세계의 제제개발 아웃소싱 시장 - 산업 규모, 점유율, 동향, 기회, 예측 : 서비스별, 제제별, 치료영역별, 지역별, 경쟁별(2020-2030년)
Formulation Development Outsourcing Market - Global Industry Size, Share, Trends, Opportunity & Forecast, Segmented By Service, By Formulation, By Therapeutic Area, By Region & Competition, 2020-2030F
상품코드:1785316
리서치사:TechSci Research
발행일:2025년 08월
페이지 정보:영문 188 Pages
라이선스 & 가격 (부가세 별도)
ㅁ Add-on 가능: 고객의 요청에 따라 일정한 범위 내에서 Customization이 가능합니다. 자세한 사항은 문의해 주시기 바랍니다.
한글목차
세계의 제제 개발 아웃소싱 시장 규모는 2024년 402억 5,000만 달러였고, 2030년까지 CAGR 6.02%로 확대되어 573억 1,000만 달러에 이를 것으로 예측됩니다.
세계의 제제 개발 아웃소싱 시장은 최근 몇 년 동안 큰 성장을 이루고 있으며, 그 주요 요인은 제약 업계가 비용 효율성, 시장 출시 기간 단축, 전문 지식에 대한 액세스를 중시하게 되었습니다. 의약품 개발이 복잡해짐에 따라 제약회사는 첨단기술, 확장가능한 자원, 규제준수의 전문지식을 활용하기 위해 제제개발을 CRO(의약품 개발 업무수탁기관)나 CDMO(의약품 개발 및 제조업무수탁기관)에 위탁하는 경우가 늘고 있습니다. 이 전략적 전환을 통해 기업은 R&D 프로세스를 간소화하고 자본 지출을 줄이고 제품의 상업화를 가속화할 수 있습니다.
시장 개요
예측 기간
2026-2030년
시장 규모 : 2024년
402억 5,000만 달러
시장 규모 : 2030년
573억 1,000만 달러
CAGR : 2025-2030년
6.02%
급성장 부문
사전 포뮬레이션
최대 시장
북미
시장을 형성하는 주요 동향에는 고급 제제 기술과 특수 취급이 필요한 맞춤형 의료 및 생물 제제에 대한 수요 증가가 포함됩니다. 또한 나노기술, 약물전달 시스템, 연속 제조의 진보가 제제 개발 아웃소싱의 기술 혁신을 촉진하고 있습니다. 만성 질환의 만연과 세계 인구의 노령화는 신규하고 효과적인 제형에 대한 수요를 더욱 높여줍니다. 게다가 신흥 시장에 대한 투자 증가와 의약품 아웃소싱을 지원하는 정부의 호의적인 정책이 새로운 성장의 길을 열고 있습니다.
이러한 긍정적인 요인에도 불구하고 시장은 엄격한 규제 요구 사항, 지적 재산권 보호에 대한 우려, 품질 관리 문제와 같은 문제에 직면해 있습니다. 또한 아웃소싱 파트너의 능력 변동과 지리적 위험도 원활한 협업을 방해할 수 있습니다. 또한 공급망 혼란과 임상시험 지연은 제제 개발 아웃소싱 프로젝트에 운영 위험을 초래합니다.
시장 성장 촉진요인
비용 효율성과 자본 지출 감소
주요 시장 과제
엄격한 규정 준수 및 승인 프로세스
주요 시장 동향
맞춤형 의료 및 생물 제제의 상승
목차
제1장 개요
제2장 조사 방법
제3장 주요 요약
제4장 고객의 목소리
제5장 세계의 제제 개발 아웃소싱 시장 전망
시장 규모와 예측
금액별
시장 점유율 및 예측
서비스별(프리포뮬레이션, 제제 개발)
제제별(경구, 주사, 국소, 기타)
치료 영역별(종양학, 감염증, 신경학, 혈액학, 호흡기학, 순환기학, 피부과, 기타)
지역별
기업별(2024년)
시장 맵
제6장 북미의 제제 개발 아웃소싱 시장 전망
시장 규모와 예측
시장 점유율 및 예측
북미 : 국가별 분석
미국
캐나다
멕시코
제7장 유럽의 제제 개발 아웃소싱 시장 전망
시장 규모와 예측
시장 점유율 및 예측
유럽 : 국가별 분석
독일
영국
이탈리아
프랑스
스페인
제8장 아시아태평양의 제제 개발 아웃소싱 시장 전망
시장 규모와 예측
시장 점유율 및 예측
아시아태평양 : 국가별 분석
중국
인도
일본
한국
호주
제9장 남미의 제제 개발 아웃소싱 시장 전망
시장 규모와 예측
시장 점유율 및 예측
남미 : 국가별 분석
브라질
아르헨티나
콜롬비아
제10장 중동 및 아프리카의 제제 개발 아웃소싱 시장 전망
시장 규모와 예측
시장 점유율 및 예측
중동 및 아프리카 : 국가별 분석
남아프리카
사우디아라비아
아랍에미리트(UAE)
제11장 시장 역학
성장 촉진요인
과제
제12장 시장 동향과 발전
최근 동향
제품 출시
합병과 인수
제13장 세계 제제 개발 아웃소싱 시장 : SWOT 분석
제14장 경쟁 구도
Charles River Laboratories
Aizant Drug Research Solutions Private Limited
Catalent Inc.
Laboratory Corporation of America Holdings
Syngene International Ltd.
Irisys LLC
Intertek Group PLC
Piramal Pharma Solutions
Qiotient Sciences Ltd.
Patheon Inc.
Emergent BioSolutions Inc.
Lonza Group
제15장 전략적 제안
제16장 기업 소개와 면책사항
JHS
영문 목차
영문목차
Global Formulation Development Outsourcing market was valued at USD 40.25 Billion in 2024 and is expected to reach USD 57.31 Billion by 2030 with a CAGR of 6.02%. The global Formulation Development Outsourcing market has witnessed significant growth in recent years, driven primarily by the pharmaceutical industry's increasing focus on cost efficiency, time-to-market reduction, and access to specialized expertise. As drug development becomes more complex, pharmaceutical companies are increasingly outsourcing formulation development to contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs) to leverage advanced technologies, scalable resources, and regulatory compliance expertise. This strategic shift enables companies to streamline their R&D processes, reduce capital expenditure, and accelerate product commercialization.
Market Overview
Forecast Period
2026-2030
Market Size 2024
USD 40.25 Billion
Market Size 2030
USD 57.31 Billion
CAGR 2025-2030
6.02%
Fastest Growing Segment
Preformulation
Largest Market
North America
Key trends shaping the market include the rising demand for personalized medicine and biologics, which require sophisticated formulation techniques and specialized handling. Additionally, advancements in nanotechnology, drug delivery systems, and continuous manufacturing are fueling innovation in outsourced formulation development. The growing prevalence of chronic diseases and an aging global population are further amplifying the demand for novel and effective drug formulations. Moreover, increasing investments in emerging markets and favorable government policies supporting pharmaceutical outsourcing are creating new growth avenues.
Despite these positive factors, the market faces challenges such as stringent regulatory requirements, concerns about intellectual property protection, and quality control issues. Variability in outsourcing partner capabilities and geographical risks can also hinder seamless collaboration. Furthermore, supply chain disruptions and delays in clinical trials pose operational risks to formulation development outsourcing projects.
Key Market Drivers
Cost Efficiency and Reduction of Capital Expenditure
Cost efficiency and reduction of capital expenditure are among the primary drivers propelling the growth of the global formulation development outsourcing market. Pharmaceutical companies face increasing pressure to optimize their operational costs while accelerating drug development timelines. Outsourcing formulation development allows these companies to significantly lower upfront investments in infrastructure, equipment, and skilled personnel, which are often costly and time-consuming to establish internally. By leveraging the capabilities of specialized contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs), pharmaceutical firms can avoid heavy capital expenditure associated with setting up and maintaining state-of-the-art laboratories and manufacturing facilities.
This strategic shift toward outsourcing enables companies to convert fixed costs into variable costs, providing greater financial flexibility and risk mitigation. Instead of committing large sums to build in-house capabilities that may not be fully utilized at all times, companies pay for services as needed, improving cash flow management. Moreover, outsourcing partners typically possess established, validated processes and regulatory know-how, which can help reduce costly delays and potential compliance issues, further contributing to overall cost savings.
Key Market Challenges
Stringent Regulatory Compliance and Approval Processes
Stringent regulatory compliance and approval processes represent one of the most significant challenges in the global formulation development outsourcing market. The pharmaceutical industry operates under rigorous regulations set by authorities such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regional regulatory bodies. These regulations ensure the safety, efficacy, and quality of drug formulations, but they also impose complex requirements on every stage of formulation development. For companies outsourcing these activities, navigating this regulatory landscape can be particularly demanding.
Outsourcing partners must adhere strictly to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other quality standards to meet regulatory expectations. Any deviation or non-compliance can lead to severe consequences, including delays in product approvals, costly recalls, or legal penalties. Pharmaceutical companies rely on their CROs and CDMOs to maintain transparency and documentation accuracy throughout the development process to satisfy these stringent criteria.
Additionally, regulatory agencies require comprehensive and robust data submissions covering formulation composition, stability, bioavailability, and manufacturing processes. Coordinating these requirements with external partners often results in complex communication channels and extensive documentation efforts, increasing the risk of errors or omissions. This complexity is further magnified when multiple regulatory jurisdictions are involved, each with unique standards and procedural nuances.
Key Market Trends
Rise of Personalized Medicine and Biologics
The rise of personalized medicine and biologics is a major trend driving the evolution of the formulation development outsourcing market. Personalized medicine focuses on tailoring treatments to individual patients based on their genetic profile, lifestyle, and disease characteristics, moving away from the traditional "one-size-fits-all" approach. This shift demands highly specialized formulation techniques that can accommodate unique drug delivery mechanisms, dosage forms, and stability requirements.
Biologics, which include complex molecules such as monoclonal antibodies, vaccines, and gene therapies, represent a rapidly growing segment within pharmaceuticals. These drugs are inherently more sensitive and challenging to formulate compared to conventional small-molecule drugs. Their development requires advanced technology platforms and stringent control over manufacturing conditions to maintain efficacy and safety.
Pharmaceutical companies often lack the in-house capabilities or the necessary infrastructure to efficiently develop and manufacture these complex biologics and personalized therapies. As a result, they increasingly turn to contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs) that possess the specialized expertise, technology, and regulatory knowledge needed to manage such complexities.
Outsourcing formulation development in this context helps companies accelerate innovation, reduce development risks, and optimize costs while ensuring high-quality standards. Moreover, these external partners are equipped to handle the stringent regulatory requirements associated with biologics and personalized medicines, facilitating faster approval processes.
Key Market Players
Charles River Laboratories
Aizant Drug Research Solutions Private Limited
Catalent Inc.
Laboratory Corporation of America Holdings
Syngene International Ltd.
Irisys LLC
Intertek Group PLC
Piramal Pharma Solutions
Qiotient Sciences Ltd.
Patheon Inc.
Emergent BioSolutions Inc.
Lonza Group
Report Scope:
In this report, the Global Formulation Development Outsourcing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Formulation Development Outsourcing Market, By Service:
Preformulation
Formulation Development
Formulation Development Outsourcing Market, By Formulation:
Oral
Injectable
Topical
Others
Formulation Development Outsourcing Market, By Therapeutic Area:
Oncology
Infectious Disease
Neurology
Hematology
Respiratory
Cardiovascular
Dermatology
Others
Formulation Development Outsourcing Market, By Region:
North America
United States
Canada
Mexico
Europe
France
United Kingdom
Italy
Germany
Spain
Asia-Pacific
China
India
Japan
Australia
South Korea
South America
Brazil
Argentina
Colombia
Middle East & Africa
South Africa
Saudi Arabia
UAE
Competitive Landscape
Company Profiles: Detailed analysis of the major companies presents in the Global Formulation Development Outsourcing Market.
Available Customizations:
Global Formulation Development Outsourcing market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:
Company Information
Detailed analysis and profiling of additional market players (up to five).
Table of Contents
1. Product Overview
1.1. Market Definition
1.2. Scope of the Market
1.2.1. Markets Covered
1.2.2. Years Considered for Study
1.2.3. Key Market Segmentations
2. Research Methodology
2.1. Objective of the Study
2.2. Baseline Methodology
2.3. Key Industry Partners
2.4. Major Association and Secondary Sources
2.5. Forecasting Methodology
2.6. Data Triangulation & Validation
2.7. Assumptions and Limitations
3. Executive Summary
3.1. Overview of the Market
3.2. Overview of Key Market Segmentations
3.3. Overview of Key Market Players
3.4. Overview of Key Regions/Countries
3.5. Overview of Market Drivers, Challenges, Trends
4. Voice of Customer
5. Global Formulation Development Outsourcing Market Outlook
5.1. Market Size & Forecast
5.1.1. By Value
5.2. Market Share & Forecast
5.2.1. By Service (Preformulation, Formulation Development)
5.2.2. By Formulation (Oral, Injectable, Topical, Others)
5.2.3. By Therapeutic Area (Oncology, Infectious Disease, Neurology, Hematology, Respiratory, Cardiovascular, Dermatology, Others)
5.2.4. By Region
5.2.5. By Company (2024)
5.3. Market Map
6. North America Formulation Development Outsourcing Market Outlook
6.1. Market Size & Forecast
6.1.1. By Value
6.2. Market Share & Forecast
6.2.1. By Service
6.2.2. By Formulation
6.2.3. By Therapeutic Area
6.2.4. By Country
6.3. North America: Country Analysis
6.3.1. United States Formulation Development Outsourcing Market Outlook
6.3.1.1. Market Size & Forecast
6.3.1.1.1. By Value
6.3.1.2. Market Share & Forecast
6.3.1.2.1. By Service
6.3.1.2.2. By Formulation
6.3.1.2.3. By Therapeutic Area
6.3.2. Canada Formulation Development Outsourcing Market Outlook
6.3.2.1. Market Size & Forecast
6.3.2.1.1. By Value
6.3.2.2. Market Share & Forecast
6.3.2.2.1. By Service
6.3.2.2.2. By Formulation
6.3.2.2.3. By Therapeutic Area
6.3.3. Mexico Formulation Development Outsourcing Market Outlook
6.3.3.1. Market Size & Forecast
6.3.3.1.1. By Value
6.3.3.2. Market Share & Forecast
6.3.3.2.1. By Service
6.3.3.2.2. By Formulation
6.3.3.2.3. By Therapeutic Area
7. Europe Formulation Development Outsourcing Market Outlook
7.1. Market Size & Forecast
7.1.1. By Value
7.2. Market Share & Forecast
7.2.1. By Service
7.2.2. By Formulation
7.2.3. By Therapeutic Area
7.2.4. By Country
7.3. Europe: Country Analysis
7.3.1. Germany Formulation Development Outsourcing Market Outlook
7.3.1.1. Market Size & Forecast
7.3.1.1.1. By Value
7.3.1.2. Market Share & Forecast
7.3.1.2.1. By Service
7.3.1.2.2. By Formulation
7.3.1.2.3. By Therapeutic Area
7.3.2. United Kingdom Formulation Development Outsourcing Market Outlook
7.3.2.1. Market Size & Forecast
7.3.2.1.1. By Value
7.3.2.2. Market Share & Forecast
7.3.2.2.1. By Service
7.3.2.2.2. By Formulation
7.3.2.2.3. By Therapeutic Area
7.3.3. Italy Formulation Development Outsourcing Market Outlook
7.3.3.1. Market Size & Forecast
7.3.3.1.1. By Value
7.3.3.2. Market Share & Forecast
7.3.3.2.1. By Service
7.3.3.2.2. By Formulation
7.3.3.2.3. By Therapeutic Area
7.3.4. France Formulation Development Outsourcing Market Outlook
7.3.4.1. Market Size & Forecast
7.3.4.1.1. By Value
7.3.4.2. Market Share & Forecast
7.3.4.2.1. By Service
7.3.4.2.2. By Formulation
7.3.4.2.3. By Therapeutic Area
7.3.5. Spain Formulation Development Outsourcing Market Outlook
7.3.5.1. Market Size & Forecast
7.3.5.1.1. By Value
7.3.5.2. Market Share & Forecast
7.3.5.2.1. By Service
7.3.5.2.2. By Formulation
7.3.5.2.3. By Therapeutic Area
8. Asia-Pacific Formulation Development Outsourcing Market Outlook
8.1. Market Size & Forecast
8.1.1. By Value
8.2. Market Share & Forecast
8.2.1. By Service
8.2.2. By Formulation
8.2.3. By Therapeutic Area
8.2.4. By Country
8.3. Asia-Pacific: Country Analysis
8.3.1. China Formulation Development Outsourcing Market Outlook
8.3.1.1. Market Size & Forecast
8.3.1.1.1. By Value
8.3.1.2. Market Share & Forecast
8.3.1.2.1. By Service
8.3.1.2.2. By Formulation
8.3.1.2.3. By Therapeutic Area
8.3.2. India Formulation Development Outsourcing Market Outlook
8.3.2.1. Market Size & Forecast
8.3.2.1.1. By Value
8.3.2.2. Market Share & Forecast
8.3.2.2.1. By Service
8.3.2.2.2. By Formulation
8.3.2.2.3. By Therapeutic Area
8.3.3. Japan Formulation Development Outsourcing Market Outlook
8.3.3.1. Market Size & Forecast
8.3.3.1.1. By Value
8.3.3.2. Market Share & Forecast
8.3.3.2.1. By Service
8.3.3.2.2. By Formulation
8.3.3.2.3. By Therapeutic Area
8.3.4. South Korea Formulation Development Outsourcing Market Outlook
8.3.4.1. Market Size & Forecast
8.3.4.1.1. By Value
8.3.4.2. Market Share & Forecast
8.3.4.2.1. By Service
8.3.4.2.2. By Formulation
8.3.4.2.3. By Therapeutic Area
8.3.5. Australia Formulation Development Outsourcing Market Outlook
8.3.5.1. Market Size & Forecast
8.3.5.1.1. By Value
8.3.5.2. Market Share & Forecast
8.3.5.2.1. By Service
8.3.5.2.2. By Formulation
8.3.5.2.3. By Therapeutic Area
9. South America Formulation Development Outsourcing Market Outlook
9.1. Market Size & Forecast
9.1.1. By Value
9.2. Market Share & Forecast
9.2.1. By Service
9.2.2. By Formulation
9.2.3. By Therapeutic Area
9.2.4. By Country
9.3. South America: Country Analysis
9.3.1. Brazil Formulation Development Outsourcing Market Outlook
9.3.1.1. Market Size & Forecast
9.3.1.1.1. By Value
9.3.1.2. Market Share & Forecast
9.3.1.2.1. By Service
9.3.1.2.2. By Formulation
9.3.1.2.3. By Therapeutic Area
9.3.2. Argentina Formulation Development Outsourcing Market Outlook
9.3.2.1. Market Size & Forecast
9.3.2.1.1. By Value
9.3.2.2. Market Share & Forecast
9.3.2.2.1. By Service
9.3.2.2.2. By Formulation
9.3.2.2.3. By Therapeutic Area
9.3.3. Colombia Formulation Development Outsourcing Market Outlook
9.3.3.1. Market Size & Forecast
9.3.3.1.1. By Value
9.3.3.2. Market Share & Forecast
9.3.3.2.1. By Service
9.3.3.2.2. By Formulation
9.3.3.2.3. By Therapeutic Area
10. Middle East and Africa Formulation Development Outsourcing Market Outlook
10.1. Market Size & Forecast
10.1.1. By Value
10.2. Market Share & Forecast
10.2.1. By Service
10.2.2. By Formulation
10.2.3. By Therapeutic Area
10.2.4. By Country
10.3. Middle East & Africa: Country Analysis
10.3.1. South Africa Formulation Development Outsourcing Market Outlook
10.3.1.1. Market Size & Forecast
10.3.1.1.1. By Value
10.3.1.2. Market Share & Forecast
10.3.1.2.1. By Service
10.3.1.2.2. By Formulation
10.3.1.2.3. By Therapeutic Area
10.3.2. Saudi Arabia Formulation Development Outsourcing Market Outlook
10.3.2.1. Market Size & Forecast
10.3.2.1.1. By Value
10.3.2.2. Market Share & Forecast
10.3.2.2.1. By Service
10.3.2.2.2. By Formulation
10.3.2.2.3. By Therapeutic Area
10.3.3. UAE Formulation Development Outsourcing Market Outlook
10.3.3.1. Market Size & Forecast
10.3.3.1.1. By Value
10.3.3.2. Market Share & Forecast
10.3.3.2.1. By Service
10.3.3.2.2. By Formulation
10.3.3.2.3. By Therapeutic Area
11. Market Dynamics
11.1. Drivers
11.2. Challenges
12. Market Trends & Developments
12.1. Recent Developments (If Any)
12.2. Product Launches (If Any)
12.3. Mergers & Acquisitions (If Any)
13. Global Formulation Development Outsourcing Market: SWOT Analysis
14. Competitive Landscape
14.1. Charles River Laboratories
14.1.1. Business Overview
14.1.2. Product & Service Offerings
14.1.3. Recent Developments
14.1.4. Financials (If Listed)
14.1.5. Key Personnel
14.1.6. SWOT Analysis
14.2. Aizant Drug Research Solutions Private Limited
