세계의 제형 개발 아웃소싱 시장 보고서(2025년)
Formulation Development Outsourcing Global Market Report 2025
상품코드 : 1807786
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

제형 개발 아웃소싱 시장 규모는 앞으로 수년간 급성장할 것으로 전망됩니다. 2029년에 CAGR은 10.2%를 나타낼 것으로 예측되고 476억 8,000만 달러로 성장할 전망입니다. 예측 기간 동안의 성장은 약물 분자의 복잡성 증가, 전략적 파트너십, 연구개발 비용 상승, 바이오의약품 혁신, 유연한 생산 능력 등에 기인할 수 있습니다. 예측 기간의 주요 트렌드로는 연속 제조 공정 통합, 서방형 제형 아웃소싱, 특수 약물 전달 시스템 협력, 아웃소싱 서비스의 규제 전문성, 제형 설계에 인공지능(AI) 활용 등이 포함됩니다.

향후 5년간 10.2% 성장 전망은 이 시장에 대한 이전 추정치 대비 0.2% 소폭 하향 조정된 수치입니다. 이 하향 조정은 주로 미국과 타국 간 관세 영향 때문입니다. 관세 인상으로 스위스 및 독일에서 수입하는 고처리량 스크리닝 장비와 제형 소프트웨어 비용이 상승하여 미국 제약사들의 운영에 차질이 발생할 가능성이 높습니다. 이는 연구개발 비용 증가와 함께 신약 개발 일정을 지연시킬 수 있습니다. 또한 상호 보복 관세와 무역 긴장 및 제한 강화로 인한 세계 경제 및 무역에 대한 부정적 영향으로 그 파급 효과는 더욱 광범위해질 것입니다.

만성 질환의 증가 추세는 향후 제형 개발 아웃소싱 시장 성장을 견인할 것으로 예상됩니다. 만성 질환은 지속적인 의료 관리가 필요하며 일상 활동을 제한할 수 있는 장기적 상태입니다. 이러한 질환에 대한 효과적인 제형 및 치료법 개발에는 전문 지식과 자원이 요구됩니다. 제형 개발 아웃소싱은 만성 질환 치료를 목표로 하는 약물 제형의 연구, 개발 및 최적화를 외부 전문가나 전문 기업과 협력하여 수행하는 것을 의미합니다. 예를 들어, 2023년 11월 룩셈부르크 정부 기관인 유로스타트(Eurostat)는 2022년 EU 인구의 3분의 1 이상(36.1%)이 장기적인 만성 건강 문제를 겪고 있다고 보고했습니다. 따라서 만성 질환 발생률의 증가는 제형 개발 아웃소싱 시장의 성장을 촉진하고 있습니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 동향과 전략

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

제5장 세계의 성장 분석과 전략 분석 프레임워크

제6장 시장 세분화

제7장 지역별, 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, 전략

제36장 부록

HBR
영문 목차

영문목차

Formulation development outsourcing involves the practice of enlisting external experts or organizations to manage the formulation and development process of a product. This outsourcing arrangement enables companies to tap into the specialized knowledge, resources, and expertise of external parties for the development or enhancement of their product formulations.

The primary services offered in formulation development outsourcing include pre-formulation and formulation development. Pre-formulation pertains to the developmental stage in pharmaceutical formulations, encompassing various therapeutic areas such as oncology, infectious disease, neurology, hematology, respiratory, cardiovascular, dermatology, among others. These formulations cover diverse administration methods, including oral, injectable, topical, and others. Formulation development outsourcing is utilized by various end-users, including pharmaceutical industries, research entities, and academic development.

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 ensuing trade tensions in spring 2025 are taking a toll on the professional services sector, especially within legal, consulting, architectural, and engineering fields. Increased duties on imported technology, software, office hardware, and digital infrastructure have pushed up operational costs for firms that rely on global systems and resources. Cross-border consulting engagements are experiencing delays and higher expenses due to elevated travel costs and limited access to international data and tools. Moreover, industries heavily impacted by tariffs such as manufacturing, construction, and logistics are reducing their reliance on outsourced services, dampening demand for professional support. In response, service providers are reassessing pricing models, strengthening ties with domestic vendors, and accelerating the adoption of AI and automation to maintain profitability and client satisfaction in an increasingly volatile environment.

The formulation development outsourcing research report is one of a series of new reports from The Business Research Company that provides formulation development outsourcing statistics, including formulation development outsourcing industry global market size, regional shares, competitors with a formulation development outsourcing share, detailed formulation development outsourcing segments, market trends, and opportunities, and any further data you may need to thrive in the formulation development outsourcing industry. This formulation development outsourcing 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 formulation development outsourcing market size has grown strongly in recent years. It will grow from $29.83 billion in 2024 to $32.32 billion in 2025 at a compound annual growth rate (CAGR) of 8.4%. The growth in the historic period can be attributed to cost efficiency, focus on core competencies, regulatory compliance, accelerated drug development, and access to specialized expertise.

The formulation development outsourcing market size is expected to see rapid growth in the next few years. It will grow to $47.68 billion in 2029 at a compound annual growth rate (CAGR) of 10.2%. The growth in the forecast period can be attributed to the increased complexity of drug molecules, strategic partnerships, rising R&D costs, biopharmaceutical innovations, and flexible capacity. Major trends in the forecast period include integration of continuous manufacturing processes, outsourcing for modified-release formulations, collaborations for specialized drug delivery systems, regulatory expertise in outsourced services, and utilization of artificial intelligence (AI) in formulation design.

The forecast of 10.2% growth over the next five years reflects a modest reduction of 0.2% from the previous estimate for this market. This reduction is primarily due to the impact of tariffs between the US and other countries. Tariff escalations are likely to disrupt U.S. pharmaceutical companies by driving up costs for high-throughput screening equipment and drug formulation software imported from Switzerland and Germany, potentially delaying drug development timelines while increasing research and development expenses. 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 increasing prevalence of chronic diseases is expected to drive the growth of the formulation development outsourcing market in the future. Chronic diseases are long-lasting conditions that require ongoing medical care and can limit daily activities. Developing effective formulations and therapies for these conditions demands specialized expertise and resources. Formulation development outsourcing involves collaborating with external experts or specialized companies to handle the research, development, and optimization of drug formulations aimed at treating chronic diseases. For example, in November 2023, Eurostat, a government agency in Luxembourg, reported that over one-third (36.1%) of individuals in the EU faced a long-term chronic health condition in 2022. Therefore, the rising incidence of chronic diseases is fueling the growth of the formulation development outsourcing market.

The formulation development outsourcing market is also expected to witness growth due to the increasing demand for drugs. Drugs, substances used for medical treatment, disease prevention, symptom relief, or recreational purposes, are central to the healthcare industry. Formulation development outsourcing plays a crucial role in drug development, supporting activities such as the development of biopharmaceuticals and novel drug delivery systems, accelerating the drug development process, and providing a cost-effective solution for pharmaceutical companies. In April 2022, according to Fierce Healthcare, total drug expenditure in the United States witnessed a 7.7% growth in 2021, reaching $576.9 billion, and is projected to experience an estimated increase ranging from 4% to 6% in 2022. Therefore, the growing demand for drugs is a significant factor driving the growth of the formulation development outsourcing market.

Technological advancements represent a prominent trend gaining traction in the formulation development outsourcing market. Companies within this market are embracing cutting-edge technologies, such as artificial intelligence (AI) and machine learning (ML), to maintain their competitive positions. For example, in March 2023, Nvidia, a US-based software technology company, introduced BioNeMo Cloud, a novel component in their AI Foundations suite. This service grants researchers access to pre-trained AI models, facilitating customization with private data to expedite life sciences research, drug discovery, and protein engineering. Notably, industry leaders such as Amgen and numerous startups are leveraging this technology as a cloud service, accelerating drug development processes.

Major players in the formulation development outsourcing market are strategically focusing on enhancing various outsourcing capabilities, including method development. Method development capabilities denote an organization's or laboratory's expertise, skills, and resources to create, optimize, and validate analytical methods for analyzing various substances. For instance, in February 2022, Berkshire Sterile Manufacturing (BSM), a US-based sterile filling contract manufacturer, bolstered its clients' drug production capabilities by incorporating formulation, lyophilization, and method development expertise. BSM is expanding its services to cover first-in-human formulation development, providing materials for preclinical studies, and conducting research-level stability studies. Additionally, BSM is offering services for formulation optimization, process development, optimization, and scale-up studies, utilizing materials and equipment indicative of future Good Manufacturing Practice (GMP) manufacturing.

In August 2022, Catalent Inc., a US-based pharmaceutical company, completed the acquisition of Metrics Inc. for $475 million. This strategic move broadened, diversified, and enriched Catalent's portfolio by adding capabilities in integrated oral solid formulation development, manufacturing, and packaging. This expansion aims to assist customers in simplifying and accelerating their programs while enhancing their capacity to handle highly potent compounds. Metrics Inc. is a US-based global pharmaceutical formulation development organization specializing in novel oral dosage forms.

Major companies operating in the formulation development outsourcing market include Syngene International Ltd., Aizant Drug Research Solutions Private Limited., Catalent Inc., Intertek Group plc, Recipharm AB, SGS S.A., Lonza Group AG, Eurofins Scientific SE, Laboratory Corporation of America Holdings, Charles River Laboratories International Inc., Emergent Biosolutions Inc., IRISYS LLC, Piramal Pharma Limited., Biocon Limited., Dr Reddy's Laboratories Ltd., Quotient Sciences Ltd., Almac Group, Patheon, Evonik Industries AG, Metrics Contract Services, Aenova Group, Fareva Group, Vetter Pharma International GmbH, Aesica Pharmaceuticals, WuXi AppTec, Formosa Laboratories Inc., Aptuit LLC, ProPharma Group, Laurus Labs Limited

North America was the largest region in the global formulation development outsourcing market in 2024. The regions covered in the formulation development outsourcing market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa

The countries covered in the formulation development outsourcing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain

The formulation development outsourcing market includes revenues earned by entities by providing services such as ingredient sourcing, stability studies, analytical testing, and regulatory support. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

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.

Formulation Development Outsourcing 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 formulation development outsourcing 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 formulation development outsourcing ? 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 formulation development outsourcing 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. Formulation Development Outsourcing Market Characteristics

3. Formulation Development Outsourcing Market Trends And Strategies

4. Formulation Development Outsourcing 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 Formulation Development Outsourcing Growth Analysis And Strategic Analysis Framework

6. Formulation Development Outsourcing Market Segmentation

7. Formulation Development Outsourcing Market Regional And Country Analysis

8. Asia-Pacific Formulation Development Outsourcing Market

9. China Formulation Development Outsourcing Market

10. India Formulation Development Outsourcing Market

11. Japan Formulation Development Outsourcing Market

12. Australia Formulation Development Outsourcing Market

13. Indonesia Formulation Development Outsourcing Market

14. South Korea Formulation Development Outsourcing Market

15. Western Europe Formulation Development Outsourcing Market

16. UK Formulation Development Outsourcing Market

17. Germany Formulation Development Outsourcing Market

18. France Formulation Development Outsourcing Market

19. Italy Formulation Development Outsourcing Market

20. Spain Formulation Development Outsourcing Market

21. Eastern Europe Formulation Development Outsourcing Market

22. Russia Formulation Development Outsourcing Market

23. North America Formulation Development Outsourcing Market

24. USA Formulation Development Outsourcing Market

25. Canada Formulation Development Outsourcing Market

26. South America Formulation Development Outsourcing Market

27. Brazil Formulation Development Outsourcing Market

28. Middle East Formulation Development Outsourcing Market

29. Africa Formulation Development Outsourcing Market

30. Formulation Development Outsourcing Market Competitive Landscape And Company Profiles

31. Formulation Development Outsourcing Market Other Major And Innovative Companies

32. Global Formulation Development Outsourcing Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Formulation Development Outsourcing Market

34. Recent Developments In The Formulation Development Outsourcing Market

35. Formulation Development Outsourcing Market High Potential Countries, Segments and Strategies

36. Appendix

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