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한글목차
세계 첨단 치료제(ATMP) 시장 규모는 2024년에 307억 7,872만 달러로 평가되었습니다. 2025-2032년의 예측 기간에 CAGR 14.17%로 성장할 것으로 전망됩니다. 시장의 성장은 주로 만성 질환의 유병률 증가에 의해 초래됩니다. 유전성 질환과 암 환자 증가, 연구 개발 활동의 활성화, 주요 기업간의 제휴는 2025-2032년의 예측 기간에 첨단 치료제(ATMP) 시장의 플러스 성장에 기여하는 주요 요인입니다.
첨단 치료제(ATMP) 시장 역학
미국 질병예방관리센터(CDC)가 2024년 2월에 발표한 데이터에 따르면 미국에서는 2024년 시점에서 추정 1억 2,900만명이 심장병, 암, 당뇨병, 비만, 고혈압 등 적어도 하나의 주요 만성 질환을 앓았습니다.
암은 세계 사람들에게 영향을 미치는 주요 만성 질환입니다. International Agency for Research on Cancer가 2020년 12월에 실시한 조사에 따르면, 2020년에 세계에서 새롭게 1,930만명의 암 환자가 발생하는 것으로 추정되었습니다. 세포 요법은 암세포를 효과적으로 파괴하기 위해 신체의 면역 세포를 사용하는 암 면역 요법에 사용됩니다. 따라서 세포요법과 유전자 치료에 대한 수요를 창출하고 있는 암 등 만성질환의 유병률 상승은 시장 성장을 가속할 것으로 예측되고 있습니다.
2023년 2월에 발표된 World Economic Forum의 보고서에 따르면, 2021년에 세계 약 4억 7,500만 명이 희소 유전성 질환을 가지고 생활했습니다. 향후 5년 이내에 약 1,520만 명이 희소질환을 확인하기 위한 임상 유전체 검사를 받을 것으로 예측됩니다. 유전자 치료는 질병을 치료하고 질병에 대항하는 신체의 능력을 향상시키기 위해 비정상적인 유전자를 수정하거나 건강한 유전자로 대체하기 위해 개발됩니다. 따라서 유전성 질환의 환자 수가 증가하면 시장 성장이 촉진될 것으로 예상됩니다.
시장의 주요 기업은 암이나 신경 퇴행성 질환 등의 만성 질환의 치료를 향해 정밀 세포 및 유전자 치료 개발의 연구 파트너십을 확립하고 있습니다. 예를 들어 2021년 4월 Spark Therapeutics는 유전자 치료 연구를 강화하기 위해 Senti Biosciences와의 연구 협력을 발표했습니다. 이 공동 연구는 Senti Bio의 고급 유전자 회로 기술 플랫폼과 높은 처리량 합성 프로모터 설계에 대한 전문 지식을 Spark Therapeutics의 중추 신경계, 눈 및 간을 대상으로 한 임상시험 중 유전자 치료제에 통합하는 것입니다. 첨단 유전자 치료를 개발하기 위한 이러한 연구 협력은 개발을 뒷받침할 것으로 예측됩니다.
그러나 세포 및 유전자 치료의 높은 비용과 첨단 치료제(ATMP)과 관련된 안전성에 대한 우려 등이 첨단 치료제(ATMP) 시장의 성장을 방해할 수 있는 주요한 억제요인이 되고 있습니다.
첨단 치료제(ATMP) 시장의 부문 분석
제품 유형별로, 질병 치료를 일변시킬 수 있기 때문에 세포 치료제 카테고리가 2024년의 첨단 치료제(ATMP) 시장에서 가장 큰 시장 점유율을 차지했습니다. 세포 요법은 생존 가능하고 기능적인 세포를 환자의 체내에 도입하고 손상된 조직을 강화 또는 대체하는 혁신적인 의료 접근법이며, 특히 세포 기능 장애 및 상실이 특정 질병의 진행에 중요한 역할을하는 경우에 유용합니다. 세포요법은 성공을 거두고 있으며, 주요 기업은 이 분야에서 암 등 다양한 질환의 치료를 위한 차세대 프로그램 세포요법의 개발에 임하고 있습니다. 예를 들어 2024년 2월 BioNTech는 세포 치료 개발 및 상업화를 위한 Autolus Therapeutics와의 제휴를 발표했습니다. 이 전략적 제휴는 여러 암을 적응증으로 하는 양사의 자기 CAR-T 프로그램을 추진하는 것을 목적으로 하고 있습니다.
CAR-T 세포 요법은 환자의 T 세포를 추출, 유전자 변형, 활성화, 확대, 정제 및 환자의 체내에 재도입하는 개별화 접근법의 대표적인 예입니다. 이러한 이점은 이 분야의 주요 기업에 의한 연구 활동을 뒷받침하고 있습니다. 브리스톨-마이어스 스퀴브 컴퍼니는 2024년 3월 미국 식품의약국(FDA)이 재발성 또는 불응성 만성 림프구성 백혈병(CLL) 또는 소림프구성 림프종(SLL) 성인 환자 치료를 위해 CD19 유도 CAR T 세포 치료제인 브라얀지(R)(리소캅타겐 마라루셀, 리소셀)에 대해 신속 승인을 부여했다고 발표했습니다.
이 보고서는 세계 첨단 치료제(ATMP) 시장에 대한 조사 분석을 통해 시장 규모와 예측, 지난 3 년간 제품/기술 개발, 시장의 주요 기업, 이용 가능한 기회 등의 정보를 제공합니다.
목차
제1장 첨단 치료제(ATMP) 시장 보고서 서론
제2장 첨단 치료제(ATMP) 시장의 주요 요약
시장 개요
제3장 경쟁 구도
제4장 규제 분석
미국
유럽
일본
중국
제5장 첨단 치료제(ATMP) 시장의 주요 요인 분석
첨단 치료제(ATMP) 시장 성장 촉진요인
첨단 치료제(ATMP) 시장 성장 억제요인과 과제
첨단 치료제(ATMP) 시장의 기회
제6장 첨단 치료제(ATMP) 시장에서 Porter's Five Forces 분석
제7장 첨단 치료제(ATMP) 시장 평가
유형별
유전자 치료제
세포 치료제
조직 공학 제품
복합 ATMP
적응증별
종양
심장
신경
유전성 질환
감염증
대사성 질환
기타
지역별
북미
유럽
아시아태평양
기타 지역
제8장 첨단 치료제(ATMP) 시장 기업 및 제품 프로파일
Pfizer Inc.
Novartis AG
Gilead Sciences, Inc.
Kolon TissueGene, Inc.
Bluebird Bio, Inc.
F. Hoffmann-La Roche Ltd
Bristol-Myers Squibb Company
Organogenesis Inc.
BioNTech
Regeneron Pharmaceuticals Inc.
ALLOGENE THERAPEUTICS
CRISPR Therapeutics
Autolus Therapeutics
Anixa Biosciences, Inc.
Amgen Inc.
Intellia Therapeutics, Inc.
Adaptimmune
Voyager Therapeutics, Inc.
Sangamo Therapeutics, Inc.
Biogen
제9장 KOL의 견해
제10장 프로젝트 접근법
제11장 DelveInsight 정보
제12장 면책사항 및 문의
KTH
영문 목차
영문목차
Advanced Therapy Medicinal Products Market by Type (Gene-Therapy Medicines, Cell Therapy Medicines, Tissue Engineered Products, Combined ATMPs), Indication (Oncology, Cardiology, Neurology, Genetic Disorders, Infectious Diseases, Metabolic Disease, 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 growing prevalence of chronic disease and rising number of genetic disease and cancer cases
The advanced therapy medicinal products (ATMP) market was valued at USD 30,778.72 million in 2024, growing at a CAGR of 14.17% during the forecast period from 2025 to 2032. The growth of the advanced therapy medicinal products market is mainly driven by the growing prevalence of chronic diseases. The rising number of genetic diseases, and cancer cases, increasing R&D activities, and partnerships among key players are key factors responsible for contributing to the positive growth of the advanced therapy medicinal products market during the forecast period from 2025 to 2032.
According to the data published by the Centers for Disease Control and Prevention (CDC) in February 2024, an estimated 129 million people were suffering from at least 1 major chronic disease such as heart disease, cancer, diabetes, obesity, and hypertension in the United States as of 2024.
Cancer is a major chronic disease affecting people around the world. The study conducted by the International Agency for Research on Cancer in December 2020, mentioned that an estimated 19.3 million new cancer cases were reported in 2020 across the globe. Cell therapy is used in cancer immunotherapy which uses the immune cells of the body to destroy cancer cells effectively. Thereby, the rising prevalence of chronic diseases such as cancer which is creating the demand for cell and gene therapy is expected to drive the market growth.
A report by the World Economic Forum published in February 2023, stated that approximately 475 million individuals were living with genetic rare conditions in 2021 across the globe. Within the upcoming five years, it was anticipated that around 15.2 million people were expected to undergo clinical genomic testing specifically aimed at identifying rare conditions. Gene therapy is developed to correct or replace abnormal genes with healthy ones to cure diseases or enhance the body's ability to combat them. Thus, the rising number of genetic disease cases is expected to propel the market growth.
Key players in the market are establishing research partnerships for the development of precision cell and gene therapies for the treatment of chronic diseases such as cancer and neurodegenerative diseases. For instance, in April 2021, Spark Therapeutics announced a research collaboration with Senti Biosciences to enhance its gene therapy research. The collaboration integrates Senti Bio's advanced gene circuit technology platform and expertise in high-throughput synthetic promoter design with Spark Therapeutics' investigational gene therapies targeting the central nervous system, eye, or liver. Such research collaborations to develop advanced gene therapies are expected to boost market expansion.
However, the high cost of cell and gene therapies, and the safety concerns associated with advanced therapy medicinal products, among others are some of the key constraints that may hinder the growth of the advanced therapy medicinal products market.
Advanced Therapy Medicinal Products Market by Type (Gene-Therapy Medicines, Cell Therapy Medicines, Tissue Engineered Products, Combined ATMPs), Indication (Oncology, Cardiology, Neurology, Genetic Disorders, Infectious Diseases, Metabolic Disease, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)
In the type segment, the cell therapy medicines category is estimated to account for the largest market share in the advanced therapy medicinal products market in 2024 due to the potential of cell therapies to transform disease treatment. Cell therapy is an innovative medical approach involving the introduction of viable and functional cells into a patient's body to enhance or replace damaged tissues, particularly beneficial when cell dysfunction or loss plays a crucial role in the progression of a specific disease. Cell therapies have shown success due to which key players are working in this area to develop next-generation programmed cell therapies for the treatment of various diseases such as cancer. For instance, in February 2024, BioNTech announced its partnership with Autolus Therapeutics to develop and commercialization of cell therapies. This strategic collaboration aimed at advancing both companies' autologous CAR-T programs for the treatment of multiple cancer indications.
CAR-T cell therapy exemplifies this personalized approach where a patient's T cells are extracted, genetically modified, activated, expanded, purified, and then reintroduced into the patient's body. Such advantages have boosted the research activities made by key players in this area. In March 2024, Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Breyanzi(R) (lisocabtagene maraleucel; liso-cel), a CD19-directed CAR T cell therapy, for treating adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Further, cell therapy leverages the body's natural systems such as the cellular immune system and the capacity to repair or replace faulty genes making them preferred choices for personalized medicine. Therefore, the growing use and development of cell therapies, including stem cell therapy, CAR-T cell therapy, and tissue engineering contribute to the growth of the segment, thereby driving the growth of the advanced therapy medicinal products market during the forecast period.
North America Is Expected To Dominate The Overall Advanced Therapy Medicinal Products Market:
North America is expected to account for the largest market share of the advanced therapy medicinal products market in 2024. This can be attributed to the rising number of cancer cases and the rise in the R&D activities by key players in the region, thus driving the growth of the advanced therapy medicinal products market in North America.
According to the American Cancer Society's Cancer Facts & Figures published in 2024, nearly 2 million new cancer cases were expected to be diagnosed in the United States in 2024, up from 1.9 million in 2023. Cell therapy genetically modifies a patient's cells to express a particular receptor that targets cancer cells. These altered cells are then injected into the patient's body, where they can identify tumor antigens and destroy cancer cells expressing the targeted antigen. Therefore, the rising cancer cases that create demand for advanced therapies will drive market growth.
The data published by the National Cancer Institute in May 2024 indicated that there were an estimated 18.1 million cancer patients in the United States in 2022 and this number of cancer patients is expected to increase reaching 22.5 million by 2032 and 26 million by 2040.
Rising R&D activities of key players in the region to innovative advanced therapy medicinal products for the treatment of chronic diseases are contributing to the positive growth of the market. For instance, in February 2022, Janssen Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) approved CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). CARVYKTI(TM) is a type of CAR-T therapy that utilizes two single-domain antibodies targeting B-cell maturation antigen (BCMA). Therefore, the rising number of cancer cases and surge in R&D activities by key players in the region is expected to propel the growth of North America advanced therapy medicinal products market.
Some of the key market players operating in the advanced therapy medicinal products market include Pfizer Inc., Novartis AG, Gilead Sciences, Inc., Kolon TissueGene, Inc., Bluebird Bio, Inc., F. Hoffmann-La Roche Ltd, Bristol-Myers Squibb Company, Organogenesis Inc., BioNTech, Regeneron Pharmaceuticals Inc., ALLOGENE THERAPEUTICS, CRISPR Therapeutics, Autolus Therapeutics, Anixa Biosciences, Inc., Amgen Inc., Intellia Therapeutics, Inc., Adaptimmune, Voyager Therapeutics Inc., Sangamo Therapeutics, Inc., Biogen, and others.
Recent Developmental Activities in the Advanced Therapy Medicinal Products Market:
In April 2024, Pfizer Inc. announced that it received US FDA approval for BEQVEZ (fidanacogene elaparvovec-dzkt) for the treatment of adults with moderate to severe hemophilia B. BEQVEZ is an adeno-associated virus (AAV)-based one-time treatment gene therapy developed for patients suffering from hemophilia B.
In February 2024, BioNTech and Autolus Therapeutics announced a strategic collaboration to develop CAR-T cell therapy aimed at advancing their pipeline and expanding late-stage programs. Through this partnership, both companies focused on accelerating pipeline programs to develop advanced therapies for multiple cancer indications.
In January 2022, Fate Therapeutics announced that it received FDA clearance for an Investigational New Drug (IND) application for FT536. FT536 is a chimeric antigen receptor (CAR) NK cell product candidate for the treatment of advanced solid tumors.
In June 2022, Bristol Myers Squibb announced that the FDA approved Breyanzi (lisocabtagene maraleucel). Breyanzi is a chimeric antigen receptor (CAR) T-cell therapy for the treatment of adult patients with large B-cell lymphoma (LBCL) and other lymphatic cancers.
Key Takeaways from the Advanced Therapy Medicinal Products Market Report Study
Market size analysis for current Advanced Therapy Medicinal Products Market size (2024), and market forecast for 8 years (2025 to 2032)
Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened for the last 3 years
Key companies dominating the global Advanced Therapy Medicinal Products market.
Various opportunities available for the other competitors in the Advanced Therapy Medicinal Products Market space.
What are the top-performing segments in 2024? How these segments will perform in 2032?
Which are the top-performing regions and countries in the current Advanced Therapy Medicinal Products market scenario?
Which are the regions and countries where companies should have concentrated on opportunities for Advanced Therapy Medicinal Products market growth in the coming future?
Target Audience who can be benefited from this Advanced Therapy Medicinal Products Market Report Study
Advanced Therapy Medicinal Products related organizations, associations, forums, and other alliances
Government and corporate offices
Start-up companies, venture capitalists, and private equity firms
Distributors and Traders dealing in Advanced Therapy Medicinal Products
Various end-users who want to know more about the Advanced Therapy Medicinal Products Market and the latest technological developments in the Advanced Therapy Medicinal Products Market.
Frequently Asked Questions for the Advanced Therapy Medicinal Products Market:
1. What are Advanced Therapy Medicinal Products?
Advanced Therapy Medicinal Products are innovative therapeutic drugs that utilize advanced technologies to manipulate cells, tissues, or genes for the purpose of diagnosis, prevention and treatment of chronic diseases.
2. What is the market for Advanced Therapy Medicinal Products?
The advanced therapy medicinal products (ATMP) market was valued at USD 30,778.72 million in 2024, growing at a CAGR of 14.17% during the forecast period from 2025 to 2032.
3. What are the drivers for the global Advanced Therapy Medicinal Products market?
The advanced therapy medicinal products market is expected to grow at a rapid pace due to the increasing prevalence of chronic diseases. Factors such as the rising occurrences of genetic diseases and cancers, along with increasing research and development initiatives and collaborations among major industry players, are pivotal in driving the growth of the market during the forecast period from 2025 to 2032.
4. Who are the key players operating in the global Advanced Therapy Medicinal Products market?)
Some of the key market players operating in the advanced therapy medicinal products market include Pfizer Inc., Novartis AG, Gilead Sciences, Inc., Kolon TissueGene, Inc., Bluebird Bio, Inc., F. Hoffmann-La Roche Ltd, Bristol-Myers Squibb Company, Organogenesis Inc., BioNTech, Regeneron Pharmaceuticals Inc., ALLOGENE THERAPEUTICS, CRISPR Therapeutics, Autolus Therapeutics, Anixa Biosciences, Inc., Amgen Inc., Intellia Therapeutics, Inc., Adaptimmune, Voyager Therapeutics Inc., Sangamo Therapeutics, Inc., Biogen, and others.
5. Which region has the highest share in the global Advanced Therapy Medicinal Products market?
North America is expected to account for the largest market share of the advanced therapy medicinal products market in 2024. This can be attributed to the rising number of cancer cases and the rise in the R&D activities by key players in the region, thus driving the growth of the advanced therapy medicinal products market in North America.
