The global immunoglobulins market size was valued at USD 15.79 billion in 2022. It is estimated to reach USD 31.06 billion by 2031, growing at a CAGR of 7.81% during the forecast period (2023–2031).
Immunoglobulins are antibodies produced by plasma cells that are part of the body's immune system. Chemically, immunoglobulins are glycoprotein molecules secreted in response to an antigen that enters the body. There are various types of immunoglobulins based on their structure: IgA, IgE, IgM, IgG, and IgD. Each immunoglobulin has a specific function in the body. IgG is the most common class of immunoglobulins in almost all body parts. Based on the amino acid sequence of the heavy chain of IgG structure, it is classified into four subclasses, namely, IgG1, IgG2, IgG3, and IgG4.
Immunoglobulins are available in three forms: intravenous, subcutaneous, and intramuscular immunoglobulins. In various autoimmune diseases, such as primary and secondary immunodeficiency, immunoglobulins are used as replacement therapy to strengthen the weak immune system by restoring the normal level of antibodies or immunoglobulins in the body. Plasma extracted from a donor contains various plasma proteins such as immunoglobulins, albumin, fibrinogen, clotting factors, anti-clotting factors, and other complementary proteins.
Recent advancements and the expansion of immunoglobulin products in treating numerous rare and autoimmune diseases have fueled the development of the market. Vendors in the plasma-derived therapy market are concentrating on introducing newer products. This growth is boosted due to the regulatory approvals for new products. For instance, in 2018, the FDA approved Hizentra, manufactured by CSL Behring, for treating chronic inflammatory demyelinating polyneuropathy or CIDP. Hizentra is a 20% subcutaneous immunoglobulin solution. The therapy became the first subcutaneous immunoglobulin therapy for CIDP.
Similarly, in 2021, Pfizer Inc. announced the approval of its new and innovative immunoglobulin product named Panzyga, a 10% intravenous immunoglobulin solution. Panzyga received approval for treating CIDP in adults. The treatment became the first intravenous immunoglobulin formulation with two FDA-approved dosing options used as maintenance therapy in people suffering from CIDP. Furthermore, in 2019, ADMA Biologics announced that it received FDA approval for its product Asceniv for treating primary humoral immunodeficiencies. Asceniv is a 10% intravenous immunoglobulin solution by ADMA Biologics.
Organ transplants are incredibly crucial. However, while undergoing a transplant operation, it is essential to receive an organ from a donor with antigens similar to the patients. If the organ has different antigens, the body's immune system considers this organ a threat and produces antibodies against it. These antibodies then attack and destroy the organ, making the transplant fail. In such cases, immunoglobulins inhibit the immune system after transplantation. The receiver's bloodstream's HLA antibody, produced in reaction to the donor's HLA antigen, is the most crucial factor in transplant failure.
HLA, or human leukocyte antigen, is a part of the body's mechanism to recognize foreign bodies. HLA-sensitive patients will attack organs with various antigens after receiving them. In this case, administering immunoglobulins calms down the HLA antibodies by reducing their HLA sensitivity. This reduces the production of HLA antibodies and their ability to attack the transplanted organ. Several studies have also shown the use of immunoglobulins in post-transplant management, driving the market growth.
There has always been a shortage of immunoglobulin products due to the shortage of plasma to produce immunoglobulin. This is caused not due to the lack of raw materials and the increasing demand for immunoglobulin products. The most common reasons behind this increase in demand are the improved diagnosis of immune deficiency disorders and the growing use of immunoglobulin in secondary immune deficiencies such as cancer and neurological disorders. The lag time for manufacturing Ig-based products ranges between 8-12 months, meaning it takes almost a year to manufacture the product from the time of procuring the raw materials. Although companies are expanding plasma collection centers across the globe, the high lag time makes it harder to match the supply with the demand, hampering the market growth.
With the increasing prevalence of chronic conditions among the global population, home healthcare has become a rapidly developing healthcare sector. Autoimmune diseases are chronic conditions where a person needs long-term treatment. Intravenous immunoglobulins, primarily introduced as a treatment option, require patients to receive the infusion for several hours in hospitals and clinics. It also involves the stress of traveling to the healthcare facility to receive treatment.
Due to the abovementioned challenges, patients who require immunoglobulins now prefer subcutaneous immunoglobulins that can be self-administered. This process allows people to receive treatment for chronic autoimmune conditions at home. Intravenous immunoglobulins can also be administered in homecare settings but only by healthcare professionals such as nurses. However, intravenous formulations are only prescribed in exceptional cases where a patient is unable to visit any healthcare facility. In such cases, physicians prescribe home care under the surveillance of a nurse. Subcutaneous immunoglobulins are majorly prescribed for home care due to the ease of administration. Such factors create tremendous opportunities for market growth.
The global immunoglobulins market is segmented by product, application, and end-user.
Based on product, the global market is bifurcated into intravenous immunoglobulin, subcutaneous immunoglobulin, and intramuscular immunoglobulin.
The intravenous immunoglobulin segment dominates the global market and is predicted to grow at a CAGR of 7.10% over the forecast period. The most common type of immunoglobulin used to treat autoimmune disorders and immunodeficiency is intravenous immunoglobulins or IVIG. Since immunoglobulins have been proposed for therapeutic use, they have been administered intravenously, which offers the highest bioavailability and effectiveness. Generally, a 10% immunoglobulin solution is administered through the intravenous route. As it requires a professional for administration, the treatment is only offered in a hospital setting. In addition, IVIGs are often criticized for being uncomfortable to receive as the infusion process takes several hours to complete. Hence, people are now opting for subcutaneous formulations.
Subcutaneous immunoglobulin is administered through the fatty layer of the stomach or thigh. As it is administered through the subcutaneous layer, anyone who has basic knowledge about subcutaneous administration can administer it. Due to the ease of administration, subcutaneous preparations are increasingly used in home care settings. Recent developments in the market, especially the increasing regulatory approvals for various subcutaneous immunoglobulin formulations, have increased the demand for subcutaneous immunoglobulins.
Based on application, the global market is divided into primary immunodeficiency, chronic immune deficiency polyradiculoneuropathy, secondary immunodeficiency, immune thrombocytopenic purpura, myasthenia gravis, and others.
The primary immunodeficiency segment is responsible for the largest market share and is anticipated to exhibit a CAGR of 7.06% over the forecast period. Immunoglobulins are commonly used to treat primary immunodeficiency. The global prevalence varies based on the region. Western regions such as North America, Latin America, and Western Europe witnessed the highest prevalence of primary immunodeficiency, ranging between 10-15 per 100,000 people. Primary immunodeficiency is characterized by a lack of immunity, making them more susceptible to infectious diseases. For such people, immunoglobulins are used for replacement therapy or immunoglobulin replacement therapy (IRT).
CIDP, or chronic inflammatory demyelinating polyradiculoneuropathy, is a rare autoimmune disorder in which the body's immune system identifies myelin as a foreign material or entity and attacks it, thereby causing its destruction. This causes the impairment of the peripheral nervous system, where neurons fail to transmit the signal from the brain to the organ and vice versa. CIDP is characterized by numbness or loss of sensation, tingling sensation in the legs, loss of reflexes, and fatigue while walking.
Based on end-user, the global market is segmented into hospitals and clinics and homecare.
The hospitals and clinics segment owns the largest market share and is estimated to exhibit a CAGR of 7.27% during the forecast period. The hospitals and clinics segment includes the revenue generated from immunoglobulin formulations in hospital, clinic, and inpatient settings. The segment generally uses intravenous immunoglobulins that require a healthcare professional to administer the dose. In addition, patients who require immunoglobulin therapy in hospitals or clinics are administered intravenous immunoglobulins. The biggest challenge for hospitals and clinics is to overcome the inconvenience caused to patients during treatment. Many people suffering from autoimmune diseases struggle to travel to hospitals for treatment. Patients also feel stressed in a hospital environment and find home-based therapy more relaxing.
The homecare segment is witnessing rapid growth due to growth in the home healthcare business. Most people suffering from autoimmune disorders are either pediatric or geriatric. Home care is ideal for such patients as it saves time and reduces travel frequency to hospitals and clinics. Also, people feel more comfortable in their homes than in hospitals. Challenges involved in immunoglobulin treatment at home include monitoring the patient for potential side effects. In adverse reactions, the patient must be transported to the hospital for expert care. This can be prevented with the help of home health care services.
Based on region, the global immunoglobulins market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.
North America is the most significant global market shareholder and is anticipated to grow at a CAGR of 6.62% during the forecast period. The North American market is mature. Therefore, the region is expected to witness slower steady growth than the other areas during the forecast period. Self-sufficiency programs introduced in other regions are expected to lower the quantity of plasma imported by these countries from the US. Also, many countries opt for domestically manufactured plasma-derived medicinal products for higher acceptance and availability. In addition, the US and Canada have the highest volume of consumption of IVIG products. This is attributed to several factors, such as increased awareness towards personal health, a patient-centric healthcare system, advancements in healthcare, higher throughput of plasma collection centers, and leading global vendors native to the market. High personal health awareness among the population in the US and Canada ensures active participation of people in plasma collection programs, thus ensuring higher throughput. Therefore, the factors mentioned above fuel the market growth in the region.
Europe is estimated to exhibit a CAGR of 7.34% over the forecast period. The market expansion is attributed to higher awareness toward blood and plasma donation, high acceptance of plasma-derived medicinal products, a well-regulated market, and several critical vendors in the plasma-derived therapy market. The European market has benefitted from vendors who are proactive in increasing awareness of blood and plasma donations. In addition, the European Plasma Alliance, or EPA, is an alliance formed by vendors in the European market for plasma-derived medicinal products. It includes Biotest, CSL Plasma, Europlasma, Grifols, Haema, KEDPLASMA, Octapharma, Plasmavita, Ruhrplasma, Takeda Pharmaceuticals, and Unicaplasma. EPA aims to spread awareness toward safe blood collection practices in the region.
Additionally, with the region's growing diagnosis of autoimmune diseases, the demand for immunoglobulin products is also increasing, boosting the market growth. According to the European Society of Immunodeficiencies or ESID, the prevalence of immunodeficiencies rose from 154 cases across 19 centers in Europe in 2004 to almost 19,355 cases across 126 centers across Europe in 2014.
The market in Asia-Pacific is increasing due to the higher blood and plasma collection rate. It is an emerging market for immunoglobulin products needed for treating autoimmune disorders. The Asia-Pacificmarket is led by China, which has an enormous population in the world. In addition, the Chinese population is highly aware of blood donation and its possible use in manufacturing life-saving products. Such is the case with Japan, where the people of voluntary donors is high. Both countries have well-regulated blood collection and plasma fractionation businesses monitored by their respective governments, thus driving the market's growth.
Latin America is generally considered a low-resource region with a general need for more awareness of public health. For instance, the region's blood and plasma donations awareness could be higher. The primary factor driving blood donation in the region is monetary benefits. Due to this, people from Mexico travel to the US to donate their blood and plasma for higher economic benefits. It is one of the significant challenges for the market in Latin America. The region's need for developed plasma fractionation plants restricts the market's rapid growth.
The Middle East and Africa region is anticipated to proliferate during the forecast period. Significant countries in the Middle East and Africa region, such as South Africa, Saudi Arabia, and Turkey, have a well-regulated blood and plasma collection process. Most of the donations in these countries are voluntary and without compensation. These countries have their plasma fractionation plants and have partnered with various vendors in the plasma fractionation market to be self-sufficient in meeting the demand for plasma-derived medicinal products.
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