Global Biopharmaceuticals Market Size research report offers in-depth assessment of revenue growth, market definition, segmentation, industry potential, influential trends for understanding the future outlook and current prospects for the market. -/- Biopharmaceuticals are complex medicines extracted or semisynthesized from biological sources using biotechnological methods. They can be sugars, proteins, nucleic acids, living cells, or tissues used for therapeutic or in vivo diagnostic purposes and are produced by means other than direct extraction from a native or non-engineered biological source. (...) -/- Drivers & Restraints -/- The global biopharmaceuticals market size stood at USD 470.80 Billion in 2023 and is projected to reach USD 799.76 Billion by 2030, exhibiting at a CAGR of 7.9% in the forecast period -/- This study provides information about the sales and revenue during the historic and forecasted period of (2024 to 2030). Understanding the segments helps in identifying the importance of different factors that aid market growth. Estimations about the CAGR value for specific forecast period, market drivers, market restraints, and competitive strategies are assessed in this Biopharmaceuticals Market report. -/- This report focuses on Biopharmaceuticals Market volume and value at the global level, regional level and company level. From a global perspective, this report represents overall Biopharmaceuticals Market market size by analysing historical data and future prospect. Regionally, this report focuses on several key regions: North America, Europe, Asia-Pacific, Latin America and Middle East and Africa. -/- Competitive Strategic Window: -/- The Competitive Strategic Window analyses the competitive landscape in terms of markets, applications, and geographies to help the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. It describes the optimal or favorable fit for the vendors to adopt successive merger and acquisition strategies, geography expansion, research & development, and new product introduction strategies to execute further business expansion and growth during a forecast period. -/- An Overview of the Impact of COVID-19 on this Market: -/- The advancement of COVID-19 has conveyed the world to a stop. We fathom that this prosperity crisis amazingly influences associations across ventures. Nevertheless, everything fortunate or unfortunate should reach a conclusion. There are a couple of organizations that are fighting and some are thriving. By and large, essentially every region is relied upon to be impacted by the pandemic. (shrink)

Global Biopharmaceuticals Market Size research report offers in-depth assessment of revenue growth, market definition, segmentation, industry potential, influential trends for understanding the future outlook and current prospects for the market. -/- Get a Sample Copy of the Report at – -/- Biopharmaceuticals are complex medicines extracted or semisynthesized from biological sources using biotechnological methods. They can be sugars, proteins, nucleic acids, living cells, or tissues used for therapeutic or in vivo diagnostic purposes and are produced by means other (...) than direct extraction from a native or non-engineered biological source. -/- Drivers & Restraints -/- The global biopharmaceuticals market size stood at USD 470.80 Billion in 2023 and is projected to reach USD 799.76 Billion by 2030, exhibiting at a CAGR of 7.9% in the forecast period -/- This study provides information about the sales and revenue during the historic and forecasted period of (2024 to 2030). Understanding the segments helps in identifying the importance of different factors that aid market growth. Estimations about the CAGR value for specific forecast period, market drivers, market restraints, and competitive strategies are assessed in this Biopharmaceuticals Market report. -/- This report focuses on Biopharmaceuticals Market volume and value at the global level, regional level and company level. From a global perspective, this report represents overall Biopharmaceuticals Market market size by analysing historical data and future prospect. Regionally, this report focuses on several key regions: North America, Europe, Asia-Pacific, Latin America and Middle East and Africa. -/- Competitive Strategic Window: -/- The Competitive Strategic Window analyses the competitive landscape in terms of markets, applications, and geographies to help the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. It describes the optimal or favorable fit for the vendors to adopt successive merger and acquisition strategies, geography expansion, research & development, and new product introduction strategies to execute further business expansion and growth during a forecast period. -/- An Overview of the Impact of COVID-19 on this Market: -/- The advancement of COVID-19 has conveyed the world to a stop. We fathom that this prosperity crisis amazingly influences associations across ventures. Nevertheless, everything fortunate or unfortunate should reach a conclusion. There are a couple of organizations that are fighting and some are thriving. By and large, essentially every region is relied upon to be impacted by the pandemic. -/- We are advancing incessant endeavors to help your business support and create during COVID-19 pandemics. Considering our experience and expertise, we will offer you an impact examination of Covid episode across ventures to help you with preparing for what's to come. -/- Key players covered in the global Biopharmaceuticals Market research report: -/- Pfizer Inc. (U.S.) AbbVie Inc. (U.S.) Bristol-Myers Squibb Company (U.S.) Johnson & Johnson Services, Inc. (U.S.) Bayer AG (Germany) Lilly (U.S.) Sanofi (France) Merck & Co., Inc. (U.S.) F. Hoffmann-La Roche Ltd. (Switzerland) Novartis AG (Switzerland) GSK plc (U.K.) Takeda Pharmaceutical Company Limited. (Japan). (shrink)

The issues relating to the licensing of a biopharmaceutical are described. In particular attention is focused on the mind of the regulator who has the responsibility of recommending licensure. There are two key factors which operate on the mind when confronted with such a task: psychology and ethics. The different factors which influence the psychological acceptability of a product for licensure are many and varied; they include perceived need, novelty, education, context and others. Also involved is the regulator’s view of (...) the ethicality of such products and the organisms which make them, with particular reference to those which are genetically engineered. These ethical views are in turn derived by reference to basic systems of ethics which provide guidelines for behavior. It is important for the manufacturers of biopharmaceuticals to be aware of both the psychological and ethical aspects of the regulator’s mind when addressing such individuals with a view to obtaining a license to manufacture a particular biopharmaceutical. (shrink)

The issues relating to the licensing of a biopharmaceutical are described. In particular attention is focused on the mind of the regulator who has the responsibility of recommending licensure. There are two key factors which operate on the mind when confronted with such a task: psychology and ethics. The different factors which influence the psychological acceptability of a product for licensure are many and varied; they include perceived need, novelty, education, context and others. Also involved is the regulator’s view of (...) the ethicality of such products and the organisms which make them, with particular reference to those which are genetically engineered. These ethical views are in turn derived by reference to basic systems of ethics which provide guidelines for behavior. It is important for the manufacturers of biopharmaceuticals to be aware of both the psychological and ethical aspects of the regulator’s mind when addressing such individuals with a view to obtaining a license to manufacture a particular biopharmaceutical. (shrink)

In recent years, the biopharmaceutical industry has seen an increase in the development of so-called orphan drugs for the treatment of rare and neglected diseases. This increase has been spurred on by legislation in the United States, Europe, and elsewhere designed to promote orphan drug development. In this article, we examine the drivers of corporate social responsibility (CSR) activities in orphan drug markets and the extent to which biopharmaceutical firms engage in these activities with a strategic orientation. The unique context (...) of orphan drugs constitutes a research opportunity to test the applicability of existing theoretical perspectives on CSR and strategic CSR. Using Schwartz and Carroll’s (Bus Ethics Q, 13(4):503–530, 2003) three-domain approach to CSR and the literature on strategic CSR as a theoretical background, we employ a combination of semi-structured interviews and a quantitative website content analysis to study practices of biopharmaceutical firms in the United States and European Union. Our findings show that both US- and EU-based companies engaged in orphan drugs development perceive their involvement as a responsible business activity beyond the economic dimension of CSR. However, for the majority of these companies their CSR activities do not qualify as strategic according to the criteria established in the literature. We also find significant differences between larger and smaller firms in their use of CSR. Based on these findings, we make several suggestions regarding orphan drug legislation and other measures that might help firms exploit strategic CSR benefits. (shrink)

BackgroundThe biopharmaceutical industry operates at the intersection of life sciences, clinical research, clinical care, public health, and business, which presents distinct operational and ethical challenges. This setting merits focused bioethics consideration to complement legal compliance and business ethics efforts. However, bioethics as applied to a biopharmaceutical industry setting often is construed either too broadly or too narrowly with little examination of its proper scope.Main textAny institution with a scientific or healthcare mission should engage bioethics norms to navigate ethical issues that (...) arise from the conduct of biomedical research, delivery of clinical care, or implementation of public health programs. It is reasonable to assume that while bioethics norms must remain constant, their application will vary depending on the characteristics of a given setting. Context “specification” substantively refines ethics norms for a particular discipline or setting and is an expected, needed and progressive ethical activity. In order for this activity to be meaningful, the scope for bioethics application and the relevant contextual factors of the setting need to be delineated and appreciated. This paper defines biopharmaceutical bioethics as: the application of bioethics norms (concepts, principles, and rules) to the research, development, supply, commercialization, and clinical use of biopharmaceutical healthcare products. It provides commentary on this definition, and presents five contextual factors that need to be considered when applying bioethics norms to a biopharmaceutical industry setting: (1) dual missions; (2) timely and pragmatic guidance; (3) resource stewardship; (4) multiple stakeholders; and (5) operational complexity.ConclusionUnderstanding the scope of the biopharmaceutical enterprise and contextual factors of a biopharmaceutical industry setting is foundational for the application of bioethics norms. Establishing a common language and approach for biopharmaceutical bioethics will facilitate breadth and depth of discussion and subsequent implementation to benefit patients, the healthcare system and society. (shrink)

Enhancing research and development and ensuring equitable pricing and access to cutting-edge treatments are both vital to a biopharmaceutical innovation system that works in the public interest. However, despite delivering numerous therapeutic advances, the existing system suffers from major problems: a lack of directionality to meet key needs, inefficient collaboration, high prices that fail to reflect the public contribution, and an overly-financialized business model.

Safety testing of biological pharmaceuticals is often carried out by contract testing laboratories which perform these tests on behalf of the drug’s developer. These laboratories are confronted with a number of ethical issues related to selling their services, maintaining confidentiality, and the handling of results. This paper outlines these issues, and, by way of illustration, discusses how one such laboratory addresses them.

Razvoj biofarmaceutika predstavlja izazov u bioetici. Za razliku od uobicajenih lekova male molekulske mase, biofarmaceutici su proteini kompleksne trodimenzionalne strukture koji se dobijaju tehnologijom rekombinantne DNK i tehnikom hibridoma. Imunogenost biofarmaceutika treba uvek proveriti u klinickim studijama zbog male prediktivne prednosti pretklinickih animalnih modela. Medjutim, primati i transgeni sojevi miseva mogu se upotrebiti da bi se naznacili neki aspekti imunogenosti. Znacajni napori su ucinjeni u cilju smanjenja upotrebe primata u razvoju biofarmaceutika, npr. poboljsanja dizajna istrazivanja i promene u zakonskoj regulativi. (...) Osim toga, u ovoj oblasti su aktivne i pojedine ekspertske grupe. Uprkos tome, postoji rastuci trend upotrebe primata izuzev coveka u pretklinickom ispitivanju bezbednosti biofarmaceutika, posebno kada su u pitanju monoklonska antitela. Druga bioeticka pitanja koja se mogu dovesti u vezu sa razvojem biofarmaceutika su odnos njihove cene i efikasnosti, procena bezbednosti u klinickim uslovima, proizvodnja bioloski slicnih lekova i uporedjivanje njihove efikasnosti sa placebom u zemljama u kojima ne postoji namera o plasmanu. Upoznavanje humanog genoma otvorilo je mnoga bioeticka pitanja. Razvoj biofarmaceutika je vazno bioeticko pitanje iz vise razloga. Ono povezuje sve aspekte savremene bioetike: biomedicinu, dobrobit zivotinja i najnovija dostignuca u biotehnologiji. Posebno, razvoj biofarmaceutika je izazov kada je u pitanju lecenje retkih bolesti. (shrink)

This paper will review the strategies and learning trajectories followed to tap the opportunities opened by the successive waves of biotechnologies: early imitators followed by late imitators in the first generation of biosimilars (erythropoietin, insulins, interferons), and then sequential entry and skipping stages during the second generation (monoclonal antibodies).

In an effort to create a mechanism for addressing a critical need of providing medicines for economically developing countries, the Chiron Corporation and the Global Alliance for TB Drug Development have entered into an innovative public-private partnership. In the following interview, Craig Wheeler discusses the origins and nature of this agreement that could set a pattern for how corporations and nonprofit organizations can work together in drug development.

Public discourse on race-specific medicine typically erects a wall between the scientific use of race as a biological category and the ideological battle over race as a social identity. Scientists often address the potential for these therapeutics to reinforce a damaging understanding of “race” with precautions for using them rather than questioning their very development. For example, Esteban Gonzalez Burchard, an associate professor of medicine and biopharmaceutical sciences at the University of California, San Francisco, states, “We do see racial differences (...) between populations and shouldn’t just close our eyes. Unfortunately, race is a politically charged topic, and there will be evildoers. But the fear should not outweigh the benefit of looking.” Although it is recognized that ideology influences thesocialmeaning of race, it is usually assumed that there is a separate, prior scientific understanding of race that is not contaminated by politics. (shrink)

Alzheimer’s disease (AD) may be situated within a cultural landscape produced, in part, by demographics and the marketing strategies of an aggressive biopharmaceutical industry. The simultaneously corporeal and visual domain of advertisements for anti-AD drugs generates dynamic images of gender and embodiment, and it also lends itself to feminist interventions engaging with the images and ideas circulating around aging, medicine and the body. In this article, we investigate advertisements targeting medical practitioners treating patients with AD. Working within a methodological framework (...) we identify as ‘feminist visual studies of technoscience’, we want to propel the discussion in the direction of a broader corpus of medical media. Through this limited exercise, we hope to make a scholarly contribution to the feminist community by critiquing some of the images emerging within popular/scientific media with regard to Alzheimer’s, a disease collectively imagined within an aging Western population. (shrink)

BackgroundThis study presents an empirical investigation of the ethical reasoning and ethical issues at stake in the daily work of physicians and molecular biologists in Denmark. The aim of this study was to test empirically whether there is a difference in ethical considerations and principles between Danish physicians and Danish molecular biologists, and whether the bioethical principles of the American bioethicists Tom L. Beauchamp and James F. Childress are applicable to these groups.MethodThis study is based on 12 semi-structured interviews with (...) three groups of respondents: a group of oncology physicians working in a clinic at a public hospital and two groups of molecular biologists conducting basic research, one group employed at a public university and the other in a private biopharmaceutical company.ResultsIn this sample, the authors found that oncology physicians and molecular biologists employed in a private biopharmaceutical company have the specific principle of beneficence in mind in their daily work. Both groups are motivated to help sick patients. According to the study, molecular biologists explicitly consider nonmaleficence in relation to the environment, the researchers' own health, and animal models; and only implicitly in relation to patients or human subjects. In contrast, considerations of nonmaleficence by oncology physicians relate to patients or human subjects. Physicians and molecular biologists both consider the principle of respect for autonomy as a negative obligation in the sense that informed consent of patients should be respected. However, in contrast to molecular biologists, physicians experience the principle of respect for autonomy as a positive obligation as the physician, in dialogue with the patient, offers a medical prognosis based upon the patients wishes and ideas, mutual understanding, and respect. Finally, this study discloses utilitarian characteristics in the overall conception of justice as conceived by oncology physicians and molecular biologists from the private biopharmaceutical company. Molecular biologists employed at a public university are, in this study, concerned with allocation, however, they do not propose a specific theory of justice.ConclusionThis study demonstrates that each of the four bioethical principles of the American bioethicists Tom L. Beauchamp & James F. Childress – respect for autonomy, beneficence, nonmaleficence and justice – are reflected in the daily work of physicians and molecular biologists in Denmark. Consequently, these principles are applicable in the Danish biomedical setting. (shrink)

In this article the problem of _discoverability_ and _abductive creativity_ in scientific cognition will be characterized by the analysis of current difficulties that affect various aspects of the scientific enterprise such as in the case of the organization of Research and Development in biopharmaceutical companies. I will contend that this case symbolizes a paradigmatic example of what I have called “impoverished epistemic niches” in which it seems that some of the fundamental aspects that qualify modern science are jeopardized. To refer (...) to some recent challenges to the crucial role played in scientific abductive cognition by the so-called “maximization of eco-cognitive openness” and “optimization of eco-cognitive situatedness”, I will propose the new concept of “_epistemic irresponsibility_”. I will emphasize the importance of the so-called _knowledge in motion_ – in multidisciplinary, interdisciplinary, and transdisciplinary scientific research: the concept of knowledge in motion is also the necessary conceptual premise of the analysis of various kinds of epistemic irresponsibility. I indeed will illustrate the current increasing expansion of commodification and commercialization of science, marketing of technoscientific products, impoverishment of the epistemic niches, showing that a consequence is and could further be an attack to the possibility of a further flourishing of human fecund and successful abductive creative cognition in science, and so at the same time human creativity severely compromised. (shrink)

Interventional clinical studies of convalescent plasma to treat COVID-19 were predominantly funded and led by public sector actors, including blood services operators. We aimed to analyze the processes of clinical studies of convalescent plasma to understand alternatives to pharmaceutical industry biopharmaceutical research and development, particularly where public sector actors play a dominant role. We conducted a qualitative, critical case study of purposively sampled prominent and impactful clinical studies of convalescent plasma during 2020-2021.

This article explores the issue of discoverability and abductive creativity in scientific cognition, focusing on the challenges faced by biopharmaceutical companies in their R&D organization. The author argues that these companies are generating “impoverished epistemic niches”, which threaten fundamental aspects of modern science. The author proposes the concept of epistemic irresponsibility, emphasizing the importance of “knowledge in motion” in multidisciplinary, interdisciplinary, and transdisciplinary scientific research. The increasing expansion of commodification and commercialization of science, marketing of technoscientific products, and the impoverishment (...) of epistemic niches seem to already threaten the flourishing of human creativity and successful abductive creative cognition in science. (shrink)

This article examines some of the controversial issues emerging from the privatization of biomedical research and commercialization of biotechnology. The aim is to identify the dominant social, political, and ethical risks associated with the recent shift from academic to corporate science and from the increasing emphasis on investing in research projects that will result in the award of a monopoly patent. Identifying these risks may ultimately assist policy makers in designing new policies or reforming existing practices that will come closer (...) to achieving an equitable balance between science pursued for the advance of knowledge and science pursued for patents and profit. The discussion may also assist the research directors or managers of biopharmaceutical companies in designing corporate policies that will optimize the balance between the serendipity of scientific discovery and the discipline of strategic business planning. (shrink)

The creation of transgenic animals has application in the following areas of pharmaceutical and biomedical research: the production of biopharmaceuticals for human use; the production of organs for xenotransplantation; and the generation of animal models for human genetic diseases. Nuclear transfer technology offers a more precise and efficient way of performing genetic modification and creating transgenic animals than the more traditional method of pronuclear microinjection. This paper will review nuclear transfer as ameans of producing transgenic animals; introduce advantages nuclear (...) transfer technology offers in the field of animal transgenesis; and highlight some of the animal welfare issues and ethical concerns raised by the generation and use of transgenic animals in the aforementioned fields of study. Finally, the influence of objectifying language and terminology used to describe transgenic animals will be considered, and the impact of phrases such as “living bioreactor” and “spare part supplier” examined. (shrink)

Seemingly distant practices of molecular biology and indigenous Xhosa healing have commonalities that I would like to bring into conversation in this article. The preclinical trial of an indigenous medicine brings them together in a research consortium. In this instance, both sets of experts are meant to collaborate in preparing a wild bush for it to pass the tests of the randomized clinical trial (RCT) and to potentially become a biopharmaceutical to counter the tuberculosis pandemic. I aim to tease out (...) how the two sets of actors and their respective practices converge and diverge in their healing hopes and ways of managing uncertainty. Ultimately, I am interested in understanding how the preferred process of making medicine “work” by each set of actors relies upon particular ways of knowing and not knowing life, bringing some ontologies into being, letting others wither away. The shared ways of knowing life as a movement of opening at the edges of the RCT are proposed as paths of recognition between one and the other practice. (shrink)

This article presents results from an empirical investigation of the role and importance of ethics in the daily work of Danish oncologyphysicians and Danish molecular biologists. The study is based on 12 semi-structured interviews with three groups of respondents: a group of oncology physicians working in a clinic at a public hospital and two groups of molecular biologists conducting basic research, one group employed at a public university and the other in a private biopharmaceutical company.We found that oncology physicians consider (...) ethical evaluation as part of their daily work. They discuss how to treat patients in groups and they have interdisciplinary seminars. In contrast, molecular biologists employed at the university do not think that basic research causes significant ethical problems, they do not talk about ethics in their daily work and they do not want to prioritise seminars on ethics. Molecular biologists employed in a private biopharmaceutical company do not think that basic research causes significant ethical problems, but the private company prioritises ethical evaluation. If the company behaves unethical, they will be punished by the consumers and by the investors in the last end. In general, oncology physicians working in the clinic experience a closer relationship between their daily work and ethical problems concerning human beings than molecular biologists conducting basic research. (shrink)

Alzheimer’s disease is emerging into public view in unprecedented ways. Foremost among these is the embodied form of elderly men and women appearing in commercial imagery for patient advocacy groups or pharmaceutical advertisements, but scientific imagery also seeps into the visual media cultures that surround us. The recent reconfiguration of Alzheimer’s disease is due to expanding ageing populations, an aggressive biopharmaceutical industry becoming a fast-growing material-semiotic realm that is providing powerful images of both gendered and racialized embodiment. Such a visual, (...) and yet highly material, realm is in need of feminist interventions, engaging with the images and ideas that circulate around ageing, medicine, human and non-human embodiment. From a non-representationalist and posthumanist perspective identified as feminist visual studies of technoscience, the authors seek to further the discussion in the direction of understanding the ‘scattered ontologies’ of Alzheimer’s — in laboratory practice, the realm of medical media and in commercial appeals to coherent individuality and human cognition — as gendered domains of figural reality and performative matter. (shrink)

BackgroundCORE (Clarity and Openness in Reporting: E3-based) Reference (released May 2016 by the European Medical Writers Association [EMWA] and the American Medical Writers Association [AMWA]) is a complete and authoritative open-access user’s guide to support the authoring of clinical study reports (CSRs) for current industry-standard-design interventional studies. CORE Reference is a content guidance resource and is not a CSR Template.TransCelerate Biopharma Inc., an alliance of biopharmaceutical companies, released a CSR Template in November 2018 and recognised CORE Reference as one of (...) two principal sources used in its development.MethodsThe regulatory medical writing and statistical professionals who developed CORE Reference conducted a critical review of the TransCelerate CSR Template. We summarise our major findings and recommendations in this communication. We also re-examined and edited the Version 1 CORE Reference Terminology Table that we first published in 2016, and we present this as Version 2 in this communication.ResultsOur major critical review findings indicate that opportunities remain to refine the CSR Template structure and instructional text, enhance content clarity, add web links to referenced guidance documents, improve transparency to support the broad readership of CSRs, and develop supporting resources.The CORE Reference ‘Terminology Table’ Version 2 includes estimand as a defined term and an adaptation of the original ‘worked study example’ to incorporate the recently evolved concept of ‘estimands’.ConclusionsAs TransCelerate’s CSR Template represents an important milestone in authoring CSRs, we offer CSR authors advice and recommendations on its use, similarities, and differences with CORE Reference and advise them to consider shared interpretations between the two.RegistrationCORE Reference is registered with the EQUATOR Network. The TransCelerate CSR Template is not registered with any external organisation to the knowledge of the authors of this paper. (shrink)