특수 제네릭 시장 보고서(2026년)
Specialty Generics Global Market Report 2026
상품코드 : 1957820
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

전문 제네릭 의약품 시장 규모는 최근 급성장하고 있습니다. 2025년 1,071억 4,000만 달러에서 2026년에는 1,227억 달러에 이르고, CAGR 14.5%의 성장이 전망되고 있습니다. 지금까지의 성장은 자가면역질환 유병률 증가, 브랜드 전문의약품의 특허 만료, 헬스케어 인프라에 대한 투자 증가, 병원 및 소매 약국 네트워크 확대, 주요 시장에서의 바이오시밀러의 조기 도입 등이 주요 요인으로 꼽힙니다.

특수 제네릭 시장 규모는 향후 몇 년간 급성장이 전망됩니다. 2030년에는 2,142억 2,000만 달러에 이르고, CAGR은 14.9%를 나타낼 전망입니다. 예측 기간 동안의 성장 요인으로는 특수 제네릭 제품 포트폴리오의 확대, 생물학적 제제 제조 기술의 발전, 헬스케어 지출 증가, 개인 맞춤형 치료에 대한 수요 증가, 제약사와 CDMO(위탁개발생산기관)간의 제휴 증가 등을 꼽을 수 있습니다. 예측 기간의 주요 동향으로는 바이오의약품 및 바이오시밀러 도입 확대, 전문 약국 서비스 확대, 개인 맞춤형 의료의 통합, 규제 준수 복잡성 증가, 만성질환 치료 수요 증가 등을 들 수 있습니다.

만성질환의 유병률 증가는 특수 제네릭 시장 수요 증가 요인으로 작용할 것으로 예측됩니다. 만성질환은 대부분 완치는 불가능하지만, 관리와 통제가 가능한 장기적인 병태를 말합니다. 생활습관과 식습관의 변화, 부적절한 체중 관리는 만성질환 증가에 크게 기여하고 있으며, 특정 장기적인 만성 감염은 암 위험을 증가시킬 수 있습니다. 이러한 질환에 대한 노출이 지속적으로 증가함에 따라, 복잡하고 장기적인 질환을 관리하기 위한 전문 제네릭 의약품에 대한 수요가 증가하고 있습니다. 예를 들어, 영국 비영리단체 GOV.UK에 따르면, 2025년 3월 기준 영국 17세 이상 성인의 GP(일반의) 기록상 2형 당뇨병 유병률은 2024년 3월 7.0%로 2023년 3월의 6.8%에서 증가했다고 합니다. 따라서 만성질환의 급증은 특수 제네릭 시장의 성장을 가속하고 있습니다.

전문 제네릭 시장에서 사업을 전개하는 주요 기업들은 효과적인 의약품에 대한 수요 증가에 대응하기 위해 리덱사메페타민 디메실산염과 같은 약품 승인을 획득하고 있습니다. 전문의약품 제네릭 허가란 특허 만료 후 복잡한 질환이나 희귀질환 치료에 사용되는 브랜드 전문의약품과 생물학적 동등성 및 치료적 동등성을 입증한 의약품 제품에 부여되는 규제적 허가를 말합니다. 예를 들어, 2023년 8월 아일랜드에 본사를 둔 전문 제약기업인 말린로드사는 SpecGx LLC 전문 제네릭 부문에서 주의력결핍 및 과잉행동장애(ADHD) 치료제로 리덱사메페타민 디메실레이트 캡슐의 FDA 승인을 획득했습니다. 리덱사메페타민 디메실산염은 ADHD 및 기타 적응증 치료에 사용되는 전문 제네릭 의약품으로, 연방 규제 물질(CII)로 지정되어 있습니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 공급망 분석

제4장 세계 시장 동향과 전략

제5장 최종 이용 산업 시장 분석

제6장 시장 : 금리, 인플레이션, 지정학, 무역 전쟁과 관세의 영향, 관세 전쟁과 무역 보호주의의 공급망에 대한 영향, 코로나 팬데믹이 시장에 미치는 영향을 포함한 거시경제 시나리오

제7장 세계 전략 분석 프레임워크, 현재 시장 규모, 시장 비교 및 성장률 분석

제8장 TAM(Total Addressable Market) 규모

제9장 시장 세분화

제10장 지역별/국가별 분석

제11장 아시아태평양 시장

제12장 중국 시장

제13장 인도 시장

제14장 일본 시장

제15장 호주 시장

제16장 인도네시아 시장

제17장 한국 시장

제18장 대만 시장

제19장 동남아시아 시장

제20장 서유럽 시장

제21장 영국 시장

제22장 독일 시장

제23장 프랑스 시장

제24장 이탈리아 시장

제25장 스페인 시장

제26장 동유럽 시장

제27장 러시아 시장

제28장 북미 시장

제29장 미국 시장

제30장 캐나다 시장

제31장 남미 시장

제32장 브라질 시장

제33장 중동 시장

제34장 아프리카 시장

제35장 시장 규제 상황과 투자환경

제36장 경쟁 구도와 기업 개요

제37장 기타 주요 기업 및 혁신 기업

제38장 세계 시장 경쟁 벤치마킹과 대시보드

제39장 주요 인수합병(M&A)

제40장 시장 잠재력이 높은 국가, 부문, 전략

제41장 부록

LSH
영문 목차

영문목차

Specialty generics refer to generic versions of complex, high-cost, or high-touch medications that typically require enhanced patient support and specialized handling. These drugs often involve complex formulations, manufacturing processes, or delivery mechanisms and require substantial service participation for effective management. Specialty generics also include biologics and biosimilars, which follow distinct regulatory approval pathways. Most specialty medications are used in the treatment of conditions such as cancer, rheumatoid arthritis, multiple sclerosis, and other chronic or rare diseases.

The main routes of administration for specialty generics include injectables, oral, and other routes. Injectable specialty generics are widely used and can be administered through intravenous, subcutaneous, intradermal, intraperitoneal, intramuscular, and other methods to treat a broad range of medical conditions, from oncology to autoimmune disorders. Drug injections typically involve the use of a hollow hypodermic needle to deliver the medication directly into the bloodstream or targeted tissue. Specialty generics are commonly indicated for oncology, autoimmune diseases, infectious diseases, and other therapeutic areas, and they are distributed through retail pharmacies, specialty pharmacies, and hospital pharmacies.

Tariffs have influenced the specialty generics market by increasing the cost of imported active pharmaceutical ingredients (APIs) and biologics components, thereby impacting production costs. The injectables and oral segments are particularly affected, with North America and Europe facing higher regulatory and cost pressures. While tariffs may raise prices, they also encourage domestic manufacturing investments and local sourcing strategies, fostering innovation and supply chain resilience in the specialty generics sector.

The specialty generics market research report is one of a series of new reports from The Business Research Company that provides specialty generics market statistics, including specialty generics industry global market size, regional shares, competitors with a specialty generics market share, detailed specialty generics market segments, market trends and opportunities, and any further data you may need to thrive in the specialty generics industry. This specialty generics 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 specialty generics market size has grown rapidly in recent years. It will grow from $107.14 billion in 2025 to $122.7 billion in 2026 at a compound annual growth rate (CAGR) of 14.5%. The growth in the historic period can be attributed to rising prevalence of autoimmune diseases, patent expirations of branded specialty drugs, increasing investment in healthcare infrastructure, growth of hospital and retail pharmacy networks, early adoption of biosimilars in key markets.

The specialty generics market size is expected to see rapid growth in the next few years. It will grow to $214.22 billion in 2030 at a compound annual growth rate (CAGR) of 14.9%. The growth in the forecast period can be attributed to expansion of specialty generics portfolio, advancements in biologics manufacturing technology, increasing healthcare expenditure, growing demand for personalized therapies, rising collaborations between pharma companies and CDMOs. Major trends in the forecast period include growth in biologics and biosimilars adoption, expansion of specialty pharmacy services, personalized medicine integration, increasing regulatory compliance complexity, rise in chronic disease treatment demand.

The rising prevalence of chronic diseases is expected to drive demand in the specialty generics market. Chronic diseases are long-term conditions that often cannot be completely cured but can be managed or controlled in many cases. Changes in lifestyle, dietary habits, and poor weight management contribute significantly to the increasing incidence of chronic conditions, while certain long-standing chronic infections can elevate the risk of cancer. As exposure to these diseases continues to grow, the need for specialty generics to manage complex and long-term conditions is increasing. For instance, in March 2025, according to GOV.UK, a UK-based non-profit government organization, GP-recorded type 2 diabetes prevalence among adults aged 17 and over in England reached 7.0% in March 2024, up from 6.8% in March 2023. Therefore, the surge in chronic diseases is fueling the growth of the specialty generics market.

Major companies operating in the specialty generic market are obtaining approvals for drugs such as Lisdexamfetamine Dimesylate to meet the growing need for effective medications. Approval in specialty generics refers to the regulatory authorization granted to pharmaceutical products that demonstrate bioequivalence and therapeutic equivalence to branded specialty drugs, which are typically used to treat complex or rare medical conditions after patent expiration. For instance, in August 2023, Mallinckrodt plc, an Ireland-based specialty pharmaceutical company, received FDA approval for its Lisdexamfetamine Dimesylate Capsules under the SpecGx LLC Specialty Generics segment for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). Lisdexamfetamine dimesylate is a specialty generic and a federally controlled substance (CII) used in the treatment of ADHD and other indications.

In March 2025, Mallinckrodt Pharmaceuticals, an Ireland-based provider of specialty pharmaceuticals, specialty generics, sterile injectables, and active pharmaceutical ingredients (APIs), merged with Endo Inc. for an enterprise value of approximately US$6.7 billion. Through this merger, the companies aim to combine their specialty generics and sterile injectables capabilities, generating operational synergies across manufacturing, regulatory compliance, and research and development. The transaction also includes plans for a future spin-off of the combined generics and sterile injectables business as a standalone entity. This merger highlights the ongoing consolidation within the specialty generics market and reflects a strategic focus on high-barrier, complex generics and sterile injectable products. Endo Inc. is a US-based provider of generics and sterile injectable products.

Major companies operating in the specialty generics market are Teva Pharmaceutical Industries Ltd., Endo International plc, Akorn Operating Company LLC, Mallinckrodt Pharmaceuticals, Dr. Reddy's Laboratories Ltd., Fresenius Kabi Brasil Ltda, STADA Arzneimittel AG, Cipla Limited, Lupin Ltd, Aurobindo Pharma Limited, Aspen Pharmacare Holdings Limited, Pfizer Inc., Accord Healthcare Limited, Amneal Pharmaceuticals Inc., Sandoz International GmbH, Zydus Lifesciences Ltd., Torrent Pharmaceuticals Ltd., Perrigo Company plc, Impax Laboratories Inc., Par Pharmaceutical Companies Inc., Alvogen, Alkem Laboratories Ltd., Wockhardt Ltd., Strides Pharma Science Limited, Indoco Remedies Ltd., Unichem Laboratories Ltd., Alembic Pharmaceuticals Ltd., Jubilant Life Sciences Ltd.

North America was the largest region in the specialty generics market in 2025. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in the specialty generics market report are Asia-Pacific, South East Asia, Western Europe, Eastern Europe, North America, South America, Middle East, Africa.

The countries covered in the specialty generics market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Taiwan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The specialty generics market consists of sales of biologics and biosimilars. 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.

Specialty Generics Market Global Report 2026 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses specialty generics 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 specialty generics ? 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 specialty generics 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, total addressable market (TAM), market attractiveness score (MAS), competitive landscape, market shares, company scoring matrix, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.

Scope

Added Benefits available all on all list-price licence purchases, to be claimed at time of purchase. Customisations within report scope and limited to 20% of content and consultant support time limited to 8 hours.

Table of Contents

1. Executive Summary

2. Specialty Generics Market Characteristics

3. Specialty Generics Market Supply Chain Analysis

4. Global Specialty Generics Market Trends And Strategies

5. Specialty Generics Market Analysis Of End Use Industries

6. Specialty Generics Market - Macro Economic Scenario Including The Impact Of Interest Rates, Inflation, Geopolitics, Trade Wars and Tariffs, Supply Chain Impact from Tariff War & Trade Protectionism, And Covid And Recovery On The Market

7. Global Specialty Generics Strategic Analysis Framework, Current Market Size, Market Comparisons And Growth Rate Analysis

8. Global Specialty Generics Total Addressable Market (TAM) Analysis for the Market

9. Specialty Generics Market Segmentation

10. Specialty Generics Market Regional And Country Analysis

11. Asia-Pacific Specialty Generics Market

12. China Specialty Generics Market

13. India Specialty Generics Market

14. Japan Specialty Generics Market

15. Australia Specialty Generics Market

16. Indonesia Specialty Generics Market

17. South Korea Specialty Generics Market

18. Taiwan Specialty Generics Market

19. South East Asia Specialty Generics Market

20. Western Europe Specialty Generics Market

21. UK Specialty Generics Market

22. Germany Specialty Generics Market

23. France Specialty Generics Market

24. Italy Specialty Generics Market

25. Spain Specialty Generics Market

26. Eastern Europe Specialty Generics Market

27. Russia Specialty Generics Market

28. North America Specialty Generics Market

29. USA Specialty Generics Market

30. Canada Specialty Generics Market

31. South America Specialty Generics Market

32. Brazil Specialty Generics Market

33. Middle East Specialty Generics Market

34. Africa Specialty Generics Market

35. Specialty Generics Market Regulatory and Investment Landscape

36. Specialty Generics Market Competitive Landscape And Company Profiles

37. Specialty Generics Market Other Major And Innovative Companies

38. Global Specialty Generics Market Competitive Benchmarking And Dashboard

39. Key Mergers And Acquisitions In The Specialty Generics Market

40. Specialty Generics Market High Potential Countries, Segments and Strategies

41. Appendix

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