Cooperation Invitation | Frost & Sullivan is about to release the '2026 Global Oncolytic Virus Industry Development Blue Book'.

As precision tumor treatment and immunotherapy continue to evolve, how to improve the immunosuppressive microenvironment in solid tumors, address treatment resistance, and enhance long-term patient benefits has become an important focus in the development of innovative drugs. Lytic viruses possess dual mechanisms: direct cell tumor lysis and activation of anti-tumor immunity, making them a key direction for exploring new treatment options for solid tumor care. Ongoing innovations in engineered virus vector modification, combination therapy, systemic delivery, and large-scale production are expanding the clinical development landscape for lytic viruses and placing higher demands on product research and development, clinical validation, and industrial chain coordination.

In recent years, clinical and commercial advancements in the field of lytic viruses have been continuously accumulating. In August 2026, Replimune’s Tudriqev™ in combination with nivolumab received accelerated approval from the US FDA for use in adult patients with unresectable advanced skin melanoma that had progressed after prior PD-1 blocking antibody therapy. The single-arm Phase III BOND-003 study published in The Lancet Oncology that same year demonstrated that the lytic adenovirus creostimogene in 75.5% of 110 evaluable high-risk non-muscle layer invasive bladder cancer in situ patients who were non-responsive to BCG achieved complete remission (CR) at any time post-treatment, further highlighting the potential application of such therapies for refractory tumors.

Based on ongoing research into global innovation in tumor treatment and the biopharmaceutical industry, Frost & Sullivan (hereafter referred to as "Sullivan") is currently working on the preparation of the '2026 Global Lytic Virus Industry Development Blue Book'. The blue book will systematically outline the development trajectory of the global lytic virus industry, covering industry overview, regulatory policies, virus vectors, combination therapies, research and development and manufacturing processes, market development, and capital trends—providing a research reference that combines technical depth and commercial perspective for industry participants.

Based on a global perspective, this blue book systematically introduces the basic definition, biological characteristics, and dual anti-tumor mechanism of lytic viruses, outlines their clinical position and application potential in tumor treatment, and presents industry research and commercialization progress based on existing marketed products and under-development pipelines. At the regulatory level, the blue book will focus on major markets such as China, the United States, Europe, and Japan, outlining the regulatory framework and technical requirements of these markets, and analyzing key issues such as pharmaceutical research, clinical evaluation, and biosecurity management during product development.

At the technical and clinical levels, the blue book will analyze DNA- and RNA-based lytic viruses, covering representative vectors such as herpes simplex virus, adenovirus, vaccinia virus, and influenza virus, and comparing their biological features, engineered modification pathways, and clinical development directions. It will also systematically outline the combined use of lytic viruses with immune checkpoint inhibitors, chemoradiation, CAR-T, and other innovative therapies, and, in conjunction with representative studies, explore synergistic mechanisms, clinical evidence, and subsequent development opportunities. New technologies such as multi-functional immune armament are also expanding the development value of lytic viruses. The 2025 Nature paper on VG161, a multi-center Phase I study, used an engineered lytic virus expressing multiple immune regulatory molecules for treatment of refractory hepatocellular carcinoma, observing preliminary anti-tumor activity and changes in the tumor immune microenvironment—providing clinical research evidence for exploring new options after systemic treatment resistance. Thus, lytic viruses exhibit further development potential as local immune regulators and expression platforms for therapeutic molecules.

At the industrialization level, the blue book will systematically outline the key stages of lytic virus development, from virus seed batch establishment, host cell culture, viral amplification, downstream purification, formulation development, and quality control, and analyze key challenges such as scale-up, viral infectivity maintenance, batch consistency, and efficacy assessment. It will also outline technical approaches such as one-time sealed production, enhanced culture, and formulation stability optimization, and present supporting industrial chain capabilities such as research and development outsourcing, process development, and production services.

On this basis, the blue book will also analyze the development potential, core driving factors, and long-term trends of the global and Chinese lytic virus markets, outline industry financing, acquisition, and licensing cooperation cases, and include representative industry players. It will, in conjunction with their business characteristics, display technology platforms, product or service portfolios, research and development progress, and industrialization capabilities, providing a reference for industry cooperation and strategic planning.

Sullivan sincerely invites lytic virus research and development companies and upstream and downstream industrial chain partners to participate in the research and release of this blue book. Through professional research and industrial exchanges, it will present industry innovation outcomes, enhance all parties’ understanding of technical value and commercialization pathways, and work together to promote the high-quality development of the global lytic virus industry.