Specialty Generics Market Size, Share & Trends Analysis By Type (Injectables, Oral Drugs), By Application (Oncology, Inflammatory Conditions, Hepatitis C), By End-use (Specialty, Retail), By Region, and Segment Forecasts, 2023 - 2030

Research Methodology

A three-pronged approach was followed for deducing the specialty generics market estimates and forecasts. The process has three steps: information procurement, analysis, and validation. The whole process is cyclical, and steps repeat until the estimates are validated. The three steps are explained in detail below:

Information procurement: Information procurement is one of the most extensive and important stages in our research process, and quality data is critical for accurate analysis. We followed a multi-channel data collection process for specialty generics market to gather the most reliable and current information possible.

• We buy access to paid databases such as Hoover’s and Factiva for company financials, industry information, white papers, industry journals, SME journals, and more.
• We tap into Grand View’s proprietary database of data points and insights from active and archived monitoring and reporting.
• We conduct primary research with industry experts through questionnaires and one-on-one phone interviews.
• We pull from reliable secondary sources such as white papers and government statistics, published by organizations like WHO, NGOs, World Bank, etc., Key Opinion Leaders (KoL) publications, company filings, investor documents, and more.
• We purchase and review investor analyst reports, broker reports, academic commentary, government quotes, and wealth management publications for insightful third-party perspectives.

Analysis: We mine the data collected to establish baselines for forecasting, identify trends and opportunities, gain insight into consumer demographics and drivers, and so much more. We utilized different methods of specialty generics market data depending on the type of information we’re trying to uncover in our research.

• Market Research Efforts: Bottom-up Approach for estimating and forecasting demand size and opportunity, top-down Approach for new product forecasting and penetration, and combined approach of both Bottom-up and Top-down for full coverage analysis.

• Value-Chain-Based Sizing & Forecasting: Supply-side estimates for understanding potential revenue through competitive benchmarking, forecasting, and penetration modeling.

• Demand-side estimates for identifying parent and ancillary markets, segment modeling, and heuristic forecasting.

• Qualitative Functional Deployment (QFD) Modelling for market share assessment.

Market formulation and validation: We mine the data collected to establish baselines for forecasting, identify trends and opportunities, gain insight into consumer demographics and drivers, and so much more. We utilize different methods of data analysis depending on the type of information we’re trying to uncover in our research.

• Market Formulation: This step involves the finalization of market numbers. This step on an internal level is designed to manage outputs from the Data Analysis step.

• Data Normalization: The final market estimates and forecasts are then aligned and sent to industry experts, in-panel quality control managers for validation.

• This step also entails the finalization of the report scope and data representation pattern.

• Validation: The process entails multiple levels of validation. All these steps run in parallel, and the study is forwarded for publishing only if all three levels render validated results.

Specialty Generics Market Categorization:

The specialty generics market was categorized into four segments, namely type (Injectables, Oral drugs,), application (Oncology, Inflammatory conditions, Multiple sclerosis, Hepatitis C), end use (Specialty pharmacy, Retail pharmacy, Hospital pharmacy), and regions (North America, Europe, Asia Pacific, Latin America, Middle East & Africa).

Segment Market Methodology:

The specialty generics market was segmented into type, application, end use, and regions. The demand at a segment level was deduced using a funnel method. Concepts like the TAM, SAM, SOM, etc., were put into practice to understand the demand. We at GVR deploy three methods to deduce market estimates and determine forecasts. These methods are explained below:

Market research approaches: Bottom-up

• Demand estimation of each product across countries/regions summed up to from the total market.

• Variable analysis for demand forecast.

• Demand estimation via analyzing paid database, and company financials either via annual reports or paid database.

• Primary interviews for data revalidation and insight collection.

Market research approaches: Top-down

• Used extensively for new product forecasting or analyzing penetration levels.

• Tool used invoice product flow and penetration models Use of regression multi-variant analysis for forecasting Involves extensive use of paid and public databases.

• Primary interviews and vendor-based primary research for variable impact analysis.

Market research approaches: Combined

• This is the most common method. We apply concepts from both the top-down and bottom-up approaches to arrive at a viable conclusion.

Regional Market Methodology:

The specialty generics market was analyzed at a regional level. The globe was divided into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa, keeping in focus variables like consumption patterns, export-import regulations, consumer expectations, etc. These regions were further divided into twenty-three countries, namely, the U.S.; Canada; Germany; UK.; France; Italy; Spain; Denmark, Sweden, Norway, China; Japan; India; Australia; South Korea; Thailand, Brazil; Mexico; Argentina; South Africa; Saudi Arabia; UAE; Kuwait.

All three above-mentioned market research methodologies were applied to arrive at regional-level conclusions. The regions were then summed up to form the global market.

Specialty generics market companies & financials:

The specialty generics market was analyzed via companies operating in the sector. Analyzing these companies and cross-referencing them to the demand equation helped us validate our assumptions and conclusions. Key market players analyzed include:

• TEVA PHARMACEUTICAL INDUSTRIES LTD. TEVA Pharmaceutical Industries Ltd. develops, produces, and markets generic and specialty medicines. The company operates through two business segments: Generic Medicines and Specialty Medicines. Generic Medicines provide chemical and therapeutic equivalents of originator medicines in several dosage forms, such as capsules, inhalants, ointments, tablets, liquids, and creams. This segment also includes the company’s OTC and API manufacturing businesses. The Specialty Medicines segment caters to therapeutic areas such as the central nervous system, respiratory diseases, and oncology. In addition, the company is engaged in the sale of third-party products in the U.S. and other countries. It produces about 300 APIs for its use as well as for sale to third-party entities across various therapeutic areas.

• MYLAN N.V. Mylan N.V. operates in generic pharmaceuticals, antiretroviral therapies, and active pharmaceutical ingredients. It operates in over 145 countries and territories. Mylan researches, develops, manufactures, markets, and distributes generics & specialty pharmaceutical products. The company was formerly known as Milan Pharmaceuticals Inc. till 1972, after which it adopted the name Mylan Pharmaceuticals Inc. Currently, Mylan Pharmaceuticals Inc. is a subsidiary of Mylan N.V.

• SANDOZ INTERNATIONAL GMBH Sandoz International GmbH represents the pharmaceuticals division of Novartis and is a producer and manufacturer of biosimilars and generic injectables. It operates in the therapeutic areas of ophthalmics, dermatology & antibiotics, cardiovascular, metabolism, central nervous system, pain, gastrointestinal, respiratory, and hormonal. Novartis collectively represents pharmaceuticals, Sandoz biosimilars, and Alcon ophthalmics. Sandoz markets its biosimilars in 75 countries, with a strong presence in the U.S., Canada, Japan, and Australia, as well as the EU.

• AKORN, INC. Akorn, Inc. is a manufacturer, developer, & marketer of branded & generic prescription pharmaceuticals and consumer health products. The company specializes in nonsterile dosage and difficult-to-manufacture sterile dosage forms, which include oral liquids, ophthalmics, optics, injectables, inhalants, topicals, and nasal sprays. Akorn markets its products to ophthalmologists, physicians, retail pharmacies, optometrists, clinics, hospitals, distributors, wholesalers, government agencies, and group purchasing organizations.

• MALLINCKRODT PHARMACEUTICALS Mallinckrodt Pharmaceuticals is a developer, manufacturer, and distributor of specialty pharmaceutical therapies & products. The company’s specialty brand segment focuses on rare & autoimmune diseases and specialty areas, such as rheumatology, neurology, pulmonology, nephrology, ophthalmology, neonatal respiratory critical care therapies, immunotherapy, and analgesics. Their specialty generics segment includes active pharmaceutical ingredients and specialty generic drugs.

• BAUSCH HEALTH COMPANIES, INC. Bausch Health Companies, Inc. is a developer, manufacturer, and marketer of a wide range of generic, branded, OTC, and branded generic pharmaceutical products. The company primarily operates in the therapeutic areas of dermatology, gastroenterology, and eye health. It also manufactures medical devices that include contact lenses, ophthalmic surgical equipment, intraocular lenses, and aesthetic devices. It delivers products to more than 90 countries.

• PFIZER, INC. Pfizer, Inc. is involved in the discovery, development, and manufacturing of healthcare products. Pfizer’s product portfolio includes medicines, vaccines, and consumer healthcare products. The company operates through two business segments: Pfizer Innovative Health and Pfizer Essential Health. Pfizer Innovative Health is engaged in the development & commercialization of medicines, vaccines, and consumer health products. Pfizer Essential Health includes branded generics, injectable products, legacy brands, infusion systems, and biosimilars. The company markets and distributes its products in over 125 countries.

• ENDO PHARMACEUTICALS, INC. Endo Pharmaceuticals, Inc. is a developer and marketer of high-value and quality-branded pharmaceutical products. The company’s specialty portfolio includes products for men’s health, urology, endocrinology, and orthopedics. It is one of the operating units of Endo International plc., which is a pharmaceutical company that focuses on specialty and generic branded products. Other units of Endo International include Par Pharmaceuticals and Paladin Labs.

• APOTEX INC. Apotex, Inc. is the largest pharmaceutical company in Canada, with a 3 million square feet manufacturing facility in Toronto. It has an R&D division and also manufactures & distributes its products in more than 115 countries across the globe. In 2008, it ran a clinical trial to evaluate the safety of its newly developed dipeptide for the treatment of psoriasis. In addition, Apotex is a member of Canada’s healthcare community. The company has a fully owned subsidiary, ApoPharma, Inc., which focuses on research of novel chemical entities. Apotex, Inc. is privately held, and hence, the financials of the company are not available.

• SUN PHARMACEUTICAL INDUSTRIES LTD. Sun Pharmaceutical Industries Ltd. specializes in specialty generics and Active Pharmaceutical Ingredients (APIs). The company markets its products primarily in India and also has smaller market shares in other countries. It provides pharmaceutical formulations in various fields such as anti-infectives, psychiatry, cardiology, urology, diabetology, neurology, orthopedics, gastroenterology, nephrology, dermatology, ophthalmology, gynecology, dental, oncology, respiratory, and nutrition. This company has more than 45 manufacturing sites, serves 150 markets worldwide, and offers over 2,000 products.

Value chain-based sizing & forecasting

Supply Side Estimates

• Company revenue estimation via referring to annual reports, investor presentations, and Hoover’s.

• Segment revenue determination via variable analysis and penetration modeling.

• Competitive benchmarking to identify market leaders and their collective revenue shares.

• Forecasting via analyzing commercialization rates, pipelines, market initiatives, distribution networks, etc.

Demand side estimates

• Identifying parent markets and ancillary markets

• Segment penetration analysis to obtain pertinent

• revenue/volume

• Heuristic forecasting with the help of subject matter experts

• Forecasting via variable analysis

Specialty Generics Market Report Objectives:

• Understanding market dynamics (in terms of drivers, restraints, & opportunities) in the countries.

• Understanding trends & variables in the individual countries & their impact on growth and using analytical tools to provide high-level insights into the market dynamics and the associated growth pattern.

• Understanding market estimates and forecasts (with the base year as 2023, historic information from 2018 - 2021, and forecast from 2023 to 2030). Regional estimates & forecasts for each category are available and are summed up to form the global market estimates.

Specialty Generics Market Report Assumptions:

• The report provides market value for the base year 2023 and a yearly forecast till 2030 in terms of revenue/volume or both. The market for each of the segment outlooks has been provided on region & country basis for the above-mentioned forecast period.

• The key industry dynamics, major technological trends, and application markets are evaluated to understand their impact on the demand for the forecast period. The growth rates were estimated using correlation, regression, and time-series analysis.

• We have used the bottom-up approach for market sizing, analyzing key regional markets, dynamics, & trends for various products and end-users. The total market has been estimated by integrating the country markets.

• All market estimates and forecasts have been validated through primary interviews with the key industry participants.

• Inflation has not been accounted for to estimate and forecast the market.

• Numbers may not add up due to rounding off.

• Europe consists of EU-8, Central & Eastern Europe, along with the Commonwealth of Independent States (CIS).

• Asia Pacific includes South Asia, East Asia, Southeast Asia, and Oceania (Australia & New Zealand).

• Latin America includes Central American countries and the South American continent

• Middle East includes Western Asia (as assigned by the UN Statistics Division) and the African continent.

Primary Research

GVR strives to procure the latest and unique information for reports directly from industry experts, which gives it a competitive edge. Quality is of utmost importance to us, therefore every year we focus on increasing our experts’ panel. Primary interviews are one of the critical steps in identifying recent market trends and scenarios. This process enables us to justify and validate our market estimates and forecasts to our clients. With more than 8,000 reports in our database, we have connected with some key opinion leaders across various domains, including healthcare, technology, consumer goods, and the chemical sector. Our process starts with identifying the right platform for a particular type of report, i.e., emails, LinkedIn, seminars, or telephonic conversation, as every report is unique and requires a differentiated approach.

We send out questionnaires to different experts from various regions/ countries, which is dependent on the following factors:

• Report/Market scope: If the market study is global, we send questionnaires to industry experts across various regions, including North America, Europe, Asia Pacific, Latin America, and MEA.

• Market Penetration: If the market is driven by technological advancements, population density, disease prevalence, or other factors, we identify experts and send out questionnaires based on region or country dominance.

The time to start receiving responses from industry experts varies based on how niche or well-penetrated the market is. Our reports include a detailed chapter on the KoL opinion section, which helps our clients understand the perspective of experts already in the market space.