세계의 혈장 프로테아제 C1 억제제 시장은 2024년 18억 달러로 평가되었으며 CAGR 9.7%를 나타내 2034년에는 45억 달러에 이를 것으로 추정되고 있습니다. 성부종(HAE)과 같은 드문 유전성 질환의 치료에 있어 매우 중요합니다.
혈장 분획 및 채취 방법의 기술적 진보는 혈장 유래의 치료제의 수율과 순도를 높임으로써 생물학적 제제의 상황을 재구성하고 있습니다. 임상적 관심의 고조와 맞춤형 의료의 대두에 의해 시장은 염증성 질환이나 자가면역 질환 등의 새로운 치료 응용 분야에의 침투가 진행될 것으로 예측됩니다.
| 시장 범위 | |
|---|---|
| 시작 연도 | 2024년 |
| 예측 연도 | 2025-2034년 |
| 시작 금액 | 18억 달러 |
| 예측 금액 | 45억 달러 |
| CAGR | 9.7% |
약제 클래스별로는 혈장 유래의 C1 억제제 부문이 시장을 독점해, 2024년의 세계 점유율의 59.7%를 차지했습니다. 그런데 시장 내에서는 소규모 부문에 머물러 있습니다.혈장 유래의 제형은 그 확립된 안전성 프로파일과 HAE의 급성 치료 및 예방 치료에 있어서 입증된 효능에 의해 여전히 바람직한 옵션입니다.
제형을 보면 동결건조 C1 억제제가 2024년 점유율 61.2%로 계속 시장을 선도했습니다. 콜드체인 인프라에 대한 액세스가 제한된 지역에서 사용하기에 이상적입니다.
미국 시장은 강력한 성장을 이루고 있습니다. 개선, 조기 진단에 대한 의식이 높아지고, 희귀질환 치료에 대한 폭넓은 접근이 있습니다.
이 시장 주요 기업으로는 BioCryst Pharmaceuticals, 다케다 약품 공업, KalVista, Ionis Pharmaceuticals, CSL Behring, Fresenius Kabi, Pharming, Pharvaris, Astria 등이 있습니다. 이러한 기업은 특히 면역학과 염증 분야에서 C1 억제제의 새로운 적응증을 발견하기 위해 연구 개발에 많은 투자를 실시했습니다.
The Global Plasma Protease C1-Inhibitor Market was valued at USD 1.8 billion in 2024 and is estimated to grow at a CAGR of 9.7% to reach USD 4.5 billion by 2034. Plasma protease C1-inhibitors serve a vital role in controlling the activation of the complement and contact systems within the human body. These proteins, derived from blood plasma, are crucial in the treatment of rare genetic disorders such as Hereditary Angioedema (HAE). As healthcare systems continue to evolve, there is increasing awareness surrounding rare disease management, which is significantly contributing to the demand for effective and specialized therapies like C1-inhibitors.
Technological progress in plasma fractionation and collection methods is reshaping the landscape of biologics by enhancing the yield and purity of plasma-derived therapies. In turn, these developments are making treatments more accessible, affordable, and scalable for healthcare providers and patients alike. With growing clinical interest and the emergence of personalized medicine, the market is poised to witness greater penetration across new therapeutic applications, such as inflammatory and autoimmune diseases. Regulatory support and increasing healthcare infrastructure in both developed and emerging economies are further bolstering market expansion.
| Market Scope | |
|---|---|
| Start Year | 2024 |
| Forecast Year | 2025-2034 |
| Start Value | $1.8 Billion |
| Forecast Value | $4.5 Billion |
| CAGR | 9.7% |
In terms of drug classes, the plasma-derived C1-inhibitor segment dominated the market, accounting for 59.7% of the global share in 2024. While alternative options like selective bradykinin B2 receptor antagonists and Kallikrein inhibitors are also available, they currently serve as smaller segments within the market. Plasma-derived formulations remain the preferred option due to their established safety profiles and proven efficacy in managing acute and prophylactic treatment for HAE.
When looking at dosage forms, lyophilized C1-inhibitors continue to lead the market with a 61.2% share in 2024. These freeze-dried formulations are favored for their extended shelf life and do not require refrigeration, making them ideal for use in regions with limited access to reliable cold chain infrastructure. This advantage is particularly critical in rural healthcare settings and low-to-middle-income countries where consistent storage conditions can be a challenge.
The U.S. Plasma Protease C1-Inhibitor Market is experiencing robust growth. Valued at USD 729.4 million in 2024, it is projected to reach USD 1.8 billion by 2034. The expansion is driven by the rising prevalence of HAE, improvements in genetic screening, increased awareness of early diagnosis, and broader access to rare disease treatments. The U.S. FDA's continued support for orphan drugs, particularly for conditions like HAE, is accelerating product approvals and encouraging more innovation in this space.
Key players in the market include BioCryst Pharmaceuticals, Takeda Pharmaceutical Company, KalVista, Ionis Pharmaceuticals, CSL Behring, Fresenius Kabi, Pharming, Pharvaris, and Astria. These companies are heavily investing in R&D to discover new indications for C1-inhibitors, especially in the fields of immunology and inflammation. Strategic collaborations are also fueling growth by expanding product pipelines and fast-tracking next-generation therapies.