세계의 세포·유전자 치료 제조 시장 규모는 2024년에 47억 4,918만 달러로, 2032년까지 98억 490만 달러에 달할 것으로 예측되며, 2025-2032년의 예측 기간에 CAGR로 9.50%의 성장이 전망됩니다.
세포 및 유전자 치료제 제조 시장 역학
암, 희귀 유전성 질환 등 유전성 질환과 만성질환의 유병률 증가로 인해 첨단 치료법에 대한 수요가 증가하고 있으며, 이에 따라 견고한 제조 능력이 요구되고 있습니다. 세포 및 유전자 치료제 파이프라인은 빠르게 확장되고 있으며, 수많은 치료법이 임상시험을 진행하고 있으며, 확장 가능하고 효율적인 제조 솔루션의 필요성이 대두되고 있습니다. 파트너십, 최첨단 제조 시설에 대한 투자, 자동화 진행 등 업계 주요 기업의 전략적 활동으로 생산 능력과 효율성이 향상되고 있습니다. 이러한 요인들을 종합하면 2025-2032년의 예측 기간 중 세계 세포 및 유전자 치료제 제조 시장의 성장이 크게 촉진될 것으로 예상됩니다.
International Agency for Research on Cancer(2024) 자료에 따르면 2022년 전 세계 신규 암 환자 수는 2,000만 명으로 추산되며, 2045년까지 3,260만 명으로 증가할 것으로 예상됩니다. 은 특정 암종을 표적으로 삼아 유망한 결과를 보이고 있으며, 이에 따라 생산 규모를 확대하기 위한 견고한 제조 공정에 대한 수요가 증가하고 있습니다. 마찬가지로 줄기세포 기반 치료를 포함한 세포 치료도 암뿐만 아니라 침습성이 강한 암 치료의 부작용에 대처하기 위해 개발되고 있습니다. 결과적으로, 암 발병률 증가는 세포 및 유전자 치료제 제조 시장을 크게 촉진하고 있습니다.
또한 호주 혈우병 재단(2024)에 따르면 호주에서 2,500명 이상이 유전성 출혈성 질환인 폰빌레브란트병(VWD)으로 진단을 받았지만, 많은 수의 환자들이 진단을 받지 못한 것으로 추정되고 있습니다.에 대한 세포-유전자 치료 접근법은 결함이 있는 VWF 유전자의 기능적 사본을 투여하여 근본적인 유전적 결함을 교정합니다. 이 전략은 바이러스 벡터 및 기타 컴포넌트를 우수의약품 제조 및 품질관리기준(GMP)을 준수하는 시설에서 전문적으로 제조해야 하므로 첨단 제조 공정 및 인프라에 대한 수요가 증가하고 있습니다. 전 세계에서 VWD의 유병률 증가와 기존 치료법의 한계로 인해 이 질환을 표적으로 하는 세포치료제 및 유전자 치료제 개발에 대한 연구와 투자가 증가하면서 전체 시장을 촉진하고 있습니다.
또한 주요 시장 기업 간의 전략적 활동은 세포 및 유전자 치료제 제조 전망을 크게 강화하고 있습니다. 예를 들어 2023년 10월 Creative Medical Technology Holdings, Inc.는 만성 요통에 대한 AlloStem(TM)(CELZ-201-DDT) 세포 치료를 이용한 StemSpine(R) 시술에 대한 임상시험에 대해 IRB(Institutional Review Board)의 승인을 받았습니다. Institutional Review Board)의 승인을 받았습니다. 이번 승인으로 회사는 30명의 디스크 환자들을 대상으로 안전성, 유효성, 내약성을 평가하는 FDA 승인 1/2상 임상시험 모집을 진행할 수 있게 되었습니다. 이러한 발전은 세포 및 유전자 치료제가 임상시험을 통해 빠르게 발전하고 있으며, 확장 가능하고 효율적인 제조 솔루션이 필요하다는 것을 입증하는 것입니다.
그러나 시장은 복잡한 제조 공정과 규제적 장애물 등의 문제에 직면해 있습니다. 세포 및 유전자 치료제의 생산에는 세포의 추출, 변형, 증식, 전달과 같은 복잡한 공정이 포함됩니다. 품질을 유지하면서 확장성과 재현성을 보장하는 것은 중요한 문제입니다. 환자가 이러한 치료의 혜택을 누릴 수 있도록 하기 위해서는 규제적 장애물을 극복해야 합니다. 또한 재료와 인력에 대한 접근성 부족, 검증되지 않은 기술과 미성숙한 공정은 생산 규모를 확대하는 데 있으며, 어려움을 겪고 있습니다. 이러한 문제를 해결하는 것은 세포·유전자 치료 제조 시장의 지속적인 성장을 위해 매우 중요합니다.
요약하면, 세포·유전자 치료 제조 시장은 만성질환 및 유전질환의 유병률 증가로 인해 크게 성장할 것으로 예상되지만, 그 잠재력을 충분히 발휘하기 위해서는 복잡한 제조 및 규제적 과제를 극복해야 합니다.
세계의 세포·유전자 치료 제조 시장에 대해 조사분석했으며, 시장 규모와 예측, 과거 3년의 제품/기술개발, 시장의 주요 기업, 이용 가능한 기회 등의 정보를 제공하고 있습니다.
Cell and Gene Therapy Manufacturing Market by Therapy Type (Cell Therapy [Allogenic and Autologous] and Gene Therapy [Viral Vector-Based Gene Therapy and Non-Viral Vector-Based Gene Therapy]), Manufacturing Type (In-house Manufacturing, Contract Manufacturing), Scale of Manufacturing (Clinical-Scale Manufacturing and Commercial-Scale Manufacturing), Application (Neurological, Oncological, Hematological, Ophthalmological and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to the rising prevalence of genetic disorders and chronic diseases, rapid expansion of the cell and gene therapy pipeline, and increasing strategic activities among the key players across the globe.
The Cell and Gene Therapy Manufacturing market was valued at USD 4,749.18 million in 2024, growing at a CAGR of 9.50% during the forecast period from 2025 to 2032 to reach USD 9,804.90 million by 2032. The rising prevalence of genetic disorders and chronic diseases such as cancer and rare inherited conditions is driving the demand for advanced therapies, thereby increasing the need for robust manufacturing capabilities. Concurrently, the rapid expansion of the cell and gene therapy pipeline, with numerous therapies advancing through clinical trials, is accelerating the demand for scalable and efficient production solutions.
Additionally, strategic initiatives by key market players including partnerships, investments in cutting-edge manufacturing facilities, and advancements in automation technologies are significantly enhancing production capacity and operational efficiency.
Collectively, these factors are expected to substantially propel the growth of the cell and gene therapy manufacturing market globally during the forecast period from 2025 to 2032.
Cell and Gene Therapy Manufacturing Market Dynamics:
The increasing prevalence of genetic disorders and chronic diseases, such as cancer and rare inherited conditions, is driving the demand for advanced therapies, thereby necessitating robust manufacturing capabilities. The rapid expansion of the cell and gene therapy pipeline, with numerous therapies advancing through clinical trials, underscores the need for scalable and efficient production solutions. Strategic activities by key industry players including partnerships, investments in state-of-the-art manufacturing facilities, and advancements in automation are enhancing production capacity and efficiency. Collectively, these factors are anticipated to significantly propel the growth of the global cell and gene therapy manufacturing market during the forecast period from 2025 to 2032.
According to data from the International Agency for Research on Cancer (2024), the global incidence of new cancer cases was estimated at 20 million in 2022, with projections indicating an increase to 32.6 million by 2045. Gene therapies, such as CAR-T cell treatments, have demonstrated promising results in targeting specific cancer types, thereby increasing the demand for robust manufacturing processes to scale production. Similarly, cell therapies, including stem cell-based treatments, are being developed to address not only cancer but also the adverse effects of aggressive cancer treatments. Consequently, the rising incidence of cancer is significantly boosting the cell and gene therapy manufacturing market.
Additionally, data from the Haemophilia Foundation Australia (2024) indicates that over 2,500 individuals in Australia have been diagnosed with Von Willebrand Disease (VWD), an inherited bleeding disorder, though many cases are believed to be undiagnosed. Cell and gene therapy approaches for VWD involve delivering a functional copy of the defective VWF gene to correct the underlying genetic defect. This strategy necessitates specialized manufacturing of viral vectors and other components in Good Manufacturing Practice (GMP)-compliant facilities, thereby increasing the demand for advanced manufacturing processes and infrastructure. The rising prevalence of VWD globally, coupled with the limitations of conventional treatments, has spurred increased research and investment in developing cell and gene therapies specifically targeting this disorder, thus boosting the overall market.
Furthermore, strategic activities among key market players are significantly enhancing the cell and gene therapy manufacturing landscape. For instance, in October 2023, Creative Medical Technology Holdings, Inc. received Institutional Review Board (IRB) approval for its clinical trial of the StemSpine(R) procedure using AlloStem(TM) (CELZ-201-DDT) cell therapy for chronic lower back pain. This approval enables the company to proceed with recruitment for its FDA-approved Phase 1/2 trial to evaluate safety, efficacy, and tolerability in 30 participants with Degenerative Disc Disease. Such developments underscore the rapid progression of cell and gene therapies through clinical trials, necessitating scalable and efficient manufacturing solutions.
However, the market faces challenges, including complex manufacturing processes and regulatory hurdles. Producing cell and gene therapies involves intricate steps such as cell extraction, modification, expansion, and delivery. Ensuring scalability and reproducibility while maintaining product quality is a significant concern. Regulatory obstacles must be overcome to ensure that patients can benefit from these treatments. Additionally, the lack of access to materials and talent, as well as unproven technologies and immature processes, pose challenges to scaling up production. Addressing these issues is crucial for the continued growth of the cell and gene therapy manufacturing market.
In summary, while the cell and gene therapy manufacturing market is poised for significant growth driven by the rising prevalence of chronic diseases and genetic disorders, it must navigate complex manufacturing and regulatory challenges to fully realize its potential.
Cell and Gene Therapy Manufacturing Market Segment Analysis:
Cell and Gene Therapy Manufacturing Market by Therapy Type (Cell Therapy [Allogenic and Autologous] and Gene Therapy [Viral Vector-Based Gene Therapy and Non-Viral Vector-Based Gene Therapy]), Manufacturing Type (In-house Manufacturing, Contract Manufacturing), Scale of Manufacturing (Clinical-Scale Manufacturing and Commercial-Scale Manufacturing), Application (Neurological, Oncological, Hematological, Ophthalmological and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)
In the therapy type segment of the cell and gene therapy manufacturing market, the allogenic sub-segment of cell therapy is anticipated to hold a significant share in 2024. Allogenic cell therapy is a major driver of market growth due to its scalability, cost-effectiveness, and broad therapeutic potential. Unlike autologous therapies, which use patient-derived cells, allogenic therapies utilize donor cells that are expanded, modified, and stored for use in multiple patients. This "off-the-shelf" approach facilitates mass production, reducing the time and costs associated with personalized treatments, and thereby improving accessibility for large patient populations suffering from chronic and life-threatening diseases.
In oncology, allogenic therapies such as CAR-T cells have demonstrated promising results in treating hematological malignancies, prompting substantial investments in their development. Beyond oncology, their application is expanding into autoimmune diseases, cardiovascular disorders, and regenerative medicine. The capability to produce large-scale, standardized cell batches ensures consistent quality, which is essential for regulatory approval and broader adoption.
Technological advancements in gene-editing tools like CRISPR-Cas9 have further enhanced the potential of allogenic therapies by enabling precise cell modifications, thereby improving efficacy and reducing the risk of immune rejection. Additionally, the adoption of advanced bioprocessing and cryopreservation techniques has improved the shelf life and global distribution capabilities of these therapies, further strengthening market penetration.
Strategic activities among key market players are also fueling the growth of the cell and gene therapy manufacturing market. For example, in December 2023, the U.S. Food and Drug Administration (FDA) approved Casgevy and Lyfgenia the first cell-based gene therapy for treating sickle cell disease (SCD) in patients aged 12 years and older. These therapies target the root cause of SCD by correcting the defective hemoglobin gene, offering potential curative solutions for a condition historically managed with symptomatic treatments like transfusions or hydroxyurea.
Overall, the combination of technological advancements, expanding therapeutic applications, and supportive regulatory developments is expected to propel the allogenic cell therapy segment, thereby boosting the global cell and gene therapy manufacturing market during the forecast period from 2025 to 2032.
North America is expected to dominate the overall cell and gene therapy manufacturing market:
North America is projected to hold the largest share of the cell and gene therapy manufacturing market in 2024. This dominance can be attributed to the region's strong presence of leading biopharmaceutical companies, robust healthcare infrastructure, and favorable regulatory environment. The U.S. Food and Drug Administration (FDA) plays a pivotal role through initiatives like fast-track designations, breakthrough therapy designations, and orphan drug approvals, expediting the development and commercialization of advanced therapies. Additionally, substantial investments from both government agencies and private entities are enhancing manufacturing capabilities and fostering innovation in the region.
The increasing prevalence of chronic diseases and genetic disorders further drives market demand. According to recent data from the Centers for Disease Control and Prevention (CDC) in 2024, approximately 1 in every 5,000 boys aged 5-9 years in the United States has Duchenne or Becker muscular dystrophy (DBMD). These X-linked genetic disorders cause progressive muscle degeneration due to mutations in the dystrophin gene. Cell and gene therapies, leveraging technologies like adeno-associated virus (AAV) vectors, are being developed to deliver functional copies of the dystrophin gene, aiming to slow disease progression and improve patient outcomes. The rising research focus on DBMD underscores the growing manufacturing need for such advanced therapies.
Furthermore, hemophilia remains a significant focus area in gene therapy development. The CDC reports that approximately 33,000 males in the United States were living with hemophilia in 2024. Gene therapies like BioMarin's Roctavian for hemophilia A and CSL Behring's Hemgenix for hemophilia B have revolutionized treatment by enabling long-term clotting factor production through a single administration. This shift toward curative solutions over traditional therapies, such as frequent factor replacement, is driving the demand for large-scale manufacturing of viral vectors and other essential components.
Product approvals continue to bolster market growth. In December 2023, the FDA approved Casgevy and Lyfgenia the first cell-based gene therapy for treating sickle cell disease (SCD) in patients aged 12 years and older. These treatments target the root cause of SCD by correcting the defective hemoglobin gene, offering potential long-term remission, and reducing dependence on symptomatic management options like blood transfusions. Such regulatory milestones emphasize the region's leadership in facilitating groundbreaking therapies.
Moreover, the region benefits from a high level of patient awareness, enabling quicker adoption of novel treatments. Strategic collaborations among biopharmaceutical companies, contract manufacturing organizations (CMOs), and academic institutions further accelerate process development and scale-up capabilities. Advances in automation, bioprocessing technologies, and supply chain management are enhancing production efficiency and consistency, ensuring timely delivery to patients.
Collectively, these factors including rising disease prevalence, supportive regulatory frameworks, technological advancements, and strategic industry initiatives are expected to significantly propel the growth of the cell and gene therapy manufacturing market in North America during the forecast period from 2025 to 2032.
Cell and Gene Therapy Manufacturing Market Key Players:
Some of the key market players operating in the cell and gene therapy manufacturing market include Lonza, Catalent, Inc., Thermo Fisher Scientific, Inc., Charles River Laboratories, WuXi AppTec, Merck KGaA, Takara Bio Inc., Oxford Biomedica PLC, Genezen, FUJIFILM Holdings Corporation, Nikon Corporation, The Discovery Labs LLC, RoslinCT, JRS Pharma, FinVector, Sarepta Therapeutics, Inc., BioCentriq, Andelyn Biosciences, ElevateBio, Anemocyte Srl, and others.
Recent Developmental Activities in the Cell and Gene Therapy Manufacturing Market:
Key Takeaways From the Cell and Gene Therapy Manufacturing Market Report Study
Target Audience Who Can be Benefited From This Cell and Gene Therapy Manufacturing Market Report Study
Frequently Asked Questions for the Cell and Gene Therapy Manufacturing Market: