Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• PARP Inhibitor Biomarkers Market , By Product:

• Kits
• Assays

• PARP Inhibitor Biomarkers Market , By Services:

• BRCA 1 & 2 Testing
• HRD Testing
• HRR Testing
• Others

• PARP Inhibitor Biomarkers Market , By Application:

• Breast Cancer
• Ovarian Cancer
• Others

• PARP Inhibitor Biomarkers Market , By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE