--- title: "CRISPR: Innovation, Ethics, and Policy" description: "Explore CRISPR Cas9 technology, CRISPR applications, and the latest ethical and policy issues driving innovation in gene editing and CRISPR Cas tech." url: https://www.independentpress.com/article/crispr-innovation-ethics-and-policy date: 2025-12-19 categories: ["Biotechnology","Healthcare"] author: "By Doris Peng" --- # CRISPR: Innovation, Ethics, and Policy ![CRISPR: Innovation, Ethics, and Policy](https://images.ctfassets.net/ewtdlsoyixc1/2QDpwKHcOb0maxQtucmVBA/cb5ee0a2e8455953cba0d1cb99d0a189/thumbnail_DNA_4.jpg) **Introduction** CRISPR-Cas 9 is a gene editing tool that provides researchers with an effective method for editing the DNA of organisms. It is currently one of the biggest breakthroughs in biotechnology. While researchers have used gene editing techniques since the 1960s, the 2012 discovery of CRISPR created a more efficient and affordable way to modify DNA compared to previous methods.1 CRISPR is being increasingly used across various industry sectors worldwide from medicine to agriculture. In Agriculture, CRISPR is being used to create crops that are more disease resistant. Though there is much excitement around the rapid expansion of CRISPR technology and how it relates to human health, there are also many concerns surrounding ethical boundaries and how the technology should be regulated.2 The global expansion of CRISPR is being influenced by a variety of factors from scientific progress to regulatory frameworks, as well as major companies driving commercialization. **Growth of Gene Editing ** ** **As DNA sequencing technology has advanced over the past 10 years, vast amounts of genomic information have been collected offering new possible therapeutic targets – or biological molecules – for treatment or modification. The fortuitous arrival of CRISPR has provided doctors and scientists with a simplified and cost-effective method for making precise edits to DNA.3 Since the discovery of CRISPR, the technology has been used to explore methods of correcting inherited mutations in rare genetic conditions, developing genetically modified immune cell therapies for treatment of various cancer types, developing food crops with increased production levels and much more. CRISPR's gene editing ability theoretically spans across all living organisms; from designing treatment options for rare diseases to creating plants that can better withstand increased temperatures and climate change.4 Scientists have already engineered crops with more drought resistance characteristics and improved production levels. From a clinical perspective, CRISPR's therapeutic capabilities include resolving inherited diseases such as sickle-cell anemia and enhancing existing CAR-T cell cancer therapies.5 The United States and China are currently leading the way in CRISPR-based clinical applications. There are more than 80 active clinical trials worldwide with most of them occurring in the U.S. and China, followed by Europe, and very few occurring in other regions like Africa or South America.6 Cancer represents the dominant area of research for clinical trials. Many trials focus on the use of CRISPR edited immune cells to target tumor cells. Treatments for fighting Beta Thalassemia and Sickle Cell Disease are also among some of the top areas of clinical interest.7 **CRISPR Industry Landscape** Many biotech companies are attempting to take CRISPR technology from theoretical lab experiments to real-life applications. Companies developing CRISPR technologies are seeking to revolutionize medicine and the way we treat disease: - [CRISPR Therapeutics](https://crisprtx.com/) has identified and developed the first CRISPR-based cure in humans for sickle-cell disease and beta-thalassemia.8 - [Editas Medicine](https://www.editasmedicine.com/) is developing potential cures for both eye and blood disorders by attempting to edit individual human genetic sequences directly inside the human body.9 - [Intellia Therapeutics](https://www.intelliatx.com/) is developing CRISPR products to treat liver disease that can be delivered directly into the body using a patient’s own bloodstream.10 - [Caribou Biosciences](https://www.cariboubio.com/) is a biotech company developing cancer therapies employing next-generation CAR-T cell therapy and precision gene editing techniques.11 - [Beam Therapeutics](https://beamtx.com/) is focused on base editing – a precision gene-editing technique that changes DNA bases without cutting the double helix – to treat diseases like sickle-cell disease.12 **Outlook for CRISPR** The CRISPR market has been expanding at an ever-increasing pace. A report from 2024 predicted that the size of the worldwide CRISPR gene editing sector would grow from $4 Billion USD in 2024 to $13.50 Billion USD by 2033 (CAGR ≈ 14.7%).13 A more recent estimate on the CRISPR market has predicted that the industry will grow from $4.6 billion USD in 2025 to $19.3 Billion USD by 2035 (CAGR ≈ 15.3%).14 As of 2025, there have been ~250 gene editing therapeutic clinical trials approved worldwide using CRISPR and other related methods.15 The approval of the first CRISPR medicine for Sickle Cell Disease/β-Thalassemia in 2023 has created an expectation that soon other biotechnology products will emerge from research centers and enter commercial avenues.16 Ultimately, the future of CRISPR will be contingent on sustained advancement towards regulatory approval and increased investment by biopharma companies to develop and scale therapeutic applications. **Ethical Issues** The advancements in CRISPR and genetic modification have created several ethical issues that society will have to confront. One of the most controversial areas in CRISPR research is human germline editing that alters the DNA of embryos and reproductive cells creating changes that will be passed on to future generations. A 2018 case in China involving the first genetically altered human embryos – two female twins who were genetically engineered to be HIV-resistant– was particularly controversial and caused many nations in the international community to quickly affirm their stance prohibiting germline editing for reproduction.17 Several scientific organizations have proposed instituting a 10-year ban on any further germline editing.18 Some major concerns include unknown long-term health impacts, the idea of needing consent from future children, and the risk of creating “designer babies”. Some of the countries that do allow research on embryo gene editing, prohibit the implantation of human embryos after the editing has been completed.19 Issues associated with fairness have added more complexity to the conversation. The first FDA-approved CRISPR therapy that was approved for sickle cell disease cost approximately $2.2 million per patient. The high price tag to CRSIPR related treatments raises concerns that only wealthy individuals and nations will be in line to benefit from genetic cures.20 As the use of CRISPR and gene editing technologies continues to grow, there is a high probability of that the technologies will be used to perpetuate inequalities within society. Imagine a world of haves and have nots where the haves possess both monetary and genetic advantages compared to the rest of society. There are also ethical worries about the unintended consequences from the implementation of untested gene editing technologies. Gene editing could cause inadvertent disruption to natural food chains as well as potentially irreversible ecological impacts on ecosystem functions.21 There are worries that CRISPR-produced crops and live stocks could mix with wild plants and animals in nature. Scientists have urged for strong environmental evaluations, as well as the development of remedial measures to be taken to reverse any potential negative impacts.22 Additional concerns have arisen regarding the creation of pathogens or biological weapons that could threaten global biosecurity. The concerns surrounding gene editing led the U.S. Intelligence Community to include gene editing in its Worldwide Threat Assessment as a potential national security threat.23 Ethical concerns have compelled scientists and other experts to advocated for the development of stronger global regulations covering the gene editing industry, improved laboratory safety protocols, and the creation of anti-CRISPR systems.24 **Global Policy Landscape** CRISPR policy regulation is highly fragmented across the world. In the United States, somatic gene editing is allowed under FDA regulation, however germline editing is completely prohibited due to legal restrictions on the FDA. The oversight of gene editing technologies is divided among multiple regulatory agencies, adding complexity and inertia to the industry’s development. For example, a genetically engineered chestnut tree altered through CRISPR would need to win approval from USDA, FDA, and EPA before it could be planted in the environment.25 In the European Union, the regulatory environment is even stricter than in the United States. Under European regulations, CRISPR-generated crops fall under strict genetically modified organisms (GMOs) rules established by the European Court of Justice ruling in 2018. These and other rulings have slowed the development and commercial introduction of all GMOs in Europe.26 Countries like Germany historically have passed restrictive laws governing the genetic manipulation of embryos, such as the Embryo Protection Act which restricts the establishment or manipulation of embryos for research purposes.27 The EU's “safety-first” policy approach has contributed to slower European advancements in the field of genetic editing compared to far less restrictive policies in the United States. Following the embryo editing scandal of 2018, China implemented stricter regulations for germline editing. In particular, the government clarified that germline editing requires government consent and that those conducting unethical research would face harsher penalties. In addition, human gene editing technologies were placed on China’s national export control list in 2023.28 Japan has a strict ethical review process that only allows gene editing on embryos for research purposes and completely bans the implantation of embryos. **Conclusion** The global evolution of CRISPR technology shows the interplay between science, ethics and regulations. The technology has expanded quickly because it offers a powerful and efficient way to edit DNA, which in turn has accelerated advances in medical, agricultural, and industrial applications. At the same time, ethical questions around germline editing, fairness, ecological risks, and biosecurity remind us that CRISPR’s benefits cannot be separated from its responsibilities. Policy responses around the world also reflect these tensions. Ultimately, the evolution of CRISPR technology will depend upon maintaining an appropriate balance between scientific progress and ethics, equitable access and the availability of well-regulated CRISPR technology. Maintaining this balance will be critical to provide significant global benefits from CRISPR technology, and for avoiding the erosion of public trust and reducing future progress. --- **Footnotes:** 1 [https://news.stanford.edu](https://news.stanford.edu/stories/2024/06/stanford-explainer-crispr-gene-editing-and-beyond#therapy) 2[ https://thebulletin.org]( https://thebulletin.org/2018/06/crispr-goes-global-a-snapshot-of-rules-policies-and-attitudes/ 3https://pmc.ncbi.nlm.nih.gov/articles/) 3[https://pmc.ncbi.nlm.nih.gov](https://pmc.ncbi.nlm.nih.gov/articles/) 4 [https://www.labiotech.eu](https://www.labiotech.eu/in-depth/crispr-cas9-review-gene-editing-tool/) 5 Ibid 6[https://www.researchgate.net](https://www.researchgate.net/publication/386018488_CRISPR_CLIP_Comprehensive_Reviews_on_Interventional_Studies_using_Precision_Recombinant_Technologies_Clinical_Landmarks_Implications_and_Prospects#:~:text=utilizing%20CRISPR%20and%20revealed%20four,Discussion) 7 Ibid 8 [https://crisprtx.com/](https://crisprtx.com/) 9 [https://www.editasmedicine.com/](https://www.editasmedicine.com/) 10 [https://www.intelliatx.com/](https://www.intelliatx.com/) 11 [https://www.cariboubio.com/](https://www.cariboubio.com/) 12 [https://beamtx.com/](https://beamtx.com/) 13 [https://www.grandviewresearch.com](https://www.grandviewresearch.com/industry-analysis/crispr-based-gene-editing-market-report) 14[ https://www.futuremarketinsights.com]( https://www.futuremarketinsights.com/reports/crispr-market?) 15 [https://www.sciencedirect.com](https://www.sciencedirect.com/science/article/) 16[ https://pmc.ncbi.nlm.nih.gov]( https://pmc.ncbi.nlm.nih.gov/articles/) 17 [https://www.statnews.com](https://www.statnews.com/2025/05/13/scientific-societies-call-for-ten-year-moratorium-on-germline-gene-editing-crispr/) 18 Ibid 19 [https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org](https://crispr-gene-editing-regs-tracker.geneticliteracyproject.org/japan-germline-embryonic/) 20 [https://www.reuters.com](https://www.reuters.com/business/healthcare-pharmaceuticals/vertexcrispr-price-sickle-cell-disease-gene-therapy-22-mln-2023-12-08/) 21 [https://thebulletin.org](https://thebulletin.org/2018/06/crispr-goes-global-a-snapshot-of-rules-policies-and-attitudes/) 22 Ibid 23[ https://pmc.ncbi.nlm.nih.gov]( https://pmc.ncbi.nlm.nih.gov/articles/) 24 Ibid 25[ https://www.thecgo.org]( https://www.thecgo.org/research/can-gene-editing-increase-ecosystem-and-species-resilience/) 26[ https://www.labiotech.eu]( https://www.labiotech.eu/in-depth/crispr-cas9-review-gene-editing-tool/) 27 [https://thebulletin.org](https://thebulletin.org/2018/06/crispr-goes-global-a-snapshot-of-rules-policies-and-attitudes/) 28[ https://www.scsp.ai]( https://www.scsp.ai/reports/2025-gaps-analysis/gaps-analysis/synthetic-biology/) ****