세계의 첨단 치료 의약품 위탁개발생산(CDMO) 시장 보고서(2025년)
Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Global Market Report 2025
상품코드 : 1825598
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

첨단 치료 의약품 위탁개발생산(CDMO) 시장 규모는 향후 수년간 급성장할 것으로 전망됩니다. 2029년에 CAGR은 15.7%를 나타낼 것으로 예측되고 111억 2,000만 달러로 성장할 전망입니다. 예측 기간 동안의 성장은 CDMO의 높은 투자, 세포 및 유전자 치료(CGT) 분야의 신흥 업체 증가, 세포 및 유전자 치료 개발을 위한 보조금 및 투자 증가, 의약품 R&D 지출 증가, 첨단 치료 의약품(ATMP)에 대한 임상 시험 증가 등에 기인할 수 있습니다. 예측 기간의 주요 동향으로는 AAV 바이오제조 시설의 발전, 세포 및 유전자 치료제 제조 확대, 세포 및 유전자 치료 기술적 발전, 첨단 플랫폼 및 기술 접근성 요구 증가, 정확도 향상을 위한 CRISPR 및 차세대 시퀀싱과 같은 첨단 기술 도입 등이 있습니다.

향후 5년간 15.7% 성장이라는 예측은 이 시장에 대한 이전 추정치 대비 0.5% 소폭 하락한 수치입니다. 이러한 감소는 주로 미국과 타국 간 관세 영향에 기인합니다. 관세 장벽은 스위스 및 한국에서 공급원되는 바이러스 벡터 생산 및 세포 치료제 제조 장비 비용을 증가시켜 미국 시장을 저해할 것으로 예상되며, 이는 획기적인 유전자 치료제 개발 지연과 바이오의약품 개발 비용 상승으로 이어질 것입니다. 또한 상호 관세 부과와 무역 긴장 및 제한 강화로 인한 전 세계 경제 및 무역에 대한 부정적 영향으로 그 파급 효과는 더욱 광범위해질 것입니다.

첨단 치료 의약품 CDMO 시장의 성장은 임상시험 증가에 의해 촉진될 것으로 예측됩니다. 의약품, 치료법, 의료기기 또는 예방 조치와 같은 의료 개입의 안전성과 효능을 평가하기 위해 인간을 대상으로 수행되는 연구인 임상 시험은 혁신적인 치료법에 대한 수요 증가와 증가하는 전 세계 질병 부담을 해결하기 위해 증가하고 있습니다. 첨단 치료 의약품의 활용은 전문 지식과 인프라를 활용하는 CDMO 제조 서비스에 대한 수요 증가로 이어집니다. 임상 시험 데이터는 제조 공정을 최적화하고 확장성을 보장하며 대규모 임상 및 상업적 수요를 충족시키기 위한 품질 유지를 지원하는 데 도움이 됩니다. 예를 들어 영국을 거점으로 하는 업계 단체인 영국 제약공업협회는 2023년 11월 영국에서 시작된 임상시험 업계 전체의 연간 건수가 4.3% 미증하고 2021년 394건에서 2022년 411건으로 증가한다고 보고하고 있습니다. 이와 같이 임상시험 건수 증가가 첨단 치료 의약품 CDMO 시장의 성장을 뒷받침하고 있습니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 동향과 전략

제4장 시장 : 금리, 인플레이션, 지정학, 무역전쟁과 관세, 그리고 코로나 및 회복이 시장에 미치는 영향을 포함한 거시경제 시나리오

제5장 세계의 성장 분석과 전략 분석 프레임워크

제6장 시장 세분화

제7장 지역별 및 국가별 분석

제8장 아시아태평양 시장

제9장 중국 시장

제10장 인도 시장

제11장 일본 시장

제12장 호주 시장

제13장 인도네시아 시장

제14장 한국 시장

제15장 서유럽 시장

제16장 영국 시장

제17장 독일 시장

제18장 프랑스 시장

제19장 이탈리아 시장

제20장 스페인 시장

제21장 동유럽 시장

제22장 러시아 시장

제23장 북미 시장

제24장 미국 시장

제25장 캐나다 시장

제26장 남미 시장

제27장 브라질 시장

제28장 중동 시장

제29장 아프리카 시장

제30장 경쟁 구도와 기업 프로파일

제31장 기타 주요 기업 및 혁신 기업

제32장 세계 시장 경쟁 벤치마킹과 대시보드

제33장 주요 인수합병(M&A)

제34장 최근 시장 동향

제35장 시장의 잠재력이 높은 국가, 부문, 전략

제36장 부록

HBR
영문 목차

영문목차

An advanced therapy medicinal product contract development and manufacturing organization (CDMO) is a specialized service provider that aids in the development and manufacturing of advanced therapy medicinal products. The objective of an advanced therapy medicinal product CDMO is to offer the expertise, infrastructure, and resources necessary for the development and production of these advanced therapies.

The main types of products handled by advanced therapy medicinal product CDMOs include gene therapy, cell therapy, and tissue-engineered products. Gene therapy involves the introduction, removal, or alteration of genetic material within a patient's cells to treat or prevent disease. This process can utilize viral or non-viral vectors to deliver therapeutic genes to target cells across various phases, such as phase I, phase II, phase III, and phase IV clinical trials. These therapies address a range of indications, including oncology, cardiology, central nervous system and musculoskeletal conditions, infectious diseases, dermatology, endocrine and metabolic disorders, genetic diseases, immunology and inflammation, ophthalmology, and hematology.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sharp rise in U.S. tariffs and the resulting trade tensions in spring 2025 are having a significant impact on the healthcare sector, especially in the supply of essential medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are grappling with higher costs for imported surgical tools, imaging systems, and consumables like syringes and catheters, many of which have limited domestic substitutes. These escalating expenses are putting pressure on healthcare budgets, prompting some providers to delay equipment upgrades or pass increased costs on to patients. Furthermore, tariffs on raw materials and components are disrupting the manufacturing of vital drugs and devices, leading to supply chain delays. In response, the industry is adopting diversified sourcing strategies, expanding local production where feasible, and pushing for tariff exemptions on critical medical products.

The advanced therapy medicinal products contract development and manufacturing organization (CDMO) market research report is one of a series of new reports from The Business Research Company that provides advanced therapy medicinal products contract development and manufacturing organization (CDMO) market statistics, including the advanced therapy medicinal products contract development and manufacturing organization (CDMO) industry global market size, regional shares, competitors with advanced therapy medicinal products contract development and manufacturing organization (CDMO) market share, detailed advanced therapy medicinal products contract development and manufacturing organization (CDMO) market segments, market trends, and opportunities, and any further data you may need to thrive in the advanced therapy medicinal products contract development and manufacturing organization (CDMO) industry. These advanced therapy medicinal products contract development and manufacturing organization (CDMO) market research reports deliver a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

The advanced therapy medicinal products contract development and manufacturing organization (cdmo) market size has grown rapidly in recent years. It will grow from $5.31 billion in 2024 to $6.2 billion in 2025 at a compound annual growth rate (CAGR) of 16.7%. The growth in the historic period can be attributed to the increasing number of ATMP clinical trials, rising awareness and belief among researchers regarding the benefits of advanced therapy, the presence of several ATMP CDMOs, increasing efforts to develop novel therapies for various diseases, and supportive government initiatives.

The advanced therapy medicinal products contract development and manufacturing organization (cdmo) market size is expected to see rapid growth in the next few years. It will grow to $11.12 billion in 2029 at a compound annual growth rate (CAGR) of 15.7%. The growth in the forecast period can be attributed to the high investment of CDMOs, a growing number of emerging players in the cell and gene therapy (CGT) sector, increasing grants and investments for the development of cell and gene therapies, increasing pharmaceutical R&D spending, increasing number of clinical trials for ATMPs. Major trends in the forecast period include advancements in AAV biomanufacturing facilities, expansion of cell and gene therapy manufacturing, technological advancements in cell and gene therapy, increasing need for access to advanced platforms and technologies, and incorporating advanced technologies such as CRISPR and next-generation sequencing for heightened accuracy.

The forecast of 15.7% growth over the next five years reflects a modest reduction of 0.5% from the previous estimate for this market. This reduction is primarily due to the impact of tariffs between the US and other countries. Tariff barriers are expected to hamper the U.S. market by increasing the cost of viral vector production and cell therapy manufacturing equipment sourced from Switzerland and South Korea, thereby delaying breakthrough gene therapies and elevating biopharmaceutical development costs. The effect will also be felt more widely due to reciprocal tariffs and the negative effect on the global economy and trade due to increased trade tensions and restrictions.

The growth of the advanced therapy medicinal products CDMO market is anticipated to be propelled by the increasing number of clinical trials. Clinical trials, which are research studies conducted in humans to assess the safety and efficacy of medical interventions such as drugs, treatments, devices, or preventive measures, are on the rise to meet the growing demand for innovative treatments and to tackle the increasing global disease burden. The utilization of advanced therapy medicinal products leads to a heightened demand for CDMO manufacturing services, which leverage specialized expertise and infrastructure. Clinical trial data assists in optimizing manufacturing processes, ensuring scalability, and maintaining quality to meet larger clinical and commercial demands. For example, in November 2023, the Association of the British Pharmaceutical Industry, a UK-based trade association, reported a marginal increase of 4.3% in the overall number of industry clinical trials initiated in the UK per year, rising from 394 in 2021 to 411 in 2022. Thus, the escalating number of clinical trials is propelling the growth of the advanced therapy medicinal products CDMO market.

Major players in the advanced therapy medicinal products CDMO market are focusing on developing advanced cell therapy manufacturing services to address critical issues in cell therapy manufacturing and accelerate the development activities of their partners. These cell therapy manufacturing services, offered by contract development and manufacturing organizations, encompass services ranging from early preclinical development to late-stage clinical trials and commercialization. For instance, in January 2024, Pluristem Therapeutics Inc., an Israel-based biotech company specializing in cell solutions, introduced PluriCDMO, a new business division offering cell therapy manufacturing services. PluriCDMO utilizes a patented bioreactor system enabling 3D cell multiplication, facilitating the production of various cell types such as stem cells, induced pluripotent stem cells, exosomes, and immune therapies. PluriCDMO aims to deliver high-quality medicines to patients while ensuring batch-to-batch consistency in a scalable and cost-effective manner within good manufacturing practice settings.

In February 2022, Recipharm AB, a Sweden-based contract development and manufacturing organization (CDMO), acquired Vibalogics for an undisclosed sum. This acquisition is intended to bolster Recipharm's presence in advanced therapy medicinal products and enable expansion into additional biologic modalities such as viral vectors. The acquisition will allow Recipharm to broaden its technologies and modalities, positioning it to better serve the growing demand for specialist CDMO capabilities in viral manufacturing within the rapidly expanding biopharmaceutical industry. Vibalogics is a Germany-based virotherapy CDMO specializing in manufacturing oncolytic viruses, viral vaccines, and gene therapies.

Major companies operating in the advanced therapy medicinal products contract development and manufacturing organization (CDMO) market are Thermo Fisher Scientific Inc., Merck KGaA, Resonac Corporation, Lonza Group AG, Catalent Inc., Charles River Laboratories International Inc., Recipharm AB, KBI Biopharma, Takara Bio Inc., Rentschler Biopharma SE, Ajinomoto Co. Inc., ElevateBio LLC, Fujifilm Diosynth Biotechnologies, Axplora Group GmbH, WuXi Advanced Therapies Inc., Celonic Group, Batavia Biosciences B.V., BioCentriq, Cytovance Biologics, Andelyn Biosciences, Genezen, AGC Biologics, ABL Manufacturing, Minaris Regenerative Medicine, Porton Advanced Solutions

North America was the largest region in the advanced therapy medicinal product contract development and manufacturing organization (CDMO) market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the advanced therapy medicinal products contract development and manufacturing organization (CDMO) market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The countries covered in the advanced therapy medicinal products contract development and manufacturing organization (CDMO) market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain

The advanced therapy medicinal product contract development and manufacturing organization (CDMO) market includes revenues earned by entities by providing services such as process development, analytical method development, good manufacturing practice manufacturing, and quality control testing. The market value includes the value of related goods sold by the service provider or included within the service offering. The advanced therapy medicinal products CDMO market also includes sales of bioreactors and fermenters, cryopreservation equipment, and laboratory instruments. Values in this market are 'factory gate' values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses on advanced therapy medicinal products contract development and manufacturing organization (cdmo) market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.

Reasons to Purchase

Where is the largest and fastest growing market for advanced therapy medicinal products contract development and manufacturing organization (cdmo) ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The advanced therapy medicinal products contract development and manufacturing organization (cdmo) market global report from the Business Research Company answers all these questions and many more.

The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.

The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.

Scope

Table of Contents

1. Executive Summary

2. Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market Characteristics

3. Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market Trends And Strategies

4. Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market - Macro Economic Scenario Including The Impact Of Interest Rates, Inflation, Geopolitics, Trade Wars and Tariffs, And Covid And Recovery On The Market

5. Global Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Growth Analysis And Strategic Analysis Framework

6. Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market Segmentation

7. Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market Regional And Country Analysis

8. Asia-Pacific Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market

9. China Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market

10. India Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market

11. Japan Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market

12. Australia Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market

13. Indonesia Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market

14. South Korea Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market

15. Western Europe Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market

16. UK Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market

17. Germany Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market

18. France Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market

19. Italy Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market

20. Spain Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market

21. Eastern Europe Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market

22. Russia Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market

23. North America Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market

24. USA Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market

25. Canada Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market

26. South America Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market

27. Brazil Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market

28. Middle East Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market

29. Africa Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market

30. Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market Competitive Landscape And Company Profiles

31. Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market Other Major And Innovative Companies

32. Global Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market

34. Recent Developments In The Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market

35. Advanced Therapy Medicinal Products Contract Development And Manufacturing Organization (CDMO) Market High Potential Countries, Segments and Strategies

36. Appendix

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