- 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
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 its 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.
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
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.
Plasma Protein Therapeutics Market: Competitive Landscape
- This report profiles major players in the plasma protein therapeutics market based on various attributes such as company overview, financial overview, product portfolio, business strategies, and recent developments
- The plasma protein therapeutics market is fragmented, with the presence of a number of international as well as regional players
- Various players operating in the plasma protein therapeutics market are Baxter International, Biotests, CSL Behring, GRIFOLS, S.A., Kedrion, Octapharma USA, Inc., Shire Plc. And China Biologics.
Plasma Protein Therapeutics Market: Key Developments
Key players in the plasma protein therapeutics market are engaged in regulatory approvals, technologically advanced products, launch of new products, and acquisition & collaborative agreements with other companies. These strategies of key players are likely to fuel the growth of the plasma protein therapeutics market. A few expansion strategies adopted by players operating in the plasma protein therapeutics market are:
- In September 2015, Shire Plc. launched Vynase, the only drug that was approved by US FDA for treatment of Adult Binge eating disorder.
- In October 2015, Shire Plc. merged with Baxalta, Inc., for 32$bn which is completed in June, 2016 and this move makes Shire Plc. One of the leading manufacturers of products for various rare diseases associated with immune disorders.
- In February, 2015, Shire completed acquisition of NPS Pharma
- In January, 2016 Shire also completed the acquisition of Dyax corp which is primarily focused on the development of plasma kallikrein (pKal) inhibitors for the treatment of HAE, a debilitating and sometimes life-threatening rare genetic disease
- In April 2016, Octapharma invested US$90 Mn and became a minority shareholder of Glycotope GmbH Berlin. It also acquired the worldwide license to certain IP of Glycotope’s recombinant technology. A series of research and development projects of Glycotope is commissioned by Octapharma to enable the technology transfer and accelerated development of certain therapeutic proteins.
- In January, 2016, Octapharma announced the U.S. availability of NUWIQ for the treatment of children and adult with Hemophilia A. Octapharma is further investing in NUWIQ for the benefit of patients with clinical studies of the dosing process to improve protection against bleeding episodes and reduce the frequency of dosing with personalized prophylaxis.
- In August 2013, Octapharma USA announced the accessibility of Octaplas, a solvent/detergent (S/D) treated, pooled human plasma designated for the replacement of multiple coagulation factors in patients with acquired deficiencies due to undergoing cardiac surgery or liver transplant or liver disease.
The report on the plasma protein therapeutics market discussed individual strategies, followed by company profiles of manufacturers of plasma protein therapeutics market. The competitive landscape section has been included in the report to provide readers with a dashboard view and a company market share analysis of key players operating in the plasma protein therapeutics market.
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