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PARP Inhibitor Biomarkers Market Size Analysis:

PARP Inhibitor Biomarkers Market size was valued at USD 901.25 million in 2023 and is expected to reach USD 1892.80 million by 2032, growing at a CAGR of 8.64% from 2024-2032. The PARP Inhibitor Biomarkers Market Report provides distinctive insight by concentrating on the prevalence and incidence of BRCA1/2 and HRD mutations and how they propel biomarker-directed diagnostics. The report explores the trends in PARP inhibitor prescription by geography through an analysis of regulatory effects and availability. It also explores the volume trends for biomarker testing between 2020 and 2032 in response to increases in diagnostic adoption. Furthermore, it offers an in-depth evaluation of R&D expenditure on biomarker testing with a focus on innovation. Finally, the report examines healthcare expenditures on genomic testing, assessing reimbursement models through government, commercial, private, and out-of-pocket channels. Such insights provide an all-encompassing market knowledge beyond typical growth analysis.

The U.S. leads the North America PARP Inhibitor Biomarkers Market with 8.49% CAGR because of its high precision medicine adoption rates, robust regulatory approvals, and heavy investments in R&D for biomarker-based oncology therapies. Also, favorable reimbursement policies and the availability of major market players drive the adoption of biomarker testing, especially for BRCA and HRD mutations in cancer diagnosis.

PARP Inhibitor Biomarkers Market Dynamics

Drivers

  • Rising Adoption of Precision Medicine in Oncology is accelerating the market growth.

The mounting focus on precision medicine is a major growth driver for the PARP Inhibitor Biomarkers Market, as biomarker-based therapies enhance treatment effectiveness and patient survival. The mounting incidence of cancers, including breast, ovarian, and prostate cancer, has fueled the demand for biomarker testing, especially for BRCA1/2 and homologous recombination deficiency (HRD). Based on the American Cancer Society (2023), an estimated 297,790 new breast cancer cases were diagnosed in the U.S., which is a clear indication of the need for targeted treatments. Recent breakthroughs, including Roche's Elecsys PARP Inhibitor Biomarker Test (March 2023) and QIAGEN's QIAseq Platform Partnership (March 2023), further strengthen the market growth. The combination of next-generation sequencing (NGS) and companion diagnostics in oncology is promoting the use of PARP inhibitor biomarker testing, cementing its position as part of personalized cancer therapy.

  • Expanding clinical applications of PARP inhibitors are propelling the market to grow.

Biomarker testing demand is driven by the growth of clinical indications for PARP inhibitors from ovarian and breast cancer to prostate and pancreatic cancer. In 2023, the FDA approved the indication of rucaparib in BRCA-mutated prostate cancer, an important milestone for the market. As reported by the National Cancer Institute (NCI), prostate cancer was the second leading cancer in men, with more than 288,300 new cases in the United States in 2023. Pharmaceutical companies like AstraZeneca and Merck are carrying out clinical trials to test PARP inhibitors in combination with immunotherapies and other targeted therapies. The growing clinical use of HRR and HRD testing also plays a significant role in promoting the routine use of PARP inhibitor biomarkers, which are crucial in cancer treatment decisions and management.

Restraint

  • High costs and limited accessibility of biomarker testing are restraining the market growth.

One of the significant constraints in the PARP Inhibitor Biomarkers Market is the elevated cost and reduced availability of biomarker testing, especially in low- and middle-income countries (LMICs). Next-generation sequencing (NGS) and companion diagnostics (CDx) tests employed to identify BRCA mutations, HRD, and HRR are costly, with the cost of testing ranging between USD 2,000 and USD 5,000 per patient. Moreover, insurance for biomarker testing is not uniform, and hence, it is out of reach for most patients, particularly those with no complete healthcare plans. The World Health Organization (WHO) report identifies inequities in access to precision diagnostics, where sophisticated biomarker testing is more common in North America and Europe compared to Asia-Pacific or Latin America. The absence of standardized testing protocols, regulatory barriers, and reimbursement issues also constricts market growth, preventing extensive use in clinical oncology.

Opportunities

  • The PARP Inhibitor Biomarkers Market is a large opportunity with the increased adoption of companion diagnostics (CDx) and personalized medicine.

With regulatory bodies such as the FDA and EMA placing focus on biomarker-guided therapy approvals, demand for HRD, BRCA1/2, and HRR testing is on the rise to inform PARP inhibitor treatment. This is further transforming the market with the advent of liquid biopsy technology, providing non-invasive test solutions to monitor tumor development and drug reaction in real-time. Moreover, joint ventures between pharmaceutical companies and biotech companies are transforming predictive biomarker assays and broadening clinical trial entry criteria for patients from conventional genetic markers. As oncology treatment evolves toward personalized therapy, biomarker-driven drug development will continue to gain momentum, creating new revenue streams for diagnostic developers and pharma players.

Challenges

  • One of the key challenges in the PARP Inhibitor Biomarkers Market is the absence of global standardization for biomarker testing and regulatory clearances.

Regions have different requirements for biomarker validation, creating roadblocks for companies introducing companion diagnostics (CDx) and next-generation sequencing (NGS)-based assays globally. For instance, while the FDA requires rigorous clinical validation, other countries have less standardized guidelines, and hence, test accuracy and reliability may vary. Delays in regulatory approvals also hamper the implementation of new biomarker-based therapies, which reduces oncologists' confidence in prescribing PARP inhibitors. The European Society for Medical Oncology (ESMO) report emphasizes the necessity of harmonized biomarker testing frameworks to enhance clinical outcomes. Lacking clear regulatory channels and normalized biomarker interpretation, the commercialization of sophisticated diagnostic solutions is an obstacle to market expansion.

PARP Inhibitor Biomarkers Market Segmentation Analysis

By Product

The Kits segment dominated the PARP Inhibitor Biomarkers Market with a 66.12% market share in 2023 because of its simplicity, standardized protocols, and extensive use in clinical and research environments. These kits provide pre-validated reagents, controls, and streamlined workflows, facilitating effective detection of biomarkers like BRCA1/2, HRD, and HRR mutations critical to PARP inhibitor therapy guidance. The growing incorporation of companion diagnostics (CDx) for individualized treatment approaches has also driven demand for readily available test kits commercially. FDA-approved and CE-marked approvals of test kits by dominant players like Myriad Genetics and QIAGEN have strengthened market penetration. Furthermore, growth in hospital-based and reference lab testing has entrenched ready-to-use kit dominance and ensured consistent and precise biomarker measurement in oncology.

The Assays segment is expected to grow the fastest over the forecast years, fueled by innovation in next-generation sequencing (NGS) and liquid biopsy technology. In contrast to traditional kits, assay-based testing provides greater sensitivity, multiplex detection, and more profound genomic information, which is making it more popular in precision oncology research and clinical use. The growth in integrated biomarker panels, such as HRD and DDR pathway analysis, has continued to fuel the need for individualized assay solutions. Further, biopharma partnerships with diagnostics companies for creating individualized assays for drug discovery have helped in accelerating innovation. The movement toward real-time and high-throughput screening techniques in oncology-based molecular diagnostic laboratories is poised to fuel increased uptake of assay-based biomarker detection, stimulating significant market growth during the next few years.

By Services

The BRCA 1 & 2 Testing segment dominated the PARP Inhibitor Biomarkers Market, with a 44.58% market share in 2023, mainly because it plays a pivotal role in determining patients who can be treated with PARP inhibitor treatments. Mutations of BRCA1 and BRCA2 are major predictive biomarkers for several cancers, such as breast, ovarian, prostate, and pancreatic cancer, resulting in widespread clinical use. Regulatory agencies such as the FDA and EMA have cleared numerous BRCA-based companion diagnostics (CDx), including Myriad Genetics' BRACAnalysis CDx and QIAGEN's therascreen BRCA1/2 RGQ PCR Kit, further cementing their place in personalized medicine. Furthermore, the increasing incidence of hereditary cancer syndromes and greater recommendations by groups such as the NCCN and ASCO have fueled demand for BRCA testing. The increasing integration of BRCA screening into initial cancer risk evaluation programs has also helped it maintain market dominance.

By Application

The Breast Cancer segment dominated the PARP Inhibitor Biomarkers Market with around 50.12% market share in 2023 because of the widespread prevalence of breast cancer, especially BRCA1/2-mutated breast cancer, which responds significantly to PARP inhibitor treatment. PARP inhibitors like Olaparib (Lynparza) and Talazoparib (Talzenna), receiving FDA approvals for HER2-negative metastatic breast cancer with BRCA mutations, have increased biomarker testing demand even more. Companies like NCCN and ASCO suggest BRCA1/2 testing for patients with breast cancer, which is boosting the clinical usage of PARP inhibitor biomarkers. Moreover, developments in liquid biopsy as well as companion diagnostics have improved access and precision in the identification of BRCA mutations in breast cancer patients, driving the segment's market leadership. The increasing recognition of inherited breast cancer syndromes and the inclusion of genetic testing in treatment protocols have also further entrenched breast cancer as the top product in the market.

The Ovarian Cancer segment will be the fastest-growing segment with 9.30% CAGR throughout the forecast period in the PARP Inhibitor Biomarkers Market because of robust clinical evidence for the effectiveness of PARP inhibitors for the treatment of BRCA-mutated and homologous recombination-deficient (HRD) ovarian cancer. PARP inhibitor approvals as first-line and maintenance therapies for ovarian cancer for Olaparib, Niraparib (Zejula), and Rucaparib (Rubraca) have hugely widened the number of eligible patients based on biomarker analysis. Evidence, such as in the PRIMA and SOLO-1 trials, has established benefit for progression-free survival (PFS) with PARP inhibitors and contributed to uptake. Additionally, programs such as universal genetic testing for patients with ovarian cancer, endorsed by groups such as ESMO and SGO, have enhanced early biomarker detection rates. With an increasing incidence of ovarian cancer and better diagnostic technologies, this segment will witness high growth.

PARP Inhibitor Biomarkers Market Regional Insights

North America dominated the PARP inhibitor biomarkers market with a 44.08% market share in 2023 due to a well-developed healthcare infrastructure, extensive adoption of precision medicine, and robust regulatory environments favoring biomarker-based therapies. The region is favored by high research investments, large-scale clinical trials, and business partnerships between biotech players and pharma giants to improve biomarker-based cancer therapy. Also, positive payment policy and strong awareness among healthcare providers towards genetic testing for BRCA and HRD mutations drive market leadership. Major players like Roche, Myriad Genetics, and QIAGEN make the presence of the region stronger in leadership.

Europe is experiencing the fastest growth in the PARP Inhibitor Biomarkers Market with 9.49% CAGR throughout the forecast period due to growing cancer prevalence, enhanced government support for precision medicine, and increased access to genomic testing. Germany, the UK, and France are making significant investments in next-generation sequencing (NGS) and biomarker-based therapies to enhance cancer diagnosis and treatment. In addition, partnerships among academic institutions, biotech companies, and regulatory bodies are driving clinical validation and uptake of PARP inhibitor biomarkers. Increasing recognition of personalized medicine, along with programs like the European Union's Beating Cancer Plan, is driving market growth, with Europe being the fastest-growing region.

PARP Inhibitor Biomarkers Market Key Players

  • Myriad Genetics, Inc. (BRACAnalysis CDx, myChoice HRD)

  • NeoGenomics Laboratories (NeoTYPE Tumor Profiles, InVisionFirst-Lung)

  • Invitae Corporation (Invitae BRCA1/2 Test, Invitae Multi-Cancer Panel)

  • F. Hoffmann-La Roche Ltd. (AVENIO Tumor Tissue Analysis Kits, cobas EGFR Mutation Test)

  • QIAGEN N.V. (therascreen BRCA1/2 RGQ PCR Kit, GeneReader NGS System)

  • Thermo Fisher Scientific Inc. (Oncomine BRCA Assay, Ion AmpliSeq Cancer Hotspot Panel)

  • Illumina, Inc. (TruSight Tumor 170, VeriSeq Targeted Cancer Panel)

  • Agilent Technologies, Inc. (SureSelect XT HS2 DNA Kit, Dako Omnis)

  • Bio-Rad Laboratories, Inc. (QX200 Droplet Digital PCR System, BioPlex 2200 System)

  • PerkinElmer, Inc. (NEXTFLEX BRCA1/2 Panels, LabChip GX Touch)

  • Hologic, Inc. (Aptima HPV Assay, Panther Fusion System)

  • Abbott Laboratories (Vysis ALK Break Apart FISH Probe Kit, m2000 RealTime System)

  • Siemens Healthineers AG (Atellica Solution, Versant kPCR Molecular System)

  • Becton, Dickinson and Company (BD) (BD MAX System, BD Onclarity HPV Assay)

  • Genomic Health, Inc. (Oncotype DX Breast Recurrence Score, Oncotype DX Genomic Prostate Score)

  • Foundation Medicine, Inc. (FoundationOne CDx, FoundationOne Liquid CDx)

  • Guardant Health, Inc. (Guardant360, GuardantOMNI)

  • Caris Life Sciences (MI Exome, MI Transcriptome)

  • Natera, Inc. (Signatera, Prospera)

  • Pacific Biosciences of California, Inc. (Sequel II System, SMRTbell Express Template Prep Kit)

Suppliers (These suppliers provide essential reagents, assay kits, and sequencing consumables used in PARP inhibitor biomarker testing.)

  • Thermo Fisher Scientific

  • Merck KGaA

  • Agilent Technologies

  • Qiagen N.V.

  • Bio-Rad Laboratories, Inc.

  • PerkinElmer, Inc.

  • Roche Diagnostics

  • Illumina, Inc.

  • Becton, Dickinson and Company (BD)

  • Danaher Corporation

Recent Development in the PARP Inhibitor Biomarkers Market

  • March 2023 – F. Hoffmann-La Roche Ltd. (Roche), a leading biotechnology company focused on pharmaceuticals and diagnostics for serious diseases, announced a partnership with Eli Lilly and Company to accelerate the development of Roche's Elecsys PARP Inhibitor Biomarkers.

  • March 2023 – QIAGEN N.V. launched its new QIAseq Platform Partnership program. The initial partnership under the program is with medical data-analysis solution provider SOPHiA GENETICS, combining QIAGEN's QIAseq reagent technology for next-generation sequencing (NGS) with the SOPHiA DDMTM digital analytics platform to power more accurate precision medicine solutions

    PARP Inhibitor Biomarkers Market Report Scope:
    Report Attributes Details
    Market Size in 2023 US$ 901.25 million
    Market Size by 2032 US$  1892.80 million
    CAGR CAGR of 8.64% From 2024 to 2032
    Base Year 2023
    Forecast Period 2024-2032
    Historical Data 2020-2022
    Report Scope & Coverage Market Size, Segments Analysis, Competitive  Landscape, Regional Analysis, DROC & SWOT Analysis, Forecast Outlook
    Key Segments • By Product (Kits, Assays)
    • By Services (BRCA 1 & 2 Testing, HRD Testing, HRR Testing, Others)
    • By Application (Breast Cancer, Ovarian Cancer, Others)
    Regional Analysis/Coverage North America (US, Canada, Mexico), Europe (Eastern Europe [Poland, Romania, Hungary, Turkey, Rest of Eastern Europe] Western Europe] Germany, France, UK, Italy, Spain, Netherlands, Switzerland, Austria, Rest of Western Europe]), Asia Pacific (China, India, Japan, South Korea, Vietnam, Singapore, Australia, Rest of Asia Pacific), Middle East & Africa (Middle East [UAE, Egypt, Saudi Arabia, Qatar, Rest of Middle East], Africa [Nigeria, South Africa, Rest of Africa], Latin America (Brazil, Argentina, Colombia, Rest of Latin America)
    Company Profiles Myriad Genetics, Inc., NeoGenomics Laboratories, Invitae Corporation, F. Hoffmann-La Roche Ltd., QIAGEN N.V., Thermo Fisher Scientific Inc., Illumina, Inc., Agilent Technologies, Inc., Bio-Rad Laboratories, Inc., PerkinElmer, Inc., Hologic, Inc., Abbott Laboratories, Siemens Healthineers AG, Becton, Dickinson and Company (BD), Genomic Health, Inc., Foundation Medicine, Inc., Guardant Health, Inc., Caris Life Sciences, Natera, Inc., Pacific Biosciences of California, Inc., and other players.