Alkylating Agent Market: Competitive Landscape, Pipeline, and Market Analysis 2023

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An alkylating antineoplastic agent is an alkylating agent used in cancer treatment that attaches an alkyl group (CnH2n+1) to DNA. The alkyl group is attached to the guanine base of DNA, at the number 7 nitrogen atom of the purine ring. Since cancer cells, in general, proliferate faster and with less error-correcting than healthy cells, cancer cells are more sensitive to DNA damage such as being alkylated. Alkylating agents are used to treat several cancers. However, they are also toxic to normal cells (cytotoxic), particularly cells that divide frequently, such as those in the gastrointestinal tract, bone marrow, testicles, and ovaries, which can cause loss of fertility. The mechanism of action (MOA) of Alkylating Agent is via cross-linking of DNA strands and acts directly on DNA during all cell cycle processes, crosslinking the N-7-guanine residues, producing DNA strand breakage, thereby inhibiting the transcription of RNA by alkylation and keep the cell from reproducing (making copies of itself) by damaging its DNA. Alkylating Agents are used in the treatment of lymphoma, leukemia, sarcoma, carcinoma, glioblastoma, neuroepithelioma, digestive system neoplasm, immunoproliferative disorders, blood coagulation disorders, breast diseases, etc. Increased prevalence of autoimmune disorders and various cancers are the key drivers for the Alkylating Agent market. For instance, according to the World Cancer Research Fund International 2020, around there were an estimated 18.1 million cancer cases around the world in 2020; of these, 9.3 million cases were in men and 8.8 million in women. The introduction of newer products by market players may look for opportunities that have a big impact on comprehensive research and development in Alkylating Agent. For instance, Oncopeptide’s Pepaxto (Melphalan Flufenamide) launch for the treatment of multiple myeloma.  Moreover, to address the difficulties in therapy, numerous market participants are developing innovative compounds. For instances, Proacta’s PR104 for the indication of solid tumors is under the various stages of clinical studies.


Key Market Developments:

  • In April 2021, ADC Therapeutics Zynlonta (Loncastuximab Tesirine-Lpyl) has received FDA approval for patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.
  • In February 2021, Oncopeptides’s Pepaxto (Melphalan Flufenamide) has received FDA approval for the treatment in previously treated adults with relapsed or refractory multiple myeloma.
  • In February 2022, ADC Therapeutics entered into a collaboration and clinical supply agreement with Roche to evaluate Zynlonta in combination with Glofitamab and Mosunetuzumab in addition to Polatuzumab in the Phase 1 LOTIS-7 trial.
  • In July 2022, ADC Therapeutics announced to enter into Exclusive License Agreement with Sobi to develop and commercialize Zynlonta (loncastuximab tesirine-lpyl) in Europe and select international territories.


Approved Drug Molecules and Brand Names for Alkylating Agent:

  • Pepaxto (Melphalan Flufenamide)
  • Zynlonta (Loncastuximab Tesirine-Lpyl)
  • Yescarta (Axicabtagene Ciloleucel)
  • Yondelis (Trabectedin)
  • Zydelig (Idelalisib)
  • Valchlor (Mechlorethamine) Gel
  • Eloxatin (Oxaliplatin/5-Fluorouracil/Leucovorin)
  • Busulfex (Busulfan)
  • Gliadel Wafer (Carmustine Implant)


Drugs under the Pipeline for Alkylating Agent:

·         Matulane (Procarbazine Hydrochloride)

·         Ovastat (Treosulfan)

·         Zepzelca (Lurbinectedin)

·         Leukeran (Chlorambucil)

·         Evofosfamide (TH 302)

·         Lobaplatin (D19466)

·         Gliadel Wafer (Carmustine Implant)

·         Muphoran (Fotemustine)

·         Captisol-Enabled Melphalan

·         Mustargen (Mechlorethamine)

·         Valchlor (Mechlorethamine Gel)

·         Melflufen (Melphalan Flufenamide)

·         Glufosfamide (D 19575)

·         PR104

·         Dianhydrogalactitol (VAL-083)

·         Tinostamustine (EDO-S101)

·         Mipicoledine (DM-CHOC-PEN)

·         Belrapzo (Bendamustine RTD)

·         Promitil (Pegylated Liposomal Mitomycin-C Prodrug)

·         OBI-3424

·         Bendeka (Bendamustine Rapid Infusion)

·         Cymerin (Ranimustine)

·         DYV700

·         Hexalen (Altretamine)

·         TFX05-01

·         Temodex (Temozolomide Gel)

·         Cisplatin Micelle Injection (HA132)

·         Tretazicar (CB1954)


Clinical Activity and Developments of Alkylating Agent:

As of June 2023, there will be about 41 companies with over 35 compounds that focus on various forms of cancer diseases. For these molecules, more than hundreds of clinical trials are being conducted and majority are in phase-2, phase-3 clinical trials by the players across the globe. For instance,

  • In December 2020, Servier has completed phase 2, randomized study with r-dhap +/- Bortezomib as induction therapy in relapsed/refractory diffuse large b-cell lymphoma (DLBCL) patients eligible to transplantation consisting Fotemustine drug.
  • In September 2022, PharmaMar completed phase 4, Non-interventional Study to Investigate Efficacy and Safety of Yondelis (Trabectedin) in Patients With Advanced Soft Tissue Sarcoma.


Molecule  Name

Number of Studies

Yondelis (trabectedin)


Matulane (Procarbazine Hydrochloride)


Ovastat (Treosulfan)


Zepzelca (Lurbinectedin)


Leukeran (Chlorambucil)




Target Indication Analysis of Alkylating Agent

The molecules such as Pepaxto (Melphalan Flufenamide) developed by Oncopeptides for the line of treatment for previously treated adults with relapsed or refractory multiple myeloma. ADC Therapeutics Zynlonta (Loncastuximab Tesirine-Lpyl) is used in patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. Kite pharma’s Yescarta (Axicabtagene Ciloleucel) for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy and treatment of relapsed or refractory large B-cell lymphomas.

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)
  • The report covers in-detail insights about the competitor’s overview, company share analysis, key market developments, and their key strategies
  • The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market
  • The report tracks recent innovations, key developments, and start-up details that are actively working in the market
  • The report provides a plethora of information about market entry strategies, regulatory framework, and reimbursement scenario

Frequently Asked Questions

Zynlonta (Loncastuximab Tesirine-Lpyl), Yescarta (Axicabtagene Ciloleucel), Yondelis (Trabectedin), etc. are the few FDA approved Alkylating Agent.

Total sale of ADC Therapeutics Zynlonta (Loncastuximab Tesirine-Lpyl) was US$74.9 million in FY2022.

Oncopeptides, ADC Therapeutics, Kite pharma, Gilead Sciencesetc are few leading market players in GM-CSF.

Lymphoma, leukemia, sarcoma, carcinoma, glioblastoma, neuroepithelioma, digestive system neoplasm, immunoproliferative disorders, etc are the major indication of Alkylating agent.

There are a total of 28 molecules that are in the Phase-1, Phase-2, and Phase-3 clinical development.

  • Oncopeptides
  • ADC Therapeutics
  • Kite pharma
  • Gilead Sciences
  • PharmaMar
  • Leadiant Biosci
  • Medac
  • GSK
  • ImmunoGenesis
  • Arbor Pharma
  • Servier
  • Recordati
  • Helsinn
  • Eleison Pharma
  • Proacta
  • Kintara Therap
  • Mundipharma
  • Eagle Pharma
  • SymBio Pharma
  • LipoMedix
  • OBI Pharma
  • Teva
  • Mitsubishi Tanabe
  • Dyve Biosci
  • Shenzhen Yangli Pharma
  • CSPC Pharma


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