ALK (Anaplastic Lymphoma Kinase) Inhibitor Market: Competitive Landscape, Pipeline, and Market Analysis 2022

ALK (Anaplastic Lymphoma Kinase) Inhibitors are a class of targeted therapies used in the treatment of cancers that have a specific genetic alteration called ALK gene rearrangement. These inhibitors work by blocking the activity of the ALK protein, which is involved in the abnormal growth and proliferation of cancer cells. By inhibiting ALK, these drugs help to suppress the growth and spread of cancer cells. ALK Inhibitors are primarily used in the treatment of ALK-positive non-small cell lung cancer (NSCLC), but they have also shown efficacy in other ALK-positive cancers, such as anaplastic large cell lymphoma (ALCL) and neuroblastoma. According to the American Cancer Society, Lung cancer (both small cell and non-small cell) is the second most common cancer in both men and women in the United States and about 10%-15% of all lung cancers are small cell lung cancer (SCLC) and about 80% to 85% are NSCLC.

The growth drivers of the ALK Inhibitors market include an increasing prevalence of ALK-positive cancers, particularly non-small cell lung cancer (NSCLC), and the growing adoption of targeted therapies in oncology. The development of novel ALK inhibitors with improved efficacy and reduced side effects, the expanding patient pool, and advancements in diagnostic techniques contribute to the market's growth. Companies such as BMS, Pfizer, Astellas, Roche, Sino Biopharma, Amgen, Ascentage Pharma, GSK, Novartis, and Takeda cater to this category. Moreover, many companies are coming up with new molecules in this space. For instance, GSK is currently conducting a clinical trial of the drug Belizatinib for the treatment of lung neoplasms.

Key Developments

In May 2023, Genentech completed a phase II trial of Alectimab in the treatment of Solid tumors (Second-line therapy, Late-stage disease, metastatic disease) in the USA.

In June 2022, Takeda launched for non-small cell lung cancer (metastatic disease) in Poland (PO).

In January 2022, European Commission Approves LORVIQUA® (lorlatinib) as a First-Line Treatment for ALK-Positive Advanced Lung Cancer.

Approved ALK Inhibitor molecules

• Xalkori (crizotinib)
• Alecensa (alectinib)
• Zykadia (ceritinib)
• Lorbrena (lorlatinib)
• Xospata (gilteritinib)
• Alunbrig (brigatinib)
• Rozlytrek (entrectinib)
• Ensacove (ensartinib)

ALK Inhibitor Agonist Pipeline Molecules

• Iruplinalkib (WX-0593)
• Repotrectinib (TPX-0005)
• XZP-3621
• Envonalkib (TQ-B3139)
• Unecritinib (TQ-B3101)
• Alkotinib (ZG0418)
• ASP-3026
• SY-3505
• Belizatinib (TSR-011)
• Conteltinib (SY-707)
• APG-2449
• CEP-37440
• NVL-655
• PLB 1003
• TGRX-326
• TPX-0131
• TY-2136b
• Foritinib (SAF-189)

Clinical Activity and Development of ALK Inhibitors

 In the ALK inhibitor space, more than 15 companies are conducting more than 30 clinical trials in this category of drugs. For instance,

In June 2023, Pfizer completed Phase-I/II clinical trials in Non-small cell lung cancer (late-stage disease, Metastatic disease, first-line therapy) in the USA, Australia, Belgium, Canada, France, Germany, Italy, Japan, Hong Kong, South Korea, Singapore, Spain, Switzerland, Taiwan, United Kingdom

In June 2022, Takeda presented the efficacy and safety data of Brigatinib’s phase II J-ALTA trial in non-small cell lung cancer presented at the 58th annual meeting of the American Society of Clinical Oncology (ASCO-2022)