저분자 CMO/CDMO 시장 보고서(2026년)
Small Molecule CMO/CDMO Global Market Report 2026
상품코드 : 1957802
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

저분자 CMO/CDMO 시장 규모는 최근 몇 년간 크게 성장했습니다. 2025년 544억 2,000만 달러에서 2026년에는 585억 5,000만 달러에 이르고, CAGR 7.6%의 성장이 전망되고 있습니다. 지난 수년간의 성장 요인으로는 제네릭 의약품 제조 확대, 만성질환 유병률 증가, 제약 연구개발 확대, 의약품 생산의 아웃소싱, 품질과 안전에 대한 규제 당국의 추진 등을 꼽을 수 있습니다.

저분자 CMO/CDMO 시장 규모는 향후 몇 년간 강력한 성장이 전망됩니다. 2030년에는 784억 1,000만 달러에 이르고, CAGR은 7.6%를 나타낼 전망입니다. 예측 기간의 성장 요인으로는 개인 맞춤형 의료에 대한 수요 증가, 생물학적 제제 및 저분자 하이브리드 요법에 대한 투자 확대, 신흥 시장에서의 사업 확대, 합성 및 제제 기술의 발전, 신속한 규제 승인에 대한 요구 증가 등을 꼽을 수 있습니다. 예측 기간 동안 주요 동향으로는 위탁 개발 및 제조 서비스 확대, 연속 제조 공정 채택 증가, 저분자 API의 맞춤형 합성 성장, 규제 준수 및 품질 보증에 대한 관심 증가, 제약회사와 CMO 간의 전략적 제휴 등이 있습니다.

의약품 수요 증가는 향후 몇 년간 저분자 CMO/CDMO 시장의 성장을 견인할 것으로 예측됩니다. 제약산업은 정부기관 및 민간조직에 의한 의약품 및 의약품의 발견, 개발, 생산을 포괄하는 분야입니다. 저분자 CMO/CDMO 서비스는 제약업계에서 저분자 의약품의 개발, 제조, 포장 등 다양한 활동을 아웃소싱하는 데 활용되며, 제약기업은 비용 절감, 시간 절약, 공정 최적화를 실현할 수 있습니다. 예를 들어, 미국에 본사를 둔 헬스케어 기업 Cardinal Health에 따르면, 2022년 1월 현재 미국에는 FDA 승인을 받은 바이오시밀러 제품이 33개 품목이 있으며, 그 중 21개 품목이 시판되고 있습니다. 그리고 2023년까지 FDA 승인 바이오시밀러는 40개 품목으로 늘어났고, 25개 품목이 시판되고 있습니다. 이처럼 의약품에 대한 수요 증가는 저분자 CMO/CDMO 시장 확대에 기여하고 있습니다.

저분자 CMO/CDMO 시장에서 사업을 전개하는 주요 기업들은 상하이의 첨단 저분자 플랫폼 등 혁신적인 기술을 중심으로 CDMO 서비스를 강화하고 있습니다. 이 첨단 저분자 플랫폼은 저분자 의약품 개발 및 제조 기술 혁신의 최첨단을 구현하여 보다 안전하고 효과적이며 효율적으로 제조된 의약품 화합물을 창출하는 것을 목표로 하고 있습니다. 예를 들어, 2023년 6월 중국계 제약기업인 바톤파마솔루션즈(BATON Pharma Solutions Co., Ltd.)는 상하이에 첨단 소분자 플랫폼을 설립하여 CDMO 서비스를 강화했습니다. 첨단 소분자 플랫폼은 소분자 의약품의 전체 라이프사이클을 지원하는 종합적인 접근방식으로, 최첨단 기술과 연구 방법을 통합하여 원스톱 솔루션, 엔드투엔드 역량, 유연성 및 가용성, 디지털 전환을 제공합니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 공급망 분석

제4장 세계 시장 동향과 전략

제5장 최종 이용 산업 시장 분석

제6장 시장 : 금리, 인플레이션, 지정학, 무역 전쟁과 관세의 영향, 관세 전쟁과 무역 보호주의의 공급망에 대한 영향, 코로나 팬데믹이 시장에 미치는 영향을 포함한 거시경제 시나리오

제7장 세계 전략 분석 프레임워크, 현재 시장 규모, 시장 비교 및 성장률 분석

제8장 TAM(Total Addressable Market) 규모

제9장 시장 세분화

제10장 지역별/국가별 분석

제11장 아시아태평양 시장

제12장 중국 시장

제13장 인도 시장

제14장 일본 시장

제15장 호주 시장

제16장 인도네시아 시장

제17장 한국 시장

제18장 대만 시장

제19장 동남아시아 시장

제20장 서유럽 시장

제21장 영국 시장

제22장 독일 시장

제23장 프랑스 시장

제24장 이탈리아 시장

제25장 스페인 시장

제26장 동유럽 시장

제27장 러시아 시장

제28장 북미 시장

제29장 미국 시장

제30장 캐나다 시장

제31장 남미 시장

제32장 브라질 시장

제33장 중동 시장

제34장 아프리카 시장

제35장 시장 규제 상황과 투자환경

제36장 경쟁 구도와 기업 개요

제37장 기타 주요 기업 및 혁신 기업

제38장 세계 시장 경쟁 벤치마킹과 대시보드

제39장 주요 인수합병(M&A)

제40장 시장 잠재력이 높은 국가, 부문, 전략

제41장 부록

LSH
영문 목차

영문목차

A small-molecule contract manufacturing organization (CMO) or contract development and manufacturing organization (CDMO) is a company that provides services to other pharmaceutical companies on a contract basis for the execution of projects and subsequent regulatory submission. These organizations provide a variety of services, including contract development, manufacturing, and packaging of small-molecule drugs.

The main types of small-molecule CMO and CDMO are small-molecule drug products and small-molecule APIs. A small-molecule drug product refers to the final form of a medicinal product that contains an active pharmaceutical ingredient (API) made up of small molecules. It encompasses various stages, including clinical, commercial, and preclinical, is applied in oncology, neurology, infectious disease, cardiovascular disease, respiratory disorders, metabolic disorders, and others, and the end users are cardiovascular, oncology, diabetes, and immunological disorder patients.

Tariffs have impacted the small molecule CMO/CDMO market by increasing the cost of imported raw materials, APIs, and specialized manufacturing equipment, leading to higher production costs and supply chain delays. The commercial and preclinical small molecule drug segments, especially in regions such as North America and Asia-Pacific, are most affected due to reliance on cross-border sourcing. However, tariffs are encouraging local manufacturing initiatives and strategic supplier diversification, which may strengthen regional capabilities and reduce long-term dependency on imports.

The small molecule cmo/cdmo market research report is one of a series of new reports from The Business Research Company that provides small molecule cmo/cdmo market statistics, including small molecule cmo/cdmo industry global market size, regional shares, competitors with a small molecule cmo/cdmo market share, detailed small molecule cmo/cdmo market segments, market trends and opportunities, and any further data you may need to thrive in the small molecule cmo/cdmo industry. This small molecule cmo/cdmo 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 small molecule cmo/cdmo market size has grown strongly in recent years. It will grow from $54.42 billion in 2025 to $58.55 billion in 2026 at a compound annual growth rate (CAGR) of 7.6%. The growth in the historic period can be attributed to growth in generic drug manufacturing, rising prevalence of chronic diseases, expansion of pharmaceutical R&D, outsourcing of drug production, regulatory push for quality and safety.

The small molecule cmo/cdmo market size is expected to see strong growth in the next few years. It will grow to $78.41 billion in 2030 at a compound annual growth rate (CAGR) of 7.6%. The growth in the forecast period can be attributed to increasing demand for personalized medicine, rising investments in biologics and small-molecule hybrid therapies, expansion in emerging markets, technological advancements in synthesis and formulation, growing need for faster regulatory approvals. Major trends in the forecast period include expansion of contract development and manufacturing services, increasing adoption of continuous manufacturing processes, growth in custom synthesis of small-molecule apis, rising focus on regulatory compliance and quality assurance, strategic partnerships between pharma companies and cmos.

The increasing demand for pharmaceuticals is expected to drive the growth of the small-molecule CMO/CDMO market in the coming years. The pharmaceutical industry is a field that encompasses the discovery, development, and production of drugs and medicines by both government and private organizations. Small-molecule CMO/CDMO services are utilized in the pharmaceutical industry to outsource various activities, including the development, manufacturing, and packaging of small-molecule drugs, enabling pharmaceutical companies to reduce costs, save time, and optimize processes. For example, in January 2023, according to Cardinal Health Inc., a US-based healthcare company, as of January 2022, the U.S. had 33 FDA-approved biosimilar products, with 21 available on the market, and by 2023, the number of FDA-approved biosimilars had increased to 40, with 25 commercially available. Thus, the growing demand for pharmaceuticals is contributing to the expansion of the small-molecule CMO/CDMO market.

Major companies operating in the small-molecule CMO/CDMO market are emphasizing innovative technologies, such as the advanced small-molecule platform in Shanghai, to enhance CDMO services. The advanced small-molecule platform represents the leading edge of technological innovations for developing and producing small-molecule drugs, aiming to create safer, more effective, and more efficiently manufactured pharmaceutical compounds. For example, in June 2023, Porton Pharma Solutions Ltd., a China-based pharmaceutical company, launched an advanced small-molecule platform in Shanghai, enhancing CDMO services. An advanced small-molecule platform represents a comprehensive approach, integrating cutting-edge technologies and methodologies to support the entire lifecycle of small-molecule pharmaceuticals, offering one-stop-shop solutions, end-to-end capabilities, flexibility and availability, and digital transformation.

In February 2024, Novo Holdings A/S, a Denmark-based investment firm, acquired Catalent, Inc. for $16.5 billion. Through this acquisition, Novo Holdings aims to enhance its global CDMO capabilities by utilizing Catalent's extensive manufacturing network and expertise in the development, production, and supply of small-molecule and biologic therapies. Catalent, Inc. is a US-based company that provides small-molecule contract development and manufacturing (CDMO) services.

Major companies operating in the small molecule cmo/cdmo market are Patheon NV (Thermo Fisher Scientific), Johnson Matthey plc, Lonza Group Ltd., WuXi AppTec, Catalent Inc., Aurobindo Pharma, Fareva, Aesica Pharmaceuticals Limited, Siegfried holdings AG, Recipharm AB, Jubilant Life Sciences Limited, Almac Group, Piramal Pharma Solutions, Oxford Chemicals Inc., Syngene International Limited, Novasep, Pfizer CentreOne, GVK Biosciences, ChemPartner, Dishman Carbogen Amcis Ltd, ProChem Inc., Metrics Contract Services

North America was the largest region in the small molecule CMO/CDMO market in 2025. The regions covered in the small molecule cmo/cdmo market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

The countries covered in the small molecule cmo/cdmo market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The small-molecule contract manufacturing organization (CMO) or contract development and manufacturing organization (CDMO) market consists of revenues earned by entities by providing services such as drug development services, process scale-up, quality control and testing, technology transfer, and clinical trial support. The market value includes the value of related goods sold by the service provider or included within the service offering. The small-molecule contract manufacturing organization (CMO) or contract development and manufacturing organization (CDMO) market also includes sales of active pharmaceutical ingredients, drug intermediates, and drug formulation. 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.

Small Molecule CMO/CDMO Market Global Report 2026 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses small molecule cmo/cdmo 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 small molecule cmo/cdmo ? 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 small molecule cmo/cdmo 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, total addressable market (TAM), market attractiveness score (MAS), competitive landscape, market shares, company scoring matrix, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.

Scope

Added Benefits available all on all list-price licence purchases, to be claimed at time of purchase. Customisations within report scope and limited to 20% of content and consultant support time limited to 8 hours.

Table of Contents

1. Executive Summary

2. Small Molecule CMO/CDMO Market Characteristics

3. Small Molecule CMO/CDMO Market Supply Chain Analysis

4. Global Small Molecule CMO/CDMO Market Trends And Strategies

5. Small Molecule CMO/CDMO Market Analysis Of End Use Industries

6. Small Molecule CMO/CDMO Market - Macro Economic Scenario Including The Impact Of Interest Rates, Inflation, Geopolitics, Trade Wars and Tariffs, Supply Chain Impact from Tariff War & Trade Protectionism, And Covid And Recovery On The Market

7. Global Small Molecule CMO/CDMO Strategic Analysis Framework, Current Market Size, Market Comparisons And Growth Rate Analysis

8. Global Small Molecule CMO/CDMO Total Addressable Market (TAM) Analysis for the Market

9. Small Molecule CMO/CDMO Market Segmentation

10. Small Molecule CMO/CDMO Market Regional And Country Analysis

11. Asia-Pacific Small Molecule CMO/CDMO Market

12. China Small Molecule CMO/CDMO Market

13. India Small Molecule CMO/CDMO Market

14. Japan Small Molecule CMO/CDMO Market

15. Australia Small Molecule CMO/CDMO Market

16. Indonesia Small Molecule CMO/CDMO Market

17. South Korea Small Molecule CMO/CDMO Market

18. Taiwan Small Molecule CMO/CDMO Market

19. South East Asia Small Molecule CMO/CDMO Market

20. Western Europe Small Molecule CMO/CDMO Market

21. UK Small Molecule CMO/CDMO Market

22. Germany Small Molecule CMO/CDMO Market

23. France Small Molecule CMO/CDMO Market

24. Italy Small Molecule CMO/CDMO Market

25. Spain Small Molecule CMO/CDMO Market

26. Eastern Europe Small Molecule CMO/CDMO Market

27. Russia Small Molecule CMO/CDMO Market

28. North America Small Molecule CMO/CDMO Market

29. USA Small Molecule CMO/CDMO Market

30. Canada Small Molecule CMO/CDMO Market

31. South America Small Molecule CMO/CDMO Market

32. Brazil Small Molecule CMO/CDMO Market

33. Middle East Small Molecule CMO/CDMO Market

34. Africa Small Molecule CMO/CDMO Market

35. Small Molecule CMO/CDMO Market Regulatory and Investment Landscape

36. Small Molecule CMO/CDMO Market Competitive Landscape And Company Profiles

37. Small Molecule CMO/CDMO Market Other Major And Innovative Companies

38. Global Small Molecule CMO/CDMO Market Competitive Benchmarking And Dashboard

39. Key Mergers And Acquisitions In The Small Molecule CMO/CDMO Market

40. Small Molecule CMO/CDMO Market High Potential Countries, Segments and Strategies

41. Appendix

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