세계 낭포성 섬유증 치료 시장 규모는 2024년 136억 1,000만 달러에서 2032년에는 407억 6,000만 달러에 달할 것으로 예상되며, 2025-2032년의 예측 기간 동안 연평균 14.70%의 성장률을 보일 것으로 예측됩니다. 낭포성 섬유증 시장의 성장은 다양한 지역에서 낭포성 섬유증에 대한 부담 증가, 다양한 규제 기관의 승인 증가, 낭포성 섬유증 증상에 대한 일반 대중의 인식 향상에 힘입어 성장하고 있으며, 낭포성 섬유증 재단(Cystic Fibrosis Foundation)의 추산에 따르면 매년 미국에서 약 1,000명의 새로운 낭포성 섬유증 환자가 발생하고 있습니다. 낭포성 섬유증 진단을 받고 있으며, 그 중 75% 이상이 2세 이전에 진단을 받고 있습니다.
또한, 혁신적인 치료법의 빠른 도입과 환자 기반을 확대하기 위한 임상시험 증가는 시장에 유리한 성장 기회를 제공합니다. 낭포성 섬유증은 전해질 수송 시스템에 장애를 일으켜 세포가 수분과 나트륨을 보유하기 시작하여 점액 분비선 및 땀 문제를 악화시킵니다. 따라서 낭포성 섬유증 환자는 만성 기침, 폐허탈, 객혈, 호흡기 감염 등에 매우 취약합니다. 따라서 주요 의료기관과 제약사들은 증가하는 위협에 대응할 수 있는 치료 솔루션 개발에 점점 더 많은 노력을 기울이고 있습니다. 제약기업들은 표적치료제, 병용치료, 유전자 편집 기술 등을 도입하기 위한 연구개발 활동에 많은 투자를 하고 있습니다.
희귀질환 치료제 지정 및 상환 체계를 포함한 의료 정책의 지원으로 첨단 치료제에 대한 접근성이 향상되고 있습니다. 한편, 비영리 단체의 인식 제고 캠페인 증가와 정부의 이니셔티브는 신생아 선별검사 프로그램 확대를 통해 조기 진단율을 향상시켜 시장 수요를 촉진하고 있습니다.
세계의 낭포성 섬유증 치료 시장에 대해 조사 분석했으며, 시장 규모와 예측, 시장 역학, 주요 기업 개요 등의 정보를 전해드립니다.
Global cystic fibrosis therapeutics market is projected to witness a CAGR of 14.70% during the forecast period 2025-2032, growing from USD 13.61 billion in 2024 to USD 40.76 billion in 2032. The market's growth is supported by the increasing burden of cystic fibrosis in different regions, rising approvals from different regulatory bodies, and growing awareness about the condition among the general population. According to the estimates of the Cystic Fibrosis Foundation, about 1,000 new cases of cystic fibrosis are diagnosed each year in the United States, with over 75% of the cases being diagnosed by the time the patient is 2 years old.
Additionally, the rapid introduction of innovative therapies along with the growing number of clinical trials to expand the patient base are further providing lucrative growth opportunities for the market. Cystic fibrosis impairs the electrolyte transport system, because of which cells start retaining water and sodium, exacerbating issues related to mucus-producing glands and sweat. Thus, patients suffering from cystic fibrosis are highly susceptible to chronic coughs, lung collapses, hemoptysis, and respiratory infections, among others. Therefore, leading healthcare organizations and pharmaceutical companies are increasingly focusing on developing therapeutic solutions to combat the growing threat of the condition. The pharmaceutical companies are investing heavily in research and development activities to introduce targeted therapies, combination treatments, and gene editing technologies, among others.
Supportive healthcare policies, including orphan drug designations and reimbursement frameworks are enhancing accessibility to advanced therapies. Meanwhile, increasing awareness campaigns by nonprofit organizations coupled with the rising government initiatives are improving early diagnosis rates through expanded newborn screening programs, bolstering the market's demand.
Rising Regulatory Approvals Support Market Expansion
Increasing regulatory approvals are significantly driving the growth of the cystic fibrosis therapeutics market by facilitating the availability of innovative treatments and therapeutic solutions. In March 2025, ReCode Therapeutics, Inc. received orphan drug designation for RCT2100 from the United States Food and Drug Administration (US FDA). The investigational mRNA therapy is being developed for treating cystic fibrosis. RCT2100 is designed for delivering cystic fibrosis transmembrane conductance regulator mRNA directly to target cells in the lungs and is formulated by leveraging the company's selective organ targeting lipid nanoparticle platform.
Similarly, in February 2025, porosome reconstitution therapy for cystic fibrosis was granted orphan drug designation by the FDA. The therapy displayed increased efficacy in secretion of mucus during an analysis in which the plasma membrane of the cystic fibrosis transmembrane conductance regulator mutant cells were subjected to functional porosomes.
Additionally, the growing pipeline of clinical trials, supported by favorable regulatory environment and policies, continues to offer new opportunities for growth for the key players in the industry. Moreover, regulatory approvals often result in better reimbursement policies, boosting the accessibility of treatments more for the patient population, further bolstering the market's expansion.
Increasing Investments in Development of New Therapies Drive Market Growth
These initiatives are driving the growth of the market by fostering innovation and expanding the number of treatment options available. Investments are also accelerating research into biomarker development, personalized medicine, and gene editing technologies enabling early intervention and more effective treatments.
For instance, in January 2025, Glox Therapeutics Ltd. was awarded a grant of approximately USD 642,000 (£500,000) to advance the discovery and development of precision antibiotics that target antimicrobial-resistant lung infections in patients suffering from cystic fibrosis. Cystic fibrosis often causes thick mucus buildup in the lungs, leading to infections that become resistant to antibiotics over a period of time. Thus, addressing the urgent requirements for effective therapeutics and improving the lives of the patient population.
CFTR Modulators Account for Significant Share of the Market
The segment's growth can be attributed to the ability of these drugs to target the underlying genetic defect caused by mutations in the genes, providing a disease-modifying approach rather than addressing symptoms. This precision medicine strategy has significantly improved patient outcomes, due to improved lung functioning and increased life expectancy. Moreover, the convenience of oral administration also contributes to the popularity of CFTR modulators, allowing them to hold a significant share of the revenue.
Additionally, the rising research activities to evaluate the safety and efficacy of CFTR modulators on patients of different age groups is also supporting the segment's expansion. For instance, the La Societe Francaise de la Mucoviscidose is conducting an observational study to understand the response of CFTR modulators in patients with cystic fibrosis that are under 18. The study is estimated to conclude in July 2025.
North America Holds Major Market Share
The market's expansion in the region can be attributed to the high prevalence of cystic fibrosis in the region, increasing spendings in the healthcare sector, and strong presence of leading pharmaceutical companies. As per the estimates of the American Lung Association, approximately 40,000 people in the United States have cystic fibrosis and about one in thirty people in the country is a carrier. Moreover, research and development activities are heavily funded in North America, with major pharmaceutical corporations and research institutions collaborating to develop novel therapeutic solutions. Additionally, favorable reimbursement policies and government initiatives enhance patient access to these therapies.
Meanwhile, the Asia-Pacific is expected to witness significant growth over the forecast period due to rising investments towards the healthcare and pharmaceutical industries, improved access to innovative therapies, increasing awareness among the patient population, and growing number of research initiatives and clinical trials.
Future Market Scenario (2025 - 2032F)
The market is expected to witness significant growth in the coming years due to ongoing advancements in CFTR modulator therapies, growing awareness about the condition in developing regions, advent of various genetic editing solutions, and rising prevalence of cystic fibrosis. Additionally, increasing collaborations between biotech companies and research institutions are accelerating the development and availability of innovative solutions. Furthermore, gene therapies targeting permanent correction of cystic fibrosis transmembrane conductance regulator mutations are anticipated to enter the clinical stage over the coming years, potentially shifting the market from chronic disease management to curative approaches. Strategic partnerships, licensing deals, and public-private collaborations are also anticipated to play a crucial role in the market's expansion across the globe.
Key Players Landscape and Outlook
The key players of the market are focusing on launching new products and receiving approvals from the different regulatory bodies. For instance, in March 2025, Vertex Pharmaceuticals Incorporated's Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for use in patients that are six or older. Alyftrek combines enhances cystic fibrosis transmembrane regulator protein function, improving salt and water transport across cell membranes. This mechanism aids in reducing thick mucus buildup, a hallmark of cystic fibrosis, and improves lung functioning, slowing the progression of the disease. Such approvals are allowing the key players of the market to increase their revenues and improve their position in the market.
All segments will be provided for all regions and countries covered
Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.