세계의 PARP 억제제 시장 : 시장 규모, 대상환자집단, 경쟁 구도, 예측(-2034년)

Key Highlights:

• First runner LYNPARZA drew attention by treating patients with specific genetic mutations. LYNPARZA generated approximately USD 3.7 billion in revenue globally with approximately 40% revenue from the United States due to growth in usage in breast ovarian and prostate cancers.
• In contrast, latecomer ZEJULA rapidly expands market share by confirming its effects in all patients regardless of genetic mutations and proving "all-comer" indications.
• PARP inhibitors, including LYNPARZA, ZEJULA, RUBRACA, and TALZENNA, have received approval as standalone treatments from regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). Currently, PARP inhibitors are used for the treatment of various types of cancer, including breast cancer, ovarian cancer, fallopian tube cancer, primary peritoneal cancer, prostate cancer, and pancreatic cancer.
• Emerging key players in PARP inhibitors include AstraZeneca with Saruparib for breast and prostate cancers, AtlasMedx with AMXI-5001 for solid tumors, and BeiGene with Pamiparib for ovarian cancer. These companies are shaping the future of cancer treatment. Their innovations are driving progress in oncology
• In December 2024, the OlympiA clinical trial presented updated data at the San Antonio Breast Cancer Symposium, demonstrating that LYNPARZA reduced the risk of death by 28% in high-risk, BRCA-positive, HER2-negative early breast cancer after 6.1 years of follow-up.
• Moreover, several PARP inhibitors are currently being evaluated in clinical trials. An example is AbbVie's Veliparib, which is in the developmental stage and is anticipated to receive approval during the forecast period.
• With up to 85% of patients experiencing disease recurrence that requires additional treatment, LYNPARZA, and ZEJULA have played an important role in reducing the risk of recurrence since their approvals as maintenance therapies.
• PARPi possesses the unique ability to improve progression-free survival and repair DNA damage in cells. Attributed to this, these inhibitors are extensively used for the treatment of various types of cancers. Hence, the increasing burden of cancer is estimated to create lucrative sales opportunities for cancer therapeutics such as PARPi in the coming years.
• Additionally, the PARPi market is expected to experience growth as a result of the rising demand for PARPi due to its effectiveness. However, there are several obstacles that impede market progress, including the high expenses associated with clinical trials, strict regulatory standards, and frequent product recalls.
• For ovarian cancer, PARP inhibitors have revolutionized the care for patients with BRCA mutations and homologous recombination-deficient (HRD) mutations.
• There are promising opportunities for research in the field of PARP inhibitors. One such opportunity is to investigate biomarkers that can effectively identify patients who would derive the greatest benefits from PARP inhibitor treatment.
• Impact Therapeutics, Merck, Jiangsu Hengrui Pharmaceuticals, AstraZeneca, AtlasMedx, and several other companies are currently engaged in the development and production of selective PARP 1 inhibitors, which have the potential to significantly impact and enhance the PARPi market.

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.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

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.

PARP Inhibitors Epidemiology

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.

PARP Inhibitors Drug Chapters

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.

PARP Inhibitors Market Outlook

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.

PARP inhibitors Drugs Uptake

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

1. In February 2025-Allarity Therapeutics announced that the new protocol for its Phase II clinical trial of stenoparib in ovarian cancer is set to begin and will be expected to provide critical data by end of summer 2026 for a pivotal registration trial.

2. In January 2025, AstraZeneca announced that LYNPARZA has received a positive recommendation from the National Institute for Health and Care Excellence (NICE) for NHS use in England and Wales to treat adults with HER2-negative, locally advanced or metastatic breast cancer with germline BRCA1 or BRCA2 mutations after chemotherapy.

3. In December 2024, The OlympiA clinical trial presented updated data at the San Antonio Breast Cancer Symposium, demonstrating that olaparib reduced the risk of death by 28% in high-risk, BRCA-positive, HER2-negative early breast cancer after 6.1 years of follow-up.

4. In August 2024, the FDA granted Breakthrough Therapy Designation to niraparib for BRCA1/2-positive metastatic castration-resistant prostate cancer to expedite its development and review.

5. Findings presented during the 2024 ESMO Breast Cancer Congress showed that a combination of LYNPARZA, IMFINZI and FASLODEX demonstrated clinical activity and an acceptable toxicity profile when administered as a second- or third-line treatment to patients with primarily pretreated, endocrine-resistant ER-positive, HER2-negative metastatic breast cancer who expressed molecular abnormalities associated with PARP inhibitor sensitivity.

Abstract list is not exhaustive, will be provided in the final report

Scope of the Report:

• The report covers a segment of key events, an executive summary, and a descriptive overview of PARP inhibitors, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight into the competitive landscape, and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the PARP inhibitors market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the PARP inhibitors market.

PARP inhibitors report insights

• PARP Targeted Patient Pool
• PARP Inhibitors Pipeline Analysis
• PARP Inhibitors Market Size and Trends
• Existing and future Market Opportunity

PARP inhibitors report key strengths

• Ten years Forecast
• The 7MM Coverage
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions

PARP inhibitors report assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT)

Key Questions:

• What was the PARP inhibitor total market size, the market size by therapies, market share (%) distribution in 2024, and what would it look like in 2034? What are the contributing factors for this growth?
• Which drug is going to be the largest contributor in 2034?
• Which is the most lucrative market for PARP inhibitors?
• Which indication accounts for maximum PARP inhibitors sales?
• What are the pricing variations among different geographies for approved therapies?
• How the reimbursement landscape has for PARP inhibitors evolved since the first one was approved? Do patients have any access issues that are driven by reimbursement decisions?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to PARP inhibitors?
• What are the key factors hampering the growth of the PARP inhibitors market?
• What are the recent novel therapies, targets, and technologies developed to overcome the limitations of existing therapies?
• What key designations have been granted for the emerging therapies for PARP inhibitors?
• What is the cost burden of approved therapies on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to buy:

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the PARP inhibitors market.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of indication-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading indications.
• Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet need of the existing market so that the upcoming players can strengthen their development and launch strategy.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of PARP Inhibitors

4. Key Events

5. Epidemiology and Market Forecast Methodology

6. PARP Inhibitors Market Overview at a Glance in the 7MM

• 6.1. Market Share (%) Distribution by Indication in 2024
• 6.2. Market Share (%) Distribution by Indication in 2034
• 6.1. Market Share (%) Distribution by Therapies in 2024
• 6.2. Market Share (%) Distribution by Therapies in 2034

7. PARP Inhibitors: Background and Overview

• 7.1. Introduction
• 7.2. Types of PARP inhibitors
• 7.3. Treatment

8. Target Patient Pool

• 8.1. Key Findings
• 8.2. Assumptions and Rationale: 7MM
• 8.3. Epidemiology Scenario in the 7MM
  • 8.3.1. Total Incident Cases in Selected Indications for PARP Inhibitors in the 7MM
  • 8.3.2. Total Eligible Patient Pool for PARP Inhibitors in Selected Indications in the 7MM
  • 8.3.3. Total Treated Cases in Selected Indications for PARP Inhibitors in the 7MM

9. Marketed Therapies

• 9.1. Key Competitors
• 9.2. LYNPARZA: AstraZeneca
  • 9.2.1. Product description
  • 9.2.2. Regulatory milestones
  • 9.2.3. Other developmental activities
  • 9.2.4. Clinical development
  • 9.2.5. Safety and efficacy
• 9.3. ZEJULA: GlaxoSmithKline
  • 9.3.1. Product description
  • 9.3.2. Regulatory milestones
  • 9.3.3. Other developmental activities
  • 9.3.4. Clinical development
  • 9.3.5. Safety and efficacy
• 9.4. RUBRACA: Clovis Oncology
  • 9.4.1. Product description
  • 9.4.2. Regulatory milestones
  • 9.4.3. Other developmental activities
  • 9.4.4. Clinical development
  • 9.4.5. Safety and efficacy
• 9.5. TALZENNA: Pfizer
  • 9.5.1. Product description
  • 9.5.2. Regulatory milestones
  • 9.5.3. Other developmental activities
  • 9.5.4. Clinical development
  • 9.5.5. Safety and efficacy

10. Emerging Therapies

• 10.1. Key Competitors
• 10.2. AZD5305: AstraZeneca
  • 10.2.1. Product description
  • 10.2.2. Other developmental activities
  • 10.2.3. Clinical development
  • 10.2.4. Safety and efficacy
• 10.3. Veliparib: AbbVie
  • 10.3.1. Product description
  • 10.3.2. Other developmental activities
  • 10.3.3. Clinical development
  • 10.3.4. Safety and efficacy

11. PARP Inhibitors: Seven Major Market Analysis

• 11.1. Key Findings
• 11.2. Market Outlook
• 11.3. Key Market Forecast Assumptions
  • 11.3.1. Cost Assumptions and Rebates
  • 11.3.2. Pricing Trends
  • 11.3.3. Analogue Assessment
  • 11.3.4. Launch Year and Therapy Uptakes
• 11.4. Total Market Size by Indication in the 7MM
• 11.5. Total Market Size by Therapies in the 7MM
• 11.6. The United States Market Size
  • 11.6.1. Total Market Size by Indication in the United States
  • 11.6.2. Total Market Size by Therapies in the United States
• 11.7. EU4 and the UK Market Size
  • 11.7.1. Total Market Size by Indication in EU4 and the UK
  • 11.7.2. Total Market Size by Therapies in EU4 and the UK
• 11.8. Japan Market Size
  • 11.8.1. Total Market Size by Indication in Japan
  • 11.8.2. Total Market Size by Therapies in Japan

12. Market Access and Reimbursement

13. SWOT Analysis

14. KOL Views

15. Unmet Needs

16. Appendix

• 16.1. Bibliography
• 16.2. Report Methodology

17. DelveInsight Capabilities

18. Disclaimer