11 September 2023
Visiongain has published a new report entitled Immuno-Oncology Clinical Trials Market Report 2023-2033: Forecasts by Phase (Phase I, Phase II, Phase III, Phase IV), by Design (Interventional Trials, Observational Trials, Expanded Access Trials), by Indication (Solid Tumours, Hematological Cancer) AND Regional and Leading National Market Analysis PLUS Analysis of Leading Companies AND COVID-19 Impact and Recovery Pattern Analysis.
The immuno oncology clinical trials market is valued at US$6,849.8 million in 2023 and is projected to grow at a CAGR of 11.3% during the forecast period 2023-2033.
Increasing Regulatory Approval for Immuno-Oncology Drugs
Most IO medications, including Keytruda, Opdivo, Yervoy, and Tecentriq, are approved either on their own or as a component of first-line therapy. A combination of IO medicines is typically recommended if IO monotherapy fails to treat a patient. After immunotherapy fails, no second-line therapeutic options are very effective. Therefore, investigations combining traditional IO medicines like PD-1, PDL-1, and CTLA-4 with various IO targets (T-cell immunoglobulin mucin 3, T-cell immunoglobulin, killer immunoglobulin-like receptor, and V-domain immunoglobulin suppressor) are required. In the last ten years, IO treatments have dominated the field of cancer treatment. Checkpoint-modulating immunotherapies significantly impact survival and have changed the standard of oncology care.
Following are some of the regulatory approvals in IO in 2022
• January 2022: Tebentafusp-tebn was approved for unresectable or metastatic uveal melanoma, a new medical entity (NME) and first approval for this rare cancer.
• February 2022: Citacabtagene autoleucel approved for replaced or refactory multiple myeloma
• March 2022: Opdualag (nivolumab and relatlimab-rmbw) approved for unresectable or metastatic melanoma, Keytruda (pembrolizumab) for patients with advanced endometrial carcinoma
• June 2022: Lisocabtagenemaraleucel approved for second line treatment of large B-cell lymphoma
• May 2022: Tisagenlecleucel approved for relapsed or refractory follicular lymphoma
• April 2022:Axicabtagene ciloleucel approved for second line treatment of large B-cell Lymphoma
• August 2022: Fam-trastuzumab deruxtecan-nxki is the first approved therapy that targets the HER2-low breast cancer subtype.
• September 2022: Imfinzi (durvalumab) plus chemotherapy was approved in the US as the first immunotherapy regimen for patients with advanced biliary tract cancer
• October 2022: Rovelizumab, in combination with durvalumab approved for unresectable heapatocellular carcinoma
• October 2022: Tecvayl is the first bispecific therapy directed at both B-cell maturation antigen protein and a cluster of differentiation 3 protein complex and T cell co-receptor approved for the treatment of r/r myeloma
• November 2022 : Accelerated approval to mirvetux-imabsoravtansine-gynx for Fra-positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer
• December 2022 : Accelerated approval to mosunetuzmab-axgb for relapsed or refractory follicular lymphoma
Hence, the increasing regulatory approval for the IO is expected to boost the demand for Immuno oncology clinical trials.
How has COVID-19 had a Positive Impact on Immuno Oncology Clinical Trials Market?
Clinical studies for immuno oncology have been significantly impacted by the COVID-19 pandemic. Some of the major effects are as follows:
• Decreased recruiting of patients: Due to patients' reluctance to travel to clinical trial sites or take part in studies that required intimate contact with others, the number of patients enrolled in clinical trials decreased as a result of the pandemic.
• Increased chance of contracting COVID-19: Immuno oncology treatments have the potential to impair the immune system, leaving patients more prone to infection. Patients taking part in clinical trials for immuno oncology were at an elevated risk of contracting COVID-19 because of this.
• Trial design modifications: To reduce the chances of COVID-19 infection, trial sponsors and investigators had to alter the experiment's design. Virtual visits, remote monitoring, and adjustments to the dose schedule were some of these modifications.
• Trial completion delays: Clinical study completion was delayed as a result of the pandemic because trial sponsors and investigators had to find ways to get around it.
Clinical trials for immuno oncology have advanced during the epidemic despite these obstacles. In fact, some studies have produced encouraging findings, indicating that COVID-19 might respond favourably to immuno oncology treatments.
Here are several instances of clinical trials in immuno oncology that have been altered by COVID-19:
• KEYNOTE-048: In this experiment, pembrolizumab in combination with chemotherapy was being tested for its effectiveness in treating advanced non-small cell lung cancer (NSCLC). The trial was put on hold in March 2020 because of the pandemic, but it was later resumed when the trial's design had been changed. The trial is still going on; therefore, we don't yet have any results.
• Durvalumab combined with chemotherapy is being tested in this experiment, NCT04338480, to see if it may effectively treat advanced NSCLC. The trial began in May 2020 and is still going on now. The trial's results have not yet been made public.
• NCT04501725: In this trial, the effectiveness of using ipilimumab and nivolumab together to treat advanced melanoma is being examined. The trial began in August 2020 and is still going on now. The trial's results have not yet been made public.
Clinical studies for immuno oncology have been significantly impacted by the COVID-19 pandemic. Nevertheless, despite these difficulties, new immuno oncology treatments are continually being developed.
How will this Report Benefit you?
Visiongain’s 249-page report provides 96 tables and 145 charts/graphs. Our new study is suitable for anyone requiring commercial, in-depth analyses for the immuno oncology clinical trials market, along with detailed segment analysis in the market. Our new study will help you evaluate the overall global and regional market for immuno oncology clinical trials. Get financial analysis of the overall market and different segments including type, process, upstream, downstream, and company size and capture higher market share. We believe that there are strong opportunities in this fast-growing immuno oncology clinical trials market. See how to use the existing and upcoming opportunities in this market to gain revenue benefits in the near future. Moreover, the report will help you to improve your strategic decision-making, allowing you to frame growth strategies, reinforce the analysis of other market players, and maximise the productivity of the company.
What are the Current Market Drivers?
Investments in Healthcare R&D Projected to Boost Industry Growth
Healthcare R&D is a complex and diverse process that necessitates a large investment of time and resources and extensive expertise and experience with drug discovery and development. It is distinguished by significant risk and long development timeframes. The discovery, preclinical, and clinical phases of novel drug research and development typically involve successive experimentation, data compilation, and analysis spanning three major areas. Although each unique step of drug discovery has a reasonably high success rate compared to other drug development stages, the overall success rate for drug discovery is only 51%, from target to hit to lead optimization. Drug discovery is discovering new potential medicines, typically including target identification and validation, hit identification, and lead creation and optimization. Preclinical studies often include animal model studies to assess toxicity and other parameters, chemical production and therapeutic formulation optimization, and other investigations required to begin clinical trials.
Clinical trials involve studies on healthy volunteers and patients to determine drug safety and efficacy to gain regulatory approval. For instance, the Cancer Research Institute reported in July 2021 that for the fiscal year that concluded on June 30, 2021, it had granted more than US$28.5 million in research grants and fellowships. These investments help platform studies like the PORTER (prostate cancer), AMADEUS biomarker, and REVOLUTION (pancreatic cancer) investigations, which evaluate cutting-edge immunotherapy treatment combinations, get off the ground and grow. Hence, the investment in the R&D is expected to boost the demand for clinical trials in the market.
Increase in Cancer Cases has Compelled Biotech and Pharmaceutical Companies to Conduct More Clinical Immuno Oncology Tests
Cancer is a complex illness that develops through a multi-stage carcinogenesis process that involves various molecular pathway events. As a result, many obstacles are linked to cancer diagnosis, prognosis, and therapy. Because of the complexity of cancer, a single marker is ineffective in this aspect. Furthermore, each cancer differs in terms of its molecular profile. As a result, immuno oncology tests have proved very important in deciphering disease signatures and generating customized therapeutics.
Cancer has been more prevalent globally in recent years. According to estimates from the World Cancer Research Fund International for 2022, there will be 29.5 million new instances of cancer worldwide and 16.3 million cancer-related deaths by 2040. More than 60% of new cancer cases are diagnosed in Africa, Asia, and Central and South America, and these regions account for 70% of global cancer mortality. Thus, cancer's increasing incidence and prevalence have necessitated substantial research for detection and therapy, with immuno oncology tests playing a crucial role.
Thus, with the growing number of cancer cases, several companies and research institutions focusing on new therapeutic approaches are making a crucial contribution to the global immunology oncology market. According to Fierce Pharma, various players focus on developing cancer drugs. BMS, Roche, Johnson & Johnson, Pfizer, AstraZeneca, and Merck are expected to be prominent drugmakers by 2024. Hence, the increasing number of cancer cases and the rising focus of key players on cancer drug development is expected to boost the demand for immuno oncology clinical trials.
Where are the Market Opportunities?
Growing Number of Immuno Oncology Medication Clinical Studies
In recent years, there have been a lot more immuno oncology medication clinical studies. Over 9,000 immuno oncology medication clinical trials were active in 2022, up from just over 4,000 in 2017. This growth is the result of various factors, such as:
Clinical trial results for immuno oncology medications. The FDA has recently authorised several immuno oncology medications, including pembrolizumab, nivolumab, and ipilimumab, for the treatment of cancer. There has been an upsurge in funding for research in this field as a result of these medications' remarkable clinical results in patients with advanced cancer. The creation of novel immuno oncology medications. Numerous new immuno oncology medications are now being developed in addition to the medicines that have already been licenced. These medications are being investigated on various cancer types, and they target various immune checkpoints and pathways.
The immune system is being better understood. As scientists gain more understanding of the immune system's functioning, new immuno oncology medications are being developed. For instance, current study focuses on the environment around the tumour, known as the tumour microenvironment. The immune system may struggle to combat cancer in this setting because it can decrease the immunological response.
The major players operating in the immuno oncology clinical trials market are AstraZeneca plc, BioNTech SE, Bristol-Myers Squibb Company, Exscientia plc, F. Hoffmann-La Roche AG, ICON plc, IO Biotech, Inc., IQVIA Inc., Medpace, Inc., Merck & Co., Inc., Novartis AG, Pfizer Inc., and Syneos Health among others. These major players operating in this market have adopted various strategies comprising M&A, investment in R&D, collaborations, partnerships, regional business expansion, and new product launches.
• On 31st July 2023, Syneos Health reached a deal with Optimal Clinical Trials Ltd. The agreement will increase the Company's clinical trial capacity in New Zealand across a wide range of therapeutic areas, including oncology, the central nervous system, and vaccines.
• On 14th November 2022, Exscientia plc and The University of Texas MD Anderson Cancer Centre announced a collaboration to combine Exscientia's patient-focused artificial intelligence (AI) capabilities with MD Anderson's expertise in drug discovery and development to advance cutting-edge small-molecule oncology therapies.
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