Global Multiple Sclerosis Drugs Market

The autoimmune disease diagnosis market consists of sales of diagnostic assay kits, reagents, consumables and instruments used for the diagnosis of autoimmune diseases. Autoimmune diseases are the diseases in which the production of antibodies takes place in the body which attacks and destroys own healthy cells in the body. These include Crohn's disease, rheumatoid arthritis, Hashimoto’s disease, multiple sclerosis, Grave’s disease, psoriasis, coeliac disease, type 1 diabetes, lupus and inflammatory bowel syndrome, and are diagnosed by immunological tests. The autoimmune disease diagnosis market covered in this report is segmented by product into consumables & assay kits, instruments. The autoimmune disease diagnosis market is also segmented by test type into routine laboratory tests, autoantibodies tests, immunologic tests, other tests and by end-user into clinical laboratories, hospitals, other end-users. The global autoimmune disease diagnosis market is expected to grow from $3.38 billion in 2020 to $4.15 billion in 2021 at a compound annual growth rate (CAGR) of 22.8%. The growth is mainly due to the companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The autoimmune disease diagnosis market is expected to reach $5.75 billion in 2025 at a CAGR of 8%. A high incidence of autoimmune diseases contributed to the growth of the autoimmune disease diagnosis market. The percentage of the adult population diagnosed with autoimmune diseases in 2019 across countries was 7% in the US, 6% in Europe, 5% in China, 3% each in Brazil and Russia and Japan 2%. According to a report by Connect Immune Research published in 2018, the incidence of autoimmune diseases in the UK is increasing, which ranges between 3% and 9% year-on-year. In these, different autoimmune conditions such as rheumatoid arthritis 7%, type 1 diabetes 6.3%, multiple sclerosis 3.7%, coeliac disease 4-9% cases are increasing every year and the number of people in the UK with at least one autoimmune condition is 4 million. Therefore, increasing incidence of autoimmune diseases across the globe is driving the autoimmune disease diagnosis market. The high cost of diagnostic tests is a major challenge for the growth of the autoimmune disease diagnosis market. According to a survey by the National Adrenal Diseases Foundation (NADF), the cost for initial diagnosis of Addison’s disease is $1,680 per patient and according to the reports of Vasculitis Foundation of America, vasculitis affects 1 in 20 Americans and the total cost for vasculitis patient per year is $9.7 billion. According to the estimations of The National Institutes of Allergy and Infectious Diseases (NIAID), the annual cost of treating an autoimmune disease in the US is greater than $100 billion and says that annual direct and indirect cost to treat rheumatoid arthritis in the US is $10.9 billion and $8.4 billion respectively. The high cost of diagnosis is increasing the cost burdens on the patients impacting the growth of the autoimmune disease diagnosis market. Biosensors and nano biosensors for rapid detection is a novel tool for the detection of antibodies in the autoimmune disease diagnosis market. They are highly preferred because of low cost, high sensitivity, simple to use, multiplexing abilities and rapid diagnosis. Besides measuring the quantity of antibodies in human blood serum with extremely high sensitivity, it also quantifies the activity of antibodies as the assay employs portable optical label-free biosensors based on the spectral correlation interferometry. This point of care technology gives a more integrated, informative, timely and precise diagnosis of autoimmune diseases when compared to the conventional ones. Major players in the autoimmune disease diagnosis market are Thermo Fisher Scientific, Siemens Healthineers, Abbott, Danaher, Bio-Rad Laboratories, Trinity Biotech, Hycor Biomedical, Euroimmun AG, and Aesku Group GMBH & CO. KG. The regions covered in the autoimmune disease diagnosis market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the autoimmune disease diagnosis market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The global autoimmune disease diagnosis market is segmented - 1) By Product: Consumables & Assay Kits, Instruments 2) By Test Type: Routine Laboratory Tests, Autoantibodies Tests, Immunologic Tests, Other Tests 3) By End User: Clinical Laboratories, Hospitals, Other End Users

The drugs for immunotherapy market consist of sales of immunotherapy drugs. Immunotherapy drugs help the immune system to fight cancer by stimulating the immune system of the body and generate an immune response aiding the production of antibodies. The drugs for immunotherapy market covered in this report is segmented by type into monoclonal antibodies, interferons, interleukins, vaccines, checkpoint inhibitors, others. The drugs for immunotherapy market is also segmented by therapy area into cancer, autoimmune & inflammatory diseases, infectious diseases, others and by end user into hospitals & clinics, ambulatory surgical centers, others. The global drugs for immunotherapy market is expected to grow from $149.31 billion in 2020 to $160.43 billion in 2021 at a compound annual growth rate (CAGR) of 7.4%. The growth is mainly due to the companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The drugs for immunotherapy market is expected to reach $248.27 billion in 2025 at a CAGR of 11.5%. The immunotherapy drugs market is being driven by rising incidences of cancer globally. The major causes for most cancers include obesity, smoking, alcohol, improper eating habits. According to the American Cancer Society, in 2019, around 606,880 deaths were caused in USA due to prevalence of the cancer. The Cancer Research UK predicts that there will be 27.5 million new cases of cancer each year by 2040. The rising incidences of cancer are expected to increase the demand for immunotherapy drugs driving market growth. The high cost of immunotherapy drugs is acting as a restraint on the drugs for immunotherapy market as a smaller number of patients can afford the treatment. Immunotherapy drugs are expensive as drugs are made specifically for each patient and investment costs in the research and development are high. For instance, Novartis’ Kymriah and Gilead Sciences’ Yescarta are two immunotherapy treatments that cost between $373,000 and $475,000 per patient depending on the type of cancer. The Yervoy (ipilimumab) drug from Bristol-Myers Squibb, for the treatment of melanoma, a type of skin cancer costs $120,000 per course of treatment. The high cost of immunotherapy drugs makes it unaffordable, thereby affecting market growth. Manufacturers of immunotherapy drugs are increasingly collaborating or partnering with other companies to share technology, resources, product knowledge and expand business. For example, Illumina Inc. and Bristol-Myers Squibb (BMS) collaborated to utilize Illumina’s next-generation sequencing (NGS) technology to develop and commercialize in-vitro diagnostic (IVD) assays in support of Bristol-Myers Squibb's oncology portfolio. Allogene Therapeutics Inc. and Pfizer Inc. entered into an asset contribution agreement to use Pfizer’s portfolio of assets related to allogeneic CAR-T therapy. Manufacturers of immunotherapy drugs are governed by various regulatory bodies such as the Food and Drug Administration in the USA. The Food and Drug Administration (FDA) regulates drugs and biologics under the authority granted to it by the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its amendments. Under this authority, FDA regulates the pre-market testing and marketing approval for all immunotherapeutic agents, either as drugs or biologics depending on the source and function of the investigational agent. Immunotherapeutic products that are regulated as biologics include antibodies and proteins and some nucleic acids. In August 2020, Bristol Myers Squibb, an American pharmaceutical company that manufactures prescription pharmaceuticals and biologics in several therapeutic areas, including cancer, HIV/AIDS, cardiovascular disease, diabetes, hepatitis, rheumatoid arthritis and psychiatric disorders acquired Dragonfly Therapeutics’ investigational immunotherapy program for $475 million. Through this acquisition Bristol Myers Squibb will be granted Dragonfly’s extended half-life cytokine DF6002, a monovalent IL-12 immunoglobulin Fc. Dragonfly Therapeutics, Inc., a USA based discovery-stage company developing drugs to stimulate immune responses against cancer. Major players in the drugs for immunotherapy market are F. Hoffmann-La Roche Ltd, Novartis AG, Amgen, Inc., AbbVie, Inc., and Merck & Co. Inc. The regions covered in the drugs for immunotherapy market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the drugs for immunotherapy market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The global drugs for immunotherapy market is segmented - 1) By Type: Monoclonal Antibodies, Interferons, Interleukins, Vaccines, Checkpoint Inhibitors, Others 2) By Therapy Area: Cancer, Autoimmune & Inflammatory Diseases, Infectious Diseases, Others 3) By End User: Hospitals & Clinics, Ambulatory Surgical Centers, Others

The immuno-oncology drugs market consists of sales of immuno-oncology drugs used for the treatment of cancer and related services by entities (organizations, sole traders and partnerships) that produce immuno-oncology drugs for cancer treatment. Immuno-oncology is the artificial stimulation of the immune system to treat cancer, improving the immune system's ability to fight the disease. The market consists of revenue generated by the companies manufacturing immuno-oncology drugs by the sales of these products. The immuno-oncology drugs market covered in the report is segmented by type into monoclonal antibodies, immune checkpoint inhibitors, immune system modulators, cancer vaccines, others; by therapeutic application into melanoma, lung cancer, blood cancer, renal cell carcinoma, prostate cancer, bladder cancer, others; by end-user into hospitals, clinics, ambulatory surgical centers, cancer research institutes. The global immuno-oncology drugs market is expected to grow from $57.28 billion in 2020 to $62.99 billion in 2021 at a compound annual growth rate (CAGR) of 10%. The growth is mainly due to the companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The immuno-oncology drugs market is expected to reach $92.97 billion in 2025 at a CAGR of 10%. The rise in the number of cancer cases across the globe is likely to contribute to the growth of the immune-oncology drugs market. According to the American Cancer Society, there were 1.7 million new cases and 0.6 million cancer deaths in 2019 in the USA. The four most common types of cancers worldwide are lung, prostate, bowel, and female breast cancer, accounting for 43% of the new cancer cases. Therefore, the rise in cancer incidence rate globally is anticipated to boost the demand for the immune-oncology drugs market over the coming years. The high cost of immuno-oncology therapies is a key factor hampering the growth of the market. The immunotherapy drugs cost more than the other cancer drugs and people who need immunotherapy for cancer, too often are not able to afford it. High costs associated with drugs is a major issue faced by patients across the globe. The pressure to contain costs and demonstrate value is widespread. In less wealthy countries, the lack of cost-effective drugs has influenced the health conditions of the population and has led to a low average life expectancy. Immunotherapy often costs an average annual price of more than $100,000 per patient and if the value of medical assistance is included then the price would reach $850,000 per patient. Therefore, the high cost of immuno-oncology therapies is expected to hinder the growth of the immune-oncology drugs market. Companies in the immuno-oncology drugs market are increasing their product innovation through strategic collaborations. To sustain in the increasingly competitive immuno-oncology drugs market, companies are developing innovative products as well as sharing skills and expertise with other companies. While companies have long collaborated with each other as well as with academic and research institutions in this market by way of partnerships, and in- or out-licensing deals, this trend has been increasing over the recent years. In 2019, Takeda announced its decision to accelerate the discovery of next-generation cancer immunotherapies, through collaborations. The company will collaborate with Memorial Sloan Kettering Cancer Center (MSK) to discover and develop novel chimeric antigen receptor T-cell (CAR-T) products for the treatment of multiple myeloma, acute myeloid leukemia and additional solid tumor indications. In December 2019, Sanofi, a Paris-based biopharmaceutical company, acquired Synthorx, Inc. for $2.5 billion. This acquisition is expected to allow Sanofi to gain access to Synthorx's immuno-oncology drug candidate IL-2 therapeutics for solid tumors along with its expanded genetic alphabet platform. This builds a portfolio of high-quality assets for Sanofi to lead with innovation in the oncology market. Synthorx, Inc. is a US-based clinical-stage biotechnology company focused on cancer and autoimmune disorders. Major players in the immuno-oncology drugs market are Amgen, Inc., AstraZeneca Plc, Bristol-Myers Squibb, Celgene Corporation, Eli Lilly and Company, Merck & Co., F. Hoffmann-La Roche AG, Johnson & Johnson, Novartis International AG, and AbbVie Inc. The regions covered in the immuno-oncology drugs market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the immuno-oncology drugs market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The global immuno-oncology drugs market is segmented - 1) By Type: Monoclonal Antibodies, Immune Checkpoint Inhibitors, Immune System Modulators, Cancer Vaccines, Others 2) By Therapeutic Application: Melanoma, Lung Cancer, Blood Cancer, Renal Cell Carcinoma, Prostate Cancer, Bladder Cancer, Others 3) By End-User: Hospitals, Clinics, Ambulatory Surgical Centers, Cancer Research Institutes

The immunosuppressant market consists of sales of immunosuppressants or anti-rejection drugs generated by companies manufacturing immunosuppressant drugs. Immunosuppressants are medicinal substances that prevent or inhibit activity in the immune system. Immunosuppressive drugs are mainly used in organ transplantation procedures and also in the treatment of certain autoimmune diseases such as rheumatoid arthritis, psoriasis, multiple sclerosis, and others. The immunosuppressants market covered in this report is segmented by drug class into corticosteroids, monoclonal antibodies (MAbs), calcineurin inhibitors, mTOR inhibitors, anti-proliferative agents, others. The immunosuppressant market is also segmented by indication into organ transplantation, autoimmune disorders, non-autoimmune inflammatory diseases and by distribution channel into hospital pharmacies, retail pharmacies, online pharmacies. The global immunosuppressants market is expected to grow from $15.04 billion in 2020 to $16.5 billion in 2021 at a compound annual growth rate (CAGR) of 9.7%. The growth is mainly due to the companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The immunosuppressant market is expected to reach $25.33 billion in 2025 at a CAGR of 11%. The surge in organ transplant procedures such as kidney transplant and liver transplant due to the rise in incidences of organ failure is the major factor driving the immunosuppressant market growth. According to the United Network for Organ Sharing (UNOS), 39,718 organ transplants were performed in 2019 in the United States, and as of March 2020, there are more than 112,000 candidates on the U.S. national transplant waiting list, waiting for an organ transplant. According to the Global Liver Institute’s 2019 report, there are 13,192 liver patients in the U.S. waiting for a lifesaving transplant. The increasing number of cases of organ transplants and organ failure incidences in patients are, therefore, expected to drive the market growth. Stringent government regulations are expected to hamper the growth of the market. Regulators such as the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA) maintain public safety for food and drugs through a stringent regulatory drug approval process. For an immunosuppressant drug to be approved by the regulatory authorities, the sponsor must provide satisfactory evidence regarding the safety and efficacy of a drug in a patient with a defined clinical condition. Sponsors should submit to the Center for Drug Evaluation and Research (CDER) any information on the immunotoxicology evaluation of drugs whenever such information becomes available, for review. Many guidelines have also been adopted by the EU including those providing general guidance, more specific guidance on quality issues, and non-clinical and clinical aspects. Therefore, the stringent regulatory and approval process on immunosuppressant drugs are projected to hamper the overall growth of the immunosuppressants market. The phenotypic personalized medicine or PPM or a hybrid of artificial intelligence and physician intervention is a new approach to overcome the issues with immunosuppressants. For instance, Tacrolimus is the most widely used immunosuppressant for patients who are undergoing organ transplantation. When the patient is in the hospital, Tacrolimus immunosuppressant levels must be checked regularly and changed frequently. PPM approach that is based on a computational platform is used to overcome this concern. The inputs from the computational platform-based PPM approach includes the past response of the patient to the dose of the drug and other drugs that are being taken, and current data on liver and kidney. Using PPM, the physician can identify the optimal drug and dose combination from various possibilities. Therefore, it is believed that artificial intelligence is leading the way to not only more personalized and effective drug dosing but also enhancing physicians’ decision-making capabilities by providing clinical data rather than predicted responses. In 2019, AbbVie, an American publicly-traded biopharmaceutical company, acquired Allergan for $63 billion. The transaction significantly expanded and diversified AbbVie's revenue base and existing leadership position in immunology with humira and recently launched skyrizi and rinvoq, and hematologic oncology with imbruvica and venclexta. Allergan provides new growth opportunities in neuroscience, with Botox therapeutics, Vraylar, and Ubrelvy and a global aesthetics business, with leading brands including Botox and Juvéderm. Allergan is an Irish-domiciled pharmaceutical company that develops, manufactures, and markets brand name drugs and medical devices in the areas of medical aesthetics, eye care, central nervous system, and gastroenterology. Major players in the immunosuppressant market are Astellas Pharma, GlaxoSmithKline, Bristol Myers Squibb, Johnson & Johnson, Intas Pharmaceuticals Ltd., Mylan Laboratories Inc, Pfizer, Novartis, Novartis AG, and Sanofi S.A. The regions covered in the immunosuppressant market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the immunosuppressant market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The global immunosuppressants market is segmented - 1) By Drug Class: Corticosteroids, Monoclonal Antibodies (MAbs), Calcineurin Inhibitors, mTOR Inhibitors, Anti-Proliferative Agents, Others 2) By Indication: Organ Transplantation, Autoimmune Disorders, Non-Autoimmune Inflammatory Diseases 3) By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, Online Pharmacies

The lateral flow immunoassay (LFIA) based rapid test market consists of sales of devices and equipment used to run lateral flow immunoassays (LFIA) based rapid test and related services by companies that develop LFIA based rapid test equipment. These are testing devices used to assess the existence of a target, such as pathogens or biomarkers, in samples obtained from the human body or animals, or pollutants in water sources, food or animal feed. The global lateral flow immunoassay (LFIA) based rapid test market is expected to grow from $5.768 billion in 2020 to $6.136 billion in 2021 at a compound annual growth rate (CAGR) of 6.4%. The growth is mainly due to the companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $9.136 billion in 2025 at a CAGR of 10%. The demand for point-of-care testing under home care settings is expected to drive the Lateral Flow Immunoassay (LFIA) Based Rapid Test market. Point-of-care (POCT) testing is essential for rapid on-site diagnosis and treatment. The most important features for current POCT diagnostic systems are a quick analysis time with a test-to-answer format. Lateral flow immunoassays are widely used as POCTs due to their speed and precision, simplicity and low cost. For instance, the recent outbreak of coronavirus disease (COVID-19) has increased the significance of these devices to rapid screening and surveillance. Acro Biotech COVID-19 Rapid POC CE-IVD is a lateral flow immunoassay that quantifiably assesses the existence of patient-generated IgG and IgM antibodies to SARS-CoV-2, the causative agent of novel coronaviral disease COVID-19. These antibodies may be detected in whole blood, serum or plasma samples in the test cassette. OZO has developed three different variations of its products using the Latex Enhanced Lateral Flow Immunoassays method for testing COVID-19. Therefore, the need for point-of-care testing under home care settings is expected to drive the LFIA Based Rapid Test market. The low sensitivity of the Lateral Flow Immunoassay (LFIA) based rapid test is expected to limit the market. The sensitivity of the test is mainly the ability of the test to correctly identify those with the disease, which is low for LFIA based rapid test compared to other methods and that may, in some cases, require a re-test for confirmation. According to a study conducted by researchers, including those from the Harvard Medical School in the USA and also the University of British Columbia, Canada. The medical databases and preprint servers were searched from January 1 to April 30 2020, for studies measuring the sensitivity and specificity of the Covid-19 antibody test compared to the control test. It had been found that pooled sensitivities were consistently lower for the lateral flow immunoassay (LFIA) test compared to other test methods. The low level of sensitivity is anticipated to restrain the market growth for Lateral Flow Immunoassay (LFIA) based rapid test. Companies are collaborating to launch new products. In May 2020, Lateral Flow Diagnostic Company Mologic Ltd., which has teamed up with Biosure Ltd., the developer of the only CE approved HIV home testing kit, to develop a COVID-19 antibody self-test. The companies combine Mologic's validated IgG lateral flow test strip with Biosure's test kit. In July 2020, MP Biomedicals Asia Pacific Pte Ltd collaborated with a Singapore company A*STAR to create the ASSURE® SARS-CoV-2 IgG / IgM rapid antibody test kit to detect IgG and IgM antibodies in a person infected with SARS-CoV-2. The kit delivers precise results in very less time as less as 15 minutes and uses the lateral flow method. In April 2020, True Diagnostics, a leading US-based Point of Care (POC) company, partnered with Veravas and Infectolab Americas to create and distribute a fast, point-of-care immunoassay for SARS-CoV-2, the VeraTest SARS-CoV-2 IgA / IgG Fast Test will be developed to detect immunoglobulin A and immunoglobulin G antibodies to SARS-CoV-2 in the blood within 15 minutes. The test combines True Diagnostics, TrueDx lateral flow immunoassay technology with Veravas, VeraPrep clean and VeraPrep capture technologies designed to remove cross-reaction antibodies and ensure the detection of only SARS-CoV-2-specific antibodies. Veravas is an emerging US-based diagnostic company. Infectolab Americas is a US-based laboratory specialized in the lab testing for tick-borne disease. The major players covered in the global lateral flow immunoassay (LFIA) based rapid test market are Abbott Laboratories, F. Hoffmann-La Roche, Danaher Corporation, Siemens AG, Becton, Dickinson and Company, bioMérieux, Bio-Rad Laboratories, Thermo Fisher Scientific, QIAGEN NV, Hologic Inc., PerkinElmer, Inc., Quidel Corporation. The countries covered in the global lateral flow immunoassay (LFIA) based rapid test market are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The regions covered in the global lateral flow immunoassay (LFIA) based rapid test market are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The global lateral flow immunoassay (LFIA) based rapid test market is segmented - 1) By Technique: Competitive Assay, Sandwich Assay, Multiplex Detection Assay 2) By End User: Hospital & Clinic, Diagnostic Laboratory, Home Care, Others 3) By Application: Infectious Disease, Pregnancy & Fertility, Toxicology, Others

The immunochemistry diagnostic devices and equipment market consists of sales of immunochemistry diagnostic devices and related services. Immunochemistry diagnostic devices and equipment are designed to diagnose diseases or conditions by studying the functions of the immune system through analyzing the nature of specific proteins, antigens, antibodies, and their interaction. The global immunochemistry diagnostic devices and equipment market is expected to grow from $15.01 billion in 2020 to $16.49 billion in 2021 at a compound annual growth rate (CAGR) of 9.9%. The change in growth trend is mainly due to the companies stabilizing their output after catering to the demand that grew exponentially during the COVID-19 pandemic in 2020. The market is expected to reach $20.36 billion in 2025 at a CAGR of 5.4%. An increase in the incidence of target diseases is a major driver for the immunochemistry diagnostic devices and equipment market. The incidence rate of diseases such as viral infections, cardiovascular diseases, cancer, or hormonal disorders is increasing worldwide, mainly due to poor lifestyle choices. For example, according to the American Heart Association, cardiovascular disease is the leading global cause of death, accounting for over 17.6 million deaths per year. This number is expected to grow to over 23.6 million by 2030. Stringent regulatory policies related to approval of immunoassay instruments and consumables is a major restraint for the immunochemistry diagnostic devices and equipment market. Immunochemistry devices and equipment manufacturers are required to obtain multiple and separate clearances from the Food and Drug Administration (FDA) for launching their products. The entire process of regulatory approval is time-consuming, with a minimum of about 18-30 months required for approval of class III devices and around 6-9 months required for approval of class II devices. Companies in the immunochemistry diagnostic devices and equipment market are increasingly investing in automated immunoassay systems. This is mainly because automation has led to an increase in the capabilities of diagnostic devices in testing higher volumes of patient specimens. In addition, the development of various integrated clinical chemistry systems has immensely improved the efficiency of the analytical phase of clinical chemistry laboratory testing and led to further automation. For example, ichroma-50 is an automatic immunoassay analyzer of Boditech Med Inc. that measures the concentration of the targeted analyte in body fluids such as blood, urine, and other samples in few minutes, and reduces the labor cost and human error in the process. In the USA, the immunochemistry diagnostic devices and equipment market is regulated under the U.S. Food and Drug Administration (FDA), and all diagnostic laboratory tests are regulated by the clinical laboratory improvement amendments of 1988 (CLIA), which is administered by the Centers for Medicare & Medicaid Services (CMS). A CLIA/FDA compliant laboratory is required to file a PMA/510(k) for market approval of any immunochemistry device. Hence, the regulatory scenario related to immunochemistry diagnostic devices and equipment will keep a check on the companies that manufacture these devices and equipment. Major players in the market are Abbott Diagnostics, Roche Diagnostics, Siemens Healthcare Diagnostics, Diamond Diagnostics, Dynex Technologies. The countries covered in the global immunochemistry diagnostic devices and equipment market are Brazil, China, France, Germany, India, Indonesia, Japan, South Korea, Russia, UK, USA, Australia. The regions covered in the global immunochemistry diagnostic devices and equipment market are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The global immunochemistry diagnostic devices and equipment market is segmented - 1) By Product Type: Immunochemistry Analyzers, Immunochemistry Stainers, Incubators, Microscopes, Centrifuges, Autoclaves, Consumables 2) By Application: Endocrinology, Oncology, Cardiology, Therapeutic Drug Development & Monitoring, Infectious Disease Testing, Drugs Of Abuse Testing, Others 3) By End Users: Hospitals And Clinics, Diagnostic Laboratories, Research Labs And Institutes, Biopharmaceutical And Biotechnology Companies, Others 4) By Immunochemistry Analyzers: Chemiluminescence Immunoassay (CLIA) Analyzers, Immuno Fluorescence (IFA) Analyzers, Enzyme Immunoassay (EIA) Analyzers, Radioimmunoassay (RIA) Analyzers, Enzyme Linked Fluorescent Assay (ELFA) Systems, Multiplexed Assay Systems 5) By Immunochemistry Stainers: Automated Stainers, Semi-Automated Stainers 6) By Consumables: Antibodies, Antigens, Enzymes, Reagents, Stains, & Buffers, Disposables, Others

The cellular immunotherapy market consists of revenues generated by the companies engaged in developing, manufacturing, and sales of cellular immunotherapy drugs. Cellular immunotherapy is also known as adoptive cell therapy, a form of treatment that utilizes the cells of the immune system to eliminate diseases including non-Hodgkin lymphoma, cancer, and acute lymphoblastic leukaemia. The global cellular immunotherapy market is expected to grow from $2.74 billion in 2020 to $3.59 billion in 2021 at a compound annual growth rate (CAGR) of 31%. The growth is mainly due to the companies resuming their operations and adapting to the new normal while recovering from the COVID-19 impact, which had earlier led to restrictive containment measures involving social distancing, remote working, and the closure of commercial activities that resulted in operational challenges. The market is expected to reach $6.73 billion in 2025 at a CAGR of 17%. Increasing research and successful clinical trials in cellular immunotherapy are expected to drive the growth of the cellular immunotherapy market over the forecast period. Companies are focusing on developing new cellular immunotherapies for treating different diseases. The rapid growth in the development of cellular immunotherapy in clinical and preclinical stages in 2020 as compared to that in 2019 is projected to expand the landscape of cellular immunotherapy. Subsequently, generating higher revenues for the cellular immunotherapy market. The high cost of cellular immunotherapies is anticipated to hinder the cellular immunotherapy’s market growth. CAR-T therapy is a type of cellular immunotherapy and only two have been approved in the USA. The price of Yescarta and Kymriah is more than $350,000 per treatment in the USA, which is highly unaffordable for a majority of the patients especially with low income. The high cost of cellular immunotherapies discourages patients to opt for this drug, thereby, impacting the demand and the market negatively. Companies in the cellular immunotherapy market are focusing on developing off-the-shelf allogeneic therapies for new and improved cancer treatment. Off-the-shelf allogeneic therapies are produced from the cells of donors instead of the patient cells as in the case of autologous therapy. Their non-customized nature provides advantages such as cost-effectiveness, large scale, fast, and quality control production. For instance, in November 2019, Precision Biosciences, Inc., a biotechnology company, has created a new generation allogeneic CAR-T therapy and is conducting an ongoing trial of this therapy by creating its first off-the-shelf allogeneic CAR-T therapy candidate known as PBCAR0191. This is in collaboration with Servier, an international pharmaceutical company, and is mainly for the patients in need of advanced cancer treatment options. Additionally, in August 2020, Acepodia, a US-based next-generation cell immuno-technology company, initiated a phase 1 clinical trial for evaluating ACE1702 an allogeneic, off-the-shelf NK cell therapy for the treatment of solid tumors. In April 2020, resTORbio, Inc., a US-based biopharmaceutical company specialized in the development and commercialization of drugs used for the treatment of aging-related diseases, merged with Adicet Bio, Inc., a biopharmaceutical company, for an undisclosed amount. Both the companies continue their operations as ‘Adicet Bio’. This merger is expected to help the companies in advancing allogeneic gamma-delta CAR-T cell therapy technology. Adicet Bio, Inc. is a US-based company specialized in the development of Adicet’s off-the-shelf allogeneic gamma delta T cell therapies for oncology and other indications. The major players covered in the global cellular immunotherapy market are Novartis AG, Gilead Sciences Inc. (Kite Pharma), Apac Biotech, Dendreon Pharmaceuticals LLC, JW CreaGene Co. Ltd, Green Cross Corp (GC Pharma), AstraZeneca, Bristol-Myers Squibb, Pfizer Inc., Roche, Adicet Bio, ResTORbio, Celyad. The countries covered in the global cellular immunotherapy market are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA. The regions covered in the global cellular immunotherapy market are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The global cellular immunotherapy market is segmented - 1) By Therapy: Tumour-Infiltrating Lymphocyte (TIL) Therapy, Engineered T Cell Receptor (TCR) Therapy, Chimeric Antigen Receptor (CAR) T Cell Therapy, Natural Killer (NK) Cell Therapy 2) By Primary Indication: B-cell Malignancies, Prostate Cancer, Renal Cell Carcinoma, Liver Cancer, Non-Hodgkin Lymphoma, Others 3) By Application: Prostate Cancer, Breast Cancer, Skin Cancer, Ovarian Cancer, Brain Tumour, Lung Cancer, Others

G-CSF (Granulocyte Colony Stimulating Factors) Market Definition

The G-CSF (Granulocyte Colony Stimulating Factors) market consists of sales of G-CSF drugs and related services. G-CSF, granulocyte-colony stimulating factor, based drugs stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream. G-CSF also stimulates the survival, proliferation, differentiation, and function of neutrophil precursors and mature neutrophils through signal transduction pathways.