According to the latest Research by Nova One Advisor, the global biologics market size was exhibited at USD 511.04 billion in 2024 and is projected to hit around USD 1,374.51 billion by 2033, growing at a CAGR of 10.4% during the forecast period 2024 to 2033.
According to the latest Research by Nova One Advisor, the global biologics market size was exhibited at USD 511.04 billion in 2024 and is projected to hit around USD 1,374.51 billion by 2033, growing at a CAGR of 10.4% during the forecast period 2024 to 2033.
Increasing burden of cancer, neurological diseases, genetic diseases and autoimmune diseases and approval of novel biologic drugs such as gene therapy, RNAi therapeutics, and antibody-drug conjugates are a few factors driving the biologics market.
As of 2023, there were already 27 cell and gene therapy drugs approved in the U.S., with five of them receiving approval that year. Sarepta’s gene therapy SRP-9001, which is currently in phase 3 trials for the treatment of duchenne muscular dystrophy has a PDUFA date set for May 29, 2023. Other potential gene therapy candidates in the pipeline include Krystal Biotech’s Beremagene geperpavec (B-VEC) for dystrophic epidermolysis bullosa; UniQure’s AMT-130 for Huntington disease; Intellia’s NTLA-2001 and NTLA-2002 for transthyretin (ATTR) amyloidosis; Nanoscope’s MCO-010 and Pfizer’s Fidanacogene elaparvovec for hemophilia B. The approval and subsequent commercialization of these gene therapy candidates are expected to drive growth in the biologics market.
Monoclonal antibodies account for the largest number of biologics approved. While the approval of traditional monoclonal antibodies has slowed down, next-generation antibodies such a bispecific-monoclonal antibodies, antibody fragments, radio-immunotherapies, nanobodies, and antibody-drug conjugates is driving the growth of this segment. For instance, in September 2021, the U.S. FDA approved Seagen’s Tivdak a new antibody-drug conjugate for the treatment of cervical cancer.
The biologics market faces significant challenges, primarily related to the high costs associated with their development and production. Biologics are complicated compounds that necessitate specialized production procedures, and the development cost might be prohibitively expensive. Furthermore, increasing competition from biosimilars is also a key restraining factor for the market. In 2021, Europe approved seven new biosimilars, a slight decrease from the nine approved in 2020. It is anticipated that during the forecast years oncology, endocrine and blood related disorders are the key therapies areas in which biologic drugs will face patent expiry.
Get Sample Copy of Report@ https://www.novaoneadvisor.com/report/sample/7084
Key Takeaways:
- North America held the largest revenue share of 46% in 2023.
- Asia Pacific region is projected to expand at the CAGR of 11.2% during the forecast period.
- Based on the disease category, the oncology segment dominated the biologics industry with a share of 29.40% in 2023.
- The hematological disorder segment is expected to expand at the fastest CAGR of 11.8% during the forecast period.
- Based on source, the microbial segment dominated the biologics industry with a share of 59.23% in 2023.
- The mammalian expression systems segment is expected to expand at a significant CAGR during the forecast period.
- Based on manufacturing, the in-house segment dominated the market with 85.87% share in 2023.
- The outsourcing segment is projected to expand at a CAGR of 10.8% during the forecast period.
- Based on product, the monoclonal antibodies segment accounted for a share of 68% in 2023.
- The antisense and RNAi therapeutics segment is anticipated to expand at a CAGR of 20.7% during the forecast period.
What are biologics used for?
Biologic drugs are used for treatment of numerous diseases and conditions, and are the most advanced therapies available. Some biologic drugs are used for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, and other autoimmune diseases.
Available biologics have revolutionized cancer treatment, delayed or reversed the course of immune related conditions, changed the lives of people with rare diseases, and have offered hope for many patients who previously had no effective treatment options for their condition.
Examples of medical uses for biologic drugs include: Various cancers, Rheumatoid arthritis (RA), Ankylosing spondylitis, Crohn’s disease, Ulcerative colitis
Psoriasis, Diabetes, Multiple sclerosis (MS), Heart attack, Systemic lupus erythematous, Age-related macular degeneration, Diabetic retinopathy, Prevention of pneumonia, Anemia, Chronic migraine, Hepatitis B,Hemophilia, Respiratory syncytial virus (RSV) prophylaxis, HPV prevention, Varicella virus vaccine, Growth hormone deficiency, Osteoporosis, Allergic asthma, Chronic idiopathic urticaria, Infertility, Prevention of meningococcal disease, Cystic fibrosis, Paroxysmal nocturnal hemoglobinuria
Why Are Biologics Important?
While most drugs have a known structure and so can be chemically synthesized, biologics are derived from existing natural systems. This gives them a larger, more complex structure. As a result, the treatments derived from them are more challenging to produce. But the effort has paid off.
Biologics are helping to advance patient care by delivering highly effective and targeted treatment across multiple life-threatening and chronic diseases—for conditions where patients have had few effective options.
Approved by the FDA, biologics are now used in the fields of oncology, inflammation and immunology, rheumatology, gastroenterology, diabetes, neurology, and inherited conditions.
Immediate Delivery Available, Get Full Access@
https://www.novaoneadvisor.com/report/checkout/7084
Product Insights
Based on product, the monoclonal antibodies segment accounted for a share of 68% in 2023 due to higher usage of this category of drugs in different therapeutic areas. MABs allow targeting of unhealthy cells without harming the healthy cells. Monoclonal antibodies have emerged as the predominant category of approved biologic drugs till now. In 2021, the U.S. FDA achieved a significant milestone by approving its 100th monoclonal antibody product, just six years after approving its 50th product back in 2015. Based on source, the humanized monoclonal antibodies dominated the market. This is due to their lower risk of inducing an immune response when compared to murine or chimeric antibodies.
The antisense and RNAi therapeutics segment is anticipated to expand at a CAGR of 20.7% during the forecast period. These biologic products facilitate targeted and efficient gene silencing, leading to the development and approval of numerous gene silencing drugs for genetic diseases. For instance, in June 2022, Alnylam Pharmaceuticals, Inc. received FDA approval for its RNAi therapeutic AMVUTTRA for the treatment of Polyneuropathy of hereditary transthyretin-mediated amyloidosis.
Disease Category Insights
Based on the disease category, the oncology segment dominated the biologics industry with a share of 29.40% in 2023. According to the American Cancer Society, in 2023, approximately 2.82 million new cancer cases and around 609,360 cancer deaths were reported in the U.S. Cancer ranks as the second leading cause of death worldwide, with an estimated 9.6 million deaths in 2020. The advent of biologic medications, especially monoclonal antibodies and immunotherapy therapies has significantly enhanced cancer treatment by improving survival rates and reducing side effect. Biologic medications have made a substantial impact in the field of breast cancer treatment, exemplified by the positive outcomes observed with the use of Herceptin. By 2023, the global market for oncology biologics is anticipated to surpass $100 billion in value.
The hematological disorder segment is expected to expand at the fastest CAGR of 11.8% during the forecast period. The approval of gene therapy of rare blood disorders such as hemophilia is expected to be a major factor driving market growth. For instance, in November 2022, the U.S. FDA approved CSL Behring’s Hemgenix for the treatment of adults with hemophilia B. Additionally, in August 2022, BioMarin’s ROCTAVIAN was also approved for treating hemophilia A in Europe. Pfizer’s PF-07055480 (giroctocogene fitelparovec) and PF-06838435/ fidanacogene elaparvovec are in phase 3 trials for type A & B respectively.
Source Insights
Based on source, the microbial segment dominated the biologics industry with a share of 59.23% in 2023. The majority of currently approved biologics are developed and manufactured in microbial expression systems. Products such as platelet-derived growth factor, recombinant insulin, granulocyte-macrophage colony-stimulating factor, and recombinant interferons are manufactured in microbial expression systems.
The mammalian expression systems segment is expected to expand at a significant CAGR during the forecast period. These expression systems are majorly used for the development of recombinant proteins and viral-vector based vaccines. CHO and HEK are the most commonly used mammalian cell lines. Products such as Perjeta (Pertuzumab), Adcetris (Brentuximab-Vedotin), Shingrix (zoster vaccine), Kadycla (Trastuzumab emtansine), and Aimovig (erenumab) are few of the products manufactured in mammalian expression systems.
Manufacturing Insights
Based on manufacturing, the in-house segment dominated the market with 85.87% share in 2023. Biologic drug manufacturing is more complex as compared to small molecules and involves the utilization of live micro-organism cultures and adheres to strict regulatory requirements. In-house manufacturing offers the advantage of direct control, enabling better monitoring of biologic drugs on a day-to-day basis.
The outsourcing segment is projected to expand at a CAGR of 10.8% during the forecast period. Many CDMOs such as WuXI biologics, Lonza, and Samsung Biologics have established cutting-edge biologic manufacturing facilities. Collaborating with these CDMOs grants companies access to manufacturing experts, ensuring successful downstream process development and the implementation of new technologies. The market growth is significantly influenced by the increasing number of CDMOs and their expansion of production capacity. For instance, in November 2022, WuXi Biologics inaugurated its integrated biologics center in Shanghai. The 1.6 million sq. ft. facility will provide end-to-end biologics development facilities including product development, quality control and manufacturing.
Regional Insights
North America held the largest revenue share of 46% in 2023. This can be attributed to several factors, including the high prevalence of chronic diseases, the presence of numerous leading biopharmaceutical companies, favourable reimbursement policies, and significant investments in R&D. As per an article published in JAMA Network, biologics accounted for 37% of the total drug spending in the U.S. The increasing share of biologic prescriptions and growing investments in the development of targeted drugs are some of the factors contributing for the market growth. Furthermore, the approval of multiple novel biologic drugs, such as gene therapy, antisense, and RNAi therapeutics, is expected to further propel market growth.
Asia Pacific region is projected to expand at the CAGR of 11.2% during the forecast period. The rising burden of diseases such as cancer, diabetes, and cardiovascular diseases in Asia-Pacific, coupled with an increase in the geriatric population, has increased demand for biologics. Market leaders in the industry are prioritizing the fulfilment of this demand and making substantial investments in the development of advanced biologic products. A significant driver of growth in the market in this region is the adoption of biosimilars, which play a crucial role in expanding accessibility and affordability of biologic therapies.
Some of the prominent players in the global biologics market include:
- Samsung Biologics
- Amgen Inc.
- Novo Nordisk A/S
- AbbVie Inc.
- Sanofi
- Johnson & Johnson Services, Inc.
- Celltrion Healthcare Co., Ltd.
- Bristol-Myers Squibb Company
- Eli Lilly and Company
- F. Hoffmann La-Roche Ltd.
Segments Covered in the Report
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the Biologics market.
By Source
- Microbial
- Mammalian
- Others
By Product
- Monoclonal Antibodies
- MABs by Application
- Diagnostic
- Biochemical Analysis
- Diagnostic Imaging
- Therapeutic
- Direct MAB Agents
- Targeting MAB Agents
- Protein Purification
- Others
- Diagnostic
- MABs by Type
- Murine
- Chimeric
- Humanized
- Human
- Others
- MABs by Application
- Vaccines
- Recombinant Proteins
- Antisense & RNAi Therapeutics
- Others
By Disease Category
- Oncology
- By Product
- MABs
- Vaccines
- Recombinant Proteins
- Antisense & RNAi Therapeutics
- Others (Certain products under trials related to blood products etc)
- By Product
- Infectious Diseases
- By Product
- Vaccines
- MABs
- Antisense & RNAi Therapeutics
- Recombinant Proteins
- Others
- Immunological Disorders
- Cardiovascular Disorders
- Hematological Disorders
- Others
By Manufacturing
- Outsourced
- In-house
By Region
- North America
- Europe
- Asia-Pacific
- Latin America
- Middle East & Africa (MEA)
Order the 150+ Pages Detailed Report @ https://www.novaoneadvisor.com/report/checkout/7084
Call: USA: +1 650 460 3308 | IND: +91 87933 22019 |Europe: +44 2080772818
Email: sales@novaoneadvisor.com
According to the latest Research by Nova One Advisor, the global biologics market size was exhibited at USD 511.04 billion in 2024 and is projected to hit around USD 1,374.51 billion by 2033, growing at a CAGR of 10.4% during the forecast period 2024 to 2033.
Increasing burden of cancer, neurological diseases, genetic diseases and autoimmune diseases and approval of novel biologic drugs such as gene therapy, RNAi therapeutics, and antibody-drug conjugates are a few factors driving the biologics market.
As of 2023, there were already 27 cell and gene therapy drugs approved in the U.S., with five of them receiving approval that year. Sarepta’s gene therapy SRP-9001, which is currently in phase 3 trials for the treatment of duchenne muscular dystrophy has a PDUFA date set for May 29, 2023. Other potential gene therapy candidates in the pipeline include Krystal Biotech’s Beremagene geperpavec (B-VEC) for dystrophic epidermolysis bullosa; UniQure’s AMT-130 for Huntington disease; Intellia’s NTLA-2001 and NTLA-2002 for transthyretin (ATTR) amyloidosis; Nanoscope’s MCO-010 and Pfizer’s Fidanacogene elaparvovec for hemophilia B. The approval and subsequent commercialization of these gene therapy candidates are expected to drive growth in the biologics market.
Monoclonal antibodies account for the largest number of biologics approved. While the approval of traditional monoclonal antibodies has slowed down, next-generation antibodies such a bispecific-monoclonal antibodies, antibody fragments, radio-immunotherapies, nanobodies, and antibody-drug conjugates is driving the growth of this segment. For instance, in September 2021, the U.S. FDA approved Seagen’s Tivdak a new antibody-drug conjugate for the treatment of cervical cancer.
The biologics market faces significant challenges, primarily related to the high costs associated with their development and production. Biologics are complicated compounds that necessitate specialized production procedures, and the development cost might be prohibitively expensive. Furthermore, increasing competition from biosimilars is also a key restraining factor for the market. In 2021, Europe approved seven new biosimilars, a slight decrease from the nine approved in 2020. It is anticipated that during the forecast years oncology, endocrine and blood related disorders are the key therapies areas in which biologic drugs will face patent expiry.
Get Sample Copy of Report@ https://www.novaoneadvisor.com/report/sample/7084
Key Takeaways:
- North America held the largest revenue share of 46% in 2023.
- Asia Pacific region is projected to expand at the CAGR of 11.2% during the forecast period.
- Based on the disease category, the oncology segment dominated the biologics industry with a share of 29.40% in 2023.
- The hematological disorder segment is expected to expand at the fastest CAGR of 11.8% during the forecast period.
- Based on source, the microbial segment dominated the biologics industry with a share of 59.23% in 2023.
- The mammalian expression systems segment is expected to expand at a significant CAGR during the forecast period.
- Based on manufacturing, the in-house segment dominated the market with 85.87% share in 2023.
- The outsourcing segment is projected to expand at a CAGR of 10.8% during the forecast period.
- Based on product, the monoclonal antibodies segment accounted for a share of 68% in 2023.
- The antisense and RNAi therapeutics segment is anticipated to expand at a CAGR of 20.7% during the forecast period.
What are biologics used for?
Biologic drugs are used for treatment of numerous diseases and conditions, and are the most advanced therapies available. Some biologic drugs are used for the treatment of Crohn’s disease, ulcerative colitis, rheumatoid arthritis, and other autoimmune diseases.
Available biologics have revolutionized cancer treatment, delayed or reversed the course of immune related conditions, changed the lives of people with rare diseases, and have offered hope for many patients who previously had no effective treatment options for their condition.
Examples of medical uses for biologic drugs include: Various cancers, Rheumatoid arthritis (RA), Ankylosing spondylitis, Crohn’s disease, Ulcerative colitis
Psoriasis, Diabetes, Multiple sclerosis (MS), Heart attack, Systemic lupus erythematous, Age-related macular degeneration, Diabetic retinopathy, Prevention of pneumonia, Anemia, Chronic migraine, Hepatitis B,Hemophilia, Respiratory syncytial virus (RSV) prophylaxis, HPV prevention, Varicella virus vaccine, Growth hormone deficiency, Osteoporosis, Allergic asthma, Chronic idiopathic urticaria, Infertility, Prevention of meningococcal disease, Cystic fibrosis, Paroxysmal nocturnal hemoglobinuria
Why Are Biologics Important?
While most drugs have a known structure and so can be chemically synthesized, biologics are derived from existing natural systems. This gives them a larger, more complex structure. As a result, the treatments derived from them are more challenging to produce. But the effort has paid off.
Biologics are helping to advance patient care by delivering highly effective and targeted treatment across multiple life-threatening and chronic diseases—for conditions where patients have had few effective options.
Approved by the FDA, biologics are now used in the fields of oncology, inflammation and immunology, rheumatology, gastroenterology, diabetes, neurology, and inherited conditions.
Immediate Delivery Available, Get Full Access@
https://www.novaoneadvisor.com/report/checkout/7084
Product Insights
Based on product, the monoclonal antibodies segment accounted for a share of 68% in 2023 due to higher usage of this category of drugs in different therapeutic areas. MABs allow targeting of unhealthy cells without harming the healthy cells. Monoclonal antibodies have emerged as the predominant category of approved biologic drugs till now. In 2021, the U.S. FDA achieved a significant milestone by approving its 100th monoclonal antibody product, just six years after approving its 50th product back in 2015. Based on source, the humanized monoclonal antibodies dominated the market. This is due to their lower risk of inducing an immune response when compared to murine or chimeric antibodies.
The antisense and RNAi therapeutics segment is anticipated to expand at a CAGR of 20.7% during the forecast period. These biologic products facilitate targeted and efficient gene silencing, leading to the development and approval of numerous gene silencing drugs for genetic diseases. For instance, in June 2022, Alnylam Pharmaceuticals, Inc. received FDA approval for its RNAi therapeutic AMVUTTRA for the treatment of Polyneuropathy of hereditary transthyretin-mediated amyloidosis.
Disease Category Insights
Based on the disease category, the oncology segment dominated the biologics industry with a share of 29.40% in 2023. According to the American Cancer Society, in 2023, approximately 2.82 million new cancer cases and around 609,360 cancer deaths were reported in the U.S. Cancer ranks as the second leading cause of death worldwide, with an estimated 9.6 million deaths in 2020. The advent of biologic medications, especially monoclonal antibodies and immunotherapy therapies has significantly enhanced cancer treatment by improving survival rates and reducing side effect. Biologic medications have made a substantial impact in the field of breast cancer treatment, exemplified by the positive outcomes observed with the use of Herceptin. By 2023, the global market for oncology biologics is anticipated to surpass $100 billion in value.
The hematological disorder segment is expected to expand at the fastest CAGR of 11.8% during the forecast period. The approval of gene therapy of rare blood disorders such as hemophilia is expected to be a major factor driving market growth. For instance, in November 2022, the U.S. FDA approved CSL Behring’s Hemgenix for the treatment of adults with hemophilia B. Additionally, in August 2022, BioMarin’s ROCTAVIAN was also approved for treating hemophilia A in Europe. Pfizer’s PF-07055480 (giroctocogene fitelparovec) and PF-06838435/ fidanacogene elaparvovec are in phase 3 trials for type A & B respectively.
Source Insights
Based on source, the microbial segment dominated the biologics industry with a share of 59.23% in 2023. The majority of currently approved biologics are developed and manufactured in microbial expression systems. Products such as platelet-derived growth factor, recombinant insulin, granulocyte-macrophage colony-stimulating factor, and recombinant interferons are manufactured in microbial expression systems.
The mammalian expression systems segment is expected to expand at a significant CAGR during the forecast period. These expression systems are majorly used for the development of recombinant proteins and viral-vector based vaccines. CHO and HEK are the most commonly used mammalian cell lines. Products such as Perjeta (Pertuzumab), Adcetris (Brentuximab-Vedotin), Shingrix (zoster vaccine), Kadycla (Trastuzumab emtansine), and Aimovig (erenumab) are few of the products manufactured in mammalian expression systems.
Manufacturing Insights
Based on manufacturing, the in-house segment dominated the market with 85.87% share in 2023. Biologic drug manufacturing is more complex as compared to small molecules and involves the utilization of live micro-organism cultures and adheres to strict regulatory requirements. In-house manufacturing offers the advantage of direct control, enabling better monitoring of biologic drugs on a day-to-day basis.
The outsourcing segment is projected to expand at a CAGR of 10.8% during the forecast period. Many CDMOs such as WuXI biologics, Lonza, and Samsung Biologics have established cutting-edge biologic manufacturing facilities. Collaborating with these CDMOs grants companies access to manufacturing experts, ensuring successful downstream process development and the implementation of new technologies. The market growth is significantly influenced by the increasing number of CDMOs and their expansion of production capacity. For instance, in November 2022, WuXi Biologics inaugurated its integrated biologics center in Shanghai. The 1.6 million sq. ft. facility will provide end-to-end biologics development facilities including product development, quality control and manufacturing.
Regional Insights
North America held the largest revenue share of 46% in 2023. This can be attributed to several factors, including the high prevalence of chronic diseases, the presence of numerous leading biopharmaceutical companies, favourable reimbursement policies, and significant investments in R&D. As per an article published in JAMA Network, biologics accounted for 37% of the total drug spending in the U.S. The increasing share of biologic prescriptions and growing investments in the development of targeted drugs are some of the factors contributing for the market growth. Furthermore, the approval of multiple novel biologic drugs, such as gene therapy, antisense, and RNAi therapeutics, is expected to further propel market growth.
Asia Pacific region is projected to expand at the CAGR of 11.2% during the forecast period. The rising burden of diseases such as cancer, diabetes, and cardiovascular diseases in Asia-Pacific, coupled with an increase in the geriatric population, has increased demand for biologics. Market leaders in the industry are prioritizing the fulfilment of this demand and making substantial investments in the development of advanced biologic products. A significant driver of growth in the market in this region is the adoption of biosimilars, which play a crucial role in expanding accessibility and affordability of biologic therapies.
Some of the prominent players in the global biologics market include:
- Samsung Biologics
- Amgen Inc.
- Novo Nordisk A/S
- AbbVie Inc.
- Sanofi
- Johnson & Johnson Services, Inc.
- Celltrion Healthcare Co., Ltd.
- Bristol-Myers Squibb Company
- Eli Lilly and Company
- F. Hoffmann La-Roche Ltd.
Segments Covered in the Report
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the Biologics market.
By Source
- Microbial
- Mammalian
- Others
By Product
- Monoclonal Antibodies
- MABs by Application
- Diagnostic
- Biochemical Analysis
- Diagnostic Imaging
- Therapeutic
- Direct MAB Agents
- Targeting MAB Agents
- Protein Purification
- Others
- Diagnostic
- MABs by Type
- Murine
- Chimeric
- Humanized
- Human
- Others
- MABs by Application
- Vaccines
- Recombinant Proteins
- Antisense & RNAi Therapeutics
- Others
By Disease Category
- Oncology
- By Product
- MABs
- Vaccines
- Recombinant Proteins
- Antisense & RNAi Therapeutics
- Others (Certain products under trials related to blood products etc)
- By Product
- Infectious Diseases
- By Product
- Vaccines
- MABs
- Antisense & RNAi Therapeutics
- Recombinant Proteins
- Others
- Immunological Disorders
- Cardiovascular Disorders
- Hematological Disorders
- Others
By Manufacturing
- Outsourced
- In-house
By Region
- North America
- Europe
- Asia-Pacific
- Latin America
- Middle East & Africa (MEA)
Order the 150+ Pages Detailed Report @ https://www.novaoneadvisor.com/report/checkout/7084
Call: USA: +1 650 460 3308 | IND: +91 87933 22019 |Europe: +44 2080772818
Email: sales@novaoneadvisor.com