PARP (poly-ADP-ribose polymerase) Inhibitors Market: Competitive Landscape, Pipeline, and Market Analysis 2023

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PARP stands for poly-ADP-ribose polymerase and is an enzyme found in the cells which helps the cells repair their DNA whenever it is damaged. The PARP family has many essential functions in cellular processes, including the DNA damage response, apoptosis, and regulation of transcription. PARP1 and PARP2 are the two types of PARPS that are involved in DNA repair. The mechanism of action is first, PARP1 binds to sites of single-strand DNA damage via the DNA-binding domain. Further, it synthesizes the PAR part and transfers it to the acceptor protein, and PAR recruits other repair proteins to the damaged DNA site. PARP Inhibitors inhibit the enzyme PARP from doing DNA repair and thus leave the cell to proceed through the apoptosis process. These are beneficial in the treatment of various cancers like Ovarian cancer, Breast cancer, Prostate cancer, and others, wherein they block the DNA repair of cancer cells, causing their death. Companies are trying to find new and novel molecules to prevent and cure these diseases. The development and launch of newer products by the market players will significantly enhance the revenue of the PARP Inhibitors market over the forecast years. For instance, according to the World Cancer Research Fund International, in 2020, ovarian cancer was the 8TH most common cancer in women globally, with more than 313,000 new cases. Also, according to the American Cancer Society, in 2023, it is estimated that about 19,710 women will receive a new diagnosis of ovarian cancer.

Several of these inhibitors are on the market, while many are in ongoing clinical trials.  Companies in their pipelines have 112 products in various stages of clinical trials. 2 products are in Phase 4, 7 products are in Phase 3, 16 products are in Phase 2, and 7 products are in Phase 1 of the clinical trials.

Key Developments of PARP Inhibitors

  • In June 2023, Talzenna (talazoparib) was approved by the FDA in combination with XTANDI (enzalutamide) for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC).
  • In June 2023, Lynparza (Olaparib) with Abiraterone and Prednisone or Prednisolone was approved by the FDA for the treatment of adult patients with BRCA-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC) for whom chemotherapy is not clinically indicated.
  • In April 2023, European Union (EU) approved Johnson & Johnson’s Akeega for the treatment of adult patients with BRCA-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC)
  • In December 2022, Lynparza (Olaparib) with Abiraterone and Prednisone or Prednisolone was approved by the European Union (EU) for the treatment of adult patients with BRCA-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC).
  • In April 2020, Zejula (niraparib) was approved by the FDA as the only once daily dose1st line monotherapy maintenance treatment for women with Platinum-Responsive Advanced Ovarian Cancer regardless of biomarker indication.

Approved molecules

  • Lynparza (olaparib)
  • Zejula (niraparib)
  • Talzenna (talazoparib)
  • Rubraca (rucaparib) – accelerated approval

Drugs in Pipeline

  • veliparib (ABT-888)
  • Rubraca (rucaparib)
  • AiRuiYi (fluzoparib)
  • Partruvix (pamiparib)
  • iniparib (BSI 201)
  • senaparib (IMP4297)
  • BMS-986141
  • AZD5305
  • ivospemin (SBP-101)
  • stenoparib (2X-121)
  • SC10914
  • venadaparib (NOV 1401)
  • INO-1001
  • amelparib (JPI-289)
  • nesuparib (JPI-547)
  • E7016
  • NMS-293
  • TQB3823
  • atamparib (RBN-2397)
  • ABT-767
  • AMXI-5001
  • AZD2461
  • AZD9574
  • Akeega (abiraterone
  • HS-10502
  • HTMC0435
  • HWH340
  • RBN-3143
  • RP12146
  • STP1002
  • TSL-1502
  • simmiparib (SMOCL-9112)

Clinical Activity and Developments of PARP Inhibitors

As of June 2023, 112 products for 438 diseases are in clinical trials. For instance,

  • In December 2023, completed a Phase 4 trial to evaluate the real-time tolerability of Niraparib in maintenance after Platinum-based chemotherapy for patients with Ovarian Cancer late relapse.
  • In March 2022, AstraZeneca completed a Phase 4 trial to study the efficacy and safety of Olaparib maintenance monotherapy in Platinum sensitive relapsed Non gBRCAm Ovarian cancer patients.
  • In October 2021, AstraZeneca completed a Phase 3 trial to study the clinical effectiveness and safety of Olaparib maintenance monotherapy in Metastatic Breast Cancer patients.

Molecule name

Number of studies

Lynparza (Olaparib)

372

Zejula (Nilaparib)

174

Rubraca (Rucaparib)

60

AiRioYui (Fluzoparib)

60

Talzenna (Talazoparib)

8

Target Indication Analysis of PARP Inhibitors

Drugs like Lynparza (Olaparib) and Talzenna (talazoparib) are approved by the USFDA and European EU for use, i.e., patients for use the treatment of BRCA-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC) and homologous recombination repair (HRR) gene-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC) respectively. Cancer cells are killed by PARP inhibitors in a variety of ways other than just by preventing PARP from doing its job. The trapping action of PARP inhibitors on PARP is the oldest mechanism. In addition to altering the function of PARP proteins after attaching to the NAD binding site of PARP, PARP inhibitors also glue PARP proteins to damaged DNA without causing them to dissociate, which leads to the buildup of the PARP-DNA nuclear protein complex and the amplification of replication forks. In the end, not only can SSB not be repaired, but RF stalling also causes the extremely cytotoxic DSBs to degrade. Other indications for which PARP Inhibitors are used include Primary peritoneum cancer, Breast cancer, Pancreatic cancer, and Fallopian tube cancer. These are used as the 1st line, 2nd line, and also as the 3rd line of therapy either solely or in combination with other drugs to improve outcomes. There is a great opportunity for the companies to launch their new products and innovations in the market.

Frequently Asked Questions

Lynparza (olaparib), Zejula (niraparib), and Talzenna (Talazoparib) are approved by the FDA, while Rubraca (rucaparib) has received accelerated approval from the FDA.

These are being used in various indications like Ovarian cancer, Prostate cancer, Breast cancer, and others.

Merck (MSD), AstraZeneca, GSK plc., J&J, and Pfizer are some of the major market players for PARP Inhibitors.

Rising incidence of diseases, improvement in technologies, development of new treatment lines in the market, and changing lifestyles leading to different types of cancers like Breast cancer, Prostate cancer, and Fallopian tube cancer are the key opportunities for PARP Inhibitors in the market.

Key Features of the Reports

  • The report provides granular level information about the market size, regional market share, historic market (2019-2023), and forecast (2024-2030)
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  • The report provides a plethora of information about market entry strategies, regulatory framework, and reimbursement scenario
  • Merck (MSD) (
  • AstraZeneca (USA)
  • GSK plc.(UK)
  • J&J (USA)
  • Takeda Pharmaceuticals (Japan)
  • Pfizer (USA)
  • AbbVie (USA)
  • Clovis oncology (USA)
  • Jiangsu Hengrui Pharmaceuticals Co., Ltd. (China)
  • EMD Serono (USA)
  • BeiGene, Inc. (Switzerland)
  • Sanofi (France)
  • IMPACT Therapeutics (China)
  • BMS (USA)
  • Panbela Therapeutics, Inc. (USA)
  • Allarity Therapeutics Inc. (USA)
  • Oncoheroes Bioscences Inc (USA)
  • Jiangxi Qingfeng Pharmaceutical Co Ltd (China)
  • Shanghai De Novo Pharmatech (China)
  • National OncoVenture (South Korea)
  • Ildong Pharmaceutical Co Ltd (South Korea)
  • Roche (Switxerland)
  • Jeil Pharmaceutical Co Ltd (South Korea)
  • Eisai Co., Ltd (Japan)
  • Nerviano Medical Sciences (Italy)
  • Sino Biopharmaceutical Ltd. (Hong Kong)
  • Ribon Therapeutics, Inc. (USA)
  • Ono Pharmaceuticals Co., Ltd. (Japan)
  • AtlasMedx, Inc. (USA)
  • Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (China)
  • Shanghai Huilun Pharmaceutical Group Co., Ltd. (China)
  • WuXi AppTec (China)
  • Hubei Biocause Pharmaceutical Co., Ltd. (China)
  • Incozen Therapeutics Pvt. Ltd. (India)
  • Rhizen Pharmaceuticals AG (Switzerland)
  • Dong-A University (South Korea)
  • Tasly Pharmaceuticals, Ltd. (USA)
  • Shanghai Acebright Pharma (China)

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