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Specialty Generics Drugs Market Share, Size, Trends, Industry Analysis Report, By Type (Injectables, Oral Drugs, Others); By Application; By End-use; By Region; Segment Forecast, 2023- 2032

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  • Apotex Corp.
  • Bausch Health Companies Inc.(Valeant Pharmaceuticals International, Inc.)
  • Dr. Reddy's Laboratories Ltd.
  • Endo Pharmaceuticals Inc.
  • Fresenius Kabi Brasil Ltda
  • Hikma Pharmaceuticals PLC
  • Mallinckrodt
  • Novartis AG(Sandoz International GmbH)
  • STADA Arzneimittel AG
  • Sun Pharmaceutical Industries Ltd
  • Teva Pharmaceuticals Industries Ltd
  • Viatris Inc.
ksm 23.12.13

The global specialty generics drugs market size is expected to reach USD 948.04 billion by 2032, according to a new study by Polaris market research. The report "Specialty Generics Drugs Market Share, Size, Trends, Industry Analysis Report, By Type (Injectables, Oral Drugs, Others); By Application; By End-use; By Region; Segment Forecast, 2023- 2032" gives a detailed insight into current market dynamics and provides analysis on future market growth.

Many pharmaceutical, biopharmaceutical, and medical device companies have been focusing on expanding their market presence by merging with or acquiring other companies. The prevalence of life-threatening diseases, such as cancer, Multiple Sclerosis (MS), and HIV, is increasing globally, which is expected to drive the demand for specialty medicines. Chronic diseases remain a major concern, particularly in emerging countries where they are the primary cause of mortality in five of the six WHO regions. Contagious diseases, such as HIV, are still widespread in Sub-Saharan Africa and are expected to continue to be a major issue. During the forecast period, the market for specialty medicines is expected to grow rapidly due to the high prevalence of life-threatening diseases.

In 2020, the COVID-19 pandemic had a significant impact on the pharmaceutical market, causing slower growth and a decline in net sales for several companies. Manufacturing plants had to face lockdown restrictions, clinical trials and studies had to be stopped, and there was a shortage of skilled labor. Mallinckrodt is one such company that experienced a -6.6% decline in its specialty generics segment, mainly due to increased competition and a change in product mix caused by market shifts during the pandemic. However, the market is showing signs of recovery in 2021, with mass vaccinations, easing of lockdown restrictions, and a growing demand for specialty medicines to treat chronic conditions.

Virtual trials offer numerous advantages, including remote data collection, increased participant engagement, and larger population inclusion. They minimize risks associated with in-person visits and reduce the burden on participants, coordinators, and investigators. By leveraging virtual methods, the clinical trials industry can overcome challenges, improve efficiency, and facilitate prompt and effective data collection.

Specialty generics drugs Market Report Highlights

During the forecast period, the Injectables segment is expected to be the largest and fastest-growing segment in the pharmaceutical industry. This is due to its ability to have long-lasting effects and quick absorption into the body, resulting in higher patient compliance and acceptance. With the increased approvals of new products and the expansion of the market, the segment is anticipated to grow rapidly.

In 2022, the largest market share was held by the segment of inflammatory conditions. The number of individuals with inflammatory conditions like rheumatoid arthritis is increasing globally. According to the Global RA Network, around 350 Billion people are living with arthritis, while the NHS has reported that over 10 Billion people in the UK are affected. In response to this rise in prevalence, major players in the healthcare industry are expanding their market share in this sector.

In 2022, the organic segment had the largest share. Organic bread improvers are made from organic ingredients and produced using organic farming methods. This means they are free from synthetic chemicals and GMOs. These organic improvers contain natural additives sourced from organic materials.

In 2022, the specialty pharmacy segment held the largest market share. Major generic manufacturers and insurance providers often rely on specialty pharmacies to distribute their products because of the low distribution costs and the easy accessibility of medicines offered by these pharmacies.

The US Food and Drug Administration (FDA) has implemented supportive regulatory policies to simplify the approval of new products. In order to make sure the public has access to safe and effective low-cost generic drugs, the agency has put several initiatives in place, including the Generic Drug User Fee Amendments (GDUFA) under the Hatch-Waxman Act. Consequently, prominent manufacturers are constantly working to introduce specialty generic drugs to the market.

The global key market players include: Apotex Corp., Bausch Health Companies Inc. (Valeant Pharmaceuticals International, Inc.), Dr. Reddy's Laboratories Ltd., Endo Pharmaceuticals Inc., Fresenius Kabi Brasil Ltda, Hikma Pharmaceuticals PLC, Mallinckrodt, Novartis AG (Sandoz International GmbH)

Polaris market research has segmented the Speciality generics drugs market report based on type, application, end-user, and region:

Specialty generics drugs, Type Outlook (Revenue - USD Billion, 2019 - 2032)

  • Injectables
  • Oral Drugs
  • Others

Specialty generics drugs, Application Outlook (Revenue - USD Billion, 2019 - 2032)

  • Oncology
  • Inflamatory conditions
  • Multiple sclerosis
  • Hepatitis C
  • Others

Speciality generics drugs, End-Use Outlook (Revenue - USD Billion, 2019 - 2032)

  • Specialty pharmacy
  • Retail pharmacy
  • Hospital pharmacy

Speciality generics drugs, Regional Outlook (Revenue - USD Billion, 2019 - 2032)

  • North America
  • U.S.
  • Canada
  • Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Russia
  • Netherlands
  • Asia Pacific
  • China
  • India
  • Japan
  • South Korea
  • Indonesia
  • Malaysia
  • Latin America
  • Argentina
  • Brazil
  • Mexico
  • Middle East & Africa
  • UAE
  • Saudi Arabia
  • Israel
  • South Africa

Table of Contents

1. Introduction

  • 1.1. Report Description
    • 1.1.1. Objectives of the Study
    • 1.1.2. Market Scope
    • 1.1.3. Assumptions
  • 1.2. Stakeholders

2. Executive Summary

  • 2.1. Market Highlights

3. Research Methodology

  • 3.1. Overview
    • 3.1.1. Data Mining
  • 3.2. Data Sources
    • 3.2.1. Primary Sources
    • 3.2.2. Secondary Sources

4. Global Specialty Generics Drugs Market Insights

  • 4.1. Specialty Generics Drugs Market - End-Use Snapshot
  • 4.2. Specialty Generics Drugs Market Dynamics
    • 4.2.1. Drivers and Opportunities
      • 4.2.1.1. Increasing emphasizing mergers and acquisitions as a means of expanding their presence in the specialty generics market
      • 4.2.1.2. The expiration of patents on specialty drugs to drive the market growth
    • 4.2.2. Restraints and Challenges
      • 4.2.2.1. Low profitability and lack of awareness about these drugs, hinder the market growth
  • 4.3. Porter's Five Forces Analysis
    • 4.3.1. Bargaining Power of Suppliers (Moderate)
    • 4.3.2. Threats of New Entrants: (Low)
    • 4.3.3. Bargaining Power of Buyers (Moderate)
    • 4.3.4. Threat of Substitute (Moderate)
    • 4.3.5. Rivalry among existing firms (High)
  • 4.4. PESTEL Analysis
  • 4.5. Specialty Generics Drugs Market End-Use Trends
  • 4.6. Value Chain Analysis
  • 4.7. COVID-19 Impact Analysis

5. Global Specialty Generics Drugs Market, by Type

  • 5.1. Key Findings
  • 5.2. Introduction
    • 5.2.1. Global Specialty Generics Drugs Market, by Type, 2019-2032 (USD Billion)
  • 5.3. Injectables
    • 5.3.1. Global Specialty Generics Drugs Market, by Injectables, by Region, 2019-2032 (USD Billion)
  • 5.4. Oral Drugs
    • 5.4.1. Global Specialty Generics Drugs Market, by Oral Drugs, by Region, 2019-2032 (USD Billion)
  • 5.5. Others
    • 5.5.1. Global Specialty Generics Drugs Market, by Others, by Region, 2019-2032 (USD Billion)

6. Global Specialty Generics Drugs Market, by Application

  • 6.1. Key Findings
  • 6.2. Introduction
    • 6.2.1. Global Specialty Generics Drugs Market, by Application, 2019-2032 (USD Billion)
  • 6.3. Oncology
    • 6.3.1. Global Specialty Generics Drugs Market, by Oncology, by Region, 2019-2032 (USD Billion)
  • 6.4. Inflamatory conditions
    • 6.4.1. Global Specialty Generics Drugs Market, by Inflamatory conditions, by Region, 2019-2032 (USD Billion)
  • 6.5. Multiple sclerosis
    • 6.5.1. Global Specialty Generics Drugs Market, by Multiple sclerosis, by Region, 2019-2032 (USD Billion)
  • 6.6. Hepatitis C
    • 6.6.1. Global Specialty Generics Drugs Market, by Hepatitis C, by Region, 2019-2032 (USD Billion)
  • 6.7. Others
    • 6.7.1. Global Specialty Generics Drugs Market, by Others, by Region, 2019-2032 (USD Billion)

7. Global Specialty Generics Drugs Market, by End-Use

  • 7.1. Key Findings
  • 7.2. Introduction
    • 7.2.1. Global Specialty Generics Drugs Market, by End-Use, 2019-2032 (USD Billion)
  • 7.3. Specialty pharmacy
    • 7.3.1. Global Specialty Generics Drugs Market, by Specialty pharmacy, By Region, 2019-2032 (USD Billion)
  • 7.4. Retail pharmacy
    • 7.4.1. Global Specialty Generics Drugs Market, by Retail pharmacy, By Region, 2019-2032 (USD Billion)
  • 7.5. Hospital pharmacy
    • 7.5.1. Global Specialty Generics Drugs Market, by Hospital pharmacy, By Region, 2019-2032 (USD Billion)

8. Global Specialty Generics Drugs Market, by Geography

  • 8.1. Key findings
  • 8.2. Introduction
    • 8.2.1. Specialty Generics Drugs Market Assessment, By Geography, 2019-2032 (USD Billion)
  • 8.3. Specialty Generics Drugs Market - North America
    • 8.3.1. North America: Specialty Generics Drugs Market, by Type, 2019-2032 (USD Billion)
    • 8.3.2. North America: Specialty Generics Drugs Market, by End-Use, 2019-2032 (USD Billion)
    • 8.3.3. North America: Specialty Generics Drugs Market, by Application, 2019-2032 (USD Billion)
    • 8.3.4. Specialty Generics Drugs Market - U.S.
      • 8.3.4.1. U.S.: Specialty Generics Drugs Market, by Type, 2019-2032 (USD Billion)
      • 8.3.4.2. U.S.: Specialty Generics Drugs Market, by End-Use, 2019-2032 (USD Billion)
      • 8.3.4.3. U.S.: Specialty Generics Drugs Market, by Application, 2019-2032 (USD Billion)
    • 8.3.5. Specialty Generics Drugs Market - Canada
      • 8.3.5.1. Canada: Specialty Generics Drugs Market, by Type, 2019-2032 (USD Billion)
      • 8.3.5.2. Canada.: Specialty Generics Drugs Market, by End-Use, 2019-2032 (USD Billion)
      • 8.3.5.3. Canada: Specialty Generics Drugs Market, by Application, 2019-2032 (USD Billion)
  • 8.4. Specialty Generics Drugs Market - Europe
    • 8.4.1. Europe: Specialty Generics Drugs Market, by Type, 2019-2032 (USD Billion)
    • 8.4.2. Europe.: Specialty Generics Drugs Market, by End-Use, 2019-2032 (USD Billion)
    • 8.4.3. Europe: Specialty Generics Drugs Market, by Application, 2019-2032 (USD Billion)
    • 8.4.4. Specialty Generics Drugs Market - UK
      • 8.4.4.1. UK: Specialty Generics Drugs Market, by Type, 2019-2032 (USD Billion)
      • 8.4.4.2. UK.: Specialty Generics Drugs Market, by End-Use, 2019-2032 (USD Billion)
      • 8.4.4.3. UK: Specialty Generics Drugs Market, by Application, 2019-2032 (USD Billion)
    • 8.4.5. Specialty Generics Drugs Market - France
      • 8.4.5.1. France: Specialty Generics Drugs Market, by Type, 2019-2032 (USD Billion)
      • 8.4.5.2. France.: Specialty Generics Drugs Market, by End-Use, 2019-2032 (USD Billion)
      • 8.4.5.3. France: Specialty Generics Drugs Market, by Application, 2019-2032 (USD Billion)
    • 8.4.6. Specialty Generics Drugs Market - Germany
      • 8.4.6.1. Germany: Specialty Generics Drugs Market, by Type, 2019-2032 (USD Billion)
      • 8.4.6.2. Germany.: Specialty Generics Drugs Market, by End-Use, 2019-2032 (USD Billion)
      • 8.4.6.3. Germany: Specialty Generics Drugs Market, by Application, 2019-2032 (USD Billion)
    • 8.4.7. Specialty Generics Drugs Market - Italy
      • 8.4.7.1. Italy: Specialty Generics Drugs Market, by Type, 2019-2032 (USD Billion)
      • 8.4.7.2. Italy.: Specialty Generics Drugs Market, by End-Use, 2019-2032 (USD Billion)
      • 8.4.7.3. Italy: Specialty Generics Drugs Market, by Application, 2019-2032 (USD Billion)
    • 8.4.8. Specialty Generics Drugs Market - Spain
      • 8.4.8.1. Spain: Specialty Generics Drugs Market, by Type, 2019-2032 (USD Billion)
      • 8.4.8.2. Spain.: Specialty Generics Drugs Market, by End-Use, 2019-2032 (USD Billion)
      • 8.4.8.3. Spain: Specialty Generics Drugs Market, by Application, 2019-2032 (USD Billion)
    • 8.4.9. Specialty Generics Drugs Market - Netherlands
      • 8.4.9.1. Netherlands: Specialty Generics Drugs Market, by Type, 2019-2032 (USD Billion)
      • 8.4.9.2. Netherlands.: Specialty Generics Drugs Market, by End-Use, 2019-2032 (USD Billion)
      • 8.4.9.3. Netherlands: Specialty Generics Drugs Market, by Application, 2019-2032 (USD Billion)
    • 8.4.10. Specialty Generics Drugs Market - Russia
      • 8.4.10.1. Russia: Specialty Generics Drugs Market, by Type, 2019-2032 (USD Billion)
      • 8.4.10.2. Russia.: Specialty Generics Drugs Market, by End-Use, 2019-2032 (USD Billion)
      • 8.4.10.3. Russia: Specialty Generics Drugs Market, by Application, 2019-2032 (USD Billion)
  • 8.5. Specialty Generics Drugs Market - Asia Pacific
    • 8.5.1. Asia Pacific: Specialty Generics Drugs Market, by Type, 2019-2032 (USD Billion)
    • 8.5.2. Asia Pacific.: Specialty Generics Drugs Market, by End-Use, 2019-2032 (USD Billion)
    • 8.5.3. Asia Pacific: Specialty Generics Drugs Market, by Application, 2019-2032 (USD Billion)
    • 8.5.4. Specialty Generics Drugs Market - China
      • 8.5.4.1. China: Specialty Generics Drugs Market, by Type, 2019-2032 (USD Billion)
      • 8.5.4.2. China.: Specialty Generics Drugs Market, by End-Use, 2019-2032 (USD Billion)
      • 8.5.4.3. China: Specialty Generics Drugs Market, by Application, 2019-2032 (USD Billion)
    • 8.5.5. Specialty Generics Drugs Market - India
      • 8.5.5.1. India: Specialty Generics Drugs Market, by Type, 2019-2032 (USD Billion)
      • 8.5.5.2. India.: Specialty Generics Drugs Market, by End-Use, 2019-2032 (USD Billion)
      • 8.5.5.3. India: Specialty Generics Drugs Market, by Application, 2019-2032 (USD Billion)
    • 8.5.6. Specialty Generics Drugs Market - Malaysia
      • 8.5.6.1. Malaysia: Specialty Generics Drugs Market, by Type, 2019-2032 (USD Billion)
      • 8.5.6.2. Malaysia.: Specialty Generics Drugs Market, by End-Use, 2019-2032 (USD Billion)
      • 8.5.6.3. Malaysia: Specialty Generics Drugs Market, by Application, 2019-2032 (USD Billion)
    • 8.5.7. Specialty Generics Drugs Market - Japan
      • 8.5.7.1. Japan: Specialty Generics Drugs Market, by Type, 2019-2032 (USD Billion)
      • 8.5.7.2. Japan.: Specialty Generics Drugs Market, by End-Use, 2019-2032 (USD Billion)
      • 8.5.7.3. Japan: Specialty Generics Drugs Market, by Application, 2019-2032 (USD Billion)
    • 8.5.8. Specialty Generics Drugs Market - Indonesia
      • 8.5.8.1. Indonesia: Specialty Generics Drugs Market, by Type, 2019-2032 (USD Billion)
      • 8.5.8.2. Indonesia.: Specialty Generics Drugs Market, by End-Use, 2019-2032 (USD Billion)
      • 8.5.8.3. Indonesia: Specialty Generics Drugs Market, by Application, 2019-2032 (USD Billion)
    • 8.5.9. Specialty Generics Drugs Market - South Korea
      • 8.5.9.1. South Korea: Specialty Generics Drugs Market, by Type, 2019-2032 (USD Billion)
      • 8.5.9.2. South Korea.: Specialty Generics Drugs Market, by End-Use, 2019-2032 (USD Billion)
      • 8.5.9.3. South Korea: Specialty Generics Drugs Market, by Application, 2019-2032 (USD Billion)
  • 8.6. Specialty Generics Drugs Market - Middle East & Africa
    • 8.6.1. Middle East & Africa: Specialty Generics Drugs Market, by Type, 2019-2032 (USD Billion)
    • 8.6.2. Middle East & Africa.: Specialty Generics Drugs Market, by End-Use, 2019-2032 (USD Billion)
    • 8.6.3. Middle East & Africa: Specialty Generics Drugs Market, by Application, 2019-2032 (USD Billion)
    • 8.6.4. Specialty Generics Drugs Market - Saudi Arabia
      • 8.6.4.1. Saudi Arabia: Specialty Generics Drugs Market, by Type, 2019-2032 (USD Billion)
      • 8.6.4.2. Saudi Arabia.: Specialty Generics Drugs Market, by End-Use, 2019-2032 (USD Billion)
      • 8.6.4.3. Saudi Arabia: Specialty Generics Drugs Market, by Application, 2019-2032 (USD Billion)
    • 8.6.5. Specialty Generics Drugs Market - UAE
      • 8.6.5.1. UAE: Specialty Generics Drugs Market, by Type, 2019-2032 (USD Billion)
      • 8.6.5.2. UAE.: Specialty Generics Drugs Market, by End-Use, 2019-2032 (USD Billion)
      • 8.6.5.3. UAE: Specialty Generics Drugs Market, by Application, 2019-2032 (USD Billion)
    • 8.6.6. Specialty Generics Drugs Market - Israel
      • 8.6.6.1. Israel: Specialty Generics Drugs Market, by Type, 2019-2032 (USD Billion)
      • 8.6.6.2. Israel.: Specialty Generics Drugs Market, by End-Use, 2019-2032 (USD Billion)
      • 8.6.6.3. Israel: Specialty Generics Drugs Market, by Application, 2019-2032 (USD Billion)
    • 8.6.7. Specialty Generics Drugs Market - South Africa
      • 8.6.7.1. South Africa: Specialty Generics Drugs Market, by Type, 2019-2032 (USD Billion)
      • 8.6.7.2. South Africa.: Specialty Generics Drugs Market, by End-Use, 2019-2032 (USD Billion)
      • 8.6.7.3. South Africa: Specialty Generics Drugs Market, by Application, 2019-2032 (USD Billion)
  • 8.7. Specialty Generics Drugs Market - Latin America
    • 8.7.1. Latin America: Specialty Generics Drugs Market, by Type, 2019-2032 (USD Billion)
    • 8.7.2. Latin America.: Specialty Generics Drugs Market, by End-Use, 2019-2032 (USD Billion)
    • 8.7.3. Latin America: Specialty Generics Drugs Market, by Application, 2019-2032 (USD Billion)
    • 8.7.4. Specialty Generics Drugs Market - Mexico
      • 8.7.4.1. Mexico: Specialty Generics Drugs Market, by Type, 2019-2032 (USD Billion)
      • 8.7.4.2. Mexico.: Specialty Generics Drugs Market, by End-Use, 2019-2032 (USD Billion)
      • 8.7.4.3. Mexico: Specialty Generics Drugs Market, by Application, 2019-2032 (USD Billion)
    • 8.7.5. Specialty Generics Drugs Market - Brazil
      • 8.7.5.1. Brazil: Specialty Generics Drugs Market, by Type, 2019-2032 (USD Billion)
      • 8.7.5.2. Brazil.: Specialty Generics Drugs Market, by End-Use, 2019-2032 (USD Billion)
      • 8.7.5.3. Brazil: Specialty Generics Drugs Market, by Application, 2019-2032 (USD Billion)
    • 8.7.6. Specialty Generics Drugs Market - Argentina
      • 8.7.6.1. Argentina: Specialty Generics Drugs Market, by Type, 2019-2032 (USD Billion)
      • 8.7.6.2. Argentina.: Specialty Generics Drugs Market, by End-Use, 2019-2032 (USD Billion)
      • 8.7.6.3. Argentina: Specialty Generics Drugs Market, by Application, 2019-2032 (USD Billion)

9. Competitive Landscape

  • 9.1. Expansion and Acquisition Analysis
    • 9.1.1. Expansion
    • 9.1.2. Acquisitions
  • 9.2. Partnerships/Collaborations/Agreements/Exhibitions

10. Company Profiles

  • 10.1. Apotex Corp.
    • 10.1.1. Company Overview
    • 10.1.2. Financial Performance
    • 10.1.3. Product Benchmarking
    • 10.1.4. Recent Development
  • 10.2. Bausch Health Companies Inc. (Valeant Pharmaceuticals International, Inc.)
    • 10.2.1. Company Overview
    • 10.2.2. Financial Performance
    • 10.2.3. Product Benchmarking
    • 10.2.4. Recent Development
  • 10.3. Dr. Reddy's Laboratories Ltd.
    • 10.3.1. Company Overview
    • 10.3.2. Financial Performance
    • 10.3.3. Product Benchmarking
    • 10.3.4. Recent Development
  • 10.4. Endo Pharmaceuticals Inc.
    • 10.4.1. Company Overview
    • 10.4.2. Financial Performance
    • 10.4.3. Product Benchmarking
    • 10.4.4. Recent Development
  • 10.5. Fresenius Kabi Brasil Ltda
    • 10.5.1. Company Overview
    • 10.5.2. Financial Performance
    • 10.5.3. Product Benchmarking
    • 10.5.4. Recent Development
  • 10.6. Hikma Pharmaceuticals PLC
    • 10.6.1. Company Overview
    • 10.6.2. Financial Performance
    • 10.6.3. Product Benchmarking
    • 10.6.4. Recent Development
  • 10.7. Mallinckrodt
    • 10.7.1. Company Overview
    • 10.7.2. Financial Performance
    • 10.7.3. Product Benchmarking
    • 10.7.4. Recent Development
  • 10.8. Novartis AG (Sandoz International GmbH)
    • 10.8.1. Company Overview
    • 10.8.2. Financial Performance
    • 10.8.3. Product Benchmarking
    • 10.8.4. Recent Development
  • 10.9. STADA Arzneimittel AG
    • 10.9.1. Company Overview
    • 10.9.2. Financial Performance
    • 10.9.3. Product Benchmarking
    • 10.9.4. Recent Development
  • 10.10.Sun Pharmaceutical Industries Ltd
    • 10.10.1. Company Overview
    • 10.10.2. Financial Performance
    • 10.10.3. Product Benchmarking
    • 10.10.4. Recent Development
  • 10.11. Teva Pharmaceuticals Industries Ltd
    • 10.11.1. Company Overview
    • 10.11.2. Financial Performance
    • 10.11.3. Product Benchmarking
    • 10.11.4. Recent Development
  • 10.12. Viatris Inc.
    • 10.12.1. Company Overview
    • 10.12.2. Financial Performance
    • 10.12.3. Product Benchmarking
    • 10.12.4. Recent Development
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