The cervical cancer market is expected to experience significant growth, from $607 million in 2020 to $4.8 billion in 2030 across the eight major markets (8MM*) at a high compound annual growth rate of 23.0%, according to GlobalData, a leading data and analytics company.

GlobalData’s latest report, ‘Cervical Cancer – Global Drug Forecast and Market Analysis to 2030’ identifies the launch of 13 pipeline agents, the approval of a first-in-class antibody-drug conjugate (ADC) in non-US markets, and the label expansion of Merck & Co’s Keytruda (pembrolizumab) into earlier lines of therapy, as the main drivers of this substantial growth. However, growth will be tempered somewhat by the patent expiries of multiple branded agents, and the emergence of competitively priced biosimilars.

Avigayil Chalk, PhD, Oncology and Hematology Analyst at GlobalData, comments: “In 2021, the FDA approved a label expansion for Keytruda, moving it into the first line in combination with bevacizumab and chemotherapy. The approval of the first ADC, Seagen and Genmab’s Tivdak (tisotumab vedotin) as a second-line therapeutic, also occurred in 2021, further adding to the emerging treatment landscape. The approvals for Keytruda and Tivdak, have to date been limited to the US market, but expansion to other markets is expected, resulting in the standard of care (SOC) across markets being dramatically shifted during the forecast period.”

China is expected to hold the largest share of the global cervical cancer market by 2030, with sales expected to reach $2.04 billion. This is due to its large populace and a comparatively high disease incidence. The cervical cancer pipeline for China includes multiple domestically developed agents, including second-generation checkpoint inhibitors, novel bispecific checkpoint inhibitors, and a targeted therapy.

Chalk continues, “With the exception of Akeso Biopharma’s AK104 (cadonilimab), approval of domestically developed agents is expected to be limited to the Chinese market, with the Chinese trials unlikely to meet the diversity requirements needed for FDA approval. Even though Avastin (bevacizumab) has been the SOC in the US market since 2014, a delay in approval for bevacizumab in China has meant that this has not been used as a comparator in several Chinese trials. Altogether, this is expected to result in Western-developed agents experiencing significant competition from the domestically developed agents in the Chinese market.”

Despite the rapidly changing cervical cancer treatment landscape, multiple unmet needs remain in this disease setting. Currently, there is a lack of adjuvant therapy in the locally advanced setting, with 50% of patients relapsing after SOC chemoradiation. Furthermore, although the launch and expected approvals of novel immunotherapies has and will continue to redefine the cervical cancer treatment paradigm, the treatment options for patients who do not meet the criteria for checkpoint inhibitor therapy or have already been checkpoint exposed are very limited.

Chalk concludes, “Keytruda, AstraZeneca’s Imfinzi (durvalumab), and AK104 are being trialled in combination with chemoradiation, and as maintenance therapies in the locally advanced setting, and it is hoped that the approval of these agents will reduce the risk of relapse. Launch of Tivdak across markets and Iovance’s Lifileucel will provide alternative treatment options to checkpoint inhibition. However, with checkpoint inhibitors accounting for the majority of agents expected to enter the market during the forecast period, it is likely that additional novel agents will still be required. This could be an area of considerable commercial potential in the future.”

* 8MM = US, France, Germany, Italy, Spain, UK, Japan and China.