Immunotherapy Drugs Market: Global Size, Trends, Competitive, and Historical & Forecast Analysis, 2024-2032

Market Overview

Report Description

Global Immunotherapy Drugs Market is valued at US$ 166 Billion in 2024, and it is expected to grow US$ 298 Billion by 2032 with the CAGR 7.4% from 2024 to 2032.

Scope of Global Immunotherapy Drugs Market

Immunotherapy drugs refer to the pharmaceutical sector focused on developing and delivering drugs that enhance, modulate, or suppress the body’s immune system to treat various diseases. These include cancer, autoimmune disorders, infectious diseases and allergies. Immunotherapy drugs include monoclonal antibodies, immune checkpoint inhibitors, cancer vaccines, cytokines and adopted cell therapy, providing target and effective treatment options compared to traditional remedies.

Furthermore, the market is seeing a strong growth due to various major factors such as cancer and increasing prevalence of chronic autoimmune diseases, increasing demand for personal medicine and significant progress in biologics and drug delivery technologies. Immunotherapy is particularly revolutionizing oncology, where drugs such as PD-1/PD-L1 inhibitors and CAR-T cell therapy are becoming standard treatment protocols, offering better survival rates with less side effects than traditional chemotherapy.

For instance, in August 2025, the U.S. FDA approved Bristol-Myers Squibb’s Opdivo (Nivolumab) for advanced non-small cell lung cancer (NSCLC), which demonstrates increased survival benefits in clinical trials. This milestone reflects the increasing acceptance and success of immunotherapy drugs in clinical applications. The future of immunotherapy continued successes, improving the results of treatment and changed disease management globally.

Request a Sample Report is available on a Paid Subscription -https://rnpmarketresearch.com/request-sample/global-immunotherapy-drugs-market-global-size-trends-competitive-and-historical-forecast-analysis-2024-2032

Key Players of Global Immunotherapy Drugs Market Report

Some of the prominent players in the Global Immunotherapy Drugs Market include AbbVie Inc., Adaptimmune Therapeutics, Amgen Inc., AstraZeneca Plc, BeiGene Ltd., BioNTech SE, Bristol-Myers Squibb, Eli Lilly and Company, Genmab A/S, GlaxoSmithKline Plc, Incyte Corporation, Johnson & Johnson, Merck & Co., Inc., Novartis AG, copyright Inc., Regeneron Pharmaceuticals, Roche Holding AG, Sanofi S.A. and Others.

Recent Developments

AbbVie and Xilio Therapeutics Collaborate on Tumor-Activated Immunotherapies.

On February 12, 2025, AbbVie and Xilio Therapeutics announced a collaboration and option-to-license agreement to develop novel tumor-active, antibody-based immunotherapy including masked T-cell engagers. This partnership combines the oncology expertise of AbbVie with Xilio's ownership tumor-activation technology. Under the agreement, Xilio will receive US$ 52 million in upfront payment and will be eligible for up to US$ 2.1 billion in casual payment and tiered royalties.

Eli Lilly's Olomorasib Receives FDA Breakthrough Therapy Designation

On September 4, 2025, U.S. FDA provided success medical designation to Elli Lily's investigation drug, olomorasib, in combination with pembrolizumab (Keytruda). The designation is for the first treatment of patients with unnatural advanced or metastatic non-small cell lung cancer (NSCLC) harassing a KRAS G12C mutation. The decision was based on promising results from Phase 1/2 LOXO-RAS-20001 trial and the Phase 3 SUNRAY-01 trial.

Market Analysis

Rising Prevalence of Gynecological Cancers Boost the Immunotherapy Drugs Market.

Increasing prevalence of gynecological cancer in emerging markets like India, is an important driver for immunotherapy drugs market. These cancers, including endometrial and ovarian cancer, represent growing public health concern due to factors such as changing lifestyle, delayed diagnosis, and limited early detection programs. In India alone, the incidence of ovarian cancer is estimated to increase by about 36,000 cases in 2020 to over 50,000 by 2045, which reflects a strong unmet medical requirement for innovative treatment options.

For example, of this driver is the entry of GSK in the Indian oncology market declared on August 25, 2025. GSK launched two innovative accurate therapy–Jemperli (dostarlimab), the first PD-1 immunotherapy approved for second-line treatment of advanced endometrial cancer, and Zejula (niraparib), a PARP inhibitor approved as first-line monotherapy maintenance for advanced ovarian cancer. This strategic move shows that global pharmaceutical companies are focusing on emerging markets, which are meeting the patient's reach to meet the needs without treatment and expand patient access to cutting-edge therapies.

In conclusion, the immunotherapy drugs market is being propelled by multiple powerful factors, including the rising disease burden in emerging markets. These drivers encourage pharmaceutical companies to expand into underserved regions and accelerate the development of breakthrough therapies.

Regulatory Approvals Accelerating Market Expansion Drives the Market Growth in Forecast Period.

The increasing number of regulatory approvals for novel immunotherapy drugs enhances the market significantly by rapidly enabling the patient's access to innovative treatment options. Regulatory bodies such as FDA play an important role in approving success treatment, especially for rare or aggressive cancer where treatment options are limited.

A remarkable example of Incyte Corporation’s FDA approval of Zynyz (retifanlimab-dlwr) on May 15, 2025, for the first-line treatment of advanced squamous cell carcinoma of the anal canal (SCAC). Zynyz Step 3 Pod1um-304 testing became the first and only FDA-approved for advanced SCAC patients in the United States based on positive results. The test performed a significant improvement in progress free survival compared to chemotherapy alone. This regulator milestone not only valid the therapeutic capacity of the retifanlimab, but also expands treatment options for patients suffering from rare and aggressive cancer. Looking ahead, continued collaboration between regulators and industry players will further accelerate the availability of life-saving immunotherapies across global markets.

Regulatory Delays in Emerging Markets Hinder the Immunotherapy Drugs Market Growth.

The approval process for immunotherapy drugs in emerging markets such as India can be long and complex, requiring extensive clinical testing data before applying regulatory bodies. This delay in approval may obstruct timely access to immunotherapy treatment in these areas. While regulatory agencies have streamlined certain procedures, delay in approval remains a challenge for drug developers those are looking to present innovative immunotherapy quickly.

For instance, in India, unlike chemotherapy drugs, immunotherapy and radiotherapy equipment are not covered under existing discounts. This discrepancy has led the high treatment cost, causing this treatment to become ineffective for many, especially for economically weaker sections. An MP from Bangalore recently met the Union Finance Minister to request exemption from import duties on these treatments to make them more accessible.

In conclusion, regulatory delays in emerging markets face important challenges for timely introduction of immunotherapy drugs. Addressing these delays through streamlined approval procedures and policy reforms can increase the patient's reach and improve health care results in these areas.

Limited Healthcare Infrastructure in Low-Resource Settings Hamper the Immunotherapy Drugs Market Growth.

In many low- and middle-income countries (LMICS) access to optimal cancer care is quite obstructing fragmented health care systems, incomplete health insurance coverage and lack of healthcare infrastructure. These systemic challenges cause advanced cancer treatment such as immunotherapy drugs, especially in rural or remote areas. Uneven geographical distribution of healthcare units and trained oncology experts means that a large part of the population lacks timely diagnosis and access to treatment services. As a result, many cancer cases are found in advanced stages when treatment options are limited and results are usually deteriorated. For example, according to studies published by PMC, about 70% of deaths from cancer occur globally due to these obstacles in healthcare access, initial identification programs and insufficient special care centers.

Moreover, another example of efforts to remove these challenges can be seen in India, where a parliamentary committee recently recommended expanding 30% business margin cap applicable by the current government on required anti-cancer drugs. Originally applied to traditional chemotherapy drugs, the committee proposed to expand this CAP to cancer vaccines, immunotherapy treatment and oral chemotherapy drugs. The purpose of this recommendation is to make advanced cancer remedies much cheap and accessible to patients, especially from economically weaker sections. India faces more than 1.3 million new cancer cases annually. Hence, limited healthcare infrastructure in LMICS creates a great restraint on the growth and access of immunotherapy drugs, resulting in uneven cancer care and poor patient results.

Get the Freshest Market Data - Buy the Latest Version Available Now - https://rnpmarketresearch.com/request-discount/global-immunotherapy-drugs-market-global-size-trends-competitive-and-historical-forecast-analysis-2024-2032

Geography Analysis

North America

In North America, especially in rural areas of the United States, there is a challenge limited to special cancer care facilities. Despite being an advanced healthcare infrastructure, about 19% of the U.S. population lives in rural areas, where the deficiency of oncologist and special treatment centers delays cancer diagnosis and has limited access to immunotherapy drugs. For example, a recent report in 2025 highlighted that about 50% of rural cancer patients in the U.S. missed the recommended immunotherapy remedies due to insufficient local oncology experts and facilities, which led to the increased results and mortality risk.

Europe

In Europe, regulatory fragmentation in countries serves as a major obstacle. The European Union has centralized the approval of the drug through the European Medicine Agency (EMA), but the individual countries still implement their own health technology assessment (HTA) and reimbursement policies, delaying the newly approved immunotherapy to the patient. For instance, in 2025, Germany delayed the reimbursement approval for a new FDA-approved PD-1 inhibitor by over 12 months, greatly affected the patient's reach despite the EMA approval. This indicates that the individual country-level regulatory process prolongs the patient's reach in Europe.

Asia Pacific

Asia Pacific faces important challenges due to fragmented health care systems and important inequalities between urban and rural health care. According to a 2025 WHO report, more than 60% of oncology centers are concentrated in urban areas of China, India and Japan, which reduced rural population. For example, a 2025 news report stated that in China, 1 out of 10 patients for immunotherapy received treatment due to limited oncology centers and insufficient insurance coverage for these drugs.

Latin America

The Latin America struggles with the old healthcare infrastructure and a limited number of special oncology centers. A recent study has shown that more than 70% of oncology treatment in the area is concentrated in urban hubs such as Sao Paulo and Buenos Aires, while remote areas lack essential facilities. For example, in 2025, the Brazil Ministry of Health reported that less than 15% of eligible cancer patients received immunotherapy treatment due to insufficient special features and fragmented insurance policies.

Middle East & Africa

The Middle East and Africa, the problem is complicated by low health care expenses and lack of regulator harmony. For example, in sub-city Africa, only 5% of cancer patients have access to advanced treatments such as immunotherapy, roughly inadequate healthcare due to infrastructure and lack of awareness. For example, in 2025, South Africa's Health Department admitted that out of more than 60,000 new cancer cases, less than 3,000 patients were able to reach immunotherapy treatments, roughly limited special centers and high out-off-packet costs.

What you can gain from Global Immunotherapy Drugs Market Report

Provides an in-depth analysis of the dynamics of the Immunotherapy Drugs segment across various regions.

Immunotherapy Drugs Market research report provides detailed information about Market Introduction, Market Summary, Global market Revenue (Revenue US$), Market Drivers, Market Restraints, Market Opportunities, Competitive Analysis, and Regional and Country Level.

The Global Immunotherapy Drugs Market report covers extensive analysis of emerging trends and the competitive landscape.

Global Immunotherapy Drugs Market report helps to identify opportunities in the marketplace.

Browse Full Report -https://rnpmarketresearch.com/reports/global-immunotherapy-drugs-market-global-size-trends-competitive-and-historical-forecast-analysis-2024-2032

Global Immunotherapy Drugs Market Segmentation

By Drug Class:

· Adoptive Cell Therapy (ACT)

· Cancer Vaccines

· Cytokines

· Immune Checkpoint Inhibitors

· Monoclonal Antibodies (mAbs)

· Other Immunotherapy Drugs

By Route of Administration:

· Intravenous (IV)

· Oral

· Subcutaneous (SC)

· Others

By Application:

· Allergies

· Autoimmune Diseases

· Cancer

· Infectious Diseases

· Other Applications

By End User:

· Hospitals

· Specialty Clinics

· Ambulatory Care Centers

· Research Institutes

By Regional & Country Level:

· North America

o U.S.

o Canada

· Europe

o U.K.

o France

o Germany

o Italy

· Asia Pacific

o China

o Japan

o India

o Southeast Asia

· Latin America

o Brazil

o Mexico

· Middle East and Africa

o GCC

o Africa

o Rest of Middle East and Africa

About Us

R&P Market Research is a reliable source of industry intelligence and strategic insights, offering high-quality, data-driven reports for informed decision-making across various sectors.

Their focus on accuracy, integrity, and client satisfaction has established them as a preferred research partner. They provide global market assessments, trend forecasting, and tailored consulting services to meet clients’ specific goals.

Contact Us

PNRDIGI MARKET RESEARCH (OPC) PRIVATE LIMITED, INDIA
???? Email: [email protected] ???? Phone: 8975005378
???? Website: https://rnpmarketresearch.com