|Fastest Growing Market:||Asia Pacific|
|Largest Market:||North America|
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The biologics market was valued at approximately USD 302.63 billion in 2020, and it is expected to reach USD 509.23 billion by 2026, registering a CAGR of 9.06% during the forecast period, 2021-2026.
With the growing COVID-19 burden, there has been a huge demand for biologics during the pandemic, which may drive the market growth. For instance, in May 2020, the National Research Council of Canada and China-based CanSino Biologics collaborated for the clinical development of a COVID-19 vaccine in Canada. The vaccine, known as Ad5-nCoV, is an adenovirus Type 5 vector-based vaccine currently in Phase II development in Wuhan, China. Thus, extensive research and development activities taking place on biologics for the treatment of COVID-19 are expected to drive the growth of the biologics market in the near future.
The market is majorly driven by growing capital investment from the key market players, the rise in the burden of chronic diseases, loss of patent exclusivity of the leading biologic drugs, and growing demand and higher acceptability for innovative therapies.
According to the World Health Organization statistics 2018, globally, chronic diseases kill more than 41 million people each year. Cardiovascular diseases account for most chronic disease deaths, or 17.9 million people annually, followed by cancers (9 million), respiratory diseases (3.9 million), and diabetes (1.6 million). These four groups account for 80% of all chronic disorder deaths. Tobacco use, physical inactivity, alcohol consumption, and unhealthy diets create a risk of dying from non-communicable diseases. Also, the rising geriatric population is much susceptible to chronic diseases, which helps in increasing the biologics demand.
Biologic drugs are used in the treatment of major chronic diseases, notably cancer and autoimmune diseases, which has enabled big pharmaceutical companies, like Eli Lilly and Company, Bristol-Myers Squibb, Novartis, AstraZeneca, and GlaxoSmithKline (GSK), to invest in these products. In 2019, three biological drugs were approved by the United States Food and Drug Administration (FDA), one of which is an anticoagulant solution by Griffons.
There are also increasing investments that have helped in driving the overall market growth. Novartis AG invested around USD 700 million in its biologics facility in Singapore, and Bristol-Myers Squibb invested nearly USD 900 million in an Irish large-scale biologics facility which was expected to be completed by 2019.
Furthermore, biologics prove efficient in treating rheumatoid arthritis and Crohn’s disease, which boosts the market even further.
Scope of the Report
As per the scope of this report, the term biologic medicines refers to large, complex molecules that are made in living cells grown in a laboratory. Biologic medicines are often 200 to 1,000 times the size of a small molecule or chemical drug. Due to their large molecular size and fragile molecular structure, biologic medicines are majorly delivered through parenteral routes. The biologics market is segmented by product (monoclonal antibodies, vaccines, recombinant hormones/proteins, cellular-based biologics, gene-based biologics, and other products), application (cancer, infectious diseases, autoimmune diseases, and other applications), and geography (North America, Europe, Asia-Pacific, Middle-East and Africa, and South America). The report offers values (in USD billion) for the above segments.
Key Market Trends
The Cancer Segment is Expected to Dominate the Application Segment Over the Forecast Period
The cancer burden is found increasing, and cancer therapies must be modified according to regional and national priorities. The goal of biological therapy for cancer is to induce the immune system to recognize and kill cancer cells.
The COVID-19 pandemic has been found to disrupt cancer care, including delaying diagnoses and treatment and halting clinical trials. Furthermore, the healthcare systems are rapidly reorganizing cancer services to ensure that patients continue to receive essential care while minimizing exposure to SARS-CoV-2 infection. This has had a slightly negative impact, but post-pandemic, the situation is expected to get stabilized.
According to the Globocan Report 2020, globally, there are 19,292,789 new cancer cases that have been reported and 9,958,133 reported cancer deaths. The majorly affecting cancers are breast cancer, lung cancer, colorectum cancer, and prostate cancer. Biological therapy is used in the treatment of many types of cancers to prevent or slow tumor growth and prevent the spread of cancer. Biological therapy often causes fewer toxic side effects than other cancer treatments. The goal of biological therapy for cancer is to induce the immune system to recognize and kill cancer cells.
Market players are also continuously focusing on the development of novel biologic therapeutics for the treatment of cancer and are investing in research and development activities. For instance, in August 2019, Dr Reddy’s Laboratories launched its bevacizumab ‘similar biologic’, Versavo (DRZ_BZ), in India. Bevacizumab is a humanized monoclonal antibody used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney, and ovarian. Hence, all these aforementioned factors have helped in the growth of the cancer segment of the market.
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North America Holds the Largest Market Share and is Believed to Follow the Same Trend over the Forecast Period
The North American healthcare biologics market has dominated the global market, and it is estimated to show a similar trend during the forecast period. The primary factors driving the market are the increasing incidences of chronic diseases, the presence of well-established pharmaceutical companies, and an increase in the number of biotech companies.
With the rising COVID-19 pandemic, there are US-based companies that are racing to develop vaccines against COVID-19. For instance, in March 2020, a Phase 1 clinical trial began at Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle to evaluate an investigational vaccine designed to protect against COVID-19. The vaccine is being developed by NIAID scientists and their collaborators at the biotechnology company Moderna Inc.
According to the estimates of the American Cancer Society, in 2018, an estimated 1,735,350 new cancer cases were diagnosed, and 609,640 people succumbed to cancer in the United States. The most common cancers in the United States are breast cancer, lung cancer, prostate cancer, colorectum cancer, bladder cancer, and skin cancer.
In August 2020, Biocon Biologics India, a fully integrated biosimilars company and a subsidiary of Biocon Ltd, and Mylan NV announced the US launch of Semglee (insulin glargine injection). Hence, all these factors are found to boost the overall market growth in the region.
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The biologics market is moderately competitive and consists of several major players. The companies are implementing certain strategic initiatives such as mergers, new product launches, acquisitions, and partnerships that help them in strengthening their market positions. These companies have made huge capital investments in the research and development of biologics as the cost of biologics is quite high.
In August 2021, Moderna, Inc. announced that it has completed the rolling submission process for its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the full licensure of the Moderna COVID-19 Vaccine for active immunization to prevent COVID-19 in individuals 18 years of age and older.
In August 2021, Pfizer Inc.and BioNTech SE announced the initiation of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the approval of a booster (third) dose of COMIRNATY (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older.
Table of Contents
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
4.2 Market Drivers
4.2.1 Growing Capital Investment from Key Market Players
4.2.2 Rise in the Prevalence of Chronic Diseases
4.2.3 Loss of Patent Exclusivity of the Leading Biologic Drugs
4.2.4 Growing Demand and Higher Acceptability for Innovative Therapies
4.3 Market Restraints
4.3.1 Stringent Regulatory Process and Initial High Capital Investment
4.3.2 Rising Control and Cost for Accessing Biologics
4.4 Porter's Five Forces 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 in Value)
5.1 By Product
5.1.1 Monoclonal Antibodies
5.1.3 Recombinant Hormones/Proteins
5.1.4 Cellular-based Biologics
5.1.5 Gene-based Biologics
5.1.6 Other Products
5.2 By Application
5.2.2 Infectious Diseases
5.2.3 Autoimmune Diseases
5.2.4 Other Applications
5.3.1 North America
188.8.131.52 United States
184.108.40.206 United Kingdom
220.127.116.11 Rest of Europe
18.104.22.168 South Korea
22.214.171.124 Rest of Asia-Pacific
5.3.4 Middle East and Africa
126.96.36.199 South Africa
188.8.131.52 Rest of Middle East and Africa
5.3.5 South America
184.108.40.206 Rest of South America
6. COMPETITIVE LANDSCAPE
*List Not Exhaustive
6.1 Company Profiles
6.1.1 AbbVie Inc.
6.1.2 Amgen Inc.
6.1.3 Eli Lilly and Company
6.1.4 F. Hoffmann-La Roche AG
6.1.5 GlaxoSmithKline PLC
6.1.6 Johnson & Johnson
6.1.7 Merck & Co.
6.1.8 Pfizer Inc.
6.1.9 Sanofi SA
6.1.10 Bayer AG
6.1.11 AstraZeneca PLC
6.1.12 Novartis AG
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
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Frequently Asked Questions
What is the study period of this market?
The Global Biologics Market market is studied from 2018 - 2026.
What is the growth rate of Global Biologics Market?
The Global Biologics Market is growing at a CAGR of 9.06% over the next 5 years.
Which region has highest growth rate in Global Biologics Market?
Asia Pacific is growing at the highest CAGR over 2021- 2026.
Which region has largest share in Global Biologics Market?
North America holds highest share in 2020.
Who are the key players in Global Biologics Market?
AbbVie Inc., Amgen, Inc., Eli Lilly and Company, F. Hoffmann-La Roche AG, GlaxoSmithKline PLC are the major companies operating in Global Biologics Market.