The implementation of new strategies will turn the hepatocellular carcinoma (HCC) market into a land of opportunity for manufacturers, leading to a wave of new entrants. Additionally, regulatory incentives such as orphan drug designations and fast track approvals have led to a dynamic market, says GlobalData, a leading data and analytics company.

Mandana Emamzadeh, PhD, Pharma Analyst at GlobalData, comments: “Following the approval of Roche’s Avastin (bevacizumab) and Tecentriq (atezolizumab) for first-line treatment last year, the focus of research and development (R&D) in HCC has shifted toward combination therapies. Some combinations are already well represented in later-stage HCC – such as those combining either programmed cell death protein 1 (PD-1) or programmed death-ligand 1 (PD-L1) blockade with either multikinase inhibitors, anti-vascular endothelial growth factor (VEGF), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) .

“Further, the majority of late-stage HCC pipeline drugs are already marketed for other oncology indications, so HCC serves as an opportunity to expand the existing market for these products. Label expansion within HCC, to the early and intermediate stages, is another effective strategy to gain market share.

“Despite a strong presence in oncology, Novartis did not have a stake in the HCC market until its January 2021 collaboration with BeiGene. Novartis’s decision to strategically expand its oncology pipeline by in-licensing Phase III PD-1 inhibitor tislelizumab from BeiGene had a mutual benefit for both parties – with BeiGene gaining the recognition of an international pharmaceutical company to support the potential commercialization of tislelizumab and Novartis obtaining access to a promising pipeline drug in Phase III, which will ease its entry and improve uptake in the HCC market. A similar strategy was used in August by Eli Lilly to expand its pipeline into HCC.

“The enthusiasm of manufacturers resulted in the saturation of pipeline products in the same class of drugs throughout the HCC pipeline. Although key opinion leaders (KOLs) interviewed by GlobalData are happy with the progress being made in this field – considering the variety of MOAs and the wave of new entrants – they also highlighted the emergence of ‘me-too’ drugs and combinations. For instance, tislelizumab is a pipeline drug for first-line advanced HCC and will be in competition with other anti-PD-1/PD-L1 monotherapies such as BMS’s Opdivo and AstraZeneca’s Imfinzi. However, KOLs were less excited about monotherapies. Fortunately, Novartis and BeiGene announced that, under this strategic collaboration agreement, both companies can conduct clinical trials globally to investigate the combinations of tislelizumab with other cancer treatments. Therefore, this could be a promising start for Novartis as a novice in the HCC market.

“As a result, the implementation of new strategies in the HCC market will lead to a flood of new entrants providing more options to physicians and a better quality of life for HCC patients. On the contrary, the crowded pipeline products make it difficult for the new competitors to gain share in the HCC market unless an innovative strategy or novel combination is being offered.”