인슐린 바이오시밀러 시장 : 세계 산업 규모, 점유율, 동향, 기회, 예측 - 유형별, 질환 적응증별, 유통 채널별, 최종사용자별, 지역별, 경쟁별(2020-2030년)
Insulin biosimilars Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type, By Disease Indication Type, By Distribution Channel, By End user, By Region and Competition, 2020-2030F
상품코드:1881497
리서치사:TechSci Research
발행일:2025년 11월
페이지 정보:영문 187 Pages
라이선스 & 가격 (부가세 별도)
ㅁ Add-on 가능: 고객의 요청에 따라 일정한 범위 내에서 Customization이 가능합니다. 자세한 사항은 문의해 주시기 바랍니다.
한글목차
세계의 인슐린 바이오시밀러 시장은 2024년에 15억 5,000만 달러로 평가되었으며, 2030년까지 CAGR 7.3%로 성장하여 23억 7,000만 달러에 달할 것으로 예측됩니다.
인슐린 바이오시밀러는 이미 승인된 레퍼런스 인슐린 제품과 매우 유사한 생물학적 의약품으로, 동등한 품질, 안전성, 유효성을 나타내지만 생물학적 제제의 고유한 복잡성으로 인해 완전한 복제는 아닙니다. 세계 인슐린 바이오시밀러 시장은 주로 주요 브랜드 인슐린 제품의 특허 만료로 인해 바이오시밀러 대체품의 시장 진입이 촉진되고 있습니다.
시장 개요
예측 기간
2026-2030년
시장 규모 : 2024년
15억 5,000만 달러
시장 규모 : 2030년
23억 7,000만 달러
CAGR : 2025-2030년
7.3%
가장 빠르게 성장하는 부문
속효형 바이오시밀러
최대 시장
북미
주요 시장 촉진요인
전 세계 당뇨병 환자 부담의 증가는 인슐린 바이오시밀러 시장의 기본적인 촉진요인으로 작용하고 있습니다. 전 세계적으로 더 많은 사람들이 당뇨병 진단을 받음에 따라 인슐린 치료에 대한 수요는 본질적으로 확대되고 있으며, 보다 광범위하고 접근하기 쉬운 치료 옵션의 공급이 필요하게 되었습니다.
주요 시장 과제
엄격하고 복잡한 규제 승인 절차는 세계 인슐린 바이오시밀러 시장 성장에 큰 장벽으로 작용하고 있습니다. 이 과정에서 레퍼런스 제품과의 높은 유사성을 확인하기 위한 방대한 임상 데이터가 요구되며, 이는 개발 비용의 증가와 시장 진입 기간의 장기화를 초래하고 있습니다.
주요 시장 동향
상호 교환성 지정의 진전은 약국 수준의 대체를 효율화함으로써 인슐린 바이오시밀러의 채택에 큰 영향을 미치고 있습니다. 이 규제적 지위를 통해 약사는 주법에 따라 의사의 사전 승인 없이도 참조 제품과 상호 교환 가능한 바이오시밀러를 조제할 수 있습니다.
목차
제1장 개요
제2장 조사 방법
제3장 주요 요약
제4장 고객의 소리
제5장 세계의 인슐린 바이오시밀러 시장 전망
시장 규모 및 예측
금액별
시장 점유율과 예측
종류별(속효형 바이오시밀러, 지속형 바이오시밀러, 혼합형 바이오시밀러)
질환 적응 유형별(1형 당뇨병, 2형 당뇨병)
유통 채널별(병원 약국, 소매 약국, 온라인 약국)
최종사용자별(병원, 외래 수술 센터, 기타)
지역별
기업별(2024)
시장 맵
제6장 북미의 인슐린 바이오시밀러 시장 전망
시장 규모 및 예측
시장 점유율과 예측
북미 : 국가별 분석
미국
캐나다
멕시코
제7장 유럽의 인슐린 바이오시밀러 시장 전망
시장 규모 및 예측
시장 점유율과 예측
유럽 : 국가별 분석
독일
프랑스
영국
이탈리아
스페인
제8장 아시아태평양의 인슐린 바이오시밀러 시장 전망
시장 규모 및 예측
시장 점유율과 예측
아시아태평양 : 국가별 분석
중국
인도
일본
한국
호주
제9장 중동 및 아프리카의 인슐린 바이오시밀러 시장 전망
시장 규모 및 예측
시장 점유율과 예측
중동 및 아프리카 : 국가별 분석
사우디아라비아
아랍에미리트
남아프리카공화국
제10장 남미의 인슐린 바이오시밀러 시장 전망
시장 규모 및 예측
시장 점유율과 예측
남미 : 국가별 분석
브라질
콜롬비아
아르헨티나
제11장 시장 역학
성장 촉진요인
과제
제12장 시장 동향과 발전
인수합병
제품 출시
최근 동향
제13장 세계의 인슐린 바이오시밀러 시장 : SWOT 분석
제14장 Porter's Five Forces 분석
업계내 경쟁
신규 참여의 가능성
공급업체의 능력
고객의 능력
대체품의 위협
제15장 경쟁 구도
Pfizer Inc
Novartis AG
Boehringer Ingelheim GmbH
Merck KGaA
Sanofi S.A
Viatris Inc
NOVO Nordisk A/S
Intas Pharmaceuticals Ltd
Sandoz International GmbH
Fresenius Kabi AG
제16장 전략적 제안
제17장 조사 회사 소개 및 면책사항
KSM
영문 목차
영문목차
The Global Insulin biosimilars Market, valued at USD 1.55 Billion in 2024, is projected to experience a CAGR of 7.3% to reach USD 2.37 Billion by 2030. Insulin biosimilars are biological medicines highly similar to an already approved reference insulin product, demonstrating comparable quality, safety, and efficacy, though not being exact copies due to their inherent biological complexity. The global insulin biosimilars market is primarily supported by the expiration of patents for major branded insulin products, facilitating market entry for biosimilar alternatives.
Market Overview
Forecast Period
2026-2030
Market Size 2024
USD 1.55 Billion
Market Size 2030
USD 2.37 Billion
CAGR 2025-2030
7.3%
Fastest Growing Segment
Rapid Acting biosimilars
Largest Market
North America
Key Market Drivers
The increasing global burden of diabetes stands as a fundamental driver for the insulin biosimilars market. As more individuals are diagnosed with diabetes worldwide, the demand for insulin therapies inherently expands, necessitating a broader and more accessible supply of treatment options. This chronic condition requires lifelong management, ensuring a continuous and growing patient pool reliant on insulin. According to the International Diabetes Federation, December 2023, IDF Diabetes Atlas 11th Edition, approximately 589 million adults globally were living with diabetes, a number projected to reach 853 million by 2050.
Key Market Challenges
The stringent and complex regulatory approval pathway represents a significant impediment to the growth of the global insulin biosimilars market. This pathway demands extensive clinical data to confirm high similarity to reference products, which escalates development costs and extends timelines for market entry. The substantial investment required to navigate these rigorous processes directly deters potential manufacturers from initiating or continuing biosimilar development.
Key Market Trends
Advancements in interchangeability designations significantly impact insulin biosimilar adoption by streamlining pharmacy-level substitution. This regulatory status allows pharmacists to dispense an interchangeable biosimilar for its reference product without prior physician approval, subject to state laws. Such a designation builds confidence among healthcare providers and patients regarding comparable safety and efficacy, facilitating broader market acceptance. According to a study published in JAMA in April 2025, the market share for insulin glargine-yfgn, an interchangeable biosimilar, increased by 7.03 percentage points in states with less restrictive substitution laws compared to more restrictive ones after its launch.
Key Market Players
Pfizer Inc
Novartis AG
Boehringer Ingelheim GmbH
Merck KGaA
Sanofi S.A
Viatris Inc
NOVO Nordisk A/S
Intas Pharmaceuticals Ltd
Sandoz International GmbH
Fresenius Kabi AG
Report Scope:
In this report, the Global Insulin biosimilars Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Insulin biosimilars Market, By Type:
Rapid Acting biosimilars
Long Acting biosimilars
Premixed Acting biosimilars
Insulin biosimilars Market, By Disease Indication Type:
Type I Diabetes
Type II Diabetes
Insulin biosimilars Market, By Distribution Channel:
Hospital Pharmacies
Retail Pharmacies
Online Pharmacies
Insulin biosimilars Market, By End user:
Hospitals
Ambulatory Surgical Centers
Others
Insulin biosimilars Market, By Region:
North America
United States
Canada
Mexico
Europe
France
United Kingdom
Italy
Germany
Spain
Asia Pacific
China
India
Japan
Australia
South Korea
South America
Brazil
Argentina
Colombia
Middle East & Africa
South Africa
Saudi Arabia
UAE
Competitive Landscape
Company Profiles: Detailed analysis of the major companies presents in the Global Insulin biosimilars Market.
Available Customizations:
Global Insulin biosimilars Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:
Company Information
Detailed analysis and profiling of additional market players (up to five).
Table of Contents
1. Product Overview
1.1. Market Definition
1.2. Scope of the Market
1.2.1. Markets Covered
1.2.2. Years Considered for Study
1.2.3. Key Market Segmentations
2. Research Methodology
2.1. Objective of the Study
2.2. Baseline Methodology
2.3. Key Industry Partners
2.4. Major Association and Secondary Sources
2.5. Forecasting Methodology
2.6. Data Triangulation & Validation
2.7. Assumptions and Limitations
3. Executive Summary
3.1. Overview of the Market
3.2. Overview of Key Market Segmentations
3.3. Overview of Key Market Players
3.4. Overview of Key Regions/Countries
3.5. Overview of Market Drivers, Challenges, Trends
4. Voice of Customer
5. Global Insulin biosimilars Market Outlook
5.1. Market Size & Forecast
5.1.1. By Value
5.2. Market Share & Forecast
5.2.1. By Type (Rapid Acting biosimilars, Long Acting biosimilars, Premixed Acting biosimilars)
5.2.2. By Disease Indication Type (Type I Diabetes, Type II Diabetes)
5.2.3. By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies)
5.2.4. By End user (Hospitals, Ambulatory Surgical Centers, Others)
5.2.5. By Region
5.2.6. By Company (2024)
5.3. Market Map
6. North America Insulin biosimilars Market Outlook
6.1. Market Size & Forecast
6.1.1. By Value
6.2. Market Share & Forecast
6.2.1. By Type
6.2.2. By Disease Indication Type
6.2.3. By Distribution Channel
6.2.4. By End user
6.2.5. By Country
6.3. North America: Country Analysis
6.3.1. United States Insulin biosimilars Market Outlook
6.3.1.1. Market Size & Forecast
6.3.1.1.1. By Value
6.3.1.2. Market Share & Forecast
6.3.1.2.1. By Type
6.3.1.2.2. By Disease Indication Type
6.3.1.2.3. By Distribution Channel
6.3.1.2.4. By End user
6.3.2. Canada Insulin biosimilars Market Outlook
6.3.2.1. Market Size & Forecast
6.3.2.1.1. By Value
6.3.2.2. Market Share & Forecast
6.3.2.2.1. By Type
6.3.2.2.2. By Disease Indication Type
6.3.2.2.3. By Distribution Channel
6.3.2.2.4. By End user
6.3.3. Mexico Insulin biosimilars Market Outlook
6.3.3.1. Market Size & Forecast
6.3.3.1.1. By Value
6.3.3.2. Market Share & Forecast
6.3.3.2.1. By Type
6.3.3.2.2. By Disease Indication Type
6.3.3.2.3. By Distribution Channel
6.3.3.2.4. By End user
7. Europe Insulin biosimilars Market Outlook
7.1. Market Size & Forecast
7.1.1. By Value
7.2. Market Share & Forecast
7.2.1. By Type
7.2.2. By Disease Indication Type
7.2.3. By Distribution Channel
7.2.4. By End user
7.2.5. By Country
7.3. Europe: Country Analysis
7.3.1. Germany Insulin biosimilars Market Outlook
7.3.1.1. Market Size & Forecast
7.3.1.1.1. By Value
7.3.1.2. Market Share & Forecast
7.3.1.2.1. By Type
7.3.1.2.2. By Disease Indication Type
7.3.1.2.3. By Distribution Channel
7.3.1.2.4. By End user
7.3.2. France Insulin biosimilars Market Outlook
7.3.2.1. Market Size & Forecast
7.3.2.1.1. By Value
7.3.2.2. Market Share & Forecast
7.3.2.2.1. By Type
7.3.2.2.2. By Disease Indication Type
7.3.2.2.3. By Distribution Channel
7.3.2.2.4. By End user
7.3.3. United Kingdom Insulin biosimilars Market Outlook
7.3.3.1. Market Size & Forecast
7.3.3.1.1. By Value
7.3.3.2. Market Share & Forecast
7.3.3.2.1. By Type
7.3.3.2.2. By Disease Indication Type
7.3.3.2.3. By Distribution Channel
7.3.3.2.4. By End user
7.3.4. Italy Insulin biosimilars Market Outlook
7.3.4.1. Market Size & Forecast
7.3.4.1.1. By Value
7.3.4.2. Market Share & Forecast
7.3.4.2.1. By Type
7.3.4.2.2. By Disease Indication Type
7.3.4.2.3. By Distribution Channel
7.3.4.2.4. By End user
7.3.5. Spain Insulin biosimilars Market Outlook
7.3.5.1. Market Size & Forecast
7.3.5.1.1. By Value
7.3.5.2. Market Share & Forecast
7.3.5.2.1. By Type
7.3.5.2.2. By Disease Indication Type
7.3.5.2.3. By Distribution Channel
7.3.5.2.4. By End user
8. Asia Pacific Insulin biosimilars Market Outlook
8.1. Market Size & Forecast
8.1.1. By Value
8.2. Market Share & Forecast
8.2.1. By Type
8.2.2. By Disease Indication Type
8.2.3. By Distribution Channel
8.2.4. By End user
8.2.5. By Country
8.3. Asia Pacific: Country Analysis
8.3.1. China Insulin biosimilars Market Outlook
8.3.1.1. Market Size & Forecast
8.3.1.1.1. By Value
8.3.1.2. Market Share & Forecast
8.3.1.2.1. By Type
8.3.1.2.2. By Disease Indication Type
8.3.1.2.3. By Distribution Channel
8.3.1.2.4. By End user
8.3.2. India Insulin biosimilars Market Outlook
8.3.2.1. Market Size & Forecast
8.3.2.1.1. By Value
8.3.2.2. Market Share & Forecast
8.3.2.2.1. By Type
8.3.2.2.2. By Disease Indication Type
8.3.2.2.3. By Distribution Channel
8.3.2.2.4. By End user
8.3.3. Japan Insulin biosimilars Market Outlook
8.3.3.1. Market Size & Forecast
8.3.3.1.1. By Value
8.3.3.2. Market Share & Forecast
8.3.3.2.1. By Type
8.3.3.2.2. By Disease Indication Type
8.3.3.2.3. By Distribution Channel
8.3.3.2.4. By End user
8.3.4. South Korea Insulin biosimilars Market Outlook
8.3.4.1. Market Size & Forecast
8.3.4.1.1. By Value
8.3.4.2. Market Share & Forecast
8.3.4.2.1. By Type
8.3.4.2.2. By Disease Indication Type
8.3.4.2.3. By Distribution Channel
8.3.4.2.4. By End user
8.3.5. Australia Insulin biosimilars Market Outlook
8.3.5.1. Market Size & Forecast
8.3.5.1.1. By Value
8.3.5.2. Market Share & Forecast
8.3.5.2.1. By Type
8.3.5.2.2. By Disease Indication Type
8.3.5.2.3. By Distribution Channel
8.3.5.2.4. By End user
9. Middle East & Africa Insulin biosimilars Market Outlook
9.1. Market Size & Forecast
9.1.1. By Value
9.2. Market Share & Forecast
9.2.1. By Type
9.2.2. By Disease Indication Type
9.2.3. By Distribution Channel
9.2.4. By End user
9.2.5. By Country
9.3. Middle East & Africa: Country Analysis
9.3.1. Saudi Arabia Insulin biosimilars Market Outlook
9.3.1.1. Market Size & Forecast
9.3.1.1.1. By Value
9.3.1.2. Market Share & Forecast
9.3.1.2.1. By Type
9.3.1.2.2. By Disease Indication Type
9.3.1.2.3. By Distribution Channel
9.3.1.2.4. By End user
9.3.2. UAE Insulin biosimilars Market Outlook
9.3.2.1. Market Size & Forecast
9.3.2.1.1. By Value
9.3.2.2. Market Share & Forecast
9.3.2.2.1. By Type
9.3.2.2.2. By Disease Indication Type
9.3.2.2.3. By Distribution Channel
9.3.2.2.4. By End user
9.3.3. South Africa Insulin biosimilars Market Outlook
9.3.3.1. Market Size & Forecast
9.3.3.1.1. By Value
9.3.3.2. Market Share & Forecast
9.3.3.2.1. By Type
9.3.3.2.2. By Disease Indication Type
9.3.3.2.3. By Distribution Channel
9.3.3.2.4. By End user
10. South America Insulin biosimilars Market Outlook
10.1. Market Size & Forecast
10.1.1. By Value
10.2. Market Share & Forecast
10.2.1. By Type
10.2.2. By Disease Indication Type
10.2.3. By Distribution Channel
10.2.4. By End user
10.2.5. By Country
10.3. South America: Country Analysis
10.3.1. Brazil Insulin biosimilars Market Outlook
10.3.1.1. Market Size & Forecast
10.3.1.1.1. By Value
10.3.1.2. Market Share & Forecast
10.3.1.2.1. By Type
10.3.1.2.2. By Disease Indication Type
10.3.1.2.3. By Distribution Channel
10.3.1.2.4. By End user
10.3.2. Colombia Insulin biosimilars Market Outlook
10.3.2.1. Market Size & Forecast
10.3.2.1.1. By Value
10.3.2.2. Market Share & Forecast
10.3.2.2.1. By Type
10.3.2.2.2. By Disease Indication Type
10.3.2.2.3. By Distribution Channel
10.3.2.2.4. By End user
10.3.3. Argentina Insulin biosimilars Market Outlook
10.3.3.1. Market Size & Forecast
10.3.3.1.1. By Value
10.3.3.2. Market Share & Forecast
10.3.3.2.1. By Type
10.3.3.2.2. By Disease Indication Type
10.3.3.2.3. By Distribution Channel
10.3.3.2.4. By End user
11. Market Dynamics
11.1. Drivers
11.2. Challenges
12. Market Trends & Developments
12.1. Merger & Acquisition (If Any)
12.2. Product Launches (If Any)
12.3. Recent Developments
13. Global Insulin biosimilars Market: SWOT Analysis
