Specialty Generics Market Size, Share & Trends Report

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

Report ID: GVR-1-68038-629-5
Number of Pages: 101
Format: Electronic (PDF)

Historical Range: 2018 - 2021
Industry: Healthcare

Market Segmentation

Specialty Generics Type Outlook (Revenue, USD Billion; 2018 - 2030)
- Injectables
- Oral drugs
- Others
Specialty Generics Application Outlook (Revenue, USD Billion; 2018 - 2030)
- Oncology
- Inflammatory conditions
- Multiple sclerosis
- Hepatitis C
- Others
Specialty Generics End-Use Outlook (Revenue, USD Billion; 2018 - 2030)
- Specialty pharmacy
- Retail pharmacy
- Hospital pharmacy
Specialty Generics Regional Outlook (Revenue, USD Billion, 2018 - 2030)
- North America
  - North America Specialty Generics Market, By Type 2018 - 2030 (USD Billion)
    - Injectables
    - Oral drugs
    - Others
  - North America Specialty Generics Market, By Application, 2018 - 2030 (USD Billion)
    - Oncology
    - Inflammatory conditions
    - Multiple sclerosis
    - Hepatitis C
    - Others
  - North America Specialty Generics Market, by End-Use 2018 - 2030 (USD Billion)
    - Specialty pharmacy
    - Retail pharmacy
    - Hospital pharmacy
  - U.S.
    - U.S. Specialty Generics Market, By Type 2018 - 2030 (USD Billion)
      - Injectables
      - Oral drugs
      - Others
    - U.S. Specialty Generics Market, By Application, 2018 - 2030 (USD Billion)
      - Oncology
      - Inflammatory conditions
      - Multiple sclerosis
      - Hepatitis C
      - Others
    - U.S. Specialty Generics Market, by End-Use 2018 - 2030 (USD Billion)
      - Specialty pharmacy
      - Retail pharmacy
      - Hospital pharmacy
  - Canada
    - Canada Specialty Generics Market, By Type 2018 - 2030 (USD Billion)
      - Injectables
      - Oral drugs
      - Others
    - Canada Specialty Generics Market, By Application, 2018 - 2030 (USD Billion)
      - Oncology
      - Inflammatory conditions
      - Multiple sclerosis
      - Hepatitis C
      - Others
    - Canada Specialty Generics Market, by End-Use 2018 - 2030 (USD Billion)
      - Specialty pharmacy
      - Retail pharmacy
      - Hospital pharmacy
- Europe
  - Europe Specialty Generics Market, By Type 2018 - 2030 (USD Billion)
    - Injectables
    - Oral drugs
    - Others
  - Europe Specialty Generics Market, By Application, 2018 - 2030 (USD Billion)
    - Oncology
    - Inflammatory conditions
    - Multiple sclerosis
    - Hepatitis C
    - Others
  - Europe Specialty Generics Market, by End-Use 2018 - 2030 (USD Billion)
    - Specialty pharmacy
    - Retail pharmacy
    - Hospital pharmacy
  - UK
    - UK Specialty Generics Market, By Type 2018 - 2030 (USD Billion)
      - Injectables
      - Oral drugs
      - Others
    - UK Specialty Generics Market, By Application, 2018 - 2030 (USD Billion)
      - Oncology
      - Inflammatory conditions
      - Multiple sclerosis
      - Hepatitis C
      - Others
    - UK Specialty Generics Market, by End-Use 2018 - 2030 (USD Billion)
      - Specialty pharmacy
      - Retail pharmacy
      - Hospital pharmacy
  - Germany
    - Germany Specialty Generics Market, By Type 2018 - 2030 (USD Billion)
      - Injectables
      - Oral drugs
      - Others
    - Germany Specialty Generics Market, By Application, 2018 - 2030 (USD Billion)
      - Oncology
      - Inflammatory conditions
      - Multiple sclerosis
      - Hepatitis C
      - Others
    - Germany Specialty Generics Market, by End-Use 2018 - 2030 (USD Billion)
      - Specialty pharmacy
      - Retail pharmacy
      - Hospital pharmacy
  - France
    - France Specialty Generics Market, By Type 2018 - 2030 (USD Billion)
      - Injectables
      - Oral drugs
      - Others
    - France Specialty Generics Market, By Application, 2018 - 2030 (USD Billion)
      - Oncology
      - Inflammatory conditions
      - Multiple sclerosis
      - Hepatitis C
      - Others
    - France Specialty Generics Market, by End-Use 2018 - 2030 (USD Billion)
      - Specialty pharmacy
      - Retail pharmacy
      - Hospital pharmacy
  - Italy
    - Italy Specialty Generics Market, By Type 2018 - 2030 (USD Billion)
      - Injectables
      - Oral drugs
      - Others
    - Italy Specialty Generics Market, By Application, 2018 - 2030 (USD Billion)
      - Oncology
      - Inflammatory conditions
      - Multiple sclerosis
      - Hepatitis C
      - Others
    - Italy Specialty Generics Market, by End-Use 2018 - 2030 (USD Billion)
      - Specialty pharmacy
      - Retail pharmacy
      - Hospital pharmacy
  - Spain
    - Spain Specialty Generics Market, By Type 2018 - 2030 (USD Billion)
      - Injectables
      - Oral drugs
      - Others
    - Spain Specialty Generics Market, By Application, 2018 - 2030 (USD Billion)
      - Oncology
      - Inflammatory conditions
      - Multiple sclerosis
      - Hepatitis C
      - Others
    - Spain Specialty Generics Market, by End-Use 2018 - 2030 (USD Billion)
      - Specialty pharmacy
      - Retail pharmacy
      - Hospital pharmacy
  - Denmark
    - Denmark Specialty Generics Market, By Type 2018 - 2030 (USD Billion)
      - Injectables
      - Oral drugs
      - Others
    - Denmark Specialty Generics Market, By Application, 2018 - 2030 (USD Billion)
      - Oncology
      - Inflammatory conditions
      - Multiple sclerosis
      - Hepatitis C
      - Others
    - Denmark Specialty Generics Market, by End-Use 2018 - 2030 (USD Billion)
      - Specialty pharmacy
      - Retail pharmacy
      - Hospital pharmacy
  - Sweden
    - Sweden Specialty Generics Market, By Type 2018 - 2030 (USD Billion)
      - Injectables
      - Oral drugs
      - Others
    - Sweden Specialty Generics Market, By Application, 2018 - 2030 (USD Billion)
      - Oncology
      - Inflammatory conditions
      - Multiple sclerosis
      - Hepatitis C
      - Others
    - Sweden Specialty Generics Market, by End-Use 2018 - 2030 (USD Billion)
      - Specialty pharmacy
      - Retail pharmacy
      - Hospital pharmacy
  - Norway
    - Norway Specialty Generics Market, By Type 2018 - 2030 (USD Billion)
      - Injectables
      - Oral drugs
      - Others
    - Norway Specialty Generics Market, By Application, 2018 - 2030 (USD Billion)
      - Oncology
      - Inflammatory conditions
      - Multiple sclerosis
      - Hepatitis C
      - Others
    - Norway Specialty Generics Market, by End-Use 2018 - 2030 (USD Billion)
      - Specialty pharmacy
      - Retail pharmacy
      - Hospital pharmacy
- Asia Pacific
  - Asia Pacific Specialty Generics Market, By Type 2018 - 2030 (USD Billion)
    - Injectables
    - Oral drugs
    - Others
  - Asia Pacific Specialty Generics Market, By Application, 2018 - 2030 (USD Billion)
    - Oncology
    - Inflammatory conditions
    - Multiple sclerosis
    - Hepatitis C
    - Others
  - Asia Pacific Specialty Generics Market, by End-Use 2018 - 2030 (USD Billion)
    - Specialty pharmacy
    - Retail pharmacy
    - Hospital pharmacy
  - Japan
    - Japan Specialty Generics Market, By Type 2018 - 2030 (USD Billion)
      - Injectables
      - Oral drugs
      - Others
    - Japan Specialty Generics Market, By Application, 2018 - 2030 (USD Billion)
      - Oncology
      - Inflammatory conditions
      - Multiple sclerosis
      - Hepatitis C
      - Others
    - Japan Specialty Generics Market, by End-Use 2018 - 2030 (USD Billion)
      - Specialty pharmacy
      - Retail pharmacy
      - Hospital pharmacy
  - China
    - China Specialty Generics Market, By Type 2018 - 2030 (USD Billion)
      - Injectables
      - Oral drugs
      - Others
    - China Specialty Generics Market, By Application, 2018 - 2030 (USD Billion)
    - China Specialty Generics Market, by End-Use 2018 - 2030 (USD Billion)
      - Specialty pharmacy
      - Retail pharmacy
      - Hospital pharmacy
  - India
    - India Specialty Generics Market, By Type 2018 - 2030 (USD Billion)
      - Injectables
      - Oral drugs
      - Others
    - India Specialty Generics Market, By Application, 2018 - 2030 (USD Billion)
      - Oncology
      - Inflammatory conditions
      - Multiple sclerosis
      - Hepatitis C
      - Others
    - India Specialty Generics Market, by End-Use 2018 - 2030 (USD Billion)
      - Specialty pharmacy
      - Retail pharmacy
      - Hospital pharmacy
  - Australia
    - Australia Specialty Generics Market, By Type 2018 - 2030 (USD Billion)
      - Injectables
      - Oral drugs
      - Others
    - Australia Specialty Generics Market, By Application, 2018 - 2030 (USD Billion)
      - Oncology
      - Inflammatory conditions
      - Multiple sclerosis
      - Hepatitis C
      - Others
    - Australia Specialty Generics Market, by End-Use 2018 - 2030 (USD Billion)
      - Specialty pharmacy
      - Retail pharmacy
      - Hospital pharmacy
  - South Korea
    - South Korea Specialty Generics Market, By Type 2018 - 2030 (USD Billion)
      - Injectables
      - Oral drugs
      - Others
    - South Korea Specialty Generics Market, By Application, 2018 - 2030 (USD Billion)
      - Oncology
      - Inflammatory conditions
      - Multiple sclerosis
      - Hepatitis C
      - Others
    - South Korea Specialty Generics Market, by End-Use 2018 - 2030 (USD Billion)
      - Specialty pharmacy
      - Retail pharmacy
      - Hospital pharmacy
  - Thailand
    - Thailand Specialty Generics Market, By Type 2018 - 2030 (USD Billion)
      - Injectables
      - Oral drugs
      - Others
    - Thailand Specialty Generics Market, By Application, 2018 - 2030 (USD Billion)
      - Oncology
      - Inflammatory conditions
      - Multiple sclerosis
      - Hepatitis C
      - Others
    - Thailand Specialty Generics Market, by End-Use 2018 - 2030 (USD Billion)
      - Specialty pharmacy
      - Retail pharmacy
      - Hospital pharmacy
- Latin America
  - Latin America Specialty Generics Market, By Type 2018 - 2030 (USD Billion)
    - Injectables
    - Oral drugs
    - Others
  - Latin America Specialty Generics Market, By Application, 2018 - 2030 (USD Billion)
    - Oncology
    - Inflammatory conditions
    - Multiple sclerosis
    - Hepatitis C
    - Others
  - Latin America Specialty Generics Market, by End-Use 2018 - 2030 (USD Billion)
    - Specialty pharmacy
    - Retail pharmacy
    - Hospital pharmacy
  - Brazil
    - Brazil Specialty Generics Market, By Type 2018 - 2030 (USD Billion)
      - Injectables
      - Oral drugs
      - Others
    - Brazil Specialty Generics Market, By Application, 2018 - 2030 (USD Billion)
      - Oncology
      - Inflammatory conditions
      - Multiple sclerosis
      - Hepatitis C
      - Others
    - Brazil Specialty Generics Market, by End-Use 2018 - 2030 (USD Billion)
      - Specialty pharmacy
      - Retail pharmacy
      - Hospital pharmacy
  - Mexico
    - Mexico Specialty Generics Market, By Type 2018 - 2030 (USD Billion)
      - Injectables
      - Oral drugs
      - Others
    - Mexico Specialty Generics Market, By Application, 2018 - 2030 (USD Billion)
      - Oncology
      - Inflammatory conditions
      - Multiple sclerosis
      - Hepatitis C
      - Others
    - Mexico Specialty Generics Market, by End-Use 2018 - 2030 (USD Billion)
      - Specialty pharmacy
      - Retail pharmacy
      - Hospital pharmacy
  - Argentina
    - Argentina Specialty Generics Market, By Type 2018 - 2030 (USD Billion)
      - Injectables
      - Oral drugs
      - Others
    - Argentina Specialty Generics Market, By Application, 2018 - 2030 (USD Billion)
      - Oncology
      - Inflammatory conditions
      - Multiple sclerosis
      - Hepatitis C
      - Others
    - Argentina Specialty Generics Market, by End-Use 2018 - 2030 (USD Billion)
      - Specialty pharmacy
      - Retail pharmacy
      - Hospital pharmacy
- MEA
  - MEA Specialty Generics Market, By Type 2018 - 2030 (USD Billion)
    - Injectables
    - Oral drugs
    - Others
  - MEA Specialty Generics Market, By Application, 2018 - 2030 (USD Billion)
    - Oncology
    - Inflammatory conditions
    - Multiple sclerosis
    - Hepatitis C
    - Others
  - MEA Specialty Generics Market, by End-Use 2018 - 2030 (USD Billion)
    - Specialty pharmacy
    - Retail pharmacy
    - Hospital pharmacy
  - South Africa
    - South Africa Specialty Generics Market, By Type 2018 - 2030 (USD Billion)
      - Injectables
      - Oral drugs
      - Others
    - South Africa Specialty Generics Market, By Application, 2018 - 2030 (USD Billion)
      - Oncology
      - Inflammatory conditions
      - Multiple sclerosis
      - Hepatitis C
      - Others
    - South Africa Specialty Generics Market, by End-Use 2018 - 2030 (USD Billion)
      - Specialty pharmacy
      - Retail pharmacy
      - Hospital pharmacy
  - Saudi Arabia
    - Saudi Arabia Specialty Generics Market, By Type 2018 - 2030 (USD Billion)
      - Injectables
      - Oral drugs
      - Others
    - Saudi Arabia Specialty Generics Market, By Application, 2018 - 2030 (USD Billion)
      - Oncology
      - Inflammatory conditions
      - Multiple sclerosis
      - Hepatitis C
      - Others
    - Saudi Arabia Specialty Generics Market, by End-Use 2018 - 2030 (USD Billion)
      - Specialty pharmacy
      - Retail pharmacy
      - Hospital pharmacy
  - UAE
    - UAE Specialty Generics Market, By Type 2018 - 2030 (USD Billion)
      - Injectables
      - Oral drugs
      - Others
    - UAE Specialty Generics Market, By Application, 2018 - 2030 (USD Billion)
      - Oncology
      - Inflammatory conditions
      - Multiple sclerosis
      - Hepatitis C
      - Others
    - UAE Specialty Generics Market, by End-Use 2018 - 2030 (USD Billion)
      - Specialty pharmacy
      - Retail pharmacy
      - Hospital pharmacy

Specialty Generics Market Dynamics

Drivers: rising number of off-patent specialty drugs

Patents of many branded specialty drugs are expected to expire shortly. Hence, generic drugs are anticipated to pose a threat to branded drugs. Loss of patent protection for specialty drugs may greatly affect the pharmaceutical industry. Based on a session at the AMCP Specialty Pharmacy Conference, around 30 specialty drugs are expected to lose patents before 2020, thus creating lucrative opportunities for the growth of the generics market. Patented drugs generally have a lifespan of 20 years, which starts from the clinical trial phase. This reduces the commercial life of these drugs to around 15 years, thereby creating growth opportunities for generic drugs. To maintain sustainability, generic drug manufacturers are entering into partnerships and licensing strategies for the launch of new products, which is anticipated to boost sales. In the case of branded drugs, there is a time gap between patent expiration and the launch of another blockbuster drug. Generic drug manufacturers seek opportunities during this period through comarketing agreements and collaborations. The number of generic drugs being approved greatly depends on the market value of the branded drug going off-patent. Thus, early patent expirations are expected to boost sales of specialty generics, thereby fueling market growth.

Increasing Demand For Low-Cost Generic Specialty Drugs

The introduction of cost-effective drugs for the treatment of multiple sclerosis, oncological diseases, and other infectious diseases is expected to create growth opportunities for manufacturers of specialty generic drugs. For instance, with Copaxone (Glatiramer), multiple sclerosis treatment costs can be estimated to be around USD 72,000. However, with the development of the generic version of Copaxone, Novartis reduced the cost to USD 63,000. This has also encouraged many insurance companies to reimburse the cost of specialty generic drugs due to their low price. The affordable price of specialty injectable generics is a result of the elimination of certain processes such as clinical trials, advertising, and other promotional activities. Moreover, in some cases, a cluster of generic manufacturers receive approval for marketing a single product, thereby increasing competition, which results in the advent of cost-effective specialty generic drugs. Thus, the low cost of these drugs is expected to increase their demand. Specialty drugs are expensive and are usually not subject to price reduction as their consumer base is small. Generic drugs have wide applications and the number of manufacturers is high. Hence, price competition is high, leading to the availability of these drugs at affordable prices. This is expected to create lucrative opportunities in emerging and price-sensitive countries

Restraints: Stringent Regulatory Procedures

Regulatory authorities such as the FDA and EMA have issued specific guidelines for the development and manufacturing of generic specialty medicines. These drugs are approved by authorities through Abbreviated New Drug Applications (ANDAs). These guidelines aim at maintaining the safety and effectiveness of a proposed specialty generic drug. According to the FDA and other regulatory authorities, a specialty generic drug manufacturer must provide evidence to show that the active ingredient in a drug is the same as that in the branded drug. The FDA shall then review the evidence provided. Such stringent regulatory procedure is anticipated to hinder the growth of the specialty generic drugs market. In the U.S., the FDA is the governing body accountable for licensing specialty generic drugs. It is involved in determining scientific, manufacturing, and quality guidelines for generics. Some of the regulatory bodies governing generics are the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) in Mexico; the Ministry of Health, Labour and Welfare (MHLW) in Japan; Saudi Food and Drug Authority (SFDA) in Saudi Arabia; South Korean Ministry of Food and Drug Safety (MFDS) in South Korea; and Drugs and Cosmetics Act in India.

What Does This Report Include?

This section will provide insights into the contents included in this Specialty Generics market report and help gain clarity on the structure of the report to assist readers in navigating smoothly.

Specialty generics market qualitative analysis

Industry overview
Industry trends
Market drivers and restraints
Market size
Growth prospects
Porter’s analysis
PESTEL analysis
Key market opportunities prioritized
Competitive landscape
- Company overview
- Financial performance
- Product benchmarking
- Latest strategic developments

Specialty generics market quantitative analysis

Market size, estimates, and forecast from 2018 to 2030
Market estimates and forecast for product segments up to 2030
Regional market size and forecast for product segments up to 2030
Market estimates and forecast for application segments up to 2030
Regional market size and forecast for application segments up to 2030
Company financial performance

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