Biopharmaceuticals Market Size & Share Analysis - Trends, Drivers, Competitive Landscape, and Forecasts (2024 - 2030)

Biopharmaceuticals Market Data

The biopharmaceuticals market was valued at $448.1 billion in 2023, and it is expected to grow at a CAGR of 7.6% during 2024-2030, to reach $745.1 billion by 2030.

With the growing incidence of chronic diseases like CVD, cancer, and diabetes, the demand for biological drugs is rising. Also, the growing aging population, the prevalence of associated health issues, and the booming demand for advanced biologic drugs are projected to generate a healthy growth environment for market players.

Moreover, the growing clinical trials and high investments by businesses in R&D activities on novel biologics and biosimilars are anticipated to increase the growth of the industry during the forecast period. The rising number of registrations for bio-based pharmaceutical products for clinical testing and, specifically those created by novel manufacturing technologies and platforms, is further projected to fuel the growth of the market.

Biopharmaceuticals Market Trends & Drivers

Increasing R&D and Therapeutic Acceptance of Bio-Based Drugs Drive Market

• Since biosimilars for anti-TNF products were introduced, average prices in Europe have decreased by approximately 8%, while biosimilars for erythropoietin and G-CSF have decreased by 33–34%. This has contributed to the widespread acceptance of biopharmaceuticals. Moreover, the safety and effectiveness of bio-based drugs have led to their swift adoption by individuals.
• Furthermore, various businesses and organizations are focusing on R&D associated with biological pharmaceuticals. The number of New Drug Applications (NDAs)/Biologic License Applications (BLAs) registered per year has increased significantly.
• With the rising prevalence of neurological disorders, cancer, and infectious diseases, biopharmaceuticals are becoming more significant. Moreover, they are used for the neurodegenerative disorder treatments, many of which require bio-medicines to be administered directly into the brain, which is not possible with traditional synthetic agents. Also, the technical advancements in bio-based drugs have aided increase the chances of survival for patients of cancer, cure hepatitis, help in the recovery of patients with arthritis, and transform treatment options for many other diseases.

High-End Manufacturing Requirements

• Biopharmaceuticals are challenging to manufacture and need specialized and expensive processing and purification procedures. Their environmental sensitivity conditions also make it problematic to develop their , as a minor variation in the manufacture procedure may disrupt the safety and efficacy of the final product significantly. Hence, a control switch over each feature of the production process is vital for the manufacturing of biopharmaceuticals.
• The technical complications relating to the production are partially responsible for the availability of so few biosimilars, as it is extremely difficult to replicate an inventor’s manufacturing process and produce an equivalent product. The technology for biopharmaceutical development is still not yet well established.
• Unlike conventional pharmaceuticals, biopharmaceuticals are manufactured using living biological systems. Due to this, biopharmaceutical manufacturing requires specialized equipment and devices, like incubators that can support these biological systems. Also, biopharmaceuticals are complex mixtures of large and intricate molecules, which cannot be fully characterized using existing analytical methods. Due to the variability in the manufacturing process, it is not possible to produce two identical products.
• The cost of equipment used for biopharmaceutical production is quite high, as compared to regular manufacturing equipment. Additionally, most of the biopharmaceuticals require custom-built manufacturing equipment and highly specialized personnel to operate them. Due to these high-end manufacturing requirements, the resources and time required to set up a biopharmaceutical manufacturing facility are very high, which makes scaling tough.
• Biopharmaceutical production facilities also require a long time to begin the manufacturing process, considering all the regulatory standards that are expected to be met by these manufacturing facilities. Hence, the high-end manufacturing requirements are currently acting as huge restraints for the growth of the market studied.
• Production costs are looming large in management planning. For instance, large-scale biotech-manufacturing facilities require USD 200 million to USD 500 million, and around four to five years to build, which is impeding the progression of the industry. Moreover, the costs of drug development more than doubled over the past decade, owing to increased clinical trial complexity and the high failure rates for drugs tested in earlier phases of clinical studies.
• Biopharmaceutical entities are also characterized by the process of manufacturing them, due to their origin and complexity, at least by the regulators. This has an immense cost impact, as the processes are frozen at the very early stage of clinical trial lot production. Thus, process development is essential in transforming the R&D process into a manufacturing process. These high-end manufacturing processes act as restraining factors for market growth.
• Product competition, patent expirations, the introduction of second-generation therapeutics, and pricing constraints are forcing scrutiny of the economics of bringing drugs to the market. Thus, to keep pace, biopharmaceutical companies are anticipated to revisit and fundamentally reassess various strategies, techniques, and operational approaches they are using currently.
• Hence, the high cost of production of biopharmaceutical products adds up to the overall cost of biopharmaceutical products, which will be quite difficult to access and afford in some of the low- and middle-income countries, such as India, Argentina, Iran, and Iraq. Thus, the aforementioned factors are expected to be major limiting factors for the growth of the market studied.

In-Depth Segmentation Analysis

Product Type Insight

• In 2023, monoclonal antibodies’ share was the largest, at 35%, and this category will show a CAGR, of around 7.2%, over the forecast period.
• mAbs are the most-important class of biologics, which account for more than 20% of all the therapeutic candidates authorized by the Food and Drug Administration. Among the approved biologics in 2021, more than 15 were mAbs.
• Several mAbs have been approved for anti-cancer, anti-inflammatory, and other therapeutic applications. Specifically, due to their extensive use in cancer treatment, they are becoming prevalent in developed countries, such as the U.S. and the U.K. In the same way, the demand for anti-inflammatory mAbs is growing at a good pace. These agents are either used for monotherapy or in combination with conventional therapies.
• Moreover, pharma R&D investments are increasing due to the growing demand for prevention, treatment, and complete curative options for various diseases. Many pharmaceutical companies are focusing on developing more-effective products to treat life-threatening diseases and allow patients to live healthier lives with reduced disabilities. The increasing healthcare investments around the world are essentially propelling the increase in R&D activities, which is fueling the count of bio-based pharma products available around the world.
• Moreover, cytokines and interferons (IFNs) have opened a new era of biological therapies for neoplastic disorders, infectious diseases, and multiple sclerosis. Instead of directly acting on molecular and cellular targets, such as neoplastic cell receptors, or inhibiting occult cell growth or function, these agents mediate their biological effects indirectly, through several immunological and other cells, or accessory proteins.
• Cytokines have drawn immense interest from the pharmaceutical industry over the last two decades. Great effort has been devoted to finding ways to reproduce their effects or block their activity, in the quest to create novel drugs for cancer, infectious diseases, and inflammatory and autoimmune disorders.

Product types covered in the report include:

• Monoclonal Antibodies (Largest Category)
• Recombinant Growth Factors
• Purified Proteins
• Recombinant Proteins
• Recombinant Hormones
• Vaccines
• Recombinant Enzymes
• Cell and Gene Therapies (Fastest-Growing Category)
• Synthetic Immunomodulators
• Others

Therapeutic Application Assessment

• Oncology held the largest share of around 40% in 2023. In recent years, biopharmaceuticals have been dominant in cancer trials, compared to trials for non-cancer conditions. Biopharma firms have been investing billions in the development of new therapies and working with academic medical research centers, nonprofit organizations, and patient advocacy groups on cancer research, due to the widespread incidence of this disease.
• Furthermore, pharmaceutical and biotech firms are investing intensively in oncology research and pursuing completely new approaches, such as bi- and multi-specific antibodies, glycol-modified antibodies, antibody-drug conjugates (ADCs), mRNA- and DNA-based approaches, oncolytic viruses, and cell therapies. Hence, the rising number of cancer cases and increasing number of approvals help the overall market grow.
• Cell and gene therapies are expected to be the fastest-growing category. There have been many advancements in this field, representing cutting-edge research, which is being employed in clinical trials across a range of therapeutic areas, including cell and gene therapies and targeted therapies, such as precision medicine.
• Moreover, government support for clinical trials and fast drug candidate approvals are expected to improve the biopharmaceuticals market outlook by boosting the shift in the focus of bio-based pharma companies toward cell and gene therapies.
• Developed countries, such as the U.S., Canada, Australia, and the U.K., spend a large portion of their GDP on healthcare. In these economies, the cost of and demand for healthcare are growing rapidly; thus, researchers are extracting cells, proteins, and genetic material (DNA) from patients (or donors) and altering them to provide a highly personalized therapy.
• In recent years, the U.S., the U.K., and other advanced European economies have pursued advancements in and rise in the sale of biologics to reduce the cost of therapeutics and improve health services. Moreover, China, Japan, and India are significant countries extracting cells, proteins, and DNA from patients and donors and altering them to provide a highly personalized therapy.

The following therapeutic applications are included in the report:

• Oncology (Largest and Fastest-Growing Category)
• Inflammatory And Infectious Diseases
• Autoimmune Disorders
• Metabolic Disorders
• Hormonal Disorders
• Cardiovascular Diseases
• Neurological Diseases
• Others

Regional Assessment

In 2023, North America was dominant, with a global revenue share of around 45%, owing to the high R&D investments, growing adoption of technologically advanced solutions, presence of global players, and their efforts to come up with newer patents. The U.S. holds the major share in this region, which is followed by Europe and Asia-Pacific.

With the evolution of biotechnology and conventional pharma sciences, the awareness regarding the best treatments with lower side effects has also increased. The U.S. leads the global biopharmaceutical R&D list with more than 150,000 studies conducted since 2008, because of the prominence and size of its pharmaceutical sector. Within the country, California accounts for the most studies, in part, because of its robust tech industry and desire for innovation.

Moreover, the U.S. biopharmaceuticals industry has produced more than half the world’s new molecules over the last decade, because of the well-supported intellectual property framework, investments, and government initiatives.

Thus, biopharmaceuticals market sales have shown incredible growth over the past several years in the U.S. The country has been recognized as the innovation capital of the world for life sciences, and its government has put in capital investments since the early stages of pharmaceutical companies. Moreover, it is the biggest investor in healthcare due to its sizable population, established network of researchers, and expansive healthcare industry.

Regarding medical costs, the U.S. has a free-pricing marketing system. The U.S. prices of biologics are comparatively higher than in other countries, which allows biopharma firms to put in the high R&D funds on these drugs.

Further, regions and countries analyzed for this report include:

• North America (Largest Regional Market)
  • U.S. (Larger and Faster-Growing Country Market)
  • Canada
• Europe
  • Germany (Largest Country Market)
  • U.K. (Fastest-Growing Country Market)
  • France
  • Italy
  • Spain
  • Rest of Europe
• Asia-Pacific (APAC) (Fastest-Growing Regional Market)
  • China (Largest Country Market)
  • Japan
  • India (Fastest-Growing Country Market)
  • South Korea
  • Australia
  • Rest of APAC
• Latin America (LATAM)
  • Brazil (Largest Country Market)
  • Mexico (Fastest-Growing Country Market)
  • Rest of LATAM
• Middle East and Africa (MEA)
  • Saudi Arabia (Largest Country Market)
  • South Africa
  • U.A.E. (Fastest-Growing Country Market)
  • Rest of MEA

Market Nature - Consolidated

• The biopharmaceuticals market is characterized by intense competition among large multinational corporations, mid-sized companies, and emerging biotech firms. Key factors driving competition include innovative research and development (R&D), product differentiation, regulatory compliance, and market access. The companies are continuously focusing on partnerships & collaborations, mergers & acquisitions, and facility expansions.

Biopharmaceuticals Industry News

• In February 2024, F. Hoffmann-La Roche AG collaborated with PathAI to expand digital pathology capabilities for companion diagnostics.
• In January 2024,Johnson & Johnson Pte. Ltd. announced that it would acquire Ambrx Biopharma Inc. to advance next-generation antibody-drug conjugates to transform the treatment of cancer.
• In January 2024,AbbVie Inc. collaborated with Umoja Biopharma, to develop multiple in-situ generated CAR-T cell therapy candidates in oncology using Umoja's proprietary VivoVecTM platform.
• In January 2023, Sanofi acquired a biotechnology company Inhibrx. The focus of the deal is an experimental drug Inhibrx is developing for a rare lung disease known as alpha-1 antitrypsin deficiency.