시장보고서
상품코드
1631528

합성 저분자 API 시장 규모, 점유율, 동향 분석 보고서 : 제조업체별, 용도별, 지역별, 부문별 예측(2025-2030년)

Synthetic Small Molecule API Market Size, Share & Trends Analysis Report By Manufacturer (In-house, Outsourced), By Application (Oncology, Pulmonology, CNS, Endocrinology), By Region, And Segment Forecasts, 2025 - 2030

발행일: | 리서치사: Grand View Research | 페이지 정보: 영문 90 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




※ 본 상품은 영문 자료로 한글과 영문 목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문 목차를 참고해주시기 바랍니다.

합성 저분자 API 시장 성장과 동향

Grand View Research, Inc.의 최신 보고서에 따르면, 세계 합성 저분자 API 시장 규모는 2025-2030년 동안 5.6%의 CAGR을 기록하며 2030년까지 2,574억 달러에 달할 것으로 추정됩니다. 이러한 배경에는 의약품 및 저분자 기반 신약에 대한 세계 수요 증가가 있습니다. 또한, 저분자 API는 제형 간 다용도성, 정제 용이성, 수용성 및 수요 증가로 인해 저분자 API에 대한 수요가 증가하고 있습니다.

제약 산업에서 합성 의약품의 우위가 높아지고 있으며, 저분자 원료의약품과 같은 생산용 원료의 필요성이 높아질 것으로 예상됩니다. 또한, 기존 제품의 강화와 관련된 기술 발전은 저분자 치료제에 새로운 기회를 제공할 것으로 예상됩니다. 예를 들어, Evonik은 2022년 3월 경구용 저분자의 용해도를 향상시키는 새로운 EUDRATECSoluFlow 기술을 발표했습니다.

이 시장을 주도하는 것은 각국 정부의 원료의약품 생산에 대한 적극적인 지원이며, 특히 아시아 지역에서는 대부분의 원료의약품 제조업체들이 합성 저분자 원료의약품 생산을 원료의약품 공급에 의존하고 있습니다. 원료의약품 제조 아웃소싱에 대한 관심도 높아지고 있습니다. 예를 들어, 2020년 4월, COVID-19를 관리하기 위해 파장제약은 호흡기 중증 환자 관리에 필요한 특정 의약품의 주요 원료의약품 공급을 확대하여 API CDMO 서비스를 시작했습니다. 중국, 인도, 동남아시아 등 신흥 시장은 큰 성장 기회입니다.

아시아 제조업체들은 대량 생산이 가능한 덜 복잡한 분자에 초점을 맞추고 있기 때문에 새롭고 복잡한 기술에 대한 투자는 상대적으로 적습니다. 따라서 유럽과 북미 등 다른 선진 지역의 제조업체들은 고수율, 저비용 기술에 투자하는 것이 경쟁 압력을 피하기 위한 선택이 될 수 있습니다.

이 시장에서 사업을 전개하는 주요 기업들은 강력한 API 제품 생산을 위한 제휴에 집중하고 있습니다. 예를 들어, 2021년 8월 Almac Sciences는 Pila Pharma와 고활성 및 선택적 저분자 TRPV1 길항제인 API XEN-D0501의 생산 계약을 체결하였습니다. 또한, CDMO는 합성 의약품에 대한 수요 증가에 대응하기 위해 지속적으로 역량을 확대하며 진화하고 있습니다. 예를 들어, AGC Inc.는 2022년 4월 스페인의 합성 의약품 생산 시설을 7,500m2 확장한다고 발표했으며, 이 지역의 합성 저분자 원료의약품 수요 확대가 예상됩니다.

합성 저분자 API 시장 보고서 하이라이트

  • 전체 시장의 성장은 원료 수요 증가에 따른 의약품 생산 증가에 기인합니다.
  • API 시장은 합성 저분자 의약품 원료의 대량 생산에서 CDMO에 대한 선호도가 높아지는 중요한 변화를 목격하고 있습니다.
  • 제조업체별로는 중소-중견기업이 상업적 생산을 아웃소싱에 의존하고 있기 때문에 아웃소싱 부문이 예측 기간 동안 가장 빠른 CAGR을 보일 것으로 예상됩니다.
  • 용도별로는 만성질환이라는 점과 전 세계적으로 높은 유병률로 인해 2024년 심혈관질환 부문이 21.7%의 시장 점유율을 차지하며 시장을 주도했습니니다.
  • 북미는 주요 기업의 존재와 이 지역의 API 제조 역량 강화에 대한 정부의 지원 증가로 인해 2024년 시장을 주도했습니니다.

목차

제1장 조사 방법과 범위

제2장 주요 요약

제3장 합성 저분자 API 시장 변수, 동향, 범위

  • 시장 계통 전망
  • 시장 역학
    • 시장 성장 촉진요인 분석
    • 시장 성장 억제요인 분석
  • 비즈니스 환경 분석
    • 산업 분석 - Porter's Five Forces 분석
    • PESTLE 분석

제4장 합성 저분자 API 시장 : 제조업체 비즈니스 분석

  • 제조업체 시장 점유율, 2024년과 2030년
  • 제조업체 부문 대시보드
  • 시장 규모와 예측과 동향 분석, 제조업체별, 2018-2030년
  • 사내
  • 아웃소싱

제5장 합성 저분자 API 시장 : 용도 비즈니스 분석

  • 용도 시장 점유율, 2024년과 2030년
  • 용도 부문 대시보드
  • 시장 규모와 예측과 동향 분석, 용도별, 2018-2030년
  • 심혈관질환
  • 종양학
  • 중추신경계와 신경학
  • 정형외과
  • 아웃소싱
  • 내분비학
  • 호흡기과
  • 소화기내과
  • 신장학
  • 안과
  • 기타

제6장 합성 저분자 API 시장 : 지역 추정·동향 분석, 제조업체와 용도

  • 지역별 시장 점유율 분석, 2024년과 2030년
  • 지역별 시장 대시보드
  • 시장 규모와 예측 동향 분석, 2018-2030년
  • 북미
    • 미국
    • 캐나다
    • 멕시코
  • 유럽
    • 영국
    • 독일
    • 프랑스
    • 이탈리아
    • 스페인
    • 덴마크
    • 스웨덴
    • 노르웨이
  • 아시아태평양
    • 일본
    • 중국
    • 인도
    • 호주
    • 한국
    • 태국
  • 라틴아메리카
    • 브라질
    • 아르헨티나
  • 중동 및 아프리카
    • 남아프리카공화국
    • 사우디아라비아
    • 아랍에미리트
    • 쿠웨이트

제7장 경쟁 구도

  • 참여자 개요
  • 기업의 시장 포지션 분석
  • 기업 분류
  • 전략 매핑
  • 기업 개요/상장 기업
    • Merck &Co., Inc.
    • AbbVie, Inc.
    • Bristol-Myers Squibb Company
    • Albemarle Corporation
    • Boehringer Ingelheim International GmbH
    • Cipla, Inc.
    • Dr. Reddy's Laboratories Ltd.
    • Aurobindo Pharma
    • Sun Pharmaceutical Industries Ltd.
ksm 25.03.07

Synthetic Small Molecule API Market Growth & Trends:

The global synthetic small molecule API market size is estimated to reach USD 257.4 billion by 2030, registering a CAGR of 5.6% from 2025 to 2030, according to a new report by Grand View Research, Inc. This can be attributed to the increasing demand for pharmaceuticals and new small molecule-based drugs globally. Moreover, small molecules API offers versatility between dosage forms and has an easier means of purification, which makes it more acceptable and increases the demand.

There is an increasing dominance of synthetic drugs in the pharmaceutical industry, which is expected to propel the requirement of raw materials such as small molecule APIs for production. Moreover, technological advancements related to the enhancement of existing products are expected to provide new opportunities for small molecule therapeutics. For instance, in March 2022, Evonik launched the new EUDRATECSoluFlow technology that enhances the solubility of oral small molecules.

The market is driven by positive government support for the production of APIs in various regions, particularly in Asia, where the majority of API manufacturers are dependent on the supply of API for the production of synthetic small molecule APIs. There has been an increasing focus on outsourcing activities for API production. For instance, in April 2020, for managing COVID-19, Wavelength Pharmaceuticals expanded the supply of key drug ingredients for certain pharmaceutical products needed to manage respiratory critical care patients and launched API CDMO services. Emerging markets such as China, India, and Southeast Asia represent significant opportunities for growth.

The investment in new and complex technologies is relatively low for Asian manufacturers as they are more focused on less complex molecules that can be produced in bulk. Thus, the investment in high-yielding, low-cost technologies is an alternative for manufacturers in other developed regions such as Europe and North America to avoid competitive pressure.

Key players operating in the market are focusing on collaboration for the production of potent API products. For instance, in August 2021, Almac Sciences signed an agreement with Pila Pharma for the production of the API XEN-D0501, a highly potent and selective small molecule TRPV1 antagonist. Moreover, CDMOs are constantly evolving by expanding their capacities to meet the heightened demand for synthetic drugs. For instance, in April 2022, AGC Inc. announced the expansion of its Spanish facility by 7500 m2 for synthetic pharmaceutical production, which is expected to enhance the demand for synthetic small molecule active pharmaceutical ingredients in the region.

Synthetic Small Molecule API Market Report Highlights:

  • The growth of the overall market is attributed to the increasing production of pharmaceuticals with the increased demand for raw material
  • The API market is witnessing a key shift with the rise in the preference for CDMOs for the production of synthetic small molecule active pharmaceutical ingredients in bulk
  • By manufacturer, the outsourced segment is expected to witness fastest CAGR over the forecast period, owing to a dependency of small and mid-sized companies on outsourcing for commercial production
  • By application, the cardiovascular diseases segment dominated the market in 2024 with a market share of 21.7%, owing to their chronic nature and high global prevalence.
  • North America dominated the market in 2024, due to the presence of key players and rising support from the government for enhancing the API manufacturing capacity of the region.

Table of Contents

Chapter 1. Methodology and Scope

  • 1.1. Market Segmentation & Scope
  • 1.2. Segment Definitions
    • 1.2.1. Manufacturer
    • 1.2.2. Application
  • 1.3. Estimates and Forecast Timeline
  • 1.4. Research Methodology
  • 1.5. Information Procurement
    • 1.5.1. Purchased Database
    • 1.5.2. GVR's Internal Database
    • 1.5.3. Secondary Sources
    • 1.5.4. Primary Research
  • 1.6. Information Analysis
    • 1.6.1. Data Analysis Models
  • 1.7. Market Formulation & Data Visualization
  • 1.8. Model Details
    • 1.8.1. Commodity Flow Analysis
  • 1.9. List of Secondary Sources
  • 1.10. Objectives

Chapter 2. Executive Summary

  • 2.1. Market Snapshot
  • 2.2. Segment Snapshot
  • 2.3. Competitive Landscape Snapshot

Chapter 3. Synthetic Small Molecule API Market Variables, Trends, & Scope

  • 3.1. Market Lineage Outlook
  • 3.2. Market Dynamics
    • 3.2.1. Market Driver Analysis
    • 3.2.2. Market Restraint Analysis
  • 3.3. Business Environment Analysis
    • 3.3.1. Industry Analysis - Porter's Five Forces Analysis
      • 3.3.1.1. Supplier Power
      • 3.3.1.2. Buyer Power
      • 3.3.1.3. Substitution Threat
      • 3.3.1.4. Threat of New Entrants
      • 3.3.1.5. Competitive Rivalry
    • 3.3.2. PESTLE Analysis

Chapter 4. Synthetic Small Molecule API Market: Manufacturer Business Analysis

  • 4.1. Manufacturer Market Share, 2024 & 2030
  • 4.2. Manufacturer Segment Dashboard
  • 4.3. Market Size & Forecasts and Trend Analysis, by Manufacturer, 2018 to 2030 (USD Billion)
  • 4.4. In-house
    • 4.4.1. In-house Market, 2018 - 2030 (USD Billion)
  • 4.5. Outsourced
    • 4.5.1. Outsourced Market, 2018 - 2030 (USD Billion)

Chapter 5. Synthetic Small Molecule API Market: Application Business Analysis

  • 5.1. Application Market Share, 2024 & 2030
  • 5.2. Application Segment Dashboard
  • 5.3. Market Size & Forecasts and Trend Analysis, by Application, 2018 to 2030 (USD Billion)
  • 5.4. Cardiovascular Diseases
    • 5.4.1. Cardiovascular Diseases Market, 2018 - 2030 (USD Billion)
  • 5.5. Oncology
    • 5.5.1. Oncology Market, 2018 - 2030 (USD Billion)
  • 5.6. CNS and Neurology
    • 5.6.1. CNS and Neurology Market, 2018 - 2030 (USD Billion)
  • 5.7. Orthopedic
    • 5.7.1. Orthopedic Market, 2018 - 2030 (USD Billion)
  • 5.8. Outsourced
    • 5.8.1. Outsourced Market, 2018 - 2030 (USD Billion)
  • 5.9. Endocrinology
    • 5.9.1. Endocrinology Market, 2018 - 2030 (USD Billion)
  • 5.10. Pulmonology
    • 5.10.1. Pulmonology Market, 2018 - 2030 (USD Billion)
  • 5.11. Gastroenterology
    • 5.11.1. Gastroenterology Market, 2018 - 2030 (USD Billion)
  • 5.12. Nephrology
    • 5.12.1. Nephrology Market, 2018 - 2030 (USD Billion)
  • 5.13. Ophthalmology
    • 5.13.1. Ophthalmology Market, 2018 - 2030 (USD Billion)
  • 5.14. Others
    • 5.14.1. Others Market, 2018 - 2030 (USD Billion)

Chapter 6. Synthetic Small Molecule API Market: Regional Estimates & Trend Analysis Manufacturer and Application

  • 6.1. Regional Market Share Analysis, 2024 & 2030
  • 6.2. Regional Market Dashboard
  • 6.3. Market Size & Forecasts Trend Analysis, 2018 to 2030:
  • 6.4. North America
    • 6.4.1. North America Synthetic Small Molecule API Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
    • 6.4.2. U.S.
      • 6.4.2.1. Key Country Dynamics
      • 6.4.2.2. Regulatory Framework
      • 6.4.2.3. Competitive Insights
      • 6.4.2.4. U.S. Synthetic Small Molecule API Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
    • 6.4.3. Canada
      • 6.4.3.1. Key Country Dynamics
      • 6.4.3.2. Regulatory Framework
      • 6.4.3.3. Competitive Insights
      • 6.4.3.4. Canada Synthetic Small Molecule API Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
    • 6.4.4. Mexico
      • 6.4.4.1. Key Country Dynamics
      • 6.4.4.2. Regulatory Framework
      • 6.4.4.3. Competitive Insights
      • 6.4.4.4. Mexico Synthetic Small Molecule API Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
  • 6.5. Europe
    • 6.5.1. Europe Synthetic Small Molecule API Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
    • 6.5.2. UK
      • 6.5.2.1. Key Country Dynamics
      • 6.5.2.2. Regulatory Framework
      • 6.5.2.3. Competitive Insights
      • 6.5.2.4. UK Synthetic Small Molecule API Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
    • 6.5.3. Germany
      • 6.5.3.1. Key Country Dynamics
      • 6.5.3.2. Regulatory Framework
      • 6.5.3.3. Competitive Insights
      • 6.5.3.4. Germany Synthetic Small Molecule API Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
    • 6.5.4. France
      • 6.5.4.1. Key Country Dynamics
      • 6.5.4.2. Regulatory Framework
      • 6.5.4.3. Competitive Insights
      • 6.5.4.4. France Synthetic Small Molecule API Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
    • 6.5.5. Italy
      • 6.5.5.1. Key Country Dynamics
      • 6.5.5.2. Regulatory Framework
      • 6.5.5.3. Competitive Insights
      • 6.5.5.4. Italy Synthetic Small Molecule API Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
    • 6.5.6. Spain
      • 6.5.6.1. Key Country Dynamics
      • 6.5.6.2. Regulatory Framework
      • 6.5.6.3. Competitive Insights
      • 6.5.6.4. Spain Synthetic Small Molecule API Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
    • 6.5.7. Denmark
      • 6.5.7.1. Key Country Dynamics
      • 6.5.7.2. Regulatory Framework
      • 6.5.7.3. Competitive Insights
      • 6.5.7.4. Denmark Synthetic Small Molecule API Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
    • 6.5.8. Sweden
      • 6.5.8.1. Key Country Dynamics
      • 6.5.8.2. Regulatory Framework
      • 6.5.8.3. Competitive Insights
      • 6.5.8.4. Sweden Synthetic Small Molecule API Market Estimates And Forecasts, By Country, 2018 - 2030 (USD Billion)
    • 6.5.9. Norway
      • 6.5.9.1. Key Country Dynamics
      • 6.5.9.2. Regulatory Framework
      • 6.5.9.3. Competitive Insights
      • 6.5.9.4. Norway Synthetic Small Molecule API Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
  • 6.6. Asia Pacific
    • 6.6.1. Asia Pacific Synthetic Small Molecule API Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
    • 6.6.2. Japan
      • 6.6.2.1. Key Country Dynamics
      • 6.6.2.2. Regulatory Framework
      • 6.6.2.3. Competitive Insights
      • 6.6.2.4. Japan Synthetic Small Molecule API Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
    • 6.6.3. China
      • 6.6.3.1. Key Country Dynamics
      • 6.6.3.2. Regulatory Framework
      • 6.6.3.3. Competitive Insights
      • 6.6.3.4. China Synthetic Small Molecule API Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
    • 6.6.4. India
      • 6.6.4.1. Key Country Dynamics
      • 6.6.4.2. Regulatory Framework
      • 6.6.4.3. Competitive Insights
      • 6.6.4.4. India Synthetic Small Molecule API Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
    • 6.6.5. Australia
      • 6.6.5.1. Key Country Dynamics
      • 6.6.5.2. Regulatory Framework
      • 6.6.5.3. Competitive Insights
      • 6.6.5.4. Australia Synthetic Small Molecule API Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
    • 6.6.6. South Korea
      • 6.6.6.1. Key Country Dynamics
      • 6.6.6.2. Regulatory Framework
      • 6.6.6.3. Competitive Insights
      • 6.6.6.4. South Korea Synthetic Small Molecule API Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
    • 6.6.7. Thailand
      • 6.6.7.1. Key Country Dynamics
      • 6.6.7.2. Regulatory Framework
      • 6.6.7.3. Competitive Insights
      • 6.6.7.4. Thailand Synthetic Small Molecule API Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
  • 6.7. Latin America
    • 6.7.1. Latin America Synthetic Small Molecule API Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
    • 6.7.2. Brazil
      • 6.7.2.1. Key Country Dynamics
      • 6.7.2.2. Regulatory Framework
      • 6.7.2.3. Competitive Insights
      • 6.7.2.4. Brazil Synthetic Small Molecule API Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
    • 6.7.3. Argentina
      • 6.7.3.1. Key Country Dynamics
      • 6.7.3.2. Regulatory Framework
      • 6.7.3.3. Competitive Insights
      • 6.7.3.4. Argentina Synthetic Small Molecule API Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
  • 6.8. MEA
    • 6.8.1. MEA Synthetic Small Molecule API Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
    • 6.8.2. South Africa
      • 6.8.2.1. Key Country Dynamics
      • 6.8.2.2. Regulatory Framework
      • 6.8.2.3. Competitive Insights
      • 6.8.2.4. South Africa Synthetic Small Molecule API Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
    • 6.8.3. Saudi Arabia
      • 6.8.3.1. Key Country Dynamics
      • 6.8.3.2. Regulatory Framework
      • 6.8.3.3. Competitive Insights
      • 6.8.3.4. Saudi Arabia Synthetic Small Molecule API Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
    • 6.8.4. UAE
      • 6.8.4.1. Key Country Dynamics
      • 6.8.4.2. Regulatory Framework
      • 6.8.4.3. Competitive Insights
      • 6.8.4.4. UAE Synthetic Small Molecule API Market Estimates And Forecasts, 2018 - 2030 (USD Billion)
    • 6.8.5. Kuwait
      • 6.8.5.1. Key Country Dynamics
      • 6.8.5.2. Regulatory Framework
      • 6.8.5.3. Competitive Insights
      • 6.8.5.4. Kuwait Synthetic Small Molecule API Market Estimates And Forecasts, 2018 - 2030 (USD Billion)

Chapter 7. Competitive Landscape

  • 7.1. Participant Overview
  • 7.2. Company Market Position Analysis
  • 7.3. Company Categorization
  • 7.4. Strategy Mapping
  • 7.5. Company Profiles/Listing
    • 7.5.1. Merck & Co., Inc.
      • 7.5.1.1. Overview
      • 7.5.1.2. Financial Performance
      • 7.5.1.3. Product Benchmarking
      • 7.5.1.4. Strategic Initiatives
    • 7.5.2. AbbVie, Inc.
      • 7.5.2.1. Overview
      • 7.5.2.2. Financial Performance
      • 7.5.2.3. Product Benchmarking
      • 7.5.2.4. Strategic Initiatives
    • 7.5.3. Bristol-Myers Squibb Company
      • 7.5.3.1. Overview
      • 7.5.3.2. Financial Performance
      • 7.5.3.3. Product Benchmarking
      • 7.5.3.4. Strategic Initiatives
    • 7.5.4. Albemarle Corporation
      • 7.5.4.1. Overview
      • 7.5.4.2. Financial Performance
      • 7.5.4.3. Product Benchmarking
      • 7.5.4.4. Strategic Initiatives
    • 7.5.5. Boehringer Ingelheim International GmbH
      • 7.5.5.1. Overview
      • 7.5.5.2. Financial Performance
      • 7.5.5.3. Product Benchmarking
      • 7.5.5.4. Strategic Initiatives
    • 7.5.6. Cipla, Inc.
      • 7.5.6.1. Overview
      • 7.5.6.2. Financial Performance
      • 7.5.6.3. Product Benchmarking
      • 7.5.6.4. Strategic Initiatives
    • 7.5.7. Dr. Reddy's Laboratories Ltd.
      • 7.5.7.1. Overview
      • 7.5.7.2. Financial Performance
      • 7.5.7.3. Product Benchmarking
      • 7.5.7.4. Strategic Initiatives
    • 7.5.8. Aurobindo Pharma
      • 7.5.8.1. Overview
      • 7.5.8.2. Financial Performance
      • 7.5.8.3. Product Benchmarking
      • 7.5.8.4. Strategic Initiatives
    • 7.5.9. Sun Pharmaceutical Industries Ltd.
      • 7.5.9.1. Overview
      • 7.5.9.2. Financial Performance
      • 7.5.9.3. Product Benchmarking
      • 7.5.9.4. Strategic Initiatives
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