Bayer and Broad Institute Extend Research Collaboration to Develop New Cardiovascular Therapies




Bayer and Broad Institute Extend Research Collaboration to Develop New Cardiovascular Therapies

• Focus on joint discovery of novel therapeutic approaches based on findings in human genomics research related to cardiovascular diseases
• Current efforts focused on treatment options for specific forms of cardiovascular disease such as dilated cardiomyopathy
• Phase I clinical study in healthy volunteers for development of new treatment for patients with atrial fibrillation recently initiated
• Extended collaboration to further strengthen Bayer’s precision cardiology pipeline

BERLIN & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Bayer and the Broad Institute today announced that they have extended their research collaboration of 10 years by an additional five years, to further advance findings in human genomics research in cardiovascular diseases. The expanded agreement will focus on joint precision cardiology target identification, leveraging the established human cardiomyocyte platform to rapidly validate observations, and discovery of novel therapeutic approaches.

Current efforts are directed to develop potential treatment options for patients with specific forms of cardiovascular disease such as dilated cardiomyopathy (DCM), amongst others. DCM is a type of heart disease characterized by the enlargement of the heart’s chambers, which leads to a decreased ability to pump blood effectively. This condition can result in heart failure and other complications if left untreated.¹

Established in 2013, this longstanding collaboration combines the Broad Institute’s extensive expertise in genomics and biology with Bayer’s in-depth experience in small, chemically manufactured molecules and biologics drug discovery to advance drug discovery research for novel cardiovascular therapeutics. This strategic research alliance already has resulted in a number of joint publications and conference presentations, and it has paved the way for Bayer’s announcement in May 2025 regarding the initiation of a Phase I study with its investigational highly selective G-protein-coupled inwardly rectifying potassium channel 4 (GIRK4) inhibitor which has a potential to help control the electrical activity of heart cells in patients with atrial fibrillation (AFib).

“We are constantly evaluating novel approaches to treat cardiovascular diseases that affect millions of people worldwide. Our shared commitment is to explore novel therapeutic targets and modalities in various cardiovascular and renal diseases to help deliver new treatment options to patients in need,” said Andrea Haegebarth, Ph.D., Global Head of Research and Early Development for Cardiovascular, Renal, and Immunology at Bayer’s Pharmaceuticals Division. “The first joint therapeutic project entered the clinic last month and we are excited to collaborate further with the esteemed scientists at the Broad Institute to identify and develop disease-modifying therapeutics treating underlying causes of cardiovascular diseases.”

“I am delighted to see Broad and Bayer continue this fruitful collaboration in cardiovascular research,” said Todd Golub, director and founding core member of the Broad Institute. “By working together, Broad and Bayer are able to make advances that neither organization could make on its own.”

Academic collaborations are integral to Bayer’s research and development strategy, aimed at delivering innovative treatment solutions to patients, particularly in areas with significant unmet medical needs, such as cardiovascular health. Bayer’s strategic focus in cardiovascular research emphasizes precision drug development, facilitating the rapid identification of the most promising targets and commercially viable programs.

Bayer with its Bayer Research & Innovation Center (BRIC) is closely located to the Broad Institute in Kendall Square, Cambridge, MA. BRIC houses a center of precision oncology research as well as an experienced team of scientists focused on research and early development for developing precision cardiovascular, renal, and immunology therapeutics. BRIC is also home to Bayer Co.Lab Cambridge which is part of a pioneering global network of life science incubators focused on disruptive innovation and scientific breakthroughs.

Financial details have not been disclosed.

About Bayer’s Commitment in Cardiovascular Diseases

Bayer is a leader in cardiology and is advancing a portfolio of innovative treatments in cardiovascular (CV) diseases of high unmet medical need. The strategy is to unlock the strong potential of the future CV market by transforming Bayer’s portfolio into precision cardiology, addressing the high CV disease burden, and driving the long-term growth. Bayer’s portfolio already includes several innovative products as well as compounds in various stages of preclinical and clinical development.

About Bayer

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

Find more information at https://pharma.bayer.com/
Follow us on Facebook: http://www.facebook.com/bayer

aka (2025e-0114)

Forward-Looking Statements

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Contacts

Bayer Global Media Contact:

Derin Denham, phone +1 973 610 7324
Email: derin.denham@bayer.com

Bayer U.S. Media Contact:

Elaine Colon, phone +1 732 236 1587
Email: elaine.colon@bayer.com

Mirum Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)




Mirum Pharmaceuticals Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

FOSTER CITY, Calif.–(BUSINESS WIRE)–Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that on June 10, 2025, the Compensation Committee of Mirum’s Board of Directors granted inducement awards consisting of non-qualified stock options to purchase 115,620 shares of common stock and 57,740 restricted stock units (“RSUs”) to 10 new employees under Mirum’s 2020 Inducement Plan. The Compensation Committee of Mirum’s Board of Directors approved the awards as an inducement material to the new employees’ employment in accordance with Nasdaq Listing Rule 5635(c)(4).

Each stock option has an exercise price per share equal to $48.98 per share, Mirum’s closing trading price on June 10, 2025, and will vest over four years, with 25% of the underlying shares vesting on the one-year anniversary of the applicable vesting commencement date and the balance of the underlying shares vesting monthly thereafter over 36 months, subject to the new employees’ continued service relationship with Mirum through the applicable vesting dates. The RSUs will vest over three years, with 33% of the underlying shares vesting on each anniversary of the applicable vesting commencement date, subject to the new employees’ continued service relationship with Mirum through the applicable vesting dates. The awards are subject to the terms and conditions of Mirum’s 2020 Inducement Plan and the terms and conditions of an applicable award agreement covering the grant.

About Mirum Pharmaceuticals, Inc.

Mirum Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Mirum has three approved medications: LIVMARLI® (maralixibat), CHOLBAM® (cholic acid) capsules, and CTEXLI™ (chenodiol) tablets.

LIVMARLI, an IBAT inhibitor, is approved for the treatment of two rare liver diseases affecting children and adults. It is approved for the treatment of cholestatic pruritus in patients with Alagille syndrome in the U.S. (three months and older), in Europe (two months and older), and in other regions globally. It is also approved in the U.S. in cholestatic pruritus in PFIC patients 12 months of age and older; in Europe, it is approved for patients with PFIC three months of age and older. Mirum is also initiating the Phase 3 EXPAND study, a label expansion opportunity for LIVMARLI in additional settings of cholestatic pruritus. CHOLBAM is FDA-approved for the treatment of bile acid synthesis disorders due to single enzyme deficiencies and adjunctive treatment of peroxisomal disorders in patients who show signs or symptoms of liver disease. CTEXLI is FDA-approved for the treatment of cerebrotendinous xanthomatosis (CTX) in adults.

Mirum’s late-stage pipeline includes two investigational treatments for several rare diseases. Volixibat, an IBAT inhibitor, is being evaluated in two potentially registrational studies including the Phase 2 VISTAS study for primary sclerosing cholangitis (PSC) and Phase 2b VANTAGE study for primary biliary cholangitis (PBC). Volixibat has been granted Breakthrough Therapy Designation for the treatment of cholestatic pruritus in patients with PBC. Mirum is also planning for a Phase 2 study evaluating MRM-3379, a PDE4D inhibitor for the treatment of Fragile X syndrome, a rare genetic neurocognitive disorder.

To learn more about Mirum, visit mirumpharma.com and follow Mirum on Facebook, LinkedIn, Instagram and X.

Contacts

Investor Contact:
Andrew McKibben

ir@mirumpharma.com

Media Contact:
Erin Murphy

media@mirumpharma.com

Global Healthy Living Foundation Peer-Reviewed Research Shows Hidden Risks of the Inflation Reduction Act’s Drug Pricing Reform




Global Healthy Living Foundation Peer-Reviewed Research Shows Hidden Risks of the Inflation Reduction Act’s Drug Pricing Reform

Report reveals potential for higher patient costs, worse health outcomes despite lower “fair prices”

UPPER NYACK, N.Y.–(BUSINESS WIRE)–The Global Healthy Living Foundation (GHLF) has launched a research-backed public education campaign to raise awareness about the unintended consequences of drug pricing reforms under the Inflation Reduction Act (IRA). This initiative stems from a recent peer-reviewed paper co-authored by GHLF’s Chief Science Policy Officer, Dr. Robert Popovian, Pharm.D., MS, published in the Journal of Health Economics and Outcomes Research (JHEOR). It includes a podcast episode, an infographic, and an article aimed at informing patients, caregivers, and policymakers.

“The IRA’s “maximum fair price” (MFP) policy was designed to reduce out-of-pocket costs for Medicare patients. However, it may lead to the opposite: higher out-of-pocket costs and increased health risks for vulnerable patients,” report author Dr. Popovian says

“By suppressing the retail price, CMS is reducing the profit margins and revenue for pharmacy benefit managers (PBMs), which is good. Predictably, the PBMs will not stand pat—they can shift the drug to a higher formulary tier, where patients will pay more out-of-pocket to acquire the medicine so the PBM can protect its profit margin,” said Dr. Popovian in a recent episode of GHLF’s Healthcare Matters podcast.

The study specifically modeled outcomes for two widely used blood thinners, Eliquis and Xarelto. If PBMs reclassify these drugs to higher cost tiers to compensate for lost profit, patients could face an estimated $688 million more in out-of-pocket costs. This cost-shift could result in over 320,000 patients abandoning treatment, potentially leading to 145,000 major cardiovascular events and up to 97,000 deaths.

“This research underscores a serious gap in how drug pricing reforms are being implemented and monitored,” said Dr. Popovian. “Without proper oversight and transparency, policies that were meant to help patients could end up hurting them.”

The GHLF education campaign includes:

• A peer-reviewed paper published in JHEOR: “Could the Inflation Reduction Act Maximum Fair Price Hurt Patients?”
• A patient-friendly article: “Lower Prices, Higher Risk: How Drug Reform Could Backfire on Patients” published on GHLF’s website and supported by social media
• A special podcast episode of Healthcare Matters, co-hosted by Dr. Popovian
• A downloadable infographic explaining the findings at-a-glance

“This campaign is not about politics—it’s about patients,” said Seth Ginsberg, GHLF Co-Founder and President. “We want people to understand what’s at stake when reforms don’t account for the full complexity of our health care system.”

GHLF encourages policymakers, journalists, and patient advocates to explore these resources and consider how reforms like the IRA impact access to critical medications.

About GHLF

The Global Healthy Living Foundation is a U.S. based, 501(c)(3) nonprofit, international organization whose mission is to improve the quality of life for people with chronic illnesses by advocating for improved access to health care through education, patient-centered clinical research, support, advocacy, and economic and policy research. GHLF is also a staunch advocate for vaccines. The Global Healthy Living Foundation is the parent organization of CreakyJoints®, the international, digital community for millions of people living with arthritis and their supporters worldwide who seek education, support, activism, and patient-centered research in English, Spanish, and French. In addition to arthritis and autoimmune disorders, GHLF supports dermatology, gastroenterology, neurology, cardiology, oncology, infectious disease, rare disease, and pulmonary patients through a host of different programs and activities which draw more than 700,000 patients a month to GHLF websites and create more than 10 million impressions a month on seven social media platforms. In 2024, GHLF had more than 1 million views and listens with its patient-centered audio-visual content, found on YouTube and podcast platforms. GHLF never asks the public for donations, receiving funding instead through governments, non-governmental organizations, foundations, industry, family foundations, and GHLF Co-Founder Louis Tharp. Visit www.ghlf.org for more information.

Contacts

Louis Tharp

ltharp@ghlf.org
www.ghlf.org

Johnson & Johnson Elects Daniel Pinto, President, JPMorganChase to its Board of Directors




Johnson & Johnson Elects Daniel Pinto, President, JPMorganChase to its Board of Directors

NEW BRUNSWICK, N.J.–(BUSINESS WIRE)–Johnson & Johnson (NYSE: JNJ) announced today that Daniel Pinto, President, JPMorganChase, has been elected to its Board of Directors.

“We are thrilled to have Daniel join Johnson & Johnson’s Board of Directors,” said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. “He is an exceptional leader with deep financial expertise and understanding of global capital markets. Daniel’s unique perspective and wealth of experience will be a tremendous asset to Johnson & Johnson as we continue to invest in and advance the next generation of healthcare innovation for patients.”

“I’ve long admired Johnson & Johnson’s continued investment in scientific innovation and its commitment to improving health outcomes for patients facing the most challenging diseases,” said Daniel Pinto. “It’s an honor to join Johnson & Johnson’s board of directors and serve alongside board members who are dedicated to improving the health and well-being of communities around the world.”

About Daniel Pinto

Mr. Pinto is a prominent business leader with more than three decades of financial expertise helming critical leadership roles within JPMorganChase, one of the world’s preeminent global financial services firms, where he currently serves as President and as a member of the Company’s Operating Committee.

Mr. Pinto has spent his career at JPMorganChase and its predecessor companies. He began as a financial analyst and foreign exchange trader at Manufacturers Hanover in 1983 in Buenos Aires. In 1992, he was appointed head of Sales for Chemical Bank and, shortly after, became head trader and Treasurer of Chemical Bank in Mexico. Daniel moved to London in 1996 to oversee local markets in Eastern Europe, the Middle East, Africa and Asia for Chase Manhattan, later taking charge of the markets side of the firm’s emerging-market business.

In early 2006, Mr. Pinto was made global head of Emerging Markets, later expanding his remit to include Global Credit Trading & Syndicate and Global Fixed Income for the Investment Bank. He was made co-CEO of the Corporate & Investment Bank in 2012 and became sole CEO in 2014.

In January 2018, he was named Co-President and Chief Operating Officer of JPMorganChase to work closely with the CEO and the Board to identify and pursue critical firmwide opportunities. He became sole President and COO in January 2022. In January 2025, he announced that he would retire from the company at the end of 2026. He retains the role of President until June 30th, 2025, and will then serve as Vice Chairman of the company through 2026.

Mr. Pinto holds a bachelor’s degree in Public Accounting and Business Administration from Universidad Nacional de Lomas de Zamora in Buenos Aires. He is a member of the Board of Directors of the Institute of International Finance.

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Contacts

Media:
media-relations@its.jnj.com

Investors:

investor-relations@its.jnj.com

Arcus Biosciences Announces New Employment Inducement Grants




Arcus Biosciences Announces New Employment Inducement Grants

HAYWARD, Calif.–(BUSINESS WIRE)–Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for people with cancer, today announced that the Compensation Committee of the Company’s Board of Directors granted two new employees options to purchase a total of 8,400 shares of the Company’s common stock at an exercise price per share of $9.85, which was the closing price on June 9, 2025, and restricted stock units to acquire a total of 4,200 shares of the Company’s common stock. The equity awards were granted pursuant to the Company’s 2020 Inducement Plan, which was approved by the Company’s Board of Directors in January 2020 pursuant to the “inducement exception” under NYSE Listed Company Manual Rule 303A.08.

About Arcus Biosciences

Arcus Biosciences is a clinical-stage, global biopharmaceutical company developing differentiated molecules and combination therapies for people with cancer. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of first- or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has advanced multiple investigational medicines into registrational clinical trials including domvanalimab, an Fc-silent anti-TIGIT antibody being studied in combination with zimberelimab, an anti-PD-1 antibody, for upper gastrointestinal and non-small cell lung cancer, casdatifan, a HIF-2a inhibitor for clear cell renal cell carcinoma, and quemliclustat, a small-molecule CD73 inhibitor for pancreatic cancer. For more information about Arcus Biosciences’ clinical and preclinical programs, please visit www.arcusbio.com.

Inducement PR

Source: Arcus Biosciences

Contacts

Investor Inquiries:
Pia Eaves

VP of Investor Relations & Strategy

(617) 459-2006

peaves@arcusbio.com

Media Inquiries:
Holli Kolkey

VP of Corporate Communications

(650) 922-1269

hkolkey@arcusbio.com

Maryam Bassiri

AD, Corporate Communications

(510) 406-8520

mbassiri@arcusbio.com

Backing the Future of Global Biotech: Reynold Lemkins’ Strategy Across Borders and Stages




Backing the Future of Global Biotech: Reynold Lemkins’ Strategy Across Borders and Stages

HONG KONG–(BUSINESS WIRE)–#biotech—Reynold Lemkins Group, an international investment firm focused on value-driven cross-border capital deployment, announced the continued advancement of its strategic focus in late-stage healthcare, AI-powered therapeutics, and Asia-centered biotech commercialization.

As part of this strategy, Reynold Lemkins recently participated in the IPO of VISEN Pharmaceuticals on the Hong Kong Stock Exchange (HKEX: 02561). VISEN, a biopharmaceutical company specializing in long-acting growth hormone therapies, attracted strong institutional demand and represents the kind of regulatory-validated, commercially scalable business the firm targets. Reynold Lemkins invested alongside globally recognized healthcare investors including HongShan Capital Group (previously Sequoia China), Sofinnova, Vivo Capital, OrbiMed, and WuXi Biologics (HKEX: 2269), reinforcing its commitment to cross-border innovation and long-term capital alignment.

This investment underscores Reynold Lemkins’ broader strategy of supporting science-driven, late-stage companies with scalable market potential—particularly those operating at the convergence of AI, therapeutics, and Asia-Pacific commercialization.

“Our approach focuses on more than capital—we provide strategic insight and cross-border connectivity to help companies scale,” said Kris Haoran Liu, President and Chief Investment Officer at Reynold Lemkins Group. “Biotech firms entering public markets need partners who understand both the science and the structure of global growth.”

With Asia playing an increasingly pivotal role in global healthcare, Reynold Lemkins sees a growing need for capital strategies that link scientific innovation with scalable regional execution. At the same time, the firm closely tracks trends in the U.S. and other mature markets, where biotech companies are navigating longer paths to liquidity and require strategic partners with global reach. Reynold Lemkins positions itself at this intersection—bridging East and West, public and private markets—to support companies shaping the next era of patient-centered care.

To learn more, visit www.reynoldlemkins.com, follow us on LinkedIn, or explore our insights on Medium.

Contacts

Reynold Lemkins Group

reynoldlemkins@reynoldlemkins.com

20/20 Onsite Expands Mobile Vision Fleet, Strengthening Nationwide Reach and Clinical Trial Support Capacity




20/20 Onsite Expands Mobile Vision Fleet, Strengthening Nationwide Reach and Clinical Trial Support Capacity

BOSTON–(BUSINESS WIRE)–20/20 Onsite, the leading provider of point-of-need ophthalmic services for clinical trials, announces the deployment of its latest mobile vision clinic, bringing its fleet to 16 units, including a mix of mobile clinics, pods, and suites. The new unit hit the road in early May and is now fully operational, enabling 20/20 Onsite to support a higher tempo of decentralized and hybrid clinical trials nationwide.

This milestone reinforces 20/20 Onsite’s ability to scale with sponsors, CROs, and sites, offering advanced, patient-centric ophthalmic services at trial sites nationwide.

“Most people don’t realize just how expansive our fleet has become,” said Sonali Bloom, CEO at 20/20 Onsite. “With 16 units now in operation and more coming due to high demand, we can get to a patient anywhere in the country in 2 days or less. We can confidently say we’re built to provide advanced ophthalmic support to trials with dozens of sites across multiple geographic regions.”

20/20 Onsite has supported over 45 clinical trials, conducted 85,000+ point-of-need patient visits, and continues to position itself to meet the rising demand for ocular endpoint protection in hybrid or decentralized trials.

The new unit is already deployed on active trials and staffed with certified technicians and optometrists equipped to deliver best-in-class imaging and eye assessments. As the 20/20 Onsite fleet expands, it ensures trial continuity by simplifying patient logistics and reducing travel burden, making it easier for sponsors to retain participants, meet study timelines, and protect ocular endpoints.

About 20/20 Onsite

20/20 Onsite is a clinical trial solutions company specializing in quality ocular endpoint protection through its nationwide point-of-need fleet. By bringing advanced ophthalmic assessments directly to clinical trial participants—whether at sites, homes, or community locations—20/20 Onsite makes it easier for sponsors, CROs, and sites to collect critical data, reduce patient burden, and improve trial outcomes.

20/20 Onsite has supported over 45 clinical trials, served more than 85,000 patients, achieved 100% of screening timelines, and consistently delivered patient Net Promoter Scores (NPS) above 95.

To learn more about how 20/20 Onsite delivers quality ocular endpoint protection at scale, visit www.2020onsite.com.

Contacts

Media Contact:
Josh Anderson

Senior Director of Marketing

janderson@2020onsite.com

Agenus Announces Virtual Annual Shareholders Meeting




Agenus Announces Virtual Annual Shareholders Meeting

LEXINGTON, Mass.–(BUSINESS WIRE)–Agenus Inc. (“Agenus”) (NASDAQ: AGEN), a leader in immuno-oncology innovation, today announced that its Annual Shareholders Meeting will begin at 10:30 a.m. ET on June 17, 2025, and will be conducted in a virtual format only. Registration for attendees will start at 10:15 a.m. ET.

To participate in the Annual Shareholders Meeting, shareholders should visit www.virtualshareholdermeeting.com/AGEN2025 and enter the 16-digit control number found in their proxy materials. Guests may also access the Annual Shareholders Meeting, but in listen-only mode. No control number is required for guests.

Webcast Information:

Date: Tuesday, June 17, 2025

Time: 10:30 a.m. ET

A live webcast and replay will be accessible on the Company’s website at https://investor.agenusbio.com/events-and-presentations and at www.virtualshareholdermeeting.com/AGEN2025.

Voting Information:

Shareholders of Agenus as of the April 24th, 2025, record date can vote. Alliance Advisors, Agenus’s proxy solicitor, can assist shareholders with voting at 844-202-6561 or AGEN@AllianceAdvisors.com.

About Agenus

Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants (through SaponiQx). Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels.

Contacts

Investors
917-362-1370

investor@agenusbio.com

Media
781-674-4422

communications@agenusbio.com

Top Players Shaping the Future of the Preimplantation Genetic Testing Market – ResearchAndMarkets.com




Top Players Shaping the Future of the Preimplantation Genetic Testing Market – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Preimplantation Genetic Testing Market – Global Industry Size, Share, Trends, Opportunity, and Forecast, 2020-2030F” has been added to ResearchAndMarkets.com’s offering.

The Preimplantation Genetic Testing Market was valued at USD 0.66 Billion in 2024 and is expected to reach USD 1.05 Billion by 2030, rising at a CAGR of 8.20%.

Preimplantation Genetic Testing (PGT) is a pivotal procedure within assisted reproductive technologies, primarily used during in vitro fertilization (IVF) to screen embryos for genetic abnormalities prior to implantation.

The two key types of PGT include PGT-A, which identifies chromosomal aneuploidies, and PGT-M, which detects monogenic disorders. This testing enhances the chances of a successful pregnancy and reduces the risk of transmitting hereditary diseases. With its capacity to improve embryo selection and mitigate genetic risks, PGT is gaining traction globally, especially among couples with known genetic predispositions. Growing awareness, advancements in genetic diagnostics, and increased access to fertility services are fueling the expansion of this market.

Key Market Drivers

Rising Incidence of Genetic Disorders: A major factor propelling the preimplantation genetic testing market is the increasing prevalence of genetic disorders across global populations. These conditions affect a significant percentage of live births and early-life diagnoses, with approximately 5.3% of individuals worldwide being diagnosed with a genetic condition by age 25. This rising incidence has heightened the demand for early detection and intervention solutions, particularly among couples with hereditary risk factors.

In regions such as the Middle East and North Africa, where consanguineous marriages are prevalent, the uptake of PGT is particularly strong due to elevated genetic risks. PGT offers a proactive approach to identifying embryos unaffected by hereditary diseases, improving reproductive outcomes and reducing long-term healthcare burdens. Its adoption is further supported by growing public and clinical awareness about genetic disorders and their impact on offspring health.

Key Market Challenges

Ethical And Moral Concern: Ethical and moral concerns surrounding the use of PGT remain a prominent challenge in the market. The technology’s potential to enable selection based on non-medical traits – such as physical appearance or cognitive abilities – raises fears of societal discrimination and the possible emergence of “designer babies.” These concerns fuel debates about fairness, equity, and human diversity.

Additionally, the screening and possible discarding of embryos with genetic conditions is a contentious issue, particularly in societies where abortion and embryo manipulation are morally or religiously opposed. Such dilemmas pose regulatory hurdles and may limit acceptance and accessibility in certain regions, thereby restraining the market’s growth despite its clinical potential.

Key Market Trends

Growing Number of Fertility Clinics Offering Preimplantation Genetic Testing (PGT) Services: An expanding network of fertility clinics offering PGT services is a notable trend boosting market accessibility and growth. As these clinics extend their reach into diverse geographies, patients in both urban and remote areas gain improved access to advanced reproductive and genetic services. The integration of PGT into fertility clinic offerings enhances the convenience of comprehensive care by combining IVF and genetic diagnostics under one roof.

This growing availability fosters competitive service provision, technological innovation, and cost efficiencies. Furthermore, broader adoption of PGT in clinical settings is accelerating advancements in testing accuracy, turnaround times, and scope, including the ability to detect an expanded range of genetic abnormalities – thereby improving patient outcomes and expanding the market’s potential.

Key Market Players:

• California Pacific Medical Center (CPMC)
• CombiMatrix Corp
• CooperSurgical, Inc.
• F. Hoffmann-La Roche Ltd.
• Genea Limited
• Genesis Genetics
• Good Start Genetics, Inc.
• IGENOMIX
• Illumina, Inc.
• Invitae Corporation
• Laboratory Corporation of America Holdings

Report Scope:

In this report, the Global Preimplantation Genetic Testing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Preimplantation Genetic Testing Market, By Procedure:

• Preimplantation Genetic Screening
• Preimplantation Genetic Diagnosis

Preimplantation Genetic Testing Market, By Product:

• Reagents and Consumables
• Instruments
• Software

Preimplantation Genetic Testing Market, By Technology:

• Next Generation Sequencing (NGS)
• Polymerase Chain Reaction (PCR)
• Fluorescent In-Situ Hybridization (FISH)
• Others

Preimplantation Genetic Testing Market, By Application:

• Chromosomal Abnormalities
• X-linked Diseases
• Embryo Testing
• Aneuploidy Screening
• HLA Typing
• Other

Preimplantation Genetic Testing Market, By End User:

• Fertility Centers
• Hospitals
• Diagnostic Centers
• Research Centers and Academic Labs

Preimplantation Genetic Testing Market, By Region:

• North America
  • United States
  • Canada
  • Mexico
• Europe
  • France
  • United Kingdom
  • Italy
  • Germany
  • Spain
• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

For more information about this report visit https://www.researchandmarkets.com/r/2l3alm

About ResearchAndMarkets.com

ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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Navigating Ethical Challenges: Regulatory Considerations in the Global Cloning & Mutagenesis Market – ResearchAndMarkets.com




Navigating Ethical Challenges: Regulatory Considerations in the Global Cloning & Mutagenesis Market – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Cloning & Mutagenesis Market – Global Industry Size, Share, Trends, Opportunity, and Forecast, 2020-2030F” has been added to ResearchAndMarkets.com’s offering.

The Cloning & Mutagenesis Market was valued at USD 2.67 Billion in 2024 and is expected to reach USD 7.58 Billion by 2030, rising at a CAGR of 18.99%.

This market is witnessing rapid growth, largely fueled by expanding applications of cloning techniques in fields such as genetic and reproductive research. The increasing number of product launches involving cloning and mutagenesis kits, along with rising governmental investment in stem cell research for therapeutic development, is further driving demand.

Additionally, the global rise in the aging population-more susceptible to chronic illnesses and metabolic disorders-is expected to significantly contribute to market expansion. Heightened awareness of gene therapy benefits and early diagnostic tools, combined with increased healthcare spending on chronic disease management, also supports the market’s growth trajectory. Moreover, the global burden of diseases like head and neck cancer continues to drive demand for genetic engineering tools for advanced treatment solutions.

Key Market Drivers: Rising Demand for Genetically Engineered Products in Biotechnology and Pharmaceuticals

The global demand for genetically engineered products is one of the major growth catalysts for the cloning and mutagenesis market. These technologies are vital in developing new drugs, gene therapies, vaccines, and synthetic biological products. Cloning and mutagenesis techniques allow scientists to manipulate genes for desired traits, making them indispensable in genetic research and biopharmaceutical manufacturing.

Significant public investments reinforce this trend- for instance, the U.S. Department of Health and Human Services allocated over $2.5 billion to BARDA in 2023 to support advanced vaccine and therapeutic development, much of which relies on gene manipulation techniques. Similarly, under its Horizon Europe framework, the European Commission has earmarked over €1 billion for health innovation, focusing on gene-based solutions and personalized medicine.

Key Market Challenges: Ethical and Regulatory Concerns Around Genetic Manipulation

The ethical and regulatory landscape surrounding genetic engineering poses a major challenge for the cloning and mutagenesis market. Concerns about biosafety, environmental impact, and moral implications, especially in human applications like germline editing and embryonic cloning, have led to global scrutiny. While somatic cell gene editing is generally accepted, public and institutional opposition to germline modifications persists.

Following incidents like the unauthorized editing of human embryos in 2018, regulatory bodies such as the WHO and UNESCO have called for stricter oversight. Regulatory inconsistencies between regions further complicate the market-while agencies like the FDA and EMA allow controlled gene therapy, other countries enforce bans on certain genetic techniques. The EU, for example, imposes rigorous regulations on GMOs, often delaying their approval. These regulatory and ethical hurdles not only slow innovation but also increase compliance costs, especially for companies operating in sensitive sectors like human therapeutics and agricultural biotechnology.

Key Market Trends: Integration of Artificial Intelligence in Genetic Engineering Workflows:

The adoption of artificial intelligence in genetic research is a transformative trend in the cloning and mutagenesis market. AI and machine learning technologies are being increasingly utilized to automate gene synthesis, select optimal mutagenesis sites, design primers, and predict protein behavior after mutation. These tools help researchers conduct high-precision experiments more efficiently and cost-effectively.

AI-driven analysis of large genomic datasets enables faster identification of gene targets and potential phenotypic outcomes, streamlining drug development and genetic research. Government support is also fostering this integration. For instance, the U.S. has prioritized AI in healthcare through the National Artificial Intelligence Initiative Act and allocated over $1.5 billion for related research in 2023. Similarly, Europe’s Horizon Europe program promotes AI-based innovation in biotechnology.

As AI systems become more advanced and widely adopted, their impact on genetic engineering is expected to enhance the reproducibility, speed, and accuracy of cloning and mutagenesis experiments across the pharmaceutical, agricultural, and research sectors.

Key Market Players:

• Agilent Technologies, Inc.
• Eurofins Scientific SE
• Sartorius AG
• Collecta, Inc.
• Codex DNA Inc.
• Lonza Group AG
• Charles River Laboratories International, Inc.
• TransGene Biotech Co. Ltd.
• Takara Bio, Inc.
• Thermo Fisher Scientific Inc.

Key Attributes:

Report Scope: In this report, the Global Cloning & Mutagenesis Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Cloning & Mutagenesis Market, By Gene Type:

• Standard
• Complex

Cloning & Mutagenesis Market, By Product Type:

• Cloning Kits
• Mutagenesis Kits

Cloning & Mutagenesis Market, By Technique:

• Topo PCR Cloning
• Blunt End Cloning
• Seamless Cloning
• Site-Directed Mutagenesis

Cloning & Mutagenesis Market, By Application:

• Gene Synthesis
• Gene Expression
• Gene Therapy
• Vaccine Research
• Others

Cloning & Mutagenesis Market, By End User:

• Pharmaceutical & Biotechnology Companies
• Academic & Research Institutions
• Others

Cloning & Mutagenesis Market, By Region:

• North America
  • United States
  • Mexico
  • Canada
• Europe
  • France
  • Germany
  • United Kingdom
  • Italy
  • Spain
• Asia-Pacific
  • China
  • India
  • South Korea
  • Japan
  • Australia
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • UAE

For more information about this report visit https://www.researchandmarkets.com/r/jjp45a

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