고활성 API(HPAPI) 수탁제조 시장 : 세계 산업 규모, 점유율, 동향, 기회, 예측, 제형별, 최종 용도별, 지역별, 경쟁별(2020-2030년)
High Potency API Contract Manufacturing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Formulation, By End Use, By Region and Competition, 2020-2030F
상품코드:1668141
리서치사:TechSci Research
발행일:2025년 02월
페이지 정보:영문 183 Pages
라이선스 & 가격 (부가세 별도)
ㅁ Add-on 가능: 고객의 요청에 따라 일정한 범위 내에서 Customization이 가능합니다. 자세한 사항은 문의해 주시기 바랍니다.
한글목차
세계 고활성 API(HPAPI) 수탁제조 시장은 2024년 82억 3,000만 달러로 평가되었고, 예측 기간 동안 8.89%의 연평균 복합 성장률(CAGR)로 2030년에는 116억 3,000만 달러에 달할 것으로 예상됩니다.
세계 고활성 API(HPAPI) 수탁제조 시장은 제약 및 생명공학 산업에서 복잡하고 강력한 의약품 활성 성분(API)의 제조에 있어 매우 중요한 역할을 하는 중요한 분야로 부상하고 있습니다. 암, 자가면역질환, 희귀질환 등의 질환에 대한 표적치료제 개발에 있어 매우 중요합니다. 제약회사들이 정밀의료와 특수치료에 점점 더 집중하면서 HPAPI와 수탁제조 서비스에 대한 수요가 급증하고 있으며, 이 시장의 성장을 주도하고 있습니다.
시장 개요
예측 기간
2026-2030년
시장 규모 : 2024년
82억 3,000만 달러
시장 규모 : 2030년
116억 3,000만 달러
CAGR : 2025-2030년
8.89%
급성장 부문
주사제
최대 시장
북미
HPAPI 수탁제조 시장의 주요 촉진요인 중 하나는 만성질환 및 희귀질환의 유병률 증가로 인해 신규성이 높고 강력한 의약품의 개발이 요구되고 있다는 점입니다. 이와 더불어 일부 블록버스터 의약품의 특허 만료가 겹치면서 HPAPI 제조의 비용 효율적인 아웃소싱에 대한 필요성이 증가하고 있으며, HPAPI 전문 수탁제조업체(CMO)는 공정 개발, 스케일업, 상업적 규모의 생산 등 다양한 서비스를 제공합니다. 제약회사는 의약품 개발 기간을 단축하고 자본 지출을 줄일 수 있습니다.
시장 성장 촉진요인
만성질환 및 희귀질환 증가
주요 시장 이슈
엄격한 규제 준수
주요 시장 동향
정밀의료에 대한 관심 증가
목차
제1장 개요
제2장 조사 방법
제3장 주요 요약
제4장 세계의 고활성 API(HPAPI) 수탁제조 시장 전망
시장 규모와 예측
금액별
시장 점유율과 예측
제형별(주사제, 경구 고형제, 로션제, 기타)
최종 용도별(종양학, 항당뇨병약, 자가면역약, 기타)
지역별
기업별(2024년)
시장 맵
제형별
최종 용도별
지역별
제5장 아시아태평양의 고활성 API(HPAPI) 수탁제조 시장 전망
시장 규모와 예측
금액별
시장 점유율과 예측
처방 별
최종 용도별
국가별
아시아태평양 : 국가별 분석
중국
인도
호주
일본
한국
제6장 유럽의 고활성 API(HPAPI) 수탁제조 시장 전망
시장 규모와 예측
시장 점유율과 예측
유럽 : 국가별 분석
독일
스페인
이탈리아
영국
제7장 북미의 고활성 API(HPAPI) 수탁제조 시장 전망
시장 규모와 예측
시장 점유율과 예측
북미 : 국가별 분석
멕시코
캐나다
제8장 남미의 고활성 API(HPAPI) 수탁제조 시장 전망
시장 규모와 예측
시장 점유율과 예측
남미 : 국가별 분석
아르헨티나
콜롬비아
제9장 중동 및 아프리카의 고활성 API(HPAPI) 수탁제조 시장 전망
시장 규모와 예측
시장 점유율과 예측
중동 및 아프리카 : 국가별 분석
사우디아라비아
아랍에미리트(UAE)
이집트
쿠웨이트
터키
제10장 시장 역학
성장 촉진요인
과제
제11장 시장 동향과 발전
최근 동향
제품 출시
인수합병(M&A)
제12장 세계고활성 API(HPAPI) 수탁제조 : SWOT 분석
제13장 Porter의 Five Forces 분석
업계내 경쟁
신규 참여 가능성
공급업체의 힘
고객의 힘
대체품의 위협
제14장 경쟁 구도
Catalent, Inc.
Lonza Group
Piramal Pharma Solutions
Pfizer CentreOne
Gentec Pharmaceutical Group
AbbVie Contract Manufacturing
Corden Pharma International
Curia Global, Inc.
Merck Group(SigmaAldrich Co., LLC)
Polpharma Group
제15장 전략적 제안
제16장 리서치사에 대해 & 면책사항
LSH
영문 목차
영문목차
Global High Potency API (HPAPI) Contract Manufacturing Market was valued at USD 8.23 Billion in 2024 and is expected to reach USD 11.63 Billion by 2030 with a CAGR of 8.89% during the forecast period. The Global High Potency API (HPAPI) Contract Manufacturing Market has emerged as a vital sector within the pharmaceutical and biotechnology industries, playing a pivotal role in the production of complex and potent active pharmaceutical ingredients (APIs). HPAPIs are compounds characterized by their exceptionally high pharmacological activity and low effective doses, making them crucial in the development of targeted therapies for conditions like cancer, autoimmune diseases, and rare disorders. As pharmaceutical companies increasingly focus on precision medicine and specialized treatments, the demand for HPAPIs and contract manufacturing services has surged, driving the growth of this market.
Market Overview
Forecast Period
2026-2030
Market Size 2024
USD 8.23 Billion
Market Size 2030
USD 11.63 Billion
CAGR 2025-2030
8.89%
Fastest Growing Segment
Injectables
Largest Market
North America
One of the primary drivers of the HPAPI contract manufacturing market is the rising incidence of chronic and rare diseases, necessitating the development of novel and highly potent drugs. This, coupled with the expiration of patents for several blockbuster drugs, has intensified the need for cost-effective outsourcing of HPAPI production. Contract manufacturing organizations (CMOs) specializing in HPAPIs offer a range of services, including process development, scale-up, and commercial-scale production, enabling pharmaceutical companies to expedite drug development timelines and reduce capital expenditures.
Key Market Drivers
Rising Incidence of Chronic and Rare Diseases
The rising incidence of chronic and rare diseases is a significant driving force behind the growth of the Global High Potency API (HPAPI) Contract Manufacturing Market. As the global population ages and lifestyles evolve, the prevalence of chronic diseases like cancer, diabetes, cardiovascular conditions, and autoimmune disorders has been on the rise. Simultaneously, the identification and recognition of rare diseases have improved, shedding light on a category of ailments that affect a smaller but substantial portion of the population.
For pharmaceutical companies, addressing these health challenges necessitates the development of highly specialized medications with precise targeting capabilities and minimal side effects. This is precisely where HPAPIs come into play. Their unique properties, including high pharmacological activity and low effective doses, make them essential for crafting therapies tailored to combat chronic and rare diseases effectively.
Furthermore, as patents for several blockbuster drugs have expired or are nearing expiration, pharmaceutical firms are eager to fill the void with innovative treatments. These next-generation medications often rely on HPAPIs for their potency and precision. In this competitive landscape, pharmaceutical companies are increasingly turning to HPAPI contract manufacturing services to expedite the development and production of these cutting-edge drugs.
The outsourcing of HPAPI production offers multiple advantages for pharmaceutical companies. Firstly, it allows them to harness the expertise and specialized infrastructure of CMOs, reducing the need for massive in-house investments in containment technologies and highly trained personnel. Secondly, it streamlines the drug development process, enabling faster time-to-market and cost-effective solutions. Finally, it ensures compliance with the stringent regulatory requirements governing the manufacturing of high-potency compounds.
As the burden of chronic and rare diseases continues to mount globally, the demand for HPAPI-based medications and the contract manufacturing services supporting their production is expected to remain robust.
Key Market Challenges
Stringent Regulatory Compliance
Costly Infrastructure and Technology: Building and maintaining facilities that meet the strict safety and containment standards for HPAPI production requires a substantial financial investment. CMOs must invest in specialized equipment, such as isolators and gloveboxes, which come at a high cost. Additionally, they must implement comprehensive quality control systems, which necessitate ongoing investment in technology and personnel training.
Regulatory authorities demand rigorous adherence to Good Manufacturing Practices (GMP) and other stringent guidelines throughout the HPAPI manufacturing process. This means constant monitoring, documentation, and quality assurance measures. Any deviation from these standards can result in regulatory sanctions, delays, or even product recalls, putting immense pressure on CMOs to ensure compliance at all times.
Regulatory standards in the pharmaceutical industry are constantly evolving. Keeping up with these changes and ensuring that manufacturing processes remain compliant with the latest regulations is a perpetual challenge. Failure to adapt to new guidelines can result in costly setbacks and regulatory scrutiny.
The handling of HPAPIs necessitates the implementation of rigorous safety protocols to protect workers and the environment from potential hazards. Maintaining a culture of safety and ensuring that employees are well-trained in handling HPAPIs is an ongoing commitment. This includes investing in specialized training programs and safety equipment.
Comprehensive documentation and reporting are essential in demonstrating compliance with regulatory requirements. Every step of the manufacturing process, from raw material sourcing to final product distribution, must be meticulously documented. The volume and detail of these records can be overwhelming, adding complexity and administrative burden to the operations of CMOs.
Key Market Trends
Increasing Focus on Precision Medicine
The increasing focus on precision medicine is a pivotal trend that is significantly boosting the Global High Potency API (HPAPI) Contract Manufacturing Market. Precision medicine, characterized by the customization of healthcare and drug therapies to individual patient profiles, has become a cornerstone of modern medical practice. This approach relies heavily on the development of highly targeted and specialized medications, often formulated with HPAPIs due to their exceptional potency and precision in targeting specific molecular pathways.
Pharmaceutical companies are increasingly dedicating their research and development efforts to precision medicine, aiming to provide tailored treatment options for patients with a wide range of medical conditions. These innovative therapies have demonstrated remarkable potential in improving treatment efficacy while minimizing side effects, making them an attractive choice for healthcare providers and patients alike.
As the demand for precision medicine continues to grow across various therapeutic areas, including oncology, autoimmune diseases, and rare disorders, the role of HPAPIs in drug development has become increasingly prominent. Contract manufacturing organizations (CMOs) specializing in HPAPIs have positioned themselves as indispensable partners in the production of these cutting-edge medications. They offer the necessary expertise, specialized infrastructure, and containment technologies to ensure the safe and efficient manufacturing of HPAPI-based drugs.
The trend toward precision medicine also fuels collaboration between pharmaceutical companies and HPAPI CMOs. These partnerships expedite the development and commercialization of precision therapies, as CMOs contribute their specialized capabilities in HPAPI production. This synergy enables pharmaceutical firms to focus on research and clinical trials while relying on CMOs for cost-effective and compliant HPAPI manufacturing.
Key Market Players
Catalent, Inc.
Lonza Group
Piramal Pharma Solutions
Pfizer CentreOne
Gentec Pharmaceutical Group
AbbVie Contract Manufacturing
Corden Pharma International
Curia Global, Inc.
Merck Group (SigmaAldrich Co., LLC)
Polpharma Group
Report Scope:
In this report, the Global High Potency API (HPAPI) Contract Manufacturing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
High Potency API (HPAPI) Contract Manufacturing Market, By Formulation:
Injectables
Oral Solids
Lotions
Others
High Potency API (HPAPI) Contract Manufacturing Market, By End Use:
Oncology
Antidiabetics
Autoimmune
Others
High Potency API (HPAPI) Contract Manufacturing 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
Kuwait
Turkey
Egypt
Competitive Landscape
Company Profiles: Detailed analysis of the major companies present in the Global High Potency API (HPAPI) Contract Manufacturing Market.
Available Customizations:
Global High Potency API (HPAPI) Contract Manufacturing 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. Global High Potency API (HPAPI) Contract Manufacturing Market Outlook
4.1. Market Size & Forecast
4.1.1. By Value
4.2. Market Share & Forecast
4.2.1. By Formulation (Injectables, Oral Solids, Lotions, Others)
4.2.2. By End Use (Oncology, Antidiabetics, Autoimmune, Others)
4.2.3. By Region
4.2.4. By Company (2024)
4.3. Market Map
4.3.1. By Formulation
4.3.2. By End Use
4.3.3. By Region
5. Asia Pacific High Potency API (HPAPI) Contract Manufacturing Market Outlook
5.1. Market Size & Forecast
5.1.1. By Value
5.2. Market Share & Forecast
5.2.1. By Formulation
5.2.2. By End Use
5.2.3. By Country
5.3. Asia Pacific: Country Analysis
5.3.1. China High Potency API (HPAPI) Contract Manufacturing Market Outlook
5.3.1.1. Market Size & Forecast
5.3.1.1.1. By Value
5.3.1.2. Market Share & Forecast
5.3.1.2.1. By Formulation
5.3.1.2.2. By End Use
5.3.2. India High Potency API (HPAPI) Contract Manufacturing Market Outlook
5.3.2.1. Market Size & Forecast
5.3.2.1.1. By Value
5.3.2.2. Market Share & Forecast
5.3.2.2.1. By Formulation
5.3.2.2.2. By End Use
5.3.3. Australia High Potency API (HPAPI) Contract Manufacturing Market Outlook
5.3.3.1. Market Size & Forecast
5.3.3.1.1. By Value
5.3.3.2. Market Share & Forecast
5.3.3.2.1. By Formulation
5.3.3.2.2. By End Use
5.3.4. Japan High Potency API (HPAPI) Contract Manufacturing Market Outlook
5.3.4.1. Market Size & Forecast
5.3.4.1.1. By Value
5.3.4.2. Market Share & Forecast
5.3.4.2.1. By Formulation
5.3.4.2.2. By End Use
5.3.5. South Korea High Potency API (HPAPI) Contract Manufacturing Market Outlook
5.3.5.1. Market Size & Forecast
5.3.5.1.1. By Value
5.3.5.2. Market Share & Forecast
5.3.5.2.1. By Formulation
5.3.5.2.2. By End Use
6. Europe High Potency API (HPAPI) Contract Manufacturing Market Outlook
6.1. Market Size & Forecast
6.1.1. By Value
6.2. Market Share & Forecast
6.2.1. By Formulation
6.2.2. By End Use
6.2.3. By Country
6.3. Europe: Country Analysis
6.3.1. France High Potency API (HPAPI) Contract Manufacturing 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 Formulation
6.3.1.2.2. By End Use
6.3.2. Germany High Potency API (HPAPI) Contract Manufacturing 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 Formulation
6.3.2.2.2. By End Use
6.3.3. Spain High Potency API (HPAPI) Contract Manufacturing 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 Formulation
6.3.3.2.2. By End Use
6.3.4. Italy High Potency API (HPAPI) Contract Manufacturing Market Outlook
6.3.4.1. Market Size & Forecast
6.3.4.1.1. By Value
6.3.4.2. Market Share & Forecast
6.3.4.2.1. By Formulation
6.3.4.2.2. By End Use
6.3.5. United Kingdom High Potency API (HPAPI) Contract Manufacturing Market Outlook
6.3.5.1. Market Size & Forecast
6.3.5.1.1. By Value
6.3.5.2. Market Share & Forecast
6.3.5.2.1. By Formulation
6.3.5.2.2. By End Use
7. North America High Potency API (HPAPI) Contract Manufacturing Market Outlook
7.1. Market Size & Forecast
7.1.1. By Value
7.2. Market Share & Forecast
7.2.1. By Formulation
7.2.2. By End Use
7.2.3. By Country
7.3. North America: Country Analysis
7.3.1. United States High Potency API (HPAPI) Contract Manufacturing 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 Formulation
7.3.1.2.2. By End Use
7.3.2. Mexico High Potency API (HPAPI) Contract Manufacturing 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 Formulation
7.3.2.2.2. By End Use
7.3.3. Canada High Potency API (HPAPI) Contract Manufacturing 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 Formulation
7.3.3.2.2. By End Use
8. South America High Potency API (HPAPI) Contract Manufacturing Market Outlook
8.1. Market Size & Forecast
8.1.1. By Value
8.2. Market Share & Forecast
8.2.1. By Formulation
8.2.2. By End Use
8.2.3. By Country
8.3. South America: Country Analysis
8.3.1. Brazil High Potency API (HPAPI) Contract Manufacturing 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 Formulation
8.3.1.2.2. By End Use
8.3.2. Argentina High Potency API (HPAPI) Contract Manufacturing 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 Formulation
8.3.2.2.2. By End Use
8.3.3. Colombia High Potency API (HPAPI) Contract Manufacturing 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 Formulation
8.3.3.2.2. By End Use
9. Middle East and Africa High Potency API (HPAPI) Contract Manufacturing Market Outlook
9.1. Market Size & Forecast
9.1.1. By Value
9.2. Market Share & Forecast
9.2.1. By Formulation
9.2.2. By End Use
9.2.3. By Country
9.3. MEA: Country Analysis
9.3.1. South Africa High Potency API (HPAPI) Contract Manufacturing 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 Formulation
9.3.1.2.2. By End Use
9.3.2. Saudi Arabia High Potency API (HPAPI) Contract Manufacturing 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 Drug Type
9.3.2.2.2. By End Use
9.3.3. UAE High Potency API (HPAPI) Contract Manufacturing 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 Formulation
9.3.3.2.2. By End Use
9.3.4. Egypt High Potency API (HPAPI) Contract Manufacturing Market Outlook
9.3.4.1. Market Size & Forecast
9.3.4.1.1. By Value
9.3.4.2. Market Share & Forecast
9.3.4.2.1. By Formulation
9.3.4.2.2. By End Use
9.3.5. Kuwait High Potency API (HPAPI) Contract Manufacturing Market Outlook
9.3.5.1. Market Size & Forecast
9.3.5.1.1. By Value
9.3.5.2. Market Share & Forecast
9.3.5.2.1. By Formulation
9.3.5.2.2. By End Use
9.3.6. Turkey High Potency API (HPAPI) Contract Manufacturing Market Outlook
9.3.6.1. Market Size & Forecast
9.3.6.1.1. By Value
9.3.6.2. Market Share & Forecast
9.3.6.2.1. By Formulation
9.3.6.2.2. By End Use
10. Market Dynamics
10.1. Drivers
10.2. Challenges
11. Market Trends & Developments
11.1. Recent Developments
11.2. Product Launches
11.3. Mergers & Acquisitions
12. Global High Potency API (HPAPI) Contract Manufacturing: SWOT Analysis
