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세계의 제네릭 의약품 수탁제조 시장 보고서(2025년)
Generic Pharmaceuticals Contract Manufacturing Global Market Report 2025
상품코드 : 1810900
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

제네릭 의약품 수탁제조 시장 규모는 향후 수년간 강력한 성장이 전망됩니다. 2029년 연평균 성장률(CAGR)은 7.0%로, 875억 9,000만 달러로 성장할 전망입니다. 이 예측 기간의 성장 배경에는 특수 제네릭 의약품에 대한 관심 증가, 제네릭 의약품 사용을 촉진하기 위한 정부의 구상 강화, 신흥 시장에서의 헬스케어 접근성 확대, 수탁제조 인프라에 대한 투자 증가, 확장 가능하고 적응성 있는 생산 솔루션에 대한 수요 증가 등이 있습니다. 확장 가능하고 적응력이 높은 생산 솔루션에 대한 수요 증가 등을 꼽을 수 있습니다. 이 기간 중 예상되는 주요 동향으로는 제조 자동화의 발전, 고급 품질관리 기술의 채택, 복잡한 제네릭 제제의 개발, 약물전달 시스템의 혁신, 연속 제조 기술의 발전 등이 있습니다.

바이오시밀러에 대한 수요 증가가 제네릭 의약품 수탁제조 시장의 성장을 촉진할 것으로 예측됩니다. 바이오시밀러는 승인된 레퍼런스 생물제제와 매우 유사하고 안전성, 순도, 효능 면에서 임상적으로 중요한 차이를 보이지 않는 생물제제입니다. 바이오시밀러 의약품에 대한 수요는 고가의 생물제제를 대체할 수 있는 보다 저렴한 가격의 의약품을 제공함으로써 환자의 첨단 치료 접근성을 개선하고 의료 시스템의 재정적 부담을 줄일 수 있다는 점에서 크게 증가하고 있습니다. 제네릭 의약품 수탁제조은 비용 효율적인 대규모 생산과 적시 시장 진입 및 품질 일관성에 필요한 규제적 노하우를 제공함으로써 이 분야에서 중요한 역할을 하고 있습니다. 예를 들어 카디널 헬스(Cardinal Health)에 따르면 2022년 1월 현재 미국 FDA가 승인한 바이오시밀러 제품은 33개 품목이 있으며, 그 중 21개 품목이 시판되고 있습니다. Cardinal Health에 따르면 2023년 1월까지 승인된 바이오시밀러는 40개 품목이며, 이 중 25개 품목이 시판되고 있습니다. 이러한 바이오시밀러 수요 증가는 제네릭 의약품 수탁제조 분야 확대에 크게 기여하고 있습니다.

제네릭 의약품 수탁제조 분야의 주요 기업은 전문 자회사를 설립하여 역량을 확대하고 있습니다. 이들 자회사는 원료의약품(API) 개발 및 제조를 강화하고, 의약품 개발 프로세스 전반에 걸쳐 규제 준수, 확장성, 업무 효율성을 확보하는 것을 목표로 하고 있습니다. 예를 들어 2025년 7월 인도 제네릭 제약사 루핀은 CDMO(위탁개발 및 제조)시장 진입을 목표로 새로운 자회사 루핀 제조 솔루션(LMS)을 설립했습니다. 이 전문 부서는 세계 제약 파트너를 위한 원료의약품의 개발, 제조, 판매를 지원합니다. 생명공학 및 제약업계에서 풍부한 경험을 가진 전문가들이 주요 기업을 이끌고 있는 LMS는 제약기업이 규제 기준과 비용 기준을 준수하면서 제품을 보다 빠르게 시장에 출시할 수 있도록 고품질의 수탁 서비스를 제공합니다.

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

Generic pharmaceuticals contract manufacturing involves outsourcing the production of generic medications to external manufacturers. These third-party providers offer a range of services, including formulation development, active pharmaceutical ingredient (API) production, manufacturing of tablets or injectables, packaging, and regulatory assistance. This approach enables pharmaceutical companies to lower production costs and concentrate on their core business areas.

The primary drug categories in generic pharmaceuticals contract manufacturing are branded generics and unbranded generics. Branded generics are off-patent medications marketed under a proprietary brand name, although they contain the same active components as the original branded drugs. Product types include pharmaceutical APIs, formulations, capsules, tablets, and injectables. These products are delivered through various routes of administration such as oral, parenteral, topical, and others. They serve multiple therapeutic areas, including oncology, immunology, antidiabetics, neurology, anticoagulants, cardiovascular, respiratory, pain management, and HIV antivirals, and are used by a wide range of end-users like pharmaceutical firms, contract research organizations, biotechnology companies, and generic drug manufacturers.

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 generic pharmaceuticals contract manufacturing market research report is one of a series of new reports from The Business Research Company that provides generic pharmaceuticals contract manufacturing market statistics, including generic pharmaceuticals contract manufacturing industry global market size, regional shares, competitors with a generic pharmaceuticals contract manufacturing market share, detailed generic pharmaceuticals contract manufacturing market segments, market trends and opportunities, and any further data you may need to thrive in the generic pharmaceuticals contract manufacturing industry. This generic pharmaceuticals contract manufacturing 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 generic pharmaceuticals contract manufacturing market size has grown strongly in recent years. It will grow from $62.30 billion in 2024 to $66.82 billion in 2025 at a compound annual growth rate (CAGR) of 7.3%. The growth observed during the historic period can be attributed to the rising demand for affordable medications, increased healthcare spending in developing nations, a surge in patent expirations of branded pharmaceuticals, greater outsourcing activities by drug manufacturers, and a growing prevalence of chronic illnesses.

The generic pharmaceuticals contract manufacturing market size is expected to see strong growth in the next few years. It will grow to $87.59 billion in 2029 at a compound annual growth rate (CAGR) of 7.0%. The projected growth in the forecast period can be attributed to an increasing emphasis on specialty generics, enhanced government initiatives promoting the use of generic drugs, broader healthcare access in emerging markets, rising investments in contract manufacturing infrastructure, and a heightened demand for scalable and adaptable production solutions. Key trends anticipated during this period include progress in manufacturing automation, the adoption of advanced quality control technologies, the development of complex generic formulations, innovations in drug delivery systems, and advancements in continuous manufacturing techniques.

The increasing demand for biosimilars is anticipated to drive the growth of the generic pharmaceuticals contract manufacturing market. Biosimilars are biologic medical products that closely resemble approved reference biologics, showing no clinically significant differences in terms of safety, purity, or potency. This demand is largely fueled by their potential to offer more affordable alternatives to high-cost biologic drugs, thereby improving access to advanced treatments for patients and easing the financial burden on healthcare systems. Generic pharmaceuticals contract manufacturing plays a crucial role in this space by offering cost-efficient, large-scale production and the regulatory know-how necessary for timely market entry and quality consistency. For example, as of January 2022, the United States had 33 FDA-approved biosimilar products, 21 of which were available on the market, according to Cardinal Health Inc. By January 2023, the number of approved biosimilars had grown to 40, with 25 being commercially available. This increasing demand for biosimilars is contributing significantly to the expansion of the generic pharmaceuticals contract manufacturing sector.

Leading companies in the generic pharmaceutical contract manufacturing space are expanding their capabilities by creating dedicated subsidiaries. These subsidiaries are designed to enhance the development and manufacturing of active pharmaceutical ingredients (APIs), ensuring regulatory compliance, scalability, and operational efficiency throughout the drug development process. For instance, in July 2025, Lupin, an Indian generic pharmaceutical firm, launched Lupin Manufacturing Solutions (LMS), a new subsidiary aimed at entering the contract development and manufacturing organization (CDMO) market. This specialized unit supports API development, production, and sales for global pharmaceutical partners. Led by professionals with extensive experience in biotech and pharma, LMS is set to provide high-quality contract services that help pharmaceutical companies bring products to market faster while upholding regulatory and cost standards.

In April 2024, Bora Pharmaceuticals, a CDMO based in Taiwan, acquired Upsher-Smith Laboratories for $210 million. This acquisition added substantial capacity and expertise to Bora's operations, enhancing its capabilities across the full pharmaceutical value chain-including drug development, manufacturing, quality control, packaging, and distribution. Upsher-Smith Laboratories is a U.S.-based company that offers contract manufacturing services for generic pharmaceuticals.

Major players in the generic pharmaceuticals contract manufacturing market are Teva Pharmaceutical Industries Ltd., Sandoz International GmbH, Fresenius Kabi AG, WuXi AppTec Co. Ltd., Aurobindo Pharma, Cipla Limited, Recipharm AB, Siegfried Holding AG, Curia Global Inc., Torrent Pharmaceuticals Limited., Piramal Pharma Solutions, Laurus Labs Limited., Cambrex Corp., Pfizer CentreOne, Syngene International Ltd., Wockhardt Ltd., Alcami Corp. Inc, Neuland Laboratories Limited., Panacea Biotec Ltd., and Jubilant Generics Ltd.

North America was the largest region in the generic pharmaceuticals contract manufacturing market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in generic pharmaceuticals contract manufacturing report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The countries covered in the generic pharmaceuticals contract manufacturing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The generic pharmaceuticals contract manufacturing market consists of sales of creams, syrups, sterile formulations, topical medications, and high-potency generic drugs. 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 and 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.

Generic Pharmaceuticals Contract Manufacturing 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 generic pharmaceuticals contract manufacturing 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 generic pharmaceuticals contract manufacturing ? 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 generic pharmaceuticals contract manufacturing 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. Generic Pharmaceuticals Contract Manufacturing Market Characteristics

3. Generic Pharmaceuticals Contract Manufacturing Market Trends And Strategies

4. Generic Pharmaceuticals Contract Manufacturing 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 Generic Pharmaceuticals Contract Manufacturing Growth Analysis And Strategic Analysis Framework

6. Generic Pharmaceuticals Contract Manufacturing Market Segmentation

7. Generic Pharmaceuticals Contract Manufacturing Market Regional And Country Analysis

8. Asia-Pacific Generic Pharmaceuticals Contract Manufacturing Market

9. China Generic Pharmaceuticals Contract Manufacturing Market

10. India Generic Pharmaceuticals Contract Manufacturing Market

11. Japan Generic Pharmaceuticals Contract Manufacturing Market

12. Australia Generic Pharmaceuticals Contract Manufacturing Market

13. Indonesia Generic Pharmaceuticals Contract Manufacturing Market

14. South Korea Generic Pharmaceuticals Contract Manufacturing Market

15. Western Europe Generic Pharmaceuticals Contract Manufacturing Market

16. UK Generic Pharmaceuticals Contract Manufacturing Market

17. Germany Generic Pharmaceuticals Contract Manufacturing Market

18. France Generic Pharmaceuticals Contract Manufacturing Market

19. Italy Generic Pharmaceuticals Contract Manufacturing Market

20. Spain Generic Pharmaceuticals Contract Manufacturing Market

21. Eastern Europe Generic Pharmaceuticals Contract Manufacturing Market

22. Russia Generic Pharmaceuticals Contract Manufacturing Market

23. North America Generic Pharmaceuticals Contract Manufacturing Market

24. USA Generic Pharmaceuticals Contract Manufacturing Market

25. Canada Generic Pharmaceuticals Contract Manufacturing Market

26. South America Generic Pharmaceuticals Contract Manufacturing Market

27. Brazil Generic Pharmaceuticals Contract Manufacturing Market

28. Middle East Generic Pharmaceuticals Contract Manufacturing Market

29. Africa Generic Pharmaceuticals Contract Manufacturing Market

30. Generic Pharmaceuticals Contract Manufacturing Market Competitive Landscape And Company Profiles

31. Generic Pharmaceuticals Contract Manufacturing Market Other Major And Innovative Companies

32. Global Generic Pharmaceuticals Contract Manufacturing Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Generic Pharmaceuticals Contract Manufacturing Market

34. Recent Developments In The Generic Pharmaceuticals Contract Manufacturing Market

35. Generic Pharmaceuticals Contract Manufacturing Market High Potential Countries, Segments and Strategies

36. Appendix

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