Product Code: GVR-1-68038-629-5
Specialty Generics Market Growth & Trends:
The global specialty generics market size is expected to reach USD 148.7 billion by 2030, according to a new study by Grand View Research, Inc. 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
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 GVR's 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
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