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세계의 의약품 불순물 합성 및 분리 서비스 시장 보고서(2025년)
Pharmaceutical Impurity Synthesis and Isolation Services Global Market Report 2025
상품코드 : 1811003
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

세계의 의약품 불순물 합성 및 분리 서비스 시장 규모는 향후 수년간 강력한 성장이 예상됩니다. 2029년까지 연평균 복합 성장률(CAGR) 8.3%로 확대되어 16억 3,000만 달러로 성장할 것으로 예상됩니다. 예측기간의 성장은 바이오의약품 파이프라인의 확대, 고순도 의약품원료(API) 수요 증가, 니트로소아민과 유전독성 불순물에 대한 규제의 관심이 높아지고, 맞춤형 의료의 성장, 수탁 연구 및 제조 서비스(CRO/CDMO)에 대한 투자 증가 등에 기인하고 있습니다. 이 기간에 예상되는 세계 동향에는 AI를 활용한 불순물 식별 채택, 합성 프로세스에서의 그린 케미컬 원칙 통합, 세계 준거 GMP 서비스 제공업체 확대, 고분해능 질량 분석과 핵자기 공명(NMR) 기술의 활용, 불순물 프로파일링과 분리 노력의 가속을 목적으로 한 전략적 제휴 등이 있습니다.

바이오시밀러의 생산 확대가 향후 몇 년간의 의약품 불순물 합성 및 분리 서비스 시장의 확대를 견인할 것으로 예측됩니다. 바이오시밀러는 이미 승인된 기준 제형과 매우 유사한 생물 제제이며 안전성, 효능 및 품질에 큰 차이가 없습니다. 바이오시밀러 의약품의 생산이 증가하고 있는 것은 선발품인 생물제제의 특허가 끝난 것이 주요 원인이며, 이로써 제조업체는 보다 비용 효율적인 대체품을 개발해, 치료에의 액세스를 향상시킬 수 있습니다. 의약품 불순물 합성 및 분리 서비스는 바이오시밀러 개발에 있어서 불순물의 동정, 특성 분석, 제어를 가능하게 하고, 바이오시밀러가 안전성, 품질, 규제 기준을 충족하는 것을 보증하는 중요한 역할을 담당하고 있습니다. 예를 들어, 2025년 3월, 아프리카 개발 은행은 새로운 XpandC 시설이 2032년까지 연간 바이오시밀러 생산 능력을 300만에서 765만 용량으로 증가시키는 것을 목표로 하고 있으며, 2개의 새로운 바이오시밀러의 도입을 계획하고 있다고 보고했습니다. 그 결과, 바이오시밀러의 생산량 증가가 의약품 불순물 합성 및 분리 서비스 시장의 성장을 가속하고 있습니다.

의약품 불순물 합성 및 분리 서비스 시장의 주요 기업은 의약품의 안전성을 확보하고, 규제 기준을 충족하고, 의약품의 품질을 향상시키기 위해 리도카인 불순물의 검증 및 검사 등 첨단 솔루션을 개발하고 있습니다. 리도카인의 불순물 밸리데이션과 검사는 리도카인 제제 중의 불순물을 검출 및 정량하고, 안정성, 건강 규제에 대한 준거를 확인하는 것입니다. 예를 들어, 2025년 7월, 방글라데시 제약 회사 Advent Pharma Limited는 주요 리도카인 불순물-1,4-비스(2,6-디메틸페닐)피페라진-2,5-디온의 고순도 표준물질을 도입했습니다. 이 불순물은 리도카인의 합성과 분해 시에 생성될 수 있으며, 약효와 안전성을 확보하기 위해서는 일관된 모니터링이 필요합니다. 순도 97% 이상의 Advent 스탠다드는 종합적인 분석 자료 첨부로 ICH Q3A/B나 Q2 가이드라인 등의 엄격한 규제 기준을 준수하고 있어 분석법의 검증, 안정성 검사, 규제 당국에의 제출을 지원합니다.

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

JHS
영문 목차

영문목차

Pharmaceutical impurity synthesis and isolation services involve specialized processes aimed at deliberately generating and isolating trace-level impurities that may occur during the production, storage, or degradation of pharmaceutical products. These services are critical for helping pharmaceutical companies accurately identify, characterize, and quantify impurities to meet regulatory requirements and ensure the safety, efficacy, and quality of their drug products.

The primary types of services offered include synthesis services, isolation services, and analytical services. Synthesis services involve the controlled creation of chemical compounds-such as active ingredients, intermediates, or impurities-through chemical reactions and purification techniques. These services target various impurity types, including organic impurities, inorganic impurities, and residual solvents, and utilize advanced techniques such as chromatography, spectroscopy, crystallization, hyphenated methods, and more. They are applied in areas such as drug development, commercial manufacturing, quality control, and regulatory compliance, serving a range of end users including pharmaceutical and biotechnology companies, contract research organizations (CROs), and others.

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 sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the pharmaceutical companies contend with tariffs on APIs, glass vials, and lab equipment inputs with few alternative sources. Generic drug makers, operating on razor-thin margins, are especially vulnerable, with some reducing production of low-profit medicines. Biotech firms face delays in clinical trials due to tariff-related shortages of specialized reagents. In response, the industry is expanding API production in India and Europe, increasing inventory stockpiles, and pushing for trade exemptions for essential medicines.

The pharmaceutical impurity synthesis and isolation services market research report is one of a series of new reports from The Business Research Company that provides pharmaceutical impurity synthesis and isolation services market statistics, including pharmaceutical impurity synthesis and isolation services industry global market size, regional shares, competitors with a pharmaceutical impurity synthesis and isolation services market share, detailed pharmaceutical impurity synthesis and isolation services market segments, market trends and opportunities, and any further data you may need to thrive in the pharmaceutical impurity synthesis and isolation services industry. This pharmaceutical impurity synthesis and isolation services 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 pharmaceutical impurity synthesis and isolation services market size has grown strongly in recent years. It will grow from $1.09 billion in 2024 to $1.19 billion in 2025 at a compound annual growth rate (CAGR) of 8.5%. The growth during the historic period can be attributed to stringent regulatory requirements for impurity profiling, increasing complexity of drug molecules, rising levels of outsourcing by pharmaceutical companies, expansion in generic drug manufacturing, and significant advancements in analytical instrumentation.

The pharmaceutical impurity synthesis and isolation services market size is expected to see strong growth in the next few years. It will grow to $1.63 billion in 2029 at a compound annual growth rate (CAGR) of 8.3%. The growth in the forecast period can be attributed to the expanding biopharmaceutical pipelines, increasing demand for high-purity active pharmaceutical ingredients (APIs), heightened regulatory focus on nitrosamine and genotoxic impurities, growth in personalized medicine, and rising investment in contract research and manufacturing services (CRO/CDMO). Key trends expected during this period include the adoption of AI-driven impurity identification, integration of green chemistry principles in synthesis processes, expansion of globally compliant GMP service providers, utilization of high-resolution mass spectrometry and nuclear magnetic resonance (NMR) techniques, and strategic collaborations aimed at accelerating impurity profiling and isolation efforts.

The growing production of biosimilars is anticipated to drive the expansion of the pharmaceutical impurity synthesis and isolation services market in the coming years. Biosimilars are biologic medications that closely resemble an already approved reference product, with no significant differences in terms of safety, efficacy, or quality. This increase in biosimilar production is largely due to the expiration of patents on original biologic drugs, which allows manufacturers to develop more cost-effective alternatives and enhance access to treatment. Pharmaceutical impurity synthesis and isolation services play a crucial role in biosimilar development by enabling the identification, characterization, and control of impurities, ensuring the biosimilar meets safety, quality, and regulatory standards. For example, in March 2025, the African Development Bank reported that the new XpandC facility aims to increase annual biosimilar production capacity from 3 million to 7.65 million doses by 2032 and plans to introduce two new biosimilars. As a result, the rising production of biosimilars is fueling growth in the pharmaceutical impurity synthesis and isolation services market.

Leading companies in the pharmaceutical impurity synthesis and isolation services market are developing advanced solutions, such as lidocaine impurity validation and testing, to ensure drug safety, meet regulatory standards, and improve the quality of pharmaceutical products. Lidocaine impurity validation and testing involve detecting and quantifying impurities in lidocaine formulations to confirm their safety, stability, and compliance with health regulations. For instance, in July 2025, Advent Pharma Limited, a pharmaceutical company based in Bangladesh, introduced a high-purity reference standard for a key lidocaine impurity-1,4-Bis(2,6-dimethylphenyl) piperazine-2,5-dione. This impurity can form during the synthesis or degradation of lidocaine and requires consistent monitoring to ensure drug efficacy and safety. Advent's standard, which has a purity of at least 97%, comes with comprehensive analytical documentation and complies with stringent regulatory standards such as ICH Q3A/B and Q2 guidelines, supporting method validation, stability studies, and regulatory submissions.

In October 2022, Symeres B.V., a Netherlands-based contract development and manufacturing organization, acquired Exemplify BioPharma for an undisclosed sum. This acquisition was intended to bolster Symeres' strategic footprint in the United States by integrating Exemplify BioPharma's specialized capabilities in process chemistry, analytical chemistry, and formulation development. This move enhances Symeres' comprehensive drug development offerings and strengthens its ability to serve biotech and pharmaceutical clients across North America as part of its broader transatlantic expansion plan. Exemplify BioPharma is a U.S.-based company providing services in pharmaceutical impurity synthesis and isolation.

Major players in the pharmaceutical impurity synthesis and isolation services market are Thermo Fisher Scientific Inc., Merck KGaA, Laboratory Corporation of America Holdings, SGS SA, Eurofins Scientific SE, Agilent Technologies Inc., WuXi AppTec Co. Ltd., Catalent Inc., Charles River Laboratories International Inc., Intertek Group plc, Waters Corporation, Almac Group Limited, Piramal Pharma Limited, Cambrex Corporation, Syngene International Limited, Frontage Laboratories Inc., Pharmaron Beijing Co. Ltd., Symeres B.V., Synergenics Canada Inc., Veeda Clinical Research Limited, Alfa Chemistry LLC, Epichem Pty Ltd., Creative Dynamics Inc., PCI Pharma Services LLC, and VEEPRHO s.r.o.

North America was the largest region in the pharmaceutical impurity synthesis and isolation services market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in pharmaceutical impurity synthesis and isolation services report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The countries covered in the pharmaceutical impurity synthesis and isolation services market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The pharmaceutical impurity synthesis and isolation services market consists of revenues earned by entities by providing services such as synthesis of impurities, isolation of impurities, impurity testing and characterization, and analytical control strategies. 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.

Pharmaceutical Impurity Synthesis and Isolation Services 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 pharmaceutical impurity synthesis and isolation services 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 pharmaceutical impurity synthesis and isolation services ? 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 pharmaceutical impurity synthesis and isolation services 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. Pharmaceutical Impurity Synthesis And Isolation Services Market Characteristics

3. Pharmaceutical Impurity Synthesis And Isolation Services Market Trends And Strategies

4. Pharmaceutical Impurity Synthesis And Isolation Services 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 Pharmaceutical Impurity Synthesis And Isolation Services Growth Analysis And Strategic Analysis Framework

6. Pharmaceutical Impurity Synthesis And Isolation Services Market Segmentation

7. Pharmaceutical Impurity Synthesis And Isolation Services Market Regional And Country Analysis

8. Asia-Pacific Pharmaceutical Impurity Synthesis And Isolation Services Market

9. China Pharmaceutical Impurity Synthesis And Isolation Services Market

10. India Pharmaceutical Impurity Synthesis And Isolation Services Market

11. Japan Pharmaceutical Impurity Synthesis And Isolation Services Market

12. Australia Pharmaceutical Impurity Synthesis And Isolation Services Market

13. Indonesia Pharmaceutical Impurity Synthesis And Isolation Services Market

14. South Korea Pharmaceutical Impurity Synthesis And Isolation Services Market

15. Western Europe Pharmaceutical Impurity Synthesis And Isolation Services Market

16. UK Pharmaceutical Impurity Synthesis And Isolation Services Market

17. Germany Pharmaceutical Impurity Synthesis And Isolation Services Market

18. France Pharmaceutical Impurity Synthesis And Isolation Services Market

19. Italy Pharmaceutical Impurity Synthesis And Isolation Services Market

20. Spain Pharmaceutical Impurity Synthesis And Isolation Services Market

21. Eastern Europe Pharmaceutical Impurity Synthesis And Isolation Services Market

22. Russia Pharmaceutical Impurity Synthesis And Isolation Services Market

23. North America Pharmaceutical Impurity Synthesis And Isolation Services Market

24. USA Pharmaceutical Impurity Synthesis And Isolation Services Market

25. Canada Pharmaceutical Impurity Synthesis And Isolation Services Market

26. South America Pharmaceutical Impurity Synthesis And Isolation Services Market

27. Brazil Pharmaceutical Impurity Synthesis And Isolation Services Market

28. Middle East Pharmaceutical Impurity Synthesis And Isolation Services Market

29. Africa Pharmaceutical Impurity Synthesis And Isolation Services Market

30. Pharmaceutical Impurity Synthesis And Isolation Services Market Competitive Landscape And Company Profiles

31. Pharmaceutical Impurity Synthesis And Isolation Services Market Other Major And Innovative Companies

32. Global Pharmaceutical Impurity Synthesis And Isolation Services Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Pharmaceutical Impurity Synthesis And Isolation Services Market

34. Recent Developments In The Pharmaceutical Impurity Synthesis And Isolation Services Market

35. Pharmaceutical Impurity Synthesis And Isolation Services Market High Potential Countries, Segments and Strategies

36. Appendix

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