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The immunology market size is estimated to grow by USD 65.8 billion at a CAGR of 9.45% between 2023 and 2028. The growth of the market depends on several factors, including the growing organ transplantation, the growing cases of infectious diseases, and the hurdles in the approval of biosimilars. The market is experiencing significant growth, driven by the increasing number of organ transplantations and the substantial pipeline of innovative immunology treatments. The global immunology market is expected to expand at a strong pace due to the rising prevalence of autoimmune diseases, allergies, and infectious diseases. Another key trend in the market is the entry of biosimilars, which are expected to bring down the cost of treatment and increase accessibility to a larger patient population. Additionally, the ongoing research and development in the field of immunotherapy, particularly in cancer treatment, are expected to further fuel market growth. Despite these opportunities, challenges such as regulatory complexities and the high cost of development and manufacturing remain significant barriers to market entry for new players.
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The market encompasses a range of products and services related to the study, diagnosis, and treatment of the immune response and immune system. This market is significant due to the increasing prevalence of infections, immunological disorders, and autoimmune diseases such as Rheumatoid arthritis and Psoriatic arthritis. Type 1 diabetes, Biosimilars, Biologics, monoclonal antibodies, and biological medications are key areas of focus in this market. Hospital pharmacies play a crucial role in the distribution and administration of immunology therapies, including ELISA assays, flow cytometry, PCR-based diagnostics, immune checkpoint inhibitors, and innovative therapies for Immune-related disorders. Dysregulation of the immune response can lead to various immune responses, including those associated with Autoimmune diseases, Cancer, Allergies, and Infectious diseases. Biotechnology continues to drive advancements in the development of new diagnostic tools and treatments for these conditions. Our researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.
Hurdles in the approval of biosimilars are the key factor driving the growth of the global market. A biosimilar can be defined as an approved biological product based on demonstrating a high degree of similarity to an already approved product of biological origin. Additionally, biosimilars do not show clinically significant deviations in safety profile or efficacy compared to reference products. Biosimilars allow for minor differences in clinically inactive ingredients. Additionally, they are a more affordable treatment option for patients as they are approved by the U.S. Food and Drug Administration via various shortcuts and avoid costly duplication of clinical trials. Lower development costs lower the price of biosimilars compared to patented products.
The clearance of biosimilars from the US FDA is slow, as obtaining guidance documents for a biosimilar is time-consuming. For instance, INFLECTRA was cleared by the US FDA after two months of House Subcommittee hearings. As per the Biologics Price Competition and Innovation (BPCI) Act, it is not essential for the US FDA to issue guidance before approving a biosimilar application, but this guide will help to ensure successful implementation. As biosimilar approvals get delayed, the substitutes will not enter the global market. This makes the global market continue to grow during the forecast period.
A significant pipeline of immunology is the primary trend in the global market growth. There are multiple promising immunological agents in the pipeline, which will boost market growth after their approval. Approval of a new treatment increases treatment options and increases demand for that treatment regimen. Around 51 molecules are in various stages of clinical trials worldwide. Of these, 22 molecules are in Phase II, four are in Phase III, 16 are in Phase I, and the rest are in Phase I/II clinical trials.
One of the most promising molecules from AbbVie Inc. risankizumab (SKYRIZI) is under development. Boehringer Ingelheim and AbbVie Inc. jointly worked on the molecule to get approval for new indications such as psoriasis, psoriatic arthritis, and Crohn's disease. Another molecule from AbbVie ABBV-157 is under Phase I as of October 2021 for the treatment of psoriatic arthritis. Thus, these developments will lead to the global market growth during the forecast period.
Lack of awareness of immunology is a major challenge to the growth of the global market. Lack of awareness of immune-mediated malignancies will adversely affect the growth of the global market as it limits the use of drugs. Awareness issues make it difficult to achieve true marketability of available products. Allergies are one of the growing health problems that affect people's daily lives. Despite its high prevalence, allergies are still underdiagnosed and undertreated due to a lack of information.
Also, there is a significant lack of awareness among people about fatigue as a serious symptom of rheumatoid arthritis. The NIH also states that more than one-third of patients experiencing rhinitis and asthma symptoms remain undiagnosed and have decreased their quality of life. Although effective treatments are available, factors such as individual attitudes, beliefs, and inadequate communication between clinician and patient contribute to poor treatment adherence, especially in chronic diseases such as allergies and asthma. Thus, the lack of awareness is a major challenge and is likely to hinder the global market during the forecast period.
The report includes the adoption lifecycle of the market, covering from the innovators's stage to the laggard's stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their growth strategies.
Global Market Customer Landscape
Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market.
Astellas Pharma Inc: The company offers V Cells therapy which is designed to enhance the immune system for killing cancer cells. Also, the company is involved in offering a wide range of products such as XTANDI, XOSPATA, Evrenzo used for the treatment of chronic diseases related to cancer and kidney treatment.
The report also includes detailed analyses of the competitive landscape of the market and information about 15 market companies, including:
Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.
The market share growth by the immunosuppressants segment will be significant during the forecast period. Immunosuppressants are also known as anti-rejection drugs. This class of drugs either suppresses or reduces the response of the body's immune system.
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The immunosuppressants segment was valued at USD 48.20 billion in 2018. These drugs have large applications in organ transplantation where the chances of organ rejection are high, as the body's immune system identifies the new organ as a foreign agent and tends to attack it, resulting in rejection. This is because the immune system perceives transplanted organs as foreign items and mounts an immunological response against them, causing the organs to be destroyed while also affecting other body components. Immunosuppressants prevent a patient body from having a hyper-immune response. Such factors will increase segment growth during the forecast period.
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North America is estimated to contribute 37% to the growth of the global market during the forecast period. Technavio's analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period. In North America, it is expected to register moderate growth during the forecast period owing to the increased funding from government and non-government bodies along with the rise in the prevalence rate of chronic diseases such as rheumatoid arthritis and cancer. According to the CDC, in January 2021, the incidence rate of female breast cancer was 123.9 per 100,000 people in the US. The evidence from the drug trials revealed that the effect of anti-cancer drugs lasts longer when immuno-booster drugs are given along with the anti-cancer drugs. The use of products in cancer therapy supports the market growth during the forecast period.
The market research report provides comprehensive data (region wise segment analysis), with forecasts and estimates in "USD Billion" for the period 2024 to 2028, as well as historical data from 2018 to 2022 for the following segments.
The market is a significant and rapidly expanding sector, focusing on the development of immunotherapies for various immune responses and disorders. The immune system plays a crucial role in protecting the body from infections and maintaining homeostasis. However, dysregulation of the immune response can lead to immunological disorders such as Rheumatoid Arthritis, Psoriatic Arthritis, Type 1 Diabetes, and Autoimmune Disorders. Environmental factors, toxic chemicals, and gut dysbiosis can trigger immune responses and contribute to chronic illnesses. Biosimilars and Biologics have emerged as essential treatments for various autoimmune disorders, with Monoclonal Antibodies and Fusion Proteins being popular choices. Immunosuppressants, such as Immunomodulators, are used to manage inflammatory conditions like Plaque Psoriasis, Ankylosing Spondylitis, and Inflammatory Bowel Disease. Prophylaxis is crucial in preventing infections, and Immunology Therapies, including ELISA assays, Flow Cytometry, PCR-based diagnostics, Immune Checkpoint Inhibitors, Cell-based Therapies, and CAR-T Cell Therapy, play a vital role in cancer immunotherapy and managing autoimmune diseases. Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies are essential distribution channels for these immunology therapies and biological medications. Vaccines and Immunomodulators are essential tests and assays in diagnosing and managing immune-related disorders. Overall, the Immunology Market is a dynamic and evolving sector, driven by the growing need for effective treatments for various immune responses and disorders.
Key medications like Leflunomide and Monoclonal Antibodies (mAbs), including fusion proteins, are crucial for managing autoimmune disorders, but treatment costs and adverse effects remain concerns. These therapies, along with lactoferrin products, are essential for prophylaxis of organ rejection post-transplant. The market is driven by an increasing understanding of environmental factors influencing autoimmune diseases and the development of novel therapies. Companies like Lupin play a significant role in developing treatments, focusing on improving disease indication specificity and reducing side effects. Lactoferrin products are being explored for their potential therapeutic benefits in autoimmune disorders and post-transplant care, enhancing the efficacy and safety profiles of treatment regimens. This diversification underscores ongoing efforts to broaden treatment options and improve patient outcomes in the healthcare landscape.
Market Scope |
|
Report Coverage |
Details |
Page number |
176 |
Base year |
2023 |
Historic period |
2018 - 2022 |
Forecast period |
2024-2028 |
Growth momentum & CAGR |
Accelerate at a CAGR of 9.45% |
Market growth 2024-2028 |
USD 65.8 billion |
Market structure |
Fragmented |
YoY growth 2023-2024(%) |
8.41 |
Regional analysis |
North America, Europe, Asia, and Rest of World (ROW) |
Performing market contribution |
North America at 37% |
Key countries |
US, Germany, UK, China, and Japan |
Competitive landscape |
Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks |
Key companies profiled |
3SBio Inc., AbbVie Inc., Amgen Inc., ANTARES PHARMA INC., Astellas Pharma Inc., Biogen Inc., Bristol Myers Squibb Co., Eli Lilly and Co., F. Hoffmann La Roche Ltd., GlaxoSmithKline Plc, Horizon Therapeutics Plc, ImmuNext Inc., Incyte Corp., Johnson and Johnson Services Inc., Merck KGaA, Mitsubishi Chemical Group Corp., Novartis AG, Pfizer Inc., Takeda Pharmaceutical Co. Ltd., and UCB SA |
Market dynamics |
Parent market analysis, market forecasting, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, Market growth and Forecasting, COVID 19 impact and recovery analysis and future consumer dynamics, Market condition analysis for forecast period |
Customization purview |
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1 Executive Summary
2 Market Landscape
3 Market Sizing
4 Historic Market Size
5 Five Forces Analysis
6 Market Segmentation by Type
7 Market Segmentation by Distribution Channel
8 Customer Landscape
9 Geographic Landscape
10 Drivers, Challenges, and Opportunity/Restraints
11 Competitive Landscape
12 Competitive Analysis
13 Appendix
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