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Global Specialty Generics Market to reach USD 124.43 billion by 2028.

Global Specialty Generics Market Size study, by Type (Injectables, Oral Drugs, Others), By Application (Oncology, Inflammatory Conditions, Hepatitis C, Multiple Sclerosis, Others) by End-use (, Retail, Hospital, Others) and Regional Forecasts 2022-2028

Product Code: HLSDT-34633932
Publish Date: 14-08-2022
Page: 200

Global Specialty Generics Market is valued approximately USD 67.2 billion in 2021 and is anticipated to grow with a healthy growth rate of more than 9.20% over the forecast period 2022-2028. When a specialty drug’s patent expires, it’s replaced with a generic version. These medications are used to treat chronic or complicated medical problems such as cancer, autoimmune disorders, epilepsy, and HIV. The growing acceptance of specialty generic drugs for the treatment of complicated chronic illnesses such as hepatitis C, as well as their increasing prevalence, is a significant market driver. According to the World Health Organization (WHO) report 2022, over 58 million individuals worldwide have chronic hepatitis C virus infection, with approximately 1.5 million persons infected yearly. Due to weakened immunity and high comorbid conditions, age is a key risk factor for the increased incidence of complicated chronic illnesses such as arthritis, cardiovascular disease, and cancer. According to the World Health Organization (WHO) the elderly population climbed from 1 billion in 2020 to 1.4 billion in 2021., By 2030, one in every six persons on the planet will be 60 or older. As a result, the industry’s fast rising senior population is likely to generate profitable growth prospects. To increase their market share, major pharmaceutical corporations have engaged in mergers and acquisitions. BioCena bought a Pfizer-owned Australian factory for medication therapy manufacture in October 2021. In addition, BioCena finalized the acquisition of Pfizer Inc., which is owned by Hospira Adelaide, in 2020. It is a major provider of 200 specialized generic injectables in the United States. During the projected period, such strategic activities are expected to fuel market growth. However, brand recognition and loyalty, the high complexity of specialty generic goods, and limited profitability are some of the key entry obstacles for new participants in the business, all of which contribute to growing prescription costs. Teva Pharmaceutical Industries Ltd., for example, provided smart co-pay cards to Multiple Sclerosis (MS) sufferers in order for them to purchase COPAXONE for their treatment. Cardholders who qualify receive medications at no cost. Such campaigns draw customers’ attention to their branded items, reducing the sales of specialist generic products.

The key regions considered for the Global Specialty Generics Market study includes Asia Pacific, North America, Europe, Latin America, and Rest of the World. North America dominated the speciality generics market due to favourable regulatory laws governing the approval of new drugs, and contributed 36.5% of total revenue in 2021. The FDA in the United States has launched many attempts to improve the overall approval process. As a result, the United States Food and Drug Administration (FDA) proposed Generic Drug User Fee Amendments (GDUFA) under the Hatch-Waxman Act to accelerate the delivery of safe and effective low-cost generic medications to the public. As a result, prominent manufacturers are always working to commercialise specialty generic medications in the market. Amneal Pharmaceuticals Inc., for example, introduced LYVISPAH (baclofen) in June 2022, a specialty medication approved by the US FDA for the treatment of multiple sclerosis and other spinal cord illnesses.

Major market player included in this report are:
Teva Pharmaceuticals Industries Ltd.
Viatris Inc.
Novartis AG (Sandoz International GmbH)
Hikma Pharmaceuticals PLC
Bausch Health Companies Inc. (Valeant Pharmaceuticals International, Inc.)
Dr. Reddy’s Laboratories Ltd.
Endo Pharmaceuticals Inc.
Apotex Corp.
Sun Pharmaceutical Industries Ltd.
The objective of the study is to define market sizes of different segments & countries in recent years and to forecast the values to the coming eight years. The report is designed to incorporate both qualitative and quantitative aspects of the industry within each of the regions and countries involved in the study. Furthermore, the report also caters the detailed information about the crucial aspects such as driving factors & challenges which will define the future growth of the market. Additionally, the report shall also incorporate available opportunities in micro markets for stakeholders to invest along with the detailed analysis of competitive landscape and product offerings of key players. The detailed segments and sub-segment of the market are explained below:
By Type
Oral Drugs
By Application:
Inflammatory Conditions
Hepatitis C
Multiple Sclerosis
By End-use:

By Region:
North America

Asia Pacific
South Korea
Latin America
Rest of the World

Furthermore, years considered for the study are as follows:

Historical year – 2018, 2019, 2020
Base year – 2021
Forecast period – 2022 to 2028

Target Audience of the Global Specialty Generics Market in Market Study:

Key Consulting Companies & Advisors
Large, medium-sized, and small enterprises
Venture capitalists
Value-Added Resellers (VARs)
Third-party knowledge providers
Investment bankers

Chapter 1. Executive Summary
1.1. Market Snapshot
1.2. Global & Segmental Market Estimates & Forecasts, 2020-2028 (USD Billion)
1.2.1. Specialty Generics Market, by Region, 2020-2028 (USD Billion)
1.2.2. Specialty Generics Market, by Type, 2020-2028 (USD Billion)
1.2.3. Specialty Generics Market, by Application, 2020-2028 (USD Billion)
1.2.4. Specialty Generics Market, by End-use, 2020-2028 (USD Billion)
1.3. Key Trends
1.4. Estimation Methodology
1.5. Research Assumption
Chapter 2. Global Specialty Generics Market Definition and Scope
2.1. Objective of the Study
2.2. Market Definition & Scope
2.2.1. Scope of the Study
2.2.2. Industry Evolution
2.3. Years Considered for the Study
2.4. Currency Conversion Rates
Chapter 3. Global Specialty Generics Market Dynamics
3.1. Specialty Generics Market Impact Analysis (2020-2028)
3.1.1. Market Drivers Increasing adoption of specialty generic medicines for the treatment of complex chronic diseases. Rising prevalence of complex chronic diseases such as arthritis, cardiovascular diseases, and cancer
3.1.2. Market Challenges High complex nature of specialty generic products
3.1.3. Market Opportunities Advancements in Formulation
Chapter 4. Global Specialty Generics Market Industry Analysis
4.1. Porter’s 5 Force Model
4.1.1. Bargaining Power of Suppliers
4.1.2. Bargaining Power of Buyers
4.1.3. Threat of New Entrants
4.1.4. Threat of Substitutes
4.1.5. Competitive Rivalry
4.1.6. Futuristic Approach to Porter’s 5 Force Model (2018-2028)
4.2. PEST Analysis
4.2.1. Political
4.2.2. Economical
4.2.3. Social
4.2.4. Technological
4.3. Investment Adoption Model
4.4. Analyst Recommendation & Conclusion
4.5. Top investment opportunity
4.6. Top winning strategies
Chapter 5. Risk Assessment: COVID-19 Impact
5.1.1. Assessment of the overall impact of COVID-19 on the industry
5.1.2. Pre COVID-19 and post COVID-19 Market scenario
Chapter 6. Global Specialty Generics Market, by Type
6.1. Market Snapshot
6.2. Global Specialty Generics Market by Type, Performance – Potential Analysis
6.3. Global Specialty Generics Market Estimates & Forecasts by Type 2018-2028 (USD Billion)
6.4. Specialty Generics Market, Sub Segment Analysis
6.4.1. Injectables
6.4.2. Oral Drugs
6.4.3. Others
Chapter 7. Global Specialty Generics Market, by Application
7.1. Market Snapshot
7.2. Global Specialty Generics Market by Application, Performance – Potential Analysis
7.3. Global Specialty Generics Market Estimates & Forecasts by Application 2018-2028 (USD Billion)
7.4. Specialty Generics Market, Sub Segment Analysis
7.4.1. Oncology
7.4.2. Inflammatory Conditions
7.4.3. Hepatitis C
7.4.4. Multiple Sclerosis
7.4.5. Others
Chapter 8. Global Specialty Generics Market, by End-use
8.1. Market Snapshot
8.2. Global Specialty Generics Market by End-use, Performance – Potential Analysis
8.3. Global Specialty Generics Market Estimates & Forecasts by End-use 2018-2028 (USD Billion)
8.4. Specialty Generics Market, Sub Segment Analysis
8.4.1. Hospitals
8.4.2. Retail Pharmacies
8.4.3. Others
Chapter 9. Global Specialty Generics Market, Regional Analysis
9.1. Specialty Generics Market, Regional Market Snapshot
9.2. North America Specialty Generics Market
9.2.1. U.S. Specialty Generics Market Type breakdown estimates & forecasts, 2018-2028 Application breakdown estimates & forecasts, 2018-2028 End-use breakdown estimates & forecasts, 2018-2028
9.2.2. Canada Specialty Generics Market
9.3. Europe Specialty Generics Market Snapshot
9.3.1. U.K. Specialty Generics Market
9.3.2. Germany Specialty Generics Market
9.3.3. France Specialty Generics Market
9.3.4. Spain Specialty Generics Market
9.3.5. Italy Specialty Generics Market
9.3.6. Rest of Europe Specialty Generics Market
9.4. Asia-Pacific Specialty Generics Market Snapshot
9.4.1. China Specialty Generics Market
9.4.2. India Specialty Generics Market
9.4.3. Japan Specialty Generics Market
9.4.4. Australia Specialty Generics Market
9.4.5. South Korea Specialty Generics Market
9.4.6. Rest of Asia Pacific Specialty Generics Market
9.5. Latin America Specialty Generics Market Snapshot
9.5.1. Brazil Specialty Generics Market
9.5.2. Mexico Specialty Generics Market
9.6. Rest of The World Specialty Generics Market

Chapter 10. Competitive Intelligence
10.1. Top Market Strategies
10.2. Company Profiles
10.2.1. Teva Pharmaceuticals Industries Ltd Key Information Overview Financial (Subject to Data Availability) Product Summary Recent Developments
10.2.2. Viatris Inc.
10.2.3. Novartis AG (Sandoz International GmbH)
10.2.4. Hikma Pharmaceuticals PLC
10.2.5. Mallinckrodt
10.2.6. Bausch Health Companies Inc. (Valeant Pharmaceuticals International, Inc.)
10.2.7. Dr. Reddy’s Laboratories Ltd.
10.2.8. Endo Pharmaceuticals Inc.
10.2.9. Apotex Corp.
10.2.10. Sun Pharmaceutical Industries Ltd.
Chapter 11. Research Process
11.1. Research Process
11.1.1. Data Mining
11.1.2. Analysis
11.1.3. Market Estimation
11.1.4. Validation
11.1.5. Publishing
11.2. Research Attributes
11.3. Research Assumption

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Data Collection:
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Data Analysis:
Our team of experts carefully examine the gathered data using suitable statistical techniques and qualitative analysis methods. For quantitative analysis, we employ descriptive statistics, regression analysis, and other advanced statistical methods, depending on the characteristics of the data. This analysis may also incorporate the utilization of AI tools and big data analysis techniques to extract meaningful insights.
To ensure the accuracy and reliability of our findings, we extensively leverage data science techniques, which help us minimize discrepancies and uncertainties in our analysis. We employ Data Science to clean and preprocess the data, ensuring its quality and reliability. This involves handling missing data, removing outliers, standardizing variables, and transforming data into suitable formats for analysis. The application of data science techniques enhances our accuracy, efficiency, and depth of analysis, enabling us to stay competitive in dynamic market environments.
Market Size Estimation:
Our proprietary data tools play a crucial role in deriving our market estimates and forecasts. Each study involves the creation of a unique and customized model. The model incorporates the gathered information on market dynamics, technology landscape, application development, and pricing trends. AI techniques, such as machine learning and deep learning, aid us to analyze patterns within the data to identify correlations, trends, and relationships. By recognizing patterns in consumer behavior, purchasing habits, or market dynamics, our AI algorithms aid us in more precise estimations of market size. These factors are simultaneously analyzed within the model, allowing for a comprehensive assessment. To quantify their impact over the forecast period, correlation, regression, and time series analysis are employed.
To estimate and validate the market size, we employ both top-down and bottom-up approaches. The preference is given to a bottom-up approach, where key regional markets are analyzed as separate entities. This data is then integrated to obtain global estimates. This approach is crucial as it provides a deep understanding of the industry and helps minimize errors.
In our forecasting process, we consider various parameters such as economic tools, technological analysis, industry experience, and domain expertise. By taking all these factors into account, we strive to produce accurate and reliable market forecasts. When forecasting, we take into consideration several parameters, which include:
Market driving trends and favorable economic conditions
Restraints and challenges that are expected to be encountered during the forecast period.
Anticipated opportunities for growth and development
Technological advancements and projected developments in the market
Consumer spending trends and dynamics
Shifts in consumer preferences and behaviors.
The current state of raw materials and trends in supply versus pricing
Regulatory landscape and expected changes or developments.
The existing capacity in the market and any expected additions or expansions up to the end of the forecast period.
To assess the market impact of these parameters, we assign weights to each one and utilize weighted average analysis. This process allows us to quantify their influence on the market and derive an expected growth rate for the forecasted period. By considering these various factors and applying a weighted analysis approach, we strive to provide accurate and reliable market forecasts.
Insight Generation & Report Presentation:
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