Oral Biologics & Biosimilars Global Market Report 2022 – By Therapy (Lymphocyte Modulators, Interleukin Inhibitors, and Tumor Necrosis Factor-Alpha Inhibitors), By Disease (Asthma, Crohn's Disease, Carcinoma, Arthritis, Diabetes, Multiple Myeloma, Enterocolitis, Multiple Sclerosis, Sarcoma, Psoriasis and Other Diseases), By Molecule Type (Vaccines, Proteins and Peptides, Monoclonal Antibodies, and Other Molecule Types), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies) – Market Size, Trends, And Global Forecast 2022-2026

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The oral biologics and biosimilar market consist of sales of oral biologics and biosimilar products and related services by entities (organizations, sole traders, partnership) used to treat chronic diseases such as diabetes, arthritis, and cancer. Biologics are drugs made from living cells using highly complex technology, while biosimilars are created to function similarly to biologics but are not identical to biologics. Biosimilars offer the same active properties as any licensed biological drug. The oral biologics and biosimilar market comprise biologics and biosimilar drugs taken orally for the targeted treatment of Alzheimer's, multiple sclerosis, HIV/AIDS, and other serious conditions.

The main therapy types of oral biologics and biosimilar lymphocytes are modulators, interleukin inhibitors, and tumor necrosis factor-alpha inhibitors. Interleukin inhibitors are immunosuppressive drugs that stop interleukins from working. The various diseases include asthma, Crohn's disease, carcinoma, arthritis, diabetes, multiple myeloma, enterocolitis, multiple sclerosis, sarcoma, psoriasis, and others that are treated by molecular types such as vaccines, proteins and peptides, monoclonal antibodies, and other diseases. These are distributed through hospital pharmacies, retail pharmacies, and online pharmacies.

The global oral biologics & biosimilars market size is expected to grow from $4.24 billion in 2021 to $5.24 billion in 2022 at a compound annual growth rate (CAGR) of 23.4%. The global oral biologics & biosimilars market size is expected to grow to $9.44 billion in 2026 at a compound annual growth rate (CAGR) of 15.9%.

The rising prevalence of chronic diseases such as arthritis, asthma, and cancer is expected to propel the growth of the oral biologics and biosimilar market. Long working hours, limited physical activity, and unhealthy eating and drinking habits contribute to the prevalence of chronic diseases, and biologics are increasingly used to treat these chronic diseases. Biologics stimulate the immune system's attack on cancer cells, aiding the body's natural defenses in getting rid of the disease-causing cells. According to a United Nations article and a US-based intergovernmental organization, by 2030, chronic diseases are predicted to account for 70% of all fatalities worldwide. It is anticipated that chronic diseases will account for nearly 60% of all deaths worldwide. Therefore, the rise in the prevalence of chronic diseases is driving the growth of the biologics and biosimilar market.

Stringent regulations imposed on the approval of biosimilar are anticipated to hinder the growth of oral biologics and the biosimilar market in the forecast period. The governments of different regions impose different rules regarding the production and use of biologics and biosimilars. Further, issues such as patent infringement or agreement issues restrict the manufacturers of biologics and biosimilars from commercializing the government-approved biosimilars. The US Food and Drug Administration requires a double regulatory approval for biosimilars, restricting the use of biosimilars as interchangeable drugs for biologics whereas, in Europe, the European Medicines Agency (EMA) approves biosimilars as interchangeable products for biologics. In February 2019, out of the total 17 approved biosimilars, only 7 biosimilars, including 4 originating biologics, could enter the US commercial market. The robust government policies for approval of these drugs impact the manufacturers in the oral biologics and biosimilar markets.

The creation of new insulin biosimilar is a key trend gaining popularity in the oral biologics and biosimilar market. The key players operating in the oral biologics and biosimilar market are investing in creating a biosimilar copy of insulin to capture the market share. For instance, in 2019, Mylan, a US-based pharmaceutical company, in partnership with Biocon, launched a biosimilar insulin glargine named Semglee in Australia. Biocon is an Indian-based biopharmaceutical company. Also in 2019, Oramed Pharmaceuticals, a Jerusalem-based pharmaceutical company, developed an oral insulin drug named ORMD-0801 to treat type 2 diabetes. Thus, companies in the oral biologics and biosimilar market are investing in the trend of developing biosimilar of insulin to gain profit.

Major players in the oral biologics & biosimilar drugs market are Novartis, Rani Therapeutics, Eli Lilly and Co., AstraZeneca plc, Novo Nordisk A/S, Biocon Limited, Oramed Pharmaceuticals, BiosanaPharma, Entera Bio Ltd., Allergan plc, and Emisphere Technologies.

North America was the largest region in the global oral biologics and biosimilar drugs market in 2021. The Middle East is expected to be the fastest-growing region in the global oral biologics & biosimilars market during the forecast period. The regions covered in the global oral biologics & biosimilars market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, the Middle East, and Africa.

The countries covered in the oral biologics & biosimilar drugs market are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, the UK, and the USA.

The global oral biologics & biosimilars market is segmented -

1) By Therapy: Lymphocyte Modulators, Interleukin Inhibitors, and Tumor Necrosis Factor-Alpha Inhibitors

2) By Disease: Asthma, Crohn's Disease, Carcinoma, Arthritis, Diabetes, Multiple Myeloma, Enterocolitis, Multiple Sclerosis, Sarcoma, Psoriasis and Others

3) By Molecule Type: Vaccines, Proteins and Peptides, Monoclonal Antibodies, and Others

4) By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies

    Table Of Contents

    1. Executive Summary

    2. Oral Biologics & Biosimilars Market Characteristics

    3. Oral Biologics & Biosimilars Market Trends And Strategies

    4. Impact Of COVID-19 On Oral Biologics & Biosimilars

    5. Oral Biologics & Biosimilars Market Size And Growth

    5.1. Global Oral Biologics & Biosimilars Historic Market, 2016-2021, $ Billion

    5.1.1. Drivers Of The Market

    5.1.2. Restraints On The Market

    5.2. Global Oral Biologics & Biosimilars Forecast Market, 2021-2026F, 2031F, $ Billion

    5.2.1. Drivers Of The Market

    5.2.2. Restraints On the Market

    6. Oral Biologics & Biosimilars Market Segmentation

    6.1. Global Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

    Lymphocyte Modulators

    Interleukin Inhibitors

    Tumor Necrosis Factor-Alpha Inhibitors

    6.2. Global Oral Biologics & Biosimilars Market, Segmentation By Disease, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

    Asthma

    Crohn'S Disease

    Carcinoma

    Arthritis

    Diabetes

    Multiple Myeloma

    Enterocolitis

    Multiple Sclerosis

    Sarcoma

    Psoriasis and Others

    6.3. Global Oral Biologics & Biosimilars Market, Segmentation By Molecule Type, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

    Vaccines

    Proteins & Peptides

    Monoclonal Antibodies

    Others

    6.4. Global Oral Biologics & Biosimilars Market, Segmentation By Distribution Channel, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

    Hospital Pharmacies

    Retail Pharmacies

    Online Pharmacies

    7. Oral Biologics & Biosimilars Market Regional And Country Analysis

    7.1. Global Oral Biologics & Biosimilars Market, Split By Region, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

    7.2. Global Oral Biologics & Biosimilars Market, Split By Country, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

    8. Asia-Pacific Oral Biologics & Biosimilars Market

    8.1. Asia-Pacific Oral Biologics & Biosimilars Market Overview

    Region Information, Impact Of COVID-19, Market Information, Background Information, Government Initiatives, Regulations, Regulatory Bodies, Major Associations, Taxes Levied, Corporate Tax Structure, Investments, Major Companies

    8.2. Asia-Pacific Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

    9. China Oral Biologics & Biosimilars Market

    9.1. China Oral Biologics & Biosimilars Market Overview

    9.2. China Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F,$ Billion

    10. India Oral Biologics & Biosimilars Market

    10.1. India Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

    11. Japan Oral Biologics & Biosimilars Market

    11.1. Japan Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

    12. Australia Oral Biologics & Biosimilars Market

    12.1. Australia Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

    13. Indonesia Oral Biologics & Biosimilars Market

    13.1. Indonesia Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

    14. South Korea Oral Biologics & Biosimilars Market

    14.1. South Korea Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

    15. Western Europe Oral Biologics & Biosimilars Market

    15.1. Western Europe Oral Biologics & Biosimilars Market Overview

    15.2. Western Europe Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

    16. UK Oral Biologics & Biosimilars Market

    16.1. UK Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

    17. Germany Oral Biologics & Biosimilars Market

    17.1. Germany Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

    18. France Oral Biologics & Biosimilars Market

    18.3. France Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

    19. Eastern Europe Oral Biologics & Biosimilars Market

    19.1. Eastern Europe Oral Biologics & Biosimilars Market Overview

    19.2. Eastern Europe Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

    20. Russia Oral Biologics & Biosimilars Market

    20.1. Russia Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

    21. North America Oral Biologics & Biosimilars Market

    21.1. North America Oral Biologics & Biosimilars Market Overview

    21.2. North America Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

    22. USA Oral Biologics & Biosimilars Market

    22.1. USA Oral Biologics & Biosimilars Market Overview

    22.2. USA Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

    23. South America Oral Biologics & Biosimilars Market

    23.1. South America Oral Biologics & Biosimilars Market Overview

    23.2. South America Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

    24. Brazil Oral Biologics & Biosimilars Market

    24.1. Brazil Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

    25. Middle East Oral Biologics & Biosimilars Market

    25.1. Middle East Oral Biologics & Biosimilars Market Overview

    25.2. Middle East Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

    26. Africa Oral Biologics & Biosimilars Market

    26.1. Africa Oral Biologics & Biosimilars Market Overview

    26.2. Africa Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion

    27. Oral Biologics & Biosimilars Market Competitive Landscape And Company Profiles

    27.1. Oral Biologics & Biosimilars Market Competitive Landscape

    27.2. Oral Biologics & Biosimilars Market Company Profiles

    27.2.1. Novartis

    27.2.1.1. Overview

    27.2.1.2. Products and Services

    27.2.1.3. Strategy

    27.2.1.4. Financial Performance

    27.2.2. Rani Therapeutics

    27.2.2.1. Overview

    27.2.2.2. Products and Services

    27.2.2.3. Strategy

    27.2.2.4. Financial Performance

    27.2.3. Eli Lilly and Co.

    27.2.3.1. Overview

    27.2.3.2. Products and Services

    27.2.3.3. Strategy

    27.2.3.4. Financial Performance

    27.2.4. AstraZeneca plc

    27.2.4.1. Overview

    27.2.4.2. Products and Services

    27.2.4.3. Strategy

    27.2.4.4. Financial Performance

    27.2.5. Novo Nordisk A/S

    27.2.5.1. Overview

    27.2.5.2. Products and Services

    27.2.5.3. Strategy

    27.2.5.4. Financial Performance

    28. Oral Biologics & Biosimilars Pipeline Analysis

    29. Key Mergers And Acquisitions In The Oral Biologics & Biosimilars Market

    30. Oral Biologics & Biosimilars Market Future Outlook and Potential Analysis

    31. Appendix

    31.1. Abbreviations

    31.2. Currencies

    31.3. Research Inquiries

    31.4. The Business Research Company

    31.5. Copyright And Disclaimer

List Of Tables

    Table 1: Global Historic Market Growth, 2016-2021, $ Billion
  • Table 2: Global Forecast Market Growth, 2021-2026F, 2031F, $ Billion
  • Table 3: Global Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Table 4: Global Oral Biologics & Biosimilars Market, Segmentation By Disease, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Table 5: Global Oral Biologics & Biosimilars Market, Segmentation By Molecule Type, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Table 6: Global Oral Biologics & Biosimilars Market, Segmentation By Distribution Channel, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Table 7: Global Oral Biologics & Biosimilars Market, Split By Region, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Table 8: Global Oral Biologics & Biosimilars Market, Split By Country, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Table 9: Asia-Pacific, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Table 10: China, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Table 11: India, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Table 12: Japan, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Table 13: Australia, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Table 14: Indonesia, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Table 15: South Korea, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Table 16: Western Europe, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Table 17: UK, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Table 18: Germany, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Table 19: France, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Table 20: Eastern Europe, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Table 21: Russia, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Table 22: North America, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Table 23: USA, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Table 24: South America, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Table 25: Brazil, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Table 26: Middle East, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Table 27: Africa, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Table 28: Novartis Financial Performance
  • Table 29: Rani Therapeutics Financial Performance
  • Table 30: Eli Lilly and Co. Financial Performance
  • Table 31: AstraZeneca plc Financial Performance
  • Table 32: Novo Nordisk A/S Financial Performance

List Of Figures

    Figure 1: Global Historic Market Growth, 2016-2021, $ Billion
  • Figure 2: Global Forecast Market Growth, 2021-2026F, 2031F, $ Billion
  • Figure 3: Global Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Figure 4: Global Oral Biologics & Biosimilars Market, Segmentation By Disease, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Figure 5: Global Oral Biologics & Biosimilars Market, Segmentation By Molecule Type, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Figure 6: Global Oral Biologics & Biosimilars Market, Segmentation By Distribution Channel, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Figure 7: Global Oral Biologics & Biosimilars Market, Split By Region, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Figure 8: Global Oral Biologics & Biosimilars Market, Split By Country, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Figure 9: Asia-Pacific, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Figure 10: China, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Figure 11: India, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Figure 12: Japan, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Figure 13: Australia, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Figure 14: Indonesia, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Figure 15: South Korea, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Figure 16: Western Europe, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Figure 17: UK, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Figure 18: Germany, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Figure 19: France, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Figure 20: Eastern Europe, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Figure 21: Russia, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Figure 22: North America, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Figure 23: USA, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Figure 24: South America, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Figure 25: Brazil, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Figure 26: Middle East, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Figure 27: Africa, Oral Biologics & Biosimilars Market, Segmentation By Therapy, Historic and Forecast, 2016-2021, 2021-2026F, 2031F, $ Billion
  • Figure 28: Novartis Financial Performance
  • Figure 29: Rani Therapeutics Financial Performance
  • Figure 30: Eli Lilly and Co. Financial Performance
  • Figure 31: AstraZeneca plc Financial Performance
  • Figure 32: Novo Nordisk A/S Financial Performance
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