Report Overview

Global Generic Drugs Market- Industry Trends & Forecast Report 2028

The global generic drugs market was valued at USD 405 billion in 2021 and is further projected to grow at a CAGR of 7.9% during the forecast period (2022-2028) and reach USD 745 billion by 2028. The growth of the global generic drugs market can be attributed to the growing pharmaceutical industry, increasing healthcare expenditure, growing prevalence of health issues, and rising health awareness among masses. Various favorable government initiatives to control diseases and provide better healthcare to people in poor and middle-income countries are also supporting the growth of the global generic drugs market.

Generic Drugs Overview:

Generic drugs are considered to be a cheaper alternative to branded drugs. According to the FDA (Food and Drug Administration), generic drugs are identical or bioequivalent to branded drugs in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. Generic drugs contain the same active pharmaceutical ingredient (API) as branded drugs, have the same strength, dosage form, and route of administration, and have the same indications, dosing, and labeling, and provide the same efficacy and safety profile to patients.

Global Generic Drugs Forecast and Trend

Growth Drivers

Growing pharmaceutical industry is powering the global generic drugs market

The pharmaceutical industry is one of the largest and essential industries in the world and is growing at a significant rate in recent years. According to the European Federation of Pharmaceutical Industries and Associations (EFPIA), Europe’s pharmaceutical production stood at USD 345.77 billion in 2020, 5.72% up from USD 327.05 billion in 2019. Additionally, EFPIA states that generic drugs make up a large share of pharmaceutical sales in Europe. Furthermore, generic drugs accounted for 77% of total drug sales in Russia in 2020 and 67.3% in Italy, followed by 58% in Serbia.

Restraints

Stringent regulatory requirements of bioequivalence

Fees prescribed by regulatory bodies for filing Abbreviated New Drug Applications have surged for generic drugs manufacturers. It is also a challenge for generic drug manufacturers to meet safety and efficacy requirements. When bioequivalence of the generic drug matches the innovator's Reference listed drug (RLD), then only it is deemed that safety and efficacy requirements have been met. In addition, generic drugs should adhere to the doctrine of equivalence or be capable of developing an invalidation strategy to receive approval from regulatory authorities. These stringent regulatory requirements can restrict the entry of new players into the market and hamper the growth of the global generic drugs market.

Impact of COVID-19 in the Global Generic Drugs  Market

The COVID-19 affected all the industries around the world; however, only a selected few industries were affected as severely as the pharmaceutical industry. The generic drug manufacturers received the least approval, 737, for drugs in 2020, a decline of 22% from 2019 when the FDA approved 935 generic drugs. This is the least approval FDA has given for generic drugs since 2016 when it provided 651 approvals. The demand for generic drugs surged in 2020 as branded drugs were sold out and companies were unable to meet the surging demand. Generic drugs are expected to experience further growth in the coming years with several drugs awaiting approval from regulatory bodies and the growing number of health issues around the world.

Global Generic Drugs  Market : By Product Type

Simple generics, super generics, and biosimilars are the segments the global generic drugs market is categorized into, based on product type. In 2021, the simple generics segment dominated the market and held the largest share owing to the ease of manufacturing these drugs. Simple generics are easy to manufacture and are not highly complex, unlike super generics or biosimilars. Moreover, simple generics are subject to more lenient regulatory requirements, relative to other generic categories, which explains their dominant position in the market.

Global Generic Drugs  Market : By Region

Based on regions, the global generic drugs market is classified into North America, Europe, Asia-Pacific, Latin America, Middle East & Africa. In 2021, North America dominated the market owing to the presence of many global players, high demand for generic drugs due to high healthcare expenditure and high investment in R&D. The players operating in North America are quick to launch generic drugs as healthcare cost is very high in North America and people prefer generics over high cost branded drugs.

Global Generic Drugs  Market: Competitive Landscape

There are several global players operating in the generic drugs market. The market is dominated by players like Teva Pharmaceutical Industries, Fresenius Kabi, and Sandoz, a Novartis Divison. Other major players operating in the market are, Mylan N.V., Sanofi S.A., Sun Pharmaceutical Industries Limited, Mallinckrodt Pharmaceuticals, Stada Arzneimittel AG, Aurobindo Pharma Limited, Endo International plc., Aspen Pharmacare Holdings Limited, Dr. Reddy's Laboratories, Cipla Limited, Hikma Pharmaceuticals plc., Piramal Pharma Solutions, LUPIN Limited, Sawai Pharmaceutical Co. Ltd., Amneal Pharmaceuticals, Inc., Glenmark Pharmaceuticals Limited, Torrent Pharmaceuticals Ltd., and other prominent players.

The companies operating in the global generic drugs market look to launch new products & technologies, provide cost-effective services, collaborate with government & other organizations, and indulge in mergers & acquisitions to gain an advantage over other players operating in the market.

Recent Developments

• In January 2022, it was reported that Poland's largest drug maker Polpharma is working on a USD 4. billion takeover of Czech rival Zentiva. Zentiva was acquired by Boston-based private equity firm Advent in 2018 from French pharmaceutical giant Sanofi for a fee of USD 1.9 billion. Zentiva is manufacturer of a wide range of generic drugs and over-the-counter drugs.

• In January 2022, In a bid to be "radically transparent" in its price negotiations with drug companies, billionaire investor Mark Cuban launched an online pharmacy on Thursday, offering more than 100 generic prescription drugs at an affordable price. The online pharmacy was launched by The Mark Cuban Cost Plus Drug Company announced that it will help consumers avoid high drug prices by charging manufacturers' prices plus a flat 15% markup and pharmacist fee.

Scope of the Report:

By Product Type

• Simple Generics
• Super Generics
• Biosimilars

By Route of Administration

• Oral
• Topical
• Injectable
• Others

By Application

• Cardiovascular Products
• Anti-infective Drugs
• Anti-arthritis Drugs
• Central Nervous System Drugs
• Anti-Cancer Drugs
• Respiratory Products
• Others

By Region

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East & Africa

1. Research Framework
   1. Research Objective
   2. Product Type Overview
   3. Market Segmentation
2. Research Methodology
   1. Qualitative Research
      1. Primary and Secondary Sources
   2. Quantitative Research
      1. Primary and Secondary Sources
   3. Breakdown of Primary Research Respondents
      1. Secondary Research
      2. Primary Research
   4. Breakdown of Primary Research Respondents, By Industry Participants
   5. Key Questionnaire asked during Primary Interviews
   6. Key Primary Responses
   7. Market Size Estimation
   8. Assumption for the Study
   9. Market Breakdown & Data Triangulation
3. Executive Summary
4. Global Generic Drugs Market – Industry Insights
   1. Industry Value Chain/Supply Chain
   2. DROC Analysis
      1. Growth Drivers
      2. Restraints
      3. Opportunity
      4. Challenges
   3. Recent Developments / Technical Landscape
   4. Regulatory Framework
   5. Porter’s Five Forces Analysis
5. Global Generic Drugs Market Overview, 2018-2028
   1. Market Size & Forecast
      1. By Value (USD Billion)
   2. Market Share & Forecast
      1. By Product Type
         1. Simple Generics
         2. Super Generics
         3. Biosimilars
      2. By Route of Administration
         1. Oral
         2. Topical
         3. Injectable
         4. Others
      3. By Application
         1. Cardiovascular Products
         2. Anti-infective Drugs
         3. Anti-arthritis Drugs
         4. Central Nervous System Drugs
         5. Anti-Cancer Drugs
         6. Respiratory Products
         7. Other
      4. By Distribution Channel
         1. Hospitals/Clinics
         2. Retail Pharmacies
         3. Other
      5. Region
         1. North America
         2. Europe
         3. Asia-Pacific
         4. Latin America
         5. Middle East & Africa
6. North America Generic Drugs Market Overview, 2018-2028
   1. Market Size & Forecast
      1. By Value (USD Billion)
   2. Market Share & Forecast
      1. By Product Type
      2. By Route of Administration
      3. By Application
      4. By Distribution Channel
      5. By Country
         1. United States
         2. Canada
7. Europe Generic Drugs Market Overview, 2018-2028
   1. Market Size & Forecast
      1. By Value (USD Billion)
   2. Market Share & Forecast
      1. By Product Type
      2. By Route of Administration
      3. By Application
      4. By Distribution Channel
      5. By Country
         1. Germany
         2. France
         3. Italy
         4. Spain
         5. UK
         6. Netherlands
         7. Rest of Europe
8. Asia-Pacific Generic Drugs Market Overview, 2018-2028
   1. Market Size & Forecast
      1. By Value (USD Billion)
   2. Market Share & Forecast
      1. By Product Type
      2. By Route of Administration
      3. By Application
      4. By Distribution Channel
      5. By Country
         1. China
         2. India
         3. Japan
         4. South Korea
         5. Rest of Asia-Pacific
9. Latin America Generic Drugs Market Overview, 2018-2028
   1. Market Size & Forecast
      1. By Value (USD Billion)
   2. Market Share & Forecast
      1. By Product Type
      2. By Route of Administration
      3. By Application
      4. By Distribution Channel
      5. By Country
         1. Argentina
         2. Brazil
         3. Mexico
         4. Rest of Latin America
10. Middle East & Africa Generic Drugs Market Overview, 2018-2028
    1. Market Size & Forecast
       1. By Value (USD Billion)
    2. Market Share & Forecast
       1. By Product Type
       2. By Route of Administration
       3. By Application
       4. By Distribution Channel
       5. By Country
          1. Saudi Arabia
          2. South Africa
          3. UAE
          4. Rest of Middle East & Africa
11. Competitive Landscape
    1. 1. List of Key Producers and Their Offerings
       2. Market Share / Ranking Analysis (2021)
       3. Competitive Benchmarking, By Operating Parameters
       4. Key Developments & Growth Strategies
          1. Mergers & Acquisitions
12. COVID-19 Impact
13. Company Profiles (Company Overview, Financial Matrix, Key Product Type landscape, Key Personnel, Key Competitors, Contact Address, and Strategic Outlook) *
    1. Teva Pharmaceutical Industries
    2. Fresenius Kabi
    3. Sandoz, a Novartis Divison
    4. Mylan N.V.
    5. Sanofi S.A.
    6. Sun Pharmaceutical Industries Limited
    7. Mallinckrodt Pharmaceuticals
    8. Stada Arzneimittel AG
    9. Aurobindo Pharma Limited
    10. Endo International plc.
    11. Aspen Pharmacare Holdings Limited
    12. Dr. Reddy's Laboratories
    13. Cipla Limited
    14. Hikma Pharmaceuticals plc.
    15. Piramal Pharma Solutions
    16. LUPIN Limited
    17. Sawai Pharmaceutical Co. Ltd.
    18. Amneal Pharmaceuticals, Inc.
    19. Glenmark Pharmaceuticals Limited
    20. Torrent Pharmaceuticals Ltd.
    21. Other Prominent Players
14. Key Strategic Recommendations

* Financial information of non-listed Companies will be provided as per availability

**The segmentation and the companies are subjected to modifications based on in-depth study during the final deliverable.

List of Figures

Fig 1: Global Generic Drugs Segmentation

Fig 2: Global Generic Drugs Market Value Chain Analysis

Fig 3: Global Generic Drugs Market Size, By Value (USD Billion), 2018-2028

Fig 4: Global Generic Drugs Market Share, By Product Type, By Value, 2018-2028

Fig 5: Global Generic Drugs Market Share, By Route of Administration, By Value, 2018-2028

Fig 6: Global Generic Drugs Market Share, By Application, By Value, 2018-2028

Fig 7: Global Generic Drugs Market Share, By Distribution Channel, By Value, 2018-2028

Fig 8: Global Generic Drugs Market Share, By Region, By Value, 2018-2028

Fig 9: North America Generic Drugs Market Size, By Value (USD Billion), 2018-2028

Fig 10: North America Generic Drugs Market Share, By Product Type, By Value, 2018-2028

Fig 11: North America Generic Drugs Market Share, By Route of Administration, By Value, 2018-2028

Fig 12: North America Generic Drugs Market Share, By Application, By Value, 2018-2028

Fig 13: North America Generic Drugs Market Share, By Distribution Channel, By Value, 2018-2028

Fig 14: North America Generic Drugs Market Share, By Country By Value, 2018-2028

Fig 15: Europe Generic Drugs Market Size, By Value (USD Billion), 2018-2028

Fig 16: Europe Generic Drugs Market Share, By Product Type, By Value, 2018-2028

Fig 17: Europe Generic Drugs Market Share, By Route of Administration, By Value, 2018-2028

Fig 18: Europe Generic Drugs Market Share, By Application, By Value, 2018-2028

Fig 19: Europe Generic Drugs Market Share, By Distribution Channel, By Value, 2018-2028

Fig 20: Europe Generic Drugs Market Share, By Country By Value, 2018-2028

Fig 21: Asia-Pacific Generic Drugs Market Size, By Value (USD Billion), 2018-2028

Fig 22: Asia-Pacific Generic Drugs Market Share, By Product Type, By Value, 2018-2028

Fig 23: Asia-Pacific Generic Drugs Market Share, By Route of Administration, By Value, 2018-2028

Fig 24: Asia-Pacific Generic Drugs Market Share, By Application, By Value, 2018-2028

Fig 25: Asia-Pacific Generic Drugs Market Share, By Distribution Channel, By Value, 2018-2028

Fig 26: Asia-Pacific Generic Drugs Market Share, By Country By Value, 2018-2028

Fig 27: Latin America Generic Drugs Market Size, By Value (USD Billion), 2018-2028

Fig 28: Latin America Generic Drugs Market Share, By Product Type, By Value, 2018-2028

Fig 29: Latin America Generic Drugs Market Share, By Route of Administration, By Value, 2018-2028

Fig 30: Latin America Generic Drugs Market Share, By Application, By Value, 2018-2028

Fig 31: Latin America Generic Drugs Market Share, By Distribution Channel, By Value, 2018-2028

Fig 32: Latin America Generic Drugs Market Share, By Country By Value, 2018-2028

Fig 33: Middle East & Africa Generic Drugs Market Size, By Value (USD Billion), 2018-2028

Fig 34: Middle East & Africa Generic Drugs Market Share, By Product Type, By Value, 2018-2028

Fig 35: Middle East & Africa Generic Drugs Market Share, By Route of Administration, By Value, 2018-2028

Fig 36: Middle East & Africa Generic Drugs Market Share, By Application, By Value, 2018-2028

Fig 37: Middle East & Africa Generic Drugs Market Share, By Distribution Channel, By Value, 2018-2028

Fig 38: Middle East & Africa Generic Drugs Market Share, By Country By Value, 2018-2028

Fig 39: Company Share Analysis, 2021

List of Tables

Table 1: Global Generic Drugs Size, By Product Type, By Value, 2018-2028

Table 2: Global Generic Drugs Market Size, By Route of Administration, By Value, 2018-2028

Table 3: Global Generic Drugs Market Size, By Application, By Value, 2018-2028

Table 4: Global Generic Drugs Market Size, By Distribution Channel, By Value, 2018-2028

Table 5: Global Generic Drugs Market Size, By Region, By Value, 2018-2028

Table 6: North America Generic Drugs Size, By Product Type, By Value, 2018-2028

Table 7: North America Generic Drugs Market Size, By Route of Administration, By Value, 2018-2028

Table 8: North America Generic Drugs Market Size, By Application, By Value, 2018-2028

Table 9: North America Generic Drugs Market Size, By Distribution Channel, By Value, 2018-2028

Table 10: North America Generic Drugs Market Size, By Region, By Value, 2018-2028

Table 11: Europe Generic Drugs Size, By Product Type, By Value, 2018-2028

Table 12: Europe Generic Drugs Market Size, By Route of Administration, By Value, 2018-2028

Table 13: Europe Generic Drugs Market Size, By Application, By Value, 2018-2028

Table 14: Europe Generic Drugs Market Size, By Distribution Channel, By Value, 2018-2028

Table 15: Europe Generic Drugs Market Size, By Region, By Value, 2018-2028

Table 16: Asia-Pacific Generic Drugs Size, By Product Type, By Value, 2018-2028

Table 17: Asia-Pacific Generic Drugs Market Size, By Route of Administration, By Value, 2018-2028

Table 18: Asia-Pacific Generic Drugs Market Size, By Application, By Value, 2018-2028

Table 19: Asia-Pacific Generic Drugs Market Size, By Distribution Channel, By Value, 2018-2028

Table 20: Asia-Pacific Generic Drugs Market Size, By Region, By Value, 2018-2028

Table 21: Latin America Generic Drugs Size, By Product Type, By Value, 2018-2028

Table 22: Latin America Generic Drugs Market Size, By Route of Administration, By Value, 2018-2028

Table 23: Latin America Generic Drugs Market Size, By Application, By Value, 2018-2028

Table 24: Latin America Generic Drugs Market Size, By Distribution Channel, By Value, 2018-2028

Table 25: Latin America Generic Drugs Market Size, By Region, By Value, 2018-2028

Table 26: Middle East & Africa Generic Drugs Size, By Product Type, By Value, 2018-2028

Table 27: Middle East & Africa Generic Drugs Market Size, By Route of Administration, By Value, 2018-2028

Table 28: Middle East & Africa Generic Drugs Market Size, By Application, By Value, 2018-2028

Table 29: Middle East & Africa Generic Drugs Market Size, By Distribution Channel, By Value, 2018-2028

Table 30: Middle East & Africa Generic Drugs Market Size, By Region, By Value, 2018-2028

Table 31: Teva Pharmaceutical Industries Business Overview

Table 32: Teva Pharmaceutical Industries Financial Analysis

Table 33: Fresenius Kabi Business Overview

Table 34: Fresenius Kabi Financial Overview

Table 35: Sandoz, A Novartis division Business Overview

Table 36: Sandoz, A Novartis division Financial Overview

Table 37: Mylan N.V., Business Overview

Table 38: Mylan N.V., Financial Overview

Table 39: Sanofi S.A., Business Overview

Table 40: Sanofi S.A., Financial Overview

Table 41: Sun Pharmaceutical Industries Limited Business Overview

Table 42: Sun Pharmaceutical Industries Limited Financial Analysis

Table 43: Mallinckrodt Pharmaceuticals Business Overview

Table 44: Mallinckrodt Pharmaceuticals Financial Analysis

Table 45: Stada Arzneimittel AG Business Overview

Table 46: Stada Arzneimittel AG Financial Analysis

Table 47: Aurobindo Pharma Limited Business Overview

Table 48: Aurobindo Pharma Limited Financial Overview

Table 49: Endo International plc., Business Overview

Table 50: Endo International plc., Financial Overview

Table 51: Aspen Pharmacare Holdings Limited Business Overview

Table 52: Aspen Pharmacare Holdings Limited Financial Overview

Table 53: Dr. Reddy's Laboratories Business Overview

Table 54: Dr. Reddy's Laboratories Financial Analysis

Table 55: Cipla Limited Business Overview

Table 56: Cipla Limited Financial Overview

Table 57: Hikma Pharmaceuticals plc., Business Overview

Table 58: Hikma Pharmaceuticals plc., Financial Overview

Table 59: Primal Pharma Solutions Business Overview

Table 60: Primal Pharma Solutions Financial Overview

Table 61: Lupin Limited Business Overview

Table 62: Lupin Limited Financial Overview

Table 63: Sawai Pharmaceutical Co. Ltd., Business Overview

Table 64: Sawai Pharmaceutical Co. Ltd., Financial Overview

Table 65: Amneal Pharmaceuticals, Inc., Business Overview

Table 66: Amneal Pharmaceuticals, Inc. Financial Overview

Table 67: Glenmark Pharmaceuticals Limited Business Overview

Table 68: Glenmark Pharmaceuticals Limited Financial Overview

Table 69: Torrent Pharmaceuticals Ltd., Business Overview

Table 70: Torrent Pharmaceuticals Ltd., Financial Overview