세계의 합성저분자 원료의약품 시장 보고서(2025년)
Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Global Market Report 2025
상품코드 : 1811044
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

합성저분자 원료의약품 시장 규모는 향후 수년간 강력한 성장이 전망됩니다. 2029년에는 CAGR 6.3%로 2,112억 1,000만 달러로 성장합니다. 이 예측 기간 중의 성장은 생활습관병 유병률 증가, 중저소득 국가의 의료 서비스 접근성 증가, 저분자 의약품의 임상시험 활동 확대, 새로운 화학 물질의 승인 속도 향상, 국내 원료의약품 생산을 지원하는 정부 구상 증가 등에 기인하는 것으로 보입니다. 이 기간 중 예상되는 주요 동향으로는 연속 제조 기술의 발전, 공정 개발에 인공지능의 통합, 그린 케미스트리 및 지속가능한 합성법 채택, 고역가 원료의약품(HPAPI) 개발, 품질관리 및 생산 워크플로우 자동화의 진전 등이 있습니다.

비용 효율적인 제네릭 의약품에 대한 수요 증가는 향후 수년간 합성 저분자 의약품 원료의약품 시장의 성장을 촉진할 것으로 예측됩니다. 비용 효율적인 제네릭 의약품은 동일한 유효 성분을 함유하고 동일한 치료 효과를 제공하는 브랜드 의약품을 저렴하게 대체할 수 있는 제품입니다. 이러한 수요 증가는 주로 만성질환 유병률 증가로 인해 장기적이고 경제적으로 실행 가능한 치료 옵션이 필요하기 때문입니다. 합성 저분자 API는 치료 효과는 유지하면서 제조 비용을 낮추는 확장 가능하고 효율적인 제조 공정을 가능하게 함으로써 이러한 제네릭 의약품의 생산을 지원합니다. 예를 들어 2024년 9월, 미국에 본사를 둔 업계 단체인 AAM(Association for Accessible Medicines)은 바이오시밀러로 인한 절감액이 2023년에 30% 이상 증가하여 124억 달러에 달할 것이며, 제네릭과 바이오시밀러로 인한 총 절감액 은 370억 달러 증가하여 2022년 4,080억 달러에서 4,450억 달러에 달할 것이라고 보고했습니다. 이러한 수요 급증은 합성 저분자 API 시장의 성장에 기여하고 있습니다.

합성 저분자 API 시장의 주요 업체들은 API 개발의 효율성과 속도를 높이기 위해 모델 기반 공정 최적화 플랫폼과 같은 첨단 기술 개발에 주력하고 있습니다. 이 플랫폼은 예측 모델링 및 실험 설계 툴을 활용하여 물리적 테스트의 필요성을 최소화하고 화학 공정 개발을 간소화합니다. 예를 들어 스위스에 본사를 둔 개발 및 제조 수탁기관(CDMO)인 론자 그룹(Lonza Group)은 2025년 5월 모델 기반 공정 최적화 플랫폼인 Design2Optimize를 발표했습니다. 이 플랫폼은 물리 화학적 모델링과 통계적 모델링을 디지털 최적화 프레임워크 내에 통합하여 제조 공정의 디지털 트윈을 생성합니다. 다양한 개발 시나리오를 가상으로 테스트할 수 있으므로 물리적 실험을 크게 줄이고 저분자 원약의 복잡한 합성 경로 개발을 가속화할 수 있습니다.

목차

제1장 개요

제2장 시장의 특징

제3장 시장 동향과 전략

제4장 시장 : 금리, 인플레이션, 지정학, 무역 전쟁과 관세 및 Covid와 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 개요

제31장 기타 대기업과 혁신적 기업

제32장 세계의 시장 경쟁 벤치마킹과 대시보드

제33장 주요 합병과 인수

제34장 최근 시장 동향

제35장 시장 잠재력이 높은 국가, 부문, 전략

제36장 부록

KSA
영문 목차

영문목차

A synthetic small molecule active pharmaceutical ingredient (API) is a chemically synthesized, low-molecular-weight compound that functions as the principal biologically active component in a pharmaceutical drug, engineered to produce a targeted therapeutic effect through specific interaction with molecular targets in the body. These compounds are widely utilized in the development of orally administered and systemically active drugs due to their chemical stability, ease of large-scale production, and well-established pharmacological properties.

The primary categories of synthetic small molecule APIs include active pharmaceutical ingredients (APIs), key starting materials (KSMs), and intermediates. APIs refer to the chemically produced substances that deliver the intended therapeutic outcomes in medications. These compounds are manufactured through various methods, such as synthetic processes, biocatalysis, continuous flow chemistry, and batch processing, and production can be carried out in-house or outsourced. They are applied across a wide range of therapeutic areas, including cardiovascular diseases, oncology, central nervous system (CNS) and neurological disorders, orthopedics, endocrinology, pulmonology, gastroenterology, nephrology, ophthalmology, 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 synthetic small molecule active pharmaceutical ingredient (API) market research report is one of a series of new reports from The Business Research Company that provides synthetic small molecule active pharmaceutical ingredient (API) market statistics, including synthetic small molecule active pharmaceutical ingredient (API) industry global market size, regional shares, competitors with a synthetic small molecule active pharmaceutical ingredient (API) market share, detailed synthetic small molecule active pharmaceutical ingredient (API) market segments, market trends and opportunities, and any further data you may need to thrive in the synthetic small molecule active pharmaceutical ingredient (API) industry. This synthetic small molecule active pharmaceutical ingredient (API) 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 synthetic small molecule active pharmaceutical ingredients (APIs) market size has grown strongly in recent years. It will grow from $155.36 billion in 2024 to $165.52 billion in 2025 at a compound annual growth rate (CAGR) of 6.5%. The growth in the historic period can be attributed to the increasing global burden of chronic diseases, rising healthcare expenditures in both developed and emerging markets, growing demand for generic drugs, expansion of pharmaceutical manufacturing capabilities, and widespread patent expirations of blockbuster medications.

The synthetic small molecule active pharmaceutical ingredients (APIs) market size is expected to see strong growth in the next few years. It will grow to $211.21 billion in 2029 at a compound annual growth rate (CAGR) of 6.3%. The growth in the forecast period can be attributed to the rising prevalence of lifestyle-related disorders, increased access to healthcare services in low- and middle-income countries, expansion of clinical trial activities for small molecule drugs, faster approval rates for new chemical entities, and growing government initiatives supporting domestic API production. Major trends expected during this period include advancements in continuous manufacturing technologies, the integration of artificial intelligence in process development, adoption of green chemistry and sustainable synthesis methods, development of high-potency active pharmaceutical ingredients (HPAPIs), and increased automation in quality control and production workflows.

The increasing demand for cost-effective generic drugs is expected to drive the growth of the synthetic small molecule active pharmaceutical ingredients (APIs) market in the coming years. Cost-effective generic drugs are affordable alternatives to branded medications that contain the same active ingredients and provide equivalent therapeutic benefits. This growing demand is primarily due to the rising incidence of chronic diseases, which necessitate long-term, economically viable treatment options. Synthetic small molecule APIs support the production of these generics by enabling scalable and efficient manufacturing processes that help lower production costs while maintaining therapeutic effectiveness. For example, in September 2024, the Association for Accessible Medicines (AAM), a US-based trade association, reported that savings from biosimilars increased by over 30% to $12.4 billion in 2023, and total savings from generics and biosimilars rose by $37 billion, reaching $445 billion from $408 billion in 2022. This surge in demand is contributing to the growth of the synthetic small molecule API market.

Key players in the synthetic small molecule API market are emphasizing the development of advanced technologies, such as model-based process optimization platforms, to enhance the efficiency and speed of API development. These platforms utilize predictive modeling and experimental design tools to minimize the need for physical testing, thus streamlining chemical process development. For instance, in May 2025, Lonza Group, a Switzerland-based contract development and manufacturing organization (CDMO), introduced Design2Optimize, a model-based process optimization platform. This platform integrates physicochemical and statistical modeling within a digital optimization framework to create digital twins of manufacturing processes. It allows virtual testing of various development scenarios, significantly reducing physical experimentation and accelerating the development of complex synthetic routes for small molecule APIs.

In January 2022, Pharmaron Beijing Co. Limited, a life science company based in China, acquired Aesica Pharmaceuticals Limited from Recipharm Group for an undisclosed sum. This acquisition was aimed at expanding Pharmaron's comprehensive capabilities in small molecule research and development as well as commercial manufacturing. It also enhances the company's cGMP production capacity and strengthens its global operational footprint. Aesica Pharmaceuticals Limited is a UK-based manufacturer specializing in synthetic small molecule APIs.

Major players in the synthetic small molecule active pharmaceutical ingredients (apis) market are Pfizer Inc., Johnson & Johnson, Hoffmann-La Roche Ltd., Merck & Co. Inc., AbbVie Inc., Fresenius Kabi AG, Sanofi S.A., Bristol-Myers Squibb Company, AstraZeneca plc, Novartis AG, Eli Lilly and Company, Boehringer Ingelheim International GmbH, Johnson Matthey plc, Teva Pharmaceutical Industries Ltd., Daiichi Sankyo Co. Ltd., Albemarle Corporation, Dr. Reddy's Laboratories Ltd., Curia Inc., Nanjing King-Friend Biochemical Pharmaceutical Co. Ltd., Biocon Limited, and Accord Healthcare Ltd.

North America was the largest region in the synthetic small molecule active pharmaceutical ingredients (APIs) market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in synthetic small molecule active pharmaceutical ingredients (APIs) report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The countries covered in the synthetic small molecule active pharmaceutical ingredients (APIs) market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The synthetic small molecule active pharmaceutical ingredients (APIs) market consists of sales of product such as respiratory APIs, gastrointestinal APIs, dermatological APIs, antimalarial APIs, antifungal APIs, immunosuppressant APIs, and antiprotozoal APIs. 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.

Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) 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 synthetic small molecule active pharmaceutical ingredients (apis) 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 synthetic small molecule active pharmaceutical ingredients (apis) ? 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 synthetic small molecule active pharmaceutical ingredients (apis) 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. Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market Characteristics

3. Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market Trends And Strategies

4. Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) 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 Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Growth Analysis And Strategic Analysis Framework

6. Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market Segmentation

7. Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market Regional And Country Analysis

8. Asia-Pacific Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market

9. China Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market

10. India Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market

11. Japan Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market

12. Australia Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market

13. Indonesia Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market

14. South Korea Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market

15. Western Europe Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market

16. UK Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market

17. Germany Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market

18. France Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market

19. Italy Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market

20. Spain Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market

21. Eastern Europe Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market

22. Russia Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market

23. North America Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market

24. USA Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market

25. Canada Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market

26. South America Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market

27. Brazil Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market

28. Middle East Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market

29. Africa Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market

30. Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market Competitive Landscape And Company Profiles

31. Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market Other Major And Innovative Companies

32. Global Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market

34. Recent Developments In The Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market

35. Synthetic Small Molecule Active Pharmaceutical Ingredients (APIs) Market High Potential Countries, Segments and Strategies

36. Appendix

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