BIOPHARMACEUTICALS MARKET ANALYSIS

The global biopharmaceuticals market was valued at US$ 371.26 Bn in 2022 and is forecast to reach a value of US$ 654.76 Bn by 2030 at a CAGR of 7.4% between 2023 and 2030. The global biopharmaceuticals market is experiencing strong growth owing to the growing burden of chronic, infectious, and neurological diseases and growing geriatric population worldwide. Moreover, the outbreak of COVID-19 (pandemic) and increase in research and development (R&D) is expected to boost the growth of the market. However, factors such as high-end manufacturing requirements and stringent rules/regulations are expected to hamper the market growth.

Global Biopharmaceuticals Market: Regional Insights

Based on geography, the global biopharmaceuticals market is segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa.

Among regions, North America is expected to gain highest share in the market during the forecast period due to the growing burden of chronic diseases, increasing demand for biopharmaceuticals, increase in research and development, and well-established biopharmaceutical companies' in the region. For instance, with the rise in burden of chronic diseases, such as heart disease and cancer, the demand for safe and effective biopharmaceuticals is also increasing. According to the Centers for Disease Control and Prevention (CDC), heart disease is one of the leading cause of death in the U.S. One person dies every 34 seconds in the U.S. from cardiovascular disease.

Moreover, Europe and Asia Pacific are also expected to witness significant growth in the global biopharmaceuticals market owing to the increasing prevalence of chronic diseases, rise in demand for biopharmaceuticals, increase in research and development activities, and introduction of novel products in these regions. For instance, according to the Biotech-Report by the Boston Consulting Group for vfa bio, Germany continues to be the second largest producer of European Union (EU) approved active biopharmaceutical substances. Sales of biopharmaceuticals in 2020 increased by 14 percent from 2019, amounting to €14.6 billion.

Figure 1. Global Biopharmaceuticals Market Share (%), by Region, 2023

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Global Biopharmaceuticals Market Drivers:

Rise in patient pool to people the market growth

One of the key factors expected to augment the growth of the global biopharmaceuticals market during the forecast period is the growing burden of chronic, infectious, and neurological diseases an across the globe. Such a high burden of disease and rise in patient pool increase the demand for safe and effective biopharmaceuticals. According to the Alzheimer's Association, 2021 report, the Food and Drug Administration (FDA) approved five drugs, such as Rivastigmine, Galantamine, Donepezil, Memantine, and Memantine, to treat Alzheimer's. Such a high disease prevalence will increase demand for API over the coming years.

Growing geriatric population to drive market growth

Another factor which is driving the growth of the global biopharmaceuticals market is the growing geriatric population around the world. For instance, the share of older people in the population is gradually increasing. An increase in age means an increase in number and complexity of illnesses. Cardiovascular diseases, cancer, diabetes, dementia, diseases of the respiratory organs and cerebral perfusion are among the many ailments often associated with age. According to the World Health Organization (WHO), by 2030, one in six people in the world will be aged 60 years or over, and by 2050, the world’s population of people aged 60 years and older will double (2.1 billion).

Global Biopharmaceuticals Market Opportunities:

The outbreak of COVID-19 (pandemic) is expected to provide significant growth opportunities for players in the biopharmaceuticals market. For instance, in February 2022, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for a monoclonal antibody to treat COVID-19 that retains activity against the omicron variant. Bebtelovimab treats mild to moderate COVID-19 among adults and pediatric patients. It is also for those for whom alternative treatment options approved or authorized by the FDA are not accessible or clinically appropriate. In short, the pandemic had a positive impact on the market growth.

Increase in research and development (R&D) is expected to offer significant growth opportunities for players in the global biopharmaceuticals market. For instance, the ability of biopharmaceutical products to address previously untreatable conditions has paved the way for innovative drugs to be introduced to the market. In June 2022,  GSK Plc. announced that the U.S. FDA has approved Priorix (Measles, Mumps and Rubella Vaccine, Live) for active immunization for the prevention of measles, mumps and rubella (MMR) in people 12 months of age and older. Priorix is currently licensed in more than 100 countries worldwide.

Global Biopharmaceuticals Market Trends:

Acceptance of biopharmaceuticals is a recent trend

Biopharmaceuticals offer several benefits, fewer side effects, and the potential to cure the diseases instead of merely treat the symptom. Thus, the inclination towards biosimilars is slowly increasing. Moreover, the demand for biopharmaceuticals is increasing across the globe due to their low cost compared to biologic products. EMA has approved 86 biosimilar medicines since 2006. While, the US FDA has approved 33 biosimilars, 21 of which are commercially available in the market. This trend is expected to continue over the forecast period.

Rise in awareness among people is another trend

Biopharmaceuticals are the most sophisticated and elegant achievements of modern science. There is a need to educate both physicians and patients about the benefits of biopharmaceuticals as there is a lack of knowledge and awareness about biosimilars among patients. Many patients worldwide have never heard of biosimilars, and thus, there is a need to improve knowledge and awareness of biopharmaceuticals as well as the benefits of biosimilars. This trend is also expected to continue over the forecast period, driving the market growth.

Global Biopharmaceuticals Market Restraints:

High-end manufacturing requirements to hamper market growth

One of the key factors expected to hamper the growth of the global biopharmaceuticals market is the high-end manufacturing requirements. Biopharmaceuticals are challenging to manufacture and need specialized as well as expensive processing and purification methods. Their sensitivity to the environmental conditions also makes it difficult to develop their biosimilars, as a minor variation in the production process may significantly disrupt the safety and efficacy of the product. Thus, a control switch over every feature of the production process is vital for the manufacturing.

Stringent rules and regulations to hinder market growth

Another factor which is hampering growth of the global biopharmaceuticals market is the stringent rules and regulations and/or complicated and cumbersome regulatory requirements. The uncertain safety concerns involved with biopharmaceuticals triggered regulatory interests of the concerned authorities, after the introduction of biosimilars. Moreover, strict regulatory guidelines for both the clearance and approvals of these products are expected to slow down the process further. This in turn is restraining the growth of the market.    

Figure 2. Global Biopharmaceuticals Market Share (%), by Product Type, 2023

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Global Biopharmaceuticals Market Segmentation:

The global biopharmaceuticals market report is segmented into Product Type, Therapeutic Application, and Region.

Based on Product Type, the market is segmented into Monoclonal Antibodies, Recombinant Growth Factors, Purified Proteins, Recombinant Proteins, Recombinant Hormones, Vaccines, Recombinant Enzymes, Cell and Gene Therapies, Synthetic Immunomodulators, and Other Product Types. Out of which, Monoclonal Antibodies Segment is expected to dominate the biopharmaceuticals market during the forecast period and this is attributed to the rise in burden of cancer. Monoclonal antibodies find their application in the areas of cancer treatment

Vaccines Segment is also expected to witness significant growth in the near future and this is owing to the rise in patient pool and increasing demand for safe/effective vaccines.

Based on Therapeutic Application, the market is segmented into Oncology, Inflammatory and Infectious Diseases, Autoimmune Disorders, Metabolic Disorders, Hormonal Disorders, Cardiovascular Diseases, Neurological Diseases, and Other Diseases. Out of which, Oncology Segment is expected to dominate the market over the forecast period and this is attributed to the increasing prevalence of cancer around the world.

Cardiovascular Diseases Segment is also expected to witness robust growth in the near future and this is owing to increasing prevalence of cardiovascular diseases worldwide.

Global Biopharmaceuticals Market: Key Developments

In October 2022, Phanes Therapeutics, Inc. (Phanes) received clearance from the U.S. Food and Drug Administration (FDA) to commence Phase I studies with PT217, its anti-Delta-like ligand 3 (DLL3)/anti-Cluster of differentiation 47 (CD47) bispecific antibody being developed for patients with small cell lung cancer (SCLC) and other neuroendocrine cancers.

In May 2022, LOTTE purchased Bristol Myers Squibb's manufacturing facility in East Syracuse, New York. The East Syracuse site will serve as the LOTTE Center for North America Operations for LOTTE's new biologics contract development and manufacturing organization business.

In February 2022, Johnson and Johnson and its China-focused partner company Legend Biotech Corp developed a therapy to treat white blood cell cancer type approved by the US Food and Drug Administration (FDA). New therapies that aid in treating oncologic disorders.

In January 2022, Amgen collaborated with Generate Biomedicines to discover and create protein therapeutics for five clinical targets across several therapeutic areas and multiple modalities.

Global Biopharmaceuticals Market: Key Companies Insights

The global biopharmaceuticals market is highly competitive. This is attributed to the rise in burden of chronic, infectious, and neurological diseases across the globe, as a result, players in the market are focusing on launching novel products in the market.

Some of the key players in the global biopharmaceuticals market are Amgen Inc., Abbvie Inc., GlaxoSmithKline PLC, Pfizer Inc., Novo Nordisk AS, Novartis AG, Johnson & Johnson, Eli Lilly and Company, Bristol-Myers Squibb Company, and F. Hoffmann-La Roche Ltd., among others.

*Definition: A biopharmaceutical is a pharmaceutical drug manufactured in, extracted from, or semi-synthesized from biological sources. Biopharmaceuticals include a wide range of products such as vaccines, therapeutic proteins, blood, blood components, tissues, etc. Biopharmaceuticals are among the most sophisticated and elegant achievements of modern science.