치료용 혈장 교환 시장 규모는 2024년에 11억 5,000만 달러로 평가되었고, 2026-2032년 연평균 7.5% 성장하여 2032년에는 21억 9,000만 달러에 달할 것으로 예측됩니다.
치료적 혈장교환술(TPE)은 환자의 혈액에서 혈장을 제거하고 식염수나 기증자 혈장 등의 대체액으로 교환하는 의료 시술입니다.
치료적 혈장교환의 주요 목적은 각종 질병 및 증상의 원인이 되는 항체, 독소, 이상 단백질 등 혈장 내 유해물질을 제거하는 것입니다.
치료용 혈장 교환은 자가면역질환(예: 길랑-바레 증후군, 중증 근무력증), 혈액질환(예: 혈전성 혈소판감소성 자반병), 특정 신장질환 등 다양한 증상의 치료에 일반적으로 이용되고 있습니다.
이 과정에는 일반적으로 혈액을 구성 성분으로 분리하는 어펠레시스 장치가 사용됩니다. 혈장은 제거되고 남은 혈액 세포는 환자에게 돌려주기 전에 교환액과 혼합됩니다.
세계 치료용 혈장 교환 시장을 형성하는 주요 시장 역학은 다음과 같습니다.
주요 촉진요인
자가면역질환의 유병률 증가: 중증 근무력증, 길랑-바레 증후군과 같은 자가면역질환의 유병률 증가는 치료용 혈장 교환에 대한 수요를 크게 견인하고 있습니다. 예를 들어, 미국 국립보건원(National Institutes of Health)은 중증 근무력증의 유병률이 매년 전 세계 인구 10만 명당 약 20명꼴로 발생한다고 보고하여 효과적인 치료 옵션의 필요성을 강조하고 있습니다.
고령화 사회는 치료용 혈장 교환이 필요한 만성질환에 걸릴 확률이 높아집니다. 2050년까지 유럽 일부 국가에서는 인구의 30% 이상이 65세 이상이 될 것으로 예상되며, 노화와 관련된 건강 문제를 해결하기 위해 치료용 혈장 교환과 같은 치료법에 대한 수요가 증가하고 있습니다.
기술 발전: 치료용 혈장 교환 기술의 끊임없는 발전은 그 효과와 안전성을 향상시켜 선호되는 치료 옵션으로 자리 잡고 있습니다. 보다 효율적인 아펠레시스 장비의 개발과 프로토콜의 개선은 시장 성장을 가속할 것으로 예측됩니다.
의료비 지출 증가: 특히 북미의 의료비 지출 증가는 치료용 혈장 교환과 같은 첨단 치료법에 대한 접근을 용이하게 하고 있습니다. 미국에서는 2021년 의료비 지출이 약 4조 3,000억 달러에 달할 것으로 예상되며, 이는 혁신적인 치료법 사용을 뒷받침하고 있습니다.
주요 과제
높은 장비 및 소모품 비용: 혈장교환요법은 아펠레시스 장치와 같은 특수 장비와 튜브, 필터와 같은 일회용 부품이 필요하기 때문에 많은 비용이 소요됩니다. 이러한 높은 비용은 특히 개발도상국의 의료진과 환자들의 접근성을 제한할 수 있습니다.
제한된 시장 수요: 치료용 혈장 교환 제품은 더 널리 사용되는 의료용 제품에 비해 시장 수요가 상대적으로 제한적일 수 있습니다. 따라서 생산 규모가 제한적이기 때문에 단위당 비용이 높아져 제조업체가 규모의 경제를 달성하기 어려울 수 있습니다.
규제 과제: 안전성과 유효성에 대한 엄격한 규제 기준을 준수하는 것은 치료용 혈장 교환 장치 및 소모품의 승인 절차를 복잡하게 만들 수 있습니다. 이로 인해 신제품 시장 진입이 지연되고 개발 비용이 증가할 수 있습니다2.
부작용 가능성: 치료용 혈장 교환을 받는 환자는 알레르기 반응, 저혈압, 전해질 불균형과 같은 부작용을 경험할 수 있습니다. 이러한 합병증은 일부 의료 서비스 제공업체가 치료적 혈장 교환을 치료 옵션으로 채택하는 것을 주저하게 만들어 시장 성장 잠재력을 제한할 수 있습니다.
주요 동향
적응증 확대: 치료용 혈장 교환의 적응증은 크게 확대되어, 현재 기존 용도를 넘어 다양한 질환을 포괄하고 있습니다. 여기에는 자가면역질환, 신경질환, 신장질환 등이 포함됩니다. 예를 들어, 한 조사에 따르면 치료용 혈장 교환술의 36.8%가 신장 질환으로, 이는 다양한 의료 상황에서 치료용 혈장 교환술의 효능이 점점 더 많이 인정받고 있음을 보여줍니다.
시술량 증가: 치료적 혈장교환술의 연간 시술 건수가 눈에 띄게 증가하고 있습니다. 국내 데이터에 따르면, 2008-2017년 사이 TPE 시술 건수는 약 3.7배 증가하여, 이 치료법이 임상현장에서 수용되고 활용되고 있음을 알 수 있습니다.
기술 발전: 아펠레시스 기술의 혁신은 치료용 혈장 교환술의 효율성과 안전성을 향상시키고 있습니다. 첨단 아펠레시스 장비의 도입은 환자의 예후를 개선하고, 프로세스를 간소화하며, 시장 성장에 기여할 것으로 예측됩니다.
인식과 수용 증가: 복잡한 질환을 관리하기 위한 TPE의 이점에 대한 의료 서비스 제공업체의 인식이 높아지면서 TPE의 채택이 증가하고 있습니다. 예를 들어, CDC는 미국에서 연간 2만-4만 건의 길랑-바레 증후군 사례를 보고하고 있으며, TPE와 같은 효과적인 치료 옵션의 필요성을 강조하고 있습니다.
Therapeutic Plasma Exchange Market size was valued at USD 1.15 Billion in 2024 and is projected to reach USD 2.19 Billion by 2032, growing at a CAGR of 7.5% from 2026 to 2032.
Therapeutic plasma exchange (TPE) is a medical procedure that involves the removal of plasma from a patient's blood and its replacement with a substitute fluid, such as saline or donor plasma.
The primary goal of therapeutic plasma exchange is to eliminate harmful substances found in the plasma, such as antibodies, toxins, or abnormal proteins, which may be responsible for various diseases and symptoms.
therapeutic plasma exchange is commonly utilized to treat a range of conditions, including autoimmune diseases (e.g., Guillain-Barre syndrome, myasthenia gravis), blood disorders (e.g., thrombotic thrombocytopenic purpura), and certain kidney diseases.
The process typically involves using an apheresis machine that separates blood into its components. Plasma is removed, and the remaining blood cells are mixed with a replacement fluid before being returned to the patient.
The key market dynamics that are shaping the global therapeutic plasma exchange market include:
Key Drivers:
Rising Prevalence of Autoimmune Diseases: The increasing incidence of autoimmune disorders, such as myasthenia gravis and Guillain-Barre syndrome, is significantly driving the demand for therapeutic plasma exchange . For instance, the National Institutes of Health reported that the prevalence of myasthenia gravis affects about 20 per 100,000 people globally each year, highlighting the need for effective treatment options.
Growing Geriatric Population: The aging population is more susceptible to chronic diseases that require therapeutic plasma exch By 2050, it is projected that over 30% of the population in some European countries will be over 65 years old, increasing the demand for therapies like therapeutic plasma exchange that address age-related health issues.
Technological Advancements: Continuous advancements in therapeutic plasma exchange technology enhance its effectiveness and safety, making it a preferred treatment option. The development of more efficient apheresis machines and improved protocols are expected to drive market growth.
Increased Healthcare Spending: Rising healthcare expenditures, particularly in North America, are facilitating access to advanced treatments like therapeutic plasma exchange. In the U.S., healthcare spending was approximately $4.3 trillion in 2021, supporting the availability of innovative therapies.
Key Challenges:
High Cost of Equipment and Consumables: The cost associated with therapeutic plasma exchange procedures is significant due to the need for specialized equipment, such as apheresis machines, and single-use disposable components like tubing and filters. This high cost can limit accessibility for healthcare providers and patients, particularly in developing regions.
Limited Market Demand: Therapeutic plasma exchange products may have relatively limited market demand compared to more widely used medical products. This limited scale of production can lead to higher per-unit costs, making it challenging for manufacturers to achieve economies of scale.
Regulatory Challenges: Compliance with stringent regulatory standards for safety and efficacy can complicate the approval process for therapeutic plasma exchange devices and consumables. This can delay market entry for new products and increase development costs2.
Potential Side Effects: Patients undergoing therapeutic plasma exchange may experience side effects such as allergic reactions, hypotension, or electrolyte imbalances. These complications can deter some healthcare providers from adopting therapeutic plasma exchange as a treatment option, limiting its market growth potential.
Key Trends:
Expansion of Indications: The indications for therapeutic plasma exchange have broadened significantly, now encompassing a wide range of conditions beyond traditional uses. This includes autoimmune diseases, neurological disorders, and renal diseases. For instance, a study indicated that renal diseases accounted for 36.8% of therapeutic plasma exchange procedures, reflecting a growing recognition of therapeutic plasma exchange's effectiveness in various medical contexts.
Increased Procedure Volume: There has been a notable increase in the number of therapeutic plasma exchange procedures performed annually. Data from South Korea showed that the number of TPE procedures increased approximately 3.7 times from 2008 to 2017, indicating a rising acceptance and utilization of this therapy in clinical practice.
Technological Advancements: Innovations in apheresis technology are enhancing the efficiency and safety of therapeutic plasma exchange procedures. The introduction of advanced apheresis machines is expected to improve patient outcomes and streamline the process, contributing to market growth.
Growing Awareness and Acceptance: Increased awareness among healthcare providers regarding the benefits of TPE for managing complex conditions is driving its adoption. For example, the CDC reported between 20,000 to 40,000 cases of Guillain-Barre syndrome annually in the U.S., highlighting the need for effective treatment options like TPE.
Here is a more detailed regional analysis of the global therapeutic plasma exchange market:
North America:
The North American therapeutic plasma exchange market is projected to reach approximately USD 280 Million by 2027, growing at a CAGR of 6.2% from 2022 to 2027, reflecting robust market potential.
The region has a high prevalence of autoimmune diseases, with the National Institutes of Health reporting that conditions like myasthenia gravis affect approximately 20 per 100,000 people annually, driving demand for TPE treatments.
According to the American Heart Association, nearly 92.1 million individuals in the U.S. suffered from cardiovascular diseases in 2018, which increases the need for therapeutic plasma exchange interventions.
North America benefits from an advanced healthcare infrastructure that supports the widespread adoption of TPE procedures, ensuring patient access to effective treatments.
Europe:
The European market is projected to grow significantly, with estimates indicating it will reach approximately USD 19 Billion by 2032, reflecting a CAGR of 7.5% from 2026 to 2032. This growth is driven by increasing prevalence of neurological, renal, and hematological disorders.
Many European countries have established healthcare systems that ensure broad access to medical treatments, including therapeutic plasma exchange. This accessibility enhances patient care and treatment outcomes.
The presence of numerous biotech companies and research institutions in Europe supports innovation and development in therapeutic plasma exchange technologies, contributing to the market's expansion.
The aging population in Europe is increasing the demand for chronic disease management solutions, with projections indicating that by 2030, nearly 20% of the European population will be over 65 years old, further driving the need for therapies like therapeutic plasma exchange.
The Global Therapeutic Plasma Exchange Market is segmented on the basis of Disease Indications, End-User and Geography.
Based on Disease Indications, the Global Therapeutic Plasma Exchange is divided into Neurological Disorders, Renal Disorders, Hematology Disorders, Metabolic Disorders, and Others. The neurological disorder segment is expected to capture the largest market share due to the high incidence of these diseases, especially in the aging population. Reports indicate that neurological conditions account for a substantial portion of TPE applications.
Based on End-User, the Global Therapeutic Plasma Exchange is divided into Hospitals, Specialty Clinics, and Ambulatory Surgical Centers. Hospitals account for a significant share of the therapeutic plasma exchange market due to their ability to accommodate patients requiring extended care and monitoring during TPE procedures.
Based on Geography, the Therapeutic Plasma Exchange Market is classified into North America, Europe, Asia Pacific, Middle East & Africa, and Latin America. The North American therapeutic plasma exchange market is projected to reach approximately USD 280 Million by 2027, growing at a CAGR of 6.2% from 2022 to 2027, reflecting robust market potential.
The "Global Therapeutic Plasma Exchange Market" study report will provide valuable insight with an emphasis on the global market including some of the major players such as Asahi Kasei Corporation, Baxter International, Inc., Terumo Corporation, B. Braun Melsungen AG, Fresenius Kabi AG, Kawasumi Laboratories, Inc., Haemonetics Corporation, Cerus Corporation, Hemacare Corporation, Medica S.p.A., and others.
Our market analysis also entails a section solely dedicated to such major players wherein our analysts provide an insight into the financial statements of all the major players, along with its product benchmarking and SWOT analysis. The competitive landscape section also includes key development strategies, market share, and market ranking analysis of the above-mentioned players globally.