Clinical-Stage Biotechnology Global Market Report 2025
상품코드:1855830
리서치사:The Business Research Company
발행일:On Demand Report
페이지 정보:영문 250 Pages
라이선스 & 가격 (부가세 별도)
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한글목차
임상 단계 생명공학 시장 규모는 최근 급속도로 확대되고 있습니다. 2024년 406억 5,000만 달러에서 2025년에는 471억 4,000만 달러에 달하고, CAGR 16.0%로 확대될 전망입니다. 실적기간 내 성장은 만성질환 유병률 증가, 표적치료에 대한 수요 증가, 생명공학 연구 투자 증가, 정밀의료 채용 확대, 맞춤 의료의 중요성 증가로 발생하였습니다.
임상단계 생명공학 시장 규모는 향후 수년간 급성장할 것으로 전망됩니다. 2029년 연평균 복합 성장률(CAGR)은 15.6%로 841억 7,000만 달러로 성장할 전망입니다. 예측기간 동안의 성장은 임상시험활동의 활성화, 규제당국의 승인취득 증가, 생명공학에 대한 정부자금 확대, 신규 치료에 대한 환자의 의식 증가, 혁신적 치료 채용 확대 등으로 이어질 것으로 예측됩니다. 예측 기간에 예상되는 주요 동향으로는 유전자 편집 기술의 진보, 맞춤형 치료제의 개발, RNA 기반 치료에 있어서의 혁신, 세포 및 유전자 치료의 진보, 학계와 산업계의 제휴 강화 등을 들 수 있습니다.
맞춤 의료에 대한 관심 증가는 향후 수년간 임상 단계 생명공학 시장의 성장을 가속화할 것으로 예측됩니다. 맞춤 의료는 특히 유전자, 바이오마커, 분자 데이터의 이용을 통하여 개별 환자의 독특한 특성에 기초하여 치료를 맞춤화하는 것을 말합니다. 이 접근법을 통해 의사는 환자의 유전적 체질에 따라 암 치료를 적응시킬 수 있으며, 보다 효과적이고 부작용이 적은 치료가 가능하기 때문에 인기가 높아지고 있습니다. 임상 단계 생명공학은 환자의 유전자 프로파일을 따르는 표적 치료를 개발함으로써 치료 효과와 안전성을 모두 향상시키는 맞춤 의료에서 중요한 역할을 합니다. 예를 들어, 2024년 2월 미국의 비영리 단체인 맞춤의료연합(Personalized Medicine Coalition)은 2023년 FDA가 희귀질환 환자를 위한 16개의 새로운 맞춤 치료를 승인했다고 보고했습니다. 그 결과 맞춤 의료가 중요해지고 임상 단계 생명공학 분야 시장 성장이 촉진될 가능성이 높습니다.
임상 단계 생명공학 시장의 주요 기업은 임상시험 서비스와 같은 혁신적인 서비스를 제공함으로써 의약품 개발 가속화, 환자 확보 및 유지 강화, 규제 준수 향상에 주력하고 있습니다. 임상시험 서비스는 신약 및 치료법의 안전성과 효능을 평가하기 위한 임상시험의 계획, 관리 및 시행에 대한 전문적인 지원을 제공합니다. 예를 들어 미국의 생명공학 기업인 이콜 생명과학은 2023년 11월 이콜 임상시험 서비스라는 새로운 부문을 개시했습니다. 이 서비스는 전임상시험의 초기 단계부터 후기 임상시험, FDA 승인에 이르기까지 생명공학 및 제약기업의 연구개발 전반을 지원하는 것으로, 회사의 CRO(의약품개발업무수탁기관) 업무를 확대하는 것입니다. 이콜 임상시험 서비스는 프로토콜 설계, 시험 실시 시설 식별 및 인증, 모집 전략, 완전한 CRO 지원을 포함한 맞춤형 솔루션을 제공합니다. 이 부서는 유연하고 개별화된 접근 방식을 채택하여 진행 중인 임상시험에서 등록 및 운영 문제를 해결하는 등 고객이 직면한 특정 과제를 해결합니다.
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
세계의 임상 단계 생명공학 : PESTEL 분석(정치, 사회, 기술, 환경, 법적 요인, 촉진요인 및 억제요인)
최종 이용 산업의 분석
세계의 임상 단계 생명공학 시장 : 성장률 분석
세계의 임상 단계 생명공학 시장 실적 : 규모와 성장(2019-2024년)
세계의 임상 단계 생명공학 시장 예측 : 규모와 성장(2024-2029년, 2034년)
세계의 임상 단계 생명공학 : 총 시장 규모(TAM)
제6장 시장 세분화
세계의 임상 단계 생명공학 시장 : 제품 유형별, 분석과 예측(2019-2024년, 2024-2029년, 2034년)
치료제
진단약
백신
기타 제품 유형
세계의 임상 단계 생명공학 시장 : 단계별, 분석과 예측(2019-2024년, 2024-2029년, 2034년)
1상
2상
3상
세계의 임상 단계 생명공학 시장 : 용도별, 분석과 예측(2019-2024년, 2024-2029년, 2034년)
종양
감염증
심혈관질환
신경영역
기타 용도
세계의 임상 단계 생명공학 시장 : 최종 사용자별, 분석과 예측(2019-2024년, 2024-2029년, 2034년)
병원
연구기관
진단센터
기타 최종 사용자
세계의 임상 단계 생명공학 시장 세분화 : 치료제 유형별, 분석과 예측(2019-2024년, 2024-2029년, 2034년)
단일클론항체
세포요법
유전자 치료
재조합 단백질
펩티드 치료제
저분자 치료제
세계의 임상 단계 생명공학 시장 세분화 : 진단약 유형별, 분석과 예측(2019-2024년, 2024-2029년, 2034년)
분자진단제
면역검정
유전자 검사
바이오마커 시험제
POC(Point of Care) 진단약
세계의 임상 단계 생명공학 시장 세분화 : 백신 유형별, 분석과 예측(2019-2024년, 2024-2029년, 2034년)
생백신
불활성화 백신
소단위 백신
mRNA 백신
바이러스 벡터 백신
세계의 임상 단계 생명공학 시장 세분화 : 기타 제품 유형 유형별, 분석과 예측(2019-2024년, 2024-2029년, 2034년)
재생 의료 제품
연구 시약
동반진단약
의료기기
제7장 지역별/국가별 분석
세계의 임상 단계 생명공학 시장 : 지역별, 분석과 예측(2019-2024년, 2024-2029년, 2034년)
세계의 임상 단계 생명공학 시장 : 국가별, 분석과 예측(2019-2024년, 2024-2029년, 2034년)
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
임상 단계 생명공학 시장 : 경쟁 구도
임상 단계 생명공학 시장 : 기업 프로파일
Sarepta Therapeutics Inc. : 개요, 제품 및 서비스, 전략 및 재무 분석
BioAge Labs Inc. : 개요, 제품 및 서비스, 전략 및 재무 분석
PTC Therapeutics Inc. : 개요, 제품 및 서비스, 전략 및 재무 분석
Evotec SE : 개요, 제품 및 서비스, 전략 및 재무 분석
Ultragenyx Pharmaceutical Inc. : 개요, 제품 및 서비스, 전략 및 재무 분석
제31장 기타 주요 기업 및 혁신 기업
Rocket Pharmaceuticals Inc.
Ventyx Biosciences Inc.
Sangamo Therapeutics Inc.
REGENXBIO Inc.
Galapagos NV
Arvinas Inc.
Editas Medicine Inc.
Zymeworks Inc.
CureVac NV
Precision BioSciences Inc.
4D Molecular Therapeutics Inc.
Domain Therapeutics SA
ProQR Therapeutics NV
Tonix Pharmaceuticals Holding Corp.
Gilgamesh Pharmaceuticals Inc.
제32장 세계 시장 경쟁 벤치마킹과 대시보드
제33장 주요 인수합병(M&A)
제34장 최근 시장 동향
제35장 시장의 잠재력이 높은 국가, 부문, 전략
임상 단계 생명공학 시장(2029년) : 새로운 기회를 제공하는 국가
임상 단계 생명공학 시장(2029년) : 새로운 기회를 제공하는 부문
임상 단계 생명공학 시장(2029년) : 성장 전략
시장 동향에 기초한 전략
경쟁 전략
제36장 부록
CSM
영문 목차
영문목차
Clinical-stage biotechnology refers to the phase of biotechnology development in which a drug, therapy, or medical product has progressed from preclinical research into human clinical trials. At this stage, the focus is on evaluating safety, efficacy, and appropriate dosing in patients through structured trial phases. This phase represents the transition from laboratory and animal testing to real-world human assessment.
The primary types of products in clinical-stage biotechnology include therapeutics, diagnostics, vaccines, and others. Therapeutics are medical products and treatments developed to prevent, manage, or cure diseases by targeting biological processes within the body. These products progress through various trial phases, such as phase I, phase II, and phase III, and are applied in areas including oncology, infectious diseases, cardiovascular diseases, neurology, and others. Primary end users include hospitals, research institutes, diagnostic centers, and others.
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 sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the pharmaceutical companies contend with tariffs on APIs, glass vials, and lab equipment inputs with few alternative sources. Generic drug makers, operating on razor-thin margins, are especially vulnerable, with some reducing production of low-profit medicines. Biotech firms face delays in clinical trials due to tariff-related shortages of specialized reagents. In response, the industry is expanding API production in India and Europe, increasing inventory stockpiles, and pushing for trade exemptions for essential medicines.
The clinical-stage biotechnology market research report is one of a series of new reports from The Business Research Company that provides clinical-stage biotechnology market statistics, including clinical-stage biotechnology industry global market size, regional shares, competitors with a clinical-stage biotechnology market share, detailed clinical-stage biotechnology market segments, market trends and opportunities, and any further data you may need to thrive in the clinical-stage biotechnology industry. This clinical-stage biotechnology market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
The clinical-stage biotechnology market size has grown rapidly in recent years. It will grow from $40.65 billion in 2024 to $47.14 billion in 2025 at a compound annual growth rate (CAGR) of 16.0%. Growth in the historic period was driven by rising prevalence of chronic diseases, increasing demand for targeted therapies, growing investment in biotechnology research, greater adoption of precision medicine, and heightened emphasis on personalized medicine.
The clinical-stage biotechnology market size is expected to see rapid growth in the next few years. It will grow to $84.17 billion in 2029 at a compound annual growth rate (CAGR) of 15.6%. Growth in the forecast period is expected to result from rising clinical trial activities, increasing regulatory approvals, expanded government funding for biotechnology, growing patient awareness of novel therapies, and higher adoption of innovative treatments. Primary trends anticipated for the forecast period include advancements in gene editing technologies, development of personalized therapeutics, innovation in RNA-based treatments, progress in cell and gene therapies, and strengthened collaborations between academia and industry.
The increasing focus on personalized medicine is expected to drive the growth of the clinical-stage biotechnology market in the coming years. Personalized medicine involves customizing medical treatments based on the unique characteristics of individual patients, particularly through the use of genetic, biomarker, and molecular data. This approach is gaining traction as it enables doctors to adapt cancer treatments according to a patient's genetic makeup, leading to more effective treatments and fewer side effects. Clinical-stage biotechnology plays a crucial role in personalized medicine by developing targeted therapies that are aligned with a patient's genetic profile, thus enhancing both treatment effectiveness and safety. For example, in February 2024, the Personalized Medicine Coalition, a US-based non-profit organization, reported that in 2023, the FDA approved 16 new personalized therapies for patients with rare diseases, a significant rise from just six approvals in 2022. As a result, the increasing emphasis on personalized medicine is likely to drive market growth in the clinical-stage biotechnology sector.
Leading companies in the clinical-stage biotechnology market are focusing on offering innovative services, such as clinical trial services, to expedite drug development, enhance patient recruitment and retention, and improve regulatory compliance. Clinical trial services provide professional support for designing, managing, and conducting clinical studies to assess the safety and efficacy of new drugs or therapies. For instance, in November 2023, Ichor Life Sciences, Inc., a US-based biotechnology firm, launched a new division called Ichor Clinical Trial Services. This service expands their contract research organization (CRO) offerings, assisting biotechnology and pharmaceutical clients throughout the entire drug development journey, from early-stage preclinical trials to late-stage clinical studies and FDA approval. Ichor Clinical Trial Services offers customized solutions, including protocol design, site identification and qualification, recruitment strategies, and full CRO support. This unit aims to address specific challenges faced by clients, such as resolving enrollment or operational issues in ongoing trials, by adopting a flexible and personalized approach.
In June 2025, BioNTech SE, a Germany-based biotechnology company, acquired CureVac N.V. for $1.25 billion. This acquisition allows BioNTech to significantly strengthen its oncology pipeline by integrating CureVac's advanced mRNA technology and extensive asset library. The move is intended to solidify BioNTech's position in the competitive cancer therapeutics market and expand its ability to develop innovative treatments. CureVac N.V. is a Germany-based clinical-stage biopharmaceutical company specializing in the development of mRNA-based therapeutics and vaccines for cancer and infectious diseases.
Major players in the clinical-stage biotechnology market are Sarepta Therapeutics Inc., BioAge Labs Inc., PTC Therapeutics Inc., Evotec SE, Ultragenyx Pharmaceutical Inc., Rocket Pharmaceuticals Inc., Ventyx Biosciences Inc., Sangamo Therapeutics Inc., REGENXBIO Inc., Galapagos NV, Arvinas Inc., Editas Medicine Inc., Zymeworks Inc., CureVac N.V., Precision BioSciences Inc., 4D Molecular Therapeutics Inc., Domain Therapeutics S.A., ProQR Therapeutics N.V., Tonix Pharmaceuticals Holding Corp., Gilgamesh Pharmaceuticals Inc., T-Cure Bioscience Inc., Opna Bio Inc., EXUMA Biotech Inc., and Prime Medicine Inc.
North America was the largest region in the clinical-stage biotechnology market in 2024. The regions covered in clinical-stage biotechnology report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
The countries covered in the clinical-stage biotechnology market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
The clinical-stage biotechnology market includes sales of gene therapies, cell therapies, drug delivery systems, small molecule drugs, and regenerative medicines. 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.
Clinical-Stage Biotechnology 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 clinical-stage biotechnology 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.
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Where is the largest and fastest growing market for clinical-stage biotechnology ? 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 clinical-stage biotechnology 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 market characteristics section of the report defines and explains the market.
The market size section gives the market size ($b) covering both the historic growth of the market, and forecasting its development.
The forecasts are made after considering the major factors currently impacting the market. These include:
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.
Market segmentations break down the market into sub markets.
The regional and country breakdowns section gives an analysis of the market in each geography and the size of the market by geography and compares their historic and forecast growth.
The competitive landscape chapter gives a description of the competitive nature of the market, market shares, and a description of the leading companies. Key financial deals which have shaped the market in recent years are identified.
The trends and strategies section analyses the shape of the market as it emerges from the crisis and suggests how companies can grow as the market recovers.
Scope
Markets Covered:1) By Product Type: Therapeutics; Diagnostics; Vaccines; Other Product Types
2) By Phase: Phase I; Phase II; Phase III
3) By Application: Oncology; Infectious Diseases; Cardiovascular Diseases; Neurology; Other Applications
4) By End-User: Hospitals; Research Institutes; Diagnostic Centers; Other End-Users
Subsegments:
1) By Therapeutics: Monoclonal Antibodies; Cell Therapy; Gene Therapy; Recombinant Proteins; Peptide Therapeutics; Small Molecule Therapeutics
2) By Diagnostics: Molecular Diagnostics; Immunoassays; Genetic Testing; Biomarker Testing; Point Of Care Diagnostics
3) By Vaccines: Live Attenuated Vaccines; Inactivated Vaccines; Subunit Vaccines; mRNA Vaccines; Viral Vector Vaccines
4) By Other Product Types: Regenerative Medicine Products; Research Reagents; Companion Diagnostics; Medical Devices
3. Clinical-Stage Biotechnology Market Trends And Strategies
4. Clinical-Stage Biotechnology Market - Macro Economic Scenario Including The Impact Of Interest Rates, Inflation, Geopolitics, Trade Wars and Tariffs, And Covid And Recovery On The Market
4.1. Supply Chain Impact from Tariff War & Trade Protectionism
5. Global Clinical-Stage Biotechnology Growth Analysis And Strategic Analysis Framework
5.1. Global Clinical-Stage Biotechnology PESTEL Analysis (Political, Social, Technological, Environmental and Legal Factors, Drivers and Restraints)
5.2. Analysis Of End Use Industries
5.3. Global Clinical-Stage Biotechnology Market Growth Rate Analysis
5.4. Global Clinical-Stage Biotechnology Historic Market Size and Growth, 2019 - 2024, Value ($ Billion)
5.5. Global Clinical-Stage Biotechnology Forecast Market Size and Growth, 2024 - 2029, 2034F, Value ($ Billion)
5.6. Global Clinical-Stage Biotechnology Total Addressable Market (TAM)
6.1. Global Clinical-Stage Biotechnology Market, Segmentation By Product Type, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Therapeutics
Diagnostics
Vaccines
Other Product Types
6.2. Global Clinical-Stage Biotechnology Market, Segmentation By Phase, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Phase I
Phase II
Phase III
6.3. Global Clinical-Stage Biotechnology Market, Segmentation By Application, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Oncology
Infectious Diseases
Cardiovascular Diseases
Neurology
Other Applications
6.4. Global Clinical-Stage Biotechnology Market, Segmentation By End-User, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Hospitals
Research Institutes
Diagnostic Centers
Other End-Users
6.5. Global Clinical-Stage Biotechnology Market, Sub-Segmentation Of Therapeutics, By Type, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Monoclonal Antibodies
Cell Therapy
Gene Therapy
Recombinant Proteins
Peptide Therapeutics
Small Molecule Therapeutics
6.6. Global Clinical-Stage Biotechnology Market, Sub-Segmentation Of Diagnostics, By Type, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Molecular Diagnostics
Immunoassays
Genetic Testing
Biomarker Testing
Point Of Care Diagnostics
6.7. Global Clinical-Stage Biotechnology Market, Sub-Segmentation Of Vaccines, By Type, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Live Attenuated Vaccines
Inactivated Vaccines
Subunit Vaccines
mRNA Vaccines
Viral Vector Vaccines
6.8. Global Clinical-Stage Biotechnology Market, Sub-Segmentation Of Other Product Types, By Type, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
Regenerative Medicine Products
Research Reagents
Companion Diagnostics
Medical Devices
7. Clinical-Stage Biotechnology Market Regional And Country Analysis
7.1. Global Clinical-Stage Biotechnology Market, Split By Region, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
7.2. Global Clinical-Stage Biotechnology Market, Split By Country, Historic and Forecast, 2019-2024, 2024-2029F, 2034F, $ Billion
