본 보고서에서는 미국, EU 4개국(독일, 프랑스, 이탈리아, 스페인), 영국, 일본의 PARP 억제제 시장을 조사했으며, 시장 배경, 시장 동향, 기존 약 및 신흥약의 개요, 경쟁 구도, 시장 점유율, 환자수, 시장 규모 추이와 예측, 언메트 메디컬 요구, 시장 접근과 상환 동향 등을 정리했습니다.
주요 하이라이트
PARP 억제제 보고서 : 인사이트
PARP 억제제 보고서 : 주요 강점
PARP 억제제 보고서 : 평가
Key Highlights:
DelveInsight's " PARP Inhibitors - Competitive Landscape, and Market Forecast - 2034" report delivers an in-depth understanding of the PARP inhibitors, historical and Competitive Landscape as well as the PARP inhibitors market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The PARP inhibitors market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM PARP inhibitors market size from 2020 to 2034. The report also covers current PARP inhibitor treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Study Period: 2020-2034
PARP Inhibitors Understanding
PARP inhibitors Overview
PARP inhibitors are targeted therapies that block PARP enzymes, preventing cancer cells from repairing themselves and leading to cell death. They show promise, especially when combined with immune checkpoint inhibitors (ICIs), offering hope for many cancer patients. While generally specific and with manageable side effects, understanding the roles of PARP1/2 throughout the cell cycle is crucial for developing new therapies and anticipating potential side effects.
The treatment landscape for cancers with PARP inhibitors is rapidly evolving. Companies like Merck, AstraZeneca, and Waverley Pharma are focusing on PARP-1 selective inhibitors, currently in lead optimization, to meet unmet needs for various tumors. PARP inhibitors are used for certain stages and types of ovarian, pancreatic, and prostate cancers, particularly those with HR-DDR mutations.
In ovarian cancer, PARP inhibitors are combined with chemotherapy for advanced cases and recommended for recurrent epithelial ovarian cancer with specific genetic markers. In prostate cancer, PARP inhibitors are most effective in cases with BRCA1/2 mutations but only benefit a quarter of patients. Research continues into their use in pancreatic cancer. Notably, a 2018 trial showed LYNPARZA benefits for women with BRCA-mutated ovarian cancer.
The PARP inhibitor epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Target pool (Incident Cases by Indication, Eligible and Treatable Cases by Indication) in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.
The drug chapter segment of the PARP inhibitors reports encloses a detailed analysis of PARP inhibitors marketed drugs and late-stage (Phase III and Phase II) and early-stage (Phase I/II) pipeline drugs. It also helps understand the PARP inhibitors' clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.
Marketed Drugs
LYNPARZA (olaparib): AstraZeneca and Merck
LYNPARZA is the -first and best-in-class oral PARP inhibitor. AstraZeneca has a global strategic oncology collaboration with Merck to co-develop and co-commercialize LYNPARZA. In August 2024, the European Commission approved LYNPARZA in combination with IMFINZI for the treatment of certain patients with advanced or recurrent endometrial cancer. LYNPARZA received FDA approval in 2014 for advanced ovarian cancer, followed by EMA approval for breast cancer in 2019. LYNPARZA has also been approved for pancreatic cancer, high-risk early breast cancer, and in 2023, for BRCA-mutated mCRPC in combination with abiraterone and prednisone. Its expanding use highlights its significance in precision oncology.
LYNPARZA is a prescription medicine that is approved in many countries across multiple tumor types including maintenance treatment of platinum-sensitive relapsed ovarian cancer, for gBRCAm, HER2-negative high-risk early metastatic breast cancer, in combination with abiraterone for the treatment of metastatic castration-resistant prostate cancer and gBRCAm metastatic pancreatic cancer. LYNPARZA is solidifying its lead as the top-selling PARP inhibitor with a first-of-its-kind FDA approval. For 1L ovarian cancer, LYNPARZA + IMFINZI + bevacizumab is presently undergoing Phase III evaluation. For 1L BRCAwt ovarian cancer, LYNPARZA is in Phase III; results is expected in H1 2025.
ZEJULA (niraparib): GlaxoSmithKline
ZEJULA is an oral, potent, highly selective PARP1 and PARP2 inhibitor. ZEJULA continues to be an important maintenance treatment option for appropriate patients in the second-line or later setting and for patients who are in complete or partial response to first-line platinum-based chemotherapy. The FDA approved ZEJULA in 2019 for HRD-positive advanced ovarian, fallopian tube, or primary peritoneal cancer after multiple chemotherapy treatments, and in 2020 for maintenance treatment following platinum-based chemotherapy. In 2023, the European Commission approved AKEEGA (niraparib and abiraterone acetate) with prednisone or prednisolone for treating BRCA-mCRPC.
Emerging Drugs
Saruparib (AZD5305): AstraZeneca
Saruparib is a next-generation, highly selective PARP1 inhibitor developed by AstraZeneca, currently in clinical trials for multiple advanced solid tumors. In 2024, saruparib advanced towards potential registrational trials for prostate cancer in combination with new hormonal agents, demonstrating good tolerability at higher doses. Key ongoing trials include Phase III EvoPAR-Prostate01 for HRRm and non-HRRm mCSPC, evaluating saruparib with physician's choice of new hormonal agents, Phase III EvoPAR-Breast01 for BRCA1, BRCA2, or PALB2m, HR-positive, HER2-negative advanced breast cancer, assessing saruparib with camizestrant; Phase I/IIa PETRA (NCT04644058) for advanced solid tumors, investigating safety, tolerability, and efficacy across multiple combination arms; and Phase I/IIa PETRANHA for metastatic prostate cancer, evaluating saruparib in combination with abiraterone, enzalutamide, or atezolizumab. Saruparib's clinical progress underscores the growing therapeutic potential of next-generation PARP1 inhibitors across various oncology indications. Saruparib is highly selective for PARP1. The first-in-class PARP1 selective inhibitor saruparib (AZD5305) elicited promising response rates across all dose levels and was well tolerated in patients with advanced solid tumors that harbored BRCA1/2, PALB2, and RAD51C/D mutations, according to Timothy Yap, MBBS, PhD, FRCP.
Veliparib: AbbVie
Veliparib, developed by AbbVie, is a PARP inhibitor with potential anti-cancer properties. In September 2024, AbbVie presented updated safety and efficacy results from the Phase III VELIA trial evaluating veliparib in combination with chemotherapy for patients with advanced ovarian cancer. The results highlighted a significant improvement in progression-free survival and were featured at the European Society for Medical Oncology (ESMO) Congress.
The market for PARP inhibitors are expected to grow significantly in the coming years. This is due to the increasing number of patients who are being diagnosed with cancer, the growing awareness of PARP inhibitors, and the increasing number of PARP inhibitors that are being approved by the FDA. To date, approved PARP inhibitors include LYNPARZA, TALZENNA, ZEJULA, and RUBRACA. Currently, LYNPARZA is dominating the PARP inhibitors market. LYNPARZA also demonstrated sustained and clinically meaningful improvements in the primary and secondary endpoints of IDFS and DDFS. LYNPARZA reduced the risk of invasive breast cancer recurrence, second cancers or death by 35 and reduced the risk of distant disease recurrence or death by 35% versus placebo. The benefit with LYNPARZA was consistent across all key subgroups, including patients with high-risk, hormone-receptor-positive disease. BRCA nonmutated disease is the main target for the two companies' ovarian cancer trials utilizing their PD-1 inhibitors, because PARP drugs such as LYNPARZA and ZEJULA are already standard first-line maintenance treatments among BRCA-mutated patients. Between the two leading PARP inhibitors, ZEJULA holds a broad FDA label for ovarian cancer, allowing use regardless of biomarker status. However, limited efficacy in BRCA non-mutated patients has curbed its adoption in this group.
This restrained uptake is evident in ZEJULA's performance-despite exclusive access to the non-mutated segment, it generated only USD 450 million in sales in the first nine months of 2024. In contrast, LYNPARZA, marketed by AstraZeneca in partnership with Merck, reported USD 2.2 billion in sales over the same period. .
RUBRACA's primary source of revenue at the moment is its utilization as a second-line maintenance treatment for ovarian cancer. However, if there were limitations imposed on its label specifically for this indication, it would significantly increase the risk of Clovis, the company behind RUBRACA, facing potential bankruptcy.
The promising results from the clinical trial have positioned TALZENNA as a potential competitor to two other well-known PARP inhibitors: LYNPARZA by AstraZeneca and Merck, and ZEJULA by GSK. However, the success of TALZENNA in treating mCRPC may not solely rely on its own merits but could be further enhanced by its therapeutic partner, XTANDI. XTANDI is currently a leading product in the field of prostate cancer treatment.
Several key players, including AstraZeneca, Allarity Therapeutics, AtlasMedx, BeiGene, and others, are involved in developing drugs for PARP inhibitors for various indications such as ovarian cancer, breast cancer, prostate cancer, pancreatic cancer, and others. Overall, this is an exciting class of agents with great potential for development. Maturation of current studies over the next few years will lead to a better understanding of PARP inhibitors and define their role in the therapy of cancer.
This section focuses on the uptake rate of potential approved and emerging PARP inhibitors expected to be launched in the market during 2025-2034. LYNPARZA continues to be the most widely prescribed medication in the PARP inhibitor family for four tumor types. It is being used for conditions like breast, ovarian, and prostate cancer and pancreatic cancer. Increasing rates of HRD testing and utilization in first-line HRD-positive ovarian cancer in Europe. Additionally, LYNPARZA's uptake has increased in advanced HER2-negative breast cancer and BRCAm mCRPC.
PARP Inhibitors Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics. The presence of numerous drugs under different stages is expected to generate immense opportunity for PARPi market growth over the forecasted period.
Pipeline development activities
The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for PARP inhibitors emerging therapies.
The increasing strategic collaborations among major market players to enhance the growth of their pipeline products are anticipated to drive market expansion. For example, in January 2019, GSK completed the acquisition of TESARO, enabling the expansion of its ovarian cancer portfolio. This acquisition grants GSK marketing rights for ZEJULA, a treatment for ovarian cancer.
KOL Views
To keep up with current and future market trends, we take Industry Experts' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on PARP inhibitors evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along challenges related to accessibility.
DelveInsight's analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers such as MD Anderson Cancer Center, Texas from UT Southwestern Medical Center in Dallas, Cancer Research UK Barts Centre in London, MD Anderson Cancer Center, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or PARP inhibitors market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
Qualitative Analysis
We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.
Market Access and Reimbursement
Reimbursement for PARP inhibition has been universal in the United States and even in Europe. However, there is a specific requirement for reimbursement in the case of the bevacizumab-olaparib combination, where a companion diagnostic is necessary. Generally, reimbursement is limited to patients who exhibit molecular HRD (homologous recombination deficiency). As oral cancer therapies, PARP inhibitors are typically covered under pharmaceutical drug benefits, often falling under specialty drug tiers. In the case of Medicare Part D beneficiaries, there is a risk of significant out-of-pocket spending on drugs as there is no absolute limit on such expenses. Research has shown that higher patient out-of-pocket costs for oral cancer therapies can lead to increased rates of prescription abandonment, delayed treatment initiation, and non-adherence. To alleviate some of the financial burden associated with these expensive oral medications, companies often provide support through copay assistance programs and foundations. However, there remains a considerable financial burden for patients.
The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.
Key Updates on PARP Inhibitors
Abstract list is not exhaustive, will be provided in the final report
PARP inhibitors report insights
PARP inhibitors report key strengths
PARP inhibitors report assessment