ALK Inhibitors, Potential Market Opportunity & Clinical Pipeline Insights 2019

  • OI-92
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  • Published date: Apr, 2019
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  • Life Sciences & Healthcare
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  • 0 Pages

ALK gene alterations play a vital role in the pathogenesis of several cancers after it was first discovered in anaplastic large cell lymphoma and hence the name anaplastic lymphoma kinase (ALK).  ALK is referred as a receptor tyrosine kinase (RTK) that belongs to the insulin receptor (IR) superfamily. In humans the ALK gene encodes ALK, and immunohistochemical analysis revealed that ALK expression is scattered partially in pericytes, neural cells, and endothelial cells of adult human brain tissues. ALK mRNA is found to be expressed in the small intestine, prostate, testis, and colon. ALK was found to be rearranged, mutated, or amplified in various tumors including non-small cell lung cancer (NSCLC), diffuse large B cell lymphoma, inflammatory myofibroblastic tumors, cell carcinoma, colon cancer, breast carcinoma neuroblastoma, and esophageal cancer.

Market Overview

The theories and practices of the individual cancer therapy have significantly influenced the approval of the first-generation ALK inhibitor, crizotinib (Xalkori; PF-02341066; Pfizer), by the US Food and Drug Administration (FDA). Second-generation ALK inhibitors like ceritinib [Zykadia], alectinib [Alectinib], and brigatinib [Alunbrig] are developed to overcome crizotinib-resistant mutations, to increase anti-ALK activity, and to improve their activity in CNS disease.  Crizotinib was using as the reference treatment for patients with ALK+ NSCLC and as a promising treatment for tumors.  Many of the patients have developed acquired resistance in the first year of treatment, unfortunately, and thus its efficacy is limited in CNS disease. Hence strategies urgently have to be developed to overcome inherent and acquired resistance of using ALK inhibitors. Nowadays, many of the second-generation ALK inhibitors are under various stages of clinical development, which are showing activity in crizotinib-resistant disease with promising activity in CNS disease patients. The third-generation ALK inhibitors (such as lorlatinib) came into existence in patients with CNS involvement.

Currently, the marketed ALK inhibitors of Zykadia (ceritinib) and Alecensa (alectinib) are indicated for the treatment of non-small cell lung cancer and gastrointestinal cancer. The ALK inhibitors pipeline included more than 15 molecules, and they are expected to achieve regulatory approval in the near future, some of them include ensartinib (X-396), CEP-18050, X-339, X-390, EBI-215, ASP3026, and EBI-600215. Novel potent ALK inhibitors have become existence with promising results recently in the last few years, and with a good toxicity profile that includes ceritinib (LDK378), brigatinib (AP26113), alectinib (RG7853/AF-802/RO5424802/CH5424802), entrectinib (RXDX-101, NMS-E628), MEDI4736 (durvalumab), TSR-011, X-376/X-396, PF-06463922, ASP3026 and CEP-28122/CEP-37440.

The aim to increase the inhibitory activity against ALK and to defeat the inevitable development of drug resistance adds fuel to the emergence of new ALK inhibitors. The procedure of resistance presents the need for new collaborations and education within the multidisciplinary team. In the sequence of generalized progression, an understanding of the present molecular mechanism of resistance is evolved as a key to decision-making and clinical management that highlights the role of the pathologist. The strong clinical evidence has shown that ALK is one key driving factors of oncogenesis, which will make it a key drug target. A key challenge is to understand why ALK-positive patients are not getting benefit from checkpoint inhibition and the need to develop new therapeutic strategies to tackle the immune system to identify ALK-positive cancers effectively

Key Developments

  • On 21 Feb 2019, Durvalumab was launched for Non-small cell lung cancer (Inoperable/Unresectable, Late-stage disease, Second-line therapy or greater) in Japan.

  • In Jan 2019, The Lonza team (USA) collaborated with Takeda to provide support from early drug product development studies through commercial supply to help bring new cancer treatment of ALUNBRIG (brigatinib) to patients previously treated with crizotinib.

  • In Nov 2018, Pfizer received approval of its third-generation ALK inhibitor lorlatinib, a follow-up to its first-generation Xalkori product, which is facing increasing competition.


This pipeline analysis report segments the ALK inhibitors based on therapies employed (monotherapy and undisclosed), RoA (oral and undisclosed), therapeutic modalities (small molecules and disclosed), drugs under development (discovery, pre-clinical, phase I, phase I/II, phase II, and phase III), and recruitment status (recruiting, active not recruiting, enrolling by invitation, and undisclosed).

The key players in developing the ALK Inhibitors market growth include Betta Pharmaceuticals Co Ltd, Novartis, Pfizer, Ignyta, Daiichi Sankyo, Teva Pharmaceutical Industries, and others.

Report Description: The report covers in-depth analysis on ALK Inhibitors Pipeline Insights, 2019. The report assesses the ALK Inhibitors pipeline by stage of development (early development, pre-clinical, clinical and in approval), by application (non-small cell lung cancer (NSCLC), diffuse large B cell lymphoma, inflammatory myofibroblastic tumors, and others). In addition, the report includes key insights on other development activities, including (but not limited to) – licensing (In and Out), collaborations, acquisitions, reimbursement, patent, and regulatory designations.

The report includes in-depth company profiles of key players in ALK Inhibitors Pipeline. The company profile includes key information on overview, financial highlights, product portfolio, business strategies, and key recent developments.

The report highlights information on emerging companies with potentially disruptive technologies and new market entrants.


  • Provides detailed analysis of the product pipeline structure along with forecast of the various segments and sub-segments of the ALK InhibitorsPipeline.

  • Provides a comparative analysis of key marketed products and pipeline ALK Inhibitors

  • Provides key information on players involved on the ALK Inhibitors Pipeline.

  • Provides a complete overview of market segments and the regional outlook of ALK Inhibitors Pipeline.

  • Provides in-depth coverage of key news related toALK Inhibitors Pipeline, including major mergers and acquisitions and product development updates such as clinical trial progression updates and regulatory updates

Our research works on a holistic 360° approach to deliver high quality, validated and reliable information in our market reports. The Market estimation and forecasting involve the following steps:

  • Data Collation (Primary & Secondary)

  • In-house Estimation (Based on proprietary databases and Models)

  • Market Triangulation

  • Forecasting

  • Market-related information is assembled from both primary and secondary sources. 

  • Primary sources involved participants from all global stakeholders such as experts from several related industries and suppliers that have been interviewed to obtain and verify critical information as well as to assess prospects of the market. The participants included are CXOs, VPs, and managers. Plus, our in-house industry experts having decades of industry experience contribute their consulting and advisory services. 

  • Secondary sources include public sources such as regulatory frameworks, government IT spending, government demographic indicators, industry association statistics, and company publications annual reports press releases along with paid sources such as Factiva, OneSource, Bloomberg among others. 

  • Top-down and bottom-up approaches: The overall market size was used in the top-down approach to estimate the sizes of other individual submarkets (mentioned in the market segmentation by product, type of manufacturing, and disease) through percentage splits from secondary and primary research. The bottom-up approach was also implemented (wherever applicable) for data extracted from secondary research to validate the market segment revenues obtained. 


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