Immuno-oncology: Market Size, Trends and Analysis

Immunotherapy, or immuno-oncology, is steering hopes of more effective, sustainable cancer treatment regimes in which the patient’s own body is programmed to destroy malignant cells.?This revolutionary approach in #oncology is formulated by strategies that are based on innate #immunity and adaptive immunity, as well as various signaling pathways. These therapies have become the fifth pillar of cancer treatment, alongside #surgery, #radiotherapy, #chemotherapy, and other targeted therapies.

The field of #immunooncology (IO) involves the development of therapies that can harness the body’s ability to elicit and sustain, naturally or artificially, an effective immune response against cancer. At #GlobalData , our research is predominantly focused on active #immunotherapy products, which contribute to the cancer immunity cycle shown in the figure below.

Increasing cancer incidence and favorable treatment outcomes drives market:

According to the American Cancer Society, in 2022, there will be an estimated 1.9 million new #cancer cases diagnosed and 609,360 cancer deaths in the US alone. The trend is similar in other geographies and this surge in the incidences of cancer will result in the growth of immune-oncology market in the years to come. The pronounced advantages of immunotherapy including personalization, long-term remission, and fewer side effects due to better targeting are resulting in increasing dependency on IO drugs. This growth is undoubtedly fueled by the advent of immune checkpoint molecules which have a great potential as future anti-cancer therapy targets. GlobalData estimates that the global immuno-oncology market is expected to reach $238 billion in 2030.

Classification of IO drugs:

In the last three decades, researchers have gathered enough evidence that tumors are recognized by the immune system and that their growth can be controlled for a prolonged duration via immunosurveillance. The different forms of IO agents that help in this process include Checkpoint Modulators, CAR-T therapies, oncolytic #viruses , #anticancer vaccines, Cytokines, and bispecific #antibodies, which have been investigated over this time period. Bispecific antibodies are notably the most popular type of IO in the investigation as they have consistently dominated the development pipeline.?The market is led by Checkpoint Modulators such as Keytruda and Opdivo which are marketed for multiple indications. The current leader in the bispecific antibody segment of immuno-oncology is Amgen Inc. (Amgen), which is the only company in oncology with an FDA-approved bispecific T-cell engager antibody (Blincyto). Cytokines are also seeing significantly more development in solid tumours compared to #bloodcancers. According to researchers, the next step in cytokine research includes using synthetic cytokines in a targeted manner, rather than a systemic manner.

Research & Development:

Immuno-Oncology (IO) is at the forefront of biological drug development and that has generated much buzz in the last decade. IO therapies represent nearly one thirds of the biologics pipeline. In this aspect, the launch of Monoclonal Antibody (MAb) Immune Checkpoint Inhibitors (ICIs) such as Yervoy (Bristol Myer Squibb) in the past decade has revolutionized the industry and provided new treatment routes across the spectrum of tumor types. Many companies are now focusing on development of #celltherapies with reduced toxicity, that can be administered in out-patient setting.

Numerous grants and fundings are being made available for research in oncology across various therapeutic types around the world. In July 2021, the Cancer Research Institute announced that it has awarded more than $28.5 million in research grants and fellowships during the 2021 fiscal year ending June 30, 2021. These grants total $10.7 million for the launch, expansion, and ongoing support of platform studies including the PORTER (prostate cancer), AMADEUS biomarker study, and REVOLUTION (pancreatic cancer) studies testing novel immunotherapy combinations to treat these cancers. In June 2022, the Mark Foundation for Cancer Research and Johns Hopkins University Bloomberg Kimmel Institute for Cancer Immunotherapy announced that they have partnered on a $10 million investment in #immunotherapy research.

China and the US have the highest number of academic institutions and companies developing CAR cell therapies. Since cancer is among the high-priority disease area with patients experiencing a significant health burden and unmet needs, as highlighted in the Chinese government’s Healthy China Action Plan (2019–2030). Numerous startups are more focused on the development of immuno-oncology therapies and are making progress, for example, in September 2020, Shanghai-based Junshi Biosciences announced that it has received the Breakthrough Therapy designation from the US FDA for toripalimab as a treatment for nasopharyngeal carcinoma.

According to GlobalData #research, oncology drugs are known to have higher number of FDA accelerated approvals in comparison to all other therapeutic areas combined. The FDA’s accelerated approval scheme enables quick entry of potent drugs such as Novartis’s Gleevec (imatinib) in chronic myeloid leukemia.

An analysis of GlobalData’s Pharma Intelligence Center shows that oncology drugs account for 66% of all FDA accelerated approvals since 2000, with 88 distinct drugs gaining such approval, followed by #infectiousdiseases. Interestingly, considerable preference is given to immuno-oncology therapies that target cancers of high unmet need to file for regulatory approval with Phase II data.

As of May 2022, over 5,000 clinical trials are investigating IO across the 8MM with 797 drugs in development.

Effect of Covid 19:

The COVID-19 pandemic impact almost all the global markets, causing considerable disruption to clinical practice as well. Cancer care and trials of novel drugs were affected negatively, alike other therapeutic research areas. However, approximately 37% of #oncologytrials that have been disrupted by #covid19 have resumed and this recovery is set to accelerate in the following years.

However, positive outcome from the pandemic period for immunotherapy research is that of #cancervaccine developments. The proven efficiency of vaccines against COVID19 is likely to be helpful for the introduction of cancer vaccines into clinical practice, since they both function on similar mechanism, i.e., through mRNA delivery.?

Increasing strategic partnerships and M&As

Companies in the immunotherapy market are leveraging on strategic collaboration to accelerate the development of investigational drugs. For example, AstraZeneca entered a development collaboration with Innate Pharma for further co-development and co-commercialization. AstraZeneca plc has also acquired Alexion Pharmaceuticals Inc, a biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions. Gilead Sciences, Inc., has acquired a 100% stake in Immunomedics Inc, which discovers, develops, manufactures, and commercializes monoclonal antibody-drug conjugates for #cancertreatment and #autoimmune disorders.

While identifying robust predictive biomarkers, bringing down the cost of therapy continues to be challenging, immunotherapy market is growing by leaps and bounds taking researchers one step closer to precision oncology.

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