Key Highlights
• Specialty generics are low-cost medications used to treat chronic and complex conditions such as diabetes, cancer, HIV, multiple sclerosis (MS), and rheumatoid arthritis. Furthermore, some medications necessitate specialised handling and administration, frequently via injection or infusion. When a specialty medicine's patent ceases to exist, a generic form replaces it. Low-cost oral or injectable speciality generics are used to treat complex clinical illnesses such as HIV/AIDS, cancer, hepatitis, and multiple sclerosis. They are sometimes referred to as biological medicines, which are injected or infused medicines derived from living cells. In accordance with the US FDA, generic medications cost about 80% & 85% lower than brand-name drugs since they do not incur massive production and marketing costs. As a result, the number of medications on prescription that aren't covered by a patent has grown, which will contribute to the long-term growth of the specialised generic drugs industry.
• The worldwide Specialty Generics Industry was evaluated with USD 62.15 billion by 2022 & is expected to reach approximately USD 163.55 billion in 2032, rising with a CAGR of 9.18% from 2023 to 2032.
• Mar’22: Nevakar Injectables Inc., the biopharmaceutical firm producing numerous sterile injectable solutions for use in both critical & ambulatory care settings, has announced its ready-to-use Ephedrine Sulphate Injection, which comes in a 10mL vial and is pre-diluted at a 5mg/mL concentration.
• The rise of chronic diseases has fueled market expansion. Chronic diseases are long-term illnesses with no known cure. It is, however, occasionally curable and controlled. Chronic illnesses are triggered by a shift in lifestyle, inadequate nutrition, and inability to maintain a normal body weight; a few more long-term chronic infections raise the risk of acquiring cancer. As people become more exposed to these diseases, the demand for specialty generics to treat difficult chronic conditions grows.
Scope of the Industry Profile
Key Players
• Teva Pharmaceuticals Industries Ltd.
• Viatris Inc.
• Novartis AG (Sandoz International GmbH)
• Hikma Pharmaceuticals PLC
• Mallinckrodt
• Bausch Health Companies Inc. (Valeant Pharmaceuticals International, Inc.)
• Dr. Reddy’s Laboratories Ltd.
• Endo Pharmaceuticals Inc.
• Apotex Corp.
• Sun Pharmaceutical Industries Ltd.
• Fresenius Kabi Brasil Ltd.
• STADA Arzneimittel AG
What To Expect from Industry Profile
1. Save time carrying out entry-level research by identifying the size, growth, major segments, and leading players in the Specialty Generics industry in the world.
2. Use the PORTER’s Five Forces analysis to determine the competitive intensity and therefore market attractiveness of the global Specialty Generics market.
3. Leading company profiles reveal details of key Specialty Generics market players’ global operations, strategies, financial performance & their recent developments.
4. Add weight to presentations and pitches by understanding the future growth prospects of the Global Specialty Generics market with forecast for decade by both market share (%) & revenue (USD Million).
Segmentation
By Type
• Injectables
• Oral drugs
• Others
By Application
• Oncology
• Inflammatory Conditions
• Multiple Sclerosis
• Hepatitis C
• Others
By End-Use
• Specialty Pharmacy
• Retail Pharmacy
• Hospital Pharmacy
Recent developments
• Apr’22: In the United States, Dr. Reddy's Laboratories developed methylprednisolone sodium succinate an injectable for the treatment of rheumatoid arthritis, blood issues, and specific rare tumours.
• June’22: Elixir launched its copay solutions enhancement programme to help patients manage the expense of speciality generic pharmaceuticals. Through this programme, a qualified patient can receive a free generic equivalent of a specialty medicine.
• June’22: Amneal Pharmaceuticals Inc. launched LYVISPAH (baclofen), a specialty medicine approved by the US FDA and the Drug Administration for the therapeutic management of multiple sclerosis (MS) and other spinal cord illnesses.
Segment Insights
• In recognition of the beneficial properties of injectables, including long-lasting effects and rapid acceptance, which boost patient compliance and acceptance, the injectables category is expected to grow at the fastest rate during the projection period, owing to rising approval of products and greater market penetration.
• Because of the increasing prevalence of inflammatory illnesses such as rheumatoid arthritis, the inflammation-related ailments category will lead the market for speciality generics in 2022, accounting for major share of total revenue.
• The specialty pharmacy subcategory covered the market for speciality generics in 2022, with a highest revenue share. The market is expected to increase at a lucrative rate throughout the forecast period. As a result of reduced distribution costs and easy access to drugs, major specialty generic drug producers and insurance companies choose specialty pharmacies to distribute their products.
Regional Insights
• North America leads the market, accounting for approx. 35% of revenue in 2022, owing to favourable regulatory conditions regulating new drug clearance. The FDA has introduced a variety of programmes aimed at streamlining the overall approval process. As a result, the FDA introduced the Hatch-Waxman Act's Generic Drug User Fee Amendments (GDUFA) to accelerate the delivery of affordable, safe, and effective generic pharmaceuticals to the general population.
• Over the forecast period, the market for specialty generics is expected to grow rapidly in Asia Pacific. The region's expansion is being driven by high insufficient low-cost medical demand and the release of new generic pharmaceuticals. BDR Pharma launched MSTARIN, a generic form of Midostaurin, in 2021 to treat the symptoms of rare tumours such as Acute Myeloid Leukaemia (AML).
1 INTRODUCTION
1.1 Study Objectives
1.2 Market Definitions
1.2.1 Inclusions & Exclusions
1.2.2 Region: Inclusions & Exclusions
1.2.3 Study Scope
1.2.3.1 Markets Covered
1.2.3.2 Regional Scope
1.2.3.3 Years Considered
1.2.4 Currency Considered
1.2.5 Limitations
1.2.6 Summary Of Report (Chapter Wise Summary)
2 RESEARCH METHODOLOGY
2.1 Research Data
2.1.1 Secondary & Primary Research
2.1.2 Secondary Data
2.1.2.1 Secondary Sources
2.1.3 Primary Data
2.1.3.1 Primary Sources
2.2 Market Breakdown & Data Triangulation
2.3 Market Size Estimation
2.3.1 Bottom-Up Approach
2.3.2 Top-Down Approach
2.4 Research Assumptions & Limitations
2.4.1 Assumptions
2.4.2 Limitations
3 EXECUTIVE SUMMARY
4 ACROSS THE GLOBE
4.1 Upcoming Attractive Market Opportunities
4.2 Country Wise Market Growth
4.3 Segment Wise Market Growth
5 MARKET OVERVIEW
5.1 Market Introduction
5.2 Market Dynamics
5.2.1 Drivers
5.2.2 Restraints
5.2.3 Opportunities
5.2.4 Challenges
5.3 PORTOR’S Five Forces Analysis
5.3.1 Threat of New Entrants
5.3.2 Threat of Substitutes
5.3.3 Bargaining Power of Suppliers
5.3.4 Bargaining Power of Buyers
5.3.5 Intensity of Competitive Rivalry
5.4 Market Premium insights (Enterprise license)
5.4.1 Case Study Analysis
5.4.2 Country Wise Import & Export Data (If
Applicable)
5.4.3 Regulatory Bodies & Authorization
Across the Globe
5.4.4 Key Conferences & Events: 2022 &
2023
5.4.5 Top Patents for The Market: 2022
6 SPECIALTY GENERICS MARKET OVERVIEW,
BY TYPE
6.1 Global Market Revenue & Share Analysis, By Type
6.1.1 Injectables
6.1.2 Oral drugs
6.1.3 Others
6.2 Global Market Revenue & Share Analysis, 2018 – 2022
6.3 Global Market Revenue & Share Forecast Analysis, 2023 –
2032
6.4 Key Takeaways
7 SPECIALTY GENERICS MARKET OVERVIEW,
BY APPLICATION
7.1 Global Market Revenue & Share Analysis, By Application
7.1.1 Oncology
7.1.2 Inflammatory Conditions
7.1.3 Multiple Sclerosis
7.1.4 Hepatitis C
7.1.5 Others
7.2 Global Market Revenue & Share Analysis, 2018 – 2022
7.3 Global Market Revenue & Share Forecast Analysis, 2023 –
2032
7.4 Key Takeaways
8 SPECIALTY GENERICS MARKET OVERVIEW,
BY END-USE
8.1 Global Market Revenue & Share Analysis, By End-Use
8.1.1 Specialty Pharmacy
8.1.2 Retail Pharmacy
8.1.3 Hospital Pharmacy
8.2 Global Market Revenue & Share Analysis, 2018 – 2022
8.3 Global Market Revenue & Share Forecast Analysis, 2023 –
2032
8.4 Key Takeaways
9 SPECIALTY GENERICS MARKET OVERVIEW,
BY REGION
9.1 Global Market Revenue & Share Analysis, By Region
9.1.1 North America
9.1.2 Europe
9.1.3 Asia Pacific
9.1.4 Middle East & Africa
9.1.5 South America
9.2 Global Market Revenue & Share Analysis, 2018 – 2022
9.3 Global Market Revenue & Share Forecast Analysis, 2023 –
2032
9.4 Key Takeaways
10 NORTH AMERICA MARKET
ANALYSIS
10.1 North America Market Revenue & Share Analysis, By Type
10.2 North America Market Revenue & Share Analysis, By
Application
10.3 North America Market Revenue & Share Analysis, By End-Use
10.4 North America Market Revenue & Share Analysis, By Country
10.4.1 US
10.4.2 Canada
10.4.3 Mexico
10.5 Key Takeaways
11 EUROPE MARKET ANALYSIS
11.1 Europe Market Revenue & Share Analysis, By Type
11.2 Europe Market Revenue & Share Analysis, By Application
11.3 Europe Market Revenue & Share Analysis, By End-Use
11.4 Europe Market Revenue & Share Analysis, By Country
11.4.1 UK
11.4.2 Italy
11.4.3 Spain
11.4.4 Germany
11.4.5 France
11.4.6 Rest of Europe
11.5 Key Takeaways
12 ASIA PACIFIC MARKET ANALYSIS
12.1 APAC Market Revenue & Share Analysis, By Type
12.2 APAC Market Revenue & Share Analysis, By Application
12.3 APAC Market Revenue & Share Analysis, By End-Use
12.4 APAC Market Revenue & Share Analysis, By Country
12.4.1 China
12.4.2 Japan
12.4.3 India
12.4.4 South Korea
12.4.5 Rest of APAC
12.5 Key Takeaways
13 MIDDLE EAST & AFRICA MARKET
ANALYSIS
13.1 MEA Market Revenue & Share Analysis, By Type
13.2 MEA Market Revenue & Share Analysis, By Application
13.3 MEA Market Revenue & Share Analysis, By End-Use
13.4 MEA Market Revenue & Share Analysis, By Country
13.4.1 GCC
13.4.2 South Africa
13.4.3 Rest of MEA
13.5 Key Takeaways
14 SOUTH AMERICA MARKET ANALYSIS
14.1 SA Market Revenue & Share Analysis, By Type
14.2 SA Market Revenue & Share Analysis, By Application
14.3 SA Market Revenue & Share Analysis, By End-Use
14.4 SA Market Revenue & Share Analysis, By Country
14.4.1 Brazil
14.4.2 Argentina
14.4.3 Rest of SA
14.5 Key Takeaways
15 COMPETITIVE SCENARIO
15.1 Overview
15.2 Key Players Market Share Analysis
15.3 Recent Developments & Product Launches
15.4 Mergers & Acquisitions
15.5 Partnerships, Agreements & Collaborations
16 COMPANY PROFILES
16.1 Overview
16.2 Key players
16.2.1 Teva Pharmaceuticals Industries Ltd.
16.2.1.1 Business Overview
16.2.1.2 Products Offered
16.2.1.3 Financial Insights
16.2.1.4 Strategic Developments
16.2.1.4.1 New Product Launches
16.2.1.4.2 Agreements & Collaborations
16.2.1.5 Business Aspects (NOISE Analysis)
16.2.1.5.1 Key Strengths
16.2.1.5.2 Opportunities
16.2.1.5.3 Weaknesses & Competitive Threats
16.2.1.5.4 Needs & Improvements
16.2.2 Viatris Inc.
16.2.3 Novartis AG (Sandoz International GmbH)
16.2.4 Hikma Pharmaceuticals PLC
16.2.5 Mallinckrodt
16.2.6 Bausch Health Companies Inc. (Valeant
Pharmaceuticals International, Inc.)
16.2.7 Dr. Reddy’s Laboratories Ltd.
16.2.8 Endo Pharmaceuticals Inc.
16.2.9 Apotex Corp.
16.2.10 Sun Pharmaceutical Industries Ltd.
17 DISCLAIMER
18 APPENDIX
