|
市場調査レポート
商品コード
1276518
血漿タンパク質治療薬の世界市場規模、シェア、産業動向分析レポート:エンドユーザー別、製品タイプ別(免疫グロブリン、アルブミン、血漿由来第VIII因子、その他)、用途別、地域別展望と予測、2023~2029年Global Plasma Protein Therapeutics Market Size, Share & Industry Trends Analysis Report By End User, By Product Type (Immunoglobulin, Albumin, Plasma derived factor VIII, and Others), By Application, By Regional Outlook and Forecast, 2023 - 2029 |
||||||
血漿タンパク質治療薬の世界市場規模、シェア、産業動向分析レポート:エンドユーザー別、製品タイプ別(免疫グロブリン、アルブミン、血漿由来第VIII因子、その他)、用途別、地域別展望と予測、2023~2029年 |
出版日: 2023年04月28日
発行: KBV Research
ページ情報: 英文 231 Pages
納期: 即納可能
|
血漿タンパク質治療薬市場規模は、2029年までに391億米ドルに達すると予測され、予測期間中にCAGR5.5%で上昇すると予想されています。
人体の各構成タンパク質は、恒常性を維持するための明確な目的を持っているため、血漿タンパク質の欠落や不足は致命的となり得る。血漿タンパク質は、多くの臨床病理学的状況において欠乏または機能不全が指摘されています。臨床現場では、新鮮凍結血漿(FFP)と輸血用血漿の両方が使用されます。
輸血用血漿は、一般的な凝固因子欠乏症の治療、血栓溶解療法における線溶亢進の是正、プラズマフェレーシス療法における欠乏因子の補充に利用されます。また、精製血漿由来製剤が不足している場合の凝固因子欠乏症の分離にも使用される方法です。輸血時に感染する血液感染症の拡大を防ぐため、ドナー排除、ドナー情報、ドナースクリーニングに加え、検疫時間や病原体の不活性化などの安全対策がとられています。
COVID-19影響度分析
COVID-19管理薬開発の大きなチャンスは、多くの先進国でこれらの医薬品が不足していることからもたらされました。COVID-19ワクチンや医薬品の需要の増加により、医薬品およびバイオテクノロジー産業の将来の成長が予測されます。これは、血漿タンパク質の需要に大きな影響を及ぼすと予想されます。さらに、血漿タンパク質の治療薬の製品発売や関連研究プロジェクトの増加により、市場の拡大が予想されます。したがって、パンデミックは血漿タンパク質治療薬市場に好影響を与えたと結論付けることができます。
市場成長要因
技術革新のための資金調達の増加
血漿からタンパク質を分画する効率的で安価な方法の技術開発により、血漿タンパク質治療薬の市場は成長すると予測されています。A&B型肝炎、狂犬病、破傷風、水痘などの感染症が増加しているため、より多くの研究開発が行われています。さらに、慢性炎症性脱髄性多発神経炎(CIDP)、特発性血小板減少性紫斑病など、免疫系や神経系に影響を及ぼす200以上の生命を脅かす病気があります。したがって、これらすべての要因が、予測期間を通じて市場の成長を促進することになります。
さまざまな疾患の治療における免疫グロブリンへのニーズの高まり
Igの適応外使用は、かなりの量の血漿が使用されています。最も一般的なIVIGの適応外使用の例としては、多巣性運動神経障害(MMN)、乳児溶血性疾患、急性汎神経症、自己免疫性粘膜皮膚水疱症、および急性心筋症が挙げられます。診断の進歩や平均寿命の延長により、これらの薬剤の臨床需要はここ数年で急増しています。今後も増加傾向が続くと予測されています。Igの需要は、免疫不全だけでなく、様々な適応症、特に特定の神経疾患の治療の一環として適応外処方が慢性的に行われているために上昇しています。
市場抑制要因
償還の問題や厳しい規制による市場打撃のリスク
新興国の血漿採取要件は、分画装置のそれとは異なります。これらの地域では、原料の口径に始まり、事業の口径に関する厳しい法律や規範を遵守しています。血漿については、特定の分画装置が作られています。例えば、分画に使用する血漿プールは、欧州保健当局によってパルボウイルスB、A型肝炎、B型肝炎、C型肝炎、そしてHIVをチェックする必要があります。しかし、残念ながら、多くの施設の採血活動では、これらの要件を満たせないことが多く、回収された血漿が無駄になることがあります。また、医療財政への圧力も高まっています。したがって、これらの要因が、今後数年間の市場拡大の妨げになる可能性があります。
製品タイプの展望
製品タイプ別に見ると、血漿タンパク質治療薬市場は、免疫グロブリン、アルブミン、血漿由来第VIII因子、その他に分類されます。2022年の血漿タンパク質治療薬市場では、免疫グロブリンセグメントが最も高い収益シェアを獲得しています。このセグメントの成長は、さまざまな疾患の治療における免疫グロブリンの使用の高まりに負っています。免疫グロブリンは、免疫系を制御し、細菌やウイルスのような外敵を排除するタンパク質です。さらに、自己免疫疾患や原発性・二次性免疫不全の治療にも使用されています。
アプリケーションの展望
血漿タンパク質治療薬市場は、用途別に、血友病、特発性血小板減少性紫斑病、原発性免疫不全症、その他に分類されます。2022年の血漿タンパク質治療薬市場では、原発性免疫不全障害分野が大きな収益シェアを記録しました。原発性免疫不全症(PID)は、430を超える珍しい病気で、免疫系の欠陥によってもたらされる長引く病気です。PIDは世界で600万人以上が罹患しています。そのため、PIDを治療するための血漿タンパク質治療薬の需要は、予測期間を通じて大きく伸びることが予想されます。
エンドユーザーの展望
エンドユーザーに基づき、血漿タンパク質治療薬市場は病院とその他に区分されます。2022年の血漿タンパク質治療薬市場では、その他セグメントがかなりの成長率を獲得しました。この成長は、血友病のような自己免疫疾患で病院を訪れる人の数の増加や、病院でのタンパク質治療薬の利用しやすさに起因していると考えられます。診療所やその他の患者ケアインフラの利用は、その手頃な価格、予約のしやすさ、患者のアクセスや利便性への取り組みなどの結果、拡大しました。
地域別の展望
血漿タンパク質治療薬市場は、地域別に北米、欧州、アジア太平洋、LAMEAで分析されています。北米セグメントは、2022年の血漿タンパク質治療薬市場において最も高い収益シェアを調達しました。北米では、免疫疾患の有病率が上昇し、珍しい病気が増えており、血漿タンパク質治療薬に対する研究資金が増加しています。さらに、血漿タンパク質治療薬を製造する大手企業の増加も、この地域の市場拡大に寄与しています。高い購買力と確立されたヘルスケアシステムの存在も、市場拡大を後押しすると予想される要因です。
List of Figures
The Global Plasma Protein Therapeutics Market size is expected to reach $39.1 billion by 2029, rising at a market growth of 5.5% CAGR during the forecast period.
Pharmaceuticals known as plasma protein therapeutics are created from proteins extracted from human blood plasma. The biological actions of these proteins include controlling immunological response, blood clotting, and preserving the body's fluid balance. Blood problems, immunological deficiencies, as well as genetic disorders are just a few of the ailments that are treated with plasma protein therapeutics. They are frequently given by injection or infusion, and careful monitoring is necessary to ensure appropriate dosage and reduce any potential side effects.
Plasma is the form of fluid or a part of blood in which cellular components like leucocytes, red blood cells, and platelets are suspended. Plasma makes up 55% of total blood, with 89% of it being water, 2% salt, 3% lipids, and 6% protein. The 2,000-4,000 distinct proteins that make up the plasma proteins (60 g/L) have varying concentrations of hormones as well as about 40 mg/mL (albumin), and their total weight is 60 g/L.
An absence or deficit of a plasma protein could be fatal since each component protein in the human body has a distinct purpose in maintaining homeostasis. Plasma proteins are noted as being absent or dysfunctional in numerous clinical pathological circumstances. In clinical settings, fresh frozen plasma (FFP) or plasma for transfusion both are employed.
Plasma for transfusion is utilized in the treatment of general clotting factor deficiencies as well as in the correction of hyper-fibrinolysis in thrombolysis, replacement of deficient factors during plasmapheresis therapy. The method is also used in isolating deficiencies of clotting factor in lack of purified plasma-derived products. Safety precautions, such as a quarantine time and/or pathogen inactivation, are used in addition to donor exclusion, donor information, and donation screening to avoid the spread of blood-borne illnesses that are transferred during transfusions.
COVID-19 Impact Analysis
Large opportunities for COVID-19 management drug development were offered by the dearth of these medicines in many developed nations. Due to the increasing demand for COVID-19 vaccines and medications, future growth in the pharmaceutical and biotechnology industries is projected. This is expected to have a substantial influence on the demand for plasma protein. In addition, the market is anticipated to expand as a result of more plasma protein therapies product launches and related research projects. Therefore, it can be stated conclusively that the pandemic had a positive impact on the plasma protein therapeutics market.
Market Growth Factors
Growing funding for technological innovation
The market for plasma protein therapeutics is projected to grow due to technological developments in efficient and affordable methods for fractionating proteins from plasma. More R&D is being conducted because of the rising infectious diseases like hepatitis A&B, rabies, tetanus, and varicella. In addition, over 200 life-threatening diseases affect the immune or neurological systems, including chronic inflammatory demyelinating polyneuropathy (CIDP), idiopathic thrombocytopenic purpura. Hence, all these factors will promote the market's growth throughout the forecast period.
Rising need for immunoglobulins for the treatment of various disorders
A significant amount of plasma is used in Ig's widespread off-label usage. Examples of the most prevalent off-label IVIG usage include multifocal motor neuropathy (MMN), infant hemolytic illness, acute panautonomic polyneuropathy, autoimmune mucocutaneous blistering disorders, and acute cardiomyopathy. Due to ongoing advancements in diagnosis and higher life expectancy, the clinical demand for these medications has surged over the past several years. It is predicted to continue on its upward trajectory. The demand for Ig is rising due to immunological inadequacies as well as the chronic usage of off-label prescribing in various indications, especially as part of the treatment of certain neurological diseases.
Market Restraining Factors
Risk of market harm from reimbursement issues and strict regulation
Emerging nations' plasma collection requirements differ from those of fractionators. These areas adhere to stringent laws and norms regarding the caliber of their operations, beginning with the caliber of the raw materials. For plasma, specific fractionators have been created. For instance, the plasma pool used for fractionation must be checked for Parvovirus B, hepatitis A, B, and C, as well as HIV, by the European health authorities. Unfortunately, many facilities' blood collection efforts frequently fail to meet these requirements, wasting some recovered plasma. There is increasing pressure on health finances. Therefore, all these factors may hamper the expansion of the market in the coming years.
Product Type Outlook
Based on product type, the plasma protein therapeutics market is categorized into immunoglobulin, albumin, plasma derived factor VIII, and others. The immunoglobulin segment garnered the highest revenue share in the plasma protein therapeutics market in 2022. The growth of the segment is owed to the rising use of immunoglobulins in treating various diseases. Immunoglobulins are proteins that control the immune system and eliminate foreign invaders like bacteria and viruses. Additionally, it is employed in treating autoimmune diseases and primary and secondary immunodeficiency.
Application Outlook
On the basis of application, the plasma protein therapeutics market is divided into hemophilia, idiopathic thrombocytopenic purpura, primary immunodeficiency disorder, and others. The primary immunodeficiency disorder segment recorded a significant revenue share in the plasma protein therapeutics market in 2022. Primary Immunodeficiency Diseases (PID) are more than 430 uncommon in number, and are long-lasting illnesses brought on by immune system flaws. PID affects over 6.0 million individuals globally. Therefore, the demand for plasma protein therapeutics to treat PID is expected to grow significantly throughout the projection period.
End User Outlook
Based on end user, the plasma protein therapeutics market is segmented into hospitals and others. The others segment garnered a considerable growth rate in the plasma protein therapeutics market in 2022. This growth can be attributed to a rise in the number of people visiting hospitals with autoimmune diseases like hemophilia and the accessibility of protein therapies in hospitals. The use of clinics and other patient care infrastructure has expanded as a result of its affordability, ease of booking appointments, and commitment to patient accessibility and convenience.
Regional Outlook
On the basis of region, the plasma protein therapeutics market is analyzed across North America, Europe, Asia Pacific, and LAMEA. The North America segment procured the highest revenue share in the plasma protein therapeutics market in 2022. The prevalence of immunological illnesses is rising, uncommon diseases are becoming more common, and research funding for plasma protein therapies is increasing in North America. Additionally, an increase in the number of major companies producing plasma protein therapies contributes to the market expansion in this region. High purchasing power and the availability of well-established healthcare systems are further factors anticipated to fuel market expansion.
The major strategies followed by the market participants are Acquisitions. Based on the Analysis presented in the Cardinal matrix; CSL Limited (CSL Behring), Baxter International, Inc., Bayer AG, and Takeda Pharmaceutical Company Limited are the forerunners in the Plasma Protein Therapeutics Market. Companies such as Grifols, S.A., Kedrion S.p.A, and ADMA Biologics, Inc. are some of the key innovators in Plasma Protein Therapeutics Market.
The market research report covers the analysis of key stake holders of the market. Key companies profiled in the report include Bayer AG, Abeona Therapeutics, Inc., Takeda Pharmaceutical Company Limited, Grifols, S.A., Baxter International, Inc., Kedrion S.p.A, Octapharma AG, CSL Limited (CSL Behring), Taibang Biological Group Co., Ltd and ADMA Biologics, Inc.
Recent Strategies Deployed in Plasma Protein Therapeutics Market
Partnerships, Collaborations and Agreements:
Oct-2022: Takeda partnered with United Nations Institute for Training and Research (UNITAR), a Switzerland headquartered research and training institute. The partnership involves launching the educational program with the intention to create an UN-based platform that would enable stakeholders to gather and discuss solutions related to plasma and plasma-derived therapy shortfalls.
Sep-2022: Grifols entered into an agreement with the National Blood Authority of Canada, a Canadian provider of Blood Services. With this agreement, the entities aimed to accelerate the self-sufficiency of the country in terms of immunoglobulin medicines, which are necessary plasma-protein therapies in order to cure a broad range of immunodeficiencies as well as other medical malignancies.
Feb-2022: Grifols came into collaboration with Endpoint Health, a US-based therapeutics company. The collaboration includes Grifols supporting through its expertise in plasma protein therapies and would act as an exclusive supplier of AT-III. AT-III is a plasma protein that is intended for the treatment of patients with blood clotting. This collaboration reinforces Grifols plasma economics.
Mergers and Acquisitions:
Mar-2023: Takeda took over Nimbus Lakshmi from Nimbus Therapeutics. Nimbus Lakshmi is a US-based developer of medicines for various autoimmune diseases. The addition of Nimbus Lakshmi reinforces Takeda's evolving pipeline and perfectly aligns with its strategy and competence.
Dec-2022: Kedrion acquired UNICAplasma s.r.o and UNICAplasma Morava s.r.o., Czech companies that operate five plasma collection centers in the Czech Republic. The addition of the two Czech-based companies would add significant value to the acquiring company and would further provide Kedrion with high-quality plasma for their production facilities, which in turn would enable the company to develop therapeutics for rare conditions.
Jan-2022: Kedrion formed a merger with Bio Products Laboratory, a company involved in the manufacture of human blood plasma products. Following this merger, the companies aimed to manufacture and develop a strong player within the global plasma derivatives market. Moreover, the new merger would allow the companies to treat patients with hazardous and rare conditions with human blood plasma-derived medicines.
Oct-2202: Kedrion Biopharma took over Prometic, a life sciences business. Through this acquisition, the company aimed to integrate the first-ever FDA-approved Congenital Plasminogen Deficiency treatment medicine of Prometic, Ryplazim. Furthermore, this acquisition would allow Kedrion to expand its footprint throughout North America.
Aug-2021: Bayer acquired Vividion Therapeutics, a US-based developer of a drug discovery platform. The addition of Vividion reinforces the acquiring company's small molecule capabilities and broadens its presence into new modalities. Further, this acquisition acts as a base for Bayer's strategy to power its pipeline with innovation.
Mar-2021: Takeda completed its acquisition of Maverick Therapeutics, a biopharmaceutical company. Under this acquisition, Takeda would leverage the COBRA T-cell engager platform of Maverick to develop more efficient therapies.
Mar-2021: Grifols acquired BPL Plasma, a subsidiary of Bio Products Laboratory. Through this acquisition, the company aimed to reinforce, expand, and diversify its robust network capacity as well as centers in order to deliver life-improving plasma-derived medicines.
Trials and Approvals:
Feb-2023: Octapharma received approval from Europea Medical Authorities for the lyophilized presentation of the well-established octaplasLG, an S/D treated plasma for transfusion. The approved product would be sold in Europe in the form of powder and solvent. The octaplasLG can be reconstituted in a short span of time and can be stored at room temperature. Further, the approval complements the company's commitment to supporting the prevention of uncontrolled hemorrhage.
Feb-2023: FDA approved ADMA's eighth plasma collection center located in Hammond, Louisiana, United States of America. This FDA approval enables the company's eighth collection center to collect, and introduce into interstate commerce, human source plasma. Further, this approval complements the company's aim to be plasma self-sufficient and supports the company in improving its profitability.
Geographical Expansions:
Mar-2023: Takeda expanded its global footprint by setting up a new facility intended for plasma-derived therapies. The new facility is located in Japan. The therapy developing facility reinforces the company's manufacturing and supply capabilities and further enables the company to better take care of the evolving needs for Plasma-Derived Therapies (PDTs) in Japan as well as the rest of the world.
Oct-2022: Grifols established a new manufacturing facility in Ireland. The new facility is established to cater to the evolving needs for plasma-based medicines. The new facility in Ireland triples the company's annual filling production capacity. Further, the geographical expansion demonstrates the company's commitment to investing in plasma medicines infrastructure.
Sep-2022: Takeda expanded its global footprint by setting up a new manufacturing facility in Belgium and expanding its already existing warehouse in Lessines, Belgium. The new facility in Belgium would be equipped with a water recycling system that would reduce freshwater consumption by 90%.
Market Segments covered in the Report:
By End User
By Product Type
By Application
By Geography
Companies Profiled
Unique Offerings from KBV Research