Biologic Therapy Market Analysis

Biologic Therapy Market Overview

Biologic Therapy Market size was valued at USD 382.85 billion in 2022. The Biologic Therapy market industry is projected to grow from USD 419.22 Billion in 2023 to USD 998.36 billion by 2032, exhibiting a compound annual growth rate (CAGR) of 9.3% during the forecast period (2023 - 2032).

The increasing reimbursement for biologics, rising burden of cancer, genetic diseases, and autoimmune diseases is driving the market growth.

Source: Secondary Research, Primary Research, MRFR Database and Analyst Review

In March 2024, Biocon Biologics announced that it has reached a patent settlement agreement with Bayer Inc and Regeneron Pharmaceuticals Inc. This agreement allows Biocon Biologics to introduce a biosimilar product in Canada. According to a regulatory filing by Biocon Biologics, the settlement agreement will facilitate the entry of Yesafili, a potential biosimilar of Eeylea (aflibercept) injectable, onto the Canadian market. According to the agreement, Biocon Biologics has guaranteed a launch date for the product by July 1, 2025 at the latest. Yesafili is an ophthalmology product specifically designed to treat neovascular age-related macular degeneration (wet AMD) and other related conditions. 

Yesafili (2 mg vials) received provisional authorization from Health Canada in March 2023, pending the resolution of any patent disputes, according to Biocon Biologics. The settlement concludes various concurrent patent infringement cases in the Federal Court of Canada, which encompass six patents, as well as related judicial review cases, under Canada's Patented Medicines (Notice of Compliance) Regulations that pertain to pre-entry pharmaceutical patent disputes.

In November 2023, Novartis declared that the FDA has granted permission for Cosentyx (secukinumab) to be used as a treatment for individuals who have moderate to severe hidradenitis suppurativa (HS). According to Novartis, Cosentyx is the sole biologic that has been approved by the FDA and is totally human.

It works by directly blocking interleukin-17A (IL17A), which is a tiny signaling protein called a cytokine that is thought to be linked to the inflammation of HS. Secukinumab is the second biologic medication that has been authorized for the treatment of HS. Hidradenitis suppurativa (HS) is a persistent, widespread, and distressing dermatological condition characterized by recurrent abscesses resembling boils that can rupture into ulcers, frequently occurring in delicate regions and leading to permanent harm. 

A significant number of patients seeking treatment present with an advanced manifestation of HS, as it may take them a decade to receive an accurate diagnosis. For those persons, HS can have a substantial influence on their quality of life. The FDA approval was granted based on results from the biggest Phase II program in HS, as reported by Novartis.

Biologic Therapy  Market Trends

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  Increasing prevalence and incidence of cancers boosts the market growth.

  
  

The increasing prevalence of cancers raises the demand of biology therapy which directly propel the growth of biologic therapy market. As per the Centre for Disease Control and Prevention in 2020, approximate 1,603,844 new cases of cancer reported as well as for every 100,000 people, 403 new cases were reported in the US. Moreover, World Research Cancer Fund International, approximate 18.1 million cancer cases across the globe. Of these, approximate, 8.8 million in women and 9.3 million cases were men.  According to the World Cancer Research Fund in 2019, around 387,820 cases of cancer were diagnosed in 2019, of these cancer cases, 187,434 were in women and 200,386 were in men. 

As compared with the 2017 data, this was an increase of around 5.8%. Cases in men was increased around 7.2% as well as cases of cancer had increased up to 4.4% in women. Thus, rising prevalence and incidence of cancer also create the interest of major players for new therapy development which directly raise the demand of biologic therapy market across the globe.

Biologic Therapy Market Segment Insights

Biologic Therapy Product Type Insights

The Biologic Therapy Market segmentation, based on product type, includes drugs, instruments & kits, services. The drugs segment is to hold the majority share in 2022 in the Biologic Therapy Market revenue due to the drugs provide better therapeutic effect and increasing number of clinical trial ongoing in development of new therapeutics in biologic therapy market.

June 2022: Aeglea BioTherapuetics announced that it had disastrous to guarantee a biologics license application (BLA) from the FDA after administrators issued a negation to file for the company’s biologic pegzilarginase.

Biologic Therapy, Therapy Insights

The Biologic Therapy Market segmentation is based on therapy that includes monoclonal antibodies, vaccines, others. The monoclonal antibodies segment has dominated the market in 2022 due to the use of monoclonal antibodies in the management and control of disorders such as cancer can be combined to the producers of various disorders. It can also be used to target diseased cells while causing no harm to good cells of the human body.

May 2021: Moderna has entered into manufacturing service agreement with Samsung Biologics for finish commercial manufacturing of mRNA-1273, Moderna’s COVID-19 vaccine.

The Biologic Therapy Market segmentation is based on applications that include cancer, infectious diseases, autoimmune diseases, and others. The cancer segment has dominated the market in 2022 due to the increasing prevalence of cancers across the globe dominating this segment growth in biologic therapy market. As per Globocan, the incidence of cancer is predicted to rise from 19.3 million in 2020 to 24.6 million in 2030.

February 2022: The Janssen Pharmaceutical Companies received the US FDA approval for its product CARVYKTI (ciltacabtagene autoleucel; cilia-cel). This biologic medicine is utilized for the treatment of adults with reverted or refractory multiple myeloma (RRMM) after four or more former lines of therapy, including a monoclonal antibody, proteasome inhibitor, an immunomodulatory agent, and an anti-CD38.

The Biologic Therapy Market segmentation is based on end user that includes hospitals & clinics, specialty centers, research centers. The hospitals & clinics segment has dominated the market in 2022 due to the increasing number of hospitals & clinics across the globe and hospitals and clinics provide better treatment facilities as well as availability of skilled workforce drive the growth of this segment in biologic therapy market.

August 2021: Pfizer Inc. and BioNTech SE announced that they have initiated a supplemental Biologics License Application with the FDA to obtain approval for a booster dosage of COMIRNATY to inhibit COVID-19 in patients aged 16 and up.

Figure 2: Biologic Therapy Market, By End User, 2023 & 2032 (USD BILLION)

Source: Secondary Research, Primary Research, MRFR Database, and Analyst Review

By Region, the study segments the market into North America, Europe, Asia-Pacific, and Rest of the World. North America accounted for the largest market share in 2022 owing to the North Americas is expected to command the largest market share due to the increasing incidence of cancer and rising mortality rate of cancer. As per Globocan, the incidence of cancer is predicted to rise from 19.3 million in 2020 to 24.6 million in 2030. Furthermore, there is a growing prevalence of neurological disorders such as Parkinson’s disease and Alzheimer’s disease. It is predicted that the prevalence of Alzheimer's disease will grasp 78 million in 2030 and by 2050, it will rise to 139 million. 

The new product approval is further driving the growth of this market. For instance, in January 2023, Eisai Inc received US FDA approval for its product Leqembi (lecanemab-irmb) for the treatment of Alzheimer's disease.

 Further, the major countries studied are the U.S., Canada, Germany, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.

Figure 3: Biologic Therapy Market, By Region, 2023 & 2032 (USD BILLION)

Source: Secondary Research, Primary Research, MRFR Database, and Analyst Review

Europe Biologic Therapy market is expected to account for the second-largest market share due to the growth of the market are the increasing research and development activity, growing number of clinical trials. The rising presence of major key players in the market, increasing incidence of neurologic disease in the Europe region drive the growth of biologic therapy market in the Europe. Furthermore, the Germany Biologic Therapy market held the largest market share in 2022 and UK Biologic Therapy market is the fastest growing market in the Europe region.

The Asia-Pacific Biologic Therapy market is expected to grow at a CAGR of 8.40% from 2019 to 2032. This is due to the epidemiology factor, increasing investment by foreign companies in the emerging economies, rising out of packet expenditure, developing economy drive the growth of this market in the Asia-Pacific region. Moreover, Japan biologic therapy market held the largest market share in 2022 and India biologic therapy market is the fastest growing market in the Asia-Pacific region.

The Rest of the World includes the Middle East, Africa, and Latin America. Latin America holds the major market share in the middle east and Africa region due to the increasing government support, rising the demand of better medical treatment market across the region which drives the growth of the market. This is expected to bolster the market for biologic therapy in this region.

Biologic Therapy Key Market Players & Competitive Insights

The Biologic Therapy Market is distinguished by the presence of numerous global, regional, and local players catering to the increasing need for products in the emerging threat. Moreover, factors such as the increasing threat of bioterrorism, growing awareness of the potential for pandemics, and advances in biotechnology have made it possible to develop new and more effective Biologic Therapy products. Moreover, the numerous pipeline products are responsible for the intense competition and huge opportunities during the forecast period.

Additionally, manufacturers are entering into strategic alliances such as acquisitions, mergers, collaborations, product launches, and product approvals. These strategic alliances are creating intense rivalry for the newcomer as well as for the existing brand.

Hoffmann-La Roche Ltd (Roche) is one of the leading companies in the field of diagnostics and pharmaceuticals. It develops & markets products for diagnosis & treatment of anemia, cancer, anticoagulation therapy, cardiovascular diseases, diabetes, central nervous system, chlamydia, dermatology, gonorrhea, gout, hepatitis B and C, hemostasis disorders, HIV/AIDS, HPV, infectious diseases, and autoimmune diseases. The company specializes in the field of molecular diagnostics & medicines for oncology, virology, inflammation, metabolism, central nervous system (CNS), clinical chemistry, immunology, urinalysis, blood screening, genetics, infectious diseases, and microbiology. The firm operates in two major business segments, namely, pharmaceuticals and diagnostics. 

The pharmaceutical segment offers a wide range of drugs for therapeutic areas such as oncology, inflammation, neuroscience, infectious diseases, ophthalmology, and among others. Diagnostics segment offers a wide range of tests for cancer and companion diagnostic tests. The company has a strong presence in North America, Europe, Asia, and the Middle East.

Key Companies in the Biologic Therapy Market Include.

• Samsung Biologics (South Korea)


• Amgen Inc (US)


• Novo Nordisk A/S (Denmark)


• Sanofi (France)


• Johnson & Johnson Services, Inc (US)


• Celltrion Healthcare Co., Ltd (South Korea)


• Bristol-Myers Squibb Company (US)


• Eli Lilly and Company (US)


• Hoffmann La-Roche Ltd (Switzerland)


• Aeglea BioTherapuetics (US)

Biologic Therapy Industry Developments

March 2023: Novartis showed its division Sandoz's plan to spend approximately USD 400 million in the development of a biologics manufacturing facility located in Slovenia.

November 2022: CSL Behring’s received US FDA approval for its product Hemgenix for the treatment of adults with hemophilia B. This product’s approval strengthens its business in the US.

Biologic Therapy Market Segmentation

Biologic Therapy Product Type Outlook

• Drugs


• Instruments & Kits


• Services

Biologic Therapy Therapy Outlook

• Monoclonal Antibodies


• Vaccines


• Others

Biologic Therapy Application Outlook

• Cancer


• Infectious Diseases


• Autoimmune Diseases


• Others

Biologic Therapy End User Outlook

• Hospitals & Clinics


• Specialty Centers


• Research Centers

Biologic Therapy Regional Outlook

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  Middle East
  
  


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  Africa