Specialty Generics Market Size, Share, Trends, Growth, Production, Consumption, Revenue, Company Analysis and Forecast 2021-2030

Published Date : Mar 2021 | No. of Pages : 250 Pages | Category : Healthcare

global Specialty Generics market size is expected to be worth around US$ 274.9  billion by 2030, according to a new report by Vision Research Reports.

The global Specialty Generics market size was valued at US$ 40.0 billion in 2020 and is anticipated to grow at a CAGR of 23.0 % during forecast period 2021 to 2030.

Growth Factors

Rise in demand for low-cost generic specialty drugs is a major factor estimated to accelerate the market growth during the forecast period. Introduction of cost-effective drugs for the treatment of multiple sclerosis, cancer, and other infectious diseases is expected to showcase huge opportunities for the specialty generic drug manufacturers. According to U.S. FDA, generic drugs cost 80% to 85% lower as compared to branded drugs. One of the factors contributing to their affordable price is that they do not need to repeat expensive clinical trials, advertising, and promotional activities. Thus, low cost of generic specialty drugs is expected to accelerate the demand for these medicines.

Rise in number of off-patent specialty drugs is another major factor expected to support growth of the specialty generic drugs market. For instance, the patent for Gilenya, a blockbuster drug by Novartis, will expire in 2019. This drug led to USD 3.1 billion in sales in 2016 for Novartis, with 14% sales growth. In April 2017, Novartis failed to acquire patent extension for Gilenya till 2026 in the U.S. Federal Circuit. Such early patent expirations are expected to boost the entry of new generics.

Report Highlights

the injectables segment accounted for the largest market share because of several advantages, such as quick absorption, long duration of action, and immediate dose distribution. The rise in prevalence of chronic diseases such as inflammatory conditions, multiple sclerosis, and cancer is also expected to drive the demand for injectables.

According to Multiple Sclerosis Foundation 2015 statistics, nearly 400,000 in the U.S. and 2.5 million people across the world suffered from multiple sclerosis. Every year, around 10,000 new cases of this disease are diagnosed, as stated by MultipleSclerosis.net. Thus, increase in number of multiple sclerosis cases has led to huge demand for specialty generic drugs. Teva Pharmaceuticals Ltd. ventured into management of multiple sclerosis by launching Copaxone (glatiramer acetate).

The injectables segment is expected to grow at the fastest rate during the forecast period because of growing adoption of self-administered injectables by patients. The leading players such as Pfizer, Inc.; Sun Pharma; and Teva are undertaking various strategic initiatives, such as acquisitions and new product launches, to gain a higher share in the injectables market. For instance, in September 2015, Pfizer, Inc. completed the acquisition of Hospira, Inc for USD 17 billion. After the acquisition, Pfizer has access to Hospira’s injectable drugs, infusion technologies, and biosimilars business.

The oral drug segment is expected to exhibit lucrative growth over the study period due to rising incidence of arthritis, inflammatory conditions, and cancer. The demand for these products, such as Gleevec and Tarceva, is rising because patients can self-administer the drugs instead of visiting a healthcare provider for an infusion or injection.

Application Insights

In 2016, the oncology segment dominated the overall market in terms of revenue. Increased incidence of cancer, such as breast cancer, prostate cancer, melanoma, colon cancer, lung cancer, and leukemia, has led to rise in demand for generic specialty medicines across the globe. According to the International Agency for Research on Cancer (IARC), globally, around 14.1 million new cases of cancer were diagnosed in 2012, and this number is projected to reach about 21.7 million by 2030.

As compared to developed countries, death rate due to cancer is higher in underdeveloped and developing countries. The high cost of cancer treatment and drugs as well as inaccessibility to advanced healthcare infrastructure in these countries are some of the foremost factors accountable for high mortality rate. Thus, there is a huge demand for low-cost generics that are highly effective and less expensive compared to branded drugs.

The inflammatory conditions segment is expected to grow at a lucrative rate during the forecast period due to rise in the incidence of asthma, tuberculosis, rheumatoid arthritis, and Crohn's disease. According to the CDC, around 54.4 million people in the U.S. had some form of arthritis, lupus, gout, or fibromyalgia during the year 2013 to 2015.

There are several leading vendors, including Teva Pharmaceuticals USA; Novartis; Pfizer, Inc.; Mylan N.V.; and Sun Pharmaceutical Industries Ltd., that provide advanced oral therapeutics for treatment of such chronic diseases. For instance, in September 2016, Teva Pharmaceutical Industries Ltd. launched the generic version of Epzicom1 (abacavir and lamivudine) tablets, 600 mg/300 mg in the U.S.

specialty pharmacy held the largest revenue share in the overall market as these specialty medicines are highly complex, costly, and need to be handled very carefully. Thus, these drugs are specifically distributed by manufacturers through these pharmacies. Some of the major pharmacies are CVS Health, Express Scripts Holding Company, and Diplomat Pharmacy, Inc.

Furthermore, increase in focus on improvement of healthcare infrastructure in developing countries of Asia Pacific and African regions is expected to accelerate the growth of the segment. Rising healthcare awareness and availability of innovative therapeutics for the treatment of various chronic diseases are projected to propel the segment growth.

Retail pharmacy held the second largest share in the end-use segment in 2016, and it is expected to grow at a significant rate during the forecast period. The significant share can be attributed to high accessibility to retail stores and affordability. The affordability is a result of reimbursement on prescription prices that encourages patients to rely on retail pharmacies.

Hospital pharmacy held a significant market share due to increase in the number of admissions of patients suffering from cancer, multiple sclerosis, inflammatory conditions, and hepatitis C. Specialty generics are used for various treatments such as chemotherapy. Thus, there is a rise in demand for these drugs for treatment of admitted patients, which is anticipated to drive the segment growth.

North America dominated the market with the largest revenue share due to favorable healthcare reforms by the government and well-developed healthcare facilities in this region. Furthermore, healthcare organizations, such as WHO, are extensively involved in formulating policies, such as the National Cancer Control Programmes, and they are anticipated to widen the growth potential in this region.

Europe was the second largest market for specialty generic drugs due to high demand for advanced therapeutics for chronic diseases. In addition, strong distribution network of leading players, including Teva Pharmaceuticals USA, Inc.; Sandoz International GmbH; Mylan N.V.; Mallinckrodt; and Pfizer, Inc., supports growth. Moreover, highly developed healthcare infrastructure, especially in Germany, the UK, Switzerland, and France, is projected to drive the regional market.

The Asia Pacific market is expected to grow at the highest rate during the forecast period. The market is driven by rise in prevalence of chronic diseases as well as high demand for cost-effective generic drugs. In addition, rise in disposable income, which increases the probability of usage of specialty generics, and continual upgradation of healthcare infrastructure are presumed to provide the market with high potential growth opportunities over the forecast period.

Key Players

Mylan N.V.; Teva Pharmaceuticals USA, Inc.; Sandoz International GmbH; Mallinckrodt; Akorn, Inc.; Valeant Pharmaceuticals International, Inc.; Endo Pharmaceuticals, Inc.; Pfizer, Inc.; Sun Pharmaceutical Industries Ltd.; and Apotex Corp.

Market Segmentation

  • Type Outlook

    • Injectables

    • Oral

    • Others

  • Application Outlook 

    • Oncology

    • Inflammatory conditions

    • Multiple sclerosis

    • Hepatitis C

    • Others

  • End-use Outlook

    • Specialty pharmacy

    • Retail pharmacy

    • Hospital pharmacy

  • Regional Outlook 

    • North America

      • The U.S.

      • Canada

    • Europe

      • Germany

      • UK

      • France

      • Italy

      • Spain

    • Asia Pacific

      • Japan

      • China

      • India

    • Latin America

      • Brazil

      • Mexico

    • MEA

      • South Africa

      • Saudi Arabia

The Specialty Generics market research report covers definition, classification, product classification, product application, development trend, product technology, competitive landscape, industrial chain structure, industry overview, national policy and planning analysis of the industry, the latest dynamic analysis, etc., and also includes major. The study includes drivers and restraints of the global market. It covers the impact of these drivers and restraints on the demand during the forecast period. The report also highlights opportunities in the market at the global level.

The report provides size (in terms of volume and value) of Specialty Generics market for the base year 2020 and the forecast between 2021 and 2030. Market numbers have been estimated based on form and application. Market size and forecast for each application segment have been provided for the global and regional market.

This report focuses on the global Specialty Generics market status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Specialty Generics market development in United States, Europe and China.

It is pertinent to consider that in a volatile global economy, we haven’t just conducted Specialty Generics market forecasts in terms of CAGR, but also studied the market based on key parameters, including Year-on-Year (Y-o-Y) growth, to comprehend the certainty of the market and to find and present the lucrative opportunities in market.

In terms of production side, this report researches the Specialty Generics capacity, production, value, ex-factory price, growth rate, market share for major manufacturers, regions (or countries) and type.

In terms of consumption side, this report focuses on the consumption of Specialty Generics by regions (countries) and application.

Buyers of the report will have access to verified market figures, including global market size in terms of revenue and volume. As part of production analysis, the authors of the report have provided reliable estimations and calculations for global revenue and volume by Type segment of the global Specialty Generics market. These figures have been provided in terms of both revenue and volume for the period 2017 to 2030. Additionally, the report provides accurate figures for production by region in terms of revenue as well as volume for the same period. The report also includes production capacity statistics for the same period.

With regard to production bases and technologies, the research in this report covers the production time, base distribution, technical parameters, research and development trends, technology sources, and sources of raw materials of major Specialty Generics market companies.

Regarding the analysis of the industry chain, the research of this report covers the raw materials and equipment of Specialty Generics market upstream, downstream customers, marketing channels, industry development trends and investment strategy recommendations. The more specific analysis also includes the main application areas of market and consumption, major regions and Consumption, major Chinese producers, distributors, raw material suppliers, equipment providers and their contact information, industry chain relationship analysis.

The research in this report also includes product parameters, production process, cost structure, and data information classified by region, technology and application. Finally, the paper model new project SWOT analysis and investment feasibility study of the case model.

Overall, this is an in-depth research report specifically for the Specialty Generics industry. The research center uses an objective and fair way to conduct an in-depth analysis of the development trend of the industry, providing support and evidence for customer competition analysis, development planning, and investment decision-making. In the course of operation, the project has received support and assistance from technicians and marketing personnel in various links of the industry chain.

The Specialty Generics market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies’ focus related to Specialty Generics market.

Prominent players in the market are predicted to face tough competition from the new entrants. However, some of the key players are targeting to acquire the startup companies in order to maintain their dominance in the global market. For a detailed analysis of key companies, their strengths, weaknesses, threats, and opportunities are measured in the report by using industry-standard tools such as the SWOT analysis. Regional coverage of key companies is covered in the report to measure their dominance. Key manufacturers of Specialty Generics market are focusing on introducing new products to meet the needs of the patrons. The feasibility of new products is also measured by using industry-standard tools.

Key companies are increasing their investments in research and development activities for the discovery of new products. There has also been a rise in the government funding for the introduction of new Specialty Generics market. These factors have benefited the growth of the global market for Specialty Generics. Going forward, key companies are predicted to benefit from the new product launches and the adoption of technological advancements. Technical advancements have benefited many industries and the global industry is not an exception.

New product launches and the expansion of already existing business are predicted to benefit the key players in maintaining their dominance in the global market for Specialty Generics. The global market is segmented on the basis of region, application, en-users and product type. Based on region, the market is divided into North America, Europe, Asia-Pacific, Latin America and Middle East and Africa (MEA).

In this study, the years considered to estimate the market size of Specialty Generics are as follows:

  • Historic Year: 2017-2020
  • Base Year: 2021
  • Forecast Year 2021 to 2030

Reasons to Purchase this Report:

- Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
- Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
- Market value USD Million and volume Units Million data for each segment and sub-segment
- Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
- Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players

Research Methodology:

In-depth interviews and discussions were conducted with several key market participants and opinion leaders to compile the research report.

This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.

Market Size Estimation

Top-down and bottom-up approaches are used to estimate and validate the global market size for company, regional division, product type and application (end users).

The market estimations in this report are based on the selling price (excluding any discounts provided by the manufacturer, distributor, wholesaler or traders). Market share analysis, assigned to each of the segments and regions are achieved through product utilization rate and average selling price.

Major manufacturers & their revenues, percentage splits, market shares, growth rates and breakdowns of the product markets are determined through secondary sources and verified through the primary sources.

All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or others factors are accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from Vision Research Reports and presented in this report.

Market Breakdown and Data Triangulation

After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation. Extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub-segments listed in this report.

Secondary Sources

Secondary Sources occupies approximately 25% of data sources, such as press releases, annual reports, Non-Profit organizations, industry associations, governmental agencies and customs data, and so on. This research study includes secondary sources; directories; databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), TRADING ECONOMICS, and avention; Investing News Network; statista; Federal Reserve Economic Data; annual reports; investor presentations; and SEC filings of companies.

Primary Sources

 In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include product manufacturers (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers, etc.

The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end users (product buyers), and related key executives from various key companies and organizations operating in the global market.

The study objectives of this report are:

  • To analyze and study the global market capacity, production, value, consumption, status (2017-2020) and forecast (2021-2030);
  • Focuses on the key manufacturers, to study the capacity, production, value, market share and development plans in future.
  • Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
  • To define, describe and forecast the market by type, application and region.
  • To analyze the global and key regions market potential and advantage, opportunity and challenge, restraints and risks.
  • To identify significant trends and factors driving or inhibiting the market growth.
  • To analyze the opportunities in the market for stakeholders by identifying the high growth segments.
  • To strategically analyze each submarket with respect to individual growth trend and their contribution to the market
  • To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market
  • To strategically profile the key players and comprehensively analyze their growth strategies.

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