IMMUNOTHERAPY DRUGS MARKET ANALYSIS

Market Size and Trends

Global immunotherapy drugs market is estimated to be valued at USD 166.55 Bn in 2024 and is expected to reach USD 351.73 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 11.3% from 2024 to 2031.

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The immunotherapy drugs market is witnessing positive growth trends over the years. Immune checkpoint inhibitors, which help unleash the body's own immune response against cancer, have emerged as a major category of immunotherapy. Checkpoint inhibitor drugs such as Keytruda, Opdivo and Tecentriq are widely adopted drugs. Rising incidence of cancer cases globally and increasing preference for precision medicines are key factors boosting demand for immunotherapy drugs over the forecast period.

Rising awareness about cancer immunotherapy

With increasing incidence of various types of cancer worldwide, there is rising awareness among public as well as medical professionals about innovative treatment options. Cancer immunotherapy is gaining prominence as it utilizes body's own immune system to fight cancer in a novel way. Various advocacy groups are educating people about this option through awareness campaigns. These are highlighting how immunotherapy helps activate patient's own T cells to identify and destroy cancer cells in a targeted manner. This avoids non-specific killing of normal cells like other treatment options. The success stories showcased by advocacy groups and patients who benefited from immunotherapy are helping change perceptions. Where earlier surgery or chemo was the default option, now patients ask doctors about immunotherapy upfront. Medical conferences are dedicating special sessions to share research advances and real-world experiences with immunotherapy.

Market Concentration and Competitive Landscape

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Another important driver is the encouraging results seen with combining different immunotherapy drugs or combining immunotherapy with other treatment modalities. Early successes with checkpoint inhibitors led to focus on their potential to work even better when paired together or added to conventional therapies. Ongoing research is exploring diverse combination regimens tailored to individual cancer types and stages of disease. Some combinations show response rates much higher than any drug alone. These are also helping widen the pool of patients who can benefit. For instance, combining a PD-1 inhibitor with CTLA-4 antibody is giving durable responses in melanoma, lung and other cancers. Adding these to chemotherapy prior to surgery in early breast cancer patients improves pathologic response rates. Similarly, providing immunotherapy before or after radiation helps recruit immune cells to target radiation boosted tumor cells or residuals. The scope is also extending to accelerator drugs that can enhance effects of PD-1/PDL-1 inhibitors when given together.

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The immunotherapy drugs market currently faces several challenges. High development costs of these drugs coupled with low success rates pose significant investment risks for pharmaceutical companies. Additional testing is needed to understand long term safety and efficacy profiles of these novel drugs. Many cancer types have remained untouched where immunotherapy shows little promise. Monotherapy response rates have been moderate so far and combination strategies need more data. Patient access has also been an issue due to high costs of these therapies.

Market Opportunities – Development of innovative immunotherapies

The drugs have shown promising results against several cancer types and their adoption is increasing. As more clinical evidence from combination regimens emerge, response rates are expected to improve. Newer immunotherapies continue to be tested against different cancer indications providing scope for label expansions. The approaches can also potentially be adapted for non-oncology diseases thereby, creating lucrative market growth opportunities over the forecasted period.

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Therapy Type segment is sub-segmented into immune checkpoint inhibitors, monoclonal antibodies, vaccines, adoptive cell therapies, immune system modulators, and oncolytic virus therapy. Monoclonal antibodies segment is estimated to hold 28.4% share of the market in 2024. Monoclonal antibodies are engineered versions of human antibodies that can be designed to precisely target specific proteins on tumor or diseased cells, allowing them to eliminate those cells with minimal off-target effects. This targeted precision has made them increasingly popular for treating various cancer types as well as autoimmune diseases. Compared to other immunotherapy drugs, monoclonal antibodies offer an ability to pinpoint disease markers and disrupt their signaling more selectively. The market has seen a rapid uptake of several monoclonal antibody drugs in recent years for treating cancers like breast and lung cancer. Their precision also makes them well-suited for combining with other therapies like chemotherapy to achieve synergistic effects. Advancements in antibody engineering are further improving their precision and efficacy. Overall, monoclonal antibodies' mechanism of delivering targeted therapy with minimal side effects has positioned them as the leading therapy type segment.

Insights, By Route of Administration: Oral segment contributes the highest share of the market, owing to convenience and ease of administration

Route of Administration segment is sub-segmented into intravenous (IV), oral, intramuscular, subcutaneous, and others. Oral segment is anticipated to hold 47.2% of the market share in 2024. Patients generally prefer oral drugs over other forms of administration as they are less invasive and can be self-administered without any medical assistance. This makes the treatment process far more convenient for patients as there is no need for hospital visits or medical supervision every time a dosage is required. The oral drugs also provide improved treatment compliance as patients find it simpler to take pills along with their regular diet rather than regular and painful injections. The non-invasive nature of oral drugs also makes them more reassuring for patients. This significantly improves treatment outcomes as patients tend to continue their prescribed dosage schedules for longer durations without any apprehensions. The psychological advantage of oral drugs is a big factor that contributes to their heightened preference over more interventional forms of drugs administration. Their easy availability without any prescriptions also improves accessibility and flexibility of treatment.

Insights, By Indication: Growing Prevalence Drives Growth of Cancer Segmentf

Indication segment includes cancer, autoimmune diseases, and others. Cancer segment is anticipated to hold 84.7% of the market share in 2024. Cancer remains one of the leading causes of mortality worldwide with over 10 million new cases diagnosed annually. The growing cancer burden has prompted heightened efforts into developing innovative immunotherapies. Several checkpoint inhibitors and other novel modalities have been approved specifically for treating various cancer types in recent years. With improving diagnosis rates and growing focus on quality of life, cancer patients are increasingly being prescribed immunotherapy drugs. The availability of complimentary diagnostic tests has also enabled patient selection and improved outcomes.

Regional Insights

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North America has established itself as the dominant region in the global immunotherapy drugs market and is projected to hold 42.1% of the market share in 2024. With major pharmaceutical companies headquartered in the U.S. and Canada, the region has a strong industry presence and is at the forefront of research and development of novel immunotherapies. Several immunotherapies that have been approved in recent years were first developed by companies based in North America. This early mover advantage has helped the region gain significant market share. In addition, factors such as higher healthcare expenditure per capita, availability of favorable reimbursement policies, and presence of sophisticated healthcare infrastructure have supported adoption of high-priced immunotherapies. North American payers have shown more willingness to pay for immunotherapies compared to other regions due to better affordability. This pricing flexibility provides an important revenue stream for immunotherapy drug manufacturers.

The Asia Pacific region, on the other hand, is witnessing the fastest growth and emerging as an important market globally. Rising healthcare expenditure, growing middle-class population, increasing focus on quality healthcare services are driving the overall oncology market in Asia Pacific, in turn aiding immunotherapy drug adoption. Countries like India, China, Japan, South Korea and Australia have become key markets within the region.

Market Report Scope

Key Developments

• In June 2023, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorization for the medicinal product nivolumab (Opdivo), an immune checkpoint inhibitor when used in combination with platinum-based chemotherapy is indicated for the neoadjuvant treatment of resectable NSCLC at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥1%.
• In September 2022, the University of Texas MD Anderson Cancer Center and Virogin Biotech, a biotechnology company, announced a strategic collaboration to accelerate the development of oncolytic virus research and development for treating advanced cancers. This collaboration brings together MD Anderson’s clinical trials expertise and infrastructure with Virogin’s innovative pipeline of investigational oncolytic viruses and support the clinical development of Virogin’s therapies with multiple clinical trials in various cancer types to evaluate the safety and clinical benefit of these therapies and to identify prognostic biomarkers of response.
• In March 2022, Merck KGaA, a biopharmaceutical company, announced that the U.S. Food and Drug Administration had approved pembrolizumab (Keytruda) as a single agent for patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). Pembrolizumab is a PD-1 checkpoint inhibitor for a subset of patients with endometrial carcinoma that is microsatellite instability high or mismatch repair deficient
• In January 2022, Immunocore Ltd., a biotechnology company, announced that the U.S. Food and Drug Administration had approved tebentafusp-tebn (Kimmtrak), a bispecific gp100 peptide-HLA-directed CD3 T cell engager, for HLA-A 02:01-positive adult patients with unresectable or metastatic uveal melanoma.

*Definition: Immunotherapy Drugs Market consists of pharmaceutical therapies that utilize the body's own immune system to help treat cancer or autoimmune diseases. These drugs work by either boosting the existing immune response in the body against tumors or by helping restore normal immune function. Some of the major immunotherapy drugs included in this market are checkpoint inhibitors, monoclonal antibodies, interferons, interleukins, and other immune system modulators.

Market Segmentation

• Therapy Type Insights (Revenue, USD Bn, 2019 - 2031)
• • Immune checkpoint inhibitors
  • Monoclonal antibodies
    • Naked monoclonal antibodies
    • Conjugated monoclonal antibodies
    • Bispecific monoclonal antibodies
  • Vaccines
    • Preventive Vaccines
    • Therapeutic Vaccines
    • Adoptive Cell Therapies
  • Tumor-infiltrating lymphocyte (TIL) therapy
    • CAR T-cell therapy
    • Engineered T-cell receptor (TCR) therapy
    • Natural killer (NK) cell therapy
  • Immune System Modulators
    • Interferons
    • Immunomodulators (IMiDs)
    • Interleukins
  • Oncolytic Virus Therapy
•  Route of Administration Insights (Revenue, USD Bn, 2019 - 2031)
  • Intravenous (IV)
  • Oral
  • Intramuscular
  • Subcutaneous 
  • Others
•  Indication Insights (Revenue, USD Bn, 2019 - 2031)
  • Cancer
    • Lung Cancer
    • Lymphoma
    • Breast Cancer
    • Skin Cancer
    • Bladder Cancer
    • Colorectal Cancer
    • Kidney Cancer
    • Others
  • Autoimmune Diseases
  • Others
• Distribution Channel Insights (Revenue, USD BN, 2019 - 2031)
  • Hospital Pharmacies
  • Retail Pharmacies
  • Online Pharmacies
• Regional Insights (Revenue, USD Bn, 2019 - 2031)
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Argentina
    • Mexico
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • Spain
    • France
    • Italy
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC Countries
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • North Africa
    • Central Africa
• Key Players Insights
  • Bristol-Myers Squibb Company
  • Pfizer Inc
  • Novartis AG
  • Merck & Co., Inc.
  • AstraZeneca
  • Amgen Inc.
  • GSK plc.
  • Gilead Sciences, Inc.
  • Johnson & Johnson
  • Actym Therapeutics, Inc.
  • Fate Therapeutics.
  • Gritstone bio
  • Incyte
  • Acumen Pharmaceuticals, Inc
  • Arcus Biosciences, Inc.
  • immunitybio inc
  • Autolus Therapeutics
  • ADC Therapeutics SA.
  • BioNTech SE
  • Cellectis