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市場調査レポート
商品コード
1439635
生物製剤の世界市場:洞察、競合情勢、市場予測:2030年Biologics - Market Insights, Competitive Landscape, and Market Forecast - 2030 |
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生物製剤の世界市場:洞察、競合情勢、市場予測:2030年 |
出版日: 2024年02月01日
発行: DelveInsight
ページ情報: 英文 150 Pages
納期: 2~10営業日
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世界の生物製剤の市場規模は、2023年に3,331億米ドルとなりました。同市場は、2024年から2030年までの予測期間中に9.59%のCAGRで拡大し、2030年には5,770億3,000万米ドルに達すると予測されています。生物製剤市場は、関節リウマチなどの自己免疫疾患の有病率の上昇、がんの有病率の上昇、感染症の有病率の上昇、遺伝性疾患の症例の増加、生物製剤に関する最新の技術革新を伴う製品開発活動の増加などの要因により、プラスの成長が見込まれています。
生物製剤市場の主な促進要因の1つは、関節リウマチなどの自己免疫疾患の有病率の上昇です。世界保健機関(WHO)のファクトシート(2023年)によると、約1,400万人が関節リウマチ(RA)を患っています。RAは全身性の自己免疫疾患で、関節の痛み、腫れ、変形を引き起こし、全身症状を伴うこともあります。生物製剤は、従来の低分子薬剤とは異なり、標的特異的に作用するため、RAのような自己免疫疾患における治療の選択肢として好まれています。関節リウマチの治療に使用される主な生物製剤は、ヒュミラ(アダリムマブ)、レミケード(インフリキシマブ)、アバタセプト(オレンシア)、アナキンラ(キネレット)、リツキシマブ(リツキサン)です。生物製剤の需要は、RAの主要な危険因子と考えられている高齢化と肥満の増加により、今後数年間でRAの発症率が増加するため、増加の一途をたどり、予測期間中の世界の生物製剤市場の成長にプラスの影響を与えます。
生物製剤市場の成長をもたらすもう1つの主要因は、遺伝性疾患の有病率の上昇です。遺伝子疾患は遺伝子由来の異常によって発生するため、遺伝子治療に対する需要が高まっています。遺伝子治療は、がん、嚢胞性線維症、心臓病、糖尿病、血友病、エイズなど幅広い疾患の治療に有望視されています。例えば、米国食品医薬品局は、脊髄性筋萎縮症(SMA)の2歳未満の小児に対する初の遺伝子治療薬であるゾルゲンスマ(onasemnogene abeparvovec-xioi)を承認しました。ゾルゲンスマは、脊髄性筋萎縮症の中でも最も重症で、乳幼児死亡の主要な遺伝的原因である脊髄性筋萎縮症(SMA)の小児に対する治療薬です。ZOLGENSMAはアデノ随伴ウイルスベクターを用いた遺伝子治療薬です。遺伝子治療に基づく生物製剤は、がん、血友病、高コレステロール血症、神経変性疾患などの遺伝性疾患において、遺伝子の置換やノックダウンからワクチン接種まで幅広い応用が可能であり、遺伝子の投与要件も異なります。
さらに、遺伝子治療はより持続的な治療アプローチを提供するため、遺伝性疾患の管理において一般的な選択肢のひとつとなっています。その結果、多くの遺伝子治療薬が臨床開発段階にあります。American Gene &Cell Therapyが引用したデータによると、2022年5月までに、前臨床段階から医薬品登録前段階まで、1,745の遺伝子治療が開発中でした。このことは、今後数年のうちに市場に登場する可能性のある治療法の多さを示しており、予測期間中の生物製剤市場の成長をさらに後押しします。
当レポートでは、世界の生物製剤市場について調査し、市場の概要とともに、製品タイプ別、用途別、製造タイプ別、地域別動向、および市場に参入する企業のプロファイルなどを提供しています。
Figures 1 Competitive Analysis
Figures 2 COVID-19 Impact Analysis on Biologics Market
Figures 3 Biologics Market in Global (2021-2030)
Figures 4 Biologics Market in Global by Product Type (2021-2030)
Figures 5 Biologics Market in Global by Application (2021-2030)
Figures 6 Biologics Market in Global by Manufacturing Type (2021-2030)
Figures 7 Biologics Market in Global by Geography (2021-2030)
Figures 8 Biologics Market in North America (2021-2030)
Figures 9 Biologics Market in North America by Product Type (2021-2030)
Figures 10 Biologics Market in North America by Application (2021-2030)
Figures 11 Biologics Market in North America by Manufacturing Type (2021-2030)
Figures 12 Biologics Market in North America by Country (2021-2030)
Figures 13 Biologics Market in the US (2021-2030)
Figures 14 Biologics Market in Canada (2021-2030)
Figures 15 Biologics Market in Mexico (2021-2030)
Figures 16 Biologics Market in Europe (2021-2030)
Figures 17 Biologics Market in Europe by Product Type (2021-2030)
Figures 18 Biologics Market in Europe by Application (2021-2030)
Figures 19 Biologics Market in Europe by Manufacturing Type (2021-2030)
Figures 20 Biologics Market in Europe by Country (2021-2030)
Figures 21 Biologics Market in France (2021-2030)
Figures 22 Biologics Market in Germany (2021-2030)
Figures 23 Biologics Market in the United Kingdom (2021-2030)
Figures 24 Biologics Market in Italy (2021-2030)
Figures 25 Biologics Market in Spain (2021-2030)
Figures 26 Biologics Market in Russia (2021-2030)
Figures 27 Biologics Market in Rest of Europe (2021-2030)
Figures 28 Biologics Market in APAC (2021-2030)
Figures 29 Biologics Market in APAC by Product Type (2021-2030)
Figures 30 Biologics Market in APAC by Application (2021-2030)
Figures 31 Biologics Market in APAC by Manufacturing Type (2021-2030)
Figures 32 Biologics Market in APAC by Country (2021-2030)
Figures 33 Biologics Market in China (2021-2030)
Figures 34 Biologics Market in Japan (2021-2030)
Figures 35 Biologics Market in India (2021-2030)
Figures 36 Biologics Market in Australia (2021-2030)
Figures 37 Biologics Market in South Korea (2021-2030)
Figures 38 Biologics Market in Rest of APAC (2021-2030)
Figures 39 Biologics Market in Rest of World (2021-2030)
Figures 40 Biologics Market in RoW by Product Type (2021-2030)
Figures 41 Biologics Market in RoW by Application (2021-2030)
Figures 42 Biologics Market in RoW by Manufacturing Type (2021-2030)
Figures 43 Biologics Market in RoW by Region (2021-2030)
Figures 44 Biologics Market in Middle East (2021-2030)
Figures 45 Biologics Market in Africa (2021-2030)
Figures 46 Biologics Market in South America (2021-2030)
Figures 47 Market Drivers
Figures 48 Market Barriers
Figures 49 Marker Opportunities
Figures 50 PORTER'S Five Force Analysis
Biologics Market By Product Type (Cell-Based Biologics, Gene-Based Biologics, Monoclonal Antibodies, Vaccines, Recombinant Protiens, And Others), By Application (Oncology, Immunology, Infectious Diseases, Neurological Diseases, And Others), By Manufacturing Type (In-House And Outsourced), and by geography is expected to grow at a steady CAGR forecast till 2030 owing to rising prevalence of autoimmune disorders such as rheumatoid arthiritis and genetic disorders.
Global biologics market was valued at USD 333.10 billion in 2023, growing at a CAGR of 9.59% during the forecast period from 2024 to 2030, in order to reach USD 577.03 billion by 2030. The biologics market is witnessing a positive market growth owing to the factors such as rising prevalence of autoimmune disorders such as rheumatoid arthritis, rising prevalence of cancers, increasing prevalence of infectious diseases, increasing cases of genetic disorders, and increasing product development activities with latest innovation with respect to biologics among others.
Biologics Market Dynamics:
One of the main drivers of the biologics market is the rising prevalence autoimmune disorders such as rheumatoid arthritis. According to the World Health Organization factsheet (2023), approximately 14 million people have rheumatoid arthritis (RA). RA is a systemic autoimmune disorder that causes pain, swelling, and deformation of the joints and may be accompanied by systemic symptoms. Biologics are being preferred as a choice of treatment in autoimmune diseases such as RA due to their target-specific action unlike conventional small-molecule drugs. The key biologics used for treating rheumatoid arthritis are Humira (Adalimumab) and Remicade (Infliximab), Abatacept (Orencia), Anakinra (Kineret), and Rituximab (Rituxan). The demand for biologics is set to witness an increase owing to the increasing incidence of RA in coming years owing to increasing aging population and obesity which are considered as major risk factors of RA, thereby positively impacting the global biologics market growth during the forecast period.
Another key factor responsible for the growth of the biologics market is the rising prevalence of genetic disorders. As genetic disorders occur due to anomalies of genetic origin, there has been a growing demand for gene therapies. Gene therapy holds promise for treating a wide range of diseases, such as cancer, cystic fibrosis, heart disease, diabetes, hemophilia and AIDS. For instance, the US Food and Drug Administration approved Zolgensma (onasemnogene abeparvovec-xioi), the first gene therapy for the treatment of children less than two years of age with spinal muscular atrophy (SMA), the most severe form of spinal muscular atrophy and a leading genetic cause of infant mortality. ZOLGENSMA is an adeno-associated virus vector-based gene therapy. Gene therapy based biologics has a wide range of applications, from gene replacement and knockdown to vaccination in genetic diseases such as cancer, hemophilia, hypercholesterolemia, and neurodegenerative diseases, with different gene administration requirements.
Furthermore, gene therapy offer a more sustainable treatment approach, thereby becoming one of the popular choices in the management of genetic diseases. This has resulted in a large number of potential gene therapies being in clinical development. As per the data cited by the American Gene & Cell Therapy, till May 2022, there were 1,745 gene therapies in development from preclinical through preregistration phases of drug development. This indicates the plethora of potential therapies that may reach the market in coming years, further boosting the growth of biologics market during the forecast period.
Along with the factors mentioned above, the COVID-19 pandemic presented another major opportunity for growth for the manufacturers operating in the biopharmaceutical domain. The effect of the pandemic accelerated the drug development activities for the SARS-Cov-2 virus across the globe. The dire need for developing a vaccine in order to contain the pandemic led to the approval and emergency use authorization of numerous vaccines for prophylactic use across the globe. For instance, COVISHIELD, manufactured by the Serum Institute of India is a recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike (S) glycoprotein. It is one of the eight COVID-19 vaccines approved by the World Health Organization. Furthermore, there are more than 80 different candidates in development as a potential therapy for COVID-19 infection.
However, challenging manufacturing process and high cost of biologics, and availability of biosimilars may prove to be major deterrent in biologics market growth.
The biologics market was one of the few domains that exhibited positive growth during the COVID-19 pandemic. Even though lockdown restrictions severely affected production capacities in various industries across the globe, the urgency of developing vaccines for COVID-19 infection presented huge growth opportunities for the biopharmaceutical manufacturers. With the development and the emergency authorization of the first COVID-19 vaccine (the Pfizer-BioNTech COVID-19 Vaccine) in late December 2020, the development and approvals of such vaccines picked up pace across the globe. This led to numerous collaborations and partnerships among pharmaceutical companies and contract manufacturing organizations in order to meet the global supply of these vaccines in the short span of time, which presented a positive outlook for the biologics market despite the disruption of supply chains among other factors.
Biologics Market Segment Analysis:
Biologics Market by Product Type (Cell-Based Biologics, Gene-Based Biologics, Monoclonal Antibodies, Vaccines, Recombinant Proteins, and Others), by Application (Oncology, Immunology, Infectious Diseases, Neurological Diseases, and Others), by Manufacturing Type (In-House and Outsourced), and by Geography (North America, Europe, Asia-Pacific, and Rest of the World)
In the product type segment of the biologics market, the monoclonal antibodies category is estimated to register significant share in market revenue during the forecast period. This can be attributed to the specific features associated with them. Monoclonal antibodies are considered to be highly specific thereby resulting in fewer side effects in patients. One exceptional advance that accelerated the approval of therapeutic mAbs was the generation of humanized antibodies by the complementary-determining region (CDR) grafting technique. The recent development of bispecific antibodies offers attractive new opportunities for the design of novel protein therapeutics, mAbs are increasingly used for a broad range of targets; oncology, immunology, and hematology remain the most prevalent medical applications.
In recent years, many monoclonal antibodies have also been approved for other indications such as migraine, rheumatoid arthritis, HIV infection among others. Keeping the development of COVID-19 pandemic in focus, there have been increased efforts in the development of therapies for treating COVID-19 infection. For instance, in November 2022, Cellitron Group received the marketing authorization for their monoclonal antibody- Regkirona in patients over the age of 12 years and do not require supplemental oxygen and are at increased risk of their disease becoming severe. Therefore, considering the advantages associated with monoclonal antibodies, this product category is expected to witness a considerable growth eventually contributing the overall growth of the global biologics market in the forecast period.
North America is expected to dominate the Overall Biologics Market:
Among all the regions, North America is expected to account for the largest share in the global biologic drugs market. This can be ascribed to the high focus on therapy development for rare diseases with orphan designations, rising prevalence of cancers, and a supportive regulatory environment among other factors in the region. Furthermore, high disposable income, sophisticated healthcare infrastructure, and increased awareness regarding new treatments coupled with extensive insurance coverage for these treatments are also expected to aid in the biologics market growth in this region.
One of the key supporting factors for the growth of the North America biologics market is the increasing focus on developing therapies for rare diseases in North American countries, particularly in the United States. As per the data provided by the US Food and Drug Administration (FDA) (2023), there are more than 7,000 rare diseases affect more than 30 million people in the United States. Depending on the huge number of indications and such small patient population for each indication on an average, the pharmaceutical companies find it difficult to develop therapies for such indications which prompted the US FDA to implement the Orphan Drug Act and Orphan Product Grants Program.
The Orphan Drug Act is a law passed in 1983 that incentivizes the development of drugs to treat rare diseases. This has resulted in a considerable number of companies in the country developing therapeutics aimed at treating rare diseases. For instance, in 2019, the US FDA granted an approval for a gene therapy to treat pediatric patients younger than two years of age with spinal muscular atrophy. As per the US FDA, in 2019, the FDA approved 76 orphan indications, which included 22 novel drugs and biologics with orphan designation. Therefore, the increasing focus of the US FDA and the US government in catering to the medical needs of people suffering from rare diseases in the country is also expected to drive the US biologics market in coming years.
Furthermore, the increasing prevalence of various cancers has also resulted in growing demand for biologics in the country. As per the data provided by the American Cancer Society, in 2022, an estimated 1.9 million new cancer cases diagnosed and 608,570 cancer deaths in were expected to be reported in the United States. The high cancer prevalence of various etiologies has led to the development of different immunotherapies owing to their advantages in cancer treatment. Immunotherapy has been an effective treatment for patients with certain types of cancer that have been resistant to chemotherapy and radiation treatment. Moreover, it has been established that immunotherapy can provide long-term protection against cancer as it stimulates the immune system in recognizing and differentiating cancer cells.
This has led to the development and launch of numerous novel immunotherapies in the country. For instance, in April 2022, the US FDA granted accelerated approval to JEMPERLI (dostarlimab-gxly) manufactured by GlaxoSmithKline for the treatment of recurrent or advanced mismatch repair-deficient endometrial cancer.
Therefore, the North America biologics market is expected to witness a significant growth in revenue during the forecast period.
Biologics Market Key Players:
Some of the key market players operating in the biologics market includes GlaxoSmithKline, Eli Lilly & Company, F. Hoffmann-La Roche Ltd, AbbVie Inc., Amgen Inc, Sanofi, Merck & Co., Inc, Novo Nordisk, Novartis AG, Pfizer Inc, AstraZeneca, Bristol Myers Squibb., Regeneron Pharmaceuticals Inc., Gilead Sciences, Inc., Boehringer Ingelheim International GmbH., Genentech, Inc, Biogen., bluebird bio, Inc, Janssen Global Services, LLC,., Cellitron Group and others.
Recent Developmental Activities in Biologics Market:
In October 15, 2022, the US FDA approved atezolizumab (Tecentriq) by Genentech, Inc. for adjuvant treatment following resection and platinum-based chemotherapy in patients with stage II to IIIA non-small cell lung cancer (NSCLC).
In August 2022, Bristol Myers Squibbs received the conditional marketing authorization for Abecma (idecabtagene vicleucel) by the European Commission for the treatment of adult patients with relapsed and refractory multiple myeloma. It is a irst-in-class B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy.
In June 2022, the US FDA approved the product approval to Biogen Inc's Aduhelm (aducanumab) for the treatment of Alzheimer's disease in an accelerated approval pathway.
Key Takeaways from the Biologics Market Report Study
Market size analysis for current biologics market size (2023), and market forecast for 5 years (2024-2030)
The effect of the COVID-19 pandemic on this market is significant. To capture and analyze suitable indicators, our experts are closely watching the biologics market.
Top key product/services/technology developments, merger, acquisition, partnership, joint venture happened for last 3 years
Key companies dominating the global biologics market.
Various opportunities available for the other competitor in the biologics market space.
What are the top performing segments in 2023? How these segments will perform in 2030.
Which is the top-performing regions and countries in the current biologics market scenario?
Which are the regions and countries where companies should have concentrated on opportunities for biologics market growth in the coming future?
Target Audience who can be benefited from this Biologics Market Report Study
Biologics products providers
Research organizations and consulting companies
Biologics-related organizations, associations, forums, and other alliances
Government and corporate offices
Start-up companies, venture capitalists, and private equity firms
Distributors and Traders dealing in biologics
Various End-users who want to know more about the biologics market and latest technological developments in the biologics market.
Frequently Asked Questions for Biologics Market
Biologics are products that are produced from living organisms or contain components of living organisms. There are several types of biologic drugs which include blood, blood components, vaccines, cells, genes, allergens, tissues, and recombinant proteins.
Global biologics market was valued at USD 333.10 billion in 2023, growing at a CAGR of 9.59% during the forecast period from 2024 to 2030, in order to reach USD 577.03 billion by 2030.
The biologics market is witnessing a positive market growth owing to the factors such as rising prevalence of autoimmune disorders such as rheumatoid arthritis, rising prevalence of cancers, increasing prevalence of infectious diseases, increasing cases of genetic disorders, and increasing product development activities with latest innovation with respect to biologics among others.
Some of the key market players operating in the biologics market includes GlaxoSmithKline, Eli Lilly & Company, F. Hoffmann-La Roche Ltd, AbbVie Inc, Amgen Inc, Sanofi, Merck & Co., Inc, Novo Nordisk, Novartis AG, Pfizer Inc, AstraZeneca, Bristol Myers Squibb., Regeneron Pharmaceuticals Inc., Gilead Sciences, Inc., Boehringer Ingelheim International GmbH., Genentech, Inc, Biogen., bluebird bio, Inc, Janssen Global Services, LLC,., Cellitron Group and others.
North America is expected to hold the highest share in the revenue in the Biologics market during the forecast period. This can be ascribed to the high focus on therapy development for rare diseases with orphan designations, rising prevalence of cancers, and a supportive regulatory environment among other factors in the region. Furthermore, high disposable income, sophisticated healthcare infrastructure, and increased awareness regarding new treatments coupled with extensive insurance coverage for these treatments are also expected to aid in the biologics market growth in this region.