의약품 수탁제조 시장 : 제조 제품 유형별, 원료의약품 유형별, 원료의약품 약리 활성별, FDF 유형별, 제형별, 포장 유형별, 사업 규모별, 최종사용자별, 지역별 : 산업 동향 및 세계 예측(-2035년)
Pharmaceutical Contract Manufacturing Market by Type of Product Manufactured, Type of API, API Potency, Type of FDF, Dosage Form, Type of Packaging Offered, Scale of Operation, End Users and Regions: Industry Trends and Global Forecasts, Till 2035
상품코드 : 1616879
리서치사 : Roots Analysis
발행일 : 2024년 12월
페이지 정보 : 영문 545 Pages
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한글목차

세계 의약품 수탁제조 시장 규모는 2035년까지 예측 기간 동안 4.3%의 CAGR로 확대되어 현재 990억 달러에서 2035년까지 1,560억 달러로 성장할 것으로 예상됩니다.

의약품 수탁제조 시장은 주로 제품 출시의 효율성과 유연성에 대한 수요로 인해 크게 성장하고 있습니다. 업무 전문성, 첨단 장비, 전문 시설 등의 요인으로 인해 아웃소싱이 증가하고 있습니다. 세계 CMO 및 CDMO에 제조 업무를 아웃소싱함으로써 기업은 공급망을 다변화하고 정치적, 경제적 불확실성에 따른 리스크를 줄일 수 있다는 점은 주목할 만합니다. 또한 자동화, 연속 생산, 데이터 분석과 같은 첨단 기술의 통합은 생산능력을 향상시키고 고품질의 결과를 보장합니다. 빠르게 진화하는 제약 산업에서 제약 위탁생산 업체들은 복잡한 규제 환경을 극복하고, 제조 워크플로우를 최적화하며, 임상시험에서 상업적 규모의 제조로 원활하게 전환할 수 있는 전문성을 보유하고 있습니다. 앞서 언급한 요인들은 예측 기간 동안 위탁 서비스 제공업체들에게 유리한 시장 성장 기회를 제공할 가능성이 높습니다.

본 보고서는 세계의 의약품 수탁제조 시장에 대해 조사했으며, 시장 개요와 함께 제조 제품 유형별, 원료의약품 유형별, 원료약리활성별, FDF 유형별, 제형별, 포장 유형별, 사업 규모별, 최종사용자별, 지역별 동향, 시장 진출 기업 프로파일 등을 정리하여 전해드립니다.

목차

제1장 서문

제2장 조사 방법

제3장 경제 및 기타 프로젝트 특유의 고려사항

제4장 주요 요약

제5장 소개

제6장 의약품 수탁제조 : 규제 상황

제7장 의약품 수탁제조 : 시장 상황

제8장 지역별 능력

제9장 기업 개요

제10장 쇼트 프로파일

제11장 제조인가 구입인가 의사 의사결정 프레임워크

제12장 인수합병

제13장 최근의 확장

제14장 용량 분석

제15장 수요 분석

제16장 시장에 대한 영향 분석 : 촉진요인, 억제요인, 기회, 과제

제17장 세계의 의약품 수탁제조 시장

제18장 의약품 수탁제조 시장(제조 제품 유형별)

제19장 원료의약품 수탁제조 시장(원료의약품 유형별)

제20장 원료의약품 수탁제조 시장(원료의약품 약리 활성별)

제21장 의약품 FDF 수탁제조 시장(FDF 유형별)

제22장 의약품 FDF 수탁제조 시장(제형별)

제23장 의약품 수탁제조 시장(포장 유형별)

제24장 의약품 수탁제조 시장(최종사용자별)

제25장 의약품 수탁제조 시장(사업 규모별)

제26장 의약품 수탁제조 시장(주요 지역별)

제27장 의약품 수탁제조 시장(주요 기업별)

제28장 사례 연구 : 저분자약과 고분자약/치료법의 비교

제29장 결론

제30장 이그제큐티브 인사이트

제31장 부록 I : 표형식 데이터

제32장 부록 II : 기업 및 단체 리스트

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영문 목차

영문목차

PHARMACEUTICAL CONTRACT MANUFACTURING MARKET: OVERVIEW

As per Roots Analysis, the global pharmaceutical contract manufacturing market is estimated to grow from USD 99 billion in the current year to USD 156 billion by 2035, at a CAGR of 4.3% during the forecast period, till 2035.

The market sizing and opportunity analysis has been segmented across the following parameters:

Type of Product Manufactured

Type of API

API Potency

Type of FDF

Dosage Form

Type of Packaging Offered

Scale of Operation

Type of End-user

Key Geographical Regions

PHARMACEUTICAL CONTRACT MANUFACTURING MARKET: GROWTH AND TRENDS

The pharmaceutical contract manufacturing market is poised for significant growth, primarily driven by the demand for efficiency and flexibility in bringing products to the market. Factors such as operational expertise, advanced equipment and specialized facilities have led to an increase in outsourcing operations. It is worth highlighting that by outsourcing manufacturing operations to CMOs and CDMOs with a global footprint, companies can diversify their supply chains and reduce risks associated with political and economic uncertainties. Moreover, the integration of advanced technologies, such as automation, continuous manufacturing and data analytics, boosts production capabilities and ensures high-quality outcomes. With the rapidly evolving pharmaceutical landscape, contract manufacturers bring expertise in navigating complex regulatory frameworks, optimizing production workflows, and supporting a seamless transition from clinical studies to commercial scale manufacturing. The aforementioned factors are likely to present lucrative market growth opportunities for contract service providers during the forecast period.

PHARMACEUTICAL CONTRACT MANUFACTURING MARKET: KEY INSIGHTS

The report delves into the current state of the pharmaceutical contract manufacturing market and identifies potential growth opportunities within the industry. Some key findings from the report include:

1. Presently, close to 425 organizations offer pharmaceutical contract manufacturing services; of these, majority of the CMOs provide fill-finish / packaging and labelling services.

2. A relatively larger proportion of CMOs manufacture FDFs; close to 15% of the players have the required capabilities to manufacture all types of finished dosage forms.

3. In pursuit of building a competitive edge and to establish themselves as one-stop shops, stakeholders are actively consolidating their capabilities related to small molecule manufacturing through mergers and acquisitions.

4. In order to meet the rising demand for APIs and finished products, CMOs have made elaborate investments in expanding their existing capacities and capabilities; this trend is most pronounced in the US and India.

5. The global pharmaceutical contract manufacturing capacity is well distributed across different facilities worldwide; notably, large and very large players account for 80% of the total capacity.

6. Owing to the increase in outsourcing activity for small molecule manufacturing operations, the demand for pharmaceutical contract manufacturing is anticipated to rise significantly over the decade.

7. In the past decade, a shift in trend has been observed in the pharmaceutical contract manufacturing industry as more players have set up their manufacturing facilities in developing regions across Asia-Pacific.

8. Driven by the increasing pace of expansions and mergers between the stakeholders in this domain, the market for pharmaceutical contract manufacturing is poised to witness steady growth in the foreseeable future.

9. The pharmaceutical contract manufacturing market is anticipated to grow at a steady rate, till 2035; North America is expected to capture the majority share (over 35%) of the market by 2035.

10. In the long term, small and mid-sized companies are likely to drive the growth of the pharmaceutical contract manufacturing market; oral solids is expected to capture the majority share (~50%) by 2035.

PHARMACEUTICAL CONTRACT MANUFACTURING MARKET: KEY SEGMENTS

FDF segment is Likely to Dominate the Pharmaceutical Contract Manufacturing Market During the Forecast Period

Based on the type of product manufactured, the market is segmented into API & Intermediates and FDF. It is worth highlighting that majority of the current pharmaceutical contract manufacturing market is captured by the FDF segment and this trend is likely to remain the same in the forthcoming years. This can be attributed to the growing demand for ready-to-make products, high value addition and stringent regulatory guidelines.

Currently, Generic and Originator APIs Hold Similar Market Share of the Pharmaceutical Contract Manufacturing Market

Based on the type of APIs, the market is segmented into generic API and originator API. It is worth highlighting that, at present, both generic and originator APIs capture almost similar market share in the pharmaceutical contract manufacturing market. This can be attributed to competitive pricing and quality standards maintained by generic manufacturers. It is worth noting that there is continued demand for branded drugs from originator companies.

High Potent API Segment is the Fastest Growing Segment of the Pharmaceutical Contract Manufacturing Market

Based on the types of API by potency, the market is segmented into low potent API and high potent API. Owing to their enhanced efficacy, lower dosage requirements and increasing demand for targeted therapies, the highly potent API (HPAPI) market is likely to grow at a relatively higher CAGR.

Currently, Originator FDF Occupies the Largest Share of the Pharmaceutical Contract Manufacturing Market

Based on the type of FDFs, the market is segmented into generic FDF and originator FDF. Owing to brand loyalty, ongoing investments in research and development, and established market presence, the originator FDF holds the maximum share within the pharmaceutical contract manufacturing market.

Liquid Dosage Form is the Fastest Growing Segment of the Pharmaceutical Contract Manufacturing Market

Based on the dosage forms, the market is segmented into oral solids, liquids, emulsions and others. It is worth highlighting that, due to the simplicity of administration, growing applications in pediatric and geriatric populations and enhanced patient adherence, liquids are likely to grow at a higher CAGR in the forthcoming years.

Currently, Bottles Occupy the Largest Share of the Pharmaceutical Contract Manufacturing Market

Based on the type of packaging offered, the market is segmented into bottles, blisters, parenterals and others. It is worth highlighting that, at present, bottles hold the maximum share within the pharmaceutical contract manufacturing market. Bottles offer various advantages, such as cost-effectiveness, versatility and capability to accommodate various types of formulations and dosages.

By Scale of Operation, Commercial Scale is Likely to Dominate the Pharmaceutical Contract Manufacturing Market

Based on the scale of operation, the market is segmented into clinical and commercial scale. Whilst commercial scale manufacturing will be the primary driver of the overall market, it is worth highlighting that the pharmaceutical contract manufacturing market at the clinical scale is likely to grow at a relatively higher CAGR.

Small Companies Account for the Largest Share of the Pharmaceutical Contract Manufacturing Market

Based on the type of end-user, the market is segmented into small, mid-sized, and large and very large companies. It is worth highlighting that, at present, small companies capture the highest share within the pharmaceutical manufacturing market. This trend is unlikely to change in the near future.

North America Accounts for the Largest Share of the Market

Based on key geographical regions, the market is segmented into North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America. Majority share is expected to be captured by contract manufacturers based in North America. It is worth highlighting that over the years, the market for Asia-Pacific is expected to grow at a higher CAGR.

Example Players in the Pharmaceutical Contract Manufacturing Market

Primary Research Overview

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders. The research report features detailed transcripts of interviews held with the following industry stakeholders:

PHARMACEUTICAL CONTRACT MANUFACTURING MARKET: RESEARCH COVERAGE

KEY QUESTIONS ANSWERED IN THIS REPORT

REASONS TO BUY THIS REPORT

ADDITIONAL BENEFITS

TABLE OF CONTENTS

1. PREFACE

2. RESEARCH METHODOLOGY

3. ECONOMIC AND OTHER PROJECT SPECIFIC CONSIDERATIONS

4. EXECUTIVE SUMMARY

5. INTRODUCTION

6. PHARMACEUTICAL CMOs: REGULATORY LANDSCAPE

7. PHARMACEUTICAL CMOs: MARKET LANDSCAPE

8. REGIONAL CAPABILITY

9. COMPANY PROFILES

10. SHORT PROFILES

11. MAKE VERSUS BUY DECISION FRAMEWORK

12. MERGERS AND ACQUISITIONS

13. RECENT EXPANSIONS

14. CAPACITY ANALYSIS

15. DEMAND ANALYSIS

16. MARKET IMPACT ANALYSIS: DRIVERS, RESTRAINTS, OPPORTUNITIES AND CHALLENGES

17. GLOBAL PHARMACEUTICAL CONTRACT MANUFACTURING MARKET

18. PHARMACEUTICAL CONTRACT MANUFACTURING MARKET, BY TYPE OF PRODUCT MANUFACTURED

19. PHARMACEUTICAL API CONTRACT MANUFACTURING MARKET, BY TYPE OF API

20. PHARMACEUTICAL API CONTRACT MANUFACTURING MARKET, BY API POTENCY

21. PHARMACEUTICAL FDF CONTRACT MANUFACTURING MARKET, BY TYPE OF FDF

22. PHARMACEUTICAL FDF CONTRACT MANUFACTURING MARKET, BY DOSAGE FORM

23. PHARMACEUTICAL CONTRACT MANUFACTURING MARKET, BY TYPE OF PACKAGING OFFERED

24. PHARMACEUTICAL CONTRACT MANUFACTURING MARKET, BY END-USERS

25. PHARMACEUTICAL CONTRACT MANUFACTURING MARKET, BY SCALE OF OPERATION

26. PHARMACEUTICAL CONTRACT MANUFACTURING MARKET, BY KEY GEOGRAPHICAL REGIONS

27. PHARMACEUTICAL CONTRACT MANUFACTURING MARKET, BY LEADING PLAYERS

28. CASE STUDY: COMPARISON OF SMALL AND LARGE MOLECULES DRUGS / THERAPIES

29. CONCLUDING REMARKS

30. EXECUTIVE INSIGHTS

31. APPENDIX I: TABULATED DATA

32. APPENDIX II: LIST OF COMPANIES AND ORGANIZATIONS

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