Cancer immunotherapy market is expected to grow at the CAGR between 9-10% from 2022 to 2030 as this therapy is being rapidly adopted in the cancer treatment space. The major market drivers such as higher efficiency of cancer immunotherapy than traditional cancer treatments, rise in global cancer burden, initiatives by government cancer care funding, and easy reimbursement for cancer immunotherapy increase the overall acceptance of this therapy and boost the growth of the market. However, high product prices and stringent regulations related to cancer immunotherapy can restrain immunotherapy market growth. Further, Technological advancements such as AI to determine suitable immunotherapy can act as a new opportunity to boost immunotherapy’s acceptance as a treatment option for cancer.
Further, according to a report by Johns Hopkins Medicine, over 70 immunotherapy medications are in the clinical pipeline, and more than 1,000 immunotherapy clinical studies are now being conducted worldwide. Thus, growth in the immunotherapy market has attracted a lot of funding and attention in developers’ efforts.
Owing to these factors global cancer immunotherapy market is expected to cross the $200 billion market size by 2030.
Cancer Immunotherapy Market Major Drivers
1. Higher Efficiency of Cancer Immunotherapy Than Traditional Cancer Treatments
Cancer Immunotherapy has become a reliable cornerstone of cancer care and a practical method that has improved the prognosis for many patients with various malignancies. Immunotherapy works to treat the underlying causes of cancer rather than just the symptoms, providing long-term cancer prevention and possibly reducing the likelihood of cancer recurrence. Thus, among various methods of managing cancer, such as surgery, hormone therapy, radiotherapy, and chemotherapy, immunotherapy has revolutionized treatment.
In March 2021 Dr. Franco Locatelli and colleagues published, the results of the immunotherapy vs Chemotherapy Randomized Clinical Trial for the treatment of B-Cell Acute Lymphoblastic Leukemia, Immunotherapy results in better study outcomes as compared to chemotherapy.
Source: Journal of the American Medical Association
More, in various clinical studies, it has been found that cancer immunotherapy does have incomparable advantages over traditional anti-tumor therapy. For instance, Keytruda doubles the survival rate in non-small-cell lung cancer (NSCLC) patients compared to chemotherapy (Source: Results of a clinical trial published in CancerConnect- June 2022).
Source: CancerConnect
Such high survival rate as compared to other antitumor therapy increase the cancer immunotherapy preference among HCPs and patients.
Further, patients with cancer who have not responded to chemotherapy, surgery, and radiation have found success with immunotherapy. For instance, OPDIVO and YERVOY are considered the first-line treatment for unresectable malignant pleural mesothelioma (MPM) where no other treatment option is available (Source: UC Health). Moreover, in October 2020, the Food and Drug Administration (FDA), US, also authorized these two new drugs for the treatment of malignant pleural mesothelioma, which was also the first development for MPM in the previous 16 years.
Thus, higher efficiencies of cancer immunotherapy may increase its overall acceptance over the traditional therapies thereby driving market demand.
2. Rise in Global Cancer Burden
The rising frequency of risks such as smoking, low food quality, and less physical inactivity in economically developing nations, the cancer burden has increased significantly in recent few years and is likely to grow in near future. According to the report of the national library of medicine (NLM), by 2030, there will be approximately 26 million new cancer cases and about 17 million cancer deaths per year. Also, according to the world health organization (WHO), in 2020, cancer was the leading cause of deaths
Source: Union for International Cancer Control (UICC)
Further, population aging will have a direct connection to the global cancer burden as cancer is more prevalent in elders. As per the GLOBOCAN report (published in 2020), people in the age group of 65 contribute more than 50% of the number of cancer global cancer cases. Moreover, it is also estimated that the 65 years and above age group population share will rise from 9.1% in 2020 to 15.9% (1.5 billion people) in 2050.
Thus, a rise in cancer incidence, as well as the need to lessen the negative effects of existing cancer treatments, are projected to propel the cancer immunotherapy market forward.
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3. Initiatives by Government Cancer Care Funding
Globally, the prevalence of cancer is increasing, imposing a heavy burden on communities and health systems at all income levels. However, cancer care funds by various governments are helping underprivileged and unprivileged patients to avail costly cancer treatment. Following are some of the government programs from developed and developing nations that can assist in funding cancer treatment, including immunotherapy, in various nations.
3.1 US
In February 2022, US relaunched the Cancer Moonshot, which outlined new objectives, including a minimum 50% reduction in the death rate from cancer. Earlier, In December 2016, Congress approved the 21st Century Cures Act, allowing $1.8 billion in financing over 7 years for the Cancer Moonshot. Over those seven years, funds must be appropriated each fiscal year (FY). Congress funded National Cancer Institute (NCI) with $300 million in FY 2017 and 2018, $400 million in FY 2019 and 2020, and $195 million for FY 2021.
3.2 UK
In order to provide UK patients with quick access to highly novel cancer care drugs when the clinical evidence is not yet sufficiently developed, National Health Service (NHS) England established the Cancer Drugs Fund (CDF) in 2016. Cancer medications are funded in England through the CDF. Patients receive quick access to the treatment under a CDF-managed access agreement, and pharmaceutical companies are reimbursed for their products. Further on June 6, 2022, NHS England launched the Innovative Medicines Fund (IMF), an extension to the existing Cancer Drugs Fund (CDF), with a pot of £340 million.
3.3 Japan
For more than 50 years, Japan has had a well-developed universal healthcare system. Through this system, every citizen has access to healthcare at the hospital or clinic of their choice for a set cost. Japanese citizens must pay up to 30% of the cost of their treatment. Where the individual part of 70 years old or older age population or has poor income population, or under the age of six population does not require to pay the cost of treatment.
3.4 India
In India, the Health Minister’s Cancer Patient Fund (HMCPF) was established in 2009 to offer financial support to underprivileged cancer patients. A ₹100 Crore (~$21.3 million) corpus fund has been established and invested in fixed deposits. The financial aid is paid for with the interest that has accrued. According to rules, patients receiving treatment at 27 Regional Cancer Centers (RCC) are given financial aid for their cancer-related illnesses.
Exhibit-4
Funds Allocated and Released by Indian Health Minister’s Cancer Patient Fund (HMCPF) (2019-23) (₹ Crore/ ~$ Million)
| Year | Allocated (₹ Crore/ ~$ Million) | Released (₹ Crore/ ~$ Million) |
|---|---|---|
|
2019-20 |
50/ 6.93 |
35.67/ 4.94 |
|
2020-21 |
50/ 6.78 |
18.1/ 2.45 |
|
2021-22 |
40/ 5.26 |
6.83/ 8.99 |
|
2022-23 |
40/ 5.13 |
0.78/ 0.10 |
Source: Press Information Bureau Government of India
3.5 UAE
In 2021, to assist patients without insurance or with limited coverage, the Ministry of Health and Prevention signed a collaboration with Merck Serono Middle East and Al Manzil healthcare services. Cancer patients who cannot afford their therapies will receive financial assistance from this new UAE program called “Rawan”. Residents who have been diagnosed with head and neck, urothelial, or colorectal cancer are eligible for the program.
Thus, cancer care funds by governments can help patients in availing of expensive cancer treatments such as immunotherapy for underprivileged and unprivileged patients. This may increase the growth rate of cancer immunotherapy in the market.
4. Easy Reimbursement for Cancer Immunotherapy
The best way to deal with the increasing medical expenditures of fatal diseases like cancer is reimbursement by health insurance. It is now supported by many public and private health insurance partners in developed and developing nations. For instance, according to the Innovative Partnership for Action Against Cancer IPAAC, (2019) survey (conducted for 23 European countries) immunotherapies and indications had the best access in terms of reimbursement.
- Pembrolizumab as monotherapy for the treatment of advanced melanoma was reimbursed in 90.5% of countries.
- Nivolumab as second-line monotherapy was reimbursed in 82% of the countries for the treatment of advanced renal cell carcinoma and 78.3% for the treatment of non-small cell lung cancer
- Pembrolizumab, as monotherapy for the first-line treatment of metastatic NSCLC in adults whose tumors express PD-L1 with a TPS ≥ 50% was also reimbursed in 78.3% of the countries.
Thus, reimbursement of cancer immunotherapy across the European countries would increase the number of people who can have curative cancer immunotherapy treatment thereby driving the cancer immunotherapy market.
Further, in the US, private-sector health insurers such as Medicare Advantage are supporting reimbursement for cancer treatments. According to the manufacturer, Merck, the list price of a 200-milligram dose of Keytruda (for the US), is $9,869.94, when received once every 3 weeks. However, around 41% of patients with the Medicare Advantage Plan did not pay any costs for the drug. Further, 80% of the total patients who spent the drug from their pocket, paid between $0 and $925 per infusion, after paying the deductible. Also, around 80% of people enrolled in original Medicare paid between $1,000 and $1,950 per infusion, after paying the deductible.
Source: Innovative Partnership for Action Against Cancer (iPAAC)
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Major Opportunities in Cancer Immunotherapy Market
1. AI For Determining Suitable Cancer Immunotherapy
Imaging a patient’s cancer and the immune system’s reactions can give important information that could direct immunotherapeutic treatment choices during the course of therapy. A recent focus in immunotherapy has been drawn to technological developments like the real-time, non-invasive observation of particular cells or the use of artificial intelligence (AI) in pathology.
In 2019, researchers of Case Western Reserve University developed a novel artificial intelligence (AI) based method to determine which cancer patients may benefit from immunotherapy, an advance that helps reduce health care costs for underprivileged cancer patients. A CT scan was utilized by the researchers to examine tissue samples taken from 50 patients. They trained the AI system to develop an algorithm for recognizing changes in lung cancer lesions using these scans. This new technique was able to match patients who will react to immunotherapy.
Thus rather than spending time and money on other treatment options patients can directly go for suitable immunotherapy treatment. This technological advancement can act as a new opportunity to boost immunotherapy’s acceptance as a treatment option for cancer.
Major Threats and Challenges in Cancer Immunotherapy Market
1. Stringent Regulations Related to Cancer Immunotherapy Products
The introduction of immunotherapy medication has increased survival rates and made fatal illnesses more tolerable. However, these fresh features create a lot of clinical, moral, and legal concerns. Numerous promising treatments are being researched, but they are being held back from commercialization or delayed by regulatory issues with marketing authorization.
For oncology drugs, development time includes up to 6 years for FDA-mandated preclinical toxicology, pharmacology, and efficacy assessments. From activation of initial clinical trials, it now takes a median of 7.8 years until submission of a New Drug Application to the FDA and a median of 1.3 years from New Drug Application submission to FDA approval. Thus, overall, estimate that processes required for compliance with regulations directly or indirectly account for at least 5 years of the 12- to 15-year drug approval process.
Further, there is also an indirect impact of the regulatory burden that decreases both the number of patients and the number of physicians who are willing or able to participate in clinical research. For instance, patients who enroll in a trial must fulfill significantly stricter data collecting and documentation standards (required for FDA approval) than patients who get routine medication outside of a trial. For cancer patients, the protocol’s intricacy, the selection and recruiting of research participants, and the intensive visitation schedules are unworkable. Additionally, oncologists put in extra effort and time performing testing and analyses (for FDA submission) of clinical studies without receiving extra payment for it.
Thus, the regulatory challenges faced during the development process hinder the availability of novel and effective therapies such as immunotherapy to a broader population.
2. The High Product Price of Cancer Immunotherapy Products
Immunotherapies have revolutionized cancer care and increased patient survival as well as the quality of life. However, the high price of cancer immunotherapy treatment has become a concern. Immunotherapy is an expensive treatment when compared to other anticancer treatment options, which can limit market growth.
For oncology drugs, development time includes up to 6 years for FDA-mandated preclinical toxicology, pharmacology, and efficacy assessments. From activation of initial clinical trials, it now takes a median of 7.8 years until submission of a New Drug Application to the FDA and a median of 1.3 years from New Drug Application submission to FDA approval. Thus, overall, estimate that processes required for compliance with regulations directly or indirectly account for at least 5 years of the 12- to 15-year drug approval process.
Further, there is also an indirect impact of the regulatory burden that decreases both the number of patients and the number of physicians who are willing or able to participate in clinical research. For instance, patients who enroll in a trial must fulfill significantly stricter data collecting and documentation standards (required for FDA approval) than patients who get routine medication outside of a trial. For cancer patients, the protocol’s intricacy, the selection and recruiting of research participants, and the intensive visitation schedules are unworkable. Additionally, oncologists put in extra effort and time performing testing and analyses (for FDA submission) of clinical studies without receiving extra payment for it.
Thus, the regulatory challenges faced during the development process hinder the availability of novel and effective therapies such as cancer immunotherapy to a broader population.
Source: Healthmatch, Medigence, Bookimed, Europeanpharmaceuticalreview, Gofundme, Thesun, ValueinHealthMediglobus, Costhelper, HealthTorisam, Asbestos, Talktomira, Thegreenjournal.
In addition, prices of cancer immunotherapy vary considerably between nations and may not be directly correlated with the gross national product (GNP). There is a significant range in medicine pricing, with up to a 13-fold difference across countries in Europe and Oceania. Prices for cancer medications are highest in the United States, where they are 2-6 times more than elsewhere in the globe and more than twice as expensive as in Europe.
Source: Journal of Market Access & Health Policy
Further, low-income countries have 7.9% average health insurance coverage, therefore, it is difficult to bear the high price of cancer immunotherapy products for unprivileged cancer patients. The majority of patients in LMICs cannot afford to pay for these therapies out of pocket, even when they are on the market. Thus, it is extremely difficult to increase access to such treatment in LMICs thereby restraining cancer immunotherapy market growth.
