Report

The Biopharmaceuticals Market size is estimated at USD 516.79 billion in 2024, and is expected to reach USD 761.80 billion by 2029, growing at a CAGR of 8.07% during the forecast period (2024-2029).

The COVID-19 pandemic had a significant impact on the biopharmaceutical industry. Most biopharmaceutical companies strived extensively to develop vaccines against the SARS-CoV-2 virus. For example, in April 2021, Mission COVID Suraksha was announced by the Government of India to accelerate the development and production of indigenous COVID vaccines, which the Department of Biotechnology implemented.

The production capacity of Covaxin increased from 1 crore vaccine doses in April 2021 to 6-7 crore vaccine doses per month between July/August 2021. Also, it will reach nearly ten crore doses per month during September 2021. On the other hand, in June 2022, Pfizer announced its commitment to US manufacturing with a USD 120 million investment at its Kalamazoo (Michigan) facility, enabling United States-based production for its COVID-19 oral treatment, PAXLOVID (nirmatrelvir [PF-07321332] tablets and ritonavir tablets).

The investment represents yet another significant step in Pfizer's initiative to expand the amount of critical biopharmaceutical manufacturing in the US, enhancing Pfizer's capacity to manufacture and provide treatments and medications for patients in the US and around the world. Similarly, in August 2021, the Government of Canada announced an agreement with leading COVID-19 vaccine developer Moderna, Inc. to build an mRNA vaccine facility in Canada. The goals of the recently unveiled biomanufacturing and life science strategy were in line with Moderna's aspirations to build an mRNA vaccine manufacturing facility in Canada. The action will improve Canada's overall industrial competence and boost the whole value chain of the biomanufacturing and life sciences industry, from talent acquisition and retention to greater clinical trial capacity. The increased interest in manufacturing COVID-19 vaccines has significantly added to the growth of the biopharmaceutical market during the COVID-19 pandemic.

Factors like increasing acceptance of and huge market demand for biopharmaceuticals and the biopharmaceuticals' ability to treat previously untreatable diseases are driving the market's growth. According to the Alzheimer's Association 2021 report, the US Food and Drug Administration (FDA) approved five drugs for treating Alzheimer's. They are rivastigmine, galantamine, donepezil, memantine, and memantine, combined with donepezil. As per the same source, the vast majority of people who develop Alzheimer's dementia are 65 years and above. It is called late-onset Alzheimer's.

In the US, nearly 5.3% of people aged 65 to 74 years, 13.8% of people aged 75 to 84 years, and 34.6% of people aged 85 years or above have Alzheimer's dementia. Additionally, 6.2 million Americans aged 65 years and above are living with Alzheimer's dementia in 2021 and projected to reach 13.5 million by 2050. Such a higher disease prevalence will bolster the demand for API among the patient population over the coming years.

The biopharmaceutical products' capability to address previously untreatable conditions has paved the way for introducing innovative drugs in the market. For instance, in September 2022, bluebird bio, Inc.'s SKYSONA (elivaldogene autotemcel) slows the progression of neurologic dysfunction in boys 4-17 years of age with early, active cerebral adrenoleukodystrophy (CALD), was approved by CBER. Similarly, in June 2022, CBER approved PRIORIX, a live vaccine for measles, mumps, and rubella, manufactured by GSK plc.

Also, 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 will add to the market growth over the forecast period.

However, high-end manufacturing and complicated and cumbersome regulatory requirements will hinder market growth over the forecast period.

Biopharmaceutical Market Trends

Monoclonal Antibodies is Expected to Witness High Growth Over the Forecast Period

Monoclonal antibodies (also called moAbs or mAbs) are proteins made in laboratories that behave like the antibodies in our systems. The successful use of monoclonal antibodies and antibody derivatives in therapeutics is the primary driver for the rapid growth of the studied segment. The therapeutic applications of monoclonal antibodies include cancer, rheumatoid arthritis, multiple sclerosis, and cardiovascular diseases.

Growing approvals, clinical trials, and increasing research expenditure are critical factors in this segment's growth. In October 2022, PT217, a bispecific anti-Delta-like ligand 3 (DLL3)/anti-Cluster of Differentiation 47 (CD47) antibody, was developed by Phanes Therapeutics, Inc. It is a clinical-stage biotech company focused on oncology for patients with small cell lung cancer (SCLC) and other neuroendocrine cancers. It received Phase 1 clearance from the US Food and Drug Administration (FDA). Additionally, the growing FDA approvals and new product launches for various indications will drive the segment. For instance, in February 2022, the US Food and Drug Administration issued an Emergency Use Authorization (EUA) for a new monoclonal antibody to treat COVID-19 that retains activity against the omicron variant. The EUA for bebtelovimab treats mild to moderate COVID-19 among adults and pediatric patients with a positive COVID-19 test who are at high risk for progression to severe COVID-19, including hospitalization or death. It is also for those for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.

Thus, the monoclonal antibodies segment will witness significant growth over the forecast period due to the abovementioned factors.

North America is Expected to Dominate the Biopharmaceuticals Market

The growing burden of chronic diseases and increasing investments in research and development activities in the US are the major factors driving the biopharmaceuticals market in North America. The US market for biopharmaceuticals will grow due to increasing chronic disease incidences, well-established biopharmaceutical companies' presence, and an increase in biotech companies. The rising geriatric population and increased research and developments in the country also drive market growth.

In addition, the Centers for Disease Control and Prevention's (CDC) data updated in July 2022 shows that coronary heart disease is the most common type of heart disease, and approximately 20.1 million adults of age 20 and older suffer from the ailment in the US. Additionally, per the CDC data, every 40 seconds, someone suffers from a heart attack, and nearly 805,000 people in the US have a heart attack annually. Thus, the high burden of cardiovascular diseases demands the availability of advanced drugs for treatment.

In May 2022, Eli Lilly and Company announced an investment of USD 2.1 billion to expand its manufacturing footprint in Indiana, US. Similarly, 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 (CDMO) business in the US.

Thus, given the factors mentioned above, the studied market is expected to grow significantly in North America over the forecast period.

Biopharmaceutical Industry Overview

The biopharmaceuticals market is fragmented in nature due to the presence of several companies operating. The competitive landscape includes analyzing a few well-known international and local companies that hold market shares and are famous, including Amgen Inc., Eli Lily and Company, Johnson and Johnson, Sanofi SA, AstraZeneca PLC, and Pfizer Inc., among others.

In March 2022, BioNTech SE reported the expansion of its strategic collaboration with Regeneron to advance the Company's FixVac candidate BNT116 in combination with Libtayo (cemiplimab), a PD-1 inhibitor, in advanced non-small cell lung cancer (NSCLC). Under the terms of the agreement, the companies plan to jointly conduct clinical trials to evaluate their combination in different patient populations with advanced NSCLC.

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