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Global Specialty Generics Market Size, Share & Trends Analysis Report by Type (Injectables, Oral Drugs), by Application (Oncology, Inflammatory Conditions, Hepatitis C), by End-use (Specialty, Retail), by Region, and Segment Forecasts, 2022-2030

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    Report

  • 101 Pages
  • July 2022
  • Region: Global
  • Grand View Research
  • ID: 4418838
The global specialty generics market size is expected to reach USD 148.7 billion by 2030, The market is expected to expand at a CAGR of 9.2% from 2022 to 2030. The growth in the market is largely driven by increasing product approvals and the rising prevalence of complex chronic diseases, such as multiple sclerosis.

In April 2022, Dr. Reddy’s Laboratories launched a methylprednisolone sodium succinate injection in the U.S. for the treatment of patients with arthritis, blood disorders, and certain rare cancers. Furthermore, in June 2022, Elixir launched copay solutions enhancement program for the management of specialty generic medication prices. Under this program, an eligible patient receives a generic version of specialty medication at zero cost. Thus, the launch of new low-cost generic injectables and the availability of such programs is projected to fuel market growth.

Increased claim settlements and availability of specialty generic drugs increase their prescription rates due to the high safety, efficacy, and tolerability associated with them. According to the Human Resources Benefits Office University of Michigan annual report (2021), around 1,383 claims were settled for specialty generic drugs such as glatiramer acetate (Copaxone/Glatopa), teriflunomide (Aubagio), and fingolimod (Gilenya) in 2021, compared to 1,360 in 2020, with a rise of 1.7% for the treatment of patients with multiple sclerosis.

However, high costs associated with specialty generics may hamper their uptake. The lack of ability to attract patients toward drugs, marketing rights acquired by companies for off-patent drugs with no generic competition, and small target patient pool, subsequently increases the prices of products. According to the University of Michigan Prescription Drug Plan Formulary report, the average cost of specialty generic is over USD 4,500 monthly per person, compared to USD 17 to 22 for a generic prescription.

Specialty Generics Market Report Highlights

  • Based on type, the injectables segment dominated the market in 2021. It is estimated to maintain its dominance during the forecast period due to its high prescription rate on account of long-term effects, and immediate absorption compared to oral drugs
  • Based on application, the oncology segment is expected to witness significant growth during the projection period owing to the increasing prevalence of cancer. According to Globocan, the number of new cancer cases is anticipated to reach 28.4 million within the next two decades worldwide
  • On the basis of end-use, the specialty pharmacy segment dominated the market in 2021 owing to features like timely delivery, optimized patient access, and effective distribution management
  • Based on region, North America dominated the market in 2021 due to the presence of supportive regulatory policies regarding the approval of new products. The U.S. FDA introduced Generic Drug User Fee Amendments (GDUFA) under the Hatch-Waxman act to quicken the approval of new generic drugs


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Table of Contents

Chapter 1 Methodology and Scope
1.1 Market Segmentation
1.1.1 Estimates and Forecast Timeline
1.2 Research Methodology
1.3 Information Procurement
1.3.1 Purchased Database
1.3.2 Internal Database
1.3.3 Secondary Sources
1.3.4 Primary Research
1.3.5 Details of Primary Research
1.4 Information or Data Analysis
1.4.1 Data Analysis Models
1.5 Market Formulation & Validation
1.6 Model Details
1.6.1 Commodity Flow Analysis
1.6.1.1 Approach 1: Commodity Flow Approach
1.6.1.2 Approach 2: Country-wise market estimation using bottom-up approach
1.7 Global Market: CAGR Calculation
1.8 Research Assumptions
1.9 List of Secondary Sources
1.10 List of Primary Sources
1.11 List of Abbreviations
1.12 Objectives
1.12.1 Objective 1
1.12.2 Objective 2
1.12.3 Objective 3
1.12.4 Objective 4

Chapter 2 Executive Summary
2.1 Market Snapshot

Chapter 3 Market Variables, Trends, & Scope
3.1 Market Lineage Outlook
3.1.1 Parent Market Outlook
3.2 Penetration & Growth Prospect Mapping
3.3 Regulatory and Reimbursement Framework
3.4 Market Variable Analysis
3.4.1 Market driver analysis
3.4.1.1 Rising number of off-patent specialty drugs
3.4.1.2 Escalating demand for low-cost generic specialty drugs
3.4.1.3 Increasing prevalence of chronic disease
3.4.1.4 Increasing emphasis to cut down healthcare expenditure
3.4.2 Market restraint analysis
3.4.2.1 High costs associated with specialty generics
3.4.2.2 Delay in new drug launches
3.5 Industry Analysis Tools
3.5.1 Porter's five forces analysis
3.5.2 PESTEL Analysis
3.6 Pipeline Analysis

Chapter 4 Specialty Generics Market - Segment Analysis, by Type, 2018 - 2030 (USD Billion)
4.1 Specialty Generics Market: Type Movement Analysis
4.2 InjecTables
4.2.1 InjecTables market, 2018 - 2030 (USD Billion)
4.3 Oral Drugs
4.3.1 Oral drugs market, 2018 - 2030 (USD Billion)
4.4 Others
4.4.1 Others market, 2018 - 2030 (USD Billion)

Chapter 5 Specialty generics Market - Segment Analysis, by Application, 2018 - 2030 (USD Billion)
5.1 Specialty Generics Market: Application Movement Analysis
5.2 Oncology
5.2.1 Oncology market, 2018 - 2030 (USD Billion)
5.3 Inflammatory Conditions
5.3.1 Inflammatory conditions market, 2018 - 2030 (USD Billion)
5.4 Multiple Sclerosis
5.4.1 Multiple sclerosis market, 2018 - 2030 (USD Billion)
5.5 Hepatitis C
5.5.1 Hepatitis C market, 2018 - 2030 (USD Billion)
5.6 Others
5.6.1 Others market, 2018 - 2030 (USD Billion)

Chapter 6 Specialty generics Market - Segment Analysis, by End-Use, 2018 - 2030 (USD Billion)
6.1 Specialty Generics Market: End-Use Movement Analysis
6.2 Specialty Pharmacy
6.2.1 Specialty pharmacy market, 2018 - 2030 (USD Billion)
6.3 Retail Pharmacy
6.3.1 Retail pharmacy market, 2018 - 2030 (USD Billion)
6.4 Hospital Pharmacy
6.4.1 Hospital pharmacy market, 2018 - 2030 (USD Billion)

Chapter 7 Specialty generics Market - Segment Analysis, By Region, 2018 - 2030 (USD Billion)
7.1 Specialty Generics Market, Market Share by Region, 2021 & 2030
7.1.1 North America
7.1.1.1 North America market estimates and forecast, 2018 - 2030 (USD Billion)
7.1.1.2 U.S.
7.1.1.2.1 U.S. market estimates and forecast, 2018 - 2030 (USD Billion)
7.1.1.3 Canada
7.1.1.3.1 Canada market estimates and forecast, 2018 - 2030 (USD Billion)
7.1.2 Europe
7.1.2.1 Europe market estimates and forecast, 2018 - 2030 (USD Billion)
7.1.2.2 U.K.
7.1.2.2.1 U.K. market estimates and forecast, 2018 - 2030 (USD Billion)
7.1.2.3 Germany
7.1.2.3.1 Germany market estimates and forecast, 2018 - 2030 (USD Billion)
7.1.2.4 France
7.1.2.4.1 France market estimates and forecast, 2018 - 2030 (USD Billion)
7.1.2.5 Spain
7.1.2.5.1 Spain market estimates and forecast, 2018 - 2030 (USD Billion)
7.1.2.6 Italy
7.1.2.6.1 Italy market estimates and forecast, 2018 - 2030 (USD Billion)
7.1.3 Asia Pacific
7.1.3.1 Asia Pacific market estimates and forecast, 2018 - 2030 (USD Billion)
7.1.3.2 Japan
7.1.3.2.1 Japan market estimates and forecast, 2018 - 2030 (USD Billion)
7.1.3.3 China
7.1.3.3.1 China market estimates and forecast, 2018 - 2030 (USD Billion)
7.1.3.4 India
7.1.3.4.1 India market estimates and forecast, 2018 - 2030 (USD Billion)
7.1.3.5 Australia
7.1.3.5.1 Australia market estimates and forecast, 2018 - 2030 (USD Billion)
7.1.3.6 South Korea
7.1.3.6.1 South Korea market estimates and forecast, 2018 - 2030 (USD Billion)
7.1.4 Latin America
7.1.4.1 Latin America market estimates and forecast, 2018 - 2030 (USD Billion)
7.1.4.2 Brazil
7.1.4.2.1 Brazil market estimates and forecast, 2018 - 2030 (USD Billion)
7.1.4.3 Mexico
7.1.4.3.1 Mexico market estimates and forecast, 2018 - 2030 (USD Billion)
7.1.4.4 Argentina
7.1.4.4.1 Argentina market estimates and forecast, 2018 - 2030 (USD Billion)
7.1.5 Middle East and Africa
7.1.6 Middle East and Africa market estimates and forecast, 2018 - 2030 (USD Billion)
7.1.6.1 South Africa
7.1.6.1.1 South Africa market estimates and forecast, 2018 - 2030 (USD Billion)
7.1.6.2 Saudi Arabia
7.1.6.2.1 Saudi Arabia market estimates and forecast, 2018 - 2030 (USD Billion)
7.1.6.3 UAE
7.1.6.3.1 UAE market estimates and forecast, 2018 - 2030 (USD Billion)

Chapter 8 Specialty Generics Market-Competitive Analysis
8.1 Major Deals and Strategic Alliances Analysis
8.1.1 New Product Launch
8.1.2 Mergers and Acquisitions
8.1.3 Partnerships and Strategic Collaborations
8.1.4 Conferences and Campaigns
8.2 Company Categorization
8.2.1 Market Differentiators
8.2.2 Innovators
8.2.3 Market Leaders
8.3 Vendor Landscape
8.3.1 List of key distributors and channel partners
8.3.2 Key customers
8.4 Heat map analysis
8.5 Public Companies
8.5.1 Key company market share analysis, 2021
8.5.2 Company Market Position Analysis
8.6 Private Companies
8.6.1 List of key emerging companies
8.6.2 Regional Network Map
8.7 Company Profiles
8.7.1 Teva Pharmaceutical Industries Ltd
8.7.1.1 Company overview
8.7.1.2 Financial performance
8.7.1.3 Product benchmarking
8.7.1.4 Strategic initiatives
8.7.2 Viatris Inc.
8.7.2.1 Company overview
8.7.2.2 Financial performance
8.7.2.3 Product benchmarking
8.7.2.4 Strategic initiatives
8.7.3 Novartis AG (Sandoz International GmbH)
8.7.3.1 Company overview
8.7.3.2 Financial performance
8.7.3.3 Product benchmarking
8.7.3.4 Strategic initiatives
8.7.4 Fresenius Kabi Brasil Ltda
8.7.4.1 Company overview
8.7.4.2 Financial performance
8.7.4.3 Product benchmarking
8.7.4.4 Strategic initiatives
8.7.5 Mallinckrodt
8.7.5.1 Company overview
8.7.5.2 Financial performance
8.7.5.3 Product benchmarking
8.7.5.4 Strategic initiatives
8.7.6 Bausch Health Companies Inc. (Valeant Pharmaceuticals International, Inc.)
8.7.6.1 Company overview
8.7.6.2 Financial performance
8.7.6.3 Product benchmarking
8.7.6.4 Strategic initiatives
8.7.7 STADA Arzneimittel AG
8.7.7.1 Company overview
8.7.7.2 Financial performance
8.7.7.3 Product benchmarking
8.7.8 Endo Pharmaceuticals Inc.
8.7.8.1 Company overview
8.7.8.2 Financial performance
8.7.8.3 Product benchmarking
8.7.8.4 Strategic initiatives
8.7.9 Apotex Corp.
8.7.9.1 Company overview
8.7.9.2 Product benchmarking
8.7.9.3 Strategic initiatives
8.7.10 Sun Pharmaceutical Industries Ltd.
8.7.10.1 Company overview
8.7.10.2 Financial performance
8.7.10.3 Product benchmarking
8.7.10.4 Strategic initiatives
8.7.11 Dr. Reddy's Laboratories Ltd
8.7.11.1 Company overview
8.7.11.2 Financial performance
8.7.11.3 Product benchmarking
8.7.11.4 Strategic initiatives
8.7.12 Hikma Pharmaceuticals PLC
8.7.12.1 Company overview
8.7.12.2 Financial performance
8.7.12.3 Product benchmarking
8.7.12.4 Strategic initiatives

List of Tables
Table 1 List of secondary sources
Table 2 List of abbreviation
Table 3 Regulatory framework
Table 4 Leading market players anticipated to witness highest growth
Table 5 List of key distributors and compounding pharmacies
Table 6 North America Specialty Generics Market, By Type, 2018-2030 (USD Billion)
Table 7 North America Specialty Generics Market, By Application, 2018-2030 (USD Billion)
Table 8 North America Specialty Generics Market, By End-use, 2018-2030 (USD Billion)
Table 9 U.S. Specialty Generics Market, By Type, 2018-2030 (USD Billion)
Table 10 U.S. Specialty Generics Market, By Application, 2018-2030 (USD Billion)
Table 11 U.S. Specialty Generics Market, By End-use, 2018-2030 (USD Billion)
Table 12 Canada Specialty Generics Market, By Type, 2018-2030 (USD Billion)
Table 13 Canada Specialty Generics Market, By Application, 2018-2030 (USD Billion)
Table 14 Canada Specialty Generics Market, By End-use, 2018-2030 (USD Billion)
Table 15 Europe Specialty Generics Market, By Type, 2018-2030 (USD Billion)
Table 16 Europe Specialty Generics Market, By Application, 2018-2030 (USD Billion)
Table 17 Europe Specialty Generics Market, By End-use, 2018-2030 (USD Billion)
Table 18 U.K. Specialty Generics Market, By Type, 2018-2030 (USD Billion)
Table 19 U.K. Specialty Generics Market, By Application, 2018-2030 (USD Billion)
Table 20 U.K. Specialty Generics Market, By End-use, 2018-2030 (USD Billion)
Table 21 Germany Specialty Generics Market, By Type, 2018-2030 (USD Billion)
Table 22 Germany Specialty Generics Market, By Application, 2018-2030 (USD Billion)
Table 23 Germany Specialty Generics Market, By End-use, 2018-2030 (USD Billion)
Table 24 France Specialty Generics Market, By Type, 2018-2030 (USD Billion)
Table 25 France Specialty Generics Market, By Application, 2018-2030 (USD Billion)
Table 26 France Specialty Generics Market, By End-use, 2018-2030 (USD Billion)
Table 27 Italy Specialty Generics Market, By Type, 2018-2030 (USD Billion)
Table 28 Italy Specialty Generics Market, By Application, 2018-2030 (USD Billion)
Table 29 Italy Specialty Generics Market, By End-use, 2018-2030 (USD Billion)
Table 30 Spain Specialty Generics Market, By Type, 2018-2030 (USD Billion)
Table 31 Spain Specialty Generics Market, By Application, 2018-2030 (USD Billion)
Table 32 Spain Specialty Generics Market, By End-use, 2018-2030 (USD Billion)
Table 33 Asia Pacific Specialty Generics Market, By Type, 2018-2030 (USD Billion)
Table 34 Asia Pacific Specialty Generics Market, By Application, 2018-2030 (USD Billion)
Table 35 Asia Pacific Specialty Generics Market, By End-use, 2018-2030 (USD Billion)
Table 36 Japan Specialty Generics Market, By Type, 2018-2030 (USD Billion)
Table 37 Japan Specialty Generics Market, By Application, 2018-2030 (USD Billion)
Table 38 Japan Specialty Generics Market, By End-use, 2018-2030 (USD Billion)
Table 39 China Specialty Generics Market, By Type, 2018-2030 (USD Billion)
Table 40 China Specialty Generics Market, By Application, 2018-2030 (USD Billion)
Table 41 China Specialty Generics Market, By End-use, 2018-2030 (USD Billion)
Table 42 India Specialty Generics Market, By Type, 2018-2030 (USD Billion)
Table 43 India Specialty Generics Market, By Application, 2018-2030 (USD Billion)
Table 44 India Specialty Generics Market, By End-use, 2018-2030 (USD Billion)
Table 45 Australia Specialty Generics Market, By Type, 2018-2030 (USD Billion)
Table 46 Australia Specialty Generics Market, By Application, 2018-2030 (USD Billion)
Table 47 Australia Specialty Generics Market, By End-use, 2018-2030 (USD Billion)
Table 48 South Korea Specialty Generics Market, By Type, 2018-2030 (USD Billion)
Table 49 South Korea Specialty Generics Market, By Application, 2018-2030 (USD Billion)
Table 50 South Korea Specialty Generics Market, By End-use, 2018-2030 (USD Billion)
Table 51 Latin America Specialty Generics Market, By Type, 2018-2030 (USD Billion)
Table 52 Latin America Specialty Generics Market, By Application, 2018-2030 (USD Billion)
Table 53 Latin America Specialty Generics Market, By End-use, 2018-2030 (USD Billion)
Table 54 Brazil Specialty Generics Market, By Type, 2018-2030 (USD Billion)
Table 55 Brazil Specialty Generics Market, By Application, 2018-2030 (USD Billion)
Table 56 Brazil Specialty Generics Market, By End-use, 2018-2030 (USD Billion)
Table 57 Mexico Specialty Generics Market, By Type, 2018-2030 (USD Billion)
Table 58 Mexico Specialty Generics Market, By Application, 2018-2030 (USD Billion)
Table 59 Mexico Specialty Generics Market, By End-use, 2018-2030 (USD Billion)
Table 60 Argentina Specialty Generics Market, By Type, 2018-2030 (USD Billion)
Table 61 Argentina Specialty Generics Market, By Application, 2018-2030 (USD Billion)
Table 62 Argentina Specialty Generics Market, By End-use, 2018-2030 (USD Billion)
Table 63 Middle East & Africa Specialty Generics Market, By Type, 2018-2030 (USD Billion)
Table 64 Middle East & Africa Specialty Generics Market, By Application, 2018-2030 (USD Billion)
Table 65 Middle East & Africa Specialty Generics Market, By End-use, 2018-2030 (USD Billion)
Table 66 South Africa Specialty Generics Market, By Type, 2018-2030 (USD Billion)
Table 67 South Africa Specialty Generics Market, By Application, 2018-2030 (USD Billion)
Table 68 South Africa Specialty Generics Market, By End-use, 2018-2030 (USD Billion)
Table 69 Saudi Arabia Specialty Generics Market, By Type, 2018-2030 (USD Billion)
Table 70 Saudi Arabia Specialty Generics Market, By Application, 2018-2030 (USD Billion)
Table 71 Saudi Arabia Specialty Generics Market, By End-use, 2018-2030 (USD Billion)
Table 72 UAE Specialty Generics Market, By Type, 2018-2030 (USD Billion)
Table 73 UAE Specialty Generics Market, By Application, 2018-2030 (USD Billion)
Table 74 UAE Specialty Generics Market, By End-use, 2018-2030 (USD Billion)

List of Figures
Fig. 1 Specialty Generics Market Segmentation
Fig. 2 Market Research Process
Fig. 3 Information Procurement
Fig. 4 Primary Research Pattern
Fig. 5 Market Research Approaches
Fig. 6 Value-Chain-Based Sizing & Forecasting
Fig. 7 QFD Modeling for Market Share Assessment
Fig. 8 Market Formulation & Validation
Fig. 9 Market Summary
Fig. 10 Penetration & Growth Prospect Mapping
Fig. 11 Market Driver Impact Analysis (Current & future impact)
Fig. 12 Market Restraint Impact Analysis (Current & future impact)
Fig. 13 Porter's Five Forces Analysis
Fig. 14 Specialty generics market type outlook: Key takeaways
Fig. 15 InjecTables market, 2018-2030 (USD Billion)
Fig. 16 Oral drugs market, 2018-2030 (USD Billion)
Fig. 17 Others market, 2018-2030 (USD Billion)
Fig. 18 Specialty generics market application outlook: Key takeaways
Fig. 19 Specialty generics market: Application movement analysis
Fig. 20 Oncology market, 2018-2030 (USD Billion)
Fig. 21 Inflammatory conditions market, 2018-2030 (USD Billion)
Fig. 22 Multiple sclerosis market, 2018-2030 (USD Billion)
Fig. 23 Hepatitis C market, 2018-2030 (USD Billion)
Fig. 24 Others market, 2018-2030 (USD Billion)
Fig. 25 Specialty generics market end-use outlook: Key takeaways
Fig. 26 Specialty generics market: End-use movement analysis
Fig. 27 Specialty pharmacy market, 2018-2030 (USD Billion)
Fig. 28 Retail pharmacy market, 2018-2030 (USD Billion)
Fig. 29 Hospital pharmacy market, 2018-2030 (USD Billion)
Fig. 30 Specialty generics: Regional Outlook
Fig. 31 Regional outlook, 2021 & 2030
Fig. 32 North America
Fig. 33 North America market estimates and forecast, 2018-2030 (USD Billion)
Fig. 34 U.S.
Fig. 35 U.S. market estimates and forecast, 2018-2030 (USD Billion)
Fig. 36 Canada
Fig. 37 Canada market estimates and forecast, 2018-2030 (USD Billion)
Fig. 38 Europe
Fig. 39 Europe market estimates and forecast, 2018-2030 (USD Billion)
Fig. 40 U.K.
Fig. 41 U.K. market estimates and forecast, 2018-2030 (USD Billion)
Fig. 42 Germany
Fig. 43 Germany market estimates and forecast, 2018-2030 (USD Billion)
Fig. 44 France
Fig. 45 France market estimates and forecast, 2018-2030 (USD Billion)
Fig. 46 Spain
Fig. 47 Spain market estimates and forecast, 2018-2030 (USD Billion)
Fig. 48 Italy
Fig. 49 Italy market estimates and forecast, 2018-2030 (USD Billion)
Fig. 50 Asia Pacific
Fig. 51 Asia Pacific market estimates and forecast, 2018-2030 (USD Billion)
Fig. 52 Japan
Fig. 53 Japan market estimates and forecast, 2018-2030 (USD Billion)
Fig. 54 China
Fig. 55 China market estimates and forecast, 2018-2030 (USD Billion)
Fig. 56 India
Fig. 57 India market estimates and forecast, 2018-2030 (USD Billion)
Fig. 58 Australia
Fig. 59 Australia market estimates and forecast, 2018-2030 (USD Billion)
Fig. 60 South Korea
Fig. 61 South Korea market estimates and forecast, 2018-2030 (USD Billion)
Fig. 62 Latin America
Fig. 63 Latin America market estimates and forecast, 2018-2030 (USD Billion)
Fig. 64 Brazil
Fig. 65 Brazil market estimates and forecast, 2018-2030 (USD Billion)
Fig. 66 Mexico
Fig. 67 Mexico market estimates and forecast, 2018-2030 (USD Billion)
Fig. 68 Argentina
Fig. 69 Argentina market estimates and forecast, 2018-2030 (USD Billion)
Fig. 70 Middle East & Africa
Fig. 71 MEA market estimates and forecast, 2018-2030 (USD Billion)
Fig. 72 South Africa
Fig. 73 South Africa market estimates and forecast, 2018-2030 (USD Billion)
Fig. 74 Saudi Arabia
Fig. 75 Saudi Arabia market estimates and forecast, 2018-2030 (USD Billion)
Fig. 76 UAE
Fig. 77 UAE market estimates and forecast, 2018-2030 (USD Billion)
Fig. 78 Market differentiators
Fig. 79 Heat Map Analysis
Fig. 80 Key company market share analysis, 2021
Fig. 81 Company market position analysis
Fig. 82 Company market position analysis

Companies Mentioned

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

Methodology

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Table Information