- According to Transparency Market Research’s latest report on the Plasma Protein Therapeutics Market for the historical period 2017–2018 and forecast period 2019–2027, Growing Investment in Innovation, Rising Demand for Immunoglobulin (IG), Rising Indications and Therapeutic use of Plasma Derived Protein Therapeutics are projected to drive the plasma protein therapeutics market
- According to the report, the Plasma Protein Therapeutics Market was valued at US$ 22.41 Bn in 2018 and is projected to expand at a CAGR of 7.0% from 2019 to 2027
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Growing Investment in Innovation: Key Drivers
- Quality and advancements have been the success drivers of the plasma protein industry in order to increase the quality of life of patients and to guarantee donor safety. Plasma acquired via apheresis technology or complete blood donation processing can either be assembled or fractionated into plasma protein products that comprise one or more purified plasma protein or transfused directly to patients.
- The plasma protein industry has been investing in research and development of new plasma proteins therapies (e.g.: Ceruloplasmin, IgA, Plasmin) leading to innovative treatments for the benefits of patients. In March 2016, Grifols announced that it will invest US$ 360 Mn to expand production capabilities for plasma-derived therapies. The investment will increase the plasma fractionation capacity and purification of several proteins.
- This has been also evident from advancements such as the product presentations (e.g. subcutaneous IG, IVIG 10% concentration, and IVIG liquid presentation), manufacturing process (e.g. improvement of yield), added virus elimination technologies (e.g. nanofiltration), and development of new plasma proteins (e.g. protein C and purified factor V)
- Technological advancements in efficient and cost-effective procedures for fractionating proteins from plasma are anticipated to boost the plasma protein therapeutic market. According to the World Health Organization, global blood donation come from the high income countries, i.e., more than half of the 108 million, which is the home for 18% of the world’s population.
- Rising incidence of over 200 life threatening diseases affecting immune or neurological system such as chronic inflammatory demyelinating polyneuropathy (CIPD), multifocal motor neuropathy (MMN), ideopathic thrombocytopenic purpura (ITP), and other infectious diseases including hepatitis A&B, rabies, tetanus, and varicella is driving the market.
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Rising Demand for Immunoglobulins (IG)
- The number of clinical indications for IG has been increasing. IG has become an important treatment option in a number of clinical indications beyond primary immunodeficiency, including autoimmune and acute inflammatory conditions. Also, off-label prescribing has crossed over into almost every medical specialty. Chronic use of off-label prescribing in some indications, particularly for the treatment of some neurological illnesses, in addition to immune deficiencies is increasing demand for IG.
- Plasma-derived IG is used for a wide range of autoimmune and inflammatory diseases. Increased recognition and treatment of immune deficiencies in developing world have added to the global demand for IG. However, increased use of high dose therapy, particularly in autoimmune neurologic diseases is the major reason for the continued strong growth in demand for IG products.
- Widespread off-label use of IG demonstrates use of large volume of plasma. Examples of most common off-label uses for IVIG in the U.S. are multifocal motor neuropathy (MMN), acute panautonomic polyneuropathy, hemolytic disease of the newborn, autoimmune mucocutaneous blistering diseases, and acute cardiomyopathy.
- The clinical demand for these medicines has increased in the past few years and the trend is likely to continue due to constant improvement in diagnosis and improved life-expectancy
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Stringent Regulation and Reimbursement Issues Threat to Hamper Market
- The plasma collection standards in emerging countries do not match those required by the fractionators. These regions follow strict rules and regulations regarding the quality of their operations, starting with the quality of the raw material. Specific fractionators are designed for plasma. For instance, the European health authorities require that the plasma pool for fractionation be tested for HIV, hepatitis A, B and C, and Parvovirus B. The blood collected by many centers is often unable to comply with these regulations, causing some recovered plasma to be unused.
- Health budgets have been subjected to growing pressures. Funding through reimbursement pathways from private and public payers has come under inspection and it has drawn plasma protein therapies into the landscape of Health Technology Assessments (HTA), including the possible application of cost-utility analysis (CUA) in the distribution of reimbursement funds. Given the high cost of the therapies and the comparatively nascent nature of many of the indications, application of these tools of health economics can constraint the supply of products for patients in genuine need.
- Regulatory and quality policies affect every step of the plasma protein therapy lifecycle, which includes donor safety, quality and compliance, biological license application process, therapy safety and efficacy, and pharmacovigilance. For example, licensing and inspecting of plasma collection centers and plasma protein therapy manufacturing facilities can be tedious and time consuming.
- Plasma protein therapies used by Medicare beneficiaries predominately are reimbursed through Medicare Part B, which covers physician-administered therapies. In addition to being a complex technology, prices of raw materials and multiple safety measures contribute to the cost of these products. Hence, it is essential that reimbursement for plasma protein therapies is sufficient to maintain access.
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