The biopharmaceuticals market is expected to grow from US$ 3,29,966.22 million in 2022 to US$ 7,00,873.94 million by 2028; it is expected to grow at a CAGR of 13.4% from 2022 to 2028.
Rising applications in cancer therapeutics and potential to treat rare diseases are a few factors driving the biopharmaceuticals market growth.
North America is likely to continue its dominance in the biopharmaceuticals market during the forecast period. The US held the largest market share in this region in 2022. According to The International Trade Administration report, the US is the largest market for biopharmaceuticals accounting for approximately a third of the global biopharmaceutical market with pioneers in biopharmaceutical R&D. Also, the economic impact of the biopharmaceutical industry in the US economy is substantial. In 2018, over US$ 17 billion in biopharmaceutical exports were from most foreign-owned firms operating in the US. Moreover, in the same year, these majority foreign-owned firms spent ~US$ 20 billion on R&D.
On the other hand, Asia Pacific is expected to witness lucrative growth over the forecast period. This is due to China’s biopharmaceutical industry undergoing a tremendous shift evolving from a generics-focused to a thriving innovation hub. Additionally, promoting industrialization and growing application of novel drugs and high-end medical devices and techniques are a few factors responsible for the growth of the biopharmaceuticals market in China. For instance, in March 2022, CANbridge Pharmaceuticals Inc., a pioneer China-based biopharmaceutical company, announced that the Taiwan Food and Drug Administration (TFDA) had accepted the New Drug Application/Orphan Drug Registration (NDA/ODR) for "CAN108 [maralixibat oral solution (LIVMARLI TM)]" intended for treating cholestatic pruritus among patients suffering from Alagille syndrome (ALGS) for 1 year of age and older. Such aforementioned factors are responsible for influential growth of biopharmaceuticals market in Asia Pacific during 2022-2028.
Accelerated Clinical Trials
Accelerated progress of clinical trials will ultimately result in the development and commercialization of new drugs targeting rare as well as common inherited diseases. Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is an aggressive, acute leukemia that has been historically difficult to diagnose. Also, the disease is extremely rare?it impacts fewer than 1,000 patients in the US annually. In December 2018, Tagraxofusp became the first therapy approved for treating BPDCN, which then became the standard care method for treating these patients. During clinical trials, more than 90% of the patients who never received any treatment responded to therapy.
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that weakens muscles, impacts physical function, and causes irreversible brain and spinal cord damage. To date, only 2 products are approved for slowing the functional decline associated with ALS. The accelerated clinical trials for developing new products targeting ALS are in progress. For example, antisense oligonucleotides (ASOs) have been showing promising results in clinical trials involving patients suffering from ALS. Further, different gene therapy approaches, targeting multiple mutations in patients for both sporadic ALS and familial ALS, are also in clinical trials.
Thus, an extensive pipeline of biopharmaceuticals that are in clinical trials is expected to offer lucrative growth opportunities to the biopharmaceuticals market in the coming years.
Based on product type, the biopharmaceuticals market is segmented into monooclonal antibodies, recombinant vaccines, conventional vaccine, recombinant growth factors, purified proteins, recombinant proteins, recombinant hormones, recombinant enzymes, cell and gene therapies, cytokines/interferon/interleukins, and others (mRNA-based therapeutics, etc.). The monoclonal antibodies segment held the largest market share in 2022 and is anticipated to register a significant CAGR during the forecast period. Monoclonal antibodies (mABs) are at the forefront of the biological products market and will continue to lead resource investment in the biopharmaceutical market by providing innovative therapeutic solutions intended for immune oncology and immunotherapy. mABs treat multiple diseases such as cancer, organ transplant rejection, inflammatory and autoimmune diseases, allergies, infections, COVID-19, osteoporosis, eye disorders, migraines, high cholesterol, and nervous system disorders. There are many different mABs used to treat cancer. They work in different ways to kill or stop cancer cells from growing. They all have names that include "mab" at the end of their generic name?for example, trastuzumab (Herceptin) and rituximab (Mabthera). Approvals of monoclonal antibody therapies by the US Food and Drug Administration (FDA) have increased since the first drug containing monoclonal antibodies was approved for humans. A major benefit of monoclonal antibodies is that they have successfully been used to manufacture drugs to treat certain diseases, such as some cancers. Another benefit of monoclonal antibodies is that they are more accurate than other treatments. This improves effectiveness and can reduce some side effects. The quality of the monoclonal antibodies is standard for all production batches, which is important for both therapeutic use and diagnostics. Such aforementioned factors are responsible for the segment growth, thereby fueling the biopharmaceuticals market during the forecast period.
Based on application, the biopharmaceuticals market is segmented into oncology, inflammatory & infectious disease, autoimmune disorders, metabolic disorders, hormonal disorders & growth failure, cardiovascular diseases, neurological diseases, and others. The oncology segment held the largest share of the market in 2022; however, the inflammatory and infectious diseases segment is expected to register the highest CAGR during the forecast period. According to the National Institute of Health (NIH) report, cancer is a complex invasive genetic disease-causing significant mortality globally. For example, protein-based biopharmaceuticals have significantly extended the lives of millions of cancer patients. Further, various top companies entered a research collaboration for developing novel therapeutics-based targeted protein-based technology for cancer treatment. For instance, in April 2022, Ubix Therapeutics announced a collaboration with SK Biopharmaceuticals to develop new compounds and medicines through Ubix’s Degraducer technology for cancer treatment. Such aforementioned factors are responsible for the segment growth, thereby contributing to the market growth of biopharmaceuticals during the forecast period.
Food and Drug Administration, Japan External Trade Organization, Saudi Food and Drug Authority (SFDA), and American Hospital Association (AHA) are the primary and secondary sources referred to while preparing the report on the biopharmaceuticals market.