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特殊ジェネリック市場レポート：投与経路、適応症、流通チャネル、地域別、2024年～2032年

Specialty Generics Market Report by Route of Administration, Indication, Distribution channel, and Region 2024-2032
出版日: | 発行: IMARC | ページ情報: 英文 134 Pages | 納期: 2～3営業日

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価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=154.64円
特殊ジェネリック市場レポート：投与経路、適応症、流通チャネル、地域別、2024年～2032年
出版日: 2024年04月08日
発行: IMARC
ページ情報: 英文 134 Pages
納期: 2～3営業日
  • 全表示
  • 概要
  • 図表
  • 目次
概要

世界の特殊ジェネリック医薬品市場規模は2023年に747億米ドルに達しました。今後、IMARCグループは、2024年から2032年にかけて9.4%の成長率（CAGR）を示し、2032年までに1,725億米ドルに達すると予測しています。能力、リソース、市場でのプレゼンスを活用することを目的とした戦略的提携の増加、オンライン薬局や遠隔医療プラットフォームの進化、政府のイニシアチブの増加は、市場を推進する主な要因の一部です。

特殊ジェネリック医薬品とは、高コストの先発スペシャリティ医薬品のジェネリック医薬品を指します。これらの医薬品は、がん、関節リウマチ、多発性硬化症、HIVなどの複雑な慢性疾患の治療に使用されます。従来のジェネリック医薬品との違いは、一般的に生物学的製剤であること、特別な取り扱いや投与を必要とすること、注射剤であることが多いこと、限られたネットワークを通じて流通することが多いことです。特殊なジェネリック医薬品の開発には、関連する分子の複雑な性質やその製造に使用される複雑なプロセスのために、独特の課題があります。その結果、従来のジェネリック医薬品と比較して、規制当局による承認審査が厳しくなる可能性があります。さらに、特殊ジェネリックはヘルスケアにおいて計り知れない可能性を秘めています。ジェネリック医薬品は、患者にとって重要な治療法へのアクセスを低コストで提供するとともに、ヘルスケアシステムの財政負担を軽減します。

オンライン薬局や遠隔医療プラットフォームなどの高度な流通チャネルの進化も、特殊ジェネリック医薬品市場の成長を後押ししています。こうしたチャネルは医薬品へのアクセスを容易にし、遠隔地の患者でも必要な医薬品を入手できるようにします。これに伴い、政府のヘルスケアプログラムや民間の支払者は、高騰する医療費を抑制するための戦略を継続的に模索しています。ジェネリック医薬品、特に特殊ジェネリック医薬品の使用を重視することは、主要な戦略です。そのため、いくつかの政府や保険会社では、ジェネリック医薬品が入手可能な場合はその処方を奨励または義務付けており、これが需要を促進しています。さらに、より手頃な価格である特殊ジェネリック医薬品は、地域の多くの人々にとって好ましい選択肢となっており、必要不可欠な治療がより多くの人々の手の届く範囲にあることを保証しています。このことが市場を大きく支えています。これとは別に、よりニッチで特殊な症状向けのジェネリック医薬品の生産も市場に貢献しています。さらに、提携企業の能力、リソース、市場でのプレゼンスを活用することを目的とした戦略的提携が、市場の前向きな見通しを生み出しています。

特殊ジェネリック医薬品市場の動向と促進要因

手頃な価格のヘルスケアソリューションに対する需要の高まり

世界人口の増加が続き、非感染性疾患（NCDs）の負担が拡大する中、手頃な価格のヘルスケアソリューションを提供することが強く求められています。特殊ジェネリック医薬品医薬品業界は、このような需要に対応する独自の態勢を整えています。先発医薬品の生物学的同等品である特殊ジェネリック医薬品は、革新的な医薬品の治療効果を低コストで患者やヘルスケアシステムに提供します。さらに、日本、米国、欧州諸国など、さまざまな先進国では人口の高齢化が進み、慢性疾患の発生率が高まっています。これらの疾患は長期にわたる複雑な治療レジメンを必要とすることが多く、個人にとっても国のヘルスケア制度にとっても財政的負担が大きいです。さらに発展途上国では、中流階級の人口が拡大し、高度なヘルスケア・ソリューションへの需要が高まっているため、既存のインフラに負担がかかっています。

ブランド薬の特許切れ

特殊ジェネリック医薬品産業の最も大きな原動力のひとつは、先発医薬品の特許切れです。特許が切れると、他のメーカーがその薬のジェネリック医薬品を製造・販売できるようになります。ジェネリック医薬品の研究開発費は一般的に新薬の研究開発費よりも低いため、ジェネリック医薬品は治療効果を維持しながら、より手頃な価格で販売することができます。毎年、年間売上高が数十億米ドルに上る医薬品が特許保護を失います。これは、ジェネリック医薬品専門メーカーにとって、消費者基盤の整った既存市場を開拓する絶好の機会となります。こうして、これらの医薬品が入手しやすくなることで、より多くの人々、特に低・中所得世帯の人々に恩恵がもたらされ、市場にプラスの影響を与えることになります。

医薬品開発における技術の進歩

特殊ジェネリック医薬品業界は、より広範な医薬品セクターとともに進化しています。これに伴い、医薬品開発・製造における最近の技術進歩は、バイオシミラーなど、以前は製造が困難であったより複雑なジェネリック医薬品の製造を可能にしています。さらに、人工知能や高度な分析手法などのツールにより、これらの医薬品の研究開発（R&D）プロセスが合理化されています。このことは、ジェネリック医薬品専門メーカーが、これまで以上に幅広い疾患や病態に対応できるようになったことを意味します。さらに、製造プロセスの革新により、これらの医薬品が一貫した品質で製造され、世界の規制機関が定める厳格な基準を満たすことが保証されています。その結果、市場にも貢献しています。

目次

第1章 序文

第2章 調査範囲と調査手法

  • 調査目的
  • 利害関係者
  • データソース
    • 一次情報
    • 二次情報
  • 市場推定
    • ボトムアップアプローチ
    • トップダウンアプローチ
  • 調査手法

第3章 エグゼクティブサマリー

第4章 特殊ジェネリックの世界市場イントロダクション

第5章 特殊ジェネリック医薬品はなぜ有利なのか？

第6章 特殊ジェネリックの世界市場

  • 市場概要
  • 市場実績
  • COVID-19の影響
  • 市場内訳：投与経路別
  • 市場内訳：適応症別
  • 市場内訳：流通チャネル別
  • 市場内訳：地域別
  • 市場予測
  • SWOT分析
    • 概要
    • 強み
    • 弱み
    • 機会
    • 脅威
  • バリューチェーン分析
  • ポーターのファイブフォース分析
    • 概要
    • 買い手の交渉力
    • 供給企業の交渉力
    • 競合の程度
    • 新規参入業者の脅威
    • 代替品の脅威
  • 市場促進要因と成功要因

第7章 市場内訳：投与経路別

  • 注射剤
    • 市場動向
    • 市場予測
  • 経口剤
    • 市場動向
    • 市場予測
  • その他
    • 市場動向
    • 市場予測

第8章 市場内訳：適応症別

  • がん領域
    • 市場動向
    • 市場予測
  • 自己免疫疾患
    • 市場動向
    • 市場予測
  • 感染症
    • 市場動向
    • 市場予測
  • その他
    • 市場動向
    • 市場予測

第9章 市場内訳：流通チャネル別

  • 小売薬局
    • 市場動向
    • 市場予測
  • 専門薬局
    • 市場動向
    • 市場予測
  • 病院薬局
    • 市場動向
    • 市場予測

第10章 市場内訳：地域別

  • 北米
    • 市場概要
    • 市場実績
    • 市場内訳：国別
    • 市場予測
  • 欧州
    • 市場概要
    • 市場実績
    • 市場内訳：国別
    • 市場予測
  • アジア太平洋
    • 市場概要
    • 市場実績
    • 市場内訳：国別
    • 市場予測
  • ラテンアメリカ
    • 市場概要
    • 市場実績
    • 市場内訳：国別
    • 市場予測
  • 中東・アフリカ地域
    • 市場概要
    • 市場実績
    • 市場予測

第11章 競合情勢

  • 市場構造
  • 主要企業
  • 主要企業のプロファイル
    • Teva Pharmaceuticals Industries
    • Akorn, Inc.
    • Mylan N.V.
    • Mallinckrodt
    • Sandoz International GmbH
    • Pfizer, Inc.
    • Sun Pharmaceutical Industries Ltd.
    • Valeant Pharmaceuticals
    • Apotex Corp.
    • Endo International plc.
図表

List of Figures

  • Figure 1: Global: Specialty Generics Market: Major Drivers and Challenges
  • Figure 2: Global: Specialty Generics Market: Sales Value (in Billion US$), 2018-2023
  • Figure 3: Global: Specialty Generics Market: Breakup by Route of Administration (in %), 2023
  • Figure 4: Global: Specialty Generics Market: Breakup by Indication (in %), 2023
  • Figure 5: Global: Specialty Generics Market: Breakup by Distribution Channel (in %), 2023
  • Figure 6: Global: Specialty Generics Market: Breakup by Region (in %), 2023
  • Figure 7: Global: Specialty Generics Market Forecast: Sales Value (in Billion US$), 2024-2032
  • Figure 8: Global: Specialty Generics Industry: SWOT Analysis
  • Figure 9: Global: Specialty Generics Industry: Value Chain Analysis
  • Figure 10: Global: Specialty Generics Industry: Porter's Five Forces Analysis
  • Figure 11: Global: Specialty Generics Market (Administration through Injectables): Sales Value (in Billion US$), 2018 & 2023
  • Figure 12: Global: Specialty Generics Market (Administration through Injectables) Forecast: Sales Value (in Billion US$), 2024-2032
  • Figure 13: Global: Specialty Generics Market (Oral Administration): Sales Value (in Billion US$), 2018 & 2023
  • Figure 14: Global: Specialty Generics Market (Oral Administration) Forecast: Sales Value (in Billion US$), 2024-2032
  • Figure 15: Global: Specialty Generics Market (Other Routes of Administration): Sales Value (in Billion US$), 2018 & 2023
  • Figure 16: Global: Specialty Generics Market (Other Routes of Administration) Forecast: Sales Value (in Billion US$), 2024-2032
  • Figure 17: Global: Specialty Generics Market (Oncology): Sales Value (in Billion US$), 2018 & 2023
  • Figure 18: Global: Specialty Generics Market (Oncology) Forecast: Sales Value (in Billion US$), 2024-2032
  • Figure 19: Global: Specialty Generics Market (Autoimmune Diseases): Sales Value (in Billion US$), 2018 & 2023
  • Figure 20: Global: Specialty Generics Market (Autoimmune Diseases) Forecast: Sales Value (in Billion US$), 2024-2032
  • Figure 21: Global: Specialty Generics Market (Infectious Diseases): Sales Value (in Billion US$), 2018 & 2023
  • Figure 22: Global: Specialty Generics Market (Infectious Diseases) Forecast: Sales Value (in Billion US$), 2024-2032
  • Figure 23: Global: Specialty Generics Market (Other Indications): Sales Value (in Billion US$), 2018 & 2023
  • Figure 24: Global: Specialty Generics Market (Other Indications) Forecast: Sales Value (in Billion US$), 2024-2032
  • Figure 25: Global: Specialty Generics Market: Sales Through Retail Pharmacies (in Billion US$), 2018 & 2023
  • Figure 26: Global: Specialty Generics Market Forecast: Sales Through Retail Pharmacies (in Billion US$), 2024-2032
  • Figure 27: Global: Specialty Generics Market: Sales Through Specialty Pharmacies (in Billion US$), 2018 & 2023
  • Figure 28: Global: Specialty Generics Market Forecast: Sales Through Specialty Pharmacies (in Billion US$), 2024-2032
  • Figure 29: Global: Specialty Generics Market: Sales Through Hospital Pharmacies (in Billion US$), 2018 & 2023
  • Figure 30: Global: Specialty Generics Market Forecast: Sales Through Hospital Pharmacies (in Billion US$), 2024-2032
  • Figure 31: North America: Specialty Generics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 32: North America: Specialty Generics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 33: United States: Specialty Generics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 34: United States: Specialty Generics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 35: Canada: Specialty Generics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 36: Canada: Specialty Generics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 37: Europe: Specialty Generics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 38: Europe: Specialty Generics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 39: Italy: Specialty Generics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 40: Italy: Specialty Generics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 41: Germany: Specialty Generics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 42: Germany: Specialty Generics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 43: France: Specialty Generics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 44: France: Specialty Generics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 45: United Kingdom: Specialty Generics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 46: United Kingdom: Specialty Generics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 47: Spain: Specialty Generics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 48: Spain: Specialty Generics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 49: Asia Pacific: Specialty Generics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 50: Asia Pacific: Specialty Generics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 51: Japan: Specialty Generics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 52: Japan: Specialty Generics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 53: China: Specialty Generics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 54: China: Specialty Generics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 55: India: Specialty Generics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 56: India: Specialty Generics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 57: South Korea: Specialty Generics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 58: South Korea: Specialty Generics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 59: Latin America: Specialty Generics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 60: Latin America: Specialty Generics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 61: Brazil: Specialty Generics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 62: Brazil: Specialty Generics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 63: Mexico: Specialty Generics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 64: Mexico: Specialty Generics Market Forecast: Sales Value (in Million US$), 2024-2032
  • Figure 65: Middle East and Africa: Specialty Generics Market: Sales Value (in Million US$), 2018 & 2023
  • Figure 66: Middle East and Africa: Specialty Generics Market: Breakup by Country (in %), 2023
  • Figure 67: Middle East and Africa: Specialty Generics Market Forecast: Sales Value (in Million US$), 2024-2032

List of Tables

  • Table 1: Global: Specialty Generics Market: Key Industry Highlights, 2023 and 2032
  • Table 2: Global: Specialty Generics Market Forecast: Breakup by Route of Administration (in Billion US$), 2024-2032
  • Table 3: Global: Specialty Generics Market Forecast: Breakup by Indication (in Billion US$), 2024-2032
  • Table 4: Global: Specialty Generics Market Forecast: Breakup by Distribution Channel (in Billion US$), 2024-2032
  • Table 5: Global: Specialty Generics Market Forecast: Breakup by Region (in Billion US$), 2024-2032
  • Table 6: North America: Specialty Generics Market: Key Industry Highlights, 2023 and 2032
  • Table 7: Europe: Specialty Generics Market: Key Industry Highlights, 2023 and 2032
  • Table 8: Asia Pacific: Specialty Generics Market: Key Industry Highlights, 2023 and 2032
  • Table 9: Latin America: Specialty Generics Market: Key Industry Highlights, 2023 and 2032
  • Table 10: Middle East and Africa: Specialty Generics Market: Key Industry Highlights, 2023 and 2032
  • Table 11: Global: Specialty Generics Market Structure
  • Table 12: Global: Specialty Generics Market: Key Players
目次
Product Code: SR112024A1219

The global specialty generics market size reached US$ 74.7 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 172.5 Billion by 2032, exhibiting a growth rate (CAGR) of 9.4% during 2024-2032. The rising number of strategic collaborations aiming to leverage the capabilities, resources, and market presence, the evolution of online pharmacies and telemedicine platforms and increasing government initiatives are some of the major factors propelling the market.

Specialty generics refer to generic versions of high-cost, brand-name specialty drugs. These medications are used to treat complex, chronic conditions such as cancer, rheumatoid arthritis, multiple sclerosis, and HIV. They differ from traditional generics in that they are typically biologic-based, require special handling and administration often injectables, and are often distributed through limited networks. The development of specialty generics presents unique challenges due to the intricate nature of the molecules involved and the complex processes used in their manufacturing. As a result, regulatory pathways for their approval can be more stringent compared to conventional generic drugs. In addition, specialty generics hold immense potential in healthcare. They offer patients access to vital treatments at a reduced cost, while also alleviating the financial burden on healthcare systems.

The evolution of advanced distribution channels, such as online pharmacies and telemedicine platforms, has also propelled the growth of the specialty generics market. These channels facilitate easy access to medications, ensuring patients in even remote locations can obtain the drugs they need. Along with this, government healthcare programs and private payers are continuously seeking strategies to contain escalating healthcare costs. Emphasizing the use of generic drugs, especially specialty generics, is a primary strategy. Therefore, several governments and insurance companies now incentivize or mandate the prescription of generics where available, thereby driving demand. In addition, specialty generics, being more affordably priced, have become the preferred choice for many in regions, ensuring essential treatments are within reach of larger segments of the population. Thus, this is significantly supporting the market. Apart from this, the production of generics for more niche, and specialized conditions is contributing to the market. Moreover, strategic collaborations aiming to leverage the capabilities, resources, and market presence of partnering entities are creating a positive market outlook.

Specialty Generics Market Trends/Drivers:

Increasing Demand for Affordable Healthcare Solutions

As the global population continues to rise and the burden of non-communicable diseases (NCDs) expands, there's a significant push to provide affordable healthcare solutions. The specialty generics industry is uniquely poised to address this demand. Specialty generics, which are bioequivalent versions of brand-name drugs, offer patients and healthcare systems the therapeutic efficacy of innovative medicines but at a reduced cost. Additionally, aging populations in various developed countries, such as Japan, the United States, and numerous European nations, are leading to an increased incidence of chronic diseases. These conditions often require prolonged and complex treatment regimens, which can be financially taxing for both individuals and national healthcare systems. Furthermore, in developing nations, the expansion of middle-class populations and their demand for advanced healthcare solutions is putting a strain on existing infrastructures.

Patent Expirations of Branded Drugs

One of the most significant drivers of the specialty generics industry is the expiration of patents for branded drugs. When patents expire, it opens the door for other manufacturers to produce and market generic versions of those medications. Given that research and development (R&D) costs for generics are typically lower than for novel drugs, these medications can be priced more affordably while maintaining therapeutic efficacy. Each year, drugs with billions of dollars in annual sales lose patent protection. This presents a golden opportunity for specialty generic manufacturers to tap into established markets with a ready consumer base. Thus, the accessibility of these medications then benefits the wider population, especially those in low-to-middle-income households, positively influencing the market.

Technological Advancements in Drug Development

The specialty generics industry is evolving with the broader pharmaceutical sector. Along with this, recent technological advancements in drug development and manufacturing are enabling the production of more complex generics, such as biosimilars, which were previously challenging to produce. In addition, tools, such as artificial intelligence and advanced analytical methodologies have streamlined the research and development (R&D) process for these drugs. This means that specialty generic manufacturers now address a broader range of diseases and conditions than ever before. Furthermore, innovations in manufacturing processes are ensuring that these drugs are produced with consistent quality, meeting the rigorous standards set by global regulatory bodies. As a result, it is also contributing to the market.

Specialty Generics Industry Segmentation:

IMARC Group provides an analysis of the key trends in each segment of the global specialty generics market report, along with forecasts at the global, regional and country levels from 2024-2032. Our report has categorized the market based on route of administration, indication and distribution channel.

Breakup by Route of Administration:

Injectables

Oral

Others

Injectable dominates the market

The report has provided a detailed breakup and analysis of the market based on the route of administration. This includes injectables, oral, and others. According to the report, injectable represented the largest segment.

The injectables route of administration has emerged as a significant market driver within the specialty generics industry. This growth can be attributed to the increasing prevalence of chronic diseases and complex medical conditions. Injectables offer advantages, including precise dosing and rapid onset of action, making them suitable for managing critical health conditions. In addition, the expiration of patents for certain branded biologics and specialty drugs has opened doors for generic manufacturers to enter the market with cost-effective alternatives. Moreover, the rising focus on research and development in the pharmaceutical sector has led to innovative injectable products with improved therapeutic outcomes. These market drivers collectively contribute to the growth and prominence of the injectables route of administration in the specialty generics industry.

On the contrary, the oral route of administration plays a pivotal role as a market driver within the specialty generics industry, due to the changing consumer preferences. Numerous patients prefer oral formulations due to ease of administration, eliminating the need for injections and reducing potential discomfort. Along with this, the vast array of chronic diseases and conditions requiring long-term treatment has contributed to the popularity of oral drugs.

Breakup by Indication:

Oncology

Autoimmune Diseases

Infectious Diseases

Others

Oncology dominates the market

A detailed breakup and analysis of the market based on the indication have also been provided in the report. This includes oncology, autoimmune diseases, infectious diseases, and others. According to the report, oncology represented the largest segment.

The rising prevalence of cancer continues to rise globally, necessitating a constant demand for effective and affordable oncology treatments. With an increasing number of patients requiring long-term therapies, the accessibility and cost-effectiveness of specialty generics become essential in improving cancer care. In addition, the expiration of patents for several branded oncology drugs has opened opportunities for generic manufacturers to enter the market, offering more affordable alternatives without compromising on quality. Apart from this, advancements in research and technology have led to the development of innovative formulations and drug delivery systems, enhancing the efficacy and patient compliance of oncology generics. Moreover, government initiatives and policies aimed at reducing the burden of cancer by promoting generic drug usage have further propelled market growth.

On the other hand, the infectious diseases route of administration has emerged as a crucial market driver within the specialty generics industry, influenced by the ongoing global burden of infectious diseases, including outbreaks and pandemics, has underscored the urgent need for effective and accessible treatment options.

Breakup by Distribution channel:

Retail Pharmacies

Specialty Pharmacies

Hospital Pharmacies

Retail pharmacies dominates the market

The report has provided a detailed breakup and analysis of the market based on the distribution channel. This includes retail pharmacies, specialty pharmacies, and hospital pharmacies. According to the report, retail pharmacies represented the largest segment.

The retail pharmacies distribution channel plays a pivotal role as a market driver within the specialty generics industry, primarily influenced by the widespread presence of retail pharmacies ensuring convenient and accessible distribution of specialty generic medications to a broader patient base. As these pharmacies are typically located in various communities and neighborhoods, patients can easily access their prescribed medications without the need for specialized healthcare facilities. In addition, the rising prevalence of chronic diseases and the growing demand for long-term treatment options have amplified the significance of retail pharmacies in delivering specialty generics. Furthermore, the retail pharmacies' established relationships with healthcare providers allow for streamlined communication and collaboration, facilitating efficient prescription processing and patient care. As the demand for specialty generics continues to grow, retail pharmacies' essential role in distribution and patient support is set to reinforce the industry's expansion and accessibility to critical medications.

Breakup by Region:

North America

United States

Canada

Europe

Italy

Germany

Spain

United Kingdom

France

Asia-Pacific

China

India

Japan

South Korea

Latin America

Brazil

Mexico

Middle East and Africa

North America exhibits a clear dominance, accounting for the largest specialty generics market share

The report has also provided a comprehensive analysis of all the major regional markets, which includes North America (the United States and Canada); Europe (Italy, Germany, France, United Kingdom, and Spain); Asia Pacific (Japan, China, India, and South Korea); Latin America (Brazil, Mexico); and the Middle East and Africa. According to the report, North America accounted for the largest market share.

The North America region is driven by the increasing prevalence of chronic diseases and complex medical conditions. It is leading to a growing demand for specialized treatment options. Specialty generics, with their cost-effective alternatives to branded specialty drugs, have gained traction in managing these conditions effectively. Additionally, the expiration of patents for certain branded specialty medications has created opportunities for generic manufacturers to enter the market, providing patients with more affordable treatment options. In addition, favorable government policies and initiatives aimed at promoting the use of generic medications have supported the expansion of the specialty generics industry in North America. These policies encourage generic drug usage, leading to enhanced patient access and overall cost savings in the healthcare system. Moreover, advancements in research and development leading to the introduction of innovative specialty generics with improved therapeutic outcomes are positively influencing the market.

Competitive Landscape:

The global specialty generics market is experiencing significant growth due to the escalating investments in research and development to develop innovative formulations, drug delivery systems, and combination therapies to improve the efficacy and patient compliance of their products. Ensuring compliance with regulatory standards and obtaining necessary approvals from health authorities in various countries is a critical aspect for specialty generic companies to launch and market their products. Along with this, the expansion of product portfolios to cover a wider range of therapeutic areas, such as oncology, immunology, and rare diseases, to cater to diverse patient needs is positively influencing the market. Apart from this, companies are offering patient support programs that provide counseling, adherence assistance, and financial aid to patients, thereby improving patient outcomes and medication adherence. Furthermore, collaborating with pharmaceutical companies, research institutions, and healthcare organizations allows specialty generics companies to access new technologies is contributing to the market.

The report has provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the key players in the market include:

Teva Pharmaceuticals Industries

Akorn, Inc.

Mylan N.V.

Mallinckrodt

Sandoz International GmbH

Pfizer, Inc.

Sun Pharmaceutical Industries Ltd.

Valeant Pharmaceuticals

Apotex Corp.

Endo International plc

Recent Developments:

In July 2023, Sandoz International GmbH declared intentions to establish a new technical development facility in Slovenia. Sandoz's Biopharma Technical Development skills will be significantly enhanced by the opening of a new end-to-end drug substance and drug product development centre.

In August 2022, Akorn, Inc. declared that a generic version of Cetrorelix Acetate for Injection, 0.25 mg (Cetrorelix) has been given FDA clearance. This is the first AP-Rated bioequivalent formulation of Cetrotide that has been authorized by Merck Serono.

In February 2022, Mallinckrodt issued a Complete Response Letter (CRL) in relation to the Company's New Drug Application (NDA) asking for approval of the investigational drug terlipressin to treat adults with hepatorenal syndrome (HRS), a severe and potentially fatal condition marked by a rapid decline in kidney function for which there is not yet an FDA-approved cure.

Key Questions Answered in This Report

  • 1. What is the size of the global specialty generics market?
  • 2. What are the key factors driving the global specialty generics market?
  • 3. What has been the impact of COVID-19 on the global specialty generics market?
  • 4. What is the breakup of the global specialty generics market based on the route of administration?
  • 5. What is the breakup of the global specialty generics market based on the indication?
  • 6. What is the breakup of the global specialty generics market based on the distribution channel?
  • 7. What are the key regions in the global specialty generics market?
  • 8. Who are the key players/companies in the global specialty generics market?

Table of Contents

1 Preface

2 Scope and Methodology

  • 2.1 Objectives of the Study
  • 2.2 Stakeholders
  • 2.3 Data Sources
    • 2.3.1 Primary Sources
    • 2.3.2 Secondary Sources
  • 2.4 Market Estimation
    • 2.4.1 Bottom-Up Approach
    • 2.4.2 Top-Down Approach
  • 2.5 Forecasting Methodology

3 Executive Summary

4 Global Specialty Generics Market: Introduction

5 Why are Specialty Generics So Lucrative?

6 Global Specialty Generics Market

  • 6.1 Market Overview
  • 6.2 Market Performance
  • 6.3 Impact of COVID-19
  • 6.4 Market Breakup by Route of Administration
  • 6.5 Market Breakup by Indication
  • 6.6 Market Breakup by Distribution Channel
  • 6.7 Market Breakup by Region
  • 6.8 Market Forecast
  • 6.9 SWOT Analysis
    • 6.9.1 Overview
    • 6.9.2 Strengths
    • 6.9.3 Weaknesses
    • 6.9.4 Opportunities
    • 6.9.5 Threats
  • 6.10 Value Chain Analysis
  • 6.11 Porters Five Forces Analysis
    • 6.11.1 Overview
    • 6.11.2 Bargaining Power of Buyers
    • 6.11.3 Bargaining Power of Suppliers
    • 6.11.4 Degree of Competition
    • 6.11.5 Threat of New Entrants
    • 6.11.6 Threat of Substitutes
  • 6.12 Key Market Drivers and Success Factors

7 Market Breakup by Route of Administration

  • 7.1 Injectable
    • 7.1.1 Market Trends
    • 7.1.2 Market Forecast
  • 7.2 Oral
    • 7.2.1 Market Trends
    • 7.2.2 Market Forecast
  • 7.3 Others
    • 7.3.1 Market Trends
    • 7.3.2 Market Forecast

8 Market Breakup by Indication

  • 8.1 Oncology
    • 8.1.1 Market Trends
    • 8.1.2 Market Forecast
  • 8.2 Autoimmune Diseases
    • 8.2.1 Market Trends
    • 8.2.2 Market Forecast
  • 8.3 Infectious Diseases
    • 8.3.1 Market Trends
    • 8.3.2 Market Forecast
  • 8.4 Others
    • 8.4.1 Market Trends
    • 8.4.2 Market Forecast

9 Market Breakup by Distribution Channel

  • 9.1 Retail Pharmacies
    • 9.1.1 Market Trends
    • 9.1.2 Market Forecast
  • 9.2 Specialty Pharmacies
    • 9.2.1 Market Trends
    • 9.2.2 Market Forecast
  • 9.3 Hospital Pharmacies
    • 9.3.1 Market Trends
    • 9.3.2 Market Forecast

10 Market Breakup by Region

  • 10.1 North America
    • 10.1.1 Market Overview
    • 10.1.2 Market Performance
    • 10.1.3 Market Breakup by Country
      • 10.1.3.1 United States
        • 10.1.3.1.1 Market Trends
        • 10.1.3.1.2 Market Forecast
      • 10.1.3.2 Canada
        • 10.1.3.2.1 Market Trends
        • 10.1.3.2.2 Market Forecast
    • 10.1.4 Market Forecast
  • 10.2 Europe
    • 10.2.1 Market Overview
    • 10.2.2 Market Performance
    • 10.2.3 Market Breakup by Country
      • 10.2.3.1 Italy
        • 10.2.3.1.1 Market Trends
        • 10.2.3.1.2 Market Forecast
      • 10.2.3.2 Germany
        • 10.2.3.2.1 Market Trends
        • 10.2.3.2.2 Market Forecast
      • 10.2.3.3 France
        • 10.2.3.3.1 Market Trends
        • 10.2.3.3.2 Market Forecast
      • 10.2.3.4 United Kingdom
        • 10.2.3.4.1 Market Trends
        • 10.2.3.4.2 Market Forecast
      • 10.2.3.5 Spain
        • 10.2.3.5.1 Market Trends
        • 10.2.3.5.2 Market Forecast
    • 10.2.4 Market Forecast
  • 10.3 Asia Pacific
    • 10.3.1 Market Overview
    • 10.3.2 Market Performance
    • 10.3.3 Market Breakup by Country
      • 10.3.3.1 Japan
        • 10.3.3.1.1 Market Trends
        • 10.3.3.1.2 Market Forecast
      • 10.3.3.2 China
        • 10.3.3.2.1 Market Trends
        • 10.3.3.2.2 Market Forecast
      • 10.3.3.3 India
        • 10.3.3.3.1 Market Trends
        • 10.3.3.3.2 Market Forecast
      • 10.3.3.4 South Korea
        • 10.3.3.4.1 Market Trends
        • 10.3.3.4.2 Market Forecast
    • 10.3.4 Market Forecast
  • 10.4 Latin America
    • 10.4.1 Market Overview
    • 10.4.2 Market Performance
    • 10.4.3 Market Breakup by Country
      • 10.4.3.1 Brazil
        • 10.4.3.1.1 Market Trends
        • 10.4.3.1.2 Market Forecast
      • 10.4.3.2 Mexico
        • 10.4.3.2.1 Market Trends
        • 10.4.3.2.2 Market Forecast
    • 10.4.4 Market Forecast
  • 10.5 Middle East and Africa
    • 10.5.1 Market Overview
    • 10.5.2 Market Performance
    • 10.5.3 Market Forecast

11 Competitive Landscape

  • 11.1 Market Structure
  • 11.2 Key Players
  • 11.3 Profiles of Key Players
    • 11.3.1 Teva Pharmaceuticals Industries
    • 11.3.2 Akorn, Inc.
    • 11.3.3 Mylan N.V.
    • 11.3.4 Mallinckrodt
    • 11.3.5 Sandoz International GmbH
    • 11.3.6 Pfizer, Inc.
    • 11.3.7 Sun Pharmaceutical Industries Ltd.
    • 11.3.8 Valeant Pharmaceuticals
    • 11.3.9 Apotex Corp.
    • 11.3.10 Endo International plc.