Therapeutic Vaccine Market - Growth, Trends, COVID-19 Impact, and Forecasts (2023-2028)

The therapeutic vaccine market is expected to register a CAGR of 12.63% over the forecast period.

While the sudden outbreak of the COVID-19 pandemic impacted most of the business sectors negatively, the therapeutic vaccine market showed significant growth in the years 2020 and 2021. The studied market is still booming with the detection of new COVID-19 variants. The increase in demand for the development of new vaccines to control the spread of the coronavirus disease has driven the studied market's growth. The demand for therapeutic vaccines increased during the pandemic, as did the investments from governments and business players across the world. For instance, in April 2021, Moderna and Samsung Biologics entered into a Manufacturing Services and Supply Agreement in which Samsung Biologics in South Korea will provide large-scale, commercial fill-finish manufacturing for the COVID-19 vaccine that Moderna intends to supply markets outside of the United States. Further, as per a press release by the United Nations International Children's Emergency Fund (UNICEF) in October 2021, a new ACT-Accelerator strategy was planned, which called for a USD 23.4 billion international investment to address disparities in the availability of COVID-19 diagnostics, vaccinations, and therapies worldwide. These investments during the pandemic were anticipated to impact the therapeutic vaccine development for COVID-19. As a result, the COVID-19 pandemic initially had a positive impact on the market; however, as the pandemic has subsided, the market has lost some traction; however, it is expected to grow steadily during the study's forecast period.

Factors such as the rise in research and development (R&D) expenditures by major players, soaring government funding for the development of vaccines, and the rising prevalence of various diseases are expected to fuel the growth of the market. For instance, in February 2021, the Indian government provided funds amounting to USD 365 million (INR 26.7 billion) to the Department of Health Research. This fund was provided to develop four new national virology institutes, nine new high-containment laboratories for studies on highly infectious pathogens, and one national institution. Such initiatives in developing countries are anticipated to drive market growth.

Furthermore, an increase in research and development (R&D) activities, collaborations, strategic partnerships, product approvals, and launches has generated market growth over the analysis period. For instance, in August 2022, researchers at the School of Pharmacy at Queen’s University Belfast in Northern Ireland received funding from Breast Cancer Now to search for new treatments. The research team will be engaged in developing new treatments for an aggressive form of breast cancer. In this case, Niamh Buckley and Helen McCarthy from the School of Pharmacy secured a GBP 228,900 (USD 278,168) grant from Breast Cancer Now to tackle protein p53, found at very high levels in around 90% of triple-negative breast cancer tumors. Additionally, in August 2022, Merck (known as MSD outside the United States and Canada) and Orna Therapeutics, a biotechnology company, signed a collaboration agreement to discover, develop, and commercialize multiple programs, along with vaccines and therapeutics, in the areas of infectious disease and oncology. Orna will receive an upfront payment of USD 150 million from Merck under this collaboration agreement. Hence, these funds and investments are anticipated to generate demand for therapeutic vaccines as well. This is projected to fuel the market's growth.

Therefore, owing to the aforesaid factors, the studied market is anticipated to witness growth. However, strict legal requirements and frameworks and the high price associated with therapeutic vaccine development are likely to hinder the market's growth.

Therapeutic Vaccines Market Trends

Cancer Vaccines Segment is Expected to Witness Growth Over the Forecast Period

Cancer vaccines are a form of immunotherapy that help educate the immune system about what cancer cells 'look like' so that it can recognize and eliminate them. Owing to increasing cancer cases, an increase in clinical trials for therapeutic cancer vaccines, and research expenditure by companies and government funding, the cancer vaccines segment is expected to witness significant growth over the forecast period. For instance, as per the research published by the European Journal of Cancer in January 2022, a total of 44 ongoing (i.e., active, not recruiting, recruiting, and not yet recruiting) clinical trials were investigating therapeutic cancer vaccines in breast cancer as of June 23, 2021. Then, overall, 30 (68.2%) clinical trials enrolled patients with triple-negative breast cancer (TNBC), 21 (47.7%) clinical trials were open to patients with HER2-positive breast cancer, and only 15 (34.1%) trials had HR-positive breast cancer as inclusion criteria. Thus, these clinical trials show the engagement of research institutions as well as major pharmaceutical and biopharmaceutical players in the development of cancer therapeutic vaccines. Therefore, it is expected to contribute to the market's growth over the forecast period.

The major companies in the market are prioritizing product development and innovation to bring therapeutic vaccines to the market. For instance, in September 2022, the Central Government of India launched the country’s first vaccine against cervical cancer, the quadrivalent human papillomavirus vaccine (qHPV), which has been developed by the Serum Institute of India (SII) and the Department of Biotechnology (DBT). As per the government, 'CERVAVAC' is an outcome of a partnership between DBT and the Biotechnology Industry Research Assistance Council (BIRAC), supported by the Serum Institute for indigenous development. In addition to that, in March 2021, the European Commission awarded eTheRNA immunotherapies NV (eTheRNA), a clinical-stage company, a TIGER grant for USD 7.33 million (EUR 6.9 million). The grant was used to speed the development of a unique and potentially therapeutic mRNA cancer vaccine for treating recurrent or metastatic Human Papillomavirus strain 16 positive (HPV16+) cancers such as head and neck cancer, cervical cancer, and anogenital cancer, led by the company. Hence, these increasing mRNA vaccine and therapeutic developments and clinical trials for several cancers are anticipated to grow, thereby driving the segment's growth.

Therefore, owing to the factors mentioned above, the cancer vaccine segment is poised to witness growth over the forecast period.

North America Holds a Significant Share of the Therapeutic Vaccine Market Over the Forecast Period

The North American region is expected to contribute significantly to the market's growth during the study period. Factors such as the growing cancer burden, increasing research and development expenditures, and increasing product launches are predicted to fuel market growth. For instance, according to the American Cancer Society's data for 2022, 1.9 million new cancer cases are projected to be diagnosed in the country in 2022, of which nearly 236,740 are likely to be new lung cancer cases and 287,850 to be new breast cancer cases. The same source also states that 79,000 new cases of kidney cancer and 268,490 new cases of prostate cancer will be diagnosed in the country. This shows a high burden of cancer among the population in the United States. This is expected to boost the demand for the availability of therapeutic vaccines for treatment. This is further expected to drive market growth.

In addition, the government of Canada, through the Immunization Partnership Fund (IPF), reached populations with lower vaccine uptake by enabling informed vaccination choices. In 2020 and 2021, the IPF received USD 45.5 million in additional funding for more than 2.5 years to allow the Public Health Agency of Canada to continue supporting vaccination efforts across Canada. Through these initiatives, the Canadian government is trying to increase vaccine uptake and access to COVID-19 vaccines throughout Canada. Moreover, in May 2021, the government of Canada announced an investment of up to USD 199.16 million in Resilience Biotechnologies Inc. to increase its manufacturing and fill/finish capacity for a few vaccines and therapeutics using novel technology such as mRNA. As a result, healthcare and pharmaceutical expenditures in the countries, as well as rising government activities in the region, are expected to rise in the coming years.Therefore, these regional investments and expenditures are anticipated to drive market growth.

Moreover, strategic activities such as new product development, approvals, collaboration, and acquisition in the region are driving the therapeutic vaccine market's growth. For instance, in May 2021, Sotrovimab, developed by GSK, plc, received emergency use authorization from the Food and Drug Administration (FDA) for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older, weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death. In addition, in March 2022, Massachusetts General Hospital (MGH), in partnership with NYU Langone Health, started a multi-center phase 2 clinical trial that was launched to investigate a new BCG vaccine treatment for pediatric type 1 diabetes, even in subjects with established disease. Thus, strategic activities by major players are increasing in the region and are anticipated to grow, thus driving the growth of the market studied over the next few years.

Therefore, owing to the aforementioned factors, the North American region is expected to have significant growth over the forecast period.

Therapeutic Vaccines Market Competitor Analysis

The therapeutic vaccine market is fragmented in nature due to the presence of several companies operating globally as well as regionally. The competitive landscape includes an analysis of international and local companies that hold market shares and are well-known, including AstraZeneca, Pfizer Inc., GSK plc., Merck & Co., Inc., Novartis AG, Phio Pharmaceuticals Corp., and INOVIO Pharmaceuticals, among others.

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