|Fastest Growing Market:||Asia Pacific|
|Largest Market:||North America|
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The biologics market is expected to grow at registering a CAGR of 9.22% during the forecast period, 2022-2027.
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 on 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 shortly.
The market is majorly driven by growing capital investment from key 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 (WHO) 2021, non-communicable diseases (NCDs) are causative of 41 million deaths yearly, equivalent to 71% of the total death rate. More than 15 million people die each year from non-communicable diseases between 30 and 69 years. About 85% of these "premature" deaths occur in low- and middle-income countries. Also, 77% of all non-communicable disease casualties are in low- and middle-income countries. Cardiovascular diseases account for most non-communicable disease deaths, or 17.9 million fatalities annually, followed by cancers (9.3 million), respiratory diseases (4.1 million), and diabetes (1.5 million). These growing cases of chronic diseases are expected to further increase the demand for biologics in treating chronic diseases.
There are also increasing investments that have helped in driving the overall market growth. In January 2021, Biocon Ltd reported that the Board of its subsidiary Biocon Biologics Ltd (“Biocon Biologics”) had approved a primary equity investment by Abu Dhabi-based ADQ (“ADQ”), one of the region’s largest holding companies. As per the terms of the proposed agreement, ADQ will invest Rs 555 Crore for a 1.80% minority stake in the biosimilar business, valuing Biocon Biologics at a post-money valuation of ~USD 4.17 billion. Such investment bolsters the market growth over the forecast period.
Additionally, rising research and development activity in biologics supports market growth. For instance, in March 2022, The TXBio Pilot Grant Program is a research initiative led by The University of Texas at Austin's College of Natural Sciences and Cockrell School of Engineering that focuses on the discovery, early development, and clinical translation of biological therapies developed across the university (UT Austin). TXBio (Texas Biologics) is funded by philanthropic gifts that are being used to improve the intellectual environment and infrastructure at UT Austin that is relevant to biologics discovery and translation.
Furthermore, product launches by the key market players are anticipated to drive market growth. For Instance, in October 2021, Cadila Pharmaceuticals (Cadila) launched two similar biologics onto the Indian market: NuPTH, a similar teriparatide biologic, and Cadalimab, a similar biologic of the auto-immune treatment adalimumab. Additionally, in May 2021, Amgen reported its partner AstraZeneca submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for tezepelumab, a potential first-in-class medicine in severe asthma.
Thus, all factors above are anticipated to drive the market growth over the forecast period. However, the stringent regulatory processes, high capital investment, and loss of patent exclusivity restrained market growth over the forecast period.
Scope of the Report
As per the scope of this report, the term biologic medicines refers to large, complex molecules 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 market report also covers the estimated market sizes and trends for 17 countries across major global regions. The report offers the market size and forecasts in value (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 increasing, and cancer therapies must be modified according to regional and national priorities. Biological therapy for cancer aims to induce the immune system to recognize and kill cancer cells.
The COVID-19 pandemic has disrupted cancer care, 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 the situation is expected to stabilize post-pandemic.
According to the Globocan Report 2020, around 19,292,789 new cancer cases have been reported globally, and 9,958,133 reported cancer deaths. Breast, lung, colorectum, and prostate cancers are majorly affecting cancers. 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. Biological therapy for cancer aims to induce the immune system to recognize and kill cancer cells.
The government of different countries is taking initiatives to increase awareness about cancer and its diagnosis so that it can be detected earlier. For instance, in February 2022, The Health Minister of Tamil Nadu, State of India, stated that the government of Tamil Nadu is indulged in framing the policy to identify 66% of cancer patients in the first and second stages by 2030 and thus proper treatment could be availed and hence such policies is expected to drive the growth of the market.
Market players are also continuously focusing on developing novel biologic therapeutics for cancer treatment and are investing in research and development activities. For instance, in May 2022, Biocon Biologics and Viatris (formerly Mylan) launched the cancer drug Bevacizumab under the brand name Abevmy in Canada. The Abevmy was developed by the two companies Biologics and Viatris. Hence, all these factors above 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 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, US-based companies 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 American Cancer Society, the United States recorded 1,806,590 new cancer cases and 606,520 cancer deaths in 2020. Furthermore, according to the National Cancer Institute, the number of cancer survivors is expected to rise to 22.2 million by 2030, up from 16.9 million in 2019. The most common cancers in the United States are breast, lung, prostate, colorectum, bladder, and skin cancer. Thus, rising cancer prevalence is anticipated to drive the demand for its treatment, thereby boosting the market growth.
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 strengthen 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 February 2022, The Janssen Pharmaceutical Companies of Johnson & Johnson received the U.S. Food and Drug Administration (FDA) has approved CARVYKTI (ciltacabtagene autoleucel; cilia-cel) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
- In June 2022, Aeglea BioTherapuetics announced that it had failed to secure a biologics license application (BLA) from the FDA after administrators issued a refusal to file for the company’s biologic pegzilarginase.
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 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
4.3.3 Loss of Patent Exclusivity of the Leading Biologic Drugs
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 by Value - USD Billion)
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
126.96.36.199 United States
188.8.131.52 United Kingdom
184.108.40.206 Rest of Europe
220.127.116.11 South Korea
18.104.22.168 Rest of Asia-Pacific
5.3.4 Middle East and Africa
22.214.171.124 South Africa
126.96.36.199 Rest of Middle East and Africa
5.3.5 South America
188.8.131.52 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 2019 - 2027.
What is the growth rate of Global Biologics Market?
The Global Biologics Market is growing at a CAGR of 9.22% 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 2021.
Who are the key players in Global Biologics Market?
Amgen, Inc., Eli Lilly and Company, GlaxoSmithKline PLC, Abbvie Inc., F. Hoffmann- La Roche AG are the major companies operating in Global Biologics Market.