Biobetters Market Size
| Study Period | 2019 - 2029 |
| Base Year For Estimation | 2023 |
| CAGR | 7.80 % |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | Medium |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Need a report that reflects how COVID-19 has impacted this market and its growth?
Biobetters Market Analysis
The Biobetters market is expected to grow with an anticipated CAGR of 7.8%, during the forecast period.
Patients suffering from various medical conditions were at high risk of getting severe illnesses as a result of COVID-19 infections during the pandemic. These conditions include diabetes, cancer, renal failure, and neurodegenerative disease. For instance, according to the data updated by CDC in May 2022, it was observed that people younger than 18 with COVID-19 infections were up to 2.5 times more likely to be newly diagnosed with diabetes in the months after infection. Thus, the increased risk of these medical conditions during the pandemic had a significant impact on the usage of biobetter medications. Moreover, according to an article published by SpringerLink in January 2022, experts around the world agreed that subcutaneous biobetters could play an important role during health emergencies, such as the COVID-19 pandemic. Thus, the COVID-19 pandemic impacted the market significantly during the initial phase. However, as the pandemic has subsided currently, the studied market is expected to have normal growth during the forecast period of the study. The major factors that are enhancing the market growth include superior therapeutic efficacy and lower adverse effects, comparatively easier and less costly manufacturing processes, non-patent and market exclusivity, longer product half-life, less dosing frequency, and high investment opportunities.
According to an article published by Elsevier in January 2022, biobetters are improved biological drugs that usually have better pharmacokinetics, and techniques such as glycosylation and PEGylation are the most common strategies to develop biobetters. The source also stated that innovative trends in genetic engineering are promising for biobetters development. Thus, the increasing advantages of biobetters along with the rising biobetter development techniques are expected to boost market growth.
Furthermore, according to an article published by PubMed Central in January 2022, biobetters are considered better than the original biologic in one or more parameters and it is estimated that with a proper target and a highly efficacious original biologic, the chances of a biobetter reaching the production stage are incredibly high. The source also mentioned that the duration of research and development of a biobetter is comparatively much shorter than an innovator molecule. Thus, the superior therapeutic efficacy of biobetters and the comparatively easier and less costly manufacturing processes are expected to boost market growth.
Moreover, the increasing developments regarding biobetters are also enhancing market growth. For instance, in April 2021, the European Medicines Agency (EMA) fully backed the use of Celltrion Healthcare's biobetter subcutaneous infliximab without initial intravenous loading doses. Securing the regulatory recommendation boosts Celltrion's efforts to outcompete Johnson & Johnson's Remicade and its biosimilar rivals.
Thus, the aforementioned factors such as the increasing advantages of biobetters along with the rising biobetter development techniques, the superior therapeutic efficacy of biobetters and the comparatively easier and less costly manufacturing processes, and the increasing developments by various organizations are expected to boost the market growth. However, high investment in research and development and increasing biosimilar competition are expected to impede market growth.
Biobetters Market Trends
Cancer Segment is Expected to Hold a Significant Market Share Over the Forecast Period
Cancer is a disease in which some of the body's cells grow uncontrollably and spread to other parts of the body. The increasing prevalence of cancer around the world and the rising research and development for better oncology drugs are the major factors that are expected to boost segment growth during the forecast period of the study.
For instance, according to an article published by the Chinese Medical Journal in March 2022, China was experiencing a greater incidence of cancers. In 2022 it was expected that there will be approximately 4,820,000 new cancer cases in China, in which the most common is lung cancer. Similarly, according to the data published by National Cancer Center Japan in June 2022, an estimated 1,019,000 new cases of cancer were expected in Japan in 2022, out of which 158,200 new cases of colon/rectum cancer, 132,100 cases of stomach cancer, 128,800 cases of lung/trachea cancer, 96,400 cases of prostate cancer, and 95,000 cases of breast cancer were expected. Thus, the high prevalence of cancer is expected to boost segment growth.
Furthermore, according to the bi-annual report published by the Indian Council of Medical Research (ICMR) in December 2022, the national average of cancer cases in 2022 in India was 100.4 per 100,000, with a large number of women (an estimated 105.4 per 100,000) being diagnosed with breast cancer. The source also stated an estimated 182,000 people are living with breast cancer in India and this is expected to reach 250,000 by 2030. Thus, due to the high burden of breast cancer in the country, the demand for biobetter drugs is expected to increase which will drive the growth of the studied market.
Moreover, according to the data published by the NIH in May 2022, the estimated research funding for Cancer in the United States was expected to increase from USD 7,362 million in 2021 to USD 7,644 million in 2022. Thus, the rising research and development expenses for cancer are expected to boost segment growth.
Hence, the aforementioned factors such as the rising prevalence of cancer and the rising research and development expenses for cancer are expected to enhance the segment growth during the forecast period of the study.
North America is Expected to Hold a Significant Market Share over the Forecast Period
North America is expected to be a significant region in the biobetters market owing to the increasing geriatric population coupled with the rising burden of chronic diseases such as cancer, diabetes, and genetic disorders among others; increasing research and development activities, and the presence of key players in the region.
According to the data published by Statistics Canada in July 2022, it is estimated that around 7,330,605 people are aged 65 years or older in Canada, and this accounts for 18.8% of the total population. Thus, as the geriatric population is more prone to chronic disease, the rising geriatric population is expected to rise the demand for medical biomimetics products, thereby driving market growth in the region.
The rising prevalence of various cancer in the region is stimulating the growth of the market. For instance, as per the Canada Cancer Society's statistics for 2022 around 6,700 Canadians were diagnosed with leukemia in 2021, out of which 4,000 were men and 2,700 were women. Also, as per the American Cancer Society's data for 2023, around 59,610 new cases of leukemia and 20,380 new cases of acute myeloid leukemia (AML) are expected to be diagnosed in the United States in 2023. Thus, the high incidence of cancer cases is leading to an increase in hemato oncology testing, thereby driving the market in the region.
Moreover, according to the data published by the NIH in May 2022, the estimated research funding for diabetes in the United States was expected to increase from USD 1,124 million in 2021 to USD 1,178 million in 2022. Thus, the rising research and development expenses for diabetes are expected to boost the market growth.
Additionally, the developments by key market players are also expected to boost the market growth in the region. For instance, in October 2021, Genentech announced that the United States FDA has approved Susvimo (ranibizumab injection) 100 mg/mL, a biobetter drug, for intravitreal use via ocular implant for the treatment of people with wet age-related macular degeneration (AMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections.
Hence, the aforementioned factors such as the rising prevalence of various chronic diseases and the rising research and development are expected to enhance the market growth in the region during the forecast period of the study.
Biobetters Industry Overview
The Biobetters market is highly competitive and consists of significant major players, that dominate the market. In terms of market share, a few of the major players are currently dominating the market. Some of the companies which are currently dominating the market are Amgen Inc., Novo Nordisk A/S, F. Hoffmann-La Roche AG, Merck & Co., Inc., Sanofi, Genentech, USA Inc., Eli- Lilly and Company, Biogen Inc., CSL Behring and Pfizer Inc. Most of these companies are involved in strategies such as investing in research and development, acquisitions and collaborations.
Biobetters Market Leaders
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Amgen Inc.
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Novo Nordisk A/s
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F.Hoffmann-La Roche AG
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Merck & Co., Inc.
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Biogen Inc.
*Disclaimer: Major Players sorted in no particular order
Biobetters Market News
- In January 2023, Celltrion Healthcare announced the submission of a biologics license application (BLA) for Remsima SC, a biobetter of the company's infliximab biosimilar (Remsima) that allows for subcutaneous administration.
- In December 2022, Japan's Ministry of Health, Labor and Welfare (MHLW) approved the anti-cancer agent/humanized anti-CD20 monoclonal antibody Gazyva (obinutuzumab) intravenous infusion, a biobetter drug, for an additional indication of CD20-positive chronic lymphocytic leukemia (including small lymphocytic lymphoma).
Biobetters Market Report - Table of Contents
1. INTRODUCTION
- 1.1 Study Assumptions and Market Definition
- 1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
- 4.1 Market Overview
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4.2 Market Drivers
- 4.2.1 Superior Therapeutic Efficacy and Lower Adverse Effects
- 4.2.2 Comparatively Easier and Less Costly Manufacturing Processes
- 4.2.3 Non- Patent and Market Exclusivity
- 4.2.4 Longer product Half-life and Less Dosing Frequency
- 4.2.5 High Investment Opportunities
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4.3 Market Restraints
- 4.3.1 High Investment in Research and Development
- 4.3.2 Increasing Biosimilar Competition
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4.4 Porter's Five Force Analysis
- 4.4.1 Threat of New Entrants
- 4.4.2 Bargaining Power of Buyers/Consumers
- 4.4.3 Bargaining Power of Suppliers
- 4.4.4 Threat of Substitute Products
- 4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Market Size by Value - USD million)
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5.1 By Drug Class
- 5.1.1 Erythropoietin Biobetters
- 5.1.2 Insulin Biobetters
- 5.1.3 G-CSF Bioreactors
- 5.1.4 Monoclonal Antibodies Biobetters
- 5.1.5 Anti-Haemophilic Factor
- 5.1.6 Other Biological Drug Biobetters
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5.2 By Application
- 5.2.1 Cancer
- 5.2.2 Diabetes
- 5.2.3 Renal Disease
- 5.2.4 Neurodegenerative Disease
- 5.2.5 Genetic Disorders
- 5.2.6 Others
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5.3 By Route of Administration
- 5.3.1 Subcutaneous
- 5.3.2 Oral
- 5.3.3 Inhaled
- 5.3.4 Intravenous
- 5.3.5 Others
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5.4 By Distribution Channel
- 5.4.1 Hospital Pharmacies
- 5.4.2 Retail Pharmacies
- 5.4.3 Online Pharmacies
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5.5 Geography
- 5.5.1 North America
- 5.5.1.1 United States
- 5.5.1.2 Canada
- 5.5.1.3 Mexico
- 5.5.2 Europe
- 5.5.2.1 Germany
- 5.5.2.2 United Kingdom
- 5.5.2.3 France
- 5.5.2.4 Italy
- 5.5.2.5 Spain
- 5.5.2.6 Rest of Europe
- 5.5.3 Asia Pacific
- 5.5.3.1 China
- 5.5.3.2 Japan
- 5.5.3.3 India
- 5.5.3.4 Australia
- 5.5.3.5 South Korea
- 5.5.3.6 Rest of Asia-Pacific
- 5.5.4 Middle East and Africa
- 5.5.4.1 GCC
- 5.5.4.2 South Africa
- 5.5.4.3 Rest of Middle East and Africa
- 5.5.5 South America
- 5.5.5.1 Brazil
- 5.5.5.2 Argentina
- 5.5.5.3 Rest of South America
6. COMPETITIVE LANDSCAPE
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6.1 Company Profiles
- 6.1.1 Amgen Inc.
- 6.1.2 Novo Nordisk A/S
- 6.1.3 F. Hoffmann-La Roche AG
- 6.1.4 Merck & Co. ,Inc.
- 6.1.5 Sanofi
- 6.1.6 Genentech, USA Inc.
- 6.1.7 Eli Lilly and Company
- 6.1.8 Biogen Inc.
- 6.1.9 CSL Behring
- 6.1.10 Pfizer Inc
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
** Subject To AvailablityBiobetters Industry Segmentation
As per the scope of the report, biobetters, also known as biosuperiors, are recombinant protein drug from the same class of an existing biopharmaceutical, however not identical and are superior to the original. It is not completely a new drug and also not the generic version of an existing drug. It is a biological product developed with an intention to improve the clinical efficacy, enhancing tolerability and reducing the dosing/administration frequency. Biobetters are the upgraded versions of the existing biologics. The Biobetters market is segmented by Drug Class (Erythropoeitin Biobetters, Insulin Biobetters, G- CSF Biobetters, Monoclonal Antibodies Biobetters, Anti-Haemophlic factor and Other Biological Drug Biobetters), Application (Cancer, Diabetes, Renal Disease, Neurodegenerative Disease, Genetic Disorders, and Others), Route of Administration (Subcutaneous, Oral, Inhaled, Intravenous, and Others), Distribution Channel (Hospital Pharmacies, Retail Pharmacies, and Online Pharmacies) and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The market report also covers the estimated market sizes and trends for 17 different countries across major regions, globally. The report offers the value (in USD million) for the above segments.
| By Drug Class | Erythropoietin Biobetters | |
| Insulin Biobetters | ||
| G-CSF Bioreactors | ||
| Monoclonal Antibodies Biobetters | ||
| Anti-Haemophilic Factor | ||
| Other Biological Drug Biobetters | ||
| By Application | Cancer | |
| Diabetes | ||
| Renal Disease | ||
| Neurodegenerative Disease | ||
| Genetic Disorders | ||
| Others | ||
| By Route of Administration | Subcutaneous | |
| Oral | ||
| Inhaled | ||
| Intravenous | ||
| Others | ||
| By Distribution Channel | Hospital Pharmacies | |
| Retail Pharmacies | ||
| Online Pharmacies | ||
| Geography | North America | United States |
| Canada | ||
| Mexico | ||
| Geography | Europe | Germany |
| United Kingdom | ||
| France | ||
| Italy | ||
| Spain | ||
| Rest of Europe | ||
| Geography | Asia Pacific | China |
| Japan | ||
| India | ||
| Australia | ||
| South Korea | ||
| Rest of Asia-Pacific | ||
| Geography | Middle East and Africa | GCC |
| South Africa | ||
| Rest of Middle East and Africa | ||
| Geography | South America | Brazil |
| Argentina | ||
| Rest of South America |
Biobetters Market Research FAQs
What is the current Biobetters Market size?
The Biobetters Market is projected to register a CAGR of 7.80% during the forecast period (2024-2029)
Who are the key players in Biobetters Market?
Amgen Inc., Novo Nordisk A/s, F.Hoffmann-La Roche AG, Merck & Co., Inc. and Biogen Inc. are the major companies operating in the Biobetters Market.
Which is the fastest growing region in Biobetters Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).
Which region has the biggest share in Biobetters Market?
In 2024, the North America accounts for the largest market share in Biobetters Market.
What years does this Biobetters Market cover?
The report covers the Biobetters Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Biobetters Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
Biobetters Industry Report
Statistics for the 2024 Biobetters market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Biobetters analysis includes a market forecast outlook to 2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.
